  
  
WT/TPR/M/395/Add.1  
8 May 2020  
(20-3489) Page: 1/617 
Trade Policy Review Body  
18 and 20 February 2020  Original: English/Spanish  
anglais/espagnol  
inglés/español  
 
  
TRADE POLICY REVIEW  
EUROPEAN UNION 
MINUTES  OF THE MEETING  
Addendum  
Chairperson:  H.E. Mr. Manuel A.J. Teehankee (Philippines)  
 This document contains the advance written questions  and additional questions by WTO 
Members , and replies provided by  the European Union .1 
 
 
Organe d'examen des politiques commerciales  
18 et 20 février 2020  
EXAMEN DES POLITIQUE S COMMERCIALES  
UNION EUROPÉENNE  
COMPTE RENDU DE LA R ÉUNION  
Addendum  
Président : S.E.  M. Manuel A.J. Teehankee (Philippines)  
Le présent document contient les questions écrites communiquées à l'avance par les 
Membres de l'OMC, leurs questions additionnelles, et les réponses  fournies par  l'Union européenne .1 
 
 
Órgano de Examen de las Políticas Comerciales  
18 y 20 de febrero de 2020  
EXAMEN DE LAS POLÍTI CAS COMERCIALES  
UNIÓN EUROPEA  
ACTA DE LA REUNIÓN  
Addendum  
Presidente: Excmo.  Sr. Manuel A.J. Teehankee (Filipinas)  
En el presente documento figuran las preguntas presentadas  anticipadamente por escrito  y 
las preguntas adicionales de los Miembros de la OMC,  así como las respues tas facilitadas por  la 
Unión  Europea .1 
  
 
1 In English and Spanish only./En anglais et espagnol seulement./En inglés y español solamente.  WT/TPR/M/395/Add.1  
 
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  Contents  
ARGENTINA  ................................ ................................ ................................ .......................  4 
AUSTRALIA  ................................ ................................ ................................ ......................  16 
BRAZIL  ................................ ................................ ................................ ............................  36 
CANADA  ................................ ................................ ................................ ...........................  64 
CHILE  ................................ ................................ ................................ ............................  101  
CHINA ................................ ................................ ................................ ............................  130  
CHINA - FOLLOW -UP QU ESTIONS  ................................ ................................ .................  156  
COLOMBIA  ................................ ................................ ................................ .....................  178  
COSTA RICA  ................................ ................................ ................................ ...................  205  
DOMINICAN REPUBLIC  ................................ ................................ ................................ .. 231  
DOMINICAN REPUBLIC - ADDITIONAL QUESTIO NS ................................ ......................  235  
ECUADOR  ................................ ................................ ................................ .......................  238  
ECUADOR – ADDITIONAL  QUESTIONS  ................................ ................................ ..........  247  
EL SALVADOR  ................................ ................................ ................................ ................  255  
GUATEMALA  ................................ ................................ ................................ ...................  256  
HONDURAS  ................................ ................................ ................................ ....................  265  
HONG KONG, CHINA  ................................ ................................ ................................ ...... 267  
ICELAND  ................................ ................................ ................................ ........................  271  
INDIA  ................................ ................................ ................................ ............................  273  
INDONESIA  ................................ ................................ ................................ ...................  321  
ISRAEL  ................................ ................................ ................................ ..........................  326  
ISRAEL – ADDITIONAL QUESTI ONS ................................ ................................ ..............  329  
JAPAN  ................................ ................................ ................................ ............................  331  
KAZAKHSTAN ................................ ................................ ................................ .................  341  
KOREA, REPUBLIC OF  ................................ ................................ ................................ .... 347  
KOREA, REPUBLIC OF - ADDITIONAL QUESTION S ................................ ........................  354  
MALAYSIA  ................................ ................................ ................................ .....................  360  
MEXICO  ................................ ................................ ................................ .........................  366  
NEW ZEALAND  ................................ ................................ ................................ ...............  382  
NORWAY  ................................ ................................ ................................ ........................  387  
PANAMA  ................................ ................................ ................................ ........................  388  
PARAGUAY  ................................ ................................ ................................ .....................  390  
PERU  ................................ ................................ ................................ ..............................  405  
PHILIPPINES  ................................ ................................ ................................ .................  412  
PHILIPPINES – ADDITI ONAL QUESTIONS ................................ ................................ ..... 427  
RUSSIAN FEDERATION  ................................ ................................ ................................ .. 445  
SINGAPORE  ................................ ................................ ................................ ...................  478  
SINGAPORE – ADDITION AL QUESTIONS  ................................ ................................ ....... 483  
SWITZERLAND  ................................ ................................ ................................ ...............  485  WT/TPR/M/395/Add.1  
 
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  CHINESE TAIPEI  ................................ ................................ ................................ ............  492  
THAILAND  ................................ ................................ ................................ .....................  511  
TRINIDAD AND TOBAGO  ................................ ................................ ...............................  520  
TURKEY  ................................ ................................ ................................ .........................  527  
TURKEY – ADDITIONAL QUESTIONS  ................................ ................................ .............  527  
UKRAINE  ................................ ................................ ................................ .......................  544  
UKRAINE - ADDITIONAL  QUESTIONS  ................................ ................................ ............  552  
UNITED STATES  ................................ ................................ ................................ .............  554  
UNITED STATES - FOLL OW-UP QUESTIONS  ................................ ................................ ... 591  
URUGUAY  ................................ ................................ ................................ ......................  607  
URUGUAY – ADDITIONAL  QUESTIONS  ................................ ................................ ..........  611  
VIET NAM  ................................ ................................ ................................ ......................  617  
 WT/TPR/M/395/Add.1  
 
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  ARGENTINA  
A) Preguntas sobre el Informe de la UE WT/TPR/G/395  
3.3 Mercado de contratación pública de la UE  
"3.10. El 24 de julio de 2019, la Comisión Europea adoptó la comunicación "Directrices sobre la 
participación de licitadores y bienes de terceros países en el mercado de contratación pública de la 
UE"." 
En la mencionada Comunicación de la Comisión Europea "Directrices sobre la participación de 
licitadores y bienes de terceros países en el mercado de contratación pública de la UE" de fecha 
24 de julio de 2019, esa institución afirma que "los operadores económicos de terceros países que 
no hayan suscr ito ningún acuerdo que contemple la apertura del mercado de contratación pública 
de la UE o cuyos bienes, servicios y obras no estén cubiertos por un acuerdo de este tipo no tienen 
garantizado el acceso a los procedimientos de contratación pública en la UE  y pueden quedar 
excluidos".  
 
Q1- ¿Podría esa Comisión Europea comentar cuál es la normativa europea aplicable en 
estos casos?  
 
EU reply:  The purpose of the Guidance on the participation of third -country bidders and goods in 
the EU procurement market is to offer assistance to public buyers in the EU when dealing with 
third-country bidders' participation in tenders. The Guidance recalls that  the international 
agreements concluded by the EU on public procurement define who has secured access to the 
EU procurement market. The EU has committed itself under several international agreements (such 
as the WTO Agreement on Government Procurement and bilateral Free Trade Agreements with 
Procurement Chapters), to grant access to its public procurement market for certain works, supplies, 
services and economic operators of several third countries. Accordingly, the EU public procurement 
directives provide,  for public buyers in the EU, to accord to the works, supplies, services and 
economic operators of the signatories to those agreements treatment that is no less favourable than 
the treatment accorded to the works, supplies, services and economic operators of the EU, in so far 
as these are covered by these agreements. The Guidance clarifies that economic operators from 
third countries, which do not have any agreement providing for the opening of the EU procurement 
market or whose goods, services and works ar e not covered by such an agreement, do not have 
secured access to procurement procedures in the EU and may be excluded.  
 
3.11 Aplicación del Programa de Acción en materia de Medio Ambiente de la UE  
 
Huella ambiental  
"3.38. Ya se ha aplicado plenamente el P lan de Acción para la Economía Circular (PAEC), que fue 
adoptado en 2015 y estableció un amplio marco de medidas que abarcan todo el ciclo de vida de los 
productos: desde la producción hasta la gestión de residuos y el mercado de materias primas 
secundaria s, pasando por el consumo."  
En la Comunicación de la Comisión Europea de diciembre de 2019 relativa al "European Green Deal" 
se señala que: "Por último, la estrategia Farm to Fork se esforzará por estimular el consumo 
sostenible de alimentos y promover ali mentos saludables y asequibles para todos. Los alimentos 
importados que no cumplen con las normas ambientales pertinentes de la UE no están permitidos 
en los mercados de la UE. …La Comisión explorará nuevas formas de brindar a los consumidores 
una mejor in formación, incluso por medios digitales, sobre detalles como el origen de los alimentos, 
su valor nutricional y su huella ambiental.  
En lo que hace a los métodos de la Comisión Europea de huella ambiental del producto (PEF) y la 
huella ambiental de las org anizaciones (OEF), se inició una fase de transición en marzo de 2019, a 
fin de analizar los resultados de los proyectos pilotos.  
 
Q2- ¿Qué plazo de duración tiene la fase de transición? ¿Tiene previsto la Comisión 
Europea desarrollar una propuesta de legis lación europea sobre la implementación del 
método de cálculo de huella ambiental para productos y organizaciones? ¿Cuáles serían 
las opciones de regulación europea que podrían estar bajo consideración? ¿Se incluiría un 
etiquetado ecológico? De ser el caso,  ¿abarcaría a todos los sectores y productos? ¿Cómo 
se trataría a los productos importados y cómo se tendría en cuenta la situación de terceros 
países, incluyendo el posible reconocimiento de equivalencias? ¿Podría aclarar la 
Unión  Europea los próximos pasos previstos con respecto a esta iniciativa PEF?  WT/TPR/M/395/Add.1  
 
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  EU reply:  In the period between the end of the Environmental Footprint pilot phase and the possible 
adoption of policies implementing the Product Environmental Footprint (PEF) and Or ganisation 
Environmental Footprint (OEF) methods, a transition phase is established.  
 
The transition phase provides a framework for:  
 
• Monitoring the implementation of existing Product Environmental Footprint Category Rules 
(PEFCRs) and Organisation Environ mental Footprint Sector Rules (OEFSRs);  
• Developing new PEFCRs/OEFSRs. A call for volunteers launched in spring 2019 resulted in 
5 expressions of interest (apparel, cut flowers & potted plants, flexible packaging, floor 
coverings, and marine fish);  
• New met hodological developments. Discussions on this mainly take place in the Technical 
Advisory Board. Any Life Cycle Assessment expert can join the Technical Advisory Board.  
• The European Green Deal acknowledges the importance of reliable, comparable and 
verifiable information in making more sustainable decisions and reducing the risk of 
greenwashing. It called for regulatory and non -regulatory efforts to tackle false green claims 
and for companies to substantiate their green claims against a standard methodolog y. The 
European Commission is currently assessing different policy options in order to achieve this 
objective. Any measure resulting from this process will be designed to comply with World 
Trade Organization rules and other international obligations of the  EU. 
 
Desforestación y etiquetado  
 
"3.40. Además, la Comisión Europea adoptó la comunicación titulada "Intensificar la actuación de la 
UE para proteger y restaurar los bosques del mundo".67 El objetivo general es proteger y extender 
la cobertura boscosa mundial para mejorar la salud y los medios de subsistencia de las personas. 
Está en consonancia con el objetivo más amplio de la UE de detener la pérdida mundial de cobertura 
boscosa para 2030 y con sus compromisos internacionales. Poner freno a la  deforestación y la 
degradación forestal, junto con la realización de actividades sostenibles de restauración forestal, 
forestación y reforestación, brinda oportunidades de desarrollo económico. Ello requiere hacer 
especial hincapié en la producción y el c onsumo sostenibles de productos agrícolas y forestales."  
La Comunicación de la UE señala que 80% de la deforestación mundial es causada por la expansión 
de la tierra utilizada para la agricultura, y se centra en los países proveedores de ciertos productos 
(alimentos, piensos, biocombustibles, madera y otros productos básicos) a la UE. Más 
específicamente, se señala claramente a las importaciones de la UE de productos como el aceite de 
palma, carne, soja, cacao, maíz, madera, caucho, incluso en for ma de productos o servicios 
procesados.  
 
Q3- ¿Tiene previsto la Comisión Europea trabajar en este tema junto con los países 
proveedores de estos productos a la Unión Europea, y/o proponer medidas regulatorias 
adicionales que sean de cumplimiento necesario por parte de los países exportadores?  
EU reply:  The European Commission will this year assess regulatory and non -regulatory options for 
additional demand -side measures to minimise the risk that products linked to deforestation are 
introduced on the EU mark et. It will do so building on its previous experience, using a fact -based 
methodology and listening to all stakeholders involved — which includes third countries.  
 
Q4- En la Comunicación se indica que se prevé aumentar la financiación a los países 
product ores para la conservación y restauración sostenible ¿Podría comentar si esto 
estará disponible para los terceros países y cuales serían estas líneas de financiamiento?  
EU reply:  The recently adopted Communication recognises the role of forests for climate,  
biodiversity, the economy and human rights and proposes to step up EU action to protect and restore 
them. As regards in particular deforestation and forest degradation, the Communication highlights 
5 priority areas for further discussion and decision incl uding the EU consumption footprint, 
international and development cooperation, financing and information, research and innovation. 
Action by the EU alone is expected to have limited impact hence, it is proposed to strengthen 
cooperation and encourage consi stent action including in international fora, bilateral dialogues and 
trade agreements with third countries while also ensure that support for agricultural, mining etc. 
policies in partner countries does not contribute to deforestation and forest degradati on. The 
Communication does not however, address funding for EU Member States or third countries in that 
context.  
 WT/TPR/M/395/Add.1  
 
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  Impuesto sobre el carbono en frontera  
"3.44. En 2018, la UE adoptó una Directiva por la que se revisa el régimen de comercio de derechos 
de em isión de la UE para el período 2021 -2030 (denominado "fase 4")68, y que incluye una 
reducción anual de las cuotas del 2,2%, a partir de 2021, en lugar del 1,74% actual. También 
comprende normas estrictas, previsibles y equitativas para prevenir el riesgo d e fuga de carbono".  
La Presidente de la Comisión Europea, Ursula VON DER LEYEN, en el documento de Orientaciones 
políticas para la próxima Comisión Europea (2019 -2024) titulado "Una Unión que se esfuerza por 
lograr más resultados: Mi agenda para Europa" de l 16 julio de 2019 señala que: "Actualmente, 
nuestro objetivo para 2030 es reducir un 40 % las emisiones, pero hemos de ser más ambiciosos. 
Las emisiones de carbono deben tener un precio. Todas las personas y sectores tendrán que 
contribuir…… Para compleme ntar esta labor y garantizar que nuestras empresas puedan competir 
en igualdad de condiciones, implantaré un impuesto sobre el carbono en frontera para evitar fugas 
de carbono. Esto debe ser plenamente conforme con las normas de la Organización Mundial del  
Comercio: comenzará con una serie de "sectores seleccionados" y se ampliará gradualmente".  
 
Q5- ¿Podría esa Comisión Europea explicar si se encuentra en estudio la aplicación de un 
impuesto en frontera al carbono o si se encuentra disponible una propuesta  de 
reglamentación? En tal caso, ¿qué vinculación tendría con el Régimen de comercio de 
derechos de emisión de la UE (RCDE UE)? ¿Existen actualmente en la Unión Europea 
impuestos de este tipo para evitar fugas de carbono?  
 
EU reply:  The EU has fully translated into legislation the steps to meet its Paris Agreement target 
and expects its international partners to share a comparable level of ambition. As long as climate 
action by others in the world is not on par, there is a risk of carbon leakage. This  would lead to an 
increase in total carbon emissions in the world undermining global efforts to reach the well below 
2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU's Emissions 
Trading System.  
The European Council of 12 December 2019 endorsed the objective of achieving climate neutrality 
by 2050 and that this should include "developing effective measures to tackle carbon leakage in a 
WTO compatible way". A Carbon B order Adjustment mechanism is not designed to protect European 
industry from open competitions but rather to ensure the environmental integrity and effectiveness 
of EU climate policies as they apply to its trade -exposed industries. The design of the border  measure 
will complement the EU's carbon pricing policies (in particular a cap -and-trade system) which will 
remain the cornerstone of the EU's climate policies. The internal market of the EU will stay open to 
foreign competition under applicable rules. The  EU is a staunch defender of rules -based trade order 
and will comply with its international obligations, including the rules of the World Trade Organisation 
and our trade agreements in particular.  
There is a breadth of considerations that need to be review ed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with  respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. In the  
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 80% of  global greenhouse gas 
emissions".  
The European Green Deal states clearly that the introduction of a Carbon Border Adjustment 
mechanism would be an alternative to current measures that address the risk of carbon leakage in 
the EU's Emissions Trading System . Free allocation and border measures should not lead to 
overcompensation. Under the EU ETS, the industry currently receives a large share of allowances for 
free to prevent carbon leakage. In the last revision of the ETS Directive free allocation was exten ded 
to 2030. Free allocation, based on ambitious performance benchmarks, has been an effective 
measure to manage compliance costs until comparable action to reduce greenhouse gas emissions 
from industrial processes is taken by other economies. A lot of wor k has gone into the development 
and evolution of the EU ETS free allocation regime. The EU remains fully committed to preventing 
carbon leakage and managing the transition from the existing to the new tool in a prudent way. 
Preventing carbon leakage is a k ey enabler for increased climate ambition.  WT/TPR/M/395/Add.1  
 
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  3.13 Paquete "Energía limpia para todos los europeos"  
 
Directiva de energías renovables  
"3.46. El paquete… comprendía varias propuestas legislativas…:  
c) La Directiva sobre fuentes de energía renovables71 revisada introduce un nuevo enfoque para 
hacer frente a las emisiones derivadas del cambio indirecto del uso de la tierra (CIUT) vinculado a 
la producción de biocarburantes, biolíquidos y combustibles d e biomasa. En ella se establece un 
objetivo vinculante de la UE de uso de energías renovables del 32% para 2030, con una cláusula 
de revisión al alza para 2023. Las normas también sirven para crear un entorno propicio para 
acelerar la penetración de las en ergías renovables, así como la inversión pública y privada en 
innovación y modernización en todos los sectores clave. En el Reglamento Delegado (UE) 2019/807 
de la Comisión se establecen los criterios para determinar las materias primas de biocarburantes 
con riesgo elevado de CIUT y los criterios para certificar biocarburantes, biolíquidos y combustibles 
de biomasa con bajo riesgo de CIUT. (…)".  
El Acto Delegado UE 2019/807 estableció los criterios para determinar materias primas de 
biocombustibles con alt o y bajo riesgo de ILUC. Actualmente, solo el aceite de palma" se califica 
como "materia prima de alto riesgo de ILUC".  
La nueva Directiva de Energías Renovables para 2021 -2030 (Directiva 2018/2001) en el 3° párrafo 
del punto 1 del Artículo 26 señala que:  "Los Estados miembros podrán fijar un límite inferior y podrán 
diferenciar, a efectos de lo dispuesto en el artículo 29, apartado 1, distintos biocarburantes, 
biolíquidos y combustibles de biomasa producidos a partir de cultivos alimentarios y forrajeros,  
teniendo en cuenta los mejores datos disponibles sobre las consecuencias del ILUC. Los Estados 
miembros podrán fijar, por ejemplo, un límite más bajo para la proporción de biocarburantes, 
biolíquidos y combustibles de biomasa producidos a partir de cultiv os oleaginosos".  
 
Q6- ¿Teniendo en cuenta lo mencionado en el párrafo anterior, y que el Biodiesel de aceite 
de soja no es de alto riego de ILUC conforme al Acto Delegado UE 2019/807, podría aun 
así un Estado miembro de la UE fijar discrecionalmente para su territorio un límite más 
bajo para este tipo de Biodiesel?  
 
EU reply:  The Recast Renewable Energy Directive (Directive 2018/2001) does allow the Member 
States to set lower limits for conventional biofuels. Indeed, the Directive does not require Member 
States to support conventional biofuels at all.  
 
4.3.5 Garantizar una gestión responsable de las cadenas de suministro  
"4.45. En 2018 la UE puso en marcha el proyecto piloto 'Cadenas de suministro responsables en 
Asia', financiado durante tres años en el marco del Instrumento de Asociación de la UE y desarrollado 
conjuntamente con la OIT y la OCDE. La UE inició un proyecto similar para promover la 
responsabilidad social de las empresas y las prácticas empresariales responsables, así como los 
principi os sobre empresas y derechos humanos, en determinados países de América Latina. El 
proyecto se puso en marcha a principios de 2019 y tendrá una duración de cuatro años."  
 
Q7- ¿Podría esa Comisión Europea informar de qué se trata este Proyecto para ciertos  
países de América Latina y qué países se encuentra previsto que participen?  
 
EU reply:  The project "Responsible Business Conduct for Latin America and the Caribbean 
(RBC-LAC)" is funded by the European Union and implemented by the International Labour 
Organization (ILO), the Organisation for Economic Cooperation and Development (OECD), and the 
United Nations' Office of the High Commissioner for Human Rights (OHCHR). The project aims to 
promote intelligent, sustainable and inclusive growth in the EU, Latin America and the Caribbean, 
by supporting responsible business conduct practices, in line with relevant UN, ILO and OECD 
instruments.  
The project will carry out a number of regional activities as well as national activities in nine 
countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, and Peru. 
With regard to Argentina actions are coordinated with focal points in the national administration, 
notably the OECD national contact point.  
The project will be imp lemented in the period 2019 -2022, and involves three different pillars:  
1. Supporting LAC governments in the development and/or implementation of National Action 
Plans (NAPs) on Business and Human Rights.  WT/TPR/M/395/Add.1  
 
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  2. Enhancing the understanding and capacity of stakehold ers (especially business) to conduct 
human rights due diligence to identify, prevent, mitigate and address adverse impacts on 
human rights, decent work and the environment.  
3. Facilitating the sharing of experiences and lessons learned and develop joint initiatives that 
promote responsible practices.  
 
B) Preguntas sobre el Informe de la Secretaría WT/TPR/S/395  
 
2.4.1 Inversión y mercado interno de la UE  
"2.56. En 2018, la Comisión informó de que los Estados miembros habían realizado progresos 
importantes para ofrecer condiciones favorables a la inversión. No obstante, consideró que seguían 
existiendo desafíos considerables, y que los Estados miembros debían redoblar sus esfuerzos para 
aplicar las reformas necesarias con miras a suprimir los obstáculos a la  inversión; a este respecto, 
subrayó la importancia de contar con sistemas judiciales eficaces. La necesidad de mejorar las 
condiciones para la inversión en la UE también ocupó un lugar destacado en el proceso del Semestre 
Europeo 2019. En este contexto, l a Comisión señaló que 'todos los Estados miembros se ven 
afectados por obstáculos a la inversión en diferentes ámbitos de actuación' y que '[e]ntre las 
cortapisas a la inversión citadas con más frecuencia en la UE figuran las ineficiencias de la 
administra ción pública, las condiciones desfavorables para la actividad empresarial y la considerable 
carga administrativa y reglamentaria en sectores específicos'. En consecuencia, las recomendaciones 
específicas por país presentadas por la Comisión en el Semestre Europeo 2019 se centran en mayor 
medida en la inversión".  
El informe indica que, en 2018, la Comisión Europea informó de que los EM habían realizado 
progresos importantes para ofrecer condiciones favorables a la inversión. No obstante, consideró 
que seguía n existiendo desafíos considerables, y que los EM debían redoblar sus esfuerzos para 
aplicar las reformas necesarias con miras a suprimir los obstáculos a la inversión.  
 
Q8- ¿Podría indicar los tipos de reformas en las que piensan las autoridades comunitarias 
en materia de inversiones?  
 
EU reply:  Despite the significant progress that Member States have made in removing regulatory 
bottlenecks, barriers to investment of different types persist in some of them. Challenges for 
investment ar e, to some extent, country -specific and the policy priorities may therefore differ across 
countries.  
The Commission has mapped the relevant policy areas and identified the main challenges to 
investment faced by each Member State. Country Reports since 201 6 have included a box discussing 
the progress in addressing such challenges to investment. The Commission has also stimulated a 
series of discussions in specific policy areas in the Council.  
 
The most prominent investment barriers are regularly reflected i n the country -specific 
recommendations that are adopted within the framework of the European Semester. Examples of 
such reforms relate for example to:  
 
- improvements of infrastructure;  
- improved conditions of equity funding or access to finance, notably for innovative companies 
wanting to scale up or diversify production;  
- regulatory reform, notably in the services sector, to reduce entry barriers so as to enhance 
competition and to stimulate innovation and thus investment in services as well as in manuf acturing 
relying on inputs of services;  
- stability of legislation, in view of reducing uncertainty that may hold back or delay firms' investment 
decisions.  
 
Moreover, the exchange of good practices among Member States can contribute to keep the reform 
momentum. National Productivity Boards that were set up in a number of Member States can help 
in the debate, also by enhancing the ownership for the necessary policies and reforms at national 
level and providing high -quality and independent analysis.  
 
3.1.1 Procedimientos y requisitos aduaneros y valoración en aduana  
"3.4. La DG TAXUD también sigue trabajando en la iniciativa relativa al entorno de ventanilla única 
de la UE para las aduanas, que se puso en marcha en 2012 con el primer proyecto piloto y que 
actualmente funciona en nueve Estados miembros. Inicialmente, la ventanilla única incorporó los 
certificados para el Documento Veterinario Común de Entrada (DVCE) y el Documento Común de WT/TPR/M/395/Add.1  
 
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  Entrada. El año pasado se incorporaron nuevos certificados, a sab er: la licencia relativa a la aplicación 
de las leyes, la gobernanza y el comercio forestales (FLEGT), el certificado de inspección de productos 
orgánicos (COI), el documento sanitario común de entrada para la protección fitosanitaria (DSCE -
PP). Además, es tá en curso la incorporación de otros certificados (a saber, para las sustancias que 
agotan la capa de ozono (SAO), el gas fluorado de efecto invernadero (gas F) y las exportaciones de 
productos de doble uso); la puesta en aplicación está prevista para pri ncipios de 2021."  
 
Q9- ¿Tienen pensado las autoridades de la UE incorporar a la iniciativa al resto de los EM 
así como también en implementar procedimientos para el logro de la interoperabilidad de 
las ventanillas únicas?  
 
EU reply: At the end of 2019, the EU Single Window environment for customs core platform (so 
called EU CSW -CERTEX: see this website for more details: 
https://ec.europa.eu/taxation_customs/general -information -customs/electronic -customs/eu -single -
window -environment -for-customs_en) is used in pilot mode by 9 EU Member States. The EU targets 
an entry into force of the legislation on the EU Single Window environment for customs by early 2022 
in view of gradual implementation in the next decade with the objective to make the use of Sing le 
Window mandatory in all EU Member States. Interoperability, in particular at semantic level, is at 
the heart of the design of the EU Single Window environment for customs. In order to achieve such 
interoperability, the EU will focus on using a standard data model, the EU Customs Data Model 
(https://svn.taxud.gefeg.com/svn/Documentation/EUCDM/EN/index.htm) for the interfacing with 
customs systems via the Single Window.  
 
3.3.2 Normas y prescripciones técnicas  
3.3.2.6 Comité de Obstáculos Técnicos al Comerc io (OTC) de la OMC  
 
Etiquetado país de origen  
"3.210. Durante el período examinado, el Comité OTC recibió 13 nuevas preocupaciones comerciales 
específicas acerca de medidas adoptadas por la UE o sus Estados miembros: (…) requisitos de 
etiquetado del origen de los cereales utilizados para elaborar pastas alimenticias; (…)". Asimismo, 
en el párrafo 3.211 se menciona que "[d]urante el período examinado, los Miembros también 
hicieron referencia a nueve preocupaciones planteadas anteriormente" y entre ella s se menciona al 
"etiquetado indicativo del país de origen".  
Al respecto, la Argentina ha sostenido2 que las medidas sobre el etiquetado obligatorio del país de 
origen pueden crear discriminación en las cadenas de suministro de alimentos, si se imponen de 
hecho a los productores de los ingredientes locales, en detrimento de ingredientes similares 
importados. En particular, con relación al Reglamento UE 775/2018 sobre el etiquetado del origen 
del ingrediente primario en los alimentos .  
 
Q10- ¿Podría la UE cl arificar si existe la posibilidad de la "coexistencia " o, por el contrario 
la inconsistencia, de los regímenes nacionales de etiquetado del origen del ingrediente 
primario en los alimentos de los Estados Miembros de la UE con lo que establece el artículo 
38 del reglamento 1169/2011?  
 
EU reply: The national pilot projects on origin labelling adopted by certain EU Member States only 
apply to domestic foods and therefore, they do not give rise to obstacles to free movement of goods 
or discrimination as regards  foods from other countries. In fact, the conclusions of the evaluation 
reports carried out by few Member States on the impact of their temporary national measures in 
question on the Internal Market and food chain demonstrate that the national schemes do n ot have 
a negative effects on the market and the exchange of goods.  
 
Q11- ¿Podría la UE confirmar si todos los esquemas nacionales de etiquetado del origen 
del ingrediente primario en los alimentos de los Estados Miembros de la UE dejarán de 
tener efecto a  partir de la entrada en vigor del Reglamento de Ejecución (UE) 2018/775, 
el 1 de abril de 2020? De no ser así, ¿podría la UE explicar la causa de su continuación y 
su fundamentación legal?  
 
EU reply: Currently, two EU Member States have notified a request  for the extension of their national 
schemes by the end of 2021. Those measures are currently assessed under the overall objectives of 
 
2 Declaración de la Argentina al Comité de Obstáculos Técnicos al Comercio, 20 y 21 de junio de 2018 
(G/TBT/W/552).  WT/TPR/M/395/Add.1  
 
- 10 - 
 
  Regulation (EU) 1169/2011 and the European Commission's current priorities as announced in the 
European Green Deal.  
Teniendo en cuenta que la coexistencia de esquemas nacionales crea incertidumbre en los 
operadores, no sólo de terceros países exportadores, sino también en el propio mercado de la UE, 
debido a la existencia de múltiples normativas exigiendo diversos etiqu etados en distintos Estados 
Miembros de la Unión.3 
 
Q12- ¿Tiene previsto la UE emprender acciones a los fines de garantizar el 
desmantelamiento de los esquemas nacionales de etiquetado del origen del ingrediente 
primario en los alimentos de los Estados Mie mbros de la UE a partir de la entrada en vigor 
del Reglamento de Ejecución (UE) 2018/775, el 1 de abril de 2020? En caso afirmativo, 
¿qué tipo de acciones podrían emprenderse?  
 
EU reply: The EU would like to stress that the national schemes on origin indic ation do not interfere 
with the provisions of Implementing Regulation (EU) 2018/775. The European Commission follows 
closely the pilots on mandatory origin labelling. The EU Member States that adopted national 
measures on origin indication committed to sub mit to the Commission a report on their functioning 
and on the possible impact on the single market. The reports will be submitted by the end of the 
notified temporary national schemes. The outcome and findings of these reports will be the starting 
point f or any future Commission's reflection on a long -term solution on the origin indication under 
the EU legislation.  
 
Pesticidas  
"3.210. Durante el período examinado, el Comité OTC recibió 13 nuevas preocupaciones comerciales 
específicas acerca de medidas adoptadas por la UE o sus Estados miembros: requisitos de diseño 
ecológico para pantallas electrónicas; clorotalonil (sustancia plaguicida activa); períodos de 
transición para los LMR y consultas internacionales; producción y etiquetado de los prod uctos 
ecológicos: yerba mate; requisitos de etiquetado del origen de los cereales utilizados para elaborar 
pastas alimenticias; no renovación de la aprobación de la sustancia activa picoxistrobina; …".  
En el marco del Reglamento 1107/2009 relativo a la aut orización y comercialización en la UE de 
sustancias activas de los productos fitosanitarios; y en cuanto a los Límites Máximos de Residuos de 
pesticidas (LMRs) establecidos de acuerdo a los criterios del Reglamento 396/2005, existe en la UE 
una tendencia s ignificativa de reducción de los LMRs que pueden dificultar el acceso al mercado 
europeo. Asimismo, en la reciente comunicación por parte de la Comisión Europea sobre el "Acuerdo 
Verde Europeo" y la estrategia "De la granja a la mesa" se indica que la UE t rabajara hacia una 
reducción significativa del uso de pesticidas en su agricultura.  
 
"Tolerancias a la importación" para los Limites Máximos de Residuos (LMRs)  
La Comisión Europea ha indicado que, aun para las sustancias fitosanitarias que no se aprueben o  
no se renueven en la UE debido al criterio "cut off" (identificación del peligro) en el marco del 
Reglamento 1107/2009, se podrá solicitar "tolerancias de importación" para los LMRs, en el marco 
del Reglamento 396/2005. La Comisión Europea indicó que dich as "tolerancias a la importación" 
serán aceptadas o adoptadas con un enfoque "caso a caso".  
 
Q13- En el enfoque "caso a caso" mencionado, ¿Considerará la UE aspectos o criterios 
diferentes a los criterios específicos relativos al riesgo para definir si ace pta o adopta 
"tolerancias a la importación" para LMR de sustancias no autorizadas debido al enfoque 
"cut off"?  
 
EU reply:  The procedures laid down in Regulation 396/2005 for the management of import tolerance 
requests applies also for active substances falling under the cut -off criteria set in Regulation (EC) 
No. 1107/2009. The procedure includes a product -specific risk assessment by an evaluating EU 
member State and EFSA followed by a case -by-case decision in accordance with risk analysis 
principles. Given the regulatory situation, the EU will carefully evaluate on a case -by-case basis the 
import tolerance requests for the active substances falling under the criteria of Regulation (EC) 
No. 1107/2009, considering the objectives of consumer prot ection of the EU pesticide legislation and 
also the EU's international obligations arising from the WTO Agreement on the Application of Sanitary 
and Phytosanitary Measures.  
 
 
3 Declaración de la Argentina al Comité de Ob stáculos Técnicos al Comercio, 20 y 21 de Junio de 2018 
(G/TBT/W/552).  WT/TPR/M/395/Add.1  
 
- 11 - 
 
  Q14- De ser el caso, ¿Cuáles son "todos los factores relevantes", otras justificac iones u 
"otros factores legítimos" (de acuerdo el artículo 14 de la sección 3 del Reglamento 
396/2005)  que se tendrán en cuenta para decidir "caso por caso"? (¿Demandas sociales? 
¿Percepciones públicas?)  
 
EU reply: Current EU legislation does not provide f or an exhaustive list of legitimate factors to be 
taken into account when deciding on the most appropriate measure to reach a chosen level of 
protection. So far, the EU has not resorted to the use of "other legitimate factors" when assessing 
import toleran ces requests or establishing MRLs or when taking decisions on the same.  
 
Q15- ¿Cuándo hará público la Comisión Europea (publicación en la página web de la DG 
SANTE) su enfoque o procedimiento para la gestión o manejo de las referidas Tolerancias 
a la Impor tación?  
 
EU reply:  The Commission considers that the procedural guidance currently published on the 
European Commission's website covers the procedure for the evaluation of import tolerance requests 
for all active substances, regardless of their regulatory  status in the EU.  
https://ec.europa.eu/food/plant/pesticides/max_residue_levels/guidelines_en . 
 
3.3.3 Prescripciones sanitarias y fitosanitarias  
 
OGM y nuevas técnicas de reproducción  
"3.218. La Comisión se encarga de elaborar las propuestas de actos de ejecución. El Comité 
Permanente de Vegetales, Animales, Alimentos y Piensos es el principal organismo de 
reglamentación encargado de emitir dictámenes sobre los proyectos de medidas de aplicación. 
El Comité comprende 14 secciones, cada una de ellas respons able de diferentes aspectos de las 
MSF. Además, hay otros cinco comités encargados de cuestiones específicas relacionadas con 
las MSF:  
 
• el Comité de Reglamentación establecido en virtud de la Directiva Nº 2001/18/CE sobre la 
liberación intencional en el medio ambiente de organismos modificados genéticamente 
(OMG);  
• el Comité de Reglamentación establecido en virtud de la Directiva Nº 2009/41/CE, relativa a 
la utilización confinada de OMG; (…)"  
 
Asimismo, en el párrafo 3.228 se menciona q ue: "El procedimiento de aprobación de OMG no 
ha cambiado. Debe presentarse una solicitud de aprobación para utilizar un OMG en alimentos 
y piensos, para su cultivo o para su comercialización con otros fines (por ejemplo, flores 
cortadas) a la autoridad co mpetente de un Estado miembro. La EFSA, en colaboración con los 
organismos científicos de los Estados miembros, lleva a cabo una evaluación del riesgo y emite 
un dictamen, sobre la base del cual la Comisión elabora un proyecto de legislación con el fin de 
conceder o denegar la autorización(…)" . 
Al respecto, el 8 de noviembre de 2019, se publicaron en el Diario Oficial de la UE la Decisión 
2019/1904 por la que se solicita a la Comisión que presente un estudio, a la luz de la sentencia 
del Tribunal de Justici a en el asunto C -528/16, con respecto a la situación de las nuevas técnicas 
genómicas en el Derecho de la Unión, y una propuesta, si procede, vistos los resultados del 
estudio, y la Decisión 2019/1905 por la que se solicita a la Comisión que presente un es tudio 
sobre las opciones de la Unión para actualizar la legislación existente sobre producción y 
comercialización de materiales de reproducción vegetal y una propuesta, si procede, vistos los 
resultados del estudio.  
Respecto de la Decisión 2019/1904 del Consejo, el Considerando (4) la Decisión 2019/1904 
señala que "los productos obtenidos mediante nuevas técnicas de mutagénesis no pueden 
distinguirse, mediante los métodos actuales, de los productos resultantes de la mutación 
natural".  
Respec to de la Decisión 2019/1905 del Consejo, teniendo en cuenta que el Consejo solicita a la 
Comisión que presente un estudio sobre las opciones de la Unión para actualizar la legislación 
existente sobre producción y comercialización de materiales de reproducc ión vegetal:  
 
Q16- ¿Podría la UE indicar si al momento de elaborar el informe, a la luz de la 
sentencia del Tribunal de Justicia en el asunto C -528/16, con respecto a la situación 
de las nuevas técnicas genómicas en el Derecho de la Unión, la Comisión tend rá en 
cuenta los resultados del documento "Detection of food and feed plant products WT/TPR/M/395/Add.1  
 
- 12 - 
 
  obtained by new mutagenesis techniques, European Network of GMO Laboratories 
(ENGL), Report endorsed by the ENGL Steering Committee", publicado el 26 de marzo 
de 2019?  
 
EU reply:  The study will provide a state -of-play on the implementation and enforcement of the GMO 
legislation, as regards new genomic techniques, based on, inter alia, the work of the European Union 
Reference Laboratory, together with the European Network of  GMO Laboratories, on the detection 
of products obtained by new mutagenesis techniques.  
 
Q17- ¿Podría la UE confirmar si se ofrecerá a las partes interesadas la oportunidad 
para presentar comentarios, en particular terceros países, y en caso afirmativo, 
podría informar en qué etapa del proceso?  
 
EU reply:  The European Commission has started the consultation of Member States and EU -level 
stakeholders to gather information and data for the study. In addition, the study will contain an 
overview of factual situ ation related to legislation on new genomic techniques in third countries. This 
information will be cross -checked with relevant third countries.  
 
Q18- ¿Podría la UE señalar si una actualización de la legislación existente sobre 
producción y comercializaci ón de materiales de reproducción vegetal incluiría:  
 
a) la Directiva 2001/18/CE del Parlamento Europeo y del Consejo, de 12 de 
marzo  de 2001, sobre la liberación intencional en el medio ambiente de 
organismos modificados genéticamente, y  
b) El tratamiento  de los productos obtenidos mediante nuevas técnicas de 
mutagénesis analizadas en el asunto C -528/16 del Tribunal de Justicia?  
 
EU reply:  Regarding part a) of question 18, a possible revision of the Marketing Directives for Plant 
Reproductive Material will not address questions concerning the handling of genetically modified 
organisms. Regarding part b) of question 18: This is not envisaged.  
 
Q19- ¿Podría la UE confirmar si se ofrecerá a las partes interesadas la oportunidad 
para presentar comentarios, en particular terceros Países, y en caso afirmativo, 
podría informar en qué etapa del proceso?  
 
EU reply: As part of the standard EU legislative process, stakeholders will be consulted on the draft 
text when the draft Commission legal act has been published. The draft will also be notified to the 
SPS Committee.  
 
Bienestar animal  
"3.219. La EFSA, establecida en virtud de la Legislación Alimentaria General de 2002, es un 
organismo independiente responsable de la evaluación de los riesgos relacionados con la 
inocuidad de los alimentos y los piensos, la nutrición, la salud y el bienestar de los animales y 
la protección y preserv ación de los vegetales, así como, mediante evaluaciones del riesgo 
ambiental, la posible repercusión de la cadena alimentaria en la biodiversidad".  
El 16 de diciembre de 2019 el Consejo adoptó las conclusiones sobre Bienestar Animal como 
una parte esencial  de una producción animal sustentable, indicando en términos generales la 
necesidad de actualizar la estrategia y la actual legislación de la UE sobre bienestar animal. En 
dichas conclusiones, en su considerando 2.a) relativo a la preocupación expresada po r la opinión 
pública en la UE en materia de bienestar animal, el Consejo expresa que:  
"Eurobarometer revealed in 20151 that the majority of the respondents considered that 
improvements were needed in farm animal (82% of respondents) and companion animal ( 74% 
of respondents) welfare. In addition, citizens consider it important that imported products from 
outside the EU respect the same animal welfare standards as those applied in the EU and that 
the EU should do more to promote a greater awareness of animal  welfare, including at 
international level".  
Asimismo, en los considerandos 9, 12, y 16, respectivamente de las conclusiones se indica que: 
"……better use of the retrospective checks and the TRACES system should be ensured as well 
as active co -operation bet ween competent authorities in Member States and third countries." 
"…Voluntary animal welfare programmes connected with special labelling have already been 
launched in some Member States. ……the transparency and credibility of such schemes needs WT/TPR/M/395/Add.1  
 
- 13 - 
 
  to be ensure d". "… On the other hand, it noted that the EU has been very influential in raising 
awareness of animal welfare standards globally and that these efforts need to be continued".  
En las "conclusiones" 14 y 15, respectivamente, el Consejo: "RECOGNISES the imp ortance of 
promoting the welfare of animals globally as well as the competition that EU farmers are facing 
in global trade and, consequently, STRESSES the importance of including animal welfare in free 
trade agreements as far as possible and SEES these agr eements as one of the ways in which 
to promote animal welfare globally".  
"ENCOURAGES the continuation of that work (on OIE standards) with a particular focus on 
countries to which live animals are exported and from which animal products are imported into 
the EU".  
 
Q20- ¿Piensa la UE actualizar en el corto o mediano plazo (y dentro del marco del 
"European Green Deal" y de la estrategia "de la granja a la mesa") su legislación 
sobre bienestar animal?  
 
EU reply: In 2019, the Commission started an evaluation of  the EU animal welfare strategy 
2012-2015 (COM/2012/6 final). The evaluation is expected to be completed by the end of 2020. In 
parallel, in the context of the European Green Deal (COM/2019/640 final), the Commission has the 
intention to present a Farm to Fork Strategy in spring 2020, which will include various animal welfare 
actions. Both the evaluation of the EU animal welfare strategy and the Farm to Fork Strategy will 
contribute to design future activities in the field of animal welfare.  
 
3.3.3.4 El Comité MSF de la OMC  
 
Medicamentos Veterinarios. Resistencia Antimicrobiana  
"3.240. Durante el período examinado, los Miembros de la OMC recurrieron al Comité MSF para 
plantear 11 preocupaciones comerciales específicas nuevas referidas a medidas adoptadas por la UE 
o por alguno de sus Estados miembros, a saber: …; la revisión de la legislación de la UE sobre 
medicamentos veterinarios; …".  
El Art ículo 118 del Reglamento UE 2019/6 establece el ámbito de aplicación para los animales o 
productos de origen anim al importados en la UE desde terceros países.  
Los operadores comerciales de los terceros países no podrán utilizar los antimicrobianos reservados 
exclusivamente para el tratamiento de determinadas infecciones en las personas. Se prohíbe además 
el uso de m edicamentos antimicrobianos como promotores de crecimiento en los animales cuyos 
productos ingresen al mercado de la UE. El Reglamento será de aplicación y estará en pleno 
funcionamiento a finales de 2021.  
 
Q21- ¿Cuándo estima la UE publicar el acto deleg ado estableciendo los criterios que 
determinarán la lista de antimicrobianos reservados para uso exclusivo en medicina 
humana?  
 
EU reply:  The delegated acts establishing the criteria for the designation of antimicrobials reserved 
for treatment of certain infections in humans under Article 37(4) are to be adopted by 27 September 
2021.  
 
Q22- ¿Cuándo estima la UE publicar el acto de ejecución estableciendo la lista de 
medicamentos antimicrobianos reservados para uso exclusivo en medicina humana?  
 
EU reply: The implementing acts designating antimicrobials or groups of antimicrobials reserved for 
treatment of certain infections in humans under Article 37(5) are to be adopted by 27 January 2022.  
 
Q23- ¿Efectuará la UE consultas específicas a las parte s interesadas y/o consultas 
públicas abiertas sobre la lista que propondrá de medicamentos antimicrobianos 
reservados para uso exclusivo en medicina humana?  
 
EU reply: During the course of the preparation of the draft act(s) under Article 37(5) there will be 
several occasions on which the Commission will be able to receive external input:  
 
• During targeted stakeholders consultations , which may be launched by Commission services 
shortly after the publication on its website of the scientific advice reports pre pared by the 
European Medicines Agency (EMA). Stakeholders -such as representatives of the WT/TPR/M/395/Add.1  
 
- 14 - 
 
  pharmaceutical industry, of farmers, of veterinarians, of consumers - will be invited to 
provide comments on the scientific advice reports.  
• During the feedback mecha nism, as foreseen under the Commission's Better Regulation 
agenda4, for a period of 4 weeks. Legal acts subject to the feedback mechanisms are 
published at regular intervals on the 'Have your say' webpage of the Commission's website5 
and open to citizens and stakeholders for feedback. The Commission welcomes any feedback 
from Third Country representatives during this period.  
• During the notification of the draft acts by the Commission to the members of the WTO SPS 
Committee . On this oc casion, Third Countries will also have an opportunity to provide 
feedback on the draft acts.  
 
Q24- ¿La lista original que se establezca, será revisada periódicamente?  
 
EU reply: Any future delegated act adopted under Article 37(5) may be reviewed and upda ted, 
whenever necessary, to reflect new developments in scientific and/or epidemiologic knowledge in 
relation to antimicrobials or antimicrobial resistance.  
 
Q25- ¿Cómo considerará la UE situaciones en terceros países en los cuales debido a su 
situación zo osanitaria y sus condiciones ecológicas, climatológicas y tipos de producción, 
algunos de los medicamentos incluido en la lista de antimicrobianos reservados para uso 
exclusivo en medicina humana puedan ser necesarios para el tratamiento terapéutico en 
animales?  
 
EU reply: The Commission will lay down the detailed rules as regards the implementation of Article 
118 in the delegated acts to be adopted by 27 January 2022.  
 
Q26- ¿Cómo considerará la UE la Lista de Agentes Antimicrobianos Importantes para la 
Medicina Veterinaria, a los fines de evitar que se incluyan en la lista que establecerá la UE 
de antimicrobianos reservados para uso exclusivo en medicina humana?  
 
EU reply:  In the context of its preparatory work for the drafting of the delegated acts relati ng to 
Article 37(4), the Commission requested the European Medicines Agency (EMA) for its scientific 
advice as regards the establishment of criteria to designate in the EU antimicrobials to be reserved 
for treatment of certain infections in humans. EMA's s cientific advice report was published6 on the 
Commission's website in November 2019 and proposes for the criteria to take into account the 
importance of the antimicrobials for animal health. It sets a basis upon which the Commission may 
reflect during the drafting of the related delegated acts, while also considering feedback received 
during targeted stakeholders' consultation, the feedback mechanism and comments received from 
members of the WTO SPS Committee following notification.  
 
Q27- ¿La prohibición de uso de los antimicrobianos reservados para uso exclusivo en 
medicina humana abarcará también a los productos animales no destinado al consumo 
humano (cueros, pieles, etc.)?  
 
EU reply:  Article 118 of Regulation 2019/6 covers animals and produ cts of animal origin exported 
from Third Countries. The Commission is currently reflecting on the most suitable approach for the 
various aspects of the implementation measures relating to Article 118. In order to ensure that the 
draft delegated acts are co mprehensive, further reflection is warranted by Commission services in 
upcoming months.  
 
Q28- ¿Cuándo estima la UE publicar el acto delegado estableciendo las reglas de aplicación 
del Artículo 118 del Reglamento 2019/06?  
 
EU reply:  The delegated acts on the rules for application of Article 118 are to be adopted by 
27 January 2022.  
 
 
4 Viewed at : https://eur -lex.europa.eu/legal -content/ĽN/TX't7PDF/?uri"CĽLEX:520l5DC02l5&fľom; -'-EN. 
5 Viewed at:  https://ec.europa.eu/info/law/better -regulation/have -your-say. 
6 Available at: https://ec.europa.eu/food/sites/food/files/animals/docs/ah_vet -med_imp -reg-2019-
06_ema -advice_art -37-4.pdf.  WT/TPR/M/395/Add.1  
 
- 15 - 
 
  Q29- ¿Efectuará la UE consultas específicas a las partes interesadas y/o consultas 
públicas abiertas sobre el acto delegado estableciendo las reglas de aplicación del 
Artículo  118 del Reglamento 2019/06?  
 
EU reply: During the course of the preparation of the draft act(s) under Article 37(5) there will be 
several occasions on which the Commission will be able to receive external input:  
 
• During targeted stakeholders' consultations , which may be launched by Commission services 
shortly after the publication on its website of the scientific advice reports prepared by the 
European Medicines Agency (EMA). Stakeholders -such as representatives of the 
pharmaceutical industry, of farmers, of veterinarians, of consumers - will be invited to 
provide comments on the scientific advice reports.  
• During the feedback mechanism , as foreseen under the Commission's Better Regulation 
agenda7, for a period of 4 weeks. Legal acts subject to the feedback mechanisms are 
published at regular intervals on the 'Have your say' webpage of the Commission's website8 
and open to citizens and stakeholders for feedback. The Commission welcomes any feedback 
from Third Country representatives during this period.  
• During  the notification of the draft acts by the Commission to the members of the WTO SPS 
Committee . On this occasion, Third Countries will also have an opportunity to provide 
feedback on the draft acts.  
  
 
7 Available at:  https: //eur -lex.europa.eu/legal -content/ĽN/TX't7PDF /?uri"CĽLEX:520l5DC02l5&fľom; -'-
EN. 
8 Available at: https://ec.europa.eu/info/law/better -regulation/have -your-say. WT/TPR/M/395/Add.1  
 
- 16 - 
 
  AUSTRALIA  
Report by the Secretariat (WT/TPR/S/395)  
 
SUMM ARY 
Page 13 -14, paragraph 31  
The report states that the EU created a renewed Industry Policy Strategy in 2017 with many of the 
measures adopted in 2018 -19. The EC then invited the Commission to present a long term -vision 
for the EU's industrial future by the end of 2019 with concrete measures to implement it, and address 
the challenges European industry faces, touching upon all relevant policy areas. Following this in 
May 2019, the Council of the EU developed an EU Industrial Policy Strategy: Vision 2030, that 
focuses on the six key enabling technologies (current KETs are materials and nanotechnology; 
photonics and micro -and nano -electronics, life sciences technologies, AI, digital security and 
connectivity) to stimulate growth and jobs.  
 
Question 1  
Can the EU provide some detail on which aspects of the 2017 Strategy were most effective 
and some of the main lessons learned from the initial 2017 Strategy, including what 
aspects have been further developed in the 2030 long -term vision?  
 
EU reply :  
The long-term vision for the EU's industrial future is under preparation. The European Commission 
will adopt in March 2020 an EU industrial strategy setting out this long -term vision. Progress with 
the implementation of this strategy will be communicated publi cly by the European Commission.  
 
The industrial policy strategy can be expected to address the twin challenge of green and digital 
transformation, as announced in the European Green Deal, that the European Commission adopted 
on 11 December 2019. The strate gy for the EU's industrial future would cover aspects that affect 
the competiveness of industry in such aspects as investment and public procurement, trade, skills, 
innovation and small and medium -sized enterprises.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
1 Economic Environment  
1.2 Recent Economic Developments  
1.2.2 Fiscal Governance and Performance  
 
Page 20, Paragraph 1.16  
The report states that there are ongoing efforts to rationalise expenditures by shifting resources 
from the common agri cultural and cohesion policies to areas such as research and innovation, young 
people, the digital economy, migration, and climate objectives.  
 
Question 2  
What are the measures being put in place to shift resources into these areas? What will 
the financial  impact be on the common agricultural and cohesion policies?  
 
EU reply:   
On 2 May 2018, the Commission proposed a modern, fair and focused long -term budget 2021 -2027. 
It is the tool to translate into action the Strategic Agenda of the European Council and the political 
guidelines of the new Commission.  
The Commission proposed a long -term budget equal to 1.114% of EU 27 gross national income 
(GNI). Today the Union of 27 invests 1.16% of EU 27 GNI, including the European Development 
Fund. The prop osed budget is smaller compared to the current one. The actual size and composition 
of the budget needs to be agreed by Member States and it is currently being negotiated.  
With a moderate decrease compared to what the Union spends today in the 27 Member S tates 
without the UK, the proposed Multiannual Financial Framework (MFF) can foster policies where Union 
action can achieve more than each Member States alone: excellence in research and innovation, 
climate action, migration, border management, security an d defence, Erasmus and digital 
investments.  
The European Commission put forward a new balance between spending priorities. While cohesion 
policy and the common agricultural policy continue to play a vital role in shaping Europe's future, WT/TPR/M/395/Add.1  
 
- 17 - 
 
  they are being mo dernised in line with the new priorities – including stronger climate and 
environmental ambition – and the changing economic and social realities.  
Expressed in % of GNI, spending increases in key programmes such as Horizon 2020, Erasmus+, 
Border managemen t, the security fund and the creation of new programmes such as Digital Europe 
and the Defence fund, support the EU's strategic agenda 2019 -2024. These increases remain modest 
compared to long -standing policy areas and allow for a realistic overall MFF lev el, while making it 
possible to modernise the budget.  
In its proposal for EU's next long -term budget, the Commission has suggested, for the first time 
ever, that the combined share of funding that goes to these policy areas is slightly higher than that 
of the common agricultural policy or the cohesion policy, in line with the political priorities and in 
line with what citizens are asking for (table).  
Evolution  of the main  policy  areas  in the EU budget  
 
 
 
Report by the Secretariat (WT/TPR/S/395)  
 
1 Economic Environment  
1.2 Recent Economic Developments  
1.2.2  Fiscal governance and performance  
 
Page 20 -21, paragraph 1.16  
The report notes proposals for an EU digital services tax have been suspended until 2020.  
 
Question 3  
What are the EU's plans for the digital services tax proposal in 2020?  
 
EU reply:  
The negotiation of EU proposals for digital tax are on hold given the international tax negotiations 
aimed at reaching a global solution that are to be finalized in 2020. EU is fully engaged in the debate 
with the international partners  and is encouraged by the progress being made at the Organisation 
for Economic Co -operation and Development in this respect.  
 
WT/TPR/M/395/Add.1  
 
- 18 - 
 
  Report by the Secretariat (WT/TPR/S/395)  
 
1 Economic Environment  
1.2.5 Main challenges and policy response  
 
Page 23, paragraph 1.26  
 
The Europe 2020 Strategy is the EU's agenda for growth and jobs for the current decade that has 
five targets, including achieving a 75% employment level for people aged 20 -64. The report als o 
states that the Europe 2020 strategy seeks to achieve 3% of GDP invested in research and 
development.  
 
Question 4  
Can the EU describe what steps and mechanisms it is taking to achieve these targets, 
including describing what the key hurdles are to achieve its goals in the industry and 
manufacturing sector?  
 
EU reply:   
The Europe 2020 strategy was the EU's agenda for growth and jobs for the past decade. It 
emphasised smart, sustainable and inclusive growth in order to improve Europe's competitiveness 
and productivity and underpin a sustainable social market economy. The European Semester has 
provided a well -established framework for the coordination of economic and employment policies 
needed to guide the Union and its Member States to achieve these objectives. This has been done 
notably through i. the Annual Growth Survey (replaced since the current cycle by the Annual 
Sustainable Growth Strategy), where the Commission outlined the economic and employment policy 
priorities for the EU; ii. the country reports, that followed up on the progress in reaching the national 
targets under the Europe 2020 strategy; and iii. the country -specific recommendations where more 
progress was needed.  
All Member States have made progress with the implementation of the country -specific 
recommendations albeit to varying degrees. Since the start of the European Semester in 2011, 
Memb er States have made at least some progress with the implementation of more than two thirds 
of all the country -specific recommendations. This means that they have either fully addressed the 
recommendation or that they have announced or taken measures to do so, even though not all of 
them have been implemented yet.  
Now that the Europe 2020 strategy is approaching the end of its life cycle, it is clear that it has 
provided an important contribution to the EU's socio -economic development since its launch in 201 0. 
Europe's employment is at a record high, the greenhouse gas emissions objective and the higher 
education targets have been met, and Europe is on track with the renewable energy and energy 
efficiency targets. However, considerable progress is still neede d for stimulating more investment in 
research and innovation and for fighting poverty and social exclusion.  
With regard to the specific question on the key hurdles to achieve the goals in the industry and 
manufacturing sector, the challenges identified in the European Semester concern notably the 
development and use of new technologies, regulatory restrictions in services affecting the EU 
industry's competitiveness, higher industry -level concentration and competition issues, and low 
productivity growth, bot h in manufacturing and in related services.  
 
Question 5  
Are member states currently on track to achieve the targets?  
 
EU reply:  
The progress towards the targets at national level is monitored annually in the country reports 
(please see the executive summ ary per country and the Annex A in the 2019 country reports 
https://ec.europa.eu/info/publications/2019 -european -semester -country -reports_en). The latest 
data is regularly updated on the Eurostat website: https://ec.europa.eu/eurostat , 
https://ec.europa.eu/eurostat/web/europe -2020-indicators.  
 WT/TPR/M/395/Add.1  
 
- 19 - 
 
  Report by the European Union: paragraph 4.53.b on page 23  
Report by the Secretariat  
 
Summary, paragraph 12, page 10  
2 Trade and Investment Regimes  
2.4 Investment Regime  
2.4.2.1 Establishment of a cooperation mechanism for FDI screening  
 
Pages 47 -50, paragraphs 2.59 -2.67 
 
We welcome the information provided on the foreign investment screening framework to be 
introduced in October 2020. In the case of foreign acquisi tions not yet undertaken, we note the 
framework appears to provide for their review either when screened by a member State, or when a 
member State refers a proposed foreign acquisition in another member State it considers should be 
screened. However, befor e the acquisition takes place, its terms and conditions are normally 
commercially sensitive for the parties to the transaction.  
 
Question 6  
How will the screening framework protect the interests of parties to a proposed foreign 
acquisition in the commercia l confidentiality of its terms and conditions?  
We would welcome information on approval and recommendation under the foreign 
investment screening framework.  
 
EU reply:   
First, the European Commission is aware that the protection of business sensitive and classified 
information that may be exchanged under the Regulation is key to ensure that cooperation will 
indeed take place and that businesses will continue investing in the EU member States as in the 
past. To this end, Article 10 of the Regu lation specifically requires the Commission and Member 
States, when applying the Regulation, to ensure the protection of confidential information. In 
addition, pursuant to Article 11(2) of the Regulation, a secure and encrypted system shall be 
provided by the Commission to support direct cooperation and exchange of information.  
Second, as to the approval and recommendation under the screening framework, the Regulation 
establishes a framework for the screening by Member States of foreign direct investments i nto the 
Union on the grounds of security and public order and for a mechanism for cooperation between 
Member States and between Member States and the Commission.  
Under the cooperation mechanism, the Member States may provide comments and the Commission 
may provide an opinion to the Member State in whose territory the foreign direct investment is 
planned or has been completed. That Member State shall give due consideration to the comments 
and to the opinion. In case the foreign direct investment is likely t o affect projects or programmes 
of Union interest, the Member State in whose territory the investment is planned or has been 
completed shall take utmost account of the Commission's opinion and provide an explanation to the 
Commission if its opinion is not followed.  
The final decision with regard to the foreign direct investment remains with the Member State in 
whose territory the investment is planned or has been completed.  
 
Question 7  
Are proposed acquisitions automatically approved when member States rai se no concerns 
(in the manner of a negative test)? Or are proposed acquisitions subject to one or more 
positive tests?  
 
EU reply:  
The Regulation does not establish a harmonised screening mechanism at EU level. A foreign direct 
investment in one of the EU member States continues to be subject to the rules and procedures 
adopted by that Member State. Those rules vary from one Member State to the other. It is noted 
that the cooperation mechanism between the EU member States and the Commission kicks in eith er 
when the FDI is undergoing screening in one of the EU member States, or in case it is not screened, 
if it raises security or public order concerns in another member State or at Union level. Comments 
and/or an opinion can be issued before the screening m ember State takes its decision under its 
national rules and procedures.  
 WT/TPR/M/395/Add.1  
 
- 20 - 
 
  Question 8  
When member States raise concerns (or criteria are not met), how are decisions reached 
on approval and recommendation? And who participates in making them?  
We are also inte rested in how the establishment of a 'cooperation mechanism for the 
screening of FDI' (described under 2.4.2.1 of the WTO Secretariat Report and referred to 
in the EU Report (WT/TPR/G/395) at paragraph 4.53(b)) will interact with the objectives 
of EU inves tment policy (set out in paragraph 2.58, page 47 of the Secretariat report), 
particularly in respect to the important objective of 'making it easier to invest by creating 
a predictable and transparent business environment'.  
 
EU reply:   
Pursuant to Article s 6 and 7 of the Regulation, Member States may indeed provide comments to a 
Member State where a foreign direct investment is planned or has been completed. The Member 
State in whose territory the investment is planned or has been completed shall give due 
consideration to the comments of the other Member States. The final decision regarding the foreign 
direct investment remains however with the Member State in whose territory the investment is 
planned or completed.  
 
Question 9  
How will the EU ensure that t he cooperation mechanism (to be implemented by EU 
members) makes it easier, more predictable and/or transparent to invest in the EU?  
 
EU reply:  
Article 3 of the Regulation lays down the essential elements of the framework for the screening of 
foreign dir ect investment by Member States. First and foremost, Member States may adopt FDI 
screening mechanisms based on the grounds of security and public order – other reasons such as 
"net benefit tests" are not included. Further, it includes e.g. a requirement to  apply a timeframe for 
the screening and to provide the possibility for investors to seek recourse against screening 
decisions. In addition, the Regulation requires that rules and procedures relating to screening 
mechanisms shall be transparent and shall n ot discriminate between third countries. By laying down 
these requirements, the Regulation strikes a good balance between ensuring that FDI screening 
takes place in a business friendly and transparent way and that FDI entering the Union is less likely 
to put at risk security or public order.  
 
Question 10  
What impact will the cooperation mechanism have on decision -making timelines vis -a-vis 
inward investment proposals?  
 
EU reply:  
The Regulation was designed not to impede investments into the Union. Therefore, the timelines 
provided for the cooperation between the Member States and the Commission are limited to the 
minimum to ensure a minimal impact on the investor and the investment. In principle, the process 
under the EU cooperation mechanism should  be carried out within 35 calendar days.  
 
As a result, the cooperation mechanism will, in the majority of the Member States, have no impact 
on the actual timeframes set out in national screening mechanism legislation. In few, limited cases 
where those time lines are too short to allow a Member State to take into account the comments of 
other Member States or the opinion of the Commission, such screening mechanisms will have to be 
adjusted accordingly.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
3. Trade Polic ies and Practices by Measure  
3.1 Measures Directly Affecting Imports  
3.1.3 Tariffs  
3.1.3.2 Applied rates  
 
Page 62, Paragraph 3.39  
 
The report states there is a much greater incidence of high tariffs in the agriculture sector compared 
to non -agricultural pr oducts. Nearly all tariffs above 20% are in the agriculture sector. The highest 
tariff rates in agriculture are concentrated in the animal and animal products, dairy, and sugar and WT/TPR/M/395/Add.1  
 
- 21 - 
 
  confectionary sectors. The dairy sector continues to enjoy the highest leve ls of protection, with high 
tariffs that are all non -ad valorem  duties and with no duty -free lines.  
 
Question 11  
The EU's average applied rate for certain agriculture products remains a significant barrier 
to trade. What, if any, plans does the EU have to reduce tariff peaks for agricultural 
products? Have there been domestic debates since the EU's last TPR about the  merits of 
long-term reforms to the EU's agricultural sector?  
 
EU reply:  
The EU does not intend to make unilateral market access concessions. Any change to the bound 
tariffs in the schedule will result from successful multilateral negotiations. The EU has  successfully 
reformed its agriculture policy, making it a world leader in import and export of agricultural products.  
 
Question 12  
Has the EU assessed the economic impact of high tariffs on agricultural products imported 
into the EU, in particular the imp act on consumer prices and the economic cost on the EU 
consumers?  
 
EU reply:  
Assessing any liberalisation of agricultural trade only through the lens of costs for EU consumers 
would be too restrictive. The EU also has to take into account impact on other stakeholders and new 
issues that are important for citizens, such as climate impact.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
3 Trade Policies and Practices by Measure  
3.1 Measures Directly Affecting Imports  
3.1.3 Tariffs  
3.1.3.3 TRQs and administration  
 
Page 65, paragraph 3.44  
The report states the EU issued a regulation in January 2019 on the apportionment of the WTO tariff 
quotas between the EU and the United Kingdom, in anticipation of the latter's eventual withdrawal 
from the EU. The E U also put in place a methodology for the apportionment of TRQs for Article XXVIII 
negotiations, in order to ensure a smooth transition and a continuous process of importation under 
quotas. An implementing regulation was issued in March 2019.  The regulatio ns are currently in force 
but the articles implementing the apportionment have not been activated because they only become 
effective when Regulation (EC) No. 32/2000 ceases to apply to the United Kingdom.  
Australia is concerned that the current EU/UK proposal would diminish the commercial value of 
Australia's existing market access.  While the immediate threat of a no -deal Brexit has been avoided 
[31 January 2020] and a notional withdrawal agreement is in place, there continues to be uncertainty 
around the timing of the implementation of the Agreement and the future UK -EU trading 
relationship.  We are particularly concerned that differing methodologies taken by both the EU and 
UK to apportion current EU28 TRQs midway through a quota year would, in many in stances, mean 
our combined market access into the EU  27 and the UK would fall below our level of access under 
current EU28 TRQs.  
 
Question 13  
Could the EU please provide an explanation for the different approach it has taken from 
the UK here?  
 
EU reply:  
see reply to Q15  
 
Question 14  
How will the EU ensure that any proposal to split TRQs midway through a quota year does 
not leave quota holders worse off (i.e. that newly split TRQs/CSQs add to current EU28 
entitlements)?  
 
EU reply:  
see reply to Q15  WT/TPR/M/395/Add.1  
 
- 22 - 
 
  Question  15 
Given that post -Brexit TRQ allocations for come commodities are not commercially viable, 
how do the EU and the UK propose to compensate WTO members for the loss of market 
access?  
 
EU reply to Q13, 14 and 15:  
The EU and UK through their "joint approac h" intend to apportion the EU's WTO bound tariff rate 
quotas (TRQs) based on observed trade flows in a representative period, so that the existing level 
of market access available to other WTO Members would be maintained.  
The negotiations under the GATT A rticle XXVIII procedure are confidential and are currently ongoing 
with the WTO Members whose rights the EU recognised. During the past months, the EU has 
published detailed information on the apportioned quantities in its internal legislation (EU) 2019/21 6 
and (EU) 2019/386 in order to reduce the inevitable commercial uncertainties for operators as much 
as possible. The EU will continue to engage with trade partners in Geneva in an open and transparent 
manner.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
3 Trade Policies and Practices by Measure  
3.1 Measures Directly Affecting Imports  
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.1.6.2 Safeguards  
 
Page 84, 85, paragraph 3.92  
The report states that, in March 2018, the EU initiated procedures for a safeguard investigation on 
26 product categories of steel, pursuant to its safeguard rules in Regulations (EU) 2015/478 and 
(EU) 2015/755137; the scope of the investigation was later expanded to 28 product categories. 
Provisional  safeguard measures were put in place in July 2018, and definitive measures in February 
2019. These measures apply to 26 categories of steel products whereby TRQs have been established 
based on the level of imports over the last three -year period (2015 -17) plus 5%. In some cases, the 
TRQs were specifically allocated to a country, i.e. based on historical imports; otherwise, a general 
TRQ is allocated on a first -come -first-served basis. An additional duty rate of 25% is applicable for 
out-of-quota imports. T he safeguard measure is expected to be in place for slightly less than three 
years; it is set to expire on 30 June 2021.  
 
Question 16  
Australia notes that on 26 September 2019 the European Commission published its 
decision to adopt adjustments to these ste el safeguard measures (EU 2019/1590 
amending Implementing Regulation EU 2019/159). Can the EU provide further 
information on the process for determining these adjustments and the reasoning for 
reducing the pace of progressive increase of the import quotas from 5% to 3%?  
 
EU reply:   
The EU refers to the detailed explanation on this aspect of the measures provided in recitals 133 to 
156 of Commission Implementing Regulation (EU) 2019/1590 amending Implementing Regulation 
EU 2019/159 of 26 September 2019.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
3 Trade Policies and Practices by Measure  
3.1 Measures Directly Affecting Imports  
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.3.6.2 Safeguards  
 
Page 85, paragraph 3.94  
 
The report states that, the EU  invoked a surveillance measure on certain aluminium products 
originating in certain third countries, from April 2018 until May 2020. The Commission Implementing 
Regulation cites "recent trends in imports of aluminium products, the current excess capacity,  the 
current vulnerable situation of the Union industry and the potential trade diversion triggered by the 
United States measures" as the reasons for imposing such a measure.  
 WT/TPR/M/395/Add.1  
 
- 23 - 
 
  Question 17  
What is the process, including timing and steps, that the European Union will use to review 
the aluminium products surveillance measure outcomes?  
 
EU reply:  
Surveillance measures have a limited period of validity, which can be extended by a decision of t he 
European Commission, after having consulted the Member States, when the conditions referred to 
in Regulations (EU) 2015/478 and (EU) 2015/755  are met. Any decision to extend these measures 
should be published in the Official Journal of the European Union before the expiry of the measures 
in place.  
 
Report by the Secretariat WT/TPR/S/395  
 
3 Trade Policies by Measure  
3.3 Measures Affecting Produc tion and Trade  
3.3.1.2 State aid  
 
Page 98, Para 3.136  
In paragraph 3.136., the report notes that the Commission is currently evaluating most of the state 
aid rules in order to take stock of the results of the SAM and whether the rules are fit for purpose. 
It states that the objective is to allow the Commission to take evidence -based policy decisions as 
regards the design of state aid rules in the EU in the future.  
 
Question 18  
What is the 'evidence -base' used in these evaluations? What is the estimated time frame 
for the evaluation, and adoption of any proposals that come out of this?  
 
EU reply:   
The fitness check involves both internal analyses by the Commission and studies prepared by 
external consultants. In particular, in its internal analysis, the Commi ssion will use, in addition to 
the results of the stakeholder consultation, existing studies, monitoring results, experience from its 
extensive case practice, internal statistics, scoreboard data and information received via the Working 
group of Member Sta tes on the State aid modernisation. The Commission's internal analysis will be 
supported by external studies. On the basis of the results of the fitness check, a revision of certain 
rules might become necessary. Any such follow -up action will be accompanie d by an Impact 
Assessment, if required.  In addition, the fitness check will be based on the following evaluation 
criteria: Effectiveness, Efficiency, Relevance, Coherence and EU added -value.  
Further information on the timeframe of the process can be found  at 
https://ec.europa.eu/info/law/better -regulation/initiatives/ares -2018-6623981_en . 
Further information on the Fitness check Roadmap available at 
file:///C:/Users/mandani/AppData/Local/Packages/Microsoft.MicrosoftEdge_8wekyb3d8bbwe/Temp
State/Downloads/PART -2019-67217V1.pdf . 
 
Report by the Secretariat (WT/TPR/S/395)  
 
3 Trade Policies and Practices by Measures  
3.3 Measures Affecting Production and Tra de 
3.3.1 Incentives  
3.3.1.2 State Aid  
 
Page 100, Table 3.14  
The table shows that total state aid for "R&D including innovation" has fallen from EUR 9189.5 million 
in 2013 to EUR 8814.9 million in 2017. It also shows that in real terms, total state aid for R&D has 
fallen year on year, with the exception of 2015 to 2016.  
 
Question 19  
What are the causes for the fall in the real value of total state aid for R&D expenditures 
in the period from 2013 to 2017? Do these changes reflect evolutions of overall pol icy on 
R&D and if so could a description of these changes be provided?  
 WT/TPR/M/395/Add.1  
 
- 24 - 
 
  EU reply:   
The levels of R&D expenditures are experiencing normal fluctuations and we are not aware of any 
specific reasons behind it.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
3 Trade Policies and Practices by Measure  
3.3 Measures Affecting Production and Trade  
3.3.2 Standards and technical requirements  
 
Page 108, Table 3.20 – Principal TBT legislation, 2019  
The report notes Regulation (EU) 2019/1020 20 June 2019  on market surveillance and compliance 
of products lays down a framework for market surveillance and controls on products from third 
countries. Article 4 of the Regulation requires suppliers of goods covered by specified EU safety and 
environmental rules t o have an "economic operator " in the EU to act as a compliance contact point.  
Article 42 provides the Commission shall draw up guidelines for the practical implementation of 
Article 4 for the purposes of market surveillance authorities and economic operato rs. 
 
Question 20  
When will the guidelines be made available?  
 
EU reply:  
The aim is to publish the guidelines later in 2020.  
 
Question 21  
Will stakeholders have an opportunity to comment on the draft guidelines?  
 
EU reply:   
A consultation on the draft guidelines is currently open. Please refer to:  
https://ec.europa.eu/growth/content/your -input-wanted -guidelines -related -regulation -market -
surveillance -and-compliance -products_en . 
 
Report by the Secretariat WT/TPR/S/395  
 
3 Trade Policies by Measure  
3.3 Measures Affecting Production and Trade  
3.3.2 Standards and technical requirements  
3.3.2.6 Technical Barriers to Trade (TBT) Committee in the WTO  
 
Page 115, Para 3.209 and 3.210  
In paragraph 3.209, the report notes that in 2017 and 2018, the EU made 200 notifications to the 
TBT Committee in the WTO un der Article 10.6 to the TBT Agreement (176 in 2015 -16). In the first 
nine months of 2019, the EU made 43 such notifications. In addition, individual EU member States 
submitted 82 notifications in 2017 -18 (56 in 2015 -16).  
Paragraph 3.210 notes that during the review period, the TBT Committee received 13 new specific 
trade concerns regarding measures taken by the EU or its member States: eco -design requirements 
for electronic displays; chlorothalonil (pesticide active substance); transitional periods for min imum 
residue limits (MRLs) and international consultations; organic production and labelling - maté 
(erva -mate); labelling requirements of the origin of grains used in the preparation of dried pasta; 
non-renewal of approval of the active substance picoxyst robin; titanium dioxide: Regulation (EC) 
No. 1272/2008 (CLP Regulation).  
 
Question 22  
Australia recognises the EU's right to regulate to address legitimate public and 
occupations health concerns. However, such regulation should be proportionate and 
target ed to risks identified through rigorous scientific assessment. What process does the 
EU undertake to ensure that issues raised in the TBT Committee are revisited in light of 
the most up to date scientific data and research?  
 
EU reply:  
In the EU this process is articulated through regulatory impact assessments, which are a good 
regulatory practice aimed at informing decision -making and gathering and analyzing evidence to WT/TPR/M/395/Add.1  
 
- 25 - 
 
  support policy making. Impact assessments in the EU are carried out  in accordance with the 
European Commission's Better Regulation Guidelines available at:  
https://ec.europa.eu/info/law/law -making -process/planning -and-proposing -law/better -regulation -
why-and-how/better -regulation -guidelines -and-toolbox_en . 
 
Further to this  regulatory framework, technical regulations and conformity assessment procedures 
contained in EU harmonization legislation likely to have significant economic, environmental or social 
impact are normally subject to a prior regulatory impact assessments ca rried out by the European 
Commission.  
 
These impact assessments inform the legislative proposals prepared by the Commission, including 
proposals modifying or amending existing EU harmonization legislation that has been notified to the 
TBT Committee in the  past. As a general practice, the European Commission notifies again these 
amending legislative proposals to the TBT Committee.  
 
Report by the Secretariat WT/TPR/S/395  
 
3 Trade Policies by Measure  
3.3 Measures Affecting Production and Trade  
3.3.3 Sanitary and Phytosanitary requirements  
3.3.3.4 SPS Committee in the WTO  
 
Page 122 Paragraph 3.241  
During the review period, WTO Members referred to two concerns that had been raised previously: 
application and modification of the EU regulation on novel fo ods; and EU's revised proposal for 
categorization of compounds as endocrine disruptors.  
 
Question 23  
We note that the European Commission (DG Sante) has launched a 'fitness check' on EU 
chemicals legislation and whether it delivers on its objective of minimising overall 
exposure to endocrine disruptors. The review will look at whether criteria for identif ying 
EDs should be more broadly introduced and how EU legislation has impacted imports into 
the EU. Is there a timeframe for the conclusion of the review, the process for exporting 
members to engage in the review, and is the Commission able to provide more  information 
about how the process will be determined with the conclusion of comments?  
 
EU reply:  
As announced in the  2016 Commission Work P rogramme  of 27 October 2015, the Commission has 
been carrying out a  Regulatory Fitness and Performance programme  (REFIT ) evaluation of the EU 
pesticide legislation in order to assess if the regulations meet the needs of citizens, businesses and 
public institutions in an efficient mann er. 
The evaluation aimed to perform an evidence -based assessment of the implementation of the Plant 
Protection Products (PPP) and Maximum Residuum Level (MRL) regulations and address synergies, 
gaps, inefficiencies and administrative burdens. The exercise did not look specifically at substances 
having endocrine disrupting properties.  
The Commission published on 17 November 2016,  a Roadmap  on the REFIT Evaluation of the EU 
legislation on plant protection products and pesticides residues and set out the main evaluation 
criteria to be addressed in relation to this REFIT Evaluation.  
Stakeholders submitted their feedback on the  roadmap via  a dedicated web page.  Feedback received 
during the first four weeks after publication of the roadmap was considered in the design of the 
evaluation (i.e. in  the Terms of Reference for the external study). The  Terms of Reference  for the 
external independent study set out what the Commission services' requ ested to the contractor under 
the framework contract and formed the basis for the REFIT evaluation.  
Multiple consultations with all stakeholders, including national authorities, scientific community, 
farmers and business operators were held before the fina lization of the study, which was published 
on 18 October 2018.  
The Commission has been studying carefully the result of the evaluation and is still reflecting on the 
most appropriate way to follow up on its recommendations. A report to the Council and Euro pean 
Parliament is under preparation and expected to be finalised in spring 2020.  
 WT/TPR/M/395/Add.1  
 
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  Report by the Secretariat WT/TPR/S/395  
 
3 Trade Policies and Practices by Measures  
3.3 Measures Affecting Production and Trade  
3.3.4 Competition Policy  
3.3.4.3 Sector Inquiries and Reports  
 
Page 130, Table 3.26  
The table mentions a feasibility study on the microeconomic impact of enforcement of competition 
policies on innovation.  
 
Question 24  
Is this report available to other WTO members?  
 
EU reply:  
The report is public and can be found via the following link: 
https://ec.europa.eu/competition/publications/reports/kd0417860enn.pdf . 
 
Report by the Secretariat WT/TPR/S/395  
 
3 Trade Policies and Practices by Measures  
3.3 Measures Affecting Production and Trade  
3.3.6 Government Procurement  
 
Page 137, Box 3.3  
This box outlines the new EU strategy to address public procurement challenges. This includes 
measures such as providing guidance on green and social, and innovation procurement; the 
establishing of a network of National Innovation Procurement Centres; and boosting SME 
participation in government procurement.  
 
Question 25  
Of the measures already implemented, such as the innovation partn erships procedure, 
have these been assessed as to their impact on overall innovative activity in the economy?  
 
EU reply:   
An assessment of the innovation partnership procedure and its impact is currently ongoing.  
 
Question 26  
What are innovation procureme nt partnerships, and how do they operate? How do they 
work to improve innovation and procurement outcomes?  
 
EU reply:   
Innovation partnership is a type of public procurement procedure provided for in Directive 
2014/24/EU (Article 31) that can be used to procure innovation and its implementation in cases 
where no solution for a public buyer's needs is available on the marke t.  
The main feature of the innovative partnership is that the innovation occurs during the performance 
of the contract. The public buyer enters into a contract with the best potential supplier(s) of 
innovation. The supplier(s) is (are) expected to create the innovative solution and ensure its real -
scale implementation for the public buyer.  
Although the procedure is called a "partnership " and the participants are referred to as 'partners', it 
is a public procurement procedure, subject to relevant EU and WT O rules, notably the fundamental 
EU Treaty principle of non -discrimination.  
The innovation partnership process takes place in three phases:  
 
1. The selection phase occurs at the very beginning of the procedure, when one or more of the most 
suitable partner s are selected on the basis of their skills and abilities. The contracts establishing the 
innovation partnership are subsequently awarded based on the best price -quality ratio proposed. 
This phase is similar to a restricted procedure.  
2. In the next phase , the partner(s) develop the new solution in collaboration with the public buyer. 
This research and development phase can be further divided into several stages designated for 
evaluating concepts, developing prototypes and/or testing performance. During ea ch stage, the 
number of partners may be reduced on the basis of predetermined criteria.  WT/TPR/M/395/Add.1  
 
- 27 - 
 
  3. In the commercial phase, the partner(s) provide the final results.  
Additional information is available in the European Commission's Guidance on Innovation 
Procuremen t at https://ec.europa.eu/transparency/regdoc/rep/3/2018/EN/C -2018-3051-F1-EN-
MAIN -PART-1.PDF . 
 
Question 27  
What evidence is available to show that the measures outlined in Box 3.3 will have a 
positive impact on government procurement, and from this, economic b enefits for 
member states?  
 
EU reply:   
European companies benefit from the EU Single Market when bidding for public contracts in their 
own, as well as other EU Member States. In a globalised world, the economic integration brought 
about by the single mark et remains a key driver for wealth creation and competitiveness.  
As public authorities strive to create a fairer society based on equal opportunity, sustainable 
economic growth and wide market participation, while providing for sustainable public finances,  
public procurement is a crucial instrument of policy delivery. A smart use of public procurement can 
help tackling global challenges such as climate change and resource scarcity or the ageing society. 
It supports social policies and accelerates the transi tion to more sustainable supply -chains and 
business models. It can improve competitiveness and enable SMEs' access to procurement 
opportunities.  
 
EU Member States are developing and implementing strategic approaches to procurement policies, 
complemented b y promising local initiatives. More can be achieved through working together and 
drawing inspiration from each other. The European Commission is therefore keen to play an enabling 
role in this transformation process towards modern, innovative and sustainab le procurement 
systems fit for the 21st century, driven by an inclusive and committed EU partnership for smart 
public procurement.  
 
Question 28  
What will the role be of National Innovation Procurement Centres, and how are they 
expected to operate? How will  they work with member states, businesses and each other 
to improve innovation and procurement outcomes?  
 
EU reply :  
A competence centre on innovation procurement is an organisation that has been assigned the task 
by its government and has a mandate accor ding to national law to encourage wider use of pre -
commercial procurement (PCP) and public procurement of innovation (PPI). The activities of 
innovation procurement competences centres in EU Member States include the provision of practical 
and/or financial  assistance to public procurers in the preparation and/or implementation of PCP and 
PPI across all sectors of public interest. So far, national innovation procurement competences centres 
have been established in Austria, Estonia, Germany, Greece, Ireland, Italy, the Netherlands, 
Portugal, Spain, and Sweden.  
The ongoing EU -funded "Procure2Innovate" project supports the establishment and expansion of 
such centres, thereby improving institutional support for public procurers purchasing information 
and communi cation technologies, as well as acquiring products and services from a range of sectors 
that implement innovation procurement. Further information is available at 
https://procure2innovate.eu/ . 
 
Question 29  
How w ill "cross -border public procurement" be promoted? What measures or initiatives 
will be put in place to ensure this occurs?  
 
EU reply:   
The legal framework in place has helped to improve and further integrate procurement markets of 
EU Member States, and the European Commission has provided extensive assistance to the Member 
States during the process of turning the new public procurement di rectives into national law.  
The creation of a single EU procurement market is a major achievement compared to other regions 
of the world, and data show that total cross -border procurement (direct and indirect) has increased 
in recent years.  
The numerous a ctions taken as part of the European Commission's 2017 strategy "Making Public 
Procurement work in and for Europe" contribute to a deeper integration of the EU procurement WT/TPR/M/395/Add.1  
 
- 28 - 
 
  market, thereby further facilitating cross -border procurement. Cross -border cooperat ion among 
contracting authorities deserves particular attention.  
 
Report by the Secretariat WT/TPR/S/395  
 
4 Trade Policies by Sector  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture4.1.1.2.1 Domestic support4.1.1.2.1.1 Direct payments  
 
Page 173 Paragraphs 4.39 and 4.42  
Discussions on CAP beyond 2020. Following this preparatory process and as part of the Commission 
proposals for the Multiannual financial framework (MFF) 2021 -27, on 1 June 2018, the Commission 
published three legislative proposals for a refo rm of the CAP beyond 2020: (i) a regulation 
establishing rules on strategic plans to be drawn up by member States under the CAP49; (ii) a 
regulation amending Regulation (EU) No. 1308/2013 establishing a common market organization 
and some other regulations ; and (iii) a horizontal regulation on the financing, managing and 
monitoring of the CAP.  
The report notes that each member State is expected to prepare strategic plans setting out how to 
meet the objectives, to be assessed through performance and an evalu ation based on a set of 
common indicators related to output, result and impact.  
 
Question 30  
What is the timeframe from Member States sharing their strategic plans? What is the 
timeframe for review and implementation following on from this? [Noting that t he 
outcome of these discussions cannot be pre -judged as per paragraph 4.43]  
 
EU reply:  
The timeframe for approval of Member States CAP Strategic Plans is dependent on the outcome of 
the ongoing negotiations on Multiannual Financial Framework (MFF) and th e adoption of the 
legislative framework on CAP Reform post 2020. With a view to a transitional period, the Commission 
has tabled two transitional Regulations to ensure continued application of the current CAP in 2020 
and 2021. Submission of CAP Plans is to  take place one year before entry into force of the new CAP. 
The process of approval by the Commission thereon depends on quality and submission of missing 
information.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies by Sector  
4.1 Agriculture a nd Fisheries  
4.1.1 Agriculture  
4.1.1.2.1.2 Internal market support measures  
 
Page 176, Paragraph 4.51  
The report notes that in 2019, an amount of EUR 50 million of EU funding, to be matched by national 
funds to a maximum amount of EUR 100 million, was made available for a temporary exceptional 
adjustment aid to farmers in the beef and veal sector in Irelan d, due to particular challenges faced 
by the sector, including concerns over the sector's contribution to GHG emissions, falling domestic 
consumption, and the uncertainty around the withdrawal of the United Kingdom from the EU.  
 
Question 31  
How are the su bsidies being utilised in order to reduce greenhouse gases?  
 
EU reply:  
The EU has given information on this aid in the Regular Committee on Agriculture (in response to 
questions AGIMS ID 91004 and 92079).  
 
Aid was only given when certain conditions were  met: 
 
• Eligibility:  
o Eligibility focusses on suckler cow farmers and farmers having bovines older than 
12 months sent for slaughter.  
o Dairy farmers with less than 40 dairy cows are also eligible.  WT/TPR/M/395/Add.1  
 
- 29 - 
 
  • Conditionality (5% nitrate reduction over 1 year):  
o Aid is available to farmers that reduce organic nitrates by 5% over 1 year.  
o In addition, eligible farmers would have to be members of a Board Bio Quality Assurance 
Scheme or of a DAFM agri -environmental scheme.  
 
Aid level and controls:  
• Payments to suckler cow far mers would be EUR 40 per head, up to a maximum of 40 suckler 
cows.  
• Payments to beef finishers would be EUR 100 per head, up to a maximum of 100 bovine 
animals.  
 
No payments were made by Ireland before 15 October 2019, all payments should be made by 
31 May 2020 at latest. A report by Ireland on the whole period will be provided to the Commission 
by 31 July 2020. More information can be found in Regulation (EU) No . 2019/1132 via https://eur -
lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32019R1132&qid=1579 625184288&from=FR . 
 
Question 32  
What impact are the subsidies predicted to have on the reduction of greenhouse gases?   
 
EU reply:  
see reply to Q33  
 
Question 33  
What impact are the subsidies predicted to have on production of beef and veal?  
 
EU reply to Q32 and Q33:  
Information about the impact on the reduction of greenhouse gases and on production will be 
available after the implementation period has ended. Ire land will produce a report concerning the 
entire period, which will be sent to the European Commission by 31 July 2020 as stated in article 
3(2) of Regulation (EU) No . 2019/1132.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies by Sector  
4.1 Agr iculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2.1.2 Internal market support measures  
 
Page 177, Paragraph 4.57  
The report notes the sugar quota regime, introduced in 1968, came to an end on 
30 September  2017. White sugar remains eligible for private storage. While this provision was 
maintained it has not been used thus far. The existing provisions for agreements between EU beet 
producers and sugar processors, including value -sharing clauses, are maintained.  
 
Question 34  
What impact has the ces sation of the sugar quota regime had on production?  
 
EU reply:  
An increase of the EU sugar production following the end of production quota was anticipated. 
However, the record production of 21.3 million tonnes in marketing year 2017/2018, resulted from 
record yields. For the 2018/2019 marketing year, poor yields due to bad weather conditions 
significantly reduced production: the latest estimates are 17.6 million tonnes. For marketing year 
2019/2020, area reductions of 4 % are announced.  
 WT/TPR/M/395/Add.1  
 
- 30 - 
 
  Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies by Sector  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2.3 Market access  
 
Page 183, Paragraph 4.82  
The report notes that many agricultural products are subject to non -ad valorem duties that can also 
vary from simple specific duties to more complex forms, such as those in the Meursing Table.  
 
Question 35  
Complex tariffs can be a barrier to trade, particularly for SMEs. What is the EU doing to 
simplify their tariffs? Is the EU cons idering converting some of the complex tariffs to 
ad valorem  duties?  
 
EU reply:  
The EU does not consider that its tariff structure needs simplification. The EU's import regime for 
agricultural products, including the composition grid (Meursing table), is fully transparent and 
predictable, and is set out in the EU's WTO schedule.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies by Sector  
4.2 Energy  
 
Page 206, Paragraph 4.158  
This paragraph states that the Commission aims to invest almo st EUR 2 billion in 2020 in clean 
energy research and innovation to meet its commitment to double its public research and innovation 
in this area since 2015. It also states that 75% of EU investments in clean energy research and 
innovation is from the priv ate sector, increasing from EUR 10 billion to EUR 16 billion within a 
decade.  
 
Question 36  
Is the EU on track to meet its goal of doubling public research and innovation in clean 
energy?  
 
EU reply:  
The EU is on track on doubling its public R&I in clean energy. In the financial period between 2007 -13 
(FP7 programme) the total EU clean energy R&I budget was of EUR 3 813 million, whereas between 
2014-20 (Horizon 2020 programme) it was of EUR 10 234 million. Moreover, the Work Programmes 
2016-17 and 20 18-20 have given more priority to climate related R&D compared to the Work 
Programmes 2014 -15. 
 
Horizon 2020 is not only EU programme supporting R&I in clean energy. The share of 
energy -relevant projects under the European Structural Investment Funds also contribute 
significantly to clean energy technologies development projects.  
 
Finally, with the European Green Deal Communication published by the Commission in 
December  2019, EUR 1 billion call will be published in the Horizon 2020 Work Programme to furth er 
support clean energy R&I.  
 
Question 37  
What strategies have been put in place to further accelerate private sector investments 
into R&D and innovation in this space?  
 
EU reply:   
In the last years, the European Commission has put in place various tools and initiatives to boost 
private investments in clean energy R&I.  
Under Horizon 2020 (the current EU R&I programme of EUR 80 billion), EUR 31.7 billion go towards 
six societal challenges, including EUR 6 billion for the specific societal challenge "secure , clean and 
efficient energy", aiming at attracting private investors.  WT/TPR/M/395/Add.1  
 
- 31 - 
 
  The European Institute of Innovation and Technology (EIT) with its Knowledge and Innovation 
Community (KICs) in the field of sustainable energy (KIC InnoEnergy) and climate change (KIC 
Climate) helps to finance innovators and breakthrough companies. The Commission proposed a total 
budget for the EIT of EUR 2.8 billion for 2014 -2020 (up from EUR 309 million since its launch in 
2008).  
The European Commission also launched in March 2018 the European Innovation Council (EIC) to 
turn Europe's scientific discoveries into businesses that can scale up faster. Currently in its pilot 
phase, the EIC will become a full -fledged reality from 2021 u nder the next EU research and 
innovation programme Horizon Europe. Over EUR 2 billion of funding in 2019 -2020 will cover the 
innovation chain: "pathfinder" projects to support advanced technologies from the research base; 
and "accelerator" funding companie s will be able to access blended financing of up to EUR 15 million.  
The European Fund for Strategic Investment was launched in 2014 as leverage for securing private 
investment and is run by the European Investment Bank. Energy is the sector that benefits most of 
all from this instrument, in particular energy efficiency, renewable energies and infrastructure. Of 
the overall EUR 371.2 billion of total investments approved under EFSI since it was established, 
roughly 19% has gone to energy projects. The futur e programme called Invest EU (2021 -27) will 
include a dedicated window on Research, Innovation and Digitalisation with EUR 11.25 billion 
guarantee to bring research results to the market and fund demonstration projects. This will include 
as well the curren t InnovFin Energy Demo Projects, a programme providing loans, loan guarantees 
or equity -type financing typically between EUR 7.5 million and EUR 75 million to innovative 
demonstration projects in the fields of energy system transformation.  
Another relevant  programme attracting private investment is the Innovation Fund, one of the world's 
largest funding programmes for demonstration of innovative low -carbon technologies with an 
amount of about EUR 10 billion, depending on the carbon price (under the EU ETS).  It will be 
launched in 2020 and will play a pivotal role in creating the right financial incentives for projects to 
invest now in the next generation of technologies needed for the EU's low -carbon transition. It will 
focus on innovative low -carbon technol ogies and processes in energy intensive industries, CCU, CCS, 
innovative renewable energy generation and energy storage.  
The next programme for research and innovation, Horizon Europe, proposed by the European 
Commission, with a budget of EUR 100 billion,  will target climate objectives with 35% of its financial 
envelope, thus contributing to the overall climate mainstreaming target of 25% under the 2021 -
2027 Multi Financial Framework. Under the Horizon Europe, the Commission has proposed a budget 
of EUR 15  billion for energy, mobility and climate.  
As regards regulatory tools, the EU regulation on the governance of the energy union and climate 
action requires Member States to draft an Integrated National Energy and Climate Plan (NECP) for 
the period 2021 -2030 to define how they plan to reach the set targets. In the plan they will also 
present their "national objectives and funding targets for public and, where available, private 
research and innovation relating to the Energy Union, including, where appropria te, a timeframe for 
when the objectives are to be met."  
Within the context of the European Green Deal, the new Sustainable Europe Investment Plan, which 
will include a Just Transition Fund, will help to mobilise at least EUR 1 trillion in sustainable 
investment and orient capital flows towards climate -neutral solutions. The Commission is also 
preparing a renewed strategy on green financing, as part of the European Green Deal, which will be 
presented in the third quarter of 2020 to strengthen the foundations  for sustainable investment. 
This is to be built on the 2018 Action Plan on Sustainable Finance, which includes the development 
of a common language for sustainable finance, namely a taxonomy, the creation of EU labels for 
green financial products as well as the revision of the Non -Financial Reporting Directive, encouraging 
companies to increase their disclosure on climate and environmental data.  
Finally, the European Commission will also launch an investors' dialogue in 2020 to map financing 
instruments a vailable to leverage investment in the clean energy sphere, as well as to explore how 
investment rules and financing instruments and regimes could be modified in energy sub sectors, 
including in R&I. Setting up a sectoral investor's dialogue with the energ y finance industry and 
developing guidance/best practices will support and help implement sustainable financing in energy.  
 WT/TPR/M/395/Add.1  
 
- 32 - 
 
  Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies by Sector  
4.3 Manufacturing  
 
Page 209, Paragraph 4.170  
This paragraph sta tes that there are a number of policies, programmes and initiatives which 
contribute to EU industrial policy, with two recurring priorities across these programmes and 
initiatives being to assist SMEs and promote innovation.  
 
Question 38  
How much funding has been allocated by the EU towards innovation in manufacturing 
overall, and in manufacturing sub -sectors such as construction?  
 
Question 39  
Similarly, how much funding has been allocated by the EU towards innovation in other 
sectors, su ch as mining and services?  
 
EU Reply to Q38 and Q39 :  
Due to the cross -sectoral nature of the innovation and SME initiatives, contributions to individual 
sectors are difficult to discern.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 Trade Policies By Sec tor 
4.3 Manufacturing  
 
Page 215, 216, paragraph 4.195  
The report states that, according to the 2018 REACH Review, a number of shortcomings and room 
for improvement where found in relation to REACH, including the need to simplify the overall 
authorisation process.  
 
Question 40  
The 2018 REACH Review identified  the necessity to assess the affordability of registration 
requirements for low tonnage substances and polymers (Article 138), especially given the 
number of SMEs that might be affected. What process is the European Union undertaking 
to review the affordab ility of these registration requirements?  
 
EU reply:   
The Commission is currently assessing the possibility to extend REACH requirements to low tonnage 
substances (i.e. < 1 tonne/yr) and polymers. One of the elements taken into account is the impact 
on SM Es. In case the Commission proposes modifications, the legislative process described in the 
Regulation will be followed. This entails, among other things, public consultations and TBT 
notifications.  
 
Report by the Secretariat WT/TPR/S/395  
 
4 Trade Policies  by Sector  
4.3 Manufacturing  
 
Page 216 Chemicals Paragraph 4.196  
The report notes that when REACH was adopted, attention was paid to ensure that domestic and 
foreign businesses manufacturing or importing chemicals into the EU were treated equally. However, 
third countries have repeatedly raised concerns in the WTO TBT Committee that REACH would create 
barriers to trade and benefit the chemicals industry in the EU over foreign competitors. According to 
the Commission, however, there is no evidence th at this is the case.  
 
Question 41  
Will the Commission outline the processes they have in place to ensure REACH does not 
create barriers to trade and benefit the chemical industry in the EU over foreign 
competitors?  
 WT/TPR/M/395/Add.1  
 
- 33 - 
 
  EU reply:   
The obligations set by the RE ACH Regulation apply equally to EU and non -EU companies that want 
to trade in the EU market. Thus, there is no discriminatory treatment toward foreign competitors.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 TRADE POLICIES BY SECTOR  
4.4 Services  
4.4.1 Financial Services  
4.4.1.2.2 Banking Union  
 
Page 222, Para 4.222  
The report notes that a third pillar of the Banking Union – a European Deposit Insurance Scheme – 
was proposed but has not yet been established.  
 
Question 42  
Is the EU able to provide  an update on progress in developing a deposit insurance scheme?  
 
EU reply:   
On 24 November 2015, the European Commission proposed a Regulation to Establish a European 
Deposit Insurance Scheme (EDIS). The proposal is intended to help establish a common de posit 
insurance system in the Banking Union, to supplement existing common supervision and bank 
resolution frameworks. The legislative proposal envisages the establishment of an EDIS in three 
successive stages: a reinsurance scheme for participating nation al Deposit Guarantee Schemes 
(DGSs) for a first period of three years, a co -insurance scheme for participating national DGSs for a 
second period of four years, and full insurance for participating national DGSs in the final stage.  
On 11 October 2017, the C ommission suggested new ideas to introduce EDIS more gradually 
commensurate to progress achieved with regard to risk reduction and the tackling of legacy issues, 
starting with a more limited re -insurance phase and moving gradually to co -insurance. The time table 
for the establishment of EDIS depends on further progress in these negotiations. The new 
European  Commission, which began its mandate of 1 December 2019, remains committed to EDIS.  
In the absence of a common deposit insurance scheme, the protection o f depositors in the EU is 
regulated by the Deposit Guarantee Scheme Directive of 2014 providing for partial harmonisation at 
national level. For example, covered deposits in the EU are protected up to EUR 100,000. The 
Directive provides for Member States t o ensure by 3 July 2024 that the available financial means of 
a DGS shall reach a minimum target level of 0.8% of the amount of covered deposits of its members.  
https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_15_6152/IP_15_615
2_EN.pdf . and 
https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_17_3721/IP_17_372
1_EN.pdf . 
 
Report by the Secretariat WT/TPR/S/395  
 
4 Trade Policies by Sector  
4.4 Services  
4.4.1 Financial Services  
4.4.1.2 Regulatory developments  
 
Page 227 -228, Para 4.4.1.2.4  
The report notes the Commission is continuing to work on, inter alia , ways to strengthen partnerships 
with financial authorities in third countries, and reinvigorate the EU -wide financial market. Regarding 
intern ational financial cooperation, in July 2019, the Commission issued a communication setting 
out its overall approach to equivalence in the area of financial services. It makes assessments more 
transparent, through public feedback periods before adoption of decisions.  
 
Question 43  
Is the EU's new approach to third -country equivalence procedures expected to result in 
more equivalence decisions with more countries?  
 
EU reply:  
We do not expect major changes in the number of decisions. The Commission communicati on on 
equivalence of July 2019 confirmed the overall equivalence policy of the Commission and included WT/TPR/M/395/Add.1  
 
- 34 - 
 
  some improvements to the procedures, e.g. a best practice of public consultation before adopting a 
decision. The EU has an equivalence regime in place in  around 40 areas and already adopted more 
than 280 decisions for more than 30 jurisdictions. It is already one of the most open financial centers 
in the world, and will stay open for business in the future as well, whilst ensuring that risks are 
managed an d consumers protected.  
 
Question 44  
Do the new procedures provide for sufficient notice to be given to countries if existing 
decisions are to be repealed?  
 
EU reply:   
Yes. Before deciding whether to revoke a decision, the Commission conducts a review of the 
equivalence decision. Once gaps w ith the outcomes delivered by the EU framework have been 
identified, bilateral discussions would as a matter of principle be held with the third country 
concerned so that it can address the situation.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 TRADE POLI CIES BY SECTOR  
4.4 Services  
4.4.3 E -commerce  
4.4.3.1 E -commerce in the context of the Digital Single Market (DSM) Strategy  
 
Page 235, Para 4.273  
The report notes a considerable number of legislative measures were adopted or took effect pursuant 
to the EU's Digital Single Market Strategy during the TPR review period.  One such regulation was 
the General Data Protection Regulation (GDPR) implemented in May 2018.  
 
Question 45  
Is the EU able to provide details of any analysis on the impacts of the GDPR since 
implementation on businesses engaged in international (extra -EU) trade?  
 
EU reply:  
The GDPR entered into application in May 2018. The EU does not have an analysis on the im pact of 
the GDPR on businesses engaged in international trade at this stage.  
 
Report by the Secretariat (WT/TPR/S/395)  
 
4 TRADE POLICIES BY SECTOR  
4.4 Services  
4.4.4 Telecommunications services  
4.4.4.1 Telecommunications in the context of the DSM Strategy  
 
Page 244, Paras 4.310 -4.311  
The report notes the implementation of the digital single market strategy resulted in a major reform 
of EU rules governing the functioning of the telecommunications infrastructure and services markets, 
with the adoption of a n ew European Electronic Communications Code.  
 
Question 46  
We note some EU member states currently apply discriminatory charges for voice calls 
originating outside the EU and EEA with higher rates being applied for the termination of 
voice calls originating outside the EU or EEA.  Following the Commission's 2019 public 
consultation process on voice call termination rates we understand the Commission is 
preparing a delegated act to set the EU -wide termination rate for voice calls.  Is the EU 
able to provide an u pdate on the development of this act?  
 
EU reply :  
Under Article 75 of the European Electronic Communications Code, by December 2020 the 
Commission shall, taking utmost account of the opinion of BEREC (Body of European Regulators for 
Electronic Communications), adopt a Delegated Act by setting a single maximum Union -wide mobile 
voice termination rate and a single maximum Union -wide fixed voice termination rate.  WT/TPR/M/395/Add.1  
 
- 35 - 
 
  The draft Delegated Act is being prepared by the Commission services and will, among o ther inputs, 
take into account the results of the public consultation held between 26 July and 8 November 2019. 
A summary report of this consultation has already been published here (https://ec.europa.eu/digital -
single -market/en/news/summary -report -public -consultation -voice-call-termination -rates).  
 
Question 47  
Can the EU confirm the delegated act setting EU -wide termination rates will accord 
non-EU providers access to, and the use of, telecommunication networks and services on 
non-discriminatory terms and conditions, and ensure interconnections on 
non-discriminatory terms and conditions and at reasonable, cost ori ented rates?  
 
EU reply :  
The Delegated Act will be developed in compliance with the EU's international commitments in the 
field of Telecommunications Services. The product and geographic scope of the Delegated Act are 
among the aspects that are being examined by the Commission ser vices.  
 
The following questions are not based on information provided either in the WTO Secretariat or 
EU reports prepared for the Trade Policy Review of the EU.  
 
They refer to information contained in the official European Commission  statement  of 
11 December 2019  on the European Green Deal, where the Commission foreshadows it will 
propose a carbon border adjustment mechanism, for selected sectors, to reduce the risk of carbon 
leakage.  
 
Australia felt that it was important to ask about this policy development given that it arose after the 
preparation of both EU and WTO Secretariat reports.  
 
Question 48  
How does the Commission intend to ensure any carbon border adjustment mechanism is 
WTO compliant?  
 
Question 49  
Could the Commission provide any indication of what conceptual and methodological 
approach it will be taking when formulating options for policy measures in this area. For 
example, how does the Com mission propose to calculate the carbon footprint of imported 
products?  
 
EU reply to Q48 and Q49:  
There is a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, including in t erms of conceptual and methodological 
approach, the Commission will first carry out an impact assessment to support the preparation of 
this initiative and to inform the Commission's proposal. The assessment will notably look at economic 
efficiency, environ mental, social and financial impacts and legal feasibility, in particular with respect 
to WTO rules and our trade agreements, as well as in terms of complementarity with the ETS. As 
part of the impact assessment, the Commission will actively consult citize ns and stakeholders and 
encourage them to give their views on the best option to enforce ambitious policies against climate 
change in an open economy while addressing the risk of carbon leakage. The Commission is 
committed to transparency and the inputs fo r the consultation will be published on the Commission's 
central consultation page once all consultation activities are completed.  
 
Question 50  
What sectors will be covered initially?  
 
EU reply:  
The European Green Deal foresees that the Carbon Border Adj ustment mechanism will be proposed 
for a number of selected sectors that are at risk of carbon leakage.  
The decision in terms of scope and coverage will be informed by the impact assessment. In any 
event, compliance with World Trade Organization (WTO) rul es, trade agreements and other 
international obligations of the EU will be ensured  
  WT/TPR/M/395/Add.1  
 
- 36 - 
 
  BRAZIL  
PART I: Questions regarding the Se cretariat Report  
 
3.3.7 INTELLECTUAL PROPERTY  
PATENTS/SUPPLEMENTARY PATENT CERTIFICATES  
 
Question 1 . Regulation (EU) 2019/933 has waived the exclusive rights of European SPCs 
("supplementary patent certificate") rightholders and thus allowed competitors to 
manufacture generic/biosimilar medicines under SPCs if the products are destined for 
exportation to non -EU markets. Does that measure indicate that the EU has come to the 
conclusion that SPCs unnecessarily hinder free trade? Are there any plans to scrap SPCs 
altogether in the near future?   
 
EU reply:   
Regulation 2019/933 introduced a narrow, targeted exception to SPC ri ghts. The Regulation is in 
line with and complements the EU trade policy including on innovative medicinal products and 
generics/biosimilar. It aims at restoring the level playing field between EU based manufacturers of 
generics and biosimilars with those based in third countries in which such protection does not exist 
or has expired.  
 
Are there any plans to scrap SPCs altogether in the near future?  
 
EU reply:   
There are no such plans.  
 
GEOGRAPHICAL INDICATIONS  
 
Question 2 . The Union does not currently pro tect non -agricultural geographical indication, 
such as those used to describe handicraft, jewellery, stones or even services. With your 
accession to the Geneva Act of the Lisbon Agreement, which already allows for the 
protection of such items, should trade  partners expect that the EU legislation on GIs be 
reviewed soon regarding that aspect?   
 
EU reply :  
The EU currently provides Geographical indication protection for non -agricultural products through 
legislation available at national level in its Member St ates and at EU level through the EU collective 
trade mark rules. As regards protection at EU level, the EU will soon publish the final version of 
a 2019 external "study on the economic aspects of geographical indication protection for 
non-agricultural prod ucts at EU level" designed to assess the added value of a special (sui generis) 
protection regime for geographically rooted non -agricultural products as compared to other kinds of 
protection in particular trade marks. Based on all the evidence collected, t he Commission will decide 
on concrete further steps.  
 
GENETIC RESOURCES  
 
Question 3 . The Member is a signatory of the Convention on Biological Diversity and of 
the Nagoya Protocol and has adopted regulation 511 (511/2014), which deals with access 
to geneti c resources and benefit sharing. Would the Member care to summarise what are 
the actual sanctions foreseen in the EU Law for cases of misapprehension of such 
resources in connection with intellectual property assets? Have those ever been applied?   
 
EU reply :  
The EU is a Party to CBD and the Nagoya Protocol. Regulation (EU) 511/2014 implements compliance 
measures of the Nagoya Protocol (i.e. art. 15 -17).  
 
The Regulation and its provisions apply to genetic resources accessed in Parties to the Nagoya 
Protocol. Sanctions under the Regulations are set up by the EU Member States (see art. 11), and 
concern infringements of the Regulation. The Regulation requires that the users of genetic resources 
exercise due diligence to ascertain that genetic resources and traditional knowledge associated with 
genetic resources which they utilise have been accessed in accordance with applicable access and WT/TPR/M/395/Add.1  
 
- 37 - 
 
  benefit -sharing legisl ation or regulatory requirements. Please note that the Nagoya Protocol does 
not require to link compliance or monitoring measures to intellectual property rights.  
 
COPYRIGHT AND RELATED RIGHTS  
 
Question 4 . Article 15 of Directive 2019/190 ("on copyrights and related rights in the 
Digital Single Market") establishes an exclusive right to press publications, which now 
have the power to authorize the use of their content by internet service providers. Does 
this right extend to foreign publications?   
 
EU reply :  
Article 15(1) of Directive (EU) 2019/790 provides new related rights to publishers of press 
publications established in a Member State. Therefore, the establishment of the press publisher in 
an EU Member State is a prerequisite to benefit from the right s provided for in Article 15(1). 
Article  15 does not govern the protection of press publications published by publishers established 
in third countries.  
 
PART I: QUESTIONS REGARDING THE Secretariat Report  
 
II TRADE POLICY REGI ME: FRAMEWORK AND OB JECTIVES  
Page 10 (Para 14); Page 32 (Para 3.39) and Page183 (Para 4.82)  
 
Questions:  
 
Question 5 . How has the European Union been promoting more equitable market access 
conditions for agricultural and non -agricultural goods, taking into account that "the 
agricultural sector continues to stand out in the (EU's) tariff analysis due to significantly 
higher rates"?   
 
EU reply:  
The EU is a world leader in import of agricultural products, worth EUR 138 billion in 2018. The EU 
has concluded, and continues to neg otiate, ambitious FTA agreements to reduce agricultural tariffs 
in bilateral trade, notably with developing countries (e.g. the Economic Partnership Agreements with 
African, Caribbean and Pacific countries). In addition, developing countries benefit from t he General 
System of Preference and the EU has granted duty free quota access to the least developed 
countries, including agricultural products (EU initiative "Everything But Arms").  
 
Question 6 . Regarding "the significant use of non -ad valorem  rates and t ariff quotas" in 
the agricultural sector, does the European Union intend to drive an internal tariff 
simplication process in the near future?   
 
EU reply:  
The EU does not consider that its tariff structure needs simplification. The EU's import regime for 
agricultural products, including the composition grid (Meursing table), is fully transparent and 
predictable, and is set out in the EU's WTO schedule.  
 
Page 61 (Para 3.37)  
"3.37. Furthermore, the United Kingdom took steps to establish its schedule, as a consequence of 
its expected withdrawal from the EU. It submitted a draft schedule, indicating that the effective date 
is pending further notification, and notes that, in the meantime, it will continue to be covered by 
Schedule CLXXV -European Union. This dr aft received objections from other WTO Members; thus, it 
is not approved. The United Kingdom also initiated Article XXVIII negotiations with respect to TRQs 
on agricultural and non -agricultural goods".  
 
Question 7 . As regards the EU and the United Kingdom future schedules of concessions 
after Brexit, how does the the EU and the UK intend to proceed if Article XXVIII 
negotiations with respect to TRQs on agricultural and non -agricultural goods are not 
concluded before December 31st 2020?  
 WT/TPR/M/395/Add.1  
 
- 38 - 
 
  EU reply:  
The negot iations under the GATT Article XXVIII procedure are confidential and are currently ongoing 
with the WTO Members whose rights the EU recognised. Any agreements will be notified in 
accordance with the applicable rules.  
 
Page 64 (Para 3.44)  
"3.40. The number of non -ad valorem  tariffs in the EU also stands out, as about 10% of tariff lines 
are non -ad valorem , and their number increased over the review period. Further, of the 
non-ad valorem  tariffs, about one third are compound, mixed, or other, meaning that it is often 
difficult to determine the duty rate or calculate the real impact of the tariff".  
 
Questions:  
 
Question 8 . Could the European Union explain the verified increase of the numbe r of 
non-ad valorem  tariffs over the review period?  
 
EU reply:  
The apparent small increase in the number of non -ad valorem  tariffs is due to the nomenclature 
change from HS2012 to HS2017. In substance, there has been no change compared to the previous 
exercise.  
 
Question 9 . Is there any ongoing discussion within the EU regarding the simplification of 
tariff lines towards defining only ad valorem  duties?  
 
EU reply:  
The EU does not consider that its tariff structure needs simplification. The EU's import regime for 
agricultural products is fully transparent and predictable, and is set out in the EU's WTO schedule.  
 
Page 65 (para 3.44)  
"3.44. There were several develop ments on tariff quotas during the review period. In January 2019, 
the EU issued a regulation on the apportionment of the WTO tariff quotas between the EU and the 
United Kingdom, in anticipation of the latter's eventual withdrawal from the EU. More specific ally, 
the EU put in place a methodology for the apportionment of TRQs for Article XXVIII negotiations, in 
order to ensure a smooth transition and a continuous process of importation under quotas. The 
regulation sets out that the TRQs will be apportioned be tween the EU -27 and the United Kingdom, 
based on their respective import share of the quota during a recent representative three -year period 
(…)". 
 
Question 10 . Could the EU clarify if the information by the Secretariat – "based on their 
respective import share of the quota" – is correct or if the apportionment was made based 
on the EU -27 and the UK respective import share of the tariff lines that compose the 
quota?   
 
EU reply:  
The apportionment is based on the respective import shares of  the EU27 and the UK in a given tariff 
rate quota during a recent representative three -year period.  
 
Page 65 -66 (para 3.45)  
"3.45. (…) For the latest representative period, the use of TRQs varied significantly; some have 
100% fill rates and others have 0% but with an overall average fill rate of 52%. A fairly significant 
number, 24%, were not utilized at all (zero fill rate), and about 30% were fully utilized with 100% 
fill rates (Table A3.1)".  
 
Questions:  
Question 11 . Considering that the overall average f ill rate of TRQs was 52% and that Bali's 
Understanding on Tariff Rate Quota Administration Provisions of Agricultural Products 
threshold is of 65%, was (were) there any instance(s) in which the underfill mechanism 
established in Annex A of said Decision co uld have been made operational by the EU?   
 
EU reply:  
The EU does not consider that the management system for any of its TRQs causes low fill rates. Fill 
rates are determined by prevailing economic conditions. The EU notes that many TRQs managed on WT/TPR/M/395/Add.1  
 
- 39 - 
 
  a "first-come, first -served" basis have low fill rates. According to the provisions of the Bali Decision, 
it is up to third countries to decide on the usefulness to activate the Bali's underfill mechanism. 
EU legislation on TRQ management is fully in line with t he provisions of the Ministerial Decision on 
TRQ management.  
 
Question 12 . Does the EU have any information regarding the general causes for the rather 
modest fill rate of its TRQs? Could the European Union explain why "a fairly significant 
number, 24%, (o f TRQs) were not utilized at all (zero fill rate)"?   
 
EU reply:  
Fill rates are determined by prevailing economic conditions. After successive reforms of its 
agricultural policy, prices of EU agricultural products are aligned with global market prices, making 
them internationally competitive. As a result, a number of TRQs have become less economically 
interesting.  
 
Page 93 (para 3.121)  
"3.121. The EU has several provisions on export credit, insurance or guarantee instruments but does 
not have any  all-encompassing legislation, except on short -term official export -credit support, i.e. 
with a repayment time of up to two years. The various instruments that impose rules in this area 
are outlined in Table 3.12. Regulation (EU) No. 1233/2011 provides cer tain guidelines in the field of 
officially -supported export credits for EU member States. It basically has two functions: it legally 
incorporates the Arrangement on Officially Supported Export Credits (the Arrangement) of the OECD 
into EU law, and it provi des for annual reporting of export -credit activities to the Commission in 
order to increase transparency".  
 
Question 13 . Taking into account the absence of any all -encompassing legislation on 
export credit, insurance or guarantee instruments, how does the EU plan to guarantee 
that member States comply with the Nairobi decision on Export Competition, particularly 
in what pertains to paragraphs 13 to 16?  
 
EU reply:   
The Nairobi Ministerial Decision on Export Competition (WT/MIN(15)/45) is an international le gal 
obligation of the EU and is incorporated into internal EU law (see Council Decision (EU) 2016/77). 
Also, EU Member States are all WTO Members in their own right. The Nairobi Decision thus binds 
not only the EU but also all EU Member States and could be  enforced in the Court of Justice of the 
European Union. In practice, the EU and all its Member States fully comply with the Nairobi Decision 
as may been seen from the EU's notifications on export subsidies as well as the EU responses to the 
annual WTO Sec retariat questionnaire on export competition.  
 
Page 167 (para 4.20)  
The EU has been linking organic production to its greening policies and notifying such programs as 
Green Box measures that would meet the requirements of paragraph 12 of Annex 2 of the AoA , 
raising some concerns.  
 
First, as regards to policy -specific criteria and conditions, there is no direct exclusive relation 
between organic production and environmental conservation. Since it is almost impossible to 
completely sever agriculture from the environment, if a broad interpretation of paragraph 12 of 
Annex 2 becomes the rule, the indiscriminate notification of allegedly environmental programs could 
ensue.  
Still related to policy -specific criteria and condition, the notion of  "compensate beneficiaries for all 
or part of the additional costs and income foregone resulting from the commitments made" is 
questionable, given that so -called organic products tend to have higher selling prices. The market 
itself compensates for the eve ntual loss of productivity inherent to organic goods systems. The 
farmers would thus receive double compensation: from the market and from the government, which 
would imply that such domestic support programs have more than minimal trade -distorting effects  
or effects on production.  
 
Question 14 . Could the European Union provide:  
 
a) An updated amount of domestic support expenditure that was provided to organic 
production;  
 WT/TPR/M/395/Add.1  
 
- 40 - 
 
  EU reply:  
Payments for organic farmers are part of the EU's Rural Development Policy  (Regulation (EU) 
No. 1305/2013). Under the current programming period, up to mid -January 2020, the EU has 
allocated EUR  4.3 billion to the Member States for organic farming.  
 
b) Information on the organic market in the European Union as compared to the re gular 
agricultural market (growth, average selling prices);  
 
EU reply:  
Trends on organic markets are provided in the EU Agricultural Market Brief on organic farming in 
the EU (March 2019):  
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/market -brief-
organic -farming -in-the-eu_mar2019_en.pdf.  
 
c) Information on which crops are supported and to what level;  
 
EU reply:  
Support for organic farming under Article  29 of Regulation (EU) No . 1305/2013 is not linked to crop 
specific production, but to the organic farming practices and methods.  
 
d) Information on what is the treatment organic production is expected to receive in the 
Common Agricultural Policy post -2020 ; 
 
EU reply:  
The CAP post -2020 proposal maintains the possibility for Member States to support organic farming 
methods and practices given the role of organic production methods in contributing to environmental 
and climate related objectives. Such support will be possible under the environmental, climate and 
other management commitments under rural development. Member States can grant support for 
both conversion to and maintenance of organic farming methods as defined by the EU rules on 
organic farming. Oth er rural development measures, such as investments, can also support 
interventions linked to organic production.  
 
In the framework of direct payments, the proposal provides that Member States will be obliged to 
set up schemes beneficial for the climate and  the environment (eco -schemes), which will be 
voluntary for farmers. Farmers applying organic farming methods and practices may also benefit 
from the support provided under such schemes. It is up to Member States to propose a tailor -made 
support to organic  farming based on their specific conditions, in accordance with the needs 
assessment of the Member State.  
 
e) How the organic production contributes to the conservation of the environment in a 
manner that is different from other forms of agricultural production.  
 
EU reply:  
Certified organic production must respect a set of criteria established in EU legislation. These criteria 
imply methods of production that are less harmful to the environment than conventional farming 
practices, such as  a prohibition on the use of synthetic pesticides or synthetic fertilizers.  
 
Page 173 (para 4.42 and para 4.47)  
CAP beyond 2020 seem marked by an increased flexibility in the use of funding allocations. Transfers 
between rural development and direct paymen ts of up to 15% of the CAP allocation and a raised "de 
minimis" level of national support without approval by the Commission being important examples.  
 
Questions:  
Question 15 . Could the EU provide an explanation of the mechanism that it is going to put 
in place to guarantee that EU's domestic support entitlements are not surpassed?  
 
EU reply:   
The vast majority of EU support including most of the direct payments and rural development 
measures will continue to be Green Box. The EU will ensure that its WTO commitments are respected.  
 
Question 16 . What is the schedule for Members to notify their programs to the EU?   
 WT/TPR/M/395/Add.1  
 
- 41 - 
 
  EU reply:  
The CAP strategic plans would need to be approved after adoption of the CAP reform legislation. 
Approval of the plans could take place in the course of 2021.  
 
Question 17 . How does the EU plan to abide by G/AG/2 deadlines regarding DS:1 
notifications, having to deal with Member's increased flexibility in allocating CAP's funds?   
 
EU reply:  
The new CAP post -2020 proposal will not ch ange the notification method or timing of The EU's annual 
DS:1 notification. As discussions and documents presented in the regular Committee on Agriculture 
have shown, the EU is a leader in submitting DS:1 notifications. Those discussions also show that 
no WTO member (including Brazil) is in a position to respect the deadlines in G/AG/2 which clearly 
needs updating.  
 
Question 18 . Could the EU provide further information on the rules of state aid in the 
agricultural sector?  
 
EU reply:  
Member States have an  obligation to notify to the Commission any plans to grant or alter State aid. 
The Commission assesses the notified aid on the basis of the EU Guidelines for State aid in 
agricultural and forestry sectors and in rural areas, or as the case may be, other St ate aid Guidelines 
or frameworks. Aid can only be granted after its approval by the Commission.  
 
Member States can also grant aid which is exempted from the notification obligation. Such exempted 
aid must comply with the rules laid down in Commission Regulation (EU) 702/2014 declaring certain 
categories of aid agricultural and forestry sectors and in rural areas compatible with the internal 
market. Member States are obliged to transmit to the Commission a summary information that is 
then mad e public.   
 
Furthermore, Member States can also grant de minimis aid, subject to conditions and ceilings laid 
down in Commission Regulations (EU) 1407/2013 on the application of Articles 107 and 108 of the 
TFEU to de minimis aid and 1408/2013 on the applic ation of Articles 107 and 108 of the TFEU to de 
minimis aid in the agricultural sector. Such aid is considered not to constitute State aid, therefore, 
the notification obligation does not apply and Member States are responsible for ensuring that it is 
comp atible with the aid ceilings and other conditions laid down in the regulations.  
 
Page 176 (para 4.50)  
"4.50. The butter and skimmed milk powder stocks accumulated during the period 2015 -17, with 
total public and private stocks of skimmed milk powder reachi ng more than 415,000 tonnes at the 
end of 2016; public intervention stocks reached 380,000 tonnes at the end of 2017. The intervention 
stocks were progressively put back on the market through a tendering process, and decreased 
regularly in 2018 and in the first half of 2019, down to zero in July 2019."  
 
Questions:  
Question 19 . Could the EU provide details on its public intervention stocks policies, 
including on the tendering process?   
 
EU reply:  
Details about sales of skimmed milk powder from EU intervention stocks was provided to 
WTO members in the framework of the Regular Committee on Agriculture (AGIMS ID 92006). During 
the tender period between December 2016 and June 2019, the minimum selling prices accepted in 
the tenders for SMP ranged betwe en EUR 1 050 and EUR 2 051 per tonne. See page 4 of the Milk 
Market Observatory:  
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf .  
 
The sale of intervention stocks by the Commissio n is governed by Regulation (EU) No . 1308/2013, 
which sets the framework for the cautious approach adopted by the Commission when disposing of 
SMP intervention stocks. Sales did not take place until the market had recovered. The prices at which 
the SMP in public intervention was sold in 2018 and 2019 were in line with market reality, taking 
into account the ageing of the product and therefore its relative loss of commercial value (not the 
intrinsic quality of the product). In the period during which the bul k of the SMP intervention stocks WT/TPR/M/395/Add.1  
 
- 42 - 
 
  were disposed of (April 2018 – January 2019) EU SMP milk prices increased by more than 30% and 
Oceania SMP prices increased by more than 20%.  
The minimum selling prices accepted in the tender followed the recovery in price s in 2018 -2019. 
There was no downward pressure on market prices. On the contrary, during the period between 
January 2018 and June 2019, when most of these stocks were released to the market, the EU price 
for skimmed milk powder increased by 43%. See page 4  of the Milk Market Observatory: 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf and page 1 of the Milk Market Observatory on dairy commodity 
prices:  
https://ec.europa.eu/info/sit es/info/files/food -farming -fisheries/farming/documents/eu -dairy-
commodity -prices_en.pdf.  
 
Question 20 . How were the programs notified to the WTO?   
 
EU reply:  
Intervention support is notified as Amber Box Market Price Support, and therefore included in the  
DS:1 notification in supporting table 5.  
 
Page 176 (para 4.51)  
 
Question 21 . Could the European Union provide more details on the funds "made available 
for a temporary exceptional adjustment aid to farmers in the beef and veal sector in 
Ireland, due to particular challenges faced by the sector, including concerns over the 
sector's contribution to GHG emissions, falling domestic consumption, and the uncertainty 
around the withdrawal of the United Kingdom from the EU" and also advanced information 
on how the EU intends to notify it to the CoA?  
 
EU reply:  
The EU has given information  on this aid in the Regular Committee on Agriculture (in response to 
questions AGIMS ID 91004 and 92079).  
 
Aid was only given when certain conditions were met:  
 
• Eligibility:  
o Eligibility focusses on suckler cow farmers and farmers having bovines older than 
12 months sent for slaughter.  
o Dairy farmers with less than 40 dairy cows are also eligible.  
 
• Conditionality (5% nitrate reduction over 1 year):  
o Aid is available to farmers that reduce organic nitrates by 5% over 1 year.  
o In addition, eligible far mers would have to be members of a Board Bio Quality 
Assurance Scheme or of a DAFM agri -environmental scheme.  
 
Aid level and controls:  
• Payments to suckler cow farmers would be EUR 40 per head, up to a maximum of 
40 suckler cows.  
• Payments to beef finishers would be EUR 100 per head, up to a maximum of 100 bovine 
animals.  
 
No payments were made by Ireland before 15 October 2019; all payments should be made by 31 
May 2020 at latest. A report by Ireland on the whole period will be provided to the Commission by 
31 July 2020. More information can be found in Regulation (EU) No . 2019/1132 via  
https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32019R1132&qid=1579625184288&from=FR.  
 
Page 183 (Para 4.78)  
 
Question 22 . Taking into account that "Regulation (EU) No. 1308/2013 still provides for 
export refunds in exceptional situations", does the EU intend to modify this Regulation in 
order not to allow the concession of any form of export subsidies in the future?  
 WT/TPR/M/395/Add.1  
 
- 43 - 
 
  EU reply:  
Articles 196 -204 of Regulation (EU) No. 1308/2013 were the legal base in internal EU law for the 
payment of export refunds. All amounts had already been set to zero in this chapter, which was also 
in any event explicitly subject to the international obligations of the EU such a s the Nairobi Decision. 
The current draft legislative proposal for the CAP post -2020 now cleans up the legislation by 
repealing these provisions as well as the reference in Article 219(1) of the same Regulation 
(exceptional situations).  
 
Page 184 (Para 4.83 -4.85)  
"4.83. Tariffs for some cereals may be adjusted, based on import prices. For high -quality common 
wheat, durum wheat (high -, medium - and low -quality), maize, flint maize, sorghum, and rye, the 
duty is EUR 157.0497 minus the c.i.f. import pr ice, with further adjustments depending on the 
product, port of unloading, quality, and other factors as set out in Commission Regulation (EU) No. 
642/2010.9"  
 
Question 23 . Could the European Union explain how tariffs that may be adjusted based on 
import prices, among others, conform to the footnote of Article 4 (2) of the AoA?  
 
EU reply:  
During the UR, the EU converted into ordinary customs duties all its measures concerni ng cereals 
resulting in following bound tariffs:  
 
Product  Tariff  
(EUR per tonne)  
Durum wheat  148 
Soft wheat  95 
Rye 93 
Barley  93 
Oats 89 
Maize (except seeds and certain hybrids)  94 
Sorghum  94 
Buckwheat  37 
Millet  56 
Triticale  93 
 
For wheat, maize, rye, barley and sorghum the EU made additional commitments. In agreement 
with third countries suppliers, the EU accepted to apply duties at a level and manner that the 
duty-paid import price for such cereals would not exceed the effective interventi on price, increased 
by 55% (Headnote 5 of the EU Schedule). In the event of a modification of the current system, it 
concerns the effective support price, instead of the effective intervention price. This system has 
benefitted third -country suppliers as th e import duties continue to be lower than the bound rate.  
 
PART I: QUESTIONS REGARDING THE Secretariat Report  
II TRADE policy regime: framework and objectives  
 
Page 116 (Para 3.214)  
3.214. The new Regulation will replace Regulation (EC) No. 882/2004234 and repeal Regulation (EC) 
No. 854/2004.235 The key SPS legislation in the EU is summarized in Table 3.21.  
 
Question 24 . Do the new regulations deal with the subjects of regionalization and pest 
risk analysis? To what extent are the standards, guidelines and recommendations of the 
"three sisters" (OIE, IPPC and Codex Alimentarius) taken into account in the provisions 
related to these two issues? Could the EU provide examples?   
 
EU reply:  
The new regulation (EU) 2017/625 regulates the official c ontrols on products of animal origin 
intended for human consumption. It includes rules for performance of official controls and other 
control activities by the competent authorities of the Member States, sets out the requirements to 
be fulfilled for the en try into the EU of consignments of animals and goods from third countries. The 
issues of regionalization and pest risk analysis are regulated by the relevant sectorial EU legislation; 
Regulation (EU) 2016/429 on transmissible animal diseases (Animal Health  Law) and Regulation 
(EU) 2016/2031 on protective measures against pests of plants (Plant health Law).  WT/TPR/M/395/Add.1  
 
- 44 - 
 
  The EU and its Member States are actively participate in the work of the "three sisters" (OIE, IPPC 
and Codex Alimentarius). The relevant provisions of the EU legislation are based on the standards, 
guidelines and recommendations of these international standard setting bodies. Regulation (EC) 
No. 178/2002 on General Food Law (hereinafter, the "General Food Law ") establishes certain general 
principles unde rpinning the development of EU food law. As laid down in the Fitness Check of the 
General Food Law – a comprehensive policy evaluation of this Regulation to be found at: 
https://ec.europa.eu/food/safety/general_food_law/fitness_check_en  -, the EU has made 
considerable efforts to ensure alignment of EU food law with international standards, following its 
introduction in 2002. This is also reflected in other EU secondary food legislation, where specific 
reference to international standards in the development of food law is made; as a consequence, 
adaptation of EU law takes place in line with international standards.  
 
Page 117 (Table 3.21)  
Regulation (EC) No. 882/2004. On official controls for verification of compliance with feed and food 
law, animal health, and animal welfare rules. The Regulation sets out general rules for the 
performance of official controls to verify compliance with rules aiming, in particular, at: 
(a) preventing, eliminating or reducing to acceptable levels risks to humans and ani mals, either 
directly or through the environment; and (b) guaranteeing fair practices in the feed and food trade, 
and protecting consumer interests, including feed and food labelling and other forms of consumer 
information.  
 
Question 25 . Is it a consolidat ed understanding in the EU that fair practices in the feed 
and food trade, and the protection of consumer interests are relevant criteria for 
establishing SPS measures, especially when it comes to setting up official controls, 
inspection and approval proce dures of food imports?  
 
EU reply:  
The new regulation (EU) 2017/625 regulates the official controls on products of animal origin 
intended for human consumption. It includes rules for performance of official controls and other 
control activities by the com petent authorities of the Member States, sets out the requirements to 
be fulfilled for the entry into the EU of consignments of animals and goods from third countries.  
Article 1 of this Regulation defines the subject matter and scope and states the followi ng point 2: 
"This Regulation shall apply to the official controls performed for the verification of compliance with 
the rules, whether established at Union level or by the Member  States, to apply Union legislation, in 
the areas of:  
 
(a)  food and food safe ty, integrity and wholesomeness at any stage of production, processing and 
distribution of food, including rules aimed at ensuring fair practices in trade and protecting 
consumer interests and information, and the manufacture and use of materials and artic les 
intended to come into contact with food."   
• Official controls related to fair trade practices or consumer information (unless safety related) 
are not SPS measures. Nonetheless, the promotion of fair practices in food trade is amongst 
the objectives of the Codex Alimentarius.  
 
Page 119 (para 3.219)  
The EFSA, established under the General Food Law of 2002, is an independent agency responsible 
for risk assessment for food and feed safety, nutrition, animal health and welfare, plant protection , 
and plant health, as well as, through environmental risk assessments, the possible impact of the 
food chain on biodiversity.  
 
Questions:  
Question 26 . When establishing its norms for food safety for human consumption, does 
EFSA take into account environme ntal risk assessments and the possible impact of the 
food chain on biodiversity?   
 
EU reply:  
The European Food Safety Authority (EFSA) provides scientific advice and scientific and technical 
support underpinning the EU legislation and polices in all fields that have a direct or indirect impact 
on food and feed safety. EFSA does not establish norms  or standards.  
In order to ensure the safety of food it is necessary to consider all aspects of the food production 
chain including primary production and the production of animal feed. Since some products 
authorized under EU law such as pesticides and ad ditives in animal feed may involve risks to the WT/TPR/M/395/Add.1  
 
- 45 - 
 
  environment, some environmental aspects are assessed by the EFSA in accordance with the relevant 
legislation.  
 
Question 27 . In what pertains to the adoption of Maximum Residue Levels for plant 
protection pro ducts, EFSA has consistently been adopting MRLs lower than those 
considered safe by the Codex Alimentarius. In which stages of its risk assessment does 
EFSA take into consideration the standards, guidelines and recommendations of the Codex 
Alimentarius? Ar e the scientific reports produced by JMPR used as relevant scientific 
evidence by EFSA, when establishing these MRLs? If so, could the EU inform on which 
stages of the risk assessment it is done?  
 
EU reply:  
EFSA does not adopt MRLs, but gives a reasoned opinion on, in particular, the risks to the consumer 
associated with a plant protection product.  
 
In accordance with Article 5(3) of Regulation (EC) 178/2002, where international standards exist or 
their completion is imminent, they are to be taken into c onsideration in the development or 
adaptation of food law, except where such standards or relevant parts would be an ineffective or 
inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a 
scientific justification , or where they would result in a different level of protection from the one 
determined as appropriate in the Community. Regulation (EC) 396/2005 stipulates that MRLs set at 
international level by the Codex Alimentarius Commiss ion should be considered when  Community 
MRLs are being set, taking into account corresponding good agricultural practice. When deciding on 
the setting, modification, or deletion of a MRL, the European Commission is bound to take into 
account existing CXLs. For instance, this is done s ystematically in the context of the MRL review 
programme of all existing MRLs.  
 
In addition, before each meeting of the relevant Codex Committee (Codex Committee on Pesticides 
Residues - CCPR) EFSA carries out a systematic assessment of the draft proposed JMPR CXLs and 
delivers an opinion that will form the basis of the EU common position. If no concerns are identified 
by EFSA, the CXLs are systematically taken over in the EU legislation. If the EU has concerns, it 
makes a reservation at the CCPR meeting, t hus transparently informing the other delegations at an 
early stage that the MRL will not be taken over.  
 
Question 28 . Are relevant scientific studies and risk analysis performed by other WTO 
members (where identical or similar conditions prevail) taken into account by EFSA when 
setting MRLs?  
 
EU reply:  
EFSA assesses the risk on the basis of studies required by and defin ed in the EU data requirements 
and always examines the studies in detail. Applicants are of course free to submit studies that were 
already submitted to other trading partners also to EFSA for an assessment. As for studies submitted 
to JMPR in support of C odex MRL requests, the EU common position is derived on the basis of the 
assessment performed by JMPR. The full dossier including the individual studies and raw data are 
not available to EFSA.  
 
Question 29 . Regarding the fight against antimicrobial resist ance and the authorization, 
use and distribution of veterinary drugs (Regulation (EU) 2019/6), in which stages of its 
risk assessment does EFSA take into consideration the standards, guidelines and 
recommendations of the Codex Alimentarius and the OIE?   
 
EU reply:  
Before each meeting of the relevant Codex Committee (Codex Committee on Residues of Veterinary 
Drugs - CCRVDF) the European Medicinal Agency (EMA) carries out a systematic assessment of the 
draft proposed JECFA MRLs for those veterinary drugs tha t are authorised at EU level and delivers 
an opinion that will form the basis of the EU common position.  
 
The EU, EMA and EFSA actively participate to the work of the Codex Alimentarius Commission and 
the OIE. EMA and EFSA always take into account Codex a nd OIE standards, guidelines and 
recommendations as need be and at the early stage of their risk assessment.  
 WT/TPR/M/395/Add.1  
 
- 46 - 
 
  Page 120 (para 3.228)  
The procedure for approving GMOs has not changed. An application for approval for use of a GMO 
for food, feed, cultivation, or release on the market for other purposes (e.g. cut flowers) must be 
made to the competent authority in a member State.  
 
Question 30 . Why are procedures for GMO approval by the EU treated as SPS issues, 
although the risk assessment performed  for GMOs is not the same as the ones used for 
human health and phytosanitary issues?   
 
EU reply:  
Because the relevant EU legislation (Regulation (EC) No . 1829/2003) meets the criteria in Annex 
A.1 of the SPS Agreement.  
 
Question 31 . How does the EU deal with the subject of New Breeding Technologies in 
agricultural product development? Are there any specific regulations on the subject? Are 
the protocols for analysing food products deriving from New Breeding Technologies the 
same as those used for GMOs?   
 
EU reply:  
The Court of Justice of the European Union, in its decision C528/16, clarified that products obtained 
by New Breeding Techniques are within the scope of the existing GMO legislation. Therefore, EU  GMO 
legislation applies to products obtained by N ew Breeding Techniques. As a consequence, the 
analytical approach for food products derived from New Breeding Techniques is the same as for 
GMOs.  
  
PART I:  QUESTIONS REGARDING THE Secretariat Report  
II TRADE policy regime:  framework and objectives  
 
Page 16 (Para 1.3)  
The EU's economy has moved from recovery mode to an upturn in recent years. Since 2015, GDP 
growth rates averaged more than 2%. However, increasing global and domestic uncertainties, trade 
tensions between major global trading entities and the prospect of the United Kingdom leaving the 
EU, together with weakness in the manufacturing sector, led to a slowdown in the second half of 
2018.  
 
Questions:  
Question 32 . According to the latest official estimates available, what would the general 
economic impact of a  Brexit be for the EU economies? Which EU economic sectors would 
be most sensitive to a "hard" Brexit?   
 
EU reply:  
The recent Commission's economic forecasts were based on the purely technical assumption of 
status quo in terms of trading relations between  the EU27 and the UK. As from 1 February, the UK 
left the European Union under the terms of the Withdrawal Agreement. During a transition period 
that will last – unless extended – until end -2020, the EU acquis will continue to apply to and in the 
UK. The r isk of a disorderly, "hard" Brexit without a Withdrawal Agreement was averted. The 
long-term economic impact of the UK's exit from the EU will largely depend on future EU27 -UK 
trading arrangements. However, the results from various published studies on the  economic impact 
of Brexit point to negative effects to the UK as well as the EU.  
 
Question 33 . 2. How and to what extent has the escalation of trade tensions between the 
US and China affected the EU economies? Have the EU exports benefited from any "trad e 
diversion" as a consequence of the so -called "trade war" between the US and China? If 
so, which economic sectors benefited the most? Was it reflected in the EU outstanding 
trade and current account balances?  
 
EU reply:  
Trade tensions and elevated polic y uncertainty are among the key factors that have weighed on the 
global and European economy in the past two years and are set to remain a drag on growth at least 
in the near term to medium term. While potential benefits related to "trade diversion" are di fficult 
to establish, negative effects of escalating trade tensions have clearly outweighed any benefits in 
the last two years. This is so because tariff increases, other protectionist policy measures and WT/TPR/M/395/Add.1  
 
- 47 - 
 
  ensuing record -high policy uncertainty have created  clear obstacles to trade and investment and 
clouded the growth outlook. The European economy has been affected particularly strongly due to 
its high openness to trade and high integration in global value chains as well as its high exposure to 
China.  
 
Pages 22 -3 (Para 1.24)  
The EU's economic outlook is mainly subject to domestic policy uncertainty and rising protectionism 
in trade and investment. According to the Organization for Economic Co -operation and Development 
(OECD), the United Kingdom's withdrawal  from the EU is not a major threat to the EU's overall 
economic performance; however, countries with the closest trade links to the United Kingdom 
(e.g. Ireland) could be severely impacted if the United Kingdom left the EU without a withdrawal 
agreement. W hile the detrimental effect of a "hard" Brexit on the United Kingdom's economy would 
reduce its GDP by some 3.3% by 2020, it would reduce the EU -27 GDP by around 1%.  
 
Question 34 . What would be the main economic factors behind the asymmetrical negative 
effects on the United Kingdom and the EU -27 economies, respectively, following a "hard" 
Brexit?  
 
EU Reply:   
As from 1 February, the UK left the European Union under the terms of the Withdrawal Agreement. 
During the transition period that will last – unless extended – until end -2020, the EU acquis will 
continue to apply to and in the UK. Thus, the risk of a disorderly, "hard" Brexit without a Withdrawal 
Agreement was averted. However, various published studies on the economic impact of Brexit 
suggest that under any scenario the negative economic impact on the UK (as a share of GDP) will 
be significantly larger than the EU27 as a whole. One important reason provided in these studies 
behind the asymmetrical negative effects is that for the UK, trade with the EU -27 as share of UK's 
overall trade is much higher than trade of the EU -27 with the UK as share of EU -27 overall trade. 
Results point to highly heterogeneous effects across the EU27. Member States with stronger trade 
links with the UK will be more affected than others.  
 
Pages 42 -3 (Para 2.37)  
In April 2018, the EU and Mexico reached agreement in principle on the modernization of the trade 
part of the EU -Mexico association agreement, w hich will render it comparable in scope and level of 
ambition to the recent EU FTAs.61 Negotiations with Chile on a similar modernization of the trade 
part of the EU -Chile association agreement were launched in November 2017.62 Negotiations with 
Mercosur o n the conclusion of an association agreement, which had resumed in 2016, were 
concluded at the political level at the end of June 2019.  
 
Question 35 . Under which of the four broad classification categories for FTA's with third 
countries ("first generation" , "new generation", "deep and comprehensive", "economic 
partnership", on page 40 – Para 2.30) would the association agreement with Mercosur 
fall?  
 
EU reply:   
The trade part of the Association Agreement with Mercosur falls within the new-generation FTAs.  
 
Page 218 (Para 4.206)  
During the review period, the banking sector benefited from the positive macroeconomic 
developments in most European countries (Section 1). Banks' solvency ratios performed well, as 
Common Equity Tier 1 (CET1) ra tios increased by 14.3% in 2017 and 14.5% in 2018. Asset quality 
improved further, in a context where the average non -performing loan (NPL) ratio of EU banks 
decreased significantly (Section 4.4.1.2.1). However, profitability remained low on average, and h as 
not yet reached sustainable levels.  
 
Question 36 . How has the current monetary policy of low (and even negative) interest 
rates for an extended period affected banking profitability in any commensurate way, if 
any?  
 
EU reply:   
EU banks reacted to low i nterest environment by adjusting business models and particularly reducing 
cost by lowering the number of physical branches and fostering the digitalisation of services. Their 
average return on equity stabilized at 6.8% in 2019. Both net interest income an d non -interest WT/TPR/M/395/Add.1  
 
- 48 - 
 
  income are also stable (0.56% and 0.79% over total assets, respectively). Fees and commissions 
seem to play an increasing role in banks total income. The volume of total assets in the European 
banks has increased after years of reduction und erpinned by steady growth in loans to non -financial 
companies and households (home purchase) at about 4%. The relevance of the banking sector in 
the European economy has move upward after years of a smooth decline.  
 
Page 218 (4.207)  
The insurance market continued to be challenged by the prolonged low interest rate environment. 
Increased political uncertainty in 2018 and growing trade tensions further exacerbated the existing 
challenges.  
 
Questions:  
Question 37 . Does the threat of a " hard" Brexit lie behind the political uncertainty that 
exacerbated the existing challenges in the EU insurance market? In what practical sense?   
 
EU reply:   
The political uncertainty in 2018 does not seem to only point to the risks of a no -deal Brexit in 2 019. 
In addition, the insurance sector was not more exposed to no -deal Brexit risks than other sectors of 
financial services.  
The EU analysed the risks for financial stability of a no -deal Brexit and concluded that no EU 
contingency measures were needed i n the insurance sector. At national level, some EU Member 
States took contingency measures to address residual risks, e.g. ensure the servicing of existing UK 
insurance contracts with EU27 policyholders.  
 
Question 38 . In the same train of thought, how has  the escalation of trade tensions 
influenced the EU insurance market? Is it possible to pinpoint any export sector to which 
the EU insurance market would be highly exposed (directly or indirectly, i.e. through the 
banking system)?  
 
EU reply:  
There is an o ngoing dialogue and co -operation between the EU and other jurisdictions, on a bi - or 
multilateral basis as well as in organisations setting international standards for insurance. A decrease 
in trade activities due to trade tensions would likely to have a n egative impact on the demand of 
related insurance products and in consequence on respective insurance providers. As European 
insurers play a very active role internationally the European insurance market therefore would be 
affected, too.  
 
Page 220 (Para 4. 214)  
The changes made by the amended Capital Requirements Regulation298 (CRR II) and the Capital 
Requirements Directive299 (CRD V) include, inter alia  (.)  
 
Question 39 . What was the degree of participation of supervised institutions regarding 
the definition of these new standards?   
 
EU reply:   
The main elements of the Basel III framework already agreed at international level were 
implemented into EU legislation via amendments to the Capital Requirements Directive and the 
Capital Requirements Regula tion ("CRDV package"). The legislative proposals adopted by the 
Commission in 2016 were based on technical advice by the EU regulatory and supervisory bodies 
(the European Banking Authority – EBA - and the Single Supervisory Mechanism - SSM) and subject 
to public consultation amongst stakeholders prior to their adoption. Stakeholders' input was also 
gathered via a specific "Call for Evidence" run by the Commission in 2015/16. As such, supervised 
institutions did participate to a various extent in the consul tation process, in line with the Commission 
"Better Regulation" standard.  
 
Page 220 (Para 4.215)  
The Bank Recovery and Resolution Directive301 (BRRD II) amends the BRRD (Directive 2014/59/EU) 
regarding the loss -absorbing and recapitalization capacity of credit institutions and investment firms. 
BRRD II includes: amendments to the requirement for contractual recognition of bail -in; new 
early-intervention powers for regulators; a requirement for contractual recognition of resolu tion stay 
powers; and amendments to the MREL calculation. Member States have until 28 December 2020 to 
implement BRRD II.  WT/TPR/M/395/Add.1  
 
- 49 - 
 
  Question 40 . What is the new accounting threshold for regulatory intervention? Are the 
rules the same for all countries within the EU ?  
 
EU reply:   
The conditions to trigger early intervention measures or to trigger resolution in BRRD II have 
remained the same (Article 27 and 32 of BRRD, respectively). The rules are applicable to all EU 
countries, based on the national transposition of BRRD and the direct application of the Single 
Resolution Mechanism Regulation (SRMR).  
 
Page 221 (Para 4.218)  
The Banking Union is an essential complement to the Economic and Monetary Union (EMU) and the 
internal market, which aligns responsibility for supe rvision, resolution and a single resolution fund 
at EU level. It obliges banks across the euro area to abide by the same rules. While the Single 
Rulebook applies to all EU countries, the Banking Union applies to countries in the euro area. 
EU non-euro area  countries can also join.  
 
Question 41 . What would the main advantages and the main costs of a non -euro area 
country joining the Banking Union be?   
 
EU reply:  
Joining the banking union would bring economic benefits linked with enhanced financial integrati on, 
improved supervision of cross -border institutions and banking activities, better and more complete 
supervisory information, greater consistency of supervisory practices and reduced scope for 
competitive distortions. It would also allow improved resolut ion of cross -border groups, and 
improved and additional crisis -management tools (including a common backstop and, when finalised, 
a common deposit insurance scheme). Both the financial advantages and costs of joining the banking 
union for non -euro member s tates may depend however on the specificity of the banking system of 
each country.  
 
Page 224 (Para 4.231)  
On 20 June 2019, the EU adopted a regulation and a directive establishing a harmonized framework 
for the cross -border distribution of collective inve stment funds, with a view to reducing regulatory 
barriers that hinder cross -border distribution of funds within the EU, and to enhance fund managers' 
ability to fully benefit from the internal market.  
 
Question 42 . Is this regulation based on CGE model eva luation of the burden of non -tariff 
barriers to cross -border trade? If so, could the EU explain the basic assumptions of the 
study?   
 
EU reply:   
The cross -border fund distribution package, which was published in July 2019 is one of the priority 
actions und er Capital Market Union and is intended to improve the functioning of the single market 
for European investment funds. The package addresses regulatory and administrative obstacles to 
expand the use of the EU passport by the Asset Managers who are establis hed in the EU. The 
underlying analysis are contained in the impact assessment which accompanied the initial legislative 
proposals.  
Please see: https://ec.europa.eu/transparency/regdoc/rep/10102/2018/EN/SWD -2018-54-F1-EN-
MAIN -PART-1.PDF.  
 
Page 227 (Para 4.250)  
The Regulation for cheaper cross -border payments in euro and fairer currency conversions across 
the entire EU was adopted in March 2019. It amends certain provisions of Regulation (EU) 
No. 924/2009, which provides for harmonized charges for cr oss-border payments and domestic 
payments in the euro currency only. The amended Regulation extends the scope to domestic 
payments in the currency of EU member States that are not part of the euro area. Furthermore, it 
creates more transparency for consume rs regarding currency conversion services and resulting 
charges. Its provisions regarding EU -wide harmonization of charges will apply from end -2019; and 
those regarding conversion services from mid -2020.  
  
Question 43 . Is there a statistical survey that reveals the fraction of these payments made 
by fintechs? Are there limits for cross -border operation through these new arrangements? 
If so, what are they?   WT/TPR/M/395/Add.1  
 
- 50 - 
 
  EU reply:   
The European Central Bank (ECB) collects harmonised and comparable information on pa yments 
and payment systems in the EU on the basis of an ECB Regulation of 28 November 2013 (updated 
in 2016). In their current form, the ECB statistics do not offer specific information about the payment 
transactions performed by fintech companies or even the number of fintech companies. Said 
statistics provide data per category of payment instrument and payment service provider: credit 
institutions, E -money institutions and payment institutions. No specific category is foreseen for 
fintech companies, which  can fall under either category. Within each existing category, some 
providers could be considered as fintech companies, while others cannot.  
 
PART I: QUESTIONS REGARDING THE Secretariat Report  
I TRADE policy REVIEW  
 
Page 242 (Para 4.306)  
The Commission es timated, in 2016, that these objectives required an additional investment of circa 
EUR 155 billion.  
 
Question 44 . In the case the Com mission's estimate also considered the sources of 
funding, what were the expected shares of contribution from the public an d private 
sectors?  
 
EU reply:  
The Commission has set three ambitious targets for a gigabit society by 20259: (1) Gigabit 
connectivity for all main socio -economic drivers such as schools, transport hubs and main providers 
of public services; (2) High perf ormance 5G connectivity in urban areas and main transport corridors; 
(3) All European households, rural or urban, to have access to Internet connectivity offering 
download speed of at least 100 Mbps, upgradable to Gigabit speeds.  
 
The Commission has sought expert advice to cost some specific scenarios. This includes the study 
"Costing the new potential connectivity needs"10 and has been complemented by further work by its 
own services.  
 
The total estimated cost for the fulfilment of the three proposed  objectives by 2025 is 
c. EUR 515 billion. This entails an additional investment of EUR 155 billion, to complement the 
investment of EUR 360 billion that can already be expected in a "business as usual" or baseline 
scenario from telecommunications operator s over the 2016 to 2025 period.  
 
In more detail, the individual amounts necessary to achieve the three objectives, not counting 
synergies between them, are estimated as follows, based on plausible assumptions about the 
proportion of underlying infrastruct ure needs that would in each area already be met by "business 
as usual" market activity (e.g. fibre along motorways):  
 
• Gigabit connectivity for socio -economic drivers: Providing all main European socio -economic 
drivers with gigabit connectivity by 2025 wil l require an additional EUR 46 billion investment 
on very high capacity fixed networks to connect primary and secondary schools, local 
authority buildings, digitally intensive enterprises, business parks, universities, research 
centres, doctors' surgeries,  hospitals, stadiums, train stations, ports and airports. This will 
amount on average to an estimated maximum additional connectivity cost for each 
socio-economic driver institution of roughly EUR 3500-4000 annually. In the case of a school 
of 20 classes w ith 25 students this would translate into an additional annual connectivity 
cost of EUR 7-8 per student.  
 
• High performance 5G connectivity along main transport corridors including railways, 
motorways and national roads will require another EUR 28 billion investment in mixed fixed 
and wireless networks: EUR 5.2 billion to connect railways, EUR 1.5 billion to co nnect 
 
9 European Commission: Communication "Connectivity for a European Gigabit Society" and 
Communication and Staff Working Document – "Connectivi ty for a Competitive Digital Single Market – towards 
a European Gigabit Society": https://ec.europa.eu/digital -single -market/en/policies/improving -connectivity -
and-access download page: https://ec.europa.eu/digital -single -market/news -redirect/34110.  
10 European Commission study SMART 2015/0068 "Costing the new potential connectivity needs" by 
Analysis Mason for the European Commission. https://op.europa.eu/en/publication -detail/ -
/publication/e81ae17f -9d27-4b68-8560-7cd45dbe21d8 . WT/TPR/M/395/Add.1  
 
- 51 - 
 
  motorways, and 21 billion to connect national roads. In comparison with the scale of the 
automotive industry providing jobs for 12 million people and accounting for 4% of the EU's 
GDP (more than EUR 400 billion) the investment is feasible and would b e a logical step in 
the process of innovation of the transport sector.  
 
• Improved connectivity in rural areas will require a EUR 127 billion investment in a 
combination of fixed, wireless large and small cell -based networks:  
 
o The cost per user grows exponen tially as the network reaches less and less 
populated areas, where the number of users sharing it is smaller. While the first 
50% population coverage requires 20 -25% of the total investment, the last 5% are 
the most costly and difficult to connect. For thi s reason, the last 5% of households, 
roughly 11 million households, are assumed to be covered by macro cell 
infrastructure only (with very high capacity backhaul). Deployment of wireless 
connectivity offering the last 5% at least a download speed of 100 Mb ps is estimated 
to cost over EUR 24 billion. It is clear that this investment will require public 
intervention – public investment or publicly enabled investment.  
o For the other 95% of households, we expect a variety of approaches, between macro 
and micro c ells for wireless and FTTH/B for fixed connectivity. On the assumption 
that each type of infrastructure will account for an equal part of the future 
deployment, the investment needs would amount to EUR 103 billion.  
 
The total of EUR 201 billion, being the sum of all three options, does not take into consideration 
economies of scale and the synergies which could be used in combining more than one scenario. 
Based on the above mentioned study by Analys is Mason we assume in particular that the re -use of 
the fib re networks rollout for reaching the first objective could produce up to EUR 46 billion savings 
in the third one. Therefore the final additional investment needed would be approximately 
EUR 155 billion.  
 
In summary, the European Commission expects the mark et to solve most problems. Only in specific 
scenarios of market failure, state -aid is endorsed.  
 
These estimation was done before the enactment of the new European Electronic Communications 
Code. The Code includes some measures to attract private investme nt through more flexible 
regulation, such as by (i) promoting co -investments in certain areas, (ii) giving priority to access to 
physical infrastructure as a remedy to foster competition, (iii) the provision for wholesale -only 
operators, etc.  
 
Beyond economic regulation, the Code includes other measures that foster investment, such as the 
minimum duration of spectrum rights (at least 15 years while ensuring predictability for 20 years), 
coordinated assignment of 5G bands, consistency and certain ty as regards the deployment of small 
cells, etc.  
 
The European Electronic Communications Code is expected to close part of that EUR 155 bn gap. 
The remaining part of the EUR 155 bn gap is to be met by public support.  
 
Page 243  
Table 4.23 Selected indic ators of developments in the telecoms sector, 2010 -18 
 
Question 45 . Does the European Union have any initiatives in place focusing on the 
reduction of the telecom sector's overall revenues?  
 
EU reply:   
Addressing the reduction of the telecom sector's overa ll revenues as such is not among the 
objectives of the European regulatory framework for electronic communications, nor of any other 
European legal framework.  
 
Art 3.2 of the European Electronic Communication Code lists the following general objectives of  the 
regulatory framework, namely (not listed in order of priority): (a) promote connectivity and access 
to, and take -up of, very high capacity networks, (b) promote competition, (c) contribute to the 
development of the internal market, and (d) promote the  interests of the citizens of the Union (by 
ensuring connectivity, availability and take -up of very high capacity networks, enabling maximum WT/TPR/M/395/Add.1  
 
- 52 - 
 
  benefits in terms of choice, price and quality, ensuring a high and common level of protection for 
end-users, etc.) . 
 
The regulatory framework aims, through the above objectives, to ensure a competitive telecoms 
sector, which benefits end -users and provides conditions incentivising investments in the high -
performance communications networks.  
 
Page 245 (Para 4.313)  
The EE CC expands the scope of application of EU telecoms regulation, in line with the principle of 
technological neutrality and to keep pace with technological development. It applies to "electronic 
communications services", i.e. services "normally provided for remuneration via electronic 
communications networks", which it defines as including three types of services: Internet access; 
interpersonal communications services; and services consisting wholly or mainly of the conveyance 
of signals.  
 
Question 46 . Could the EU elaborate on the treatment given to digital services in terms of 
classification? How are over -the-top applications providing similar services to traditional 
telecom services providers, such as messaging features, classified? Could they be 
categorize d as "interpersonal communications services"?  
 
EU reply :  
In order to reflect the market and regulatory developments and the continued need for sector -
specific rules, Article 2(4) of the European Electronic Communications Code redefines the term 
'electron ic communications service' (ECS) based on a functional approach. It contains three types 
of service categories: (i) internet access service, (ii) interpersonal communications service (ICS), 
distinguishing between number -based and number -independent ICS, an d (iii)  services consisting 
wholly or mainly of the conveyance of signals, such as transmission services used for M2M 
communications and for broadcasting signals.  
 
Recital 17 of the EECC includes further clarification as regards the terms 'minor' and 'ancillary': "In 
exceptional circumstances a service should not be considered to be an interpersonal communications 
service if the interpersonal and interactive communication facility is a minor and purely ancillary 
feature to another service and for objec tive technical reasons cannot be used without that principal 
service, and its integration is not a means to circumvent the applicability of the rules governing 
electronic communications services".  
 
As regards OTT applications providing similar services to traditional telecom services providers, such 
as messaging features, they would fall under these categories and therefore qualify as electronic 
communications services to the extent that they meet the definition set out in Article 2(4) of the 
EECC.  
 
Page 24 8 (Para 4.326)  
Finally, as part of the reform of telecoms rules, certain price caps apply as from 
15 May 2019 : 19 cents per minute (+VAT) prices for international calls within the EU to 
and 6  cents per minute (+VAT) for SMS messages.  
 
Question 47 . Could th e EU provide more details regarding the methodology applied in 
calculating the price caps? Were cost models developed for this purpose. If so, what kind?  
 
EU reply :  
The co -legislators used market studies in fixed and mobile communications, comparing dome stic 
and intra -EU prices. This is explained in greater detail in recital 43 of the BEREC Regulation (EU) 
2018/1971  (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2018.321.01.0001.01.ENG&toc=OJ:L:2018:321:TOC ). 
 
Page 249 (Para 4.328)  
As at 15 June 2017, roaming charges were abolished for customers travelling periodically within the 
EU, in accordance with a Regulation adopted in November 2015. In order to avoid negative effects 
of abusive use of regulated retail roaming services by roaming customers, the Regulation allows 
roaming providers to apply a "fair use" policy. Detailed rules and conditions on this "fair use" policy 
are laid down in an Implementing Regulation adopted in December 2016.  
 WT/TPR/M/395/Add.1  
 
- 53 - 
 
  Question 48 . Could the EU share infor mation on the main findings of the review of the 
European roaming market after the end of roaming charges recently published by the 
Commission?  
 
EU reply:   
On 29 November 2019, the Commission published its first full review of the roaming market11. It 
confirms the success of the reform and the overall good functioning of the roaming market under 
the new review rules: the reform has met its objective of unleashing the untapped demand for 
roaming consumption by travellers in the EU, as confirmed by massiv e increase in roaming traffic 
since June 2017. The review report and the accompanying Staff Working Document analyse the 
retail and wholesale roaming market, following the Roam -like-at-home (RLAH) reform, which 
marked the end of retail roaming charges as o f June 2017.  
The report was positive as regards compliance with the current rules. Only few breaches were 
detected, which were quickly solved in cooperation between the national regulator and the involved 
operator(s).  
At the retail end, the increase in roa ming consumption has been rapid and massive. In summer 2018 
(Q3'18), the use of roaming data in the EU/EEA was 12 times higher than in the last summer before 
RLAH (Q3'16). The volume of roaming phone calls was 3 times higher.  
The report observes an overal l absence of so -called "waterbed effects": the overall domestic tariff 
structure remains largely unchanged, without significant changes to domestic tariffs plans. Also, the 
use of domestic -only plans has been limited. In Q1 2019, more than 95% of all subsc ribers in the 
EU/EEA were roaming enabled, a stable share over time. Furthermore, roaming prices in non -EU/EEA 
countries have continued to decline on average.  
The vast majority of operators have applied a fair use policy (95% of MNOs and 78% of MVNOs) in 
order to prevent abusive or anomalous use of roaming services at domestic prices. The volume limit 
on open data bundles is the most implemented fair use policy measure by operators (84% of mobile 
operators offering such bundles use it). The almost unanimou s use of this safeguard may indicate 
that it has indeed contributed to the continued availability of the most competitive data bundles on 
domestic markets.  
The sustainability derogation measure has also worked adequately where needed as a safeguard to 
avoid distortions, in particular increases in prices, on domestic markets. In Q1 2019, only 1.3% 
(resp. 3.1%) of the total EU/EEA retail roaming data (resp. voice) traffic was subject to a surcharge 
due to the derogation. Furthermore, operators that have been granted the derogation have been 
using it with utmost moderation many of them still offer large volumes of roaming services without 
surcharges to their subscribers in order to remain competitive on their domestic market. Where they 
apply the allowed roamin g surcharge, the latter is drastically reduced compared to before 
15 June 2017 (by more than 90% for data), so that the concerned customers substantially benefit 
from a considerable decrease in roaming prices even in such cases.  
The quality of mobile servi ces, and in particular the data speed, provided to travellers abroad is an 
essential parameter of the roaming experience and an integral part of the product whose price is 
regulated. While there is no particular evidence that roaming users get lower data s peed than local 
users, there seems to be a lack of transparency from a number of operators as regards the data 
speed provided to their customers while they roam abroad.  
Consumers widely recognise and appreciate the RLAH reform. One year after the introduc tion of 
RLAH, a Eurobarometer survey showed that 81% of travellers were aware that roaming charges had 
ended in the EU/EEA and 69% of all Europeans thought that they, or someone they know, benefit 
or will benefit. The feedback received by the Commission fr om consumer associations since June 
2017 is also very positive.  
At the wholesale end, the report notes that the impact of the large increases in roaming demand 
varies markedly between operators depending on the traffic flows of the given operator's customer 
base. Wholesale roaming prices have declined sharply12, driven mainly by (a) reductions in the 
wholesale roaming caps and (b) the significant increase in roaming volumes, which fuelled further 
competition in wholesale roaming prices belo w the ceilings. An external study, performed on behalf 
of the Commission13, shows that the wholesale roaming caps have nevertheless allowed a full 
recovery of costs at wholesale level plus margin.  
 
11 COM(2019)616 final, and accompanying Staff Working Document (SWD(2019)416 final).  
12 The average wholesale roaming price for data went down to EUR 1.78 /GB in Q1 2019, compared to 
EUR 8.22 /GB in Q1 2017. For voice, the average wholesale roaming price was EUR 1.97 cents/min in Q1 2019, 
compared to EUR 2.90 cents/min in Q1 2017  
13 Study SMART 2017/0091 'Assessment of the cost of providing mobile telecom services in the EU/EEA' 
by AXON, July 2019, available here.  WT/TPR/M/395/Add.1  
 
- 54 - 
 
  Overall, MVNOs have maintained their position on the market,  retaining or even slightly increasing 
their domestic market share (in subscriber numbers) and maintaining the average retail revenue 
per user.14 On the other hand, MVNOs in general pay higher wholesale roaming prices compared to 
MNOs, mainly because they a re in a structurally different situation from MNOs when negotiating 
wholesale roaming access.  
An external study, performed on behalf of the Commission analysed the technological and business 
developments that may influence the roaming market15. It concludes  that, despite signs of some 
competition dynamics on both the retail and wholesale roaming markets, the underlying basic 
competition conditions have not changed, and are not likely to change in the near future, to such an 
extent that retail or wholesale re gulation of the roaming market could be lifted.  
 
PART I: QUESTIONS REGARDING THE Secretariat Report  
 
II TRADE policy regime: framework and objectives  
 
Page 142 (Para 3.309)  
3.309. On 29 January 2016, the Commission presented a revised proposal for an Inte rnational 
Procurement Instrument (IPI). 365 The genesis of the IPI goes back to 2012, and is rooted in a 
longstanding EU concern about international imbalance in public procurement markets.366 
According to the Commission, the IPI would promote open access to public procurement markets 
around the world. It would allow the Commission to initiate public investigations in cases of alleged 
discrimination against EU companies in procurement markets. According to the Commission, the 
existing EU commitments, includ ing in the GPA and bilateral trade agreements, would remain 
unaffected by the IPI. Recently, the European Council called for resuming discussions on the IPI.  
 
Questions : 
Question 49 . What is the envisaged deadline for the adoption of the International 
Procurement Instrument?  
 
EU reply:   
The International Procurement Instrument Commission proposal is currently discussed by the 
co-legislators, the Council and the European Parliament: they review the proposal by the 
Commission and might propose amendments. As the legislative process is ongoing, it is impossible 
to provide any details on the timeframe for adoption or implementation of the envisaged instrument.  
 
 
Question 50 . How does the EU intend to safeguard that this instrument is compatible wi th 
commitments taken under the GPA and regional trade agreements?  
 
EU reply:   
According to the Commission's proposal, this instrument would fully comply with the EU's 
international commitments, as it would relate to procurement not covered in EU agreements at 
plurilateral and bilateral level.  
 
Page 141 (Para 3.303)  
3.303. The contracting authority may divide a procurement into lots but, if the total value of these 
lots is greater than the threshold, then EU -level rules will apply to the awarding o f each lot, except 
for small lots, for which the amounts are below the following de minimis levels:  
• EUR 80,000 for supplies or services; or  
• EUR 1 million for works; and  
• provided the aggregate value of the lots to be excluded from aggregation is no more than 20% of 
the total value.  
 
Question 51 . How is the division of procurement into lots compatible with the GPA, 
especially regarding article II:6 (a) of the Agreement?  
 
14 However, representing the situation of MVNOs throughout the EU remains  a challenge due to the 
small sample of MVNOs that have consistently provided relevant data over time.  
15 Study SMART 2018/0012 "Technological developments and roaming" by WIK Consult, July 2019, 
available here (https://ec.europa.eu/digital -single -market/en /news/technological -developments -and-roaming -
smart -20180012 -0). WT/TPR/M/395/Add.1  
 
- 55 - 
 
  EU reply:   
The division of procurements into lots is regulated by Article 46 of D irective 2014/24/EU on public 
procurement, with additional clarifications provided by recitals 78 and 79 of the same act. Similar 
provisions can be found in Directive 2014/25/EU on utilities.  
Regarding the valuation of contracts divided into lots, accordin g to Article 5, paragraphs 8 and 9 of 
Directive 2014/24/EU, where a proposed work, a proposed provision of services or a proposed 
acquisition of supplies may result in contracts being awarded in the form of separate lots, account 
shall be taken of the tota l estimated value of all such lots. Where the aggregate value of the lots is 
equal to or exceeds the applicable thresholds laid down in Article 4 of the same act, the provisions 
of the directive shall apply to the awarding of each lot.  
Equivalent provision s can be found in Article 16 of Directive 2014/25/EU on utilities.  
The division of procurements into lots can therefore not be used by contracting authorities to 
purposefully circumvent the provisions of the EU procurement directives, and therefore neither  of 
the GPA.  
 
PART I: QUESTIONS REGARDING THE Secretariat Report  
 
Page 115 (Para 3.209)  
 
Questions : 
Question 52 . After the submission of comments to European notifications, the EU has 
repeatedly argued that the changes suggested could not be incorporated into the final 
regulation. Could the EU provide examples of recent cases in which comments submitted 
by members ha ve been duly taken into account?  
 
EU reply:  
It is difficult to point to specific examples, as comments taken into account by the EU could also 
have been raised by other stakeholders in the legislative process. However, if comments are taken 
into account this will be pointed out in the reply to the third country. Generally, WTO Members' 
written comments on TBT notifications are received and collected by the EU TBT Enquiry Point and 
shared with the Commission's competent services. The relevant Commission se rvice(s) will then be 
in charge of drafting a reply to the third country comments. In some cases, comments come at a 
later stage, i.e. when the draft is in the final phase of its decision -making process and it is difficult 
to take them on board. However, t hird country comments are always analysed and replied to.  
 
One recent case during the review period that could be highlighted as to how the EU takes into 
account comments from other WTO Members concerns the adoption of Regulation (EU) 2019/1020 
on market s urveillance and compliance of products. Following comments raised at the TBT 
Committee and by other stakeholders, the Commission reduced the product coverage falling under 
the scope of this Regulation.  
 
Question 53 . How does the EU intend to safeguard that this instrument is compatible with 
commitments taken under the GPA and regional trade agreements?  
 
EU reply:   
This question  seems to be either a misunderstanding or a mistake in the references. There is no 
connecti on between TBT notifications and the GPA.  
 
Page 115 (Para 3.210)  
 
Question 54 . Brazil has raised specific trade concerns related to maté. EU addressed the 
question on the revision of its organic product regulation, but it will enter into force only 
in 2021 . Does the EU consider 3 years a reasonable timeframe to withdraw a measure 
with significant impact on international trade and no technical grounds?  
 
EU reply:   
The EU has amended its organic farming legislation to formally include maté in its scope. This was 
part of a much wider overhaul of the primary legislation covering the sector (Regulation (EU) 
2018/848). This naturally takes time for adoption as well as subsequent implementation. The new 
rules will apply from 1 January 2021. We understand that never theless in practice this should not 
have had major economic impacts.  WT/TPR/M/395/Add.1  
 
- 56 - 
 
  PART I: QUESTIONS REGARDING THE Secretariat Report  
 
3 TRADE policy AND PRACTICES BY MEASURE: SAFEGUARDS  
 
Page 79 (Para 3.79)  
The changes set out in the second amendment in 2018 are more numerous and diverse; the main 
elements are outlined in Box 3.2.125 As illustrated, the changes involve procedural aspects, such as 
shortening the time -period for provisional measures, and more s ubstantial aspects, such as how the 
injury margins are calculated. For example, in calculating the non -injurious price, a minimum profit 
of 6% is included. Another new development is the ability to take into account the presumably higher 
costs of EU indust ry compliance with social and environmental standards.  
 
Questions:  
Question 55 . How did the European Union determine that a profit of 6% should be the 
minimum profit to be considered in calculating the non -injurious price, regardless of the 
type of indust ry?  
 
EU reply:   
The minimum target profit of 6% was selected on the basis of historical information on profitability 
for the industrial sector from financial databases, such as Bloomberg and BACH.  
 
Page 84 (Para 91)  
In 2019, the EU issued Regulation (EU)  2019/287, the horizontal bilateral safeguard regulation, 
allowing for the implementation of bilateral safeguard clauses and other mechanisms for the 
temporary withdrawal of tariff preferences in certain FTAs. The Regulation currently has three 
annexes for  the FTAs with Singapore, Viet Nam, and Japan, thus operationalizing and establishing 
procedures for these bilateral safeguard clauses. It contains provisions on monitoring, initiation of 
an investigation, prior surveillance measures, imposition of provisi onal and definitive safeguards, 
confidentiality, etc. In future, it is expected to be expanded to other FTAs. This Regulation brings 
about a change in practice and a rationalization as, previously, the EU established separate 
arrangements for each FTA.  
 
Questions : 
Question 56 . Does the EU have any plans to renegotiate the provisions on bilateral 
safeguard measures foreseen in the MERCOSUR -EU FTA, in light of Regulation (EU) 
2019/287?  
 
Question 57 . 2. If so, could the EU please elaborate on which provisions it would like to 
revise?  
 
Question 58 . Could the EU please specify which objective criteria will be used in order to 
determine if a given product is a "sensitive product", as established in artic le 2.7 of 
Regulation (EU) 2019/287?  
 
Question 59 . Could the EU please specify which objective method will be used to 
determine that a given surge of imports results from the obligations incurred under a 
specific FTA, as mentioned in article 3.1.(c) of Reg ulation (EU) 2019/287?  
 
Question 60 . Under which kind of circumstances could the EU initiate bilateral safeguards 
investigations ex officio , as established in article 5.1 of Regulation (EU) 2019/287?  
 
Question 61 . Why does Regulation (EU) 2019/287 not fo resee obligations in terms of 
grace period for the reapplication of bilateral safeguard measures to products that have 
already been subject to these measures?  
 
Question 62 . Could the European Union please elaborate on the procedure that must be 
carried ou t in order for a new Agreement to be added to the Annex mentioned throughout 
Regulation (EU) 2019/287? More specifically, will the corresponding EU trade partner be 
previously notified that its Agreement with the EU will be added to such Annex? Will such 
addition be negotiated between the EU and its trade partner? Also, in the case of specific 
provisions foreseen in such trade agreements which differ from the ones set out in 
Regulation (EU) 2019/287, will all of those provisions be included in the Annex or is it WT/TPR/M/395/Add.1  
 
- 57 - 
 
  possible that the EU will follow the rules set out in its Regula tion at the expense of what 
was negotiated with its trade partner in their trade agreement?  
 
Question 63 . Could the European Union please clarify whether there are other EU 
Regulations  which apply to bilateral safeguard measures foreseen in EU trade agreements 
not included in the Annex of Regulation (EU) 2019/287?  
 
Question 64 . Has the European Union conducted investigations based on Regulation (EU) 
2019/287? If so, are there public ca se files and how could they be accessed?  
 
Question 65 . In Article 13 of Regulation (EU) 2019/287, the European Union determines 
that an annual report on the application, implementation and fulfilment of the obligations 
contained in each Agreement will be made public. Could the European Union please inform 
where such reports will be available?  
 
EU reply to Q 56 -65 
Regulation (EU) 2019/287 ( "the Regulation ") lays down provisions for the implementation of bilateral 
safeguard clauses and other mechanisms for the temporary withdrawal of tariff preferences or other 
preferential treatments contained in trade agreements concluded between the EU and one or more 
third countries. The provisions of the Regulation shall apply without prejudice to any specific 
provisions contained in such trade agreements; specific provisions not covered in the Regulation will 
be listed in the Annex pursuant to Article 1.1 (Q.56 -57). To that effect, the Annex is amended in 
order to reflect specific provisions of trade agreements as soon as these agreements become 
provisionally applicable. This is a procedure in order to implement specific provisions of trade 
agreements into the EU domesti c legislation and does not go beyond that specific purpose; the 
provisions in the trade agreements take priority in any case. Any amendment to Regulation 
2019/287 is published in the Official Journal of the EU (Q.62).  
 
The meaning of the term 'sensitive p roduct' is already clearly explained in Article 2(7) of the 
Regulation (Q.58).  
 
An assessment whether imports under preferential terms have increased following the provisional 
application of the agreement, includes a detailed analysis of import data and i n particular a 
comparison to import data from prior periods (Q.59).  
 
As explained under Article 5(1) of the Regulation, the Commission may initiate an investigation on 
its own initiative, where it has at its disposal sufficient prima facie evidence of serious injury or 
threat of serious injury to the Union industry (Q.60).  
 
The duration of safeguard measures and a possible period of non -application of measures is normally 
provided for in the safeguard clauses included in the specific trade agreements. ( Q.61).  
 
For trade agreements concluded before the publication of Regulation (EU) 2019/287, other 
Regulations have been published where appropriate, such as Regulation 19/2013 or 1528/2007 
(Q.63).  
 
So far, no investigation has been conducted under Regulati on 2019/287 (Q.64).  
 
Such report will be made available on the Commission's website (Q.65).  
 
Page 94 (Para 3.123)  
In a related development, EU financial institutions subject to the European capital requirement 
regulations are no longer required to include  export credits in their leverage ratios. This came about 
due to problems related to Basel III implementation, whereby export finance banks were essentially 
penalized for having government -backed export credits as part of their portfolio. Thus, in 2019, th e 
regulation was amended to remove the guaranteed part of exposures arising from export credits 
from the total exposure measure if certain conditions were met. Thus, if the exposures in the form 
of guarantees for officially -supported export credits are pro vided by an export -credit agency in the 
local currency, they are totally exempt and, for those offerings in other currencies, they may be 
partially or fully exempt depending on the export -credit agency's credit rating. This is expected to 
give a boost to t he export -credit business and to the banks that offer export credits, and also improve 
liquidity.  WT/TPR/M/395/Add.1  
 
- 58 - 
 
  Questions : 
Question 66 . Could the European Union provide further details about the conditions for 
partially or fully exempting credits backed by officially -supported export credit agencies 
from capital requirements?  
 
EU reply:  
The second Capital Requirements Regulation (CRRII) introduced a number of technical amendments 
on the treatment of export credit exposures. Concerned institutions are therefore no longer  required 
to include officially guaranteed export credits in their leverage ratios, and can exempt those from 
the large exposures framework. These exemptions only apply to the guaranteed part provided that 
this is already subject to a 0% risk weight. If th e exposures in the form of guarantees for 
officially -supported export credits are provided by an export -credit agency in the local currency, 
they are totally exempt. Those offered in other currencies may be partially or fully exempt depending 
on the export -credit agency's credit rating. The decision on the total or full exemption is 
responsibility of the competent authority. Additional details about these exemptions can be found in 
Articles 400(2)(l) CRR which concerns the exemption from the large exposures  framework and 
429a(f) CRR which concerns the exemption from leverage ratio.  
 
PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 13 (Para 3.40)  
In July 2019, the European Commission adopted the Communication on Stepping up EU Action to 
Protect and Restore the World's Forests. The document lists as one of the Commission's key actions 
the strengthening of standards and certification schemes that hel p to identify and promote 
deforestation -free commodities.  
 
Questions:  
Question 67 . In light of members' commitments under Article 4 of the Agreement on 
Technical Barriers to Trade (TBT), how would the EU ensure that such standards and 
certification scheme s, which may also be developed by non -governmental bodies, will be 
compliant with the Code of Good Practice (Annex 3 of the TBT Agreement)?  
 
EU reply:   
Please find reply under Question 68.  
 
Question 68 . How would the EU ensure that such standards and certification schemes are 
not more trade -restrictive than necessary to achieve its policy objectives?  
 
EU reply to Q 67 and 68):  
The Commission has launched a "Study on Certification and Verification Scheme s in the Forest Sector 
and for Wood -based Products". Part of the study is to get an overview of the different certifications 
being used, encourage the strengthening of standards and certification schemes that help to identify 
and promote deforestation -free commodities through, among other things, studies on their benefits 
and shortcomings and by developing guidance, including assessment based on certain criteria to 
demonstrate the credibility and solidity of different standards and schemes. The outcome of t he 
study is to benefit operators, competent authorities, certification schemes and other stakeholders 
and to be used in the further work on deforestation free supply chains. If later, certification is seen 
as one possibility to pursue the goals, the standa rds are to be developed as described in the answer 
to question 70 and therefore compliant with the Code of Good Practice.  
 
Page 13 (Para 3.40)  
In July 2019, the European Commission adopted the Communication on Stepping up EU Action to 
Protect and Restore t he World's Forests. The document lists as one of the Commission's key actions 
the assessment of additional demand for regulatory and non -regulatory measures to ensure a level 
playing field and a common understanding of deforestation -free supply chains.  
 
Questions:  
Question 69 . Could the EU provide examples of such regulatory and non -regulatory 
measures?   
 WT/TPR/M/395/Add.1  
 
- 59 - 
 
  EU reply:   
The policy options to be studied include, for example:  
• Calling on the industry to make voluntary pledges to free their supply chains from prod ucts 
associated with deforestation;  
• Implementing certification and labelling schemes that build on the experience of organic 
farming, for instance, or hygiene products;  
• An approach based on the EU's fight against illegal fishing (IUU), including a country 
assessment system with yellow and red cards for states that do not comply with the rules;  
• Establishing an obligation of exercising due diligence for market operators, building on 
experiences such as the EU Timber Regulation, designed to fight against illegal logging;  
• Tools similar to the product environmental footprint and organization environmental 
footprint;  
• Sustainable finance that enhances the transparency of investments and the disclosure of 
information regarding their sustainability;  
• Bilateral agreements with third countries.  
 
Question 70 . Pursuant to recommendations 34.(b) and 43.(b) of the 5th Triennial Review 
of the TBT Committee (G/TBT/26), while developing regulatory measures with a 
considerable impact on international trade, will the  EU seek to consider inputs from other 
member States during the early stages of the regulatory process, instead of notifying the 
TBT Committee a final draft regulation that is unlikely to undergo changes?  
 
EU reply:   
The EU is committed to openness and tr ansparency as it considers it essential to ensure 
inclusiveness, legitimacy and accountability and facilitates a mutual understanding of policy in any 
area by enhancing public trust. The European Commission facilitates stakeholder - including also 
non-EU countries - participation through:  
• feedback opportunities over the entire policy lifecycle, including on draft delegated and 
implementing acts;  
• a commitment to consult for a period of 12 weeks on all new proposals and evaluations; and  
• a new web -based common portal where all stakeholders can obtain information about new 
initiatives and express their views.  
To pursue a pro -active transparency poli cy on trade the European Commission publishes all its draft 
negotiating directives, reports of negotiating rounds and other relevant documents. In addition, to 
engage with civil society, public stakeholder events on trade are regularly organised with 
repre sentatives of non -governmental organisations, trade unions, business organisations and other 
groups. In this way, the European Commission receives concrete substantive input to improve its 
trade policy and to make it evidence -based.  
 
Page 16 (Para 3.52)  
As a consequence of the withdrawal of the United Kingdom from the European Union (EU), the EU, 
under Article XXVIII, has been negotiating the apportionment of tariff -rate quotas.  
 
Questions:  
Question 71 . The revised Political Declaration on the future relationship between the EU 
and the UK, issued on October 2019, foresees "an ambitious trading relationship on goods 
on the basis of a Free Trade Agreement" between both parties. How does the current EU 
proposal  for apportionment of its TRQs, negotiated under Article XXVIII, take into account 
this future relationship? More specifically, how will the EU ensure that imports of UK goods 
into the EU27 will not affect the existing level of market access for other WTO members 
with regard to its "erga omnes" TRQs?  
 
EU reply:  
The revised Political Declaration on the future relationship between the EU and the UK, issued on 
October 2019, envisages an economic partnership through a free trade agreement that would ensure 
no tariffs, fees, charges or quantitative restrictions across all sectors. Therefore, it is not expected 
that the EU and UK would be using one another's WTO TRQs.  
 WT/TPR/M/395/Add.1  
 
- 60 - 
 
  PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 10 (3.21)  
"3.21. During the reporting  period, the Common Agricultural Policy (CAP) continued on the path 
towards market orientation and away from trade -distorting support measures. The sugar production 
quota ended on 30 September 2017".  
 
The EU claims that its CAP is on a path towards market orientation, yet there will be an increase of 
the aggregate net amount of national ceiling for direct payments from EUR 41.490 bi in 2015 to 
EUR 42.485 bi in 2020 (page 165, table 4.4 of the secretariat report).  
 
Further to that, OECD's monitoring system r eveals a 91% increase in Market Price Support, from 
2011 to 2018, while the value of production increased only 7% (page 187, table 4.11 of the 
Secretariat report).  
 
The EU also made such claim, giving as example the end of the sugar production quota. That means 
that there are no further limits to production or to exports. Between 2006 and 2010, the sugar sector 
was thoroughly restructured with the support of EUR 5.4 billion. The European Union agricultural 
outlook for 2019 -30 report predicts that EU sugar p roduction is expected to reach 18.5 million tonnes 
in 2030 (compared to 17.5 million tonnes in 2019) and that EU sugar export capacity is expected to 
increase and exports could reach 2.2 million t by 2030. According to the same report, in the first 
year fo llowing the abolition of the quota system, the EU increased exports significantly and became 
a net exporter.  
 
Nonetheless, that happens in a context in which domestic support for European farmers is extremely 
high. In 2016, decoupled support (primarily BPS ) to sugar beet production in the EU amounted to 
approximately EUR 362 million. Member States also have the option of providing voluntary coupled 
support to sugar beet production. This is an option taken up by 11 Member States, States on the 
basis that the ir sugar beet production is vulnerable to decline without VCS 
(https://www.julianprice.com/jp_eu_market_report_june19.pdf) - with overall coupled support for 
sugar beet amounting in 2017 to roughly EUR 179 million  
 (https://www.eubusiness.com/topics/agri/s ugar-quotas -end). The amounts earmarked increased 
by some 3% from EUR 177 million to EUR 182.5 million in claim year 2019 and from 
EUR 170,8  million to EUR 173.4 million in claim year 2020 
(https://ec.europa.eu/info/sites/info/files/food -farming -
fisheries/ key_policies/documents/voluntary -coupled -support -note-revised -aug2018_en.pdf).  
 
There could be a serious risk of reduced opportunities to export raw and white sugar to the EU 
market and increased EU exports of sugar and subsequent displacement of white and raw sugar 
volume in global export markets and unfair competition with imports of EU refined sugar in domestic 
markets.  
 
Questions:  
Question 72 . Could the EU provide information on which policy changes were made to 
support the claim that the CAP continued on the path towards market orientation and 
away from trade -distorting support measures?  
 
EU reply:  
Direct payments and associated mechanisms (c ross compliance and greening) cover a large portion 
(90%) of the EU's farmed area and aim at mainstreaming practices beneficial for the delivery of 
public goods beneficial for climate and the environment.  
In 2007 -13, among other types of intervention, agri -environment and climate measures (AECM) 
paid farmers to care for soil, water, air and biodiversity in ways going beyond their legal obligations, 
on 48 million ha (around 25% of utilised agricultural area, UAA).  
Support for investment and knowledge buildin g made a further contribution. Specific targets related 
to carbon sequestration, cutting greenhouse gas emissions and raising the efficiency of irrigation 
systems (on 15% of irrigated land) were added for the period 2014 -20. 
In addition, the Commission ide ntified as top priorities of the post -2020 CAP: greater environmental 
and climate action ambition, better targeting of support, and a stronger reliance on Research and 
Innovation. The post -2020 CAP proposal is based on analytical work (impact assessment), public 
consultations with farmers and the general public and new EU international commitments (e.g. the 
Paris Agreement and Sustainable Development Goals).  WT/TPR/M/395/Add.1  
 
- 61 - 
 
  Question 73 . Could the European Union explain the "rationale" behind the increase of the 
aggregate n et amount of national ceiling for direct payments from EUR 41.490 bi in 2015 
to EUR 42.485 bi in 2020?  
 
EU reply:  
The increase in direct payments over the period 2015 -20 is due to the gradual phasing in of direct 
payments in some of the most recently acc eded EU Member States, particularly Bulgaria and 
Romania until 2016 and Croatia for the entire period. The figures referred to include transfers 
between the two CAP pillars and are therefore are affected by Member State decisions on such 
transfers.  
 
Questi on 74 . Could the EU provide updated information on the evolution of the weight of 
coupled support as a percentage of PAC's Pillar 1 direct payments?  
 
EU reply:  
The percentage of coupled payments (net execution figures) per financial year are:  
• 2016: 11. 11% 
• 2017: 11.13%  
• 2018: 11.52%  
• 2019: 11.45%.  
 
Question 75 . Could the EU provided updated data on disbursement, per program and/or 
scheme, to sugar beet production for the past 5 available years? Could the EU also provide 
official information on the vo lume of sugar beet production and export and the acreage of 
such production?  
 
EU reply:  
The EU has been, and remains committed to non - or minimally trade -distorting support forms. This 
is why 90% of direct payments have already been decoupled; and the rest is used for production 
limiting (coupled) supports that respect Blue Box criteria.  
 
Voluntary coupled support (VCS) does not aim to increase production; it is a Blue Box 'production 
limiting' support that only aims to aid sectors which undergo difficu lties. Accordingly, it is subject to 
strict conditions (e.g. the importance and the difficulty of the sector) and limits (budgetary limit at 
Member State level) in order to minimise its impact on the market.  
 
Ten Member States decided to support sugar beet  until 2016, which increased to 11 in 2017, when 
Lithuania also provided such support. The total allocations are relatively stable and represent only 
4% of the amount earmarked for VCS. VCS accounts for approximately 0.4% of the budget available 
for direct  payments. Moreover, the implementation data of 2015 -2018 show that the total number 
of supported hectares remained between 6% to 20% below the fixed (historical) number of hectares 
(14% lower in 2018). In addition, Member States implementing VCS only repr esent about 20% of 
the EU sugar beet production. None of the major suppliers or exporters (Germany, France, Belgium, 
etc.) grant such support. Thus, coupled support in the EU cannot be seen as creating a risk for unfair 
competition on the sugar market.  
 
For the second question, the EU can provide the following data:  
 
2013/14  2014/15  2015/16  2016/17  2017/18  
EU SUGAR PRODUCTION (Million tonnes)  16,82  19,51  14,94  16,84  21,32  
EU SUGAR EXPORTS (Million tonnes)  1,361  1,379  1,355  1,327  3,353  
EU SUGAR BEET AREA ('000 ha)  1,512  1,569  1,313  1,416  1,678  
 
Question 76 . How does the end of the sugar production quota - and the expected rise of 
production - is compatible with the VCS being notified as a blue box program, thus exempt 
from the reduction commitment?  
 
EU reply:  
For the years 2015 -2018, coupled support (volunt ary coupled support and the crop specific payment 
for cotton) varied between 11.1% and 11.6% of the total direct payments envelope.  
 WT/TPR/M/395/Add.1  
 
- 62 - 
 
  PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 11 (3.26)  
3.26. The Regulation on Official Controls will provide a  single framework for all official controls along 
the agri -food chain. Businesses and authorities will benefit from reduced administrative burdens, 
more efficient processes and strengthened controls.  
 
Question 77 . In spite of its recent record of complying  with EU regulations, Brazil's exports 
of products of animal origin to the EU have become more difficult and costly, since the 
imposition by the EU of reinforced controls. How can Brazil and other WTO Members 
benefit from this new piece of legislation? How  is the reinforced controls policy affected 
by this regulation?  
 
EU reply:  
Regulation (EU) 2017/625 establishes a more integrated approach to controls. Common rules now 
apply to controls carried out at borders on animals, products of animal origin, plants and other 
products and goods that must be checked before they enter the EU. The new import control system 
is even more risk -based, targeted and harmonised than before. Trading partners and competent 
authorities alike will benefit from the co mmon procedures and common requirements for facilities, 
equipment and staff qualifications that now apply throughout all border control posts.  
 
Detailed rules on the coordinated performance of intensified official controls have been established 
in Commissi on Implementing Regulation (EU) 2019/1873. Those rules include the criteria to meet 
for the coordinated performance to be launched (e.g. whether the notification is related to an act or 
omission for which the establishment of origin is responsible). The re sults of the intensified official 
controls are recorded in IMSOC and the competent authority of the third country concerned may be 
requested to make investigations and to adopt an action plan to remedy the situation. The common 
procedures and electronic me ans of communication (IMSOC) will help to ensure further efficiency of 
the system for intensified controls, to the benefit of trading partner and competent authorities alike.  
 
PART II:  QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 19 (Para 4.23)  
The EU is also active with partners in Latin America. In November 2017, the EU and Chile launched 
negotiations for an Association Agreement – deepening and expanding the existing Agreement. In 
2018, the EU reached a political agreement with Mexico on the modernis ation of the current 
Association Agreement. In June 2019, the EU concluded negotiations with Mercosur for an ambitious, 
balanced and comprehensive trade agreement.  
 
Question 78 . According to the latest official estimates, what would be the major 
macroecon omic effects of the EU -Mercosur agreement on both economic blocs, e.g. in 
terms of GDP (general and sectoral), external sector accounts (exports and imports), and 
prices?  
 
EU reply :  
The Sustainability Impact Assessment is currently being prepared by an i ndependent contractor, in 
this case London School of Economics. The draft interim report contains economic analysis of 
possible impacts in its chapter 3. The document can be consulted here: 
http://www.eumercosursia.com/#.  
 
Page 23 (Para 4.53c)  
In the context of a growing number of trade tensions and protectionist measures, the EU continued 
defending interests of its companies in the global market and ensured95 that European products are 
not blocked through barriers to trade.  
 
Questions:  
Question 79 . Have the EU economies been affected of late (as a targeted region) by the 
escalation of trade protectionist measures in general? Has the EU taken measures to 
respond accordingly? If so, how these protectionist measures (including the 
countervailing ones) ha ve impacted the EU external sector in terms of both exports and 
imports?  
 WT/TPR/M/395/Add.1  
 
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  EU reply:   
Since 2010, the barriers faced by EU business are analysed in the annual "Trade & Investment 
Barriers Report". At the end of 2018, 425 active barriers existed – a historic al record. Set against 
372 barriers at the end of 2016 and 396 barriers at the end of 2017, this figure confirms the 
continued rise of protectionism affecting EU stakeholders.  
In 2018 alone, 45 new barriers were recorded, as reported to the Commission and registered in the 
EU's Market Access Database. The magnitude of EU28 2018 trade flows affected by these new 
barriers represented EUR 51.4 billion.  
To respond to the rise in protectionism, the Commission has made enforcement a top priority.  
The EU Market Ac cess Partnership brings together the European Commission, Member States and 
European businesses. This Partnership identifies barriers that the EU face in third countries, defines 
a common strategy to remove them – and follows this strategy through.  
The Com mission is further reinforcing the Union's tools to focus on compliance and enforcement of 
the EU's trade agreements and created the post of Chief Trade Enforcement Officer that will be filled 
in early 2020.  
 
  WT/TPR/M/395/Add.1  
 
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  CANADA  
SECTION I: REGARDING THE EUROPEAN UNION (EU) REPORT  
 
3. Developments  in the internal market  
3.3 The EU Public Procurement Market  
 
Paragraph 3.9; Page 6  
 
Questions:  
Question 1. Has the Commission finalized its work on updating guidance on socially 
responsible public procurement? If yes, where would Canada find additional information 
regarding this guidance?  
 
EU reply:   
The second edition of the European Commission's "Buying Social" Guide to Taking Account of Social 
Considerations in Public Procurement is scheduled for publication in the third quarter of 2020. It will 
be available for download on the European Commission's website as of the time of publication.  
 
3.4 Sin gle market for services  
 
Paragraphs 3.11 -3.12; Page 7  
 
Paragraph 3.11 of the report by the EU mentions the adoption of the Directive on proportionality 
test before adoption of new regulation of professions.  Paragraph 3.12 follows with a  mention of a 
Communication, adopted following the Professional Qualification Directive , with recommendations 
on "national reforms aiming at improving the regulatory environment for a number of professional 
services with high growth and jobs potential (i.e. architects, engineers, lawyers)". By reference in 
the footnote, the Communication on reform recommendations for regulation in professional services 
mentions on p.8 other professions, such as patent agents, real estate agents  and tourist guides.  
 
As part of Greece's national reforms, the Federation of Hellenic Associations of Tourist and Travel 
Agencies (fedHATTA) has notified that, according to Greek Law 4582/2018, Article 25, in effect 
starting December 11, 2018, "it is expr essly illegal for a tour operator or travel agent outside the 
EU, without a legally operating travel agency in Greece, to provide tourism services in Greece if the 
tour operator or travel agent does not collaborate with a travel agency legally established in the 
country".  
 
Questions:  
Question 2. Could the EU please clarify what the requirement under Greek law 4582/2018, 
Article 25, entails in the context of the aforementioned Directives and Communication to 
improve the regulatory environment for profession al services?  
 
EU reply :  
Article 25 of Greek law 4582/2018 does not deal with professional qualifications and is therefore not 
covered by the Professional Qualifications Directive. As regards the new Directive on a proportionality 
test before adoption of new regulation of professions, it has not been transposed into Greek law yet. 
The deadline for this is 30 June 2020. Commission Communications have no legally binding effect.  
 
Question 3. Could the EU please explain how the requirement under Greek law 4582/2018, 
Article 25, meets the European Commission's GATS commitments and CETA obligations 
under the cross -border trade in services chapter?  
 
EU reply :  
Article 25 of law 4582/2 018 complements legislation dating back to 1976 and offers the possibility 
to foreign, non -established tour operators and travel agents to operate in the Greek market.  
 
3.7 Common Agricultural Policy  
 
Paragraph  3.24; footnote 45; Page 11  
It is noted that the EU introduced new rules for labelling products (No. 1151/2012 and No. 251/2014) 
which can increase trade barriers for imported products.  WT/TPR/M/395/Add.1  
 
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  Question 4. Can the EU explain how such labelling schemes will be enforced for both 
domestic prod ucts and imported products?  
 
EU reply:   
The new rules that are referred to in the WTO Secretariat Report do not concern the labelling of 
products but geographical indications. They aim at making geographical indications more attractive 
to farmers and cons umers, and easier to manage. The new rules will not increase trade barriers for 
imported products. The main proposed changes to the current rules are:  
 
• Allow hybrids of vitis vinifera and non -vitis vinifera vine varieties for production of wines with a 
Protected Designation of Origin;  
• Shorten the procedures for registration of geographical indications;  
• Improve protection of geographical indications, notably on internet sales and against goods in 
transit.  
 
3.11 The Implementation of the EU Environment Action Programme  
 
Paragraph 3.40; Page 13  
The report notes that EU's broader objective is "halting deforestation and forest degradation, 
combined with sustainable restoration, re - and afforestation activities, provide opportunities for 
economic  development. This requires putting a particular emphasis on the sustainable production 
and consumption of agricultural and forest -based products."  
 
Questions:  
Question 5. Could the EU provide further information on its efforts to halt deforestation 
and fo rest degradation through measures to curb demand for commodities that drive 
deforestation and forest degradation (e.g. deforestation -free supply chains)? How will the 
EU put the Communication into effect and on what timeline?  
 
EU reply:   
As stated in the European Green Deal, the European Commission will this year assess regulatory 
and non -regulatory options for additional demand side measures to minimise the risk that products 
linked to deforestation are introduced on the EU market. It wil l do so building on its previous 
experience, using a fact -based methodology and listening to the stakeholders involved. At the end 
of this process, it will come up with a policy proposal, which will need to be discussed and agreed 
with the European Parliam ent and the Council of the European Union to be approved and come into 
effect.  
 
Question 6. Could the EU elaborate on the "opportunities for economic development" that it sees 
as related to halting deforestation and forest degradation? How does the EU enc ourage or incentivize 
its trading partners to take advantage of such opportunities?  
 
EU reply:   
Well managed forests and well -developed forest value chains could generate important socio -
economic development, particularly in developing and emerging partner countries. According to FAO, 
forests could generate 45 million jobs through direct, indirect and induced employment (Source: 
Economic contribution of the world's forest sector (FAO FORESTRY PAPER 200, by Yanshu Li, 
University of Georgia Bi n Mei, University of Georgia, Thaís Linhares -Juvenal, FAO, Rome, 2019, 
unpublished). In the context of its development cooperation policy, the EU will propose to interested 
countries to establish Forest Partnership which could exploit this job potential (a long with climate 
and biodiversity objectives and support mechanisms to comply with any regulatory or non -regulatory 
measures the EU could put in place to stop "imported deforestation").  
 
Question 7. Given that the EU Stepping Up Action on Forests initiati ve (Stepping Up EU Action to 
Protect and Restore the World's Forests [SWD(2019)307]) lists the redirection of finance (Official 
Development Assistance, private investment, etc.) toward more sustainable land management 
practices as one of 5 priority areas, how is the EU integrating this into its trade policy? The Stepping 
Up Initiative also seems to indicate that return on investment in forest protection, carbon sinks and 
biodiversity conservation is more challenging. What measures are proving effective?  
 WT/TPR/M/395/Add.1  
 
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  EU reply:   
The European Green Deal, together with the EU Sustainable Finance Action Plan and follow -up 
initiatives, set the direction of travel towards sustainability. In implementing these policies the EU 
will strive to make sure the right regulatory and f inancial incentives are in place, both at EU and at 
global level. Trade policy supports the goals of the European Green Deal and EU Sustainable Finance 
Action Plan, including in promoting sustainable forest management and responsible business conduct 
respe ctively with trade partners. The EU will continue advocating for that change in the appropriate 
fora, both multilaterally (WTO, OECD etc.) and bilaterally (EU FTAs).  
As regard the 2nd part of the question, the EU considers that investors will be more reluc tant to 
invest in forest protection and biodiversity conservation as return on investment is generally 
hazardous due to the absence of reference baselines. Private investors will be more attracted by 
plantation projects where return on investment and the t imeframe are known at the beginning of 
the investment and where uncertainties and risks are more manageable.  
 
Question 8. Given the EU's experience with Voluntary Partnership Agreements (VPAs) and Forest 
Law Enforcement, Governance and Trade (FLEGT), what have been some of the best practices 
identified when determining criteria or indicators that will help to meet deforestation and forest 
degradation objectives as referenced in the Communication on Stepping up EU Action 
(e.g. Worldwide Governance Indicators  (WGI), certification systems, etc.)?  
 
EU reply:   
Currently, the Commission is conducting work on the development of indicators to help assess the 
progress of the FLEGT Action Plan and VPAs. The indicators will cover the various activities, outputs, 
outco mes and impacts of the FLEGT AP for producing countries, EU demand and investment and the 
global sphere. In addition, these indicators will help in monitoring progress towards meeting the 
EU's deforestation and forest degradation objectives, drawing on bes t practice examples from the 
VPAs and FLEGT Action Plan.  
 
3.12 The EU's Actions on Climate Change  
 
The report details the EU's actions and objectives with respect to climate change.  
 
Question 9. Could the EU elaborate on how the recently announced commitment to reduce GHG 
emissions to net zero by 2050 will affect the EU's climate actions? What stands to change, 
particularly with respect to energy?  
 
EU reply:   
The Commission presented its insights  on what it would require to become a climate neutral economy 
in the 2018 Communication 'A Clean Planet for all A European strategic long -term vision for a 
prosperous, modern, competitive and climate neutral economy' (link: https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52018DC0773 ). It concluded on seven buildings 
blocks including the need to maximise the benefits from energy efficiency, the deployment of 
renewables and the use of electricity to fully decarbonise Europe's energy supply. This was  supported 
by an in -depth analysis (link: 
https://ec.europa.eu/clima/sites/clima/files/docs/pages/com_2018_733_analysis_in_support_en_0
.pdf) looking into sectoral impacts and the required enabling framework, where also detail can be 
found on how it would c hange the EU energy system, notably in sections 4.2 to 4.5 discussing the 
EU's energy supply, building, transport and industry sectors.  
Energy policy has a key role in contributing to a successful European Green Deal and thus, it is 
important to ensure ef fective implementation of the existing energy and climate legislation. Energy 
efficiency must be prioritised and the power sector will have to be based largely on renewable 
sources. Member States will play a pivotal role in contributing to this. The Commis sion will assess 
the National Energy and Climate Plans of the Member States. This will feed into the process of review 
and revision, where necessary, the relevant energy legislation in 2021.  
A strategy for smart sector integration will promote the smart i ntegration of electricity, renewable 
and decarbonised gases, heating, transport, industry, agriculture and other sustainable solutions 
across all sectors of the economy. This should facilitate achieving decarbonisation at the lowest 
possible cost . 
 WT/TPR/M/395/Add.1  
 
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  Paragraphs 3.41 -3.44; Page 13  
On December 11, 2019, the EU announced the European Green Deal which includes a number of 
initiatives relating to climate change including a border carbon adjustment for selected sectors (with 
a tentative timeline of 2021).  
 
Questions:  
Question 10. Can the EU elaborate on its proposal in the European Green Deal for the 
development of a border carbon adjustment for selected sectors?  
 
EU reply:   
The EU has fully translated the steps to meet its Paris Agreement target into legis lation and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon  border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU's Emissions 
Trading System.  
The European Council of 12 December  2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way". A Carbon Border Adjustment mechanism is not designed to 
protect European  industry from open competitions but rather to ensure the environmental integrity 
and effectiveness of EU climate policies as they apply to its trade -exposed industries. The design of 
the border measure will complement the EU's carbon pricing policies (in particular a cap -and-trade 
system) which will remain the cornerstone of the EU's climate policies. The internal market of the 
EU will stay open to foreign competition under applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Trade Organisation and our trade agreements in 
particular. There is a breadth of considerations that need to be reviewed in the design and 
implementation of such a measure. Before any proposal is made, all potential measures will first 
have to be carefully assessed in terms of economic efficiency, environmental, social and financial 
impacts and legal feasibility, in particular with respect to WTO rules, trade agreements and other 
international commitments, and of complementarity and possible interaction with the Emission 
Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commission pledged to step  up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 80% of global greenhouse gas 
emissions".  
 
Question 11. Can  the EU describe its approach to ensuring that a border carbon 
adjustment is WTO compliant?  
 
EU reply:   
Please see reply to Q10.  
 
3.13 Clean Energy for All Europeans Package  
 
Paragraph 3.46; Page 14  
The report notes the EU's "revised Renewable Energy Sources Directive  introduces a new approach 
to address emissions from indirect land -use change ("ILUC") associated to the production of biofuels, 
bioliquids and biomass fuels. It includes a binding renewa ble energy target for the European Union 
for 2030 of 32% with an upwards revision clause by 2023. The rules also serve to create an enabling 
environment to accelerate the penetration of renewable energy, as well as public and private 
investment in innovati on and modernisation in all key sectors."  
 WT/TPR/M/395/Add.1  
 
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  Questions:  
Question 12. Could the EU elaborate on which sectors it has determined to be "key 
sectors"?  
 
EU reply:   
Such key sectors are electricity generation, heating and cooling, and transport.  
 
Question 13.  The 2018 Directive notes that the risks from ILUC are linked to various 
factors, including the type of feedstock used for fuel production, the level of additional 
demand for feedstock triggered by the use of biofuels, bioliquids and biomass fuels, and 
the extent to which land with high carbon stock is protected worldwide. Can the EU 
provide further information on how it assesses and aims to mitigate these risks for both 
EU Member States producers and non -EU Member States producers of biofuels? Is there 
a priority placed on greenhouse gases over other considerations, e.g. biodiversity, land 
use change? Is the EU considering integrating such factors into its trade policy in the 
future?  
 
EU reply:   
The contribution of conventional biofuels (i.e. those based on  food and feed crops) to reduce GHG 
emissions in transport is limited due to ILUC. Accordingly, the recast Renewable Energy Directive 
includes a limit for the contribution of all conventional (food and feed crop based) biofuels towards 
the EU renewable ene rgy targets, and an additional gradually decreasing limit for conventional 
biofuels produced from crops for which a significant expansion onto high carbon stock land has been 
observed. Low indirect land -use change -risk biofuels are excluded from this limit . Land with high 
carbon stock comprises many areas with high biodiversity value. The provision therefore also aims 
to protect biodiversity.  
 
Further, the Renewable Energy Directive also includes specific rules on biodiversity protection. 
Biofuels, bioliqui ds and biomass fuels produced from agricultural biomass obtained from land with 
high biodiversity value cannot be taken into account for contributing to the renewable energy share 
of a Member State, a renewable energy obligation or for eligibility for fina ncial support. These rules 
are described in art.29 of the Directive ("sustainability criteria").  
 
4. TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.2 The EU Bilateral Negotiating Agenda  
 
Paragraph 4.19; Page 19  
It is noted that, on June 30, 2019, the EU signed  a Free Trade Agreement (FTA) and an Investment 
Protection Agreement (IPA) with Viet  Nam. Canada notes that on the same date, the Voluntary 
Partnership Agreement (VPA) between the EU and Viet  Nam entered into force.  
 
Question:  
Question 14. According to t he EU document "Guide to the EU -Viet Nam trade and 
investment agreements"16, the signed FTA "provides for specific action to advance the 
conservation and sustainable management of natural resources. In particular, it sets 
commitments on biodiversity, including with regard to strengthening cooperation under 
CITES and addressing ill egal trade in wildlife; forestry, including with regard to 
combatting against illegal logging; …". Given that the FTA/IPA were signed on the same 
month the VPA entered into force, is there a connection between the signature of the two 
agreements and the VP A? 
 
EU reply :  
While both the VPA and the FTA demonstrate the joint commitment of EU and Viet  Nam to promote 
sustainability, fight deforestation and combat illegal logging, the ratification procedures for both 
agreements followed their own respective track s. 
 
 
16 Guide to the EU -Viet Nam trade and investment agreements, Trade and sustainable development 
chapter, p.59: https://trade.ec.europa.eu/doclib/docs/2016/june/tradoc_154622.pdf . WT/TPR/M/395/Add.1  
 
- 69 - 
 
  4.3.5 Ensuring Responsible Management of Supply Chains  
 
Paragraph 4.46; Page 22  
It is noted that horizontal due diligence legislation requires, since 2018, the disclosure of 
non-financial information, including environmental issues, in management reports of companies 
exceeding 500 employees.  
  
Questions:  
Question 15. Is this information public? Are those due diligence processes unique to each 
company or are there specific requirements dictated by the EU, for example with regard 
to defor estation and legality of timber?  
 
EU reply:  
The Non -Financial Reporting Directive requires certain large companies to disclose certain 
non-financial information, including due diligence policies that they implement. This information 
should be disclosed in the company's management report, or in a separate report, but in any case 
it is publicly available. The legislation does not require compan ies under its scope to apply any 
particular standard regarding due diligence or the reporting of due diligence.  
 
Question 16. Will the due diligence requirements related to corporate reporting be taken up in 
future EU trade policy? If so, how? Will compan ies based outside of the EU be subject to these 
requirements?  
 
EU reply:  
Through its recent trade agreements, the EU and its partners commit to promote corporate social 
responsibility/responsible business conduct in line with international standards. How ever, the 
EU trade agreements do not contain any obligations on companies themselves to undertake due 
diligence. There is at this stage no indication that this approached would change.  
 
4.3.7 Transparency, Anti -corruption and Promoting Good Governance  
 
Paragraph 4.51; Page 22  
The report notes that "EU trade policy also contributes to the prevention and fight against corruption, 
for instance by increasing the transparency of regulations a nd procurement processes, or by 
simplifying customs procedures".  
 
Question:  
Question 17. How does the increase in transparency and simplification of customs 
procedures affect imports and enforcement? For example, how does this benefit 
implementation of t he EU Timber Regulation (EUTR) when trade involves imports of forest 
products from countries where illegal logging, corruption and bribery are prevalent?  
 
EU reply:  
Trade disciplines can contribute indirectly to prevent and combat corruption, in the sense  that, in 
enforcing their obligations, parties will at the same time reduce the opportunities and motivations 
for corruption, thus making corruption less likely to occur (electronic procedures in customs, 
transparent public procurement rules, less red -tape in administrative procedures for example). 
Simplifying paper work does not mean in any way that controls are waived or less stringent.  
 
PART II: REGARDING THE SECRETARIAT REPORT  
 
2. TRADE AND INVESTMENT REGIME  
2.3.2.2 Unilateral Preferences  
 
Paragraph 2.49; Footnote 81; Page 45  
It is noted that the EU uses different criteria to select countries that can benefit from the Special 
Incentive Arrangement for Sustainable Development and Good Governance (GSP+) grants.  
 
Question:  
Question 18. In some instances, the World Bank's World Governance Index (WGI) has 
been considered as an indicator to help identify level of risk of illegal logging. Has the EU 
identified what would be an appropriate threshold for such a WGI indicator?  WT/TPR/M/395/Add.1  
 
- 70 - 
 
  EU reply:  
The EU has thresholds limits for some environmental indicators, like air quality, noise as well as 
targets related to water quality and biodiversity. The EU does not work however with specific 
thresholds for illegal timber evaluations. Since few in dicators are directly linked to forest sector, the 
EU uses some indicators as proxies to assess the risk of illegal logging.  
 
Regarding the GSP+ arrangement, none of the 27 international conventions which beneficiary 
countries are required to ratify and i mplement directly relate to illegal logging. Nevertheless, the 
World Bank's World Governance Index (WGI) is one of many tools which may be used to assess 
implementation of the United Nations' Convention Against Corruption, which is one of the required 
conventions.  
 
2.4.1 Investment and the EU internal market  
 
Paragraph 2.55; page 46  
The report speaks to the investment plan for Europe and the intent to remove barriers to investment.  
 
Question:  
Question 19. Could the EU expand on the details of the investment plan for Europe and, in 
particular plans for/actions taken with respect to t he removal of barriers to investment 
in the energy sector?  
 
EU reply:  
Details of the Investment plan for Europe (InvestEU)  
When the Juncker Commission took office in late 2014, investment in the EU had fallen by 15% 
because of the financial and economic  crisis. The Investment Plan for Europe was launched to tackle 
this investment gap and to reinstate confidence both in the European economy and in the capacity 
of EU institutions to ensure sustainable growth during the crisis recovery.  
The Investment Plan for Europe, the so -called Juncker Plan, has three objectives: to remove 
obstacles to investment; to provide visibility and technical assistance to investment projects; and to 
make smarter use of financial resources. The Third Pillar of the Investment Plan aimed at measures 
to address barriers to investment, both at the EU and at the Member State level.  
 
Third Pillar of the Investment Plan: removal of barriers to investment  
 
Action at EU level aims at stimulating investment, removing barriers across countries and at 
supporting the implementation of structural reforms. The Commission acted to remove regulatory 
barriers to cross -border trade and investment in the Single Market, through initiatives such as the 
Digital Single Market strategy, the completion of the Capital Markets Union and the Energy Union.  
At Member State level, countries are encouraged to ensure well -functioning markets and institutions 
and a favorable business environment, in particular by reducing administrative and regulatory 
bottlenecks to investment. Countries are also encouraged to invest in human capital – to make sure 
that skill shortages are not impeding growth.  
Member States should also invest in networ k industries – digital, transport and energy 
infrastructures – to meet the requirements of the contemporary economy.  
Removal of barriers to investment in the energy sector  
Energy remains among the top three sectors with most investments mobilized under th e European 
Fund for Strategic Investments (EFSI). Out of the total of EUR 459bn investments mobilized, around 
EUR 80 bn have been mobilized in the energy sector. The EFSI has helped to finance investments 
delivering renewable energy to more than 10 million  households in the EU.  
The EU has recently updated its legislative framework for energy and climate policies as a basis for 
the EU to deliver on its climate and energy targets for 2030. These targets are to reduce greenhouse 
gas emissions domestically by at least 40  % compared to 1990 levels, to reach a share of at least 
32 % in renewable energy, and to increase energy efficiency by at least 32.5  %. The updated EU's 
energy legislation includes a recast of the renewable energy directive, the energy efficien cy and 
energy performance in buildings directives, the internal market for electricity regulation and directive 
as well as a regulation on risk preparedness and a regulation on an enhanced role for the Agency 
for the cooperation of energy regulators (ACER) . In addition, the EU has put in place a new 
governance framework – the Energy Union and Climate Action governance. Under this framework, 
all Member States are developing ten -year National energy and climate plans (NECPs) for the 2021 -
2030 period in which they define their national objectives and targets along the five dimensions of 
the Energy Union Strategy, and the associated policy measures to reach them.  WT/TPR/M/395/Add.1  
 
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  The updated legislative and governance frameworks contribute to provide a conducive environment 
for planning and investment in the energy sector. For instance, there is now a more integrated set 
of rules on the design of the electricity market. These rules are improving the efficiency of the 
electricity market through increased price conv ergence and cross -border exchanges. These 
provisions allow electricity to move more freely to where it is most needed, and facilitate the 
integration of renewable energy, demand response, and storage facilities to the market at least cost. 
In addition, the  updated regulatory framework contains specific provisions to make buildings 
'smarter' and more energy efficient; to set limits to carbon emissions from cars, vans, and lorries; 
and to update rules on the eco -design of energy -related products.  
As part of t he European Green Deal adopted by the Commission on 11 December 2019, the 
Commission is working on an impact -assessed plan to increase the EU's greenhouse gas emission 
reduction target for 2030 to at least 50% and towards 55% compared with 1990 levels in a  
responsible way. To deliver this additional reduction in greenhouse gas emissions, the Commission 
will, by June 2021, review and propose where necessary, all relevant climate -related policy 
instruments. These policy reforms will help to ensure effective c arbon pricing throughout the 
economy.  
 
3. TRADE POLICIES AND PRACTICES BY MEASURE  
3.1.3.3 TRQs and Administration  
 
Paragraph 3.44; Page 65  
It is noted that the regulation for the apportionment of WTO tariff quotas between the EU and the 
UK is based on their respective import share of the quota during a recent representative three -year 
period.  
 
Question:  
Question 20. Could the EU please provi de details on how the import share is calculated to 
take into account potential trans -shipments through other EU Member states? How does 
the methodology ensure that the country of final use is the same as the country of import?  
 
EU reply:   
The EU and UK th rough their "joint approach" intend to apportion the EU's WTO bound tariff rate 
quotas (TRQs) based on observed trade flows into the EU27 and the UK in a representative period, 
so that the existing level of market access available to other WTO Members woul d be maintained. 
The methodology has been applied across all WTO TRQs concerned.  
 
It is also noted that in January 2019, the EU issued a regulation on the apportionment of the WTO 
tariff rate quotas between the EU and the UK, in anticipation of the latter' s eventual withdrawal from 
the EU (Brexit). The EU opted to put in place a methodology for apportionment of TRQs for 
Article  XXVIII negotiations.  
 
Question:  
Question 21. How does the EU intend to ensure that the proposed TRQ volumes post -Brexit 
will continue to provide meaningful agriculture market access into the EU?  
 
EU reply:   
As stated in the answer to question 20 above, the proposed TRQ volumes are based on actual 
observed trade flows under a representative period. During transition,  European Union law applies 
to and in the UK as if it was still a Member State. This means that UK is bound by the obligations 
stemming from all EU international agreements such as EU commitments under the WTO. It is worth 
noting that the EU regulations im plementing the apportioned quantities of WTO TRQs will only apply 
once EU law no longer applies to and in the UK that is after the transition period.  
 
3.1.3.5 Preferential Tariffs  
 
Paragraph 3.51; Page 68  
It is noted that the share of imports under prefere ntial tariff regimes in total EU imports account for 
13% in the case of FTAs and 3.8% in the case of unilateral preferences.  
 
Questions:  
Question 22. What are, according to the analysis conducted by the EU, the main causes of 
these results? Is the EU considering measures to increase these shares?  WT/TPR/M/395/Add.1  
 
- 72 - 
 
  EU reply:   
The percentages of 13% and 3.8% are low because they are calculated by reference to total imports: 
"Total imports of the EU" include in particular huge import amounts relating to all EU imports unde r 
MFN regime (duty -free or not) from non -preferential partners such as, for example, the People's 
Republic of China, the United States, and EU imports from many MFN partners that are producers 
of minerals, raw materials and energy (petrol and gas). In addi tion, as shown in Table 3.5. above 
paragraph 3.51, 27% of the tariff lines of the EU are MFN duty -free lines: consequently all EU 
preferential partners such as Canada (and all partners under EBA, GSP, FTAs or other preferential 
regimes) export into the EU raw materials and many other products that can enter the EU market 
under MFN 0% regime. These preferential partners of the EU only need recourse to a preferential 
regime when the MFN tariff is not zero.  
 
3.1.4 Other Charges Affecting Imports  
 
Paragraph  3.53; Page  68; Paragraphs 3.57 and 3.59; Page 69 & 70;  
It is noted that the EU has excise duty reductions for small domestic wine, spirits, and beer 
producers.  
 
Questions:  
Question 23. Can the EU confirm whether any such exemptions or reductions are currently 
in effect and to which products they apply?  
 
EU reply:   
Directive 92/83/EEC allows Member States to grant reduced excise rates to small producers of beer 
(article 4) and ethyl alcohol (article 22). Member States must ensure that any reduced rates  they 
introduce apply equally to beer and ethyl alcohol delivered into their territory from independent 
small breweries and distilleries situated outside of their territory. These provisions cannot only apply 
to domestic producers.  
The Directive does not a llow for excise duty reductions or exemptions for small producers of wine, 
other fermented beverages or intermediate products  
 
Question 24. How would the above -noted exceptions be affected by the new series of 
excise rules as noted in Paragraph 3.59, page 70 of the Secretariat report?  
 
EU reply:  
In May 2018, the Commission proposed to amend Directive 92/83/EEC. The proposal included 
reduced excise rates for certain small producers. Member States are still negotiating this proposal.  
The proposal is availab le at: 
https://ec.europa.eu/taxation_customs/sites/taxation/files/25_05_2018_proposal_excise_duties_a
lcohol_impact_assessment.pdf.  
 
Member States are still negotiating this proposal and further information on the status of these 
negotiations are available at:  
https://data.consilium.europa.eu/doc/document/ST -14863 -2019-INIT/en/pdf.  
 
Paragraph 3.59; Page 70  
The report notes that the Commission proposed a new series of rules for excise duties in 2018, 
particularly for alcoholic beverages.  
 
Questions:  
Question 25. Is there an opportunity for stakeholders outside of the EU to comment?  
 
EU reply:  
The European Commission sought the views of all interested parties on how the current rules 
(Directive 92/83/EEC) on the structures of excise duties on alcohol and alcohol products work in the 
EU today. This consultation run from 28 August to 27 November 2 015. Further information is 
available at: https://ec.europa.eu/taxation_customs/consultations -get-involved/tax -
consultations/consultation -directive -9283eec -structures -excise -duty-alcohol -alcoholic -
beverages_en.  
 WT/TPR/M/395/Add.1  
 
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  Question 26. How would the proposal seek to address disparities for imported products?  
 
EU reply:   
If Member States introduce this optional relief, the competent authorities will have to ensure that 
the national treatment principle of the WTO agreement is respected  
 
Question 27. We also understand that it may be possible for Member States to apply 
reductions or exemptions from excise duty or other taxes for certain products of a regional 
or traditional nature.  
More specifically, can the EU confirm the status of the exemptions for ouzo in Greece, ru m 
from French Overseas Departments, and for some local products in certain regions of 
Portugal are still in effect?  
 
EU reply:  
Article 349 of the Treaty on the Functioning of the European Union (TFEU) allows specific measures 
to be taken in relation to t he EU's outermost regions. These measures take account of the structural, 
social and economic situation of those territories, which is compounded by their remoteness, 
insularity, small size, difficult topography and climate, economic dependence on a few pr oducts, the 
permanence and combination of which severely restrain their development.  
Council Decision No . 189/2014/EU of 20 February 2014 authorises France to apply a reduced rate 
of certain indirect taxes on 'traditional' rum produced in Guadeloupe, French Guiana, Martinique and 
Réunion and consumed in France. Traditional rum is defined at point 1(f) of Anne x II to Regulation 
(EC) No . 110/2008 of the European Parliament and of the Council, which stipulates the strength, 
place of production and aspects of the production method. The reduced rate is capped and applies 
to a fixed quota of 144,000 hl pure alcohol per year.  
Council Decision No . 376/2014/EU of 12 June 2014 authorises Portugal to apply a reduced rate of 
excise duty in the autonomous region of Madeira on locally produced and consumed rum and liqueurs 
and in the autonomous region of the Azores on locall y produced and consumed liqueurs and 
eaux-de-vie. 
Article 23(2) of Directive 92/83/EEC allows Greece to apply a reduced rate to "those aniseed 
flavoured spirit drinks defined in Regulation (EEC) No . 1576/89 which are colourless and have a 
sugar content of 50 grams or less per litre, and in which at least 20 % of the alcoholic strength of 
the final product is composed of alcohol flavoured by distillation in traditional discontinuous copper 
stills with a capacity of 1 000 litres or less."  
 
3.1.5 Import Prohib itions, Restrictions, and Licensing  
 
Paragraph 3.67; Page 73  
It is noted that, as part of the Forest Law Enforcement, Governance and Trade (FLEGT) Action Plan, 
the EU concluded several Voluntary Partnership Agreements (VPAs) with different countries, and 
each VPA generally contains provisions on a list of products covered by the HS code, rules for the 
licensing scheme, monitoring and evaluation, and reporting and communication provisions.  
 
Questions:  
Question 28. Could the EU comment on the effectiveness of Voluntary Partnership 
Agreements (VPAs) implementation thus far in terms of combatting illegal harvesting?  
 
EU reply:   
VPAs only become fully operational, when the partner country starts issuing FLEGT licences, that 
verify that timber and timber products under the VPA have been legally produced, in accordance 
with the legislation of the partner country. Indonesia is currently the only partner country issuing 
FLEGT licences and a periodic evaluation of the functioning of the timber legality assuran ce system 
is foreseen in the VPA agreement , undertaken by a team of independent experts. The second periodic 
evaluation  (2019) concluded that the timber legality assurance system is functioning as intended by 
the VPA.  
 
Question 29. Is the EU requiring that  VPA partners implement certain criteria or indicators 
as part of their efforts to promote timber legality? Would these criteria/indicators be the 
same for all partner countries?  
 WT/TPR/M/395/Add.1  
 
- 74 - 
 
  EU reply:   
Each VPA defines 'legally produced timber', based on the laws an d regulations of the partner country. 
The criteria and indicators to be used for checking compliance with those laws are laid down in each 
VPA and are partner country specific.  
 
Question 30. Where partner countries refer to internationally recognized indic ators (such 
as the World Governance Index, as has been done in Viet  Nam's draft Decree under their 
VPA), has the EU recommended appropriate thresholds to identify countries at low risk 
for illegal logging?   
 
EU reply:   
The EU has not recommended a fixed ap propriate threshold for internationally recognised indicators 
to identify countries at low risk for illegal logging, but recommends higher scrutiny, the higher the 
risk of, e.g. corruption, in a given country.  
 
3.1.6.1 Anti -dumping and anti -subsidy measure s 
 
Box 3.2 Main Elements of the Trade Remedy Modernization, 2018 ; Pages 79 -80  
 
The EU has made several changes to its trade remedy regime recently, including the ability to 
modulate the lesser duty rule where there are raw material distortions.  
 
Question:  
Question 31. Could the EU explain how it determines that the raw material is distorted 
and what specific impact this will have on the lesser duty rule?  
 
EU reply:   
The Commission may impose anti -dumping duties at the level of the du mping margin if:  
 
- the investigation finds that there are certain raw material distortions with regard to the 
 product concerned which fulfil the conditions set in Article 7(2a) of the BR, AND  
- the investigation concludes that it is in Union interest to impose the higher duty in accordance 
 with Article 7(2b) of the BR.  
 
The distortions on raw materials consist of the following measures: dual pricing schemes, export 
taxes, export surtax, export quota, export prohibition, fiscal tax on exports, licensing requirements, 
minimum export price, value added tax (VAT) refund.  
A single raw material, whether unprocessed or processed, including energy, for which a distortion is 
found, must account for not less than 17 % of the cost of production of the product concerned. For 
the purpose of the calculation, an undistorted price of the  raw material as established in 
representative international markets shall be used.  
 
3.1.6.2 Safeguards  
 
Paragraph 3.94; Page 85  
The report notes that the EU's surveillance measure on certain aluminum products originating in 
certain third countries will be  implemented until May 2020.  
 
Questions:  
Question 32. Does the EU intend to extend surveillance on certain aluminum products 
beyond this date?  
 
EU reply:   
A decision about whether to extend or not surveillance measures on certain aluminium products 
beyond May 2020 will be taken in due course.  
Surveillance measures have a limited period of validity, which can be extended by a decision of the 
European Commiss ion, after having consulted its Member States, when the conditions referred to in 
Regulations (EU) 2015/478 and (EU) 2015/755  are met. Any decision to extend these measures 
should be published in the Official Journal of the European Union before the expiry  of the measures 
in place.  
 WT/TPR/M/395/Add.1  
 
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  3.3.1.1 EU -Level Subsidies  
 
Paragraph 3.129; Page 97  
The report notes that "the European Agricultural Fund for Rural Development (EAFRD) is worth 
EUR 100 billion over 2014 -20, with a further EUR 61 billion of public funding in EU countries. 
Member  States and regions draw up their rural development programmes, based on the needs of 
their territories and addressing at least four of the following six EU priorities: fostering knowledge 
transfer and innovation in agricultu re, forestry and rural areas; enhancing the viability and 
competitiveness of all types of agriculture, and promoting innovative farm technologies and 
sustainable forest management; …restoring, preserving and enhancing ecosystems related to 
agriculture and forestry; promoting resource efficiency and supporting the shift towards a low -
carbon and climate -resilient economy in the agriculture, food and forestry sectors; …."  
 
Questions:  
Question 33. Could the EU elaborate on effective measures related to knowledg e transfer 
and innovation in forestry? What best practices can be shared – and what lessons have 
been learned from experiences to date?  
 
EU reply:   
A range of measures can be effective. Combining measures proves to be a good practice, for 
example, in Irel and, beneficiaries of Measure 10, which relates to agri -environmental and climate 
benefiting practices have to participate in Measure 01 – "Knowledge transfer".  
Another lesson learned from experience on innovation is that sometimes it is not enough to off er 
stand -alone funding for groups cooperating on innovation projects under Measure 16 – Cooperation. 
Innovation support services and innovation brokering which work using models that are adapted to 
local conditions could play a crucial role in bringing the  right people into the projects, connecting 
farmers and advisors with researchers and helping to identify funding.  
 
Question 34. Could the EU expand on how its efforts to promote Sustainable Forest 
Management (SFM) and restore/preserve/enhance forest ecosystems address the 
challenges related to the need for more research and scientific evidence on the transition 
to more  sustainable land practices, as noted in the Stepping Up Action on Forests 
initiative?  
 
EU Reply:  
The EU research framework programme Horizon 2020 has already financed significant research and 
innovation in relevant areas. However, more research and scie ntific evidence is needed for the 
transition towards more sustainable land -use practices and supply chains to halt deforestation and 
forest degradation. The Commission will enhance its efforts on these issues, not least through the 
next EU innovation and r esearch framework, Horizon Europe.  
 
Research is being developed in the EU framework programme Horizon Europe on: climate -change 
mitigation and adaptation; transitions relevant for biodiversity, the identification and implementation 
of nature -based solutio ns; forest and landscape restoration (including reforestation with biodiversity 
safeguards); trade -flows; and market monitoring of commodities associated with deforestation and 
forest degradation. In addition, it will support the sharing of best EU practic es on renewable energy, 
smart agriculture and other relevant areas with other countries  
 
Question 35. Could the EU elaborate further on how it is aiming to find an appropriate 
balance between the competing demands facing EU MS forests (e.g. conservation an d 
enhanced carbon sinks at the same time as increased production of bioproducts and 
biofuels)?  
 
EU reply:   
The Bioeconomy strategy is recognising the conflicting demands through the priority "understanding 
the ecological boundaries of the bioeconomy" whic h addresses multiple actions on understanding 
the environmental impact of the bioeconomy. Next to this there is the EU forest strategy 2014 -20 
which was developed to provide a coherent framework for both EU forest -related policies and the 
national forestry  policies of the individual EU countries.  
 WT/TPR/M/395/Add.1  
 
- 76 - 
 
  Question 36. What portion/share of the EAFRD funding is dedicated to forestry? What kind 
of projects are supported by this EU fund (e.g. enhancing forestry sector productivity, 
fostering sustainable forest management, afforestation)?  
 
EU reply:   
During th e programming period 2014 -2020, Member States have programmed around 
EUR 4.6 billion on forestry measures (4.6% of the total EAFRD budget). This includes actions such 
as afforestation and creation of woodland, establishment of agroforestry systems, prevent ion and 
restoration of damage to forests from forest fires and natural disasters and catastrophic events, 
investments improving the resilience and environmental value of forest ecosystems, investments in 
forestry technologies and in processing, mobilising and marketing of forest products, 
forest -environmental and climate services and forest conservation.  
 
3.3.1.2 State Aid  
 
Paragraph 3.135; Page  98 
It is noted that state aid must meet the condition of "appropriateness of the aid: the proposed aid 
measure is  an appropriate policy instrument to address the objective of common interest".  
 
Questions:  
Question 37. What factors are taken into consideration to evaluate whether state aid is 
the appropriate policy instrument?  
 
EU reply:   
State aid is not the only policy instrument available to Member States as there may be other, 
better -placed instruments such as public procurement, standardisation or general fiscal measures.  
The appropriateness of a policy instrument in a given situation is normally linked t o the nature of 
the problem that is being addressed. In its compatibility analysis, the Commission takes particular 
account of any impact assessment of the proposed measure carried out by the Member State 
concerned. Measures, for which Member States have c onsidered other policy options and for which 
the advantages of using a selective instrument such as state aid are established and submitted to 
the Commission, are considered to constitute an appropriate measure.  
 
Question 38. What criteria must be met for the policy instrument to be considered 
"appropriate"?  
 
EU reply:   
Member States concerned should ensure that the aid is awarded in the form that is likely to generate 
the least distortions of competition and trad e. In cases where aid is awarded in forms that provide 
a direct pecuniary advantage (e.g. direct grants, exemptions or reductions in taxes), the Member 
State concerned must include an analysis of other options and explain why or how other potentially 
less distortive forms of aid are less appropriate.  
 
Paragraph 3.135; Page  98 
The report indicates that state aid must meet the condition of "avoidance of undue negative effects 
on competition and trade between EU member States".  
 
Question:  
Question 39. Does the  EU evaluate whether state aid measures avoid negative effects on 
competition and trade with WTO Members?  
 
EU reply:   
No, the EU only has jurisdiction and exercises its competence within the internal market.  
 
Table 3.14 Non-Crisis Related State aid, 2013 -17, page  100: 
 
The report notes that non -crisis related non -agricultural state aid provided for the 
purpose of export promotion and internationalization amounted to EUR 788 million in 
2017, which was more than a 1300% increase compared to 2016.  
 WT/TPR/M/395/Add.1  
 
- 77 - 
 
  Questions:  
Question 40. Could the EU explain the reasons for this large increase in state aid provided 
for export promotion and internationalization?  
 
Question 41. Which specific programs or measures can this increase be attributed to?  
 
EU reply to Q40 -41:  
The increase in state  aid provided for the facilitation of the internationalization of companies is 
attributed to the Spanish Goodwill III (state aid scheme). "Spanish Goodwill" is used to refer to a 
corporate tax advantage in Spain that allowed the amortization of financial g oodwill derived from 
the acquisition of significant participations in foreign companies. The amortization of that goodwill 
for tax purposes would take place over a period of 20 years. In that respect, the measure promoted 
foreign acquisitions and thus the internationalization of companies, but it did not promote export 
activities as such.  
 
In 2009 and 2011, the Commission adopted two decisions considering that the tax advantage, when 
applied to direct acquisitions of foreign companies, amounted to unlawful incompatible aid and 
should be recovered. Those Commission decisions are commonly referred as Goodwill I and II 
decisions. In 2014, the Commission adopted a third decision (Goodwill III), confirming that the 
measure also amounted to aid in the cas e of indirect acquisitions (acquisition of companies through 
a holding company) and ordered the recovery of the aid.  
 
The recovery procedure for all three 'Goodwill' cases remains open, albeit significant progress has 
been made. The delay to enforce the Co mmission decisions was attributable to the fact that they 
were challenged before the European Courts. The amount to be recovered and that has been 
reported in 2017 corresponds to total amounts of the tax advantage enjoyed by the beneficiaries 
over several years (i.e. the amortization of goodwill could potentially spread over 20 years).  
 
For further information see State Aid Scoreboard 2018: Results, trends and observations regarding 
EU28 State Aid expenditure reports for 2017, ANNEX 1.7 - PROMOTION OF EXPOR T AND 
INTERNATIONALISATION, p.39.   
https://ec.europa.eu/competition/state_aid/scoreboard/state_aid_scoreboard_2018.pdf.  
 
For further information on SA.35550 "Spanish Goodwill III " - tax amortisation of financial goodwill 
for foreign shareholding acquisitio ns see:  
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=3_SA_35550 . 
 
3.3.2 Standards and Technical Requirements  
 
Table 3.20 Principal TBT Legislation, 2019 ; Page 108  
 
Question:  
Question 42. Can the EU provide more information on which regulation affects its ability 
to recognize Accreditation Bodies outside of the EU?  
 
EU reply:  
Regulation (EC) 765/2008 of 9 July 2008 sets out the requirements for accreditation in the EU. These 
requirements include that:  
 
• Accreditation is to be operated as a public authority activity. For this reason, each 
EU Member State may appoint one single n ational accreditation body.  
• There is no competition between national accreditation bodies.  
• As a general rule, national accreditation bodies are only to be active on the territory of their 
own Member States.  
 
Taking into account these underlying principles , Article 11 of Regulation (EC) 765/2008 further 
provides that any national authority in the EU shall only (i) recognise the equivalence of the services 
delivered by the accreditation bodies which have successfully undergone the peer evaluation carried 
out by the organisation appointed by the European Commission to manage the official European 
accreditation infrastructure (European cooperation for Accreditation), and (ii) thereby accept the 
accreditation certificates of those bodies and the attestations iss ued by the conformity assessment WT/TPR/M/395/Add.1  
 
- 78 - 
 
  bodies accredited by them. The EA peer evaluation aims at demonstrating conformity by the national 
accreditation bodies with the criteria laid down in the relevant EU harmonised criteria.  
The EU regulatory system on accredi tation does not include therefore the direct acceptance by public 
authorities in the EU of accreditation certificates issued by accreditation bodies from third countries. 
Such acceptance would require a specific EU legal basis. This legal basis may be esta blished through 
a government -to-government agreement, under the conditions agreed therein, or through a legal 
provision in EU legislation that contemplates that acceptance.  
 
Paragraph 3.164; Page 109  
 
Question:  
Question 43. Can the EU describe the process it uses for conducting post market 
surveillance on products that are designed to meet the technical regulations of another 
Member State?  
 
EU reply:  
When controlling safety requirements for consumer products that are not harmonised at EU level, 
market surveillance authorities of EU Member States follow the requirements and procedures laid 
down in their national legislations in accordance with the General Product Safety Directive 
2001/95/EC.  
 
For any o ther additional national requirements on products not harmonised at EU level, market 
surveillance procedures are further laid down at domestic level in EU Member States.  
 
Moreover, for controls at the EU's external borders, Articles 27 -29 of Regulation (E C) No . 765/2008 
governing the controls of products entering the EU market apply. These provisions will be replaced 
by Articles 25 -28 of Regulation (EU) 2019/1020 as of its date of entering into force (16 July 2021).  
 
3.3.2.1 New Legislative Framework  
 
Paragraph  3.167; page  109 
Canada notes that the European Union reviewed and/or replaced certain regulatory rules under the 
New Legislative Framework to make it easier for companies, especially small and medium -sized 
enterprises (SMEs), to sell their products a cross the EU.  
 
Questions:  
Question 44. Given that, even with the above -mentioned changes, the New Legislative 
Framework has the potential to make selling products in the EU significantly more 
complicated and administratively burdensome, could the EU provide any assessment it 
has do ne on the potential effects of the NLF for companies, particularly SMEs?  
 
EU reply:   
A first and detailed assessment of the implementation of the New Legislative Framework (NLF) was 
carried out by the European Commission in 2014 and is contained in the Co mmission Communication 
"A vision for the internal products" COM(2014)25, of 22 January 2014, and in its accompanying Staff 
Working Document SWD(2014)23, available at:   
https://eur -lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2014:0025:FIN:EN:PDF . 
 
The Eu ropean Commission has also carried out several evaluations of EU harmonization legislation 
adopted under the NLF that are published at:   
https://ec.europa.eu/growth/sectors/mechanical -engineering_en.  
 
The above assessments and evaluations have proven the b enefits of the NLF for economic operators 
in the access to the EU single market. When it comes to the latest legal acts adopted in the EU under 
the NLF, the European Commission carried out an impact assessment for Regulation (EU) 2019/1020 
on market survei llance and compliance of products, which is available at:  
https://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1580393753586&uri=CELEX:52017SC0466.  
 
An impact on SMEs is integrated throughout the assessment, including also an SME test in its 
Annex  3. 
 WT/TPR/M/395/Add.1  
 
- 79 - 
 
  The European Commission also carried out an impact assessment regarding Regulation (EU) 
2019/515 on mutual recognition on goods lawfully marketed in another Member State, available at:  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=SWD:2017:0471:FIN.  
 
Question 45. Could the EU also explain what measures it is taking to ensure that 
companies are able to adjust to the new rules and that the rules do not unnecessarily 
disrupt trade?  
 
EU reply:  
Regulation (EU) 2019/1020 provides that information on compliance with EU product rules will be 
made easily accessible to economic operators through the new tool laid down in Article 8 of the 
Regulation. In particular, economic operators will have easy online access through the Your Europe 
porta l that provides information about EU product requirements. This will be operational at the end 
of this year. In addition, there will be contact points at Member State level to which further questions 
on the implementation of product requirements can be add ressed.  
Further, the Commission will provide guidelines explaining the practical implementation of Article 4, 
regarding the appointment of responsible person to act as contact point for national market 
surveillance authorities for certain types of products . The aim is to publish them in 2020 . 
 
Regulation (EU) 2019/515 also intends to improve in different ways the legal certainty for businesses 
and national authorities as to when the mutual recognition principle can be used. In accordance with 
this principle , in the non -EU harmonized areas g oods that are imported from third countries to an 
EU Member State, which comply with the technical rules of that Member State and were made 
available to end users there, are eligible for mutual recognition in other EU Memb er States. In 
particular:  
 
• Regulation (EU) 2019/515 provides for self -declarations by economic operators intended to 
make it easier to demonstrate that a product is already lawfully marketed in a Member State 
and can therefore benefit from mutual recogniti on in other Member States.  
 
• The problem -solving system building on SOLVIT, which will deal with decisions denying or 
restricting market access, will also improve legal certainty for businesses and national 
authorities. Both businesses and national authori ties will know accordingly what they can 
reasonably expect when mutual recognition is, or ought to be, applied.  
 
• Last, closer administrative cooperation, and a common IT tool will enhance communication, 
cooperation and trust among national authorities, an d thus facilitate the functioning of the 
mutual recognition principle.  In particular, decisions by the competent authorities of 
EU Member States restricting or denying market access to goods which have been lawfully 
marketed in other Member States will be notified to the Commission and the other 
EU Member States through the tool ICSMS. ICSMS will also be used for exchange of 
information among the competent authorities and the national product contact points, which 
will facilitate their communication in t he area of mutual recognition of goods.  
 
Paragraph 3.168; Page. 109  
 
Question:  
Question 46. Is there, or will there be, a publicly available list of products that do not meet 
the mutual recognition principle?  
 
EU reply:   
No such list is planned.  
 
In this regard, it should be noted that goods that are lawfully marketed in one Member State could 
be denied market access in another Member State based on public interest grounds in specific cases. 
This would not prevent that the same goods may benefit from the principle of mutual recognition in 
other EU Member States.  
 
Indeed, EU Member States can restrict or deny market access to goods that have already been 
lawfully marketed in another Member State provided that this restriction or denial is aimed at 
attaining one of the public interest objectives listed in Article 36 of the Treaty on the Functioning of 
the European Union ("TFEU"). These public interest objectives are: (i) public morality, (ii) public WT/TPR/M/395/Add.1  
 
- 80 - 
 
  policy or public security; (iii) the protection of healt h and life of humans, animals or plants; (iv) the 
protection of national treasures possessing artistic, historic or archaeological value; or (v) the 
protection of industrial and commercial property. In addition to the grounds listed in Article 36 TFEU, 
there are "overriding reasons of public interest " or "mandatory requirements " developed by the 
Court of Justice of the EU that might also be raised by EU Member States, such as protection of 
fundamental rights (e.g. the protesters' freedom of expression and freedom of assembly), consumer 
protection, child protection or the protecti on of the environment.  
 
Paragraph  3.171; page  110 
 
Questions:  
Question 47. What steps will the EU take if a Member State contravenes an EU legislation 
(e.g. in its implementation or application)?  
In the context of Regulation (EU) No . 1169/2011 of the Europ ean Parliament and of the 
Council of 25 October 2011 on the provision of food information to consumers,  what 
avenues are open to the Commission if a Member State contravenes the legislation?  
 
EU reply:   
Member States have the primary responsibility to enforce EU law. The Official Control Regulation 
(EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 regarding official 
controls on products of animal origin intended for human consum ption (OCR) lays down 
requirements concerning enforcement actions and penalties to be taken by the Member States in 
relation to EU SPS measures. Article 17(1) TEU entrusts to the Commission the task of ensuring and 
overseeing the application of EU law by t he Member States under the control of the Court of Justice 
of the EU. One crucial component of the Commission's task is to monitor Member State compliance, 
and to respond to non -compliance.  
In the area of food law and SPS, the Commission experts carry out  controls in Member States in 
accordance with Article 116 of Regulation (EU) 2017/625, in order to verify the application of the EU 
measures, including EU rules aimed at protecting consumer interests and information, such as 
Regulation (EU) No . 1169/2011. The findings of such controls are laid down in a report which also 
contains recommendations to the Member State to address the shortcomings identified. The Member 
States have a number of obligations as regards the Commission controls which are laid down in  
Article 119 of the OCR, including the obligation to take appropriate follow -up measures to remedy 
any specific or systemic shortcomings identified through the controls performed by the Commission 
experts.  
In case a Member State fails to take appropriate follow -up measures to remedy shortcomings 
identified through the controls performed by the Commission experts or where there is evidence of 
possible non -compliance from other sources (e.g. complaints to the Commission), the Commission 
may act in accordance  with Article 258 TFEU. Under Article 258 TFEU, the Commission has broad 
power to bring administrative and judicial proceedings against Member States, which it considers to 
be in breach of their obligations under EU law. That also applies when a Member Sta te contravenes 
provisions of Regulation (EU) No . 1169/2011. The stages of this procedure are outlined below:  
If the Commission considers that a Member State has failed to fulfil an obligation under the Treaties, 
it gives notice to the Member State of the a lleged infringement and it gives that Member State the 
opportunity to submit observations  
If the matter is not resolved the Commission delivers a reasoned opinion on the matter requesting 
the Member State to comply within a given period of time (normally two months, except in case of 
urgency). This is a pre -litigation phase.  
If the Member State does not comply with the opinion within the period laid down therein, the 
Commission may bring  the matter before the Court of Justice of the EU.  
If the Court of Jus tice of the EU finds that a Member State has failed to fulfil an obligation under the 
Treaties, the State is required to take the necessary measures to comply with the judgment of the 
Court.  
According to Article 260 TFEU, if the Member State concerned does  not take the necessary measures 
to comply with the judgment of the Court, the Commission may bring the case before the Court of 
Justice of the EU. If the Court finds that the Member State concerned has not complied with its 
judgment it may impose a lump s um or penalty payment on it  
Finally, in case of a serious disruption in a Member State's control system, the Commission has the 
prerogative to adopt Union enforcement measures, in accordance with Article 141 OCR.  
 WT/TPR/M/395/Add.1  
 
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  Paragraph 3.175; Page 110  
It is noted tha t the CE marking is the manufacturer's declaration that a product meets the 
requirements of the applicable EC directives. Some Canadian manufacturers of wood construction 
kits have sought clarification on what constitutes a "product" under the EC construct ion directive. 
Current requirements for CE marking of component parts have impeded trade with the EU in 
prefabricated buildings, because CE marked component parts are not readily available and are cost -
prohibitive in Canada.  
 
Question:  
Question 48. Currently, it is understood that under ETAG 007 for prefabricated wooden 
construction kits, CE marking is required of all component parts, as well as for the kit 
itself. It is understood that this is in the process of changing, and that the re quirement 
for CE marking of component parts will be removed. As a result, only the kit itself will 
need to be CE marked. Could the EU confirm this is the case, and confirm a timeline for 
publication of the new requirements?  
 
EU reply:   
CE marking under Construction Product Regulation (Regulation (EU) 305/2011; the CPR) has a 
different meaning than in other sectors. There is no declaration of conformity under the CPR, there 
is a declaration of the performance indeed and requirements for p roducts are not defined.  
 
ETAG 007 is an outdated document, because it was adopted and published under the repealed 
Construction Product Directive (89/106/EEC). The European Organisation of Technical Assessment 
(EOTA) is working on EAD 34 -0308 that will b e the European Assessment Document (EAD) covering 
timber building kits under the CPR. The Commission expects that EOTA will make available this 
document in the coming months.  
 
The probable contents of the forthcoming EAD 34 -0308 are as follows. One of the basic principle for 
EADs on kits under the CPR is that the manufacturer is responsible for the performance of the kit 
covered by the EAD, and not for its components. Therefore, even if the components are covered by 
a harmonised European standard (hENs), th e manufacturer is not obliged to CE mark them 
separately if they are incorporated in the kit, because the declaration of performance concerns the 
kit and not its components.  
However, if components are to be placed in the market separately (therefore not in corporated in 
any kit), and a hENs exists for them they have to be CE marked.  
 
3.3.2.2. Institutional Framework  
 
Paragraph 3.185, page 111:  
The Report indicates that, in October 2018, in support of Union legislation and policies, the circular 
economy was i dentified as a strategic priority for European standardization.  
 
Question:  
Question 49. How will the European Union ensure that the French Loi relative à la lutte 
contre le gaspillage et à l'économie circulaire1  (law on the fight against waste and the 
circular economy) or any other similar Member State's law, which falls under this strategic 
priority, will be consistent with the European Union's commitments under the 
WTO  Technical Barriers to Trade Agreement?  
 
EU reply:  
EU Member States are responsible for notifying national technical regulations – adopted in the 
absence of EU harmonization legislation – in accordance with the TBT Agreement through their 
respective TBT Enquiry Points.  
Moreover, under the Single  Market Transparency Directive (Directive (EU) 2015/1535), EU Member 
States are to notify technical regulations at a draft stage to the European Commission. When 
notifying under the Directive, EU Member States are to indicate, among others, if the draft ha s a 
significant impact on international trade. If EU Member States do not indicate such aspect, but the 
European Commission is of the opinion that the draft is notifiable under the TBT Agreement, the 
European Commission will accordingly inform the concerne d EU Member State. Committees 
consisting of EU Member States and the European Commission under the Single Market 
Transparency Directive and for the TBT Agreement also meet at least yearly, where this type of 
issues, among others, are discussed.  WT/TPR/M/395/Add.1  
 
- 82 - 
 
  3.3.2.6. TB T Committee in the WTO  
 
Paragraph  3.210, page  115 
Canada notes the wide depth and breadth of agricultural policy reform in the EU, particularly for 
labelling requirements (energy and expiration date). One of the thirteen new specific trade concerns 
regardi ng measures taken by the EU or its Member States included the application of Regulation 
1169/2011 and Regulation (EC) No. 1924/2006 as regards the labelling of food products.  
 
Questions:  
Question 50. Canada understands that the European Parliament's Committee on 
Environment, Public Health and Food Safety (ENVI) approved legislation in January 2019 
to require producers to list energy values (presented as KJ or Kcal) on wine labels. 
Previously, wine had been exempt from these labelling requ irements under Regulation 
No. 1169/2011. What is the policy rationale for no longer excluding wine and spirits from 
energy labelling?   
 
EU reply :  
Unlike other pre -packaged foods, Regulation (EU) No . 1169/2011 on the provision of food 
information to consumers does not require alcoholic beverages containing more than 1.2% alcohol 
to bear a list of ingredients and a nutrition declaration on the label. Nonetheless, the Regulation 
mandated the Commission to produce a report to assess whether alcoholic beverages should be 
covered by the requirement to provide the list of ingredients and the nutrition declaration, and the 
reasons justifying possible exemptions.  
Consequently, the Commission adopted in 2017 a report to the European Parliament and the Council 
regarding mandatory labelling of the list of ingredients and the nutrition declaration of alcoholic 
beverages (13.2.2017,COM(2017) 58 final). According to the report, the list of ingredients and the 
nutriti on declaration are key information particulars that help consumers make more informed and 
healthier choices. It cannot be assumed that consumers are necessarily aware of the generally 
various ingredients used in the production process and their nutritional  value. On the basis of the 
information reviewed, the Commission concluded that an exemption from the mandatory listing of 
ingredients and nutrition declaration was not justified and invited the industry to develop a uniform 
self-regulatory proposal aiming  to provide the information in question on all alcoholic beverages.  
 
After the submission of a joint self -regulatory proposal by the industry in 2018 and subsequent 
discussions between the Commission and different sectors : 
 
- on 4 June 2019 the spirits sec tor signed a Memorandum of Understanding  
(https://spirits.eu/upload/files/publications/CP.MI -098-2019-MoU-
Final%20Version%20on%20website%20without%20signature -%204%20June%202019.pdf ) in 
which the sector committed to provide the energy value on label and the list of ingredients off label 
on at least 66% of products placed on the EU market by 2022.  
- on 5 September 2019 the beer sector  signed a Memorandum of Understanding accompanied b y 
a Brewers' Ambition, in which the sector committed to label the list of ingredients and energy values 
on all beer bottles and cans in the EU by 2022.  
 
The Commission follows closely the implementation of industry's commitments, as foreseen in the 
Memoran da of the beers' and spirits' sectors. It will decide in the future whether the self -regulatory 
approach is achieving the desired objectives and if not, on the next course of action.  
 
On the other hand, the EU legislation requiring wine producers to list e nergy values has not been 
adopted yet. The wine sector  supported the establishment of legal requirements in the context of 
the ongoing negotiations to revise the common agriculture policy legislation, as opposed to a 
self-regulatory approach. Such requirem ents, which are currently being discussed by the co -
legislators, would possibly entail providing the energy value on label and the list of ingredients off -
label.  
 
Question 51. Under Article 6, Member State's Legislation, paragraph 1, it is stated that 
"Mem ber States may lay down different rules from the Community rules ." In addition, 
Article 6, paragraph 2 of this same legislation indicates that Member States shall not 
prohibit or restrict the import, sale or consumption of spirit drinks which comply with t his 
Regulation. How does the EU plan to enforce this regulation to ensure that labelling WT/TPR/M/395/Add.1  
 
- 83 - 
 
  measures of Member States are not more restrictive than necessary and do not create 
barriers to international trade?  
 
EU reply:   
This question is unclear. It appears t o refer to Regulation (EC) No . 110/2008 which lays down specific 
requirements for the production and labelling of spirit drinks that are placed on the EU market. 
Article 6(1) of that Regulation allows individual Member States to lay down stricter rules tha n those 
set out in that Regulation if they are justified from a quality point of view. However, such stricter 
rules do not necessarily extend to imported spirit drinks that comply with the requirements of 
Regulation (EC) No . 110/2008. For this reason, the possibility in Article 6(1) for Member States to 
have stricter production and labelling rules for domestic products cannot create barriers to 
international trade as imported spirit drinks do not have to abide by rules that are stricter than those 
laid down  in Regulation (EC) No . 110/2008. This is without prejudice to other provisions of EU or 
national labelling law.  
 
3.3.3. Sanitary and Phytosanitary Requirements  
 
Paragraph  3.213; Page  116 
Canada notes that the most significant change to the EU's SPS regime is Regulation (EU) 2017/625 
of the European Parliament and of the Council of 15 March 2017 regarding official controls on 
products of animal origin intended for human consumption.  
Questi on: 
 
Question 52. Can the EU please provide additional information on the provisions of its 
future legislation (such as implementing legislation and delegated acts) regarding official 
controls, and in particular on any possible measures affecting the expor t of Canadian 
agricultural products to EU Member States?  
 
EU reply:  
Regulation (EU) 2017/625 establishes a more integrated approach, as common rules now apply to 
controls carried out at borders on animals, products of animal origin, plants and other prod ucts and 
goods that must be checked before they enter the EU.  
The new import control system is even more risk -based, targeted and harmonised than before. 
Common requirements for facilities, equipment and staff qualifications will apply throughout all 
borde r control posts. All consignments to be presented at the border control posts must undergo 
documentary checks, while identity and physical checks will be carried out at a frequency depending 
on the risk linked to the specific animals or goods. The common c riteria to determine and modify 
the frequency has been established in Commission Implementing Regulation (EU) 2019/2129.  
https://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1579873070417&uri=CELEX:32019R2129  
In addition, a single standard document, the Common Health Entry Document (CHED), will be used 
by operators for the prior notification of consignments. It will be transmitted to the border control 
post through a new integrated computerised system for official controls (Integrated Manage ment 
System for Official Controls, IMSOC) which will optimise the handling and exchange of information, 
data and documents necessary for the enforcement of agri -food chain rules.  
An overview of delegated and implementing acts adopted under Regulation (EU) 2017/625 can be 
found at 
https://ec.europa.eu/food/sites/food/files/oc_qa_ocregulation_20191212_delegated_implemented
_acts_en.pdf.  
 
Table 3.21 Principal SPS Legislations ; Page 116 and Paragraph 3.229; Page 120  
 
Canada understands that the new Regulation (EU) 2019/1381 sets out objectives and general 
principles of risk communications and empowers the European Commission to set out a general plan 
on risk communication. Risk communication could be used to address pu blic perception as regards 
to the safety of products that have been assessed as safe by the European Food Safety Authority, 
including products of biotechnology, and could potentially aid in increasing public acceptance of 
these products.  
 
Question:  
Questi on 53. When does the Commission anticipate publishing its general plan on risk 
communication?   
 WT/TPR/M/395/Add.1  
 
- 84 - 
 
  EU reply:  
The Commission is committed to deliver on this obligation. However, the final text of the new 
Transparency Regulation does not provide for a legal de adline for the adoption of the General Plan 
on Risk Communication, although the Commission's proposal had foreseen a deadline of adoption 
within 2 years from the date of application of the new Regulation.  
 
Table 3.21 Principal SPS Legislation, 2019;  Page 117  
 
The report notes Regulation (EU) 2019/6 of the European Parliament and of the Council of 
11 December 2018 on veterinary medicinal products, repealing Directive 2001/82/EC. Canada has 
the following questions regarding Regulation 2019/6:  
 
Questi ons: 
Question 54. Will the EU notify to the WTO SPS Committee or otherwise consult trading 
partners on all related delegated and implementing measures as regards the Veterinary 
Medicinal Products Regulation 2019/6, including the delegated act on the criteri a as per 
Article 37 (4), the implementing act on the list for the designation of antimicrobials for 
human use as per Article 37(5) and the delegated act on rules on imports from third 
countries? What are the planned timelines?  
 
EU reply:  
The EU intends t o notify with a request for comments the draft delegated act under Article 37(4), 
the draft implementing act under Article 37(5) and the draft delegated act under Article 118 of 
Regulation 2019/6 to the WTO SPS Committee before adoption. In this context, T hird Countries will 
have an opportunity to provide feedback on the draft acts.  
Third Countries will also have the opportunity to provide input during the "feedback mechanism", as 
foreseen under the Commission's Better Regulation agenda17, for a period of 4 weeks. Legal acts 
subject to the feedback mechanisms are published at regular intervals on the "Have your say " 
webpage of the Commission's website18 and open to citizens and stakeholders for feedback.  
In terms of timing, the delegated acts under Article 37 (4) are to be adopted at the latest by 
27 September 2021, while the implementing acts under Article 37(5) as well as the delegated acts 
under Article 118 are to be adopted by 27 January 2022. The above opportunities to provide 
feedback will take place in a timely manner before such adoption.  
 
Question 55.  Could the EU provide further details on the definition of products of animal 
origin and the range of products of animal origin subject to the import restriction? Will 
the products covered by the definitio n only be those for human consumption or will the 
definition be more comprehensive?  
 
EU reply:  
Article 118 of Regulation 2019/6 covers animals and products of animal origin exported from Third 
Countries. The Commission is currently reflecting on the most  suitable approach for the various 
aspects of the implementation measures relating to Article 118. In order to ensure that the draft 
delegated acts are comprehensive, further reflection is warranted by Commission services in 
upcoming months.  
 
Question 56.  Could the EU provide further details on the definition of the live animals 
subject to the import restriction? Will the live animals covered by the definition only be 
those for human consumption or will the definition be more comprehensive?  
 
EU reply:  
Article 118 of Regulation 2019/6 is not limited to live animals for human consumption.  
 
Question 57.  Could the EU provide further details on the mechanism for control of 
compliance with Article 118, both with regards to Article 107(2) and to anti microbials 
referred to in Article 37(5), for third countries in light of the delegated act on rules on 
imports from third countries?  
 
 
17 Available at: https://eur -lex.europa.eu/legal -content/ĽN/TX't7PDF/?uri"CĽLEX:520l5DC02l5&fľom; -'-
EN. 
18 Available at: https://ec.europa.eu/info/law/better -regulation/have -your-say. WT/TPR/M/395/Add.1  
 
- 85 - 
 
  EU reply:  
The EU is currently reflecting on the most suitable approach for the various aspects of the 
implementation mea sures relating to Article 118. In order to ensure that the draft delegated acts 
are comprehensive, further reflection is warranted by Commission services in the upcoming months.  
 
Question 58.  Could the EU provide further details on the possibility of a der ogation from 
Article 118? If there is an antimicrobial for exclusive use in humans, and the veterinarian 
does not identify any other therapeutic alternative to treat an animal, does the process 
occur in the same way for derogations established in Articles 113 and 114?  
 
EU reply:  
Article 118 does not provide for the possibility of any derogations. The derogations allowed under 
Articles 112, 113 and 114 will not apply to those antimicrobials listed as reserved for treatment of 
certain human infections.  
 
Question 59.  Will the EU take into consideration the sanitary status/epidemiological 
situation of third countries when applying Article 118 for the prohibition of the use of 
antimicrobials?  
 
EU reply:   
The Commission will lay down the detaile d rules as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January 2022.  
 
Question 60.  How will the EU make a distinction in the implementation of Article 118 with 
respect to Article 107(2) given that some antimicrobials  may have multiple indications, 
including both therapeutic and production authorizations?  
 
EU reply:   
The Commission will lay down the detailed rules as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January 2022.  
 
Paragraph  3.217; Page  118 
Canada notes that several EU SPS regulatory requirements will or are being applied in the near 
future. In particular, the report notes that the Animal Health Law and some elements of the Plant 
Health Law will come into force in 2021,  and that several related measures are to be adopted in the 
meantime by the Commission to implement the new rules.  
 
Questions:  
Question 61.  Can the EU please provide additional information and the timelines for its 
future legislation (such as implementing legislation and delegated acts) detailing model 
certificates for the import of terrestrial animals and their germinal products, as well as 
for that of aquatic animals and other animals?  
 
EU reply:  
Legal acts in the form of Commission Implementing Regulations are planned to set out the future 
model import certificates containing the revised animal health import requirements stemming from 
the Animal Health Law and contained in the draft Delegated Regulation notified to the WTO SPS as 
G/SPS/N/EU/329 (https://members.wto.org/crnattachments/2019/SPS/EEC/19_3746_00_e.pdf), 
on which draft Canada and the European Commission already exchanged question s and answers. 
That Delegated Regulation has already been adopted and will be published in the coming months.  
Those Implementing Regulations will cover live terrestrial animals and germinal products, and 
aquatic animals. The Regulations are planned to be a dopted in 2020, well before their date of 
application (21  April 2021).  
No harmonized EU rules have been laid down for "other animals" as defined in Article 4(4) of the 
Animal Health Law (e.g. dolphins, amphibians, reptiles, etc.) and no such is planned for  the time 
being.  
 
Question 62.  Can the EU please provide additional information and timelines for its 
planned upcoming legislation or regulatory initiatives that may affect the export of 
Canadian SPS goods to EU member states?  
 WT/TPR/M/395/Add.1  
 
- 86 - 
 
  EU reply:  
A Commission Imp lementing Regulation is planned to lay down the list of the third countries 
authorized from animal health point of view for the entry of various food commodities, live terrestrial 
animals and germinal products, and aquatic animals, respectively. That is pl anned to be adopted 
later in 2020 and will be duly notified to the WTO SPS Committee  
 
Paragraph  3.219; Page  119 
Canada notes that the Health and Food Audits and Analysis Directorate of the Commission is 
responsible for audits, inspections, and related acti vities, to assess compliance with EU food safety 
and quality, animal health and welfare, and plant health legislation within the EU.  
 
Question:  
Question 63.  How does the Health and Food Audits and Analysis Directorate of the 
Commission work with the Member States to ensure the adequate oversight and 
implementation of EU regulations by EU Member States?  
 
EU reply:  
The European Commission's Directorate -General  for Health and Food Safety (DG SANTE) aims to 
oversee, through the work of the Health and Food Audits and Analysis Directorate, the application 
of EU rules and the functioning of the national control systems. It performs Commission controls, 
mostly audit and issues recommendations to Member States when shortcomings are detected. EU 
Member States are requested to present action plans on how they intend to address these 
shortcomings. The Directorate responsible for audits systematically monitors implementati on of 
corrective measures, mainly through package meetings known as General Follow -up Audits. 
However, when the outcome of an audit is particularly unsatisfactory, it organises sector -specific 
follow -up audits.  
The General Follow -up Audits cover all open recommendations across all "food" sectors and are 
carried out in all Member States over a cycle. The results are published on the Commission website 
through updates of Member State country profiles. When routine follow -up does not lead to 
addressing the sh ortcomings, recommendations are considered for enhanced follow up such as 
(i) cuts in financing of certain programmes, and  ii) enforcement actions such as pilots or 
infringement proceedings.  
Moreover, Member States have an obligation to prepare multi -annua l national control plans and 
report annually to the Commission on the performance of these controls. Based on these annual 
reports and the results of Commission controls (mostly audits), the Commission publishes a report 
on the operation of official contro ls in Member States.  
DG SANTE also facilitates activities that support Member States in the implementation of EU rules 
such as networks of experts/working groups, meetings of MS contact points for specific areas and 
Better Training for Safer Food training s. 
 
Paragraph 3.221, Page 119  
The report notes that to a large extent, SPS measures in the EU have been harmonized, and most 
measures are taken at the EU level. Nonetheless, EU Member States may, and sometimes do, take 
specific measures in the absence of harmonized EU requirements.  
 
Questions:  
Question 64.  Does the EU evaluate whether EU Member State measures, taken in the 
absence of harmonized EU requirements, are consistent with European Commission 
measures? If so, how does the EU undertake this evaluation?  
 
EU reply:  
According to EU rules, Member States are allowed to adopt national legislations in very limited 
circumstances in the SPS area, e.g. if they have a serious health concern and/or there are no 
harmonized rules. Member St ates are obliged to notify any such measure to the 
European  Commission and the other Member States. The Commission, together with the EU Member 
States, assesses whether the conditions for taking such measures are fulfilled and whether 
harmonised action at EU level is needed.  
 
Question 65.  Please explain how the EU ensures that the international trade commitments 
of the EU and EU Member States are met when an EU Member State implements SPS 
measures inconsistent with the harmonized European Commission measures?  
 WT/TPR/M/395/Add.1  
 
- 87 - 
 
  EU reply:  
Measures taken by EU Member States are notified by the EU notification authority both in case of 
non harmonized standards and when seeking a higher level of protection. These measures are 
discussed between the EU Commission and the EU Member States within the relevant regul atory 
committees, taking into account also the EU international obligations. The EU legal framework 
provides tools for the Commission to take legal action where necessary.  
 
Paragraph 3.232; Page 121  
The report notes that an establishment in a third country  wishing to export to the EU products of 
animal origin for human consumption and animal by -products must be added to the list of eligible 
exporters.  
 
Question:  
Question 66.  Can the EU explain the process  for re -listing of third country establishments 
that have been suspended or de -listed?  
 
EU reply:  
In case a third country intends to lift the suspension of its establishments, the third country is 
expected to inform the Commission beforehand of the reasons thereof. In case a third country 
intends to re-list establishments it has delisted, such establishments may be re -placed by the third 
country on the lists referred to in Article 127(3)(e) of Regulation (EU) 2017/625 only if, in addition 
to the guarantees laid down in Article 127(3)(e)(ii) and (iv) o f Regulation (EU) 2017/625, the third 
country gives the Commission the guarantees referred to in Article 5(2) of Delegated Regulation 
(EU) 2019/625 in relation to the concerned establishments. In this case, the third country is expected 
to give the Commiss ion the said guarantees in relation to the concerned establishments before 
updating the list of establishments and communicating it to the Commission in accordance with 
Article 127(3)(e)(iii) of Regulation (EU) 2017/625.  
 
Paragraphs  3.240 -241; Pages  122-123 
Canada notes that a number of Specific Trade Concerns (STCs) have been raised during the formal 
meeting of the WTO SPS Committee, regarding  SPS measures taken by the EU.  
 
Question:  
Question 67.  Can the EU explain on how the Commission addresses and acti ons the 
concerns raised by Members as STCs at the WTO SPS Committee regarding  SPS measures 
taken in the EU?  
 
EU reply:  
The European Union and its Member States are members of the WTO SPS and TBT Committee. The 
European Union speaks on behalf of the EU Member States at the WTO Committee meetings. In 
preparation of the SPS Committee meetings, the European Commission services discuss internally 
and conduct preparatory meetings with the Member States in order to form the EU position on all 
the points of the  agenda, including STCs. After each WTO SPS meeting a similar process applies to 
discuss and analyse the outcome.  
 
Paragraph 3.241; Page 122  
The report notes the concern WTO Members raised regarding the EU's revised proposal for 
categorization of compounds as endocrine disruptors.  
 
Questions:  
Question 68.  Could the EU confirm how an import tolerance will be authorized and 
established for an active substance falling under the cut -off criteria of EU regulation EC 
1107/2009 (Annex II , 3.6.2, 3.6.3, 3.6.4, and 3.6.5) when a dietary risk assessment 
conducted in accordance with techniques developed by the relevant international 
organizations confirms there are no unacceptable risks to human health?  
 
EU reply:  
The procedures laid down i n Regulation 396/2005 for the management of import tolerance requests 
applies also for active substances falling under the cut -off criteria set in Regulation (EC) 
No. 1107/2009. The procedure includes a product specific risk assessment by an evaluating EU 
member State and EFSA followed by a case -by-case decision in accordance with risk analysis 
principles. Given the regulatory situation, the EU will carefully evaluate on a case by case basis the WT/TPR/M/395/Add.1  
 
- 88 - 
 
  import tolerance requests for the active substances falling un der the criteria of Regulation (EC) 
No. 1107/2009, considering the objectives of consumer protection of the EU pesticide legislation and 
also the EU's international obligations arising from the WTO Agreement on the Application of Sanitary 
and Phytosanitary  Measures.  
 
a. Could the EU explain the risk management stage in addition to the risk 
communication stage in the authorization and establishment of an import 
tolerance for such an active substance?  
 
EU reply:   
There is no difference in the application of risk analysis principles as described in regulation 
178/2002, between substances that fall under the cut -off criteria and substances that do not fall 
under those criteria. Risk management is carried out by the European Commission together wi th EU 
members' states. The EU carefully evaluates the request for import tolerances and EFSA scientific 
opinion taking into account existing international standards and the EU's international obligations 
arising from the WTO Agreement on the Application of  Sanitary and Phytosanitary Measures.  
 
Question 69.Could the EU confirm whether it is possible that a positive opinion (based on 
the EU regulation EC 396/2005) from the European Food Safety Authority for the 
establishment of import tolerance for an active substance that fall under the cut -off 
criteria of EU regulation EC 1107/2009 (Annex II, 3.6.2, 3.6.3, 3.6.4, and 3.6.5) could 
then be rejected either through the EU's Standing Committee process or through some 
other mechanism? If so, could the EU explain u nder what circumstances such a rejection 
could occur?  
 
EU reply:  
Even though such a possibility theoretically exists, so far the EU has no experience with the 
circumstances described above, as no substance on which EFSA has delivered a favourable scienti fic 
opinion has ever been rejected at risk management level.  
 
1.3.5  State Trading, State -Owned Enterprises, and Privatization  
 
Table 3.27 New and Full Notifications on STEs ; page  132.  
It is noted that Alko Inc , supervised by Finland's Ministry of Social Affairs  and Health, has a sales 
monopoly of all alcoholic beverages over 5.5% alcohol.  
 
Question:  
Question 70.  Canada understand that the excise tax on alcoholic beverages increased by 
an average of 10 % at the beginning of 2018. Can the EU provide additional details on how 
the price of alcoholic beverages is established under Alko Inc 's monopoly, including any 
applicable markups, taxes, and domestic rebates?  
 
EU reply:  
The information on Alko's price -setting is included in EU's notification of Alko Inc. to the 
WTO Working Party on State Trading Enterprises of 12 July 2018 (G/STR/N17/EU). Section F of the 
notification specifies that:  
 
"The retail prices of all domestic and imported products are determine d in equal terms by adding 
the following mark -ups to the "back -door price" determined by the supplier:  
 
• Alko's margin (Coefficients for different beverage categories currently between 1,50 and 
1,81),  
• possible bottle or can deposit,  
• excise duty calculated  according to the Council directive 92/83/EEC of 19 October 1992 
on the harmonization of the structures of excise duties on alcohol and alcoholic 
beverages;  
• environmental tax on retail containers,  
• VAT, 24 %.  
 
Alko's margins and other pricing information  are openly published in Alko's website:  
https://www.alko.fi/en/alko -inc/for -suppliers/prices/price -calculator.  
 WT/TPR/M/395/Add.1  
 
- 89 - 
 
  If a foreign producer does not want to deliver the products to Alko shops, it may use any 
contractor/importer to do this or request the servic e from Alko (freight, insurance, warehouse and 
shop delivery costs are added)."  
 
Member States must also adhere to COUNCIL DIRECTIVE 92/84/EEC of 19 October 1992 on the 
approximation of the rates of excise duty on alcohol and alcoholic beverages, which set s out 
minimum rates that must applied to each category of alcoholic beverage. EU legislation only sets 
harmonised minimum rates. This means that EU countries are free to apply excise duty rates above 
these minima, according to their own national needs. Ful l details of the excise duty rates applicable 
in the EU on 1 January 2019 is available in the "Taxes in Europe" database:  
https://ec.europa.eu/taxation_customs/economic -analysis -taxation/taxes -europe -database -
tedb_en.  
 
3.3.6 Government Procurement  
 
Paragraph 3.279; Page 135   
"In 2015, total general government public procurement expenditure on works, goods and services 
in the EU (excluding utilities) amounted to EUR 2,015.3 billion (above and below public procurement 
thresholds), or about 14% of GDP, with some EUR 350 billion published on the Tenders Electronic 
Daily (TED) supplement to the Official Journal of the EU."  
 
Question:  
Question 71.  According to the above, the proportion of contracts published on TED is 
approximately 17% of the EU's total pub lic procurement expenditure. Is the information 
on the remaining contracts published elsewhere? If not, what are the reasons these 
contracts are not be published on TED?  
 
EU reply :  
Publication in TED is mandatory only for contracts above the applicable thresholds, i.e. contracts 
subject to the EU public procurement directives. Estimates on public procurement volumes, including 
below -thresholds contracts, are available in the European  Commission's Public Procurement 
Indicators 2017 report at https://ec.europa.eu/docsroom/documents/38003 .  
 
 
Paragraph 3.282; Page 135  
"The public procurement directives provide, for public buyers in the EU, to accord to the works, 
supplies, services and economic operators of the signatories to international agreements (such as 
the GPA and RTAs with procurement chapters), treatment that is no less favourable than the 
treatment accorded to the works, supplies, services and economic operators of the EU, inso far as 
these are covered by these agreements."  
 
Questions:  
Question 72.  Does the EU have a process for determining what constitutes "works, 
supplies, services and economic operators" of the signatories to its international 
agreements?  
 
EU reply :  
Interna tional trade agreements define the scope and coverage of their application. For example, the 
coverage schedules of the GPA Parties, divided in seven Annexes, determine the extent to which the 
procurement of goods and services by the various procuring entit ies of a given GPA Party is open to 
participation of suppliers / economic operators originating in the other GPA Parties. Similar coverage 
schedules can be found in each of the EU's Free Trade Agreements that include provisions on public 
procurement.  
 
Ques tion 73. How is the origin of an economic operator determined?  
 
EU reply :  
The origin of an economic operator is usually determined by the country of its establishment. Other 
elements, such as an economic operator's substantive business operations entaili ng a direct and 
effective link with a given country, are to be considered.  
 WT/TPR/M/395/Add.1  
 
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  Paragraph 3.283; Page 135  
"Previous reports outlined the changes introduced in the 2014 Directives, which entered into force 
on 17 April 2014 with 24 months for transposition into domestic law by the Member States, and 
30 months for the provisions on e -procurement. As at the end of September 2019, only one Member 
State had yet to complete the transposition process for the 2014/23/EU Concessions Directive and 
the 2014/25/EU Utilities Directive."  
 
Question:  
Question 74.  Which EU Member State has not yet completed the transposition of EU rules 
on public procurement and concessions (Directive 2014/23/EU, 2014/24/EU, 
2014/25/EU) into national law?  
 
EU reply:   
Directive 2014/24/EU  has already been transposed into the national legislation of all Member States. 
Spain is the only remaining Member State that has yet to finish transposing the Concessions 
Directive (2014/23/EU) and the Utilities Directive (2014/25/EU) into its national l egislation.  
 
Paragraph 3.286; Page 136  
"Also, according to the Commission, innovation procurement is hampered by various barriers. One 
way of improving the situation could consist of a wider use of the innovation partnerships procedure."  
 
Questions:  
Question 75.  Could the EU please explain how it defines innovation procurement, as well 
as the benefits/objectives of such procurement?  
 
EU reply:   
"Innovation procurement" refers to any procurement that has one or both of the following aspect s: 
- buying the process of innovation – research and development services – with (partial) outcomes;  
- buying the outcomes of innovation created of others.  
In the first instance, the public buyer buys the research and development services of products, 
services or processes, which do not exist yet. The public buyer describes its need, prompting 
businesses and researchers to develop innovative products, services or processes to meet the need.  
In the second instance, the public buyer, instead of buying off -the-shelf, acts as an early adopter 
and buys a product, service or process that is new to the market and contains substantially novel 
characteristics.  
By designing their procurement procedures so as to encourage innovation, public buyers increase 
the chances of receiving more state -of-the-art, better adapted or more versatile solutions, which 
are also often cheaper, more environmentally friendly or more socially responsible.  
Additional information on innovation procurement can be found in the European Commiss ion's 
guidance on this topic, available at: https://ec.europa.eu/transparency/regdoc/rep/3/2018/EN/C -
2018-3051-F1-EN-MAIN -PART-1.PDF . 
 
Question 76.  Would it be possible for the EU to provide a few examples of public 
procurements where the innovation partne rships procedure has been used?  
 
EU reply:  
Example from Finland  
The purpose of this project is the renovation of the Olympic Stadium in Helsinki. The stadium and 
its surrounding structures are protected under the Inheritance Act. The National Board of Antiquities 
had outlined that the stadium's old wooden benches were an important part of the architecture and 
that the new designs had to meet the aesthetic requirements of building protection.  
A market study revealed that there were no solutions available  to meet the requirements of the 
Olympic stadium renovation project. Therefore, an Innovation Partnership procedure was initiated. 
A contract notice was issued in June 2017, accompanied by a preliminary invitation based on the 
architect's draft. A total of  eight tenders was received. An invitation to negotiate was sent to the 
selected candidates. This phase ended with the attribution of the partnership to three companies, 
which were chosen on the basis of the following criteria: prototype seat, development plan, and 
cost-estimate. The innovation partnership started in early December 2017 and included two stages 
of development and an interim target. The assessment criteria for each development phase were: 
seat evaluation, materials/lifecycle/maintenance, and price. The ordering contract was signed in 
December 2018. The material is recyclable at the time of manufacture, when pieces of waste are 
crushed and reused.  WT/TPR/M/395/Add.1  
 
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  Example from Denmark  
In the municipality of Frederiksberg, three innovation partnership agreement s were launched with 
the objective of developing innovative rainwater collection solutions, minimising the risk of flooding, 
promoting green and blue elements in the urban environment, and including citizens and businesses. 
The three innovation partnership s encompass the development and implementation of a pilot project 
in three separate sites as well as the option of subsequent purchase of the developed solution.  
Two market dialogues were held. The first dialogue discussed existing solutions and the idea 
development of future solutions. The second dialogue presented the prerequisites for success, 
possible financing models, and the division of responsibilities. The partnerships are characterised by 
clear arrangements regarding risk sharing as well as intell ectual property.  
 
Question 77. How is such a procedure consistent with international trade obligations, 
particularly with the revised WTO GPA?  
 
EU reply :  
Innovation processes are most frequently procured by means of research and development (R&D) 
services . R&D services may be procured separately or together with commercial volumes of the final 
solution implemented in practice.  
 
The EU's international commitments at bilateral or multilateral level generally do not cover R&D 
services. In particular for GPA, Annex 5 to the EU's Appendix I to the GPA does not cover R&D 
services.  
 
Paragraph 3.289; Page 136  
The report mentions that the Commission is taking steps to promote public procurement data -driven 
policies in Member States.  
 
Question:  
Question 78. C ould the EU provide additional information on work it is conducting to 
improve public procurement data? For instance, what projects are underway? What type 
of procurement data is being targeted? Are there existing mechanisms or plans to share 
this data wit h the public and/or with the EU's foreign trading partners?  
 
EU reply :  
The main source of public procurement data gathered in the EU is the Tenders Electronic Daily (TED) 
Portal. Considering the data's relevance in developing and evaluating policies, the  European 
Commission has been investing significantly in the improvement of tools used for the collection of 
procurement data (e.g., Standard Forms) as well as in web spaces where these data are made 
publically available (TED and EU Open Data Portal).  
 
In October 2019, an implementing regulation was published regarding the new version of Standard 
Forms, now designated eForms. Contrary to previous standard forms, eForms are intended to be, to 
a large degree, filled in automatically by eProcurement systems, n ot users, thereby significantly 
reducing administrative burden. New features include data fields regarding policy priorities (green, 
social, innovative and SMEs) and greater flexibility to use the forms below thresholds. The new 
eForms can be used as of No vember 2022, and will be mandatory from October 2023 onwards.  
 
With the implementation of the new eForms, also the TED Portal will be improved in terms of 
interface and functionalities, namely regarding search parameters and a more user -friendly 
navigatio n. 
 
Notwithstanding these improvements, the Commission will continue to publish:  
 
- public procurement data on the Open Data Portal, 
https://data.europa.eu/euodp/en/data/dataset/ted -csv; 
- the Public Procurement Indicators Report, 
https://ec.europa.eu/docsroom/documents/38003 ;  
- the Single Market Scoreboard with a procurement section at 
https://ec.europa.eu/internal_market/scoreboard/performance_per_policy_area/public
_procurement/index_en.htm . 
 WT/TPR/M/395/Add.1  
 
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  Paragraph 3.292; Page 137  
The report references recommendations made by the Commission's Multi -Stakeholder Expert Group 
on e-Procurement (EXEP) via -à-vis the creation of contract registers.  
 
Question:  
Question 79.  Could the EU please provide an explan ation of what contract registers are, 
and how they may enhance public procurement processes/procedures?  
 
EU reply:  
A contract register is defined as a function, or module, of a public procurement system that gathers 
structured data and unstructured information throughout the lifecycle of a contract, at a level 
relevant for governance (e.g. country -level, regional level ). This function, or module, is also used to 
disclose information. The degree of disclosure depends on national preferences.  
 
The Commission has committed to promote initiatives for better governance of public procurement 
through improved use of data, inc luding the establishment of contract registers, as part of its 
October  2015 Strategy for the Upgrading of the Single Market. According to the information collected 
so far, a large majority of Member States already have some kind of Contract Register in pla ce, 
despite the fact that there are no legal references to the implementation of such solutions in the EU 
public procurement directives.  
 
A recommendation from the EXEP working group on the implementation of Contract Registers is 
available at https://op.e uropa.eu/en/publication -detail/ -/publication/9f187ae8 -46d9-11e9-a8ed-
01aa75ed71a1/language -en. 
 
Paragraph 3.293; Page 137  
The report indicates that to address some of the procurement challenges, the new EU strategy 
focuses on six policy priorities. One of the areas of focus under the first strategic priority 
(i.e. Ensuring wider uptake of strategic public procurement ) is to "update guidance on green and 
social procurement, and provide guidance on innovation"  
 
Question:  
Question 80.  Has the Commission updated its guidance on green and social procurement 
and provided guidance on innovation procurement? If yes, where can Canada find 
additional information regarding this guidance?  
 
EU reply:  
The European Commission's "Buying green!" ha ndbook on green public procurement (third edition) 
can be downloaded at https://ec.europa.eu/environment/gpp/pdf/Buying -Green -Handbook -3rd-
Edition.pdf . Additional information on support tools related to green public procurement is available 
at https://ec.e uropa.eu/environment/gpp/index_en.htm .  
 
The European Commission's Guidance on Innovation Procurement is available at 
https://ec.europa.eu/transparency/regdoc/rep/3/2018/EN/C -2018-3051-F1-EN-MAIN -PART-1.PDF .  
 
The European Commission's "Buying Social" Guid e to Taking Account of Social Considerations in 
Public Procurement is currently being updated. The new (second) edition of the guide is scheduled 
for publication in the third quarter of 2020. It will be available for download on the European 
Commission's w ebsite as of the time of publication.  
 
Paragraph 3.303, Page 141  
"The contracting authority may divide a procurement into lots but, if the total value of these lots is 
greater than the threshold, then EU -level rules will apply to the awarding of each lot,  except for 
small lots, for which the amounts are below the following de minimis  levels: (i) EUR 80,000 for 
supplies or services; or (ii) EUR 1 million for works; and (iii) provided the aggregate value of the 
lots to be excluded from aggregation is no more than 20% of the total value."  
 
Question  
Question 81 Can the EU explain the process it uses to divide a procurement into lots?   
 WT/TPR/M/395/Add.1  
 
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  EU reply :  
The division of procurements into lots is regulated by Article 46 of Directive 2014/24/EU on public 
procurement, with additional clarifications provided by recitals 78 and 79 of the same act. Similar 
provisions can be found in Directive 2014/25/EU on utilities. The decision on the division into lots 
rests with the respective contracting authority.  
 
Quest ion 82. How does the EU ensure that the division of lots is consistent with 
international trade obligations (e.g. revised WTO GPA)?  
 
EU reply :  
Regarding the valuation of contracts divided into lots, according to Article 5, paragraphs 8 and 9 of 
Directive  2014/24/EU, where a proposed work, a proposed provision of services or a proposed 
acquisition of supplies may result in contracts being awarded in the form of separate lots, account 
shall be taken of the total estimated value of all such lots. Where the a ggregate value of the lots is 
equal to or exceeds the applicable thresholds laid down in Article 4 of the same act, the provisions 
of the directive shall apply to the awarding of each lot. Equivalent provisions can be found in Article 
16 of Directive 2014/ 25/EU on utilities. The division of procurements into lots can therefore not be 
used by contracting authorities to purposefully circumvent the provisions of the EU procurement 
directives, and therefore neither of the GPA.  
 
Question 83. What is the percenta ge of public procurements that are divided into lots and 
in which sector?  
 
EU reply:   
The proportion of procurements divided into lots varies greatly across Member States. For example, 
in 2018, it varied from 5% in Sweden to 53% in Romania (source: EU Sin gle Market Scoreboard). 
According to internal data, the division of procurements into lots is most often used in the acquisition 
of supplies, followed by services and then works.  
 
Question 84. Would it be possible for the EU to provide examples of procure ments that 
have been divided into lots?  
 
EU reply :  
Contract notices and contract award notices on above -threshold procurements in the EU are 
published on the Tenders Electronic Daily (TED) platform. An advanced search tool allows users to 
display contrac t notices or contract award notices divided into lots 
(https://ted.europa.eu/TED/search/search.do ).  
 
Question 85. To what extent has the division of lots increased the participation of SMEs in 
procurement?  
 
EU reply :  
According to a forthcoming report co mmissioned by the European Commission, the likelihood of 
SMEs winning contracts is estimated to increase by around 4% when 2 -9 lots are used.  
 
Table A4.1 Regulatory Restrictions in Construction Services, by Selected Member State , 
Page 306  
 
There is a row indicating whether member States have "explicit preferences for local suppliers" in 
their procurement markets.  
 
Questions:  
Question 86. For those member States where the answer is "yes" (Belgium, France, 
Greece, Hungary, Italy, and Spain),  would it be possible to have the web links to access 
the relevant regulatory restrictions?  
 
EU reply:   
The information referenced here is based on the OECD Intra -EEA Trade Restrictiveness Index 
(http://www.oecd.org/trade/topics/services -trade/ ). We therefore recommend Canada to contact 
the OECD for methodological details.  
 
Question 87. Do these only apply to construction services or to all types of procurement?  WT/TPR/M/395/Add.1  
 
- 94 - 
 
  EU reply:   
The information referenc ed here is based on the OECD Intra -EEA Trade Restrictiveness Index 
(http://www.oecd.org/trade/topics/services -trade/ ). We therefore recommend Canada to contact 
the OECD for methodological details.  
 
3.3.7.2.3 Trademarks  
 
Paragraph 3.355; Page 152  
The report notes that with respect to trademarks, assignment is recognized as an alternative remedy 
to invalidating a trademark registered without the authorization of the proprietor.  
 
Question:  
Question 88. Could the EU provide additional information on the m echanics of this 
alternative remedy?  
 
EU reply :  
Art. 21 of Regulation (EU) 2017/1001 (EUTMR) implements Article 6 of the Paris Convention. Where 
an agent or representative has registered an EU trade mark (EUTM) without the authorisation of the 
proprietor  of that trade mark, the latter can request the EUIPO or a European Union trade mark 
court to assign the EUTM in his or her favour.  
The request for assignment is merely an alternative to a request for invalidation of the mark. The 
rightful owner must file  an application for invalidity and indicate whether it is requesting that the 
EUTM at issue be invalidated or assigned to it (Art. 60(1)(b) EUTMR in conjunction with Art. 8(3) 
EUTMR). If the request is granted, the applicant will become the proprietor of t he EUTM with 
retroactive effect as from the filing or priority date of the EUTM.  
 
3.3.7.2.5.1 Trade Secrets  
 
Paragraph 3.363, Page 154  
The report notes that EU Member States had until June 2018 to implement the Directive on the 
Protection of Undisclosed K now-How and Business Information (Trade Secrets) Against Their 
Unlawful Acquisition, Use and Disclosure (the Trade Secrets Directive) and that all but one Member 
States have now adopted legislation in order to align their legal framework to the Directive.  
 
Question:  
Question 89. Could the EU provide additional information on its anticipated next steps 
(and related timelines) regarding the evaluation of completeness and conformity of 
Member States' legislations implementing the Trade Secrets Directive?  
 
EU reply:  
The only Member State that has not yet implemented the Trade Secret Directive is Cyprus. The 
European Commission is currently checking  the completeness and conformity of Member States' 
legislation and we estimate to complete that evaluation duri ng the course of 2020.   
 
3.3.7.3 Enforcement  
 
Paragraph 3.373; Page 157  
The report notes that, according to the European Union Intellectual Property Office (EUIPO) 2019 
Intellectual Property Crime Threat Assessment, over the last four years, the total number of seizures 
of counterfeit items by customs authorities in the EU has gradually decreased.  
 
Questions:  
Question 90. Could the EU provide additional information on why the number of seizures 
has gradually decreased over this period?  
 
EU reply :  
The EUIPO Intellectual Property Crime Threat Assessment report cited in Paragraph 3.373 presented 
the total number of seizures of IPR -infringing goods for the period of 2014 -17. This customs data is 
based on the annual report of the European Commission s ervices. The latest data, including 2018, 
is presented in the report on the EU customs enforcement of intellectual property rights  
(https://ec.europa.eu/taxation_customs/sites/taxation/files/2019 -ipr-report.pdf  results at the 
EU border, 2018). On the basis  of this latest report, we cannot clearly affirm the there is a decrease WT/TPR/M/395/Add.1  
 
- 95 - 
 
  or increase of seizure as the report shows fluctuations during the period 2015 -18 as it depends on 
which years we consider. If we compare for instance the 2018 data with the 2017 one (see page 9 
of the report), we can see an increase of the number of cases and a decrease of the number of 
articles detained. This is a confirmation of the infringers' trend to avail their selves more and more 
of the on -line market places and to deliver/sel l the IPR infringing goods via small shipments 
containing few articles.  
 
Question 91. Does the EU have statistics relating to the number of seizures of counterfeit 
items for export?  
 
EU reply:   
The statistics available relate to year 2018 (see report on the EU customs enforcement of intellectual 
property rights  - https://ec.eu ropa.eu/taxation_customs/sites/taxation/files/2019 -ipr-report.pdf) 
and show that seizures on export account for the 0.46 % of all cases and the 0.48% of all articles 
detained.  
 
4. TRADE POLICIES BY SECTOR  
4.1.1.2.1. Domestic Support  
 
Paragraphs 4.40 -41; Pa ge 173  
 
• 4.40: "The proposals identified three general objectives to be pursued through EU support, 
funded by the EAGF and by the EAFRD under the CAP: (i) to foster a smart, resilient and 
diversified agricultural sector ensuring food security; (ii) to bolst er environmental care and 
climate action, and to contribute to the environmental - and climate -related objective of the 
EU[…]" 
• 4.41: "These three general objectives ought to be achieved through nine specific objectives: 
(i) support viable farm income and re silience across the territory, to enhance food security; 
[…] (iv) contribute to climate change mitigation and adaptation; (v) foster sustainable 
development and efficient management of natural resources, such as water, soil and air; 
[…]" 
 
Questions:  
Question 92. In addition to the Common Agricultural Policy (CAP) objectives for resilient 
agriculture, Canada notes the European Green Deal objectives to have farmers reduce 
emissions, pollution and pesticides while also using less intensive pr oduction methods. 
Agricultural innovations, such as modern biotechnology, may provide farmers with 
options to achieve these objectives. What role do you see modern biotechnology playing 
in the delivery of the EU's environmental and climate objectives?  
 
EU reply:  
Like many other instruments, modern biotechnology is one of the possible elements in the toolbox 
to tackle the environmental and climate challenges. Products from modern biotechnology have to 
comply with current EU legislation before they can be p laced on the EU market.  
 
Question 93. Canada understands that the European Commission has been requested to 
submit, by April 30, 2021, a study of the status of novel genomic techniques under Union 
law in light of the European Court of Justice ruling. How will the Timing of potential 
options resulting from this study be reconciled with the CAP objectives for resilient 
agriculture?  What options are being considered in the interim, if any?  
 
EU reply:  
Since the study is at an initial stage, the Commission is  not in a position to anticipate its outcome 
and, as a result, cannot prejudge possible measures that might be required as a follow -up to the 
study. The Court Ruling C528/16 has clarified that the existing EU GMO legislation is applicable to 
products obtai ned by novel genomic techniques, no transitional measures are necessary.  
 
4.1.1.2.1.2 Internal Market Support Measures  
 
Table 4.7 Intervention and Private Storage Aid, 2017 and 2018;  Page 175  
During this government intervention, the European Union purchase d skim milk powder at the 
intervention price of EUR 1,698 per tonne and then put it back on to markets at prices that appear WT/TPR/M/395/Add.1  
 
- 96 - 
 
  to be lower than EU domestic prices. For example, the minimum bid price in December 2018 was 
EUR 1,451 per tonne when EU domestic prices were averaging EUR 1,680 per tonne (see: 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/docu ments/eu -milk-
historical -price-series_en.xls).  
 
Questions:  
Question 94.  Was the sale of intervention stocks done at below EU domestic prices?  
 
EU reply:   
The sale of intervention stocks by the Commission is governed by Regulation (EU) No . 1308/2013, 
which sets the framework for the cautious approach adopted by the Commission when disposing of 
SMP intervention stocks. Sales did not take place until the market had recovered. The prices at which 
the SMP in public intervention was sold in 2018 and 2019 were i n line with market reality, taking 
into account the ageing of the product and therefore its relative loss of commercial value (not the 
intrinsic quality of the product).  
 
Question 95. Did any of the intervention stocks sold back on to the market go to expo rt 
markets? If so, how many tonnes were exported?  
 
EU reply:   
Intervention stocks were sold without any condition of further use. The stocks could have found their 
destination on the internal market or they could have been further processed and/or exporte d in 
powder form. The Commission does not have information about the further use of stocks released 
from intervention. If exported, these quantities were not differentiated and were counted together 
with other exports from the EU.  
 
Paragraph 4.50, page 176 
Canada notes that the European directly intervened in its milk market with the purchase and 
stockpiling of up to 380,000 tonnes of skim milk powder in 2017. These stocks of skim milk powder 
were progressively put back onto the market through a tendering pr ocess.  
 
Question:  
Question 96. With respect to this government intervention, can the European Union 
explain what steps it took to minimize potential distortions that this would have on 
domestic and global markets?  
 
EU reply:   
During the tender period bet ween December 2016 and June 2019, the minimum selling prices 
accepted in the tenders for SMP ranged between EUR 1,050 and EUR 2,051 per tonne. The minimum 
selling prices accepted in the tender followed the recovery in prices in 2018 -19. There was no 
downwa rd pressure on market prices. On the contrary, during the period between January 2018 and 
June 2019, when most of these stocks were released to the market, the EU price for skimmed milk 
powder increased by 43%.  
See page 4 of the Milk Market Observatory: https://ec.europa.eu/info/sites/info/files/food -farming -
fisheries/farming/documents/eu -milk-internal -measures -stocks_en.pdf . 
And page 1 of the Milk Market Observatory on dairy commodity prices:  
https://ec .europa.eu/info/sites/info/files/food -farming -fisheri es/farming/documents/eu -dairy-
commodity -prices_en.pdf.  
 
4.1.1.3.2 OECD Monitoring and Evaluation of Agricultural Policies  
 
Table 4.11 OECD Indicators for Support to Agriculture, 2011 -2018; Page 187 -188 
 
Question 97. The WTO Secretariat does not report any figures for the Producer Nominal 
Protection Co -efficient (NPC) in the first section of the table.  Since the OECD calculates a 
Producer NPC for the EU, is there is a reason for not including these figures?  
Based on OECD, here are the Producer NPC  figures for EU 28  
 
 2011  2012  2013  2014  2015  2016  2017  2018  
Producer 
NPC 1.03 1.05 1.07 1.04 1.05 1.05 1.04 1.05 
 WT/TPR/M/395/Add.1  
 
- 97 - 
 
  EU reply:  
The EU does not wish to comment on the methodological choices made by the WTO Secretariat.  
 
Question 98. The value of production for Beef and Veal in 2016 should be 26,685.15 
instead of 2,685.15   
 
EU reply:  
Indeed, the value of production for EU Beef and Veal in 2016 in the OECD database is 26,685.15 
(million euros).  
 
4.2 Energy  
 
Paragraph 4.132; Page 203  
The report notes that in 2018 and 2019, the EU adopted a new comprehensive legislative framework 
for energy and climate policies. The European Parliament and Council agreed on a revision of the 
EU's climate legislation, including the Emissions Trading Syst em Directive, both for stationary 
installations and for aviation, the Effort Sharing Regulation, and the Regulation on Land Use, Land 
Use Change and Forestry. They also agreed on the eight legislative proposals in the "Clean Energy 
for All Europeans" packa ge (all of which have entered into force), and on the ten mobility proposals 
following the Low -Emission Mobility Strategy. This framework is expected to put the EU on a good 
trajectory to a climate -neutral economy by 2050.  
 
Question:  
Question 99. What le ssons emerged from the process to reach agreement on the 2018 
Regulation on Land Use, Land Use Change and Forestry in developing the framework out 
to 2030? Does the EU envision any further changes may be needed to the Regulation in 
light of recent decision s under the UNFCCC and the Paris Agreement?  
 
EU reply:  
The Regulation on Land Use, Land Use Change and Forestry (EU) 2018/841 (LULUCF) enshrines 
accounting rules on emissions and removals from land for the first time in EU law. This legislation 
not only s hows the EU's commitment to effectively implement the Paris Agreement but also puts 
stringent rules and limitations on using accounted emissions and removals from LULUCF in other 
sectors, while ensuring the maintenance or increase of the EU sink in LULUCF.   
Recent decision under the UNFCCC will not require adjustments of the LULUCF Regulation. However, 
the European Green Deal announced that " By summer 2020, the Commission will present an impact 
assessed plan to increase the EU's greenhouse gas emission redu ctions target for 2030 to at least 
50% and towards 55% compared with 1990 levels in a responsible way " (COM(2019) 640 final, 
11 December  2019). In light of this new headline target " the Commission will, by June 2021, review 
and propose to revise where necessary, all relevant climate -related policy instruments ", which also 
includes the Regulation on Land Use, Land Use Change and Forestry.  
 
4.2 Energy – Decarbonizing the Economy and Becoming the World Leader in Renewable 
Energy  
 
Paragraph 4.152; Page 205  
It is noted that the revised Renewable Energy Directive aims to strengthen the EU sustainability 
criteria for bioenergy, among other goals.  
 
Question:  
Question 100. Could the EU identify to what extent third -party forest management 
certification systems m ay be used to identify sustainably sourced biomass from the forest 
sector?  
 
EU reply:   
The recast Renewable Energy Directive (2018/2001/EU) includes a new set of sustainability criteria 
for forest biomass used for energy production (heating/cooling, electricity and transport). These 
criteria aim at ensuring both proper carbon accounting and avoiding unsustainable forest harvesting 
practices. More specifically, under these new criteria, economic operators need to demonstrate that 
the forest biomass used for energy production is sourced from:  
1.a) countries or regional economic organizations (e.g. the EU) that: are a Party to the Paris 
Agreement, and account any changes in carbon stock associated with biomass harvest towards its WT/TPR/M/395/Add.1  
 
- 98 - 
 
  national GHG reduction target, or have national laws ensuring that  the reported LULUCF -sector 
emissions do not exceed removals; or  
b) forest areas subject to management systems ensuring the maintenance/strengthening of forest 
carbon stocks, over the long term; and  
2.a) countries that have national or sub -national legis lation and enforcement mechanisms ensuring: 
legal logging, forest regeneration, protection of sensitive areas, minimisation of harvesting impacts 
on soil quality and biodiversity; and long -term productivity of the forests; or b) forest areas subject 
to man agement systems that meet all the above -mentioned requirements.  
In this context, third -party forest management certification systems could be used by EU bioenergy 
operators to show compliance with the REDII bioenergy sustainability criteria.  
 
4.2. Energy – The EU's Vision for a Climate -Neutral Economy by 2050  
 
Paragraphs 4.159 -160; Page 207  
The EU mentions that the Commission published its strategic long -term vision for a prosperous, 
modern, competitive and climate -neutral economy by 2050 as its contributi on to the EU's long -term 
low GHG emission development strategy. This vision is not only to keep the global increase in 
temperature well below 2°C compared to pre -industrial levels, but also to pursue efforts to limit this 
increase to 1.5°C by achieving net -zero greenhouse gas emissions by 2050. To achieve this, the EU 
must make progress on seven strategic building blocks (energy efficiency; the deployment of 
renewables and increased electrification; clean, safe, and connected mobility; competitive industry 
and circular economy; infrastructure and interconnections; bio -economy and natural carbon sinks; 
and tackling remaining emissions with carbon capture and storage).  
 
Question:  
Question 101. In considering how to scale up the bioeconomy and natural carbon sinks as 
part of its long -term climate strategy, how has the EU considered potential trade -offs 
between these two objectives?  
 
EU reply:   
Please also s ee reply to Q9. The in -depth analysis supporting the Commission's 2018 Communication 
'A Clean Planet for all – A European strategic long -term vision for a prosperous, modern, competitive 
and climate neutral economy' looked into sectoral impacts where details can be found on the need 
for a sustainable use of natural resources, notably in sections 4. 6 to 4.7 discussing the EU's 
agriculture and land sectors. The Communication is available at:  
https://ec.europa.eu/clima/sites/clima/files/docs/pages/com_2018_733_analysis_in_support_en_0
.pdf. 
 
4.4.3.2 Improving Access for Consumers to Online Goods and Ser vices across Europe  
 
Paragraph 4.275; Page 236  
The report notes that the Directive on Electronic Commerce, adopted in 2000, constitutes the basic 
legal framework for the regulation of e -commerce in the EU.  
 
Question:  
Question 102. Could the EU describe a ny measures taken during the review period to 
address possible regulatory barriers to the growth of e -commerce with third countries?  
 
Paragraph 4.276; Page 236  
According to the Secretariat report, the EU Commission communication on the Digital Single Mark et 
strategy identified five types of regulatory barriers to the growth of cross -border e -commerce within 
the EU.  
 
Question:  
Question 103. Could the EU describe any measures taken during the review period to 
address possible regulatory barriers to the growth of e -commerce with third countries?  
 
EU reply to questions 102 and 103:  
The EU's Digital Single Market (DSM) strategy seeks to ensure better access for consumers and 
business to online goods and services across Europe. For the overall implementatio n of the DSM 
strategy see the following factsheets:  
 WT/TPR/M/395/Add.1  
 
- 99 - 
 
  https://ec.europa.eu/commission/sites/beta -
political/files/a_digital_single_market_benefit_all_europeans_en_20190319_1230.pdf.  
and https://ec.europa.eu/commission/sites/beta -political/files/dsm_roadmap_ 20190318_17.pdf . 
 
The aim of the e -commerce related package as part of the DSM strategy was to address barriers to 
cross-border online activity and to build a comprehensive e -commerce framework focusing on three 
main objectives:  
 
(i) Ensuring better access to goods and services offered online;  
(ii) Building trust for consumers and greater certainty for businesses; and  
(iii) Reducing transaction costs and administrative burden for businesses when trading online 
across borders.  
 
Relevant measures include:  
Regulation (EU) 2019/1150 "on promoting fairness and transparency for business users of online 
intermediation services" will apply from 12 July 2020 and addresses the imbalance in bargaining 
power between online platforms and small businesses conducting th eir business on the platforms. 
The Regulation covers online platform intermediaries and general online search engines that provide 
their services to businesses established in the EU and that offer goods or services to consumers 
located in the EU. The Regul ation is available at:   
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1150&from=EN.  
 
Regulation (EU) 2018/302 ("Geo -blocking Regulation") addresses the specific problem of 
geo-blocking and unjustified discrimination of customers based  on their nationality, place of 
residence or place of establishment, in order to facilitate access to offers across the borders within 
the internal market. The Regulation applies to all traders offering their goods or services to 
consumers in the EU, regar dless of whether they are established in the EU or in a non -EU country. 
The Regulation benefits all customers in Europe, including non -EU customers in Europe.  The 
Regulation is available at:   
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32 018R0302&from=EN.  
For more questions, see the Questions & Answers document published at 
https://ec.europa.eu/digital -single -market/en/news/geo -blocking -regulation -questions -and-
answers.  
 
New rules for the reduction of VAT -related administrative burden of c ross-border transactions – see 
https://ec.europa.eu/taxation_customs/business/vat/digital -single -market -modernising -vat-cross-
border -ecommerce_en - introduced major simplification provisions for cross -border sales. They will 
be applicable as of January 202 1.  
 
More information is available at https://ec.europa.eu/taxation_customs/business/vat/modernising -
vat-cross-border -ecommerce_en.  
Regulation (EU) 2019/1020 on market surveillance and compliance of products – see https://eur -
lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1020 - introduced some important 
rules aiming at improving and modernising market surveillance.  
 
Other mea sures of the Digital Single Market strategy are also meant to facilitate cross -border 
e-commerce. For example:  
 
- Regulation 2006/2004 on cooperation between national authorities responsible for the 
enforcement of consumer protection laws has been replaced b y Regulation (EU) 2017/2394 
since 17 January 2020.  
- Regulation (EU) 2018/644 on cross -border parcel delivery services aims to make prices for 
cross-border parcel delivery services more transparent and affordable and to increase 
regulatory oversight of the EU parcel market.  
- Two Directives have been adopted in 2019 aimed at harmonising the main mandatory 
consumer rights applicable to the supply of digital content and sales of goods. Member States 
will need to transpose them by 1 January 2022.  
- A package in th e area of consumer protection (New Deal for Consumers) aiming at improving 
compliance with EU consumer protection legislation is being finalised, with a first Directive 
on better enforcement and modernisation of consumer law applicable as from 28 May 2022.  
For more information see https://ec.europa.eu/info/law/law -topic/consumers/review -eu-
consumer -law-new-deal-consumers_en . WT/TPR/M/395/Add.1  
 
- 100 - 
 
  4.4.5.1 Online Platforms  
 
Para 4.33; Page 250  
Chapter II of the Recommendation on Illegal content online provides for notification mechanisms for 
illegal content. According to the Secretariat report, the hosting service provider may (on a voluntary 
basis) remove or disable access to notified content.  
 
Questions:  
Question 104. Does such notification create knowledge or awareness as defined by the 
Electronic Commerce Directive?  
Question 105. If so, does a failure to remove content after notice from a notice provider 
create potential liability?  
 
EU rep ly to questions 104 and 105:  
The Recommendation does not interpret the knowledge standard set by Article 14 of the 
E-Commerce Directive. In Recital 17 of the Recommendation, it is clarified that, in  order to allow 
the service provider to take an informed and diligent decision with regard to the effect to be given 
to the notice, such notices need to be sufficiently precise and adequately substantiated. "However, 
whether or not a given notice leads to knowledge or awareness within the meaning of Article 14 o f 
that Directive is to be to be assessed in light of the specificities of the individual case at hand, bearing 
in mind that such knowledge or awareness can also be obtained in other manners than through 
notices. " The Recommendation gives guidance on best p ractices for notification mechanisms which 
could facilitate the fight against illegal content goods and the protection of fundamental rights online.  
 
4.4.5.1 EU Cybersecurity Act  
 
Paragraph 342; Pages 251 -252  
The report notes that the EU Cybersecurity Act establishes a European cybersecurity certification 
framework to, among other things, enable a harmonized approach within the EU.  
 
Question:  
Question 106. Could the EU describe any measures to promote interoperability and 
recognition between the EU's harmonized cybersecurity certification and other national 
cyber security standards?  
 
EU reply:   
One of the aims of the European Cybersecurity Cer tification Framework is to avoid the fragmentation 
of cybersecurity certification schemes across EU Member States. Within the EU, once a scheme is in 
force under the framework  in a particular area, national schemes in the EU in that area will no longer 
be valid and EU Member States shall not introduce new national cybersecurity certification schemes 
for ICT products, services and processes already covered by a European scheme that is in force.  
Companies established within the EU or elsewhere that choose to  certify their products will be able 
to obtain certificates that are valid across the whole EU. The schemes should be non -discriminatory 
and based on European or international standards, unless those standards are ineffective or 
inappropriate to fulfil the  Union's legitimate objectives in that regards. The schemes are prepared 
by ENISA in consultation with stakeholders, European as well as non -European, and will then be 
adopted by the Commission.  
As regards cybersecurity standards, non -EU stakeholders will  continue to contribute to the 
development of both European and international standards as they do now. The development of 
cybersecurity standards does not take place within the framework but remains with the relevant 
standards development organisations. G lobally relevant standards may be taken into consideration 
in the future development of standards and voluntary certification schemes in the EU.  As one of the 
elements of a cybersecurity scheme under the European framework, the conditions for any potential  
mutual recognition of certification schemes with third countries can be covered.  
  WT/TPR/M/395/Add.1  
 
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  CHILE  
WT/TPR/S/357 - UE (WTO Secretary report)  
 
Paragraph 18 (page 11) and paragraph 3.71 (page 75)  
18. "The EU continues to apply several prohibitions, restrictions and licensing requirements on 
imports which have increased in number over the review period. New or expanded prohibitions or 
restrictions on imports that took effect during the review period concerned measures on mercury, 
invasive alien specie s, certain persistent organic pollutants and cultural goods, for example. 
A directive on the single use of plastics adopted in 2019 must be transposed by member States by 
July 2021. A regulation on conflict minerals, adopted in 2017, requires importers of tin, tungsten, 
tantalum and gold to comply with certain supply chain due diligence requirements as of 
1 January  2021.  
 
3.71. Similar to the aim of the Kimberley Process, the EU implemented a new regulation in 2017 to 
apply the Organisation for Economic Co operation and Development (OECD) Due Diligence Guidance 
for Responsible Supply Chains of Minerals from Conflict -Affected and High -Risk Areas, in order to 
limit human rights abuses and prevent the financing of armed groups in resource -rich areas. The 
Confli ct Minerals Regulation (CMR) applies to EU importers of tin, tungsten, tantalum and gold. As 
of 1 January 2021, EU importers of these metals and minerals with annual import volumes above a 
certain threshold must undertake supply chain due diligence. This i mplies that they must identify 
and mitigate the risk of conflict -financing in their supply chains; and they must also keep detailed 
records of suppliers, country of origin, and quantities and dates of extraction of the minerals or 
metals imported. These re cords are subject to compliance and ex post checks by 
specially -designated competent authorities in each Member State. Annex I to the CMR sets out the 
applicable import thresholds. For five minerals and metals, though (e.g. tantalum, gold ores and 
concentr ates, tin oxides), the thresholds will be established at the latest by July 2020.  
 
1. Question: Regarding the implementation of OECD Due Diligence Guidance for 
Responsible Supply Chains of Minerals from Conflict -Affected and High -Risk Areas, Chile 
would a ppreciate if the EU could share information and concrete cases of effective and 
successful implementation by European companies.  
 
EU reply:  
The OECD Due Diligence Guidance is primarily implemented in the EU by Regulation (EU) 2017/821, 
which lays down du e diligence requirements for EU importers of tin, tantalum, tungsten and gold. 
This Regulation was adopted and entered into force in 2017, but the requirements for EU companies 
start to apply as of 1 January 2021. Many EU companies are already implementing  due diligence 
with regard to their minerals supply chain on a voluntary basis and the EU has brought forward a 
number of supporting measures to facilitate the work of companies in this regard. The EU would 
very much welcome closer contacts and dialogue wi th Chile in this regard.  
 
2. Question : In relation to the new importer requirement: The milestones indicated in the 
on-line Q&A (https://ec.europa.eu/trade/policy/in -focus/conflict -minerals -
regulation/regulation -explained/), which do not inform of any step s between 2017 and 
2021, Chile would be thankful if the EU could indicate if it has an implementation plan 
during 2019 -2020 of this new importer requirement. In addition, Chile would like to know 
how the EU members will check and verify the content of docu ments and audit reports.  
 
EU reply:  
The Regulation explicitly sets out a number of preparatory and supporting measures that are to be 
adopted prior to the application of the requirements for EU importers as of 1 January 2021. These 
include but are not li mited to Commission Recommendation (EU) 2018/1149 on non -binding 
guidelines for the identification of conflict -affected and high -risk areas and Commission Delegated 
Regulation (EU) 2019/429 on the criteria and methodology for the assessment of supply chain  due 
diligence schemes. Later on this year, we also expect to adopt the measures set out in Articles 1(4), 
8(3) if appropriate, 9 and 14(2) of the Regulation although this is still to be confirmed. The approach 
to the ex -post checks is set out in Article 1 1 of the Regulation. Member States are in the process to 
establish the specific procedures on the basis of that Article and on the Commission non -binding 
recommendations.  
 WT/TPR/M/395/Add.1  
 
- 102 - 
 
  1 ECONOMIC ENVIRONMENT  
1.3 Developments in Trade and Investment  
1.3.1 Trends and patterns in merchandise and services trade  
 
Paragraph 1.40, page 28  
"Regarding extra -EU trade in services, the EU remained a net exporter, and the surplus in services 
trade increased during the review period. Exports grew considerably, after a slight stagnation 
between 2015 and 2016. Imports also grew in 2017 -18, but at a slower pace. Telecommunication, 
transport, travel, finance, and other business services are the main services traded by EU countries. 
The United States and Switzerland are the main partners in services trade. China and Norway also 
have significant shares ( Table 1.2)".  
 
3. Question : Paragraph 1.40 says that, regarding extra -EU trade in services, during 
2017 -18 imports grew at a slower pace. In relation with this, Chile would appreciate if EU 
could share more information about the reasons of the decrease on imports of trade in 
services during 2017 -18, provided they have identified the reasons.  
 
EU reply:  
EU services imports grew by 1.1% in 2018 following two years of decline. The EU remains the world's 
number one importer of services and accounts for almost  20% of global services imports in 2018.19 
From 2010, imports of services traded with extra -EU countries increased at a relatively rapid pace, 
with growth peaking at 22% in 2015. Imports then fell by 0.1% and 1.6% in 2016 and 2017 but 
recovered in 2018.  
 
1.3.2 Trends and patterns in foreign direct investment (FDI)  
 
Paragraph 1.43, pages 29 -30 
"FDI inflows surged, at EUR 697.5 billion, in 2015, before dropping to EUR 163.3 billion in 2017, 
reflecting large -scale investments and divestments to and from Special  Purpose Entities (SPEs), 
mainly in Luxembourg, and the Netherlands (Table 1.3). Flows into the United Kingdom and 
Germany remained solid, while France, recorded volatile FDI performance".  
 
4. Question:  Paragraph 1.43 says that FDI inflows dropped after 2 015 reflecting 
large -scale investments and divestments to and from Special Purpose Entities (SPEs). In 
this regard, Chile would be thankful if EU can further explain the concept of "Special 
Purpose Entities" (SPEs), and how do they participate in the FDI.   
 
EU reply:  
There is no universally accepted definition of a special -purpose entity (SPE) however according to 
Eurostat20 SPE's can be distinguished by the following characteristics:  
 
• a legal entity (an enterprise or sometimes a limited partnership or joint venture) formally 
registered with a national authority and subject to the fiscal and other legal obligations of 
the economy in which it is resident,  
• established to perform specific functions limited in scope or time, with one or a few primary 
creditors,  
• having no or few non -financial assets and employees, little or no production or operations 
and sometimes no physical presence beyond a "brass plate" confirming its place of 
registrat ion,  
• related to another corporation, often as a subsidiary and often resident in a territory other 
than the territory of residence of the related corporation (lacking any physical dimension, 
the residence of a SPE is determined by the economic territory u nder whose laws it is 
incorporated or registered),  
• its core business function consists of financing its group activities or holding assets and 
liabilities of its group, that is the channelling of funds from non -residents to other 
non-residents, and with o nly a minor role for managing and directing activities.  
 
There can be different reasons for setting up a SPE:  
 
19 Sources: Eurostat (bop_its_tot; bop_its6_tot) and WTO.  
20 Eurostat Statistics Glossary. Accessed: 20/01/2020. Available at:  
https://ec.europa.eu/eurostat/statistics -explained/index.php/Glossary:Special -purpose_entity_(SPE) . WT/TPR/M/395/Add.1  
 
- 103 - 
 
  1. to protect a company from financial risk, often in the context of a large project;  
2. to separate different layers of equity infusion in complex financing operations;  
3. to own and more easily dispose of assets and associated permits and rights;  
4. to engage in a public -private partnership relying on a project -finance structure.  
 
The activities of SPEs are a concern for policymakers insofar as there is potential for a substantial 
division between the productive investments of multinational enterprises and the inc ome they 
generate. There are a number of international eﬀorts to stem such ﬂows of income through tighter 
controls, for example the Action Plan on Base Erosion and Proﬁt Shifting (BEPS) initiative launched 
in 2013. By excluding foreign investments of resid ent SPEs from FDI statistics, policymakers may 
have a better idea as to the real potential impact of FDI on their economies.  
 
2 TRADE AND INVESTMENT REGIMES  
2.2 Trade Policy Formulation and Objectives  
 
Paragraph 2.15, page 36 -37 
"The review period also sa w increased interest in ways to improve the practical implementation and 
effectiveness of sustainable development provisions in EU FTAs. A debate, launched by the 
Commission in July 2017, revealed a clear consensus on the need to improve the implementation  of 
such provisions. While there were suggestions for the introduction of economic sanctions to enforce 
compliance with sustainable development provisions, this was opposed by most participants in the 
debate. The Commission pointed out that a cooperative a pproach is more appropriate and effective. 
A non -paper, issued in February 2018 concluding this debate, set out an Action Plan of 15 concrete 
steps aimed at: (i) improving coordination between EU institutions and between the EU and relevant 
international o rganizations; (ii) enabling civil society to play a more effective role in the 
implementation of sustainable development provisions, including by facilitating the monitoring role 
of civil society, allowing civil society to comment and provide advice not on ly on provisions of 
sustainable development chapters but, more generally, on other FTA provisions with implications for 
sustainable development, and reinforcing the implementation of provisions on corporate social 
responsibility; (iii) taking actions aimed  at identifying priority implementation actions for each 
partner country, a more assertive approach to enforcement, the encouragement of the early 
ratification of core international agreements, reviewing the effectiveness of implementation on an 
ongoing ba sis, developing a handbook for implementation, and stepping up resources; and 
(iv) improving transparency and communication".  
 
5. Question:  Paragraph 2.15 mentions that in 2018, a non -paper that set out an Action 
Plan with 15 concrete steps for implementation of sustainable development provisions 
was issued. In this context, Chile would appreciate if the EU could share concrete 
outcomes of the work developed.   
 
EU reply:   
Since February 2018, the European Commission has the 15 -point Action Plan i n place that aims to 
improve the implementation and enforcement of the Trade and Sustainable Development (TSD) 
Chapters in EU bilateral trade agreements. The roll -out of this action plan has been a priority. There 
are already concrete outcomes from this wo rk.  
The Commission has promoted closer cooperation on TSD matters with Member States and the 
European Parliament, and with International Organisations like the International Labour 
Organisation (ILO). The ILO support is key, notably in providing technical  assistance to partners for 
the ratification and effective implementation of core ILO conventions.  
The support that the Commission is giving to the monitoring role of civil society is also key. A 
EUR 3 million project was launched in November 2018 to offe r logistic and technical support to all 
EU domestic advisory groups created under the TSD Chapters of EU FTAs. The Commission has also 
put in place tools to mobilise private sector involvement. Two large projects to promote Corporate 
Social Responsibility (CSR) in Asia and Latin America are now under implementation.  
To focus efforts on what matters most, the Commission has established TSD implementation 
priorities per partner. This is a tool to identify and tackle implementation problems at early stages. 
For the recently concluded agreements, a clear priority has been to advance rapidly on the 
ratification of core international agreements. For that, the Commission has engaged early with 
partners like Japan, Singapore and Viet  Nam on the ratification of outst anding core ILO conventions. 
In the case of Viet  Nam, there are clearly indications that these efforts have led to concrete 
outcomes: in June 2019, Vie t Nam announced the ratification of ILO Convention No . 98 and WT/TPR/M/395/Add.1  
 
- 104 - 
 
  presented a calendar for the ratification o f two other conventions (No . 87 and No . 105). In 
November  2019, Viet  Nam approved a new Labour Code.  
Another priority for the Commission has been the reinforcement of climate provisions in TSD 
Chapters. A commitment to effectively implement the Paris Agre ement on Climate Change has been 
incorporated in the trade agreements concluded with Viet  Nam, Japan, Singapore, Mercosur and 
Mexico. The EU and Canada also adopted a Recommendation on Climate Change to pave the way to 
implement concrete joint actions in t his field.  
In addition, the Commission has adopted a more assertive stance on TSD enforcement, using all the 
tools at disposal when necessary. In December 2018, the EU requested government consultations 
to South Korea over the lack of implementation of key  labour -related TSD commitments. This led to 
the establishment of a panel of experts in December 2019. Its report is expected in 
March/April  2020. The Commission also increased engagement with Peru over concerns over the 
implementation of TSD commitments. This has created a new momentum in the implementation 
process based on a bilateral understanding reached in December 2018.  
 
Paragraphs 2.21 (page 38) and 3.165 (page 109)  
2.21. "The Commission carries out impact assessment analyses to support its decision -making for 
all proposals with significant direct impact, including in the trade policy area. In terms of trade 
agreements, up to four major types of evaluation may be cond ucted during the life of a trade 
agreement. When the Commission recommends the opening of negotiations on a trade agreement, 
it also submits the results of an impact assessment, as required by the Commission's Better 
Regulation agenda. This assessment must  verify the existence of a problem, identify its underlying 
causes, assess whether EU action is needed, and analyse the advantages and disadvantages of 
available solutions and their impacts. The assessment includes an online public consultation of 
interest ed parties. At the stage of negotiations, the Commission carries out trade sustainability 
impact assessments (SIAs) to analyse the economic, environmental, human rights and social 
impacts of the proposed trade agreements for both the EU and its trading par tners. SIAs are 
independent studies conducted by external consultants, involving comprehensive consultations with 
stakeholders and taking into account their knowledge and concerns both in the EU and in the trading 
partner. SIAs are published online. Once t he negotiations are concluded, and before the agreement 
is signed, an analysis of the economic impact of the proposed deal for the EU is prepared for the 
Parliament and the Council. After sufficient time has passed (normally five years after entry into 
force), the Commission carries out an ex post evaluation of the trade agreement, to assess whether 
the expected outcome was achieved, and also to look for unintended effects. Ex post evaluations 
are also published online.  
3.165 Most of the EU product -related  directives and regulations are drafted following the "New 
Approach" – called the New Legislative Framework (NLF) and described in the previous EU TPR. The 
NLF calls for common basic requirements for a particular product/sector and addresses a particular 
risk to be made mandatory by legislation; technical specifications aimed at achieving these 
requirements are contained in voluntary harmonized standards. As per Regulation (EU) 
No. 1025/2012, a harmonized standard "means a European standard adopted on the b asis of a 
request made by the Commission for the application of EU harmonized legislation". In the absence 
of EU harmonized technical regulations, member States may develop and apply national technical 
regulations subject to specific procedures".  
 
6. Question : With respect to the Trade Policy Formulation and Objectives, paragraph 2.21, 
and the New Legislative Framework (NLF), paragraph 3.165, Chile would appreciate if the 
EU could clarify when the regulatory impact assessments of the draft technical re gulations 
and conformity assessment procedures are carried out, together with indicate which 
entity/organization is responsible for the development of these regulatory impact 
assessments.   
 
EU reply:  
In the EU, regulatory impact assessments (IAs) are a go od regulatory practice which informs 
decision -making and aims at gathering and analysing evidence to support policy making. They are 
carried out in accordance with the European Commission's Better Regulation Guidelines. In 
particular, the adoption of techn ical regulations and conformity assessment procedures contained in 
EU harmonized legislation likely to have significant economic, environmental or social impact is 
normally subject to a prior regulatory impact assessments carried out by the European Commis sion, 
that informs the initial legislative proposal prepared and submitted by this Institution to the EU 
co-legislators (i.e. European Parliament and Council).  WT/TPR/M/395/Add.1  
 
- 105 - 
 
  Sustainability Impact Assessments (SIAs) are trade -specific and independent ex ante assessments  
run simultaneously with major trade negotiations that contribute to the integration of sustainable 
development issues into trade negotiations, to ensure that trade agreement are not an obstacle to 
sustainable development but rather promote it. They comple ment IAs by allowing a more in -depth 
analysis of the potential economic, social, human rights and environmental impacts of the agreement 
under negotiation, as well as by facilitating a wider outreach with stakeholders in both the EU and 
partner countries. They help to steer the trade negotiations by feeding them with evidence on an 
ongoing basis as one key characteristic is that contractor conclude their analyses with 
recommendations for measures to minimise risks and maximise opportunities for sustainable 
development that are created by trade negotiations. While IAs are produced by the Commission 
services, prior to adoption of the negotiation mandate, SIAs are run by independent, external 
consultants during the negotiations.  
 
2.3 Trade Agreements and Arrang ements  
2.3.2 Regional and preferential agreements  
2.3.2.1 Reciprocal preferences  
 
Paragraph 2.38, page 43  
"Negotiations with Tunisia on a deep and comprehensive free trade area (DCFTA), launched in 
October 2015, continued during the review period. Negotia tions with Morocco on the same type of 
agreement have been on hold since 2014. The DCFTAs will complement and modernize the current 
legal framework for trade relations between the EU and Tunisia and Morocco, called the 
Euro-Mediterranean Association Agreements. The key objective of these DCFTAs is to support 
Tunisia's and Morocco's development and reform agendas, the enhancement of their export 
competitiveness, and their better integration into regional and global value chain s".  
 
7. Question : Paragraph 2.38 indicates that the DCFTA " will complement and modernize 
the current legal framework for trade relations between the EU and Tunisia and Morocco ", 
where one of the key objectives is " their better integration into regional an d global value 
chains ". In this context, Chile would appreciate if the EU could indicate how it has focused 
its efforts during the negotiating process, in order to enhance their integration into 
regional and global value chains, specifically if there are c ertain provisions directly related 
to the issue, and if so, Chile would appreciate if the EU could share these approaches.   
 
EU reply:   
Negotiations of revised provisions for the Pan Euro -Med Convention on rules of origin provide an 
opportunity to further simplify these rules among interested parties and make them more 
user-friendly and conducive to additional cross -border cooperation. Once adopted, these rules will 
provide a boost to further help these countries integrate into regional and global value cha ins. 
 
2.4 Investment Regime  
2.4.2 Investment relations with third countries  
2.4.2.1 Establishment of a cooperation mechanism for the screening of FDI  
 
Paragraph 2.60, page 48  
"The European Commission President proposed the creation of an EU framework for F DI screening 
in the 2017 State of the Union address. The proposal was motivated by growing concerns regarding 
the impact on the strategic interests of the EU or its member States of certain types of FDI, especially 
foreign acquisitions in cases involving s tate-owned enterprises and strategic sectors. This legislation, 
a regulation based on the common commercial policy competence in Article 207(2) of the TFEU, was 
adopted on 19 March 2019, entered into force on 10 April 2019, and shall apply from 
11 October  2020".  
 
8. Question:  Paragraph 2.60 states that " The European Commission President proposed 
the creation of an EU framework for FDI screening in the 2017 State of the 
Union  address[...]This legislation, a regulation based on the common commercial policy 
competence in Article 207(2) of the TFEU, was adopted on 19 March 2019, entered into 
force on 10 April 2019, and shall apply from 11 October 2020 ". In this regard, Chile would 
appreciate if the EU could indicate if the regulation has a narrow, asset  - or sector specific 
approach, or a broad cross sectoral approach. In addition, Chile would appreciate if the 
EU could further elaborate on the criteria and requirements to consider that FDI is likely 
to affect security or public order .  WT/TPR/M/395/Add.1  
 
- 106 - 
 
  EU reply:  
Regula tion (EU) 2019/452 applies to all foreign direct investment into the Union and is thus not 
limited to specific assets or sectors. The Regulation provides for an assessment by the Member 
States or the Commission to examine whether FDI is likely to affect se curity or public order. To guide 
Member States and the Commission in this assessment, Article 4 of the Regulation provides an 
illustrative list of factors that may be considered. Among those are factors concerning the potential 
effects of the foreign direc t investment on critical infrastructure, critical technologies, supply of 
critical inputs, access to sensitive information or the freedom and pluralism of the media, as well as 
factors related to the foreign investor (such as control by the government incl uding through 
ownership structure or significant funding, or a serious risk that the foreign investor engages in 
illegal or criminal activities).  
 
Furthermore, it should be noted that the Regulation leaves the decision of whether or not to screen 
foreign investments to the EU Member States and does not oblige them to apply a uniform horizontal 
screening mechanism.  
 
Paragraph 2.63, page 49  
"In addition, the Regulation defines the factors that may be taken into consideration by member 
States (or the Commission) in determining whether FDI is likely to affect security or public order. In 
this respect, it provides that account may be taken of the potential effects of the investment on the 
following factors:  
"(a) critical infrastructure, whether physical  or virtual, including energy, transport, water, health, 
communications, media, data processing or storage, aerospace, defense, electoral or financial 
infrastructure, and sensitive facilities, as well as land and real estate crucial for the use of such 
infrastructure;  
(b) critical technologies and dual use items as defined in point 1 of Article 2 of Council Regulation 
(EC) No. 428/2009, including artificial intelligence, robotics, semiconductors, cybersecurity, 
aerospace, defence, energy storage, quantum a nd nuclear technologies as well as nanotechnologies 
and biotechnologies;  
(c) supply of critical inputs, including energy or raw materials, as well as food security;  
(d) access to sensitive information, including personal data, or the ability to control s uch information; 
or  
(e) the freedom and pluralism of the media."  
 
9. Question:  Paragraph 2.63 states that " the Regulation defines the factors that may be 
taken into consideration by member States (or the Commission) in determining whether 
FDI is likely to  affect security or public order". Subsequently, bullet a) of the paragraph 
refers to  "critical infrastructure, whether physical or virtual, including energy, transport, 
water, health, communications, media, data processing or storage, aerospace, defence, 
electoral or financial infrastructure, and sensitive facilities , as well as land and real estate 
crucial for the use of such infrastructure ". In this regard, Chile would appreciate if the EU 
could further develop on the term "sensitive facilities", and wha t distinguishes it from 
critical infrastructure.  
 
EU reply:  
Sensitive facilities are mentioned in Article 4 of the Regulation as one of the examples of what could 
be considered as critical infrastructure. There is no pre -defined list of sensitive faciliti es. What may 
constitute sensitive facilities needs to be decided on a case -by-case basis, taking into consideration 
the context and circumstances of the foreign investment. One factor may be, for instance, whether 
the disruption, failure, loss or destructi on of the facility would have a significant impact on security 
or public order in a Member State or in the Union.  
 
10. Question : Paragraph 2.63, bullet c) refers to " supply of critical inputs, including 
energy or raw materials, as well as food security ". In relation with this, Chile would 
appreciate if the EU could elaborate on examples of critical inputs, other than energy and 
raw materials, and what raw materials would be considered critical inputs.   
 
EU reply:  
Energy and raw materials are only examples  of critical inputs. Given the security or public order 
objectives of the Regulation, it is not appropriate to list in a comprehensive manner all raw materials 
that could be considered as critical inputs for the Union and its Member States.  
 WT/TPR/M/395/Add.1  
 
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  2.4.2.2 Agreem ents with third countries  
 
Paragraph 2.68, page 50  
"As noted above, following the advisory opinion of the CJEU of May 2017, the treatment of 
investment matters in EU agreements bifurcated. Trade agreements that deal only with matters 
within exclusive EU co mpetence, and are concluded only by the EU, include market access provisions 
with respect to FDI. Investment protection issues are addressed in separate investment protection 
agreements that include matters that fall within EU -exclusive and shared EU and m ember State 
competences and that are concluded by both the EU and the member States. These mixed EU 
investment protection agreements will replace bilateral investment agreements between individual 
EU member States and third countries."  
 
11. Question : Parag raph 2.68 states that " Investment protection issues are addressed in 
separate investment protection agreements that include matters that fall within 
EU-exclusive and shared EU and member State competences and that are concluded by 
both the EU and the membe r States. These mixed EU investment protection agreements 
will replace bilateral investment agreements between individual EU member States and 
third countries" . In relation with this, Chile would appreciate if the EU could further 
explain on the bifurcated  treatment of investment matters that follows the advisory 
opinion of the CJEU of May 2017, considering the Singapore – EU trade and investment 
agreements. To further clarify, Chile would like to know if the new architecture mandates 
the EU to always negot iate a separate investment protection agreement.   
 
EU reply:  
Following the advisory opinion of the CJEU of May 2017, the EU takes the decision on whether to 
conclude two separate agreement on trade and investment on a case -by-case basis. In some cases 
(e.g. EU -Singapore), two separate agreements were concluded: one FTA including investment 
liberalisation (exclusive EU competence) and a separate investment protection agreement (shared 
competence). In other instances, the EU can and has concluded agreements covering both 
investment liberalisation and investment protect ion (e.g. CETA, Mexico).  
 
Paragraph 2.70, pages 50 - 51 
"The dispute settlement provisions of the Investment Protection Agreement are similar to those of 
the CETA and reflect what is now commonly referred to as the Investment Court System. This new 
System results from a policy adopted by the EU in 2015 as part of the Trade for All Strategy, to work 
towards the reform of the traditional investor -state dispute settlement mechanism of international 
investment agreements. Instead of ad hoc arbitration bodies, the System provides for a permanent 
Tribunal of First Ins tance and a permanent Appeal Tribunal to hear appeals from provisional awards 
issued by the Tribunal of First Instance. The members of these Tribunals are appointed in advance 
by the contracting parties, must meet specified requirements regarding expertise  and qualifications, 
and are subject to strict rules of ethical conduct. The new rules also include detailed provisions on 
the transparency of proceedings, notably through public access to documents, hearings and the 
possibility of third persons making sub missions. In addition to the inclusion of provisions regarding 
the System in bilateral agreements, the EU is also pursuing the establishment of a multilateral 
investment court system and the reform of the investment provisions in the Energy Charter Treaty. "  
 
12. Question : Paragraph 2.70 refers to the Investment Court System, and states that the 
"System provides for a permanent Tribunal of First Instance and a permanent Appeal 
Tribunal to hear appeals from provisional awards issued by the Tribunal of First Instance ". 
In this context, Chile would appreciate if the EU could further elaborate on the background 
and elements that were considered in developing the permanent Appeal Tribunal of its 
Investment Court System and when it deems that this system will be i n place.   
 
EU reply:  
The rationale for including a permanent appeal instance in the bilateral Investment Court System 
relates to the need to ensure correctness and consistency of decisions. The function of the Appeal 
Tribunal is to correct errors in the i nterpretation of the law or the appreciation of facts in the 
provisional decision and in the latter case the Appeal Tribunal may remand the case to the Tribunal 
of First Instance. The Appeal Tribunal is also designed to perform a consistency check to ensur e 
predictability in the interpretation of the law, a key factor for both investors and states. In this sense 
an appeal mechanism is seen as enhancing public support for investor -state adjudication.  WT/TPR/M/395/Add.1  
 
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  The Investment Court System ensures that overall procedur es do not become too lengthy as clear 
timelines are foreseen and the possibility to appeal is circumscribed to well -grounded cases. An 
appeal instance also leads to very different consequences that cannot be envisaged under the 
traditional investor -state d ispute settlement (ISDS). While an annulment under ISDS leads to the 
invalidation of the original decision and the possibility to re -litigate the entire case, an appeal may 
result in the modification of the decision. In case of appeal with remand only cert ain, clearly defined 
parts of the case would need to be re -litigated.  
The Members of the Appeal Tribunal are subject to comparable professional qualifications and ethical 
rules as the judges of the Tribunal of First Instance and are appointed for a fixed t erm to secure the 
independence and impartiality of the system.  
The first agreement setting up the Investment Court System, i.e. CETA, is currently in process of 
ratification in the EU Member States' parliaments and the Investment Court System will be 
operational upon the entry into force of the agreement.  
 
Paragraph 2.72, page 51  
"EU foreign investment policy includes transition arrangements regarding bilateral investment 
treaties signed by EU member States with third countries before the entry into force of the Lisbon 
Treaty or the date of their accession to the EU. According to a notice published by the Commission 
in June 2019, more than 1,400 bilateral investment agreements were in force between EU member 
States and third states, which is more than half of the 2,353 bilateral investment agreements in 
force globally, according to the UNCTAD data base on international investment agreements. 
Regulation (EU) No. 1219/2012 lays down the conditions under which such treaties may be 
maintained until they are prog ressively replaced by investment agreements concluded by the EU. It 
also provides that the Commission may authorize member States to negotiate with third states to 
amend existing treaties or conclude new ones, subject to certain conditions".  
 
13. Question : Paragraph 2.72 states that " EU foreign investment policy includes transition 
arrangements regarding bilateral investment treaties signed by EU member States with 
third countries before the entry into force of the Lisbon Treaty or the date of their 
access ion to the EU " as well as that " Regulation (EU) No. 1219/2012 lays down the 
conditions under which such treaties may be maintained until they are progressively 
replaced by investment agreements concluded by the EU ". In relation with this, Chile 
would appre ciate if the EU could further elaborate on the transition arrangements 
regarding bilateral investment agreements signed by EU member States with third 
countries, and on its procedure. In addition, Chile would appreciate if the EU could further 
explain on t he relationship between an ongoing negotiation in accordance with Article 
218(3) TFEU and the authorisation that the Commission gives to the Member States to 
open formal negotiations with a third country to amend or conclude a bilateral investment 
agreemen t. 
 
EU reply:  
Regulation (EU) No. 1219/2012 provides a mechanism for EU member States to notify all 
agreements signed prior to the entry into force of the Lisbon Treaty and which they wished to 
maintain in force until an agreement between the EU and the r espective third country enters into 
force. The Regulation also lays down the transitional arrangements and conditions under which EU 
member States may continue to conclude new bilateral investment agreements or amend existing 
agreements. Before opening a n ew negotiation or amending an existing agreement, EU Member 
States need to notify a request for authorisation to the Commission. An authorisation cannot be 
granted to an EU member State if an EU -level investment negotiation is already ongoing with the 
same  third country or if the Commission has submitted - or decided to submit - a recommendation 
to open negotiations, pursuant to Article 218(3) of the Treaty on the Functioning of the EU, with the 
same third country. Other authorisation conditions include com patibility with Union law and 
consistency with the EU's investment policy, consistency with the objectives of the EU's external 
action and presenting no obstacles to the negotiation or conclusion of EU -level agreements.  
 WT/TPR/M/395/Add.1  
 
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  3 TRADE POLICIES AND PRACTICES BY M EASURE  
3.1 Measures Directly Affecting Imports  
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.1.6.1 Anti -dumping and anti -subsidy measures  
 
Paragraph 3.78, page 79  
"The first set of changes were introduced in 2017, and added language with respect to "normal 
value". In essence, this allows for the normal value to be determined by another method where 
there are state -induced distortions in the exporting country. In suc h circumstances, normal value is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of 
benchmarks such as international prices or costs in another representative country. A different 
methodology for determining the no rmal value is set out for non -WTO Members".  
 
Box 3.2 Main elements of the trade remedy modernization 2018, page 80  
 
- More transparency and predictability  Interested parties are informed three weeks in advance of the 
imposition of provisional measures.  
- Faster  anti-dumping 
 investigations  The time -period for the introduction of provisional measures 
was reduced from 9 to normally 7 or maximum 8 months.  
- Additional support for EU SMEs  A dedicated webpage and helpdesk were established for SMEs.  
- A chang e in injury margin 
 calculation method  New rules for the non -injurious price were put in place, 
reflecting profitability, future expenses, etc.  
- Inclusion of social and environmental 
 considerations  Implementation of social and environmental standards are 
taken into account:  
 - in determining target price for EU industry; and  
 in considering undertaking offers.  
- Changes to the use of the lesser duty 
 rule (LDR)   - In anti -dumping cases, raw material distortions will result 
 in a modulatio n of the LDR  
 - In CVD cases, the LDR will not apply unless it is against 
 the EU interest.  
- Better response to threats of 
 retaliation  Clarification that threats of retaliation to industry qualify as one 
of the special circumstances justifying ex officio  investigations.  
- Participation of trade unions in 
 investigations  The rules now allow trade unions to be interested parties in 
invest igations.  
- New rules in the EU continental shelf 
 and exclusive economic zones  Allows for trade remedy measures to be applicable to these 
regions of the EU.  
- Reimbursement of duties  Repayment of duties collected while an expiry review is 
ongoing, if th at review is terminated without the extension of 
the measures.  
 
14. Question:  Regarding the regulation that introduce a new methodology to calculate the 
normal value in terms of dumping and subsidies, mentioned in paragraph 3.78 and 
Box 3.2, Chile would appreciate if the EU could indicate the elements that, according to 
them, identify the presence of "state -induced distortions in the exporting country". In 
addition, Chile would we thankful if EU could highlight the main characteristics of the new 
rules that modifies the "injury margin calculation method".  
 
EU reply:  
Sub-paragraph (b) of the Article 2(6)(a) of the EU's Basic Anti -dumping Regulation lists in a 
non-exhaustive manner circumstances which may result in significant distortions, as follows:  
 
— the market in question being served to a significant extent by enterprises which operate under 
the ownership, control or policy supervision or guidance of the authorities of the exporting country;  
— state presence in firms allowing the state to interfere with respect to prices or costs;  
— public policies or measures discriminating in favour of domestic suppliers or otherwise influencing 
free market forces;  
— the lack, discriminatory application or  inadequate enforcement of bankruptcy, corporate or 
property laws;  
— wage costs being distorted;  WT/TPR/M/395/Add.1  
 
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  — access to finance granted by institutions which implement public policy objectives or otherwise 
not acting independently of the state.  
 
The changes to the calculation of the non -injurious price used to calculate an injury margin mean 
that the non -injurious price will reflect:  
 
- actual costs resulting from compliance with multilateral environmental agreements and 
International Labour Organisation Conventions  to which the European Union is a party as well as 
any future cost increases in that respect that would occur during the lifetime of TDI measures.  
- a minimum target profit of 6%. Higher profit margins may be possible on a case -by-case basis 
taking into a ccount various factors such as, the level of profitability before the increase of imports 
from the country under investigation, the level of profitability needed to cover full costs and 
investments, research and development and innovation, and the level of  profitability expected under 
normal conditions of competition. If the target profit so established is higher than 6%, the higher 
percentage will be used as the target profit.  
 
Paragraph 3.79, page 79  
"The changes set out in the second amendment in 2018 ar e more numerous and diverse; the main 
elements are outlined in Box 3.2. As illustrated, the changes involve procedural aspects, such as 
shortening the time -period for provisional measures, and more substantial aspects, such as how the 
injury margins are ca lculated. For example, in calculating the non -injurious price, a minimum profit 
of 6% is included. Another new development is the ability to take into account the presumably higher 
costs of EU industry compliance with social and environmental standards".  
 
Box 3.2 Main elements of the trade remedy modernization 2018, page 80  
 
15. Question: Box 3.2 and paragraph 3.79 mention that the EU AD CVD legislation 
underwent amendments which included, among other provisions, the inclusion of social 
and environmental  considerations. In this context, Chile would appreciate if the EU could 
share further details as to how these types of considerations are taken into account in AD 
and CVD investigations.  
 
EU reply:  
The European Union will take account of soc ial and environmental standards in the application of the 
trade defence instruments in the following ways:  
• In the context of selecting a representative country, when establishing normal value under the 
alternative dumping calculation methodology, from a group of several potentially suitable countries, 
an assessment of the level of social and environmental protection in the countries under 
consideration may be used in the decision.  
• Injury margins will reflect the cost of social and environmental standar ds within the European 
Union. The cost of production also includes costs that EU producers incur when complying with 
multilateral environmental agreements and with important International Labour Organisation 
conventions. It means that actual costs incurred  by EU manufacturers as well as future cost increases 
during the lifetime of TDI measures resulting from compliance with these standards will be taken 
into account, in calculating a non -injurious price.  
• In examining the acceptability of price undertakin g offers from exporters, social and environmental 
standards in the exporting country concerned may also be a consideration.  
 
3.1.6.2 Safeguards  
 
Paragraphs 3.93 and 3.94, page 85  
"As noted in the previous Review, the EU imposed steel surveillance measures  which continued to 
be in place during the review period, pursuant to Commission Implementing Regulation (EU) 
2016/670. The Regulation was amended in 2017 by Commission Implementing Regulation (EU) 
2017/1092, in order to amend the product coverage, clarify  the procedures for the surveillance 
document, exclude small shipments whose weight does not exceed 5,000 kg classified in HS heading 
7318, and to encourage the use of electronic versions of the surveillance document. For the products 
covered by the safegu ard measures, the surveillance measures were suspended.  
Similar to the surveillance measure that was put in place for steel products in 2016, the EU invoked 
a surveillance measure on certain aluminium products144 originating in certain third countries, fro m 
April 2018 until May 2020.145 The Commission Implementing Regulation cites "recent trends in 
imports of aluminium products, the current excess capacity, the current vulnerable situation of the WT/TPR/M/395/Add.1  
 
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  Union industry and the potential trade diversion triggered by  the United States measures" as the 
reasons for imposing such a measure. Thus, pursuant to the EU's safeguard rules as set out in 
Regulations (EU) 2015/478 and (EU) 2015/755, certain aluminium products whose net weight 
exceeds 2,500 kg require surveillance  documents issued by the competent authorities before the 
product can be put in free circulation.  
 
16. Question: Regarding surveillance measures for steel and aluminum products, detailed 
in paragraphs 3.93 and 3.94, Chile would appreciate if the EU could provide further details, 
particularly, if the measures include analysis of origin, and if there is any special 
requirement imposed further for the exports of these products to the EU.  
 
EU reply:  
Articles 10 -14 of Regulation (EU) 2015/478 provide the fundamental requirements concerning the 
functioning of the surveillance mechanism in the EU. More detailed requirements may be contained 
in the decisions imposing the surveillance on specific products.  Pursuant to Article 11.1 & 11.2 of 
Regulation 2015/478, in order for goods subject to surveillance to be imported into the EU, a 
surveillance document must be produced, where inter alia  the origin of the goods should be declared. 
Pursuant to Article 11.6 of the same Regulation, the origin indicated in the surveillance document 
must be proved by a certificate of origin, when this is required by the decisions imposing the 
surveillance on specific products.  
Similar requirements are contained in Articles 7 -12 of Regulation (EU) 2015/755.  
 
3.2 Measures Directly Affecting Exports  
3.2.5 Export finance, insurance, and guarantees  
 
Paragraphs 3.119, page 92 -93 
"Most EU member States have some form of officially -supported export financing, credits, insurance 
or guara ntees. These are provided by the member States through designated export -credit agencies, 
financial institutions, export -import (EXIM) banks, or similar (Table A3.3). As such, 26 EU member 
States offer export credits or guarantees through approximately 30 entities, although there are 
fluctuations year -to-year. While the operation and delivery of these products is at the national level, 
the EU has a number of provisions at the supranational level, to harmonize certain aspects or create 
a level playing field;  it also plays a coordinating role on policy".  
 
17. Question: How the EU guarantee that programs "officially -supported export financing, 
credits, insurance or guarantees" given by Members states, are not considered prohibited 
subsidies according to the AS MC? 
 
EU reply:  
Official support for export credits (including guarantees and insurance) is exempted from the general 
export subsidy prohibition of Article 3.1 (b) of ASCM if they satisfy conditions set out in items (j) 
and (k) of Annex 1 of ASCM. One of t he applicable provisions is second paragraph of item (k) 
providing safe harbour for government export credit practices that are in conformity with the 
Arrangement on Officially Supported Export Credits ("OECD Arrangement"). The OECD Arrangement 
applies to official support for medium - and long -term export credits and all categories of government 
export credits provided in the EU that comply with OECD Arrangement are covered by the safe 
harbour provision. The compliance is verifiable on the basis of notificat ions made by EU providers of 
this government support to the OECD.  
The categories of government support for export credits that do not fall under the OECD 
Arrangement safe harbour provision, benefit from other exemptions stipulated in items (j) and (k) 
of Annex 1 of ASCM if they conform with the conditions defined therein. The compliance with these 
provisions is verifiable on the basis of WTO notifications and procedures and subject to WTO dispute 
settlement mechanism.  
In addition, and specifically with re gard to short -term export credits, unless given on market conform 
terms, officially supported short -term export -credits may constitute State aid. Article 107(1) of the 
Treaty on the Functioning of the European Union states that 'any aid granted by a Member  State or 
through State resources in any form whatsoever which distorts or threatens to distort competition 
by favouring certain undertakings or the production of certain goods shall, in so far as it affects trade 
between Member States, be incompatible wit h the internal market'. Therefore, Member States may 
need to notify the support measure to the European Commission, which will then assess the notified 
measure under State aid rules.  WT/TPR/M/395/Add.1  
 
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  In particular, the rules concerning export -credit insurance with a risk period of less than two years 
are set out in the Communication from the Commission to the Member States on the application of 
Articles 107 and 108 of the Treaty on the Functioning of the European Union to short -term 
export -credit insurance (OJ C 392, 19.12 .2012, p. 1 –7). The Communication defines insurance of 
short-term credit risks for exports within the EU, but also to Australia, Canada, Iceland, Japan, New 
Zealand, Norway, Switzerland, the United Kingdom and the United States of America to be 
marketable,  meaning that there is sufficient private capacity available for insurance of such risks. 
Marketable risks can in principle only be insured by Member States if they act as market economy 
operators, i.e. on a commercial basis.  
 
3.3 Measures Affecting Produ ction and Trade  
3.3.1 Incentives  
3.3.1.1 EU -level subsidies  
 
Paragraphs 3.126 – 3.134, pages 96 -98  
 
18. Question: Could the EU further explain how "structural support" given by the European 
Maritime Fishery found does not contribute to "overfishing and overcapacity of fleets", 
and " illegal , unreported, and unregulated fishing".   
 
EU reply:   
EU structural support is provided under Regulation (EU) No . 508/2014 of the European Parliament 
and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund. Article 5 states 
that structural support "shall not result in an increase in fishing capacity". Article 10 determines that 
an application fo r structural support submitted by an operator engaged in illegal, unreported, and 
unregulated fishing shall be inadmissible.  
 
3.3.2 Standards and technical requirements  
3.3.2.1 New Legislative Framework  
 
Paragraph 3.168, page 109  
"With the aim of making the principle on the mutual recognition of goods faster, simpler and ensure 
its correct application in individual cases, Regulation (EU) 2019/515 was adopted on 19 March 2019 
and will apply as of 19 April 2020 replacing Regulation ( EC) No. 764/2008. Pursuant to the new 
Regulation, member States that use existing technical regulations to restrict market access for 
products lawfully marketed in another member State must justify their position with technical and 
scientific evidence and must grant the economic operators affected an opportunity to provide 
comments. Under the new Regulation, companies will know if their products can be sold in another 
EU country in a few months, rather than years. They will also be able to use a voluntary d eclaration 
to demonstrate that their products meet all the relevant requirements in their country. This will 
make it easier for authorities to assess whether mutual recognition principle should apply. 
Furthermore, a problem resolution mechanism is expected  to allow for a faster resolution of disputes 
between companies and national authorities".  
 
19. Question : Paragraph 3.168 address the issue of company's voluntary declarations, 
used to demonstrate that their products meet relevant requirements in their co untry. In 
this regard, Chile would appreciate if the EU could clarify who will made these 
declarations: the exporter and/or importer, or are they endorsed by the certifying body?   
 
EU reply:  
Regulation (EU) 2019/515 provides for a standard form for the vo luntary declaration of lawful 
marketing of goods for the purposes of mutual recognition ("mutual recognition declaration"). Part 
I of the mutual recognition declaration refers to information on the lawfulness of the marketing of 
the goods (including inform ation on the rules applicable in the Member State(s) in which the goods 
are claimed to be lawfully marketed), while Part II of the declaration concerns the marketing of the 
goods, including information that the goods are made available to the end users in the Member 
State(s) indicated in Part I.  
The producer of goods is best placed to draw up the mutual recognition declaration as it knows the 
goods best and is in possession of the evidence necessary to verify the information to be provided. 
The producer ma y also mandate an authorised representative to draw up such declarations on the 
behalf and responsibility of the producer.  WT/TPR/M/395/Add.1  
 
- 113 - 
 
  However, where the producer or its authorised representative are only able to provide the 
information on the lawfulness of the marke ting of the goods (part I of the declaration), it is possible 
for other economic operators (i.e. the importer or the distributor) to provide the information that 
the goods are being made available to end users in the Member State(s) concerned (part II of t he 
declaration).  
Alternatively, both parts of the mutual recognition declaration may be drawn up by the importer or 
by the distributor, provided that the signatory can supply evidence to verify the information 
contained in the declaration.  
The mutual reco gnition declaration is not endorsed by any certifying body. Economic operators who 
sign the declaration or a part of it - with the exception of the authorised representative who acts on 
behalf of the producer - shall be responsible for the context and accu racy of the information that 
they provide in the declaration.  
 
3.3.2.2 Institutional framework  
 
Paragraph 3.183, page 111  
"CEN and CENELEC standards are aligned with ISO and IEC standards. Participation in international 
standards development is arranged by  the NSB of each country via their membership of the ISO, 
the IEC, the CEN or the CENELEC".  
 
20. Question : Regarding paragraph 3.182, Chile would appreciate if the EU could share if 
there is an estimate of the percentage of CEN and CENELEC standards that a re based on 
international standards.   
 
EU reply :  
CEN and CENELEC are private independent organisations that publish statistics about their outputs 
every 3 months. This is the website:  
https://www.cencenelec.eu/aboutus/InFigures/Pages/default.aspx  
This i s the latest publication regarding the figures from Q4 2019:  
https://www.cencenelec.eu/stats/CEN_CENELEC_in_figures_quarter.htm  
From this publication, CEN standards identical to ISO are 32.6%, while CENELEC standards identical 
to IEC are 73.46% and based on IEC 6.51%, leaving purely home -grown European standards in the 
electro technical sector only to 20%.  
 
Paragraph 3.188, page 112  
"The participants of the JIS are the Commission; EU member States; EFTA countries; ESOs, CEN, 
CENELEC, and ETSI; NSBs; European industry also represented by several associations including 
SMEs; and societal stakeholders, i.e. representing environmental int erests, trade unions and 
consumers. JIS activities include a wide range of actions, such as programmes for education in 
standardization, improvement standardization awareness in national public authorities, a pilot 
project on aiding the implementation of t he Construction Products Regulation (CPR) through 
standards, and another pilot project on the increased use of standards in public procurement".  
 
21. Question : With respect to the Joint Initiative on Standardization (JIS) activities 
mentioned in paragraph  3.188, Chile would appreciate if the EU could share concrete 
examples of programmes for education in standardization.  
 
EU reply:   
The JIS "Education about Standardization (EaS)" assessed both the demand for and the supply of 
EaS in Europe. Tailor -made ass essments provided the fact base. "EaS" is defined as the transfer of 
knowledge about standardisation. The JIS focused on the teaching of students of higher education 
organizations in non -technical scientific disciplines as opposed to technical fields where  
standardization is an established working tool.  
JIS has triggered initiatives to collect knowledge and teaching methodologies used in EU academia 
and to promote the consideration of "EaS" in the design of academic teaching. These activities are 
still ong oing and supported by the DG GROW network of academics active in standardization -related 
research and teaching. On a very pragmatic level, a textbook about the basics of standardisation 
has been available assisting teachers to include standardization -related knowledge in their lectures 
(downloadable, free -of-charge from www.etsi.org/standardization -education).  
 WT/TPR/M/395/Add.1  
 
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  3.3.7 Intellectual property rights  
3.3.7.1 Copyright and related rights  
 
Paragraph 3.328 and 3.329, pages 146 y 147  
3.328. The Directive on copyrigh t in the Digital Single Market (395) is designed to further harmonize 
copyright and related rights in the EU, in particular with regard to digital and cross -border uses of 
protected content. It lays down exceptions and limitations to copyright and related rights to allow, 
with appropriate safeguards, text and data mining, in particular for scientific purposes, and to 
facilitate digital and cross -border teaching activities, and the preservation and dissemination of 
European cultural heritage.  
Footnote 395: Directive (EU) 2019/790 of the European Parliament and of the Council of 
17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 
96/9/EC and 2001/29/EC. Viewed at: https://eur -lex.europa.eu/legal -
content/EN/TXT/PD F/?uri=CELEX:32019L0790&from=EN.  
 
3.329. The Directive furthermore contains measures to improve licensing practices, and ensure wider 
access to content, in particular as regards out -of-commerce works and works of visual art upon 
expiry of the original ter m of protection. For example, it requires member States to allow collective 
management organizations to conclude non -exclusive licences with cultural heritage institutions for 
non-commercial purposes for use throughout the EU. It introduces, subject to saf eguards, collective 
licensing with an extended effect to include works by authors not having mandated collective 
management organizations to represent them. It seeks to enhance access to, and availability of, 
audiovisual works on video -on-demand platforms by requiring the establishment of impartial bodies 
or the appointment of mediators to assist parties facing difficulties in concluding licensing 
agreements".  
 
22. Question : Regarding paragraphs 3.328, 3.329 and footnote 395, Chile would 
appreciate if the EU could further explain the functioning of the measures established in 
Chapters I and II, Title III, of the Directive on copyright in the Digital Single Market 
(Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 
on copy right and related rights in the Digital Single Market and amending Directives 
96/9/EC and 2001/29/EC).   
 
EU reply :  
Title II of the DSM Directive introduces new mandatory exceptions to copyright, which will have to 
be implemented by all Member States, to a dapt exceptions and limitations to the digital and 
cross-border environment: Two new exceptions are introduced for text and data mining, allowing 
the use of data analytics tools on copyright protected content (Articles 3 and 4). The exception 
provided for in Article 3 is limited to scientific research purposes. A second, more general exception 
is introduced by Article 4, allowing all users (including outside of the research field) to carry out text 
and data mining without the need to obtain rightholders' au thorisation. This second exception, 
however, allows rightholders to opt out from its application if they do not wish their content to be 
mined by analytic software. Article 5 provides for a mandatory exception for digital and cross -border 
uses of works for  the purpose of illustration in teaching contexts. Member States can provide that 
the exception does not apply when suitable licences are available in the market. Article 6 provides 
for a mandatory exception for the purpose of preservation of works in the permanent collections of 
cultural heritage institutions.  
Title III of Directive (EU) 2019/790 includes measures to improve licensing practices and ensure 
wider access to content: Articles 8 to 11 introduce a new licensing system for out -of-commerce 
works,  which will make it easier for cultural heritage institutions to obtain the necessary licences to 
disseminate to the public the works in their collections. The mechanism allows collective 
management organisations to grant licences to cultural heritage inst itutions even when not all the 
right holders of the works have expressly mandated the collective management organisation to 
manage their rights on their behalf (the licences cover non -represented right holders, with certain 
safeguards for those right holde rs). The new rules also provide for a new mandatory exception in 
case no representative collective management organisation can issue that type of licence. Article 12 
provides rules on extended collective licensing and similar mechanisms. Under this provisi on, 
Member States are allowed to have licensing systems similar to the one for out -of-commerce works 
mentioned above for other areas, under certain conditions and safeguards for right holders. 
Article  13 provides for a negotiation mechanism to help interested parties reach agreements for the 
making available of audiovisual works on video -on-demand platforms. Article 14 clarifies that users WT/TPR/M/395/Add.1  
 
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  can use and share without restriction copies of works of art in the public domain (e.g. a photograph 
of a sculpture or painting no longer covered by copyright), under certain conditions.  
Further information is available here: https://ec.europa.eu/digital -single -market/en/modernisation -
eu-copyright -rules.  
 
Paragraph 3.330, page 147  
"Importantly, the Directive introduces new measures to achieve a well -functioning marketplace for 
copyright. In that context, it protects the rights of publishers of press publications regarding the 
online use of their publication s by information society service providers (as opposed to 
non-commercial uses of them by individual users, hyperlinking, and use of individual words or very 
short extracts)".  
 
23. Question : Regarding paragraph 3.330, Chile would appreciate if the EU could inform 
if there is a report or study that evaluates the impact of the Directive on copyright in the 
Digital Single Market in the promotion and access to press publications.   
 
EU reply:  
For a directive to take effect at national level, EU Member States mus t adopt implementing measures 
to transpose it. In the case of Directive (EU) 2019/790, the transposition must take place by 
7 June 2021. The Commission will carry out a review of the Directive no sooner than 7 June 2026. 
It is therefore too early to provid e details on the impact of the Directive on promotion and access to 
press publications.  
 
Paragraph 3.331, page 147  
"It also addresses the use of protected content by online service providers such as YouTube, Twitter, 
etc. Notably, under Article 17 of the D irective, online content -sharing service providers are held 
responsible for the sharing by users of copyright -protected materials with the public, and are obliged 
to seek relevant authorizations from right -holders. These authorizations then also cover 
non-commercial users. In the event of unauthorized dissemination, service providers are exempted 
from liability if they demonstrate that they have made the best effort to obtain authorization from 
the right -holder; and to make unavailable relevant works based on information provided by the 
right-holder and/or removed infringing content (including future uploads) after receiving a notice 
from the right -holder to this end. Less stringent requirements are placed on newly -established (less 
than three years of provi sion of services) providers with a turnover below EUR 10 million. Rather 
than a general monitoring obligation, requests for information by right -holders, and complaint and 
redress mechanisms for users, need to be established by online service providers. Ex ceptions and 
limitations, such as for use in the context of quotation, criticism, or review; and for the purpose of 
caricature, parody or pastiche, are expressly upheld."  
 
24. Question : Regarding paragraph 3.331, Chile would appreciate if the EU could inf orm 
if article 17 of the Directive on copyright in the Digital Single Market adversely impacts 
the operations of service providers to share content online, and / or the use of works 
protected by exceptions or limitations to copyright and related rights. In  addition, Chile 
would be thankful if the UE could clarify if online services providers will be the ones to 
determinate if the use of a work by a user is lawful or not?  
 
EU reply:   
For a directive to take effect at national level, EU Member States must ado pt implementing measures 
to transpose it. In the case of Directive (EU) 2019/790, the transposition must take place by 
7 June 2021. The Commission will carry out a review of the Directive no sooner than 7 June 2026. 
It is therefore too early to provide details on the impact of Article 17.  
As regards uses of protected works under exceptions and limitations to copyright, Article 17(7) of 
the Directive specifies that "The cooperation between online content -sharing service providers and 
rightholders shall not result in the prevention of the availability of works or other subject matter 
uploaded by users, which do not infringe copyright and related rights, including where such works 
or other subject matter are covered by an exception or limitation". Ad ditionally, this provision makes 
mandatory in all Member States the existing exceptions or limitations for quotation, criticism and 
review, and for uses for the purpose of caricature, parody or pastiche, when users upload and make 
available content generat ed by them on online content -sharing services.  
With regard to the question as to whether an upload by a user is lawful or not, it is not the online 
content -sharing service providers who take this decision. In order to avoid liability for unauthorised 
uses of works uploaded by their users, these service providers need to take certain actions, including WT/TPR/M/395/Add.1  
 
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  to make their best efforts to ensure the unavailability of unauthorised works. This action is, however, 
taken by the service providers only based on the info rmation received from the rightholders for their 
specific works, whose use rightholders have not authorised. Article 17(7), mentioned above, 
provides safeguards for legitimate uses, including for uses under exceptions and limitations to 
copyright. Moreover , Article 17 provides for a complaint and redress mechanism for users in case of 
disputes regarding the removal of their content. If there is no agreement, the user can have recourse 
to an impartial out -of-court dispute settlement mechanism, and ultimately  to judicial remedies, 
where the final decision would be taken.  
 
3.3.7.2 Industrial property  
3.3.7.2.1 Patents  
Supplementary protection certificates  
 
Paragraph 3.342, page 150  
"The EU legal framework offers supplementary protection certificates (SPCs) for  medicinal products 
(Regulation (EC) No. 469/2009) and plant -protection products (Regulation (EC) No. 1610/96) as a 
sui generis IP category that only applies after expiry of the basic patent. In other words, they are 
considered as legally distinct from pat ent protection, including international obligations in this 
regard, and may therefore be subject to wider exceptions than patent rights themselves. Following 
up on a Commission proposal of 28 May 2018, the EU co -legislators adopted Regulation (EU) 
2019/933  amending Regulation (EC) No. 469/2009 concerning the supplementary protection 
certificate for medicinal products, introducing an exception to let firms established in the EU 
manufacture certain pharmaceutical products for export to non -EU markets during t he term of the 
SPC. It also permits the making and stockpiling of a pharmaceutical product six months prior to the 
expiry of the certificate, in order to place it on the market of EU member States immediately after 
expiry of the certificate. These provisio ns have been described as means to level the playing field 
for Europe -based generic and biosimilar manufacturers in light of a lack of international binding rules 
on SPCs. Comparable exceptions were included in recent FTAs such as the CETA.  
 
25. Question: La regulación EU 2019/933 (de mayo de 2019), modificó la regulación  sobre 
los SPC introduciendo importantes excepciones a este derecho, a objeto de beneficiar la 
creciente industria de genéricos y biosimilares al interior de la UE.  La excepción permite 
la fabricación de genéricos para fines de exportación, así como también su 
almacenamiento por un período limitado. Según señala el reporte, esta excepción ha sido 
replicada en recientes Tratados de Libre Comercio de la UE como por ejemplo en 
CETA.  Habiendo re visado las propuestas presentadas por la UE en negociaciones en curso, 
hemos observado que tal excepción no se ha incluido en estos acuerdos de última 
generación. Nos referimos al caso de las negociaciones con Chile (X.48), Viet  Nam (art. 
12.40), Nueva Zel anda (X.41) y Australia (X.41), así como también en el reciente acuerdo 
con México (X.46). ¿Ha habido un cambio de criterio por parte de la UE en relación a la 
industria de genéricos y biosimilares que han llevado a no replicar esta excepción en estos 
acue rdos? En caso de ser efectivo lo anterior, ¿cuáles son las razones de ese cambio de 
criterio? (Párrafo 3.342).  
 
EU reply :  
There has not been any change of EU approach. CETA provided for the possibility of the parties to 
introduce a SPC exception and the EU introduced this exception only in June 2019.  
 
3.3.7.2.3 Trademarks  
 
Paragraphs 3.354 and 3.355, pages 152 - 153 
3.354."The new rules also removed the graphical representation requirement for trademarks. 
Instead, signs can be represented in any appropriate form using generally -available technology, as 
long as the representation is clear, precise, self -contained, easi ly accessible, intelligible, durable and 
objective. This enables applicants to use electronic file formats, e.g. widely -used image and sound 
file formats such as jpeg and mp3, in the registration process. The new requirements are intended 
to modernize the system, and to reduce the rate of objections related to formalities.  
3.355. The new legislation on the EUTM also streamlined the procedures before the EUIPO and 
modernized them to take into account the use of IT. In that vein, priority claims are no longe r 
examined in substance, but remain as a "mere" claim until relied upon. Applicants can invoke 
acquired distinctiveness as a subsidiary claim, allowing them to only incur the expense of gathering 
and presenting evidence of use, if necessary, if they are no tified of a negative final decision on WT/TPR/M/395/Add.1  
 
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  inherent distinctiveness as primary claim. Furthermore, opposition or cancellation claims can be 
substantiated with reference to online sources recognized by the Office (e.g. the databases of the 
national and regional  EU IP offices). Assignment is recognized as an alternative remedy to 
invalidating a trademark registered without the authorization of the proprietor. Other changes 
concern the reordering and clarification of provisions on opposition/cancellation proceedin gs and 
Boards of Appeal; the simplification of language and translation requirements; and the 
modernization of provisions on communication with the office".  
 
26. Question:  En relación a los párrafos 3.358 y 3.362. La UE demuestra un alto grado de 
armoniza ción en la regulación de indicaciones geográficas de productos agrícolas y 
agroindustriales (incluidos vinos y licores), nivel que no se refleja en otros sectores, como 
serían el sector de las artesanías. ¿De qué manera la UE da cumplimiento a su obligació n 
de proteger las indicaciones geográficas de sectores no agrícolas provenientes de  terceros 
países? ¿Cuándo estima la UE que habrá una regulación comunitaria a este tipo de 
indicaciones geográficas?  
 
EU reply :  
Please see the reply to question 27.  
 
3.3.7 .2.4 Geographical indications  
 
Paragraphs 3.358 (page 153) and 3.362 (page 154)  
3.358. "While the harmonization of the protection of GIs within the EU is advanced with regard to 
agricultural products, that for non -agricultural products is currently only av ailable at the national 
level in a number of member States. Protection for agricultural products at the EU level can be 
obtained in one of the following ways: as a protected designation of origin (PDO) or a protected GI 
(PGI) for wines and agricultural pro ducts and foodstuffs, or as a GI for spirits and aromatized wines.  
3.362. With regard to non -agricultural products, the EU commissioned a study on economic aspects 
of GI protection at the EU level, in order to (i) evaluate the effectiveness of specific GI protection in 
limiting the availability of non -authentic products; (ii) assess the value of this specific GI protection 
to consumers, and the impact on consumer search costs for authentic products with and without 
explicit GI protection; and (iii) identify  the value of this specific GI protection to producers of 
authentic geographically -rooted products. The results of the study are planned for publication in 
2020. GIs for non -agricultural products may also be protected as collective EU trademarks, and 
under  unfair competition laws."  
 
27. Question : En relación al párrafo 3.358 y 3.362. La UE demuestra un alto grado de 
armonización en la regulación de indicaciones geográficas de productos agrícolas y 
agroindustriales (incluidos vinos y licores), nivel que no se refleja en otros sectores, como 
serían el sector de las artesanías. ¿De qué manera la UE da cumplimiento a su obligación 
de proteger las indicaciones geográficas de sectores no agrícolas provenientes de  terceros 
países? ¿Cuándo estima la UE que habrá un a regulación comunitaria a este tipo de 
indicaciones geográficas?  
 
EU reply :  
Protection of foreign GIs for non -agricultural products in the EU can be achieved through registration 
of EU collective Trade Marks, through sui generis  national protection systems of GIs in Member 
States where such systems exist, through national collective or certification marks that allow for 
such a protection or, in any event, through national competition or consumer protection law.  
In 2019, the EU co nducted an external study on economic aspects of GI protection at the EU level, 
in order to (i) evaluate the effectiveness of specific GI protection in limiting the availability of 
non-authentic products; (ii) assess the value of this specific GI protectio n to consumers, and the 
impact on consumer search costs for authentic products with and without explicit GI protection; and 
(iii) identify the value of this specific GI protection to producers of authentic geographically -rooted 
products. The results of the  study will soon be published. Based on all the evidence collected, the 
EU will decide on concrete further steps.  
 
28. Question : Respecto al párrafo 3.358, de conformidad a la normativa comunitaria, ésta 
permitiría una suerte de coexistencia entre una indi cación geográfica y entre una marca 
ya registrada, similar a una indicación geográfica. ¿Cuáles serían los criterios que en la 
práctica utiliza la UE para permitir esta coexistencia sin que exista un peligro de confusión 
en el público consumidor? ¿Los crit erios aplicables son los mismos para marcas e IGs  de WT/TPR/M/395/Add.1  
 
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  origen comunitario, que entre una marca comunitaria y una IG de un país no comunitario? 
¿Podría dar algunos ejemplos prácticos de coexistencia?  
 
EU reply:   
Article 14(2) of Regulation (EU) No . 1151/2012 permits coexistence of an existing trademark and a 
geographical indication (GI) if, prior to the GI application, the trademark already had been applied 
for/registered/or established by use, in good faith, within the territory of the Union.  
In order to prevent a risk of confusion of the consumers, EU legislation provides that:  
 
• A GI shall not be registered where, in the light of a trade mark's reputation, renown and the 
length of time it has been used, registration of the name proposed as a GI would be l iable to 
mislead the consumer as to the true identity of the product (Article 6(4) of Regulation (EU) 
1151/2012);  
• A registered trademark could be invalidated under certain circumstances. Such circumstances 
include the situation when the use of a trademark "is of such a nature as to mislead the public" 
(Article 14(2) of Regulation (EU) No . 1151/2012).  
 
It should be noted that a name could be protected as a GI and a trademark simultaneously by the 
same producers, for the same products. In principle, these cas es do not create a risk of confusion 
for the consumers. As an example of coexistence is the 'Bavaria' trademark and the protected 
geographical indication "Bayerisches Bier ". More information in that respect can be found in 
Recitals  (2) to (4) of Regulation  (EC) No . 1347/2001, available via the link:  
https://eur -lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:182:0003:0004:EN:PDF.  
 
Paragraph 3.359, page 153  
"As regards GIs of products of non -EU origin, they may be protected in the EU either through direct 
application or by means of inclusion in FTAs. In the former, the application may be sent either 
directly, or through the authorities of the country where th e geographical area is located, to the 
Commission. No fees are required for applications from third countries".  
 
29. Question: Respecto al párrafo 3.359, las indicaciones geográficas extranjeras pueden 
ser protegidas en la UE por dos vías: solicitud direc ta o mediante su reconocimiento a 
través de un tratado de Libre Comercio. ¿Estas dos vías ofrecen el mismo tipo de 
protección? Es decir, ¿los derechos y acciones que tiene el titular de una IG que fue 
solicitada ante la Comisión son los mismos que disfruta  aquél cuya IG fue reconocida a 
través de un Tratado de Libre comercio?  
 
EU reply:   
The level of protection of GIs provided by EU legislation includes:  
 
• any direct or indirect commercial use of a name in respect of products not covered by the 
registration;  
• any misuse, imitation or evocation, even if the true origin of the products or services is indicated 
or if the protected name is translated or accompanied by an expression such as "style", "type", 
"method ", "as produced in ", "imitation " or similar, including when those products are used as an 
ingredient;  
• any other false or misleading indication as to the provenance, origin, nature or essential qualities 
of the product and any other practice liable to mislead the consumer as to the true o rigin of the 
product.  
 
In the agreements concluded with third -country partners, the EU aims at ensuring the level of 
protection similar to the one above while the outcome depends on each negotiation and could involve 
certain adaptations, which take into ac count the specificities of the other contracting party's system.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.2 Fisheries  
4.1.2.5 External policy  
 
Paragraph 4.115, page 196  
"Regarding arrangements with non -EU countries, the EU has two types of fishing agreements with 
Norway, Iceland, the Faroe Islands under Northern Agreements; and the Sustainable Fisheries WT/TPR/M/395/Add.1  
 
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  Partnership Agreements (SFPAs), in which the EU provides financial an d technical support in 
exchange for fishing rights, mainly with developing countries. Each SFPA protocol specifies fishing 
opportunities, amounts and methods of payments, and sectoral support. "  
 
30. Question: In relation with paragraph 4.115, Chile would be thankful if the EU 
could  share more details regarding the key elements of the fishing arrangements that EU 
has with Norway, Iceland and Faroe Island. Particularly, its main commitments and types 
of fisheries are considered in these arrangements.   
 
EU re ply:  
The EU and Norway have three fisheries arrangements: two bilateral arrangements for 2020 and a 
neighbouring arrangement for 2020. The bilateral arrangements cover the North Sea and the 
Atlantic, and Skagerrak and Kattegat, whilst the neighbouring arr angement covers the Swedish 
fishery in Norwegian waters of the North Sea.  
The EU and Norway have agreed on quotas for the jointly -managed fish stocks in the North Sea 
(cod, haddock, plaice, whiting, herring, and saithe) and Skagerrak (cod, haddock, whiting , plaice, 
shrimp, herring and sprat), as well as an exchange of reciprocal fishing possibilities.  
In the North Sea, 5 out of 6 stocks jointly -managed with Norway have been set in line with the ICES 
scientific advices, at maximum sustainable yield (MSY) levels. This results in quota reductions in 
2020 for saithe ( -15%) and whiting ( -13%), but increases in haddock (+23%) and plaice (+17%). 
A roll-over was set for herring.  
For the North Sea cod stock the TAC was set at 17.679 tonnes (50% less than in 2019). The 
agreement also includes a range of additional measures, such as closures of areas and measures to 
protect adult and juvenile cod during the year. The EU will also implement a specific control and 
inspection programme to further reduce catches of  juveniles.  
The EU and Norway also agreed to roll -over last year's agreement on quota exchanges. In particular, 
the EU received over 21,518 tonnes of Arctic cod.  
The European Union and the Faroe Islands have an agreement on reciprocal exchanges of fishing 
opportunities in each other's waters. The 2020 agreement allows for the exchange of a number of 
important quotas for the European Union, such as cod, haddock, saithe and redfish, with Norway 
pout and blue whiting for the Faroe Islands. The Parties have als o agreed reciprocal access to each 
other's waters for mackerel, Atlanto -Scandian herring and blue whiting.  
Quotas agreed for the European Union from the Faroe Islands by the parties are for 2020 Cod and 
haddock 885 tonnes, Saithe 2,600 tonnes, Redfish 100  tonnes, Blue ling and ling 1,885 tonnes, 
Flatfish 50 tonnes, Blue whiting 2,500 tonnes, other species 700 tonnes.  
Quotas agreed for the European Union for the Faroe Islands from the European Union are Ling and 
tusk 200 tonnes, Blue ling 150 tonnes, Horse  mackerel 1,600 tonnes, Norway pout 5,000 tonnes, 
Blue whiting 10,000, Sprat 1,000, other white fish 150 tonnes, Herring 250 tonnes, Northern deep -
water prawns 1,200 tonnes, Greenland halibut 110 tonnes  
The parties have also agreed access to each other's w aters for: 34,856 tonnes of mackerel, 37,500 
tonnes of blue whiting and 7,000 tonnes of Atlanto -Scandian herring.  
The EU and Iceland currently do not have a bilateral fisheries agreement.  
 
4.4 Services  
4.4.1 Financial Services  
4.4.1.2 Regulatory developmen ts 
4.4.1.2.3 Capital Markets Union (CMU)  
4.4.1.2.3.1 Measures to make the most of the Single Market through new European 
products, labels and passports  
 
Paragraph 4.228, pages 223 - 224 
"The Securitization Regulation was adopted in December 2017 and was ap plied on 1 January 2019. 
It sets transparency and other requirements for EU -regulated issuers (originators, sponsors, original 
lenders, and securitization special -purpose entities) as well as due -diligence requirements for EU 
institutional investors for th eir securitization investments. The Regulation introduces a ban on 
"resecuritization" (no securitization of securitizations is allowed), and brings the European regulation 
of securitization transactions under a unified legislative framework, marking the en d of a sectoral 
and fragmented regulatory landscape. It establishes three key obligations: (i) it requires due 
diligence and assessments that institutional investors need to run prior to, or when holding, a 
securitization position; (ii) it makes it an obli gation for the originator, sponsor or original lender to 
retain at least 5% of material net economic interest; and (iii) it requires originators, sponsors and 
securitization special -purpose entities to provide certain information to investors, competent WT/TPR/M/395/Add.1  
 
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  authorities and, where requested, to potential investors. Such information includes the underlying 
exposure, the essential documentation used in the transaction (excluding legal opinions), and the 
final offering document or prospectus used or a transaction s ummary. The Regulation enables certain 
securitization products to be designated as Simple, Transparent and Standardized (STS) if they meet 
specific eligibility criteria relating to simplicity, transparency and standardization".  
 
31. Question : Regarding pa ragraph 4.228, Chile would appreciate if the EU could share 
what the due diligence standard is, as reflected in the Securitization Regulation. In 
addition, Chile would be thankful if the EU could share how has been the implementation 
experience during this  year.   
 
EU reply:  
The due diligence requirements for EU institutional investors, to be fulfilled prior to holding 
securitisation positions, are prescribed in Article 5 of Regulation (EU) 2017/2402 ('the Securitisation 
Regulation'). The due diligence requirements consist of three main elements: (i) making sure that 
the securitisation position complies with all the general requirements of the Securitisation 
Regulation, including for securitisations originated outside the EU, (ii) assessing the  risks of the 
underlying positions of the securitisation and understanding its structural characteristics, and 
(iii) establishing appropriate procedures in order to monitor on an ongoing and frequent basis the 
performance of the securitisation position and  its underlying exposures. The due diligence 
requirements draw upon the work at international level in the Basel Committee on Banking 
Supervision (BCBS).  
The new securitisation framework has been in application since 1 January 2019. The 
European  Supervisor y Agencies are due to publish a report by January 2021 assessing the 
functioning of the securitisation framework, including the implementation of the regime for Simple, 
Transparent and Standardised (STS) securitisations.  
 
4.4.3 E -commerce  
4.4.3.2 Improvi ng access for consumers to online goods and services across Europe  
4.4.3.2.2 VAT aspects of e -commerce  
 
Paragraph 4.281, page 237  
"Reform of VAT rules is an important dimension of the DSM Strategy. In December 2017, the EU 
adopted new VAT rules as part of a modernization of VAT for e -commerce. The new rules comprise 
three legal acts, a Council Directive, a Council Regulation and a Council Implementing Regulation. 
Some of the rules became applicable on 1 January 2019, while others will become applicable o n 
1 January 2021".  
 
32. Question:  Paragraph 4.281 establishes that in December 2017, the EU adopted new 
VAT rules as part of modernization of VAT for e -commerce. In this regard, Chile would 
appreciate if the EU could clarify whether they have exclusive co mpetence on VAT or if it 
is a shared competence with Member States.   
 
EU reply:  
The EU does not have a direct role in raising taxes or setting tax rates. The EU's role is to oversee 
national tax rules to ensure they are consistent with certain EU policies  such as:  
 
• promoting economic growth and job creation;  
• ensuring the free flow of goods, services and capital around the EU in the single market;  
• making sure businesses in one country do not have an unfair advantage over competitors in 
another;  
• ensuring taxes do not discriminate against consumers, workers or businesses from other EU 
countries.  
 
Concerning VAT, Article 113 of the Treaty on the Functioning of the European Union confers the 
power to the Council to adopt provisions for the harmonisation of le gislation concerning turnover 
taxes, excise duties and other forms of indirect taxation to the extent that such harmonisation is 
necessary to ensure the establishment and the functioning of the internal market and to avoid 
distortion of competition. The go vernments of all Member States must decide unanimously on 
proposals made by the European Commission on VAT rules. The main VAT rules are set in the VAT 
Directive 2006/112, as subsequently amended.  WT/TPR/M/395/Add.1  
 
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  EU countries implement common rules set in the VAT Directi ve in their national legislation. Each 
Member State is responsible for the transposition of these provisions into national legislation and 
their correct application within its territory. The Commission is responsible for ensuring the correct 
application of  the VAT Directive. The role of the Commission, as the "Guardian of the Treaties", 
consists of ensuring that the national legislation and general practice complies with EU Law.  
 
Paragraph 4.283, page 237  
"The new VAT rules for e -commerce adopted in Decembe r 2017 were based, in part, on an 
assessment of the positive experience gained with the application of the special scheme introduced 
in 2015 regarding the application of VAT to certain services. Under this Mini One -Stop-Shop system 
(MOSS), suppliers of tel ecommunications, broadcasting and electronic services have been able to 
sell to consumers in other EU member States and account for VAT in respect of sales to all member 
States in only one member State, thus obviating the need for a separate VAT registrati on in each 
individual member State to which they sell. The VAT paid to the tax authorities of the member States 
is allocated among the member States through a mechanism managed by the Commission."  
 
33. Question : Paragraph 4.283 mentions that suppliers of electronic services have been 
able to sell to consumers in other EU member States. In this regard, Chile would 
appreciate if the EU could clarify what is its understanding of electronic services.   
 
EU reply :  
The EU VAT legislation provides th at "electronically supplied services" shall include services which 
are delivered over the Internet or an electronic network and the nature of which renders their supply 
essentially automated and involving minimal human intervention, and impossible to ensur e in the 
absence of information technology. Article 58 of the VAT Directive and Article 7 of the VAT 
Implementing Regulation provide further information on this. The Explanatory Notes on the place of 
supply for telecommunications, broadcasting and electron ically supplied services prepared by the 
European Commission provide further guidance and examples on electronic services. These 
Explanatory Notes are available in all EU languages as well as in Chinese, Japanese and Russian.  
The Geo -blocking Regulation ( EU) 302/2018 (see information in https://ec.europa.eu/digital -single -
market/en/geo -blocking -digital -single -market) provides for an obligation to treat EU customers 
(including consumers and other end -users) in the same manner when they are in the same situa tion, 
regardless of their nationality, place of residence or place of establishment (s.c. shop -like-a-local). 
In principle, the trader remains free to define the geographical area in which he or she provides 
delivery services, provided that he does not dis criminate vis à vis a foreign EU customers seeking to 
buy goods shipped within the area served by the trader. Hence, the Regulation does not introduce 
an obligation to deliver across the EU in areas not served by the trader.  
The Regulation bans the blockin g of access to websites and re -routing without the customer's prior 
consent. This increases price transparency by allowing customers to access different national 
websites. However, the prohibition of discrimination with respect to access to online interfac es 
should not be understood as creating an obligation for the trader to engage in transactions with 
customers. On the basis of the Geoblocking Regulation a trader does not have an obligation to sell 
a specific service he does not provide. The Regulation's prohibition of discrimination should not be 
understood as affecting the application of any territorial limitation or other existing limitations to 
services the trader provides.  
Regarding the sale of "Electronically supplied services " those include services  which are delivered 
over the Internet or an electronic network and the nature of which renders their supply essentially 
automated and involving minimal human intervention, and impossible to ensure in the absence of 
information technology. In this case, no  physical delivery is required, as the services are supplied 
electronically.  
See the example in the Questions & Answers document published at https://ec.europa.eu/digital -
single -market/en/news/geo -blocking -regulation -questions -and-answers.  
 
4.4.3.2.3 Proh ibition of unjustified geoblocking and other forms of discrimination based 
on customers' nationality, place of residence or place of establishment  
 
Paragraph 4.289, page 239  
"Firstly, it defines three situations involving, respectively, the sale of goods w ithout physical delivery, 
the sale of electronically -supplied services, and the sale of services provided in a physical location, 
in which traders are prohibited from applying different general conditions of access to goods or 
services for reasons related to a customer's nationality, place of residence or place of establishment."  
 WT/TPR/M/395/Add.1  
 
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  34. Question : Paragraph 4.289 refers to the sale of goods without physical delivery. In 
relation with this, Chile would appreciate if the EU could provide examples of goods that 
can be sold without physical delivery.  
 
EU reply:   
It has to be clarified that the situation referred to is the sale of goods without delivery outside the 
area served by the trader. Please see the example on p.8 in the Questions & Answers document 
publishe d at https://ec.europa.eu/digital -single -market/en/news/geo -blocking -regulation -
questions -and-answers.  
A customer buys goods, for example electronic devices, clothes, sportswear or books, which the 
trader does not deliver to the customer's Member State. Su ch customers are entitled to delivery in 
the Member State where the trader offers delivery under the same conditions as local customers.  
Example: A Belgian customer wants to buy a camera and finds the best deal on a German website, 
which however only offe rs delivery/pick -up points in Germany or collection at the trader's premises. 
The customer is entitled to order the goods and collect them at the trader's premises or have them 
delivered to another address/pick -up points in Germany, just like any German co nsumer.  
 
4.4.3.2.5 Harmonization of contract and consumer protection laws  
 
Paragraphs 4.296, 4,298 and 4.303, pages 240 -242 
4.296. " A Directive on certain aspects concerning contracts for the supply of digital content and the 
provision of digital services and a Directive on certain aspects concerning contracts for the sale of 
goods entered into force in June 2019. Member States have un til 1 July 2021 to adopt and publish 
the measures provided for in these Directives, and are required to apply them from 1 January 2022  
 
4.298. The two Directives provide for a full harmonization of rules on certain essential elements of 
consumer contract law, notably rules on the conformity of the digital content, digital service or good 
with the contract, remedies in the case of a lack of such conformity, and the modalities for the 
exercise of those remedies.  
 
4.303. The harmonization of contract laws un der the two Directives entails significant improvements 
in the rights of consumers, including, for example, the reversal of the burden of proof with respect 
to the existence of a defect at the time of the supply of a digital content or a digital service or  the 
supply of a good, and the provision of more effective remedies in the case of a lack of conformity".  
 
35. Question : Regarding the two Directives and consumer protection standards, Chile 
would be thankful if the EU could indicate which types of dispute settlement mechanisms 
are applied, if disputes arise between consumer and seller. In addition, does mediation or 
other alternative mechanism considered?  
 
EU reply:  
Directives (EU) 2019/770 and 771 form part of the body of EU consumer law. This mea ns that for 
settling disputes over rights and obligations established under the two Directives, consumers and 
traders cannot only make use of their EU fundamental right of access to the courts and initiate a 
court proceeding; they can also make use of the specific rules and non -legislative tools that have 
been put in place at EU level to make the private and public enforcement of EU consumer law more 
effective ("EU consumer law enforcement toolbox"). This toolbox includes:  
 
a) specific rules regarding judicia l procedures  on disputes over consumer contracts (e.g.  rules 
on international jurisdiction and the applicable law; specific simplified and accelerated 
procedures for cross -border low -value or uncontested payment claims; procedures where 
qualified entities can seek injunctions to cease infringements of consumer law);  
b) alternative and online dispute resolution (EU consumers and traders have access to quality -
certified ADR bodies to settle their contractual disputes over the purchase of goods or 
services. The A DR bodies can also be accessed via the European Online Dispute Resolution 
(ODR) platform, a multilingual interactive website managed by the European Commission);  
c) The European Consumer Centre network (European Consumer Centres in each EU Member 
State provid e assistance on cross -border disputes between consumers and traders);  
d) The Consumer Protection Cooperation (CPC) network  (Public consumer law enforcement 
authorities in the EU Member States and the European Commission cooperate to take 
coordinated enforceme nt actions in the event of cross -border infringements of EU consumer 
law harming consumers' interests).  WT/TPR/M/395/Add.1  
 
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  The EU is currently reinforcing its "consumer law enforcement toolbox", including under the so -called 
'New Deal for Consumers' that was proposed by the  Commission in 2018. A Directive on 
Representative Actions, under which qualified entities would have the power to bring actions not 
only for the cessation of consumer law infringements, but also for collective redress is currently 
being negotiated by the EU legislator.  
 
[NB: As any EU directive, Directives (EU) 2019/770 and 771 require to be implemented into the 
national legal order s of the EU Member States in order to apply in the EU Member States. Directives 
(EU) 2019/770 and 771 stipulate 1 July 2021 as implementation deadline.]  
 
4.4.4 Telecommunications services  
4.4.4.2 Reform of telecoms rules: the European Electronic Communications Code  
 
Paragraph 4.314, page 245  
"The introduction of the concept of "interpersonal communications services" means  that the EECC 
covers services provided through digital messaging platforms that, in recent years, have increasingly 
displaced more traditional communication services, such as voice telephony and SMS services. It 
should be noted, however, that the EECC dis tinguishes between interpersonal communications 
services which connect with publicly -assigned numbering resources (number -based interpersonal 
communications services) and interpersonal communications services which do not connect with 
publicly -assigned num bering resources (number -independent interpersonal communications 
services), and imposes more stringent regulatory obligations in respect of number -based services 
than on number -independent services. End -user-related regulatory obligations apply to Interne t 
access and number -based interpersonal communications services, whereas, in the case of number -
independent interpersonal communications services, regulatory obligations are mostly limited to 
security obligations."  
 
36. Question : Paragraph 4.314 indicates that the EECC distinguishes between 
interpersonal communications services which connect with publicly -assigned numbering 
resources (number -based interpersonal communications services) and interpersonal 
communications services which do not connect with publ icly-assigned numbering 
resources (number -independent interpersonal communications services), and imposes 
more stringent regulatory obligations in respect of number -based services than on 
number -independent services. In this regard, Chile would appreciate if the EU could 
explain why it differentiates between both type of services. Also, we would appreciate to 
know how the EU is going to determine which type would be used with apps that work 
with both publicly -assigned numbering resources and those that do n ot connect in such 
way (like Telegram or WeChat).   
 
EU reply:   
It is justified to treat "number -based" ICS differently from "number -independent" ICS for several 
reasons. First, certain services -related provisions have a direct link with numbers (e.g. numbe r 
portability, 112 emergency services). Second, number -based ICS participate in and hence also 
benefit from a publicly assured interoperable ecosystem. Third, having regard to the concept of 
functional substitutability from an end -user point of view, only number -based ICS allow to connect 
to/from services with public numbers and to assure end -to-end connectivity. Fourth, it is moreover 
legitimate to establish a high level of sector -specific end -user protection for those using services 
associated with this " public good", and to support high end -user expectations that can in turn 
reinforce the network effects in favour of this public good. "Number -based" ICS are therefore subject 
to more sector -specific regulatory requirements than number -independent ICS. Fift h, in practice, 
certain obligations, like those on switching, appear less relevant to number -independent ICS, as the 
lock-in effects which justify those provisions for number -based ICS, are less significant where 
numbers are not involved.  
In relation to th e categorisation of a certain service, "number -based" ICS comprise both (i) services 
to which end -users numbers are assigned for the purpose of ensuring end -to-end connectivity and 
(ii) services enabling end -users to reach persons to whom such numbers have  been assigned. The 
mere use of a number as an identifier (such as in some messaging apps) is not considered to be 
equivalent to the use of a number to connect with publicly assigned numbers and therefore, in itself, 
is not considered to be sufficient to q ualify a service as a number -based interpersonal 
communications service.  
 WT/TPR/M/395/Add.1  
 
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  Paragraph 4.320, page 247  
"The EECC aims to increase coordination and coherence of radio spectrum management in the EU. 
This is motivated by a concern that radio spectrum management by member States has resulted in 
widely different conditions, and that the lack of consistent EU -wide objectives and criteria for the 
assignment of radio spectrum at the member State level has created barriers to entry, hindered 
competition and reduced predictability for investors. A more harmonized approach to the assignment 
of radio spectrum is seen as being particularly important in light of the growing demand for spectrum 
due to the increase in wireless traffic".  
 
37. Question : Paragraph 4.320 indicates that a more harmonized approach to the 
assignment of radio spectrum is seen as being particularly important in light of the 
growing demand for spectrum due to the increase in wireless traffic. In this context, Chile 
would apprecia te if the EU could share some details regarding how it is planning  to 
harmonize the assignment of radio spectrum in its member States.   
 
EU reply:   
While the European Commission has a long -standing competence (since 2002) to adopt measures 
for the designat ion (or allocation) of spectrum under EU -harmonised technical conditions, the 
assignment (or authorisation) of spectrum use is still largely a Member State competence. The EECC 
provides for more coordination among Member States by ensuring: (i) common dead lines for the 
assignment of pioneer 5G bands (end -2020 for the 3,6 GHz and 26 GHz bands) and 2,5 years after 
the adoption of a harmonisation measure for any frequency band for wireless broadband; 
(ii) coherent mobile licence durations of at least 15 years;  (iii) a voluntary peer review process 
between the Member States for consistency of spectrum authorisation rules (e.g. on fees, wireless 
coverage conditions, new entrants) and developing best practice. Furthermore, the EECC 
strengthens the framework for sp ectrum and infrastructure sharing as well as for spectrum trading 
and leasing.  
 
4.4.5 Other measures adopted during the review period under the second pillar of the DSM 
Strategy  
4.4.5.1 Online platforms  
 
Paragraph 4.333, page 250  
"In addition to these pro visions that apply to all types of illegal content, the Recommendation 
contains specific provisions on terrorist content in Chapter III. It states that hosting service providers 
should expressly set out in their terms of service that they will not store te rrorist content, and should 
take measures so that they do not store terrorist content. Three types of measures are set out in 
the latter regard. Firstly, member States should ensure that their competent authorities have the 
capability to detect and identif y terrorist content and to request the removal or the disabling of 
access to such content. If a hosting service provider receives such a request, it must assess and, 
where appropriate, remove or disable access to the content, as a general rule, within one hour from 
the moment it receives the request. Secondly, hosting service providers should take proactive 
measures, including by using automated means, to identify and remove or disable access to terrorist 
content. Thirdly, hosting service providers should b e encouraged to cooperate, through the sharing 
of technological tools, to prevent the dissemination of terrorist content across different hosting 
services."  
 
38. Question : Paragraph 4.333 indicates that the Commission's non -binding 
Recommendation on measu res to effectively tackle illegal content online, contains specific 
provisions on terrorist content in Chapter III. In his context, Chile would be thankful if 
the EU would provide more details on the criteria to determine what is considered terrorist 
conte nt and the treatment of this content in case it is qualified as terrorist.   
 
EU reply:  
The Commission's Recommendation is a soft law instrument, meant to give procedural guidance to 
Member States, online hosting services and online platforms, in particula r, on the means for 
cooperation and proportionate actions with regards to illegal content online and a number of specific 
recommendations on terrorist content.  
It builds on the legal framework: legal definitions of terrorist offences and terrorist propaga nda are 
established at EU level, as well as at national level within each of the Union's Member States. For 
example, the Terrorism Directive (EU) 2017/541 (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32017L0541) contains the definition of ' terrorist offense' at EU WT/TPR/M/395/Add.1  
 
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  level, while establishing minimum rules on the definition of criminal offences in the area of terrorist 
offences, offences related to a terrorist group and offences related to terrorist activities. Member 
States had to transpose th is Directive into their national law by September 2018.  
The policy objective is to keep a very high standard of legal clarity, respect of the rule of law and 
protection of human rights in the online environment, not least in such cases where security conc erns 
require targeted actions. In this regard, it is of utmost importance that the specific definitions and 
restrictions are clearly provided by law and follow sufficient standards for due process. This is 
particularly important for preserving freedom of e xpression and information, freedom of assembly, 
rights to redress, and the protection of personal data and privacy.  
While the Recommendation (also addressed to service providers) also makes reference to definitions 
as set in the terms of service of the companies, this relates to their commitments to enforce such 
rules on their platforms.  
The co -legislators are currentl y discussing a legal intervention (Regulation on preventing the 
dissemination of terrorist content online) which aims at providing further clarity and harmonisation 
of the definitions of terrorist content and framing both the required actions for the detec tion and 
removal of such content, and a robust set of safeguards for protecting the rights of citizens online.  
 
Paragraphs 4.335, 4.336 and 4.337, page 250 -251 
4.335. "In June 2019, the EU adopted a Regulation laying down rules to improve the fairness and 
transparency of online platforms, which shall apply from 12 July 2020.455 The Regulation addresses 
potential frictions that arise from the growing dependence of business users upon providers of 
intermediation services "by laying down rules to ensure that b usiness users of online intermediation 
services and corporate website users in relation to online search engines are granted appropriate 
transparency, fairness and effective redress possibilities.  
4.336. The main provisions of this Regulation can be summar ized as follows.  
4.337. Firstly, "online intermediation services" within the meaning of this Regulation are defined as 
information society services that allow business users to offer goods or services to consumers with 
a view to facilitating the initiatin g of direct transactions between the business users and consumers, 
and which are provided to business users on the basis of contractual relationships between the 
business users and the providers of those services. The Regulation applies to providers of onl ine 
intermediation and search engine services, irrespective of whether they are established in a member 
State or outside the EU, if the business users or corporate website users are established in the EU 
and offer their goods and services to consumers loca ted within the EU at least for part of the 
transaction".  
 
39. Question:  Paragraph 4.337 indicates this Regulation applies to providers of online 
intermediation and search engine services, irrespective of whether they are established 
in a member State or ou tside the EU, if the business users or corporate website users are 
established in the EU  and offer their goods and services to consumers located within the 
EU at least for part of the transaction. In this context, Chile would be thankful if the EU 
would gi ve more details on the elements to determine if the provider is a provider of online 
intermediation and search engine services, especially if they are located outside of the 
EU, and they are considered to be offering their goods and services at least for p art of the 
transaction, and therefore is subject to the rules of the Regulation.   
 
EU reply:   
The decisive element for delineating the scope of Regulation (EU) 2019/1150 (https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:32019R1150) on promoting fairness and 
transparency for business users of online intermediation services (Article 1) is th at the relevant 
online intermediation service has any business user that is legally established in the EU and which 
uses the online intermediation service to offer their goods or services to consumers located in the 
EU. The Regulation is thus intended to c over any intra -EU commercial activities facilitated by online 
intermediation service, including by those that physically operate their services from outside the EU. 
At the same time, the Regulation is not intended to cover online intermediation services th at facilitate 
commercial activities between, on the one hand, EU consumers and non -EU business users and, on 
the other hand, EU business users and non -EU consumers. Notwithstanding, the application of the 
high-level transparency obligations of Regulation ( EU) 2019/1150 can be triggered even if a single 
EU business user uses the relevant online intermediation services to engage with consumers located 
in the EU.  
 WT/TPR/M/395/Add.1  
 
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  Paragraph 4.339, page 251  
"Thirdly, if a provider of online intermediation services decides to r estrict or suspend the provision 
of its online intermediation services to a given business user, it is required to provide a statement 
of reasons before the restriction or suspension takes effect. Where a provider of online 
intermediation services decides to terminate the whole of its online intermediation services to a 
business user, it is required to provide a statement of reasons to that business user at least 30 days 
before the termination takes effect."  
 
40. Question: Paragraph 4.339 indicates that in the case a provider of online 
intermediation services decides to terminate the whole of its online intermediation 
services to a business user, it is required to provide a statement of reasons to that 
business user at least 30 days before the termination ta kes effect. In this regard, Chile 
would be thankful if the EU would further elaborate on the requirements and elements of 
this statement, if there is a special instance for the revision of the reasons provided by 
the provider of online intermediation servi ces, and the effects in the case the business 
user opposes to the termination and/or the statement.  
 
EU reply:   
The objective of Regulation (EU) 2019/1150 is to provide predictability and fairness for business 
users. The provision referred to (Article 4 of  the Regulation) establishes a mandatory notice period 
and statement of reasons for a particularly impactful decision that providers of online intermediation 
services will remain free to undertake. The statement of reasons has to be provided on a durable 
medium for retention purposes, and it should be reasoned so as to allow business users to ascertain 
whether there is scope to challenge the decision, thereby improving the possibilities for business 
users to seek effective redress where necessary. The state ment of reasons should identify the 
grounds for the decision, based on the grounds that the provider had set out, in advance, in its 
terms and conditions, and refer in a proportionate manner to the relevant specific circumstances, 
including third party not ifications, that led to that decision. However, a provider of online 
intermediation services should not be required to provide a statement of reasons where it is subject 
to a legal or regulatory obligation not to disclose specific details or circumstances on which any 
restrictions, suspensions or terminations are based. Furthermore, a statement of reasons should not 
be required where a provider of online intermediation services can demonstrate that the business 
user concerned has repeatedly infringed the ap plicable terms and conditions, resulting in termination 
of the provision of the whole of the online intermediation services in question.  
The Regulation does not provide for a special institution to review the statement of reasons. 
However, it does require  providers of online intermediation services to provide for an internal 
complaint -handling system (Article 11), in order to enable business users, including those whose 
use of the relevant online intermediation services might have been restricted, suspende d or 
terminated, to have access to immediate, suitable and effective possibilities of redress. Providers of 
online intermediation services should also facilitate mediation by, in particular, identifying at least 
two public or private mediators with which t hey are willing to engage (Article 12).  
As regards conflicts that cannot be resolved through internal complaint -handling or mediation, the 
Regulation does not extend to such individual cases on substance as long as the procedural 
requirements have been res pected. At the same time, the Regulation does not affect the rights of 
providers of online intermediation services or business users to initiate judicial proceedings at any 
time during or after the internal complaint -handling process.  
 
Paragraph 4.341, pa ge 251  
"Fifthly, the Regulation requires that providers of online intermediation services establish an internal 
complaint -handling system to address complaints of business users and to identify in their terms 
and conditions two or more mediators with which  they are willing to engage to attempt to resolve, 
out of court, any dispute between the provider of that service and a business user. It lays down 
certain conditions that such mediators must fulfil, and provides that the Commission shall encourage 
the cre ation of organizations providing such mediation services. Finally, the Regulation defines the 
conditions under which organizations and associations representing business users or corporate 
website users, as well as public bodies set up in member States, ha ve the right to initiate proceedings 
before the competent national courts of the member States to stop or prohibit non -compliance with 
the terms of the Regulation by providers of online intermediation services or search engine services".  
 
41. Question:  Paragraph 4.341 requires from online intermediation services, the 
establishment of internal complaint -handling systems to address complaints of business 
users and to identify mediators to attempt to resolve, out of court, any dispute between WT/TPR/M/395/Add.1  
 
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  the provider of t hat service and a business user. In relation with this,  Chile would be 
thankful if the EU would provide more details regarding the conditions that such mediators 
must fulfil, and elaborate in relation to the obligation to the Commission of encouraging 
the creation of organizations providing such mediation services.   
 
EU reply:   
In order to be accessible, fair, and as swift, efficient and effective as possible, the mediators 
identified pursuant to Regulation (EU) 2019/1150 should meet certain set criteria, listed in 
Article  12(2). In addition, the identified mediators can only operate from outside of the EU provided 
that this does not effectively deprive business users of the benefit of any legal safeguards laid down 
in Union law or the law of the Member States, notably including the provisions of the Regulation 
itself as well as personal data protection and trade secrets rules. Nonetheless, providers of online 
intermediation services and their business users should remain free to jointly identify a ny mediator 
of their choice after a dispute has arisen between them, which may or may not meet the 
aforementioned criteria.  
As regards the obligation for the Commission to encourage the creation of specialised mediators, 
this is supposed to help fill a ce rtain gap that was observed in terms of the availability of specialised 
mediation services for platform -to-business commercial relations. The involvement of mediators 
having specialist knowledge of online intermediation services as well as of the specific industry 
sectors within which those services are provided should add to the confidence both parties have in 
the mediation process and should increase the likelihood of that process leading to a swift, just and 
satisfactory outcome. The Commission is curren tly devising possible strategies for how best to 
encourage providers of online intermediation services as well as organisations and associations 
representing them, keeping a close eye on relevant market -driven developments.  
 
4.4.5.1.1 EU Cybersecurity Act  
 
Paragraph 4.342, pages 251 -252 
"The EU Cybersecurity Act entered into force on 27 June 2019. It reinforces the role of the EU Agency 
for Cybersecurity (ENISA) by expanding its mandate and providing it with more resources. The 
revised mandate of ENISA is t o: contribute to the development and implementation of EU policy and 
law in the field of cybersecurity; support capacity building and preparedness across the EU; promote 
operational cooperation at the EU level; support and promote the development and imple mentation 
of EU policy on cybersecurity certification; provide analysis and advice, and raise awareness and 
identify research needs in the field of cybersecurity; and contribute to the EU's international 
cooperation in this field. The Act also establishes a European cybersecurity certification framework 
in order to increase the level of cybersecurity and enable a harmonized approach to cybersecurity 
certification within the EU, with a view to creating a single digital market for ICT products, services 
and p rocesses".   
 
42. Question : Paragraph 4.342 indicates The EU Cybersecurity Act establishes a European 
Cybersecurity  certification framework, in order to increase the level of cybersecurity and 
enable a harmonized approach to cybersecurity certification within the EU, with a view to 
creating a single digital market for ICT products, services and processes. In this regard, 
Chile would be thankful if the EU would explain the nature of the aforementioned 
certification and which regulatory body would give this kind of certification. Also, Chile 
would appreciate if the EU could explain if this certification would be applicable for non -
EU entities.   
 
EU reply:   
The Cybersecurity Act, which entered into force in June 2019, brings two major changes: a 
comprehensive reform of the European Union Agency for Cybersecurity (ENISA) and the creation of 
the European cybersecurity certification framework.  
The EU cybersecurity certification framework will allow the establishment of individual, tailor -made 
EU ce rtification schemes for ICT products and services.  
The schemes will be first prepared by ENISA in consultation with stakeholders and then will be 
adopted by the Commission. The European cybersecurity certification schemes are 
non discriminatory and based on European or international standards, unless those standards are 
ineffective or inappropriate to fulfil the Union's legitimate objectives in that regard.  
Certification may be carried out either by national cybersecurity certification authorities or priva te 
conformity assessment bodies depending on the requirements of each individual scheme.  WT/TPR/M/395/Add.1  
 
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  Companies established within the EU or elsewhere that choose to certify their products will be able 
to obtain certificates that are valid across the whole EU. As such , the new framework does not 
constitute a barrier to entry of products outside Europe into the EU market.  
The use of the new European certification schemes is voluntary.  
Nevertheless, the Cybersecurity Act provides for the Commission to regularly assess w hether an 
adopted European scheme is to be made mandatory through relevant Union law. The first 
assessment will be carried out no later than 31 December 2023, and subsequent assessments shall 
be carried out at least every two years. As the new European sch emes will be recognised across the 
entire EU, there will be a strong incentive for companies to certify products, processes and services 
at EU level.  
 
WT/TPR/G/395 - UE Report  
 
4 TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.3 Promoting a sustainable approach to trade  
4.3.6 Promoting fair and ethical trade schemes  
 
Paragraph 4.48, page 22  
 "In addition, a market study on consumer demand for fair and ethical products was finalised and 
presented in May 2018. The study focused on selected EU M ember States and concluded that 
sustainable product sourcing has become a top priority for retailers who are increasingly "greening" 
their supply chains, adopting fair and ethical trade criteria and applying sustainability standards in 
overwhelming numbers . 
 
43. Question : In relation to paragraph 4.48, we appreciate if the EU could provide more 
information on the status of the initiative Single Market ecological products. We 
understand that it has been developed some pilots projects. What are the next steps  
consider in this initiative. (See more information in 
https://ec.europa.eu/environment/eussd/smgp/index.htm )  
 
EU reply:  
The Product Environmental Footprint (PEF) and Organisation Environmental Footprint (OEF) methods 
were developed by the Commission to generate information on environmental performance that is 
comparable, reproducible and verifiable. It takes into account the whole life cycle of a product, from 
the extraction of resources until the end of life of a product, and it is able to cover 16 envi ronmental 
impacts, among which climate change. An updated version of the methods was done by the Joint 
Research Center  
(https://ec.europa.eu/environment/eussd/smgp/ef_transition.htm).  
 
The development of product -specific rules (Product Environmental Footp rint Category Rules, 
PEFCRs) and sector -specific rules (Organisation Environmental Footprint Sector Rules, OEFSRs) was 
tested through a pilot phase (2013 -18). The result was the finalisation of 21 PEFCRs/OEFSRs.  
 
The Environmental Footprint pilot phase ended in 2018. We are now in the transition phase. The 
transition phase provides a framework for the following:  
 
• Monitoring the implementation of existing PEFCRs and OEFSRs;  
• Developing new PEFCRs/OEFSRs. A call for volunteers launched in spring 2019 resulted in 
5 expressions of interest (apparel, cut flowers & potted plants, flexible packaging, floor 
coverings, and marine fish);  
• New methodological developments. Discussions on this mainly take place in the Technical 
Advisory Board (TAB). An y Life Cycle Assessment expert can join the Technical Advisory 
Board.  
 
The European Green Deal acknowledges the importance of reliable, comparable and verifiable 
information in making more sustainable decisions and reducing the risk of greenwashing. It ca lled 
for regulatory and non -regulatory efforts to tackle false green claims and for companies to 
substantiate their green claims against a standard methodology. The European Commission is 
currently assessing different policy options in order to achieve thi s objective.  
 WT/TPR/M/395/Add.1  
 
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  4.3.5 Ensuring responsible management of supply chains  
 
Paragraph 4.46, page 22  
"Regarding horizontal due diligence legislation, in 2018, for the first time, listed companies, banks 
and insurance companies with more than 500 employees were re quired to disclose non -financial 
information in their management reports relating to environmental, social and labour issues, respect 
for human rights, anti -corruption and bribery issues. The non -financial statement should include 
information on the due di ligence processes implemented by the company, as well as on the principal 
risks linked to the company's operations, including, where relevant and proportionate, how the 
company manages those risks. The so -called conflict minerals regulation of 2017 will he lp to ensure 
that EU imports of tin, tantalum, tungsten and gold and the minerals containing them do not 
contribute to armed conflict and associated human rights abuses along the supply chain. It will start 
to apply on 1 January 2021".  
 
44. Question : Paragraph 4.46, Which is the due diligence standard expected to be applied 
by listed companies, banks and insurance companies with more than 500 employees 
subject to the requirement to disclose non -financial information in their management 
reports?  How has bee n the implementation experience during this year?  
 
EU reply:   
The Non -Financial Reporting Directive does not require companies under its scope to apply any 
particular standard regarding due diligence or the reporting of due diligence. The introductory text  
to the Directive does make reference to a number of standards and frameworks regarding CSR, 
responsible business conduct and non -financial reporting, including the UN Guiding Principles on 
Business and Human Rights, and the OECD Guidelines for Multination al Enterprises.  
The European Commission has not undertaken an analysis of due diligence reporting by companies 
under the scope of the Non -Financial Reporting Directive. Some analyses published by other 
organisations suggest that company reporting on the i ssue of due diligence needs to be further 
improved (see for example: "2018 Research Report: The state of corporate sustainability disclosure 
under the EU Non -Financial Reporting Directive", Alliance for Corporate Transparency; "Enforcement 
and Regulatory A ctivities of European Accounting Enforcers in 2018", European Securities and 
Markets Authority; and "Compliance by Belgian listed companies with the requirement to publish a 
non-financial statement", Belgian Financial Services and Markets Authority").  
  WT/TPR/M/395/Add.1  
 
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  CHINA  
PART I: QUESTIONS RE GARDING THE SECRETAR IAT REPORT  
 
Page 11(Para 15)  
The EU maintains different categories of tariff rate quotas (TRQs) for both agricultural and 
non-agricultural products. ……The EU adopted regulations on the apportionment of WTO TRQs  quotas 
between the EU and the United  Kingdom, in anticipation of the latter's eventual withdrawal from the 
EU. In this regard, negotiations under Article XXVIII of the GATT 1994 were initiated.  
 
Question ： 
1. China notes that the EU maintains different categories of TRQs for some 
non-agricultural products. Could the EU please provide the out -of-quota tariff for the 
following tariff lines, namely HS 03048990, 03055110, 03055190, 03055910, 03056200, 
03056910, 
03057200,03057900,16042050,03061105,0 3061905,03062110,03062905,16054000,44
123900,44129985,53061010,53061030,70181090,72024910,72024950?  
 
EU reply: The tariff rates for all codes (HS or CN codes) can be found by checking the TARIC 
database of the EU at the following address:  
https://ec.europa.eu/taxation_customs/dds2/taric/taric_consultation.jsp?Lang=en  
For ease of reference, however, the following table has been prepared for the requested codes (th e 
rates for the codes with asterisk can be found when querying them in TARIC with a reference date 
of year 2016 at the bottom of the screen):  
 
Code  Tariff rate %  Code  Tariff rate %  
03048990  15 03062110 (*)  20 
03055110  13 03062905 (*)  20 
03055190  13 16042050  25 
03055910 (*)  13 16054000  20 
03056200  13 44123900  7 
03056910  13 44129985  10 
03057200  13 53061010  4 
03057900  13 53061030  4 
03061105 (*)  20 70181090  3 
03061905 (*)  20 72024910  7 
  72024950  7 
 
Page 12 (Para25)  
In the area of competition policy, the main legislative development during the review period was the 
adoption of a directive that strengthens the competences of national competition authorities in the 
enforcement of EU competition law. The Commission comme nced the review of the Vertical Block 
Exemption Regulation, which will expire in May 2022. In relation to anti -competitive agreements 
and abuse of dominant position, the Commission adopted several decisions concerning large firms 
in the digital services ma rket, and took action to ensure competition in gas supply markets. It also 
adopted several important decisions in merger cases.  
 
Questions  
2. Will the Directive that strengthens the enforcement of EU competition law by the 
national competition authorities  lead to substantial restrictions on or discrimination 
against third -country enterprises?  
 
EU reply:  Directive 2019/1 ( "ECN+ Directive ") aims to improve the effectiveness of the enforcement 
proceedings of the national competition authorities of the Member  States when they apply Articles 
101/102 TFEU. The Directive does not affect the substantive scope or the interpretation of Articles 
101/102 TFEU. To the extent the Directive creates rights and obligations for undertakings, it applies 
equally to them irres pective of where they are based.  
 
3. Is the EU considering revising the competition policy again in the near future? Will there 
be obstacles to the acquisition of EU enterprises by third country enterprises?  WT/TPR/M/395/Add.1  
 
- 131 - 
 
  EU reply:  The EU continuously strives to improve its current legislative framework as a response to 
the new challenges and upon detecting gaps in the current existing legislation. In the context of the 
new mandate, COMP will in particular launch an exercise to revi ew the market definition notice. The 
EU is also looking into how the current EU toolbox addresses the distortive effects of foreign subsidies 
in the internal market.  
 
Page 12 (Para26)  
One of the main developments in the area of government procurement was t he adoption by the 
Commission, in October 2017, of a public procurement strategy which aims at further improving EU 
public procurement practices by working with public authorities and other stakeholders and which 
includes three initiatives: (i) a mechanism  for large infrastructure projects, to provide clarity and 
guidance to public authorities on public procurement; (ii) a recommendation to professionalize public 
buyers; and (iii) a consultation on guidance on public procurement of innovation. To harmonize 
procedures and processes, the Commission introduced the European Single Procurement Document.  
 
Question  
4. Please elaborate on the progress made with respect to the International Procurement 
Instrument (IPI) proposed in January 2016. Will third countries b e restricted from 
entering the government procurement market of the EU? In addition, please clarify the 
relationship between the Guidance on the participation of third country bidders and goods 
in the EU participation issued on July 4 2019 and the IPI.  
 
EU reply: The European Commission is convinced of the global benefits that open procurement 
markets can bring and is concerned by the trend of an increased number of barriers that European 
companies face when participating in tenders in many third countries . 
 
Discussions on the Commission proposal on the International Procurement Instrument have resumed 
in the Council in 2019 and are ongoing. The European Parliament also restarted its work on the 
International Procurement Instrument. As the legislative proce ss is not yet completed the EU cannot 
provide any information as to what measures the International Procurement Instrument will provide 
for.  
 
The International Procurement Instrument as proposed by the European Commission would allow 
the Commission to ini tiate investigations in cases of alleged discrimination of EU companies in 
procurement markets. In case such an investigation would find discriminatory restrictions vis -à-vis 
EU goods, services and/or suppliers, the Commission would invite the country conc erned to 
consultations. Such consultations could also take place in the form of negotiations on an international 
agreement. As a last resort, the Commission could, after consultation with EU Member States, apply 
the new tool.  
 
The Guidance on participatio n of third country bidders and goods in the EU procurement market is 
part of a package of European Commission initiatives to ensure fair competition, high quality and a 
level playing field in public procurement markets. The Guidance provides practical advi ce to public 
buyers in the Member States. It helps them identify which third country bidders have secured access 
to the EU procurement market. The Guidance further aims to raise awareness among contracting 
authorities of the different instruments in the EU  public procurement toolbox. This includes measures 
that may be taken in case of abnormally low -priced offers, as well as measures to ensure that third 
country bidders respect the same quality as EU bidders in areas such as security, labour and 
environment al standards. The International Procurement Instrument on the other hand is a tool 
aiming at providing opportunities for EU companies in procurement markets of third countries 
through negotiations with such third countries.  
 
Page  13 (Para27)  
Regarding inte llectual property, several legislative measures were put in place during the review 
period, notably with respect to copyrights and related rights: (i) the Directive on copyright in the 
Digital Single Market; (ii) the Directive on television and radio progr ammes; (iii) the Regulation on 
cross-border portability of online content services in the internal market; and (iv)  the Directive and 
Regulation to implement the Marrakesh Treaty, aimed at giving blind and visually impaired or 
otherwise print -disabled peop le better access to printed materials. The unitary patent package has 
not yet entered into force. In May 2019, the EU adopted amendments to its rules on supplementary 
protection certificates for medicinal products. Various measures were taken during the re view period 
to implement substantive reforms to EU trademark legislation, based on a regulation modernizing WT/TPR/M/395/Add.1  
 
- 132 - 
 
  the EU legal framework for EU trademarks and a directive further harmonizing national trademark 
laws, adopted in 2015. Given the importance of geogr aphical indications (GI) for the EU's external 
trade, the EU has sought to include a comprehensive section on GI protection for agricultural 
products, in addition to wines and spirits, in the more recent generation of FTAs. Regarding 
undisclosed informatio n, nearly all EU member States adopted legislation to implement the Trade 
Secrets Directive adopted in June 2016.  
 
Questions ： 
5. Please provide further details on the specific positive effects of the Directive on 
copyright in the Digital Single Market on the internal market of the EU.   
 
EU reply: As explained in its Article 1, Directive (EU) 2019/790 "lays down rules which aim to further 
harmonise Union law applicable to copyright and related rights in the framework of the internal 
market, taking  into account, in particular, digital and cross -border uses of protected content. It also 
lays down rules on exceptions and limitations to copyright and related rights, on the facilitation of 
licences, as well as rules which aim to ensure a well -functionin g marketplace for the exploitation of 
works and other subject matter ". 
  
For a directive to take effect at national level, EU Member States must adopt implementing measures 
to transpose it. In the case of Directive (EU) 2019/790, a transposition must take place by 
7 June 2021. The Commission will carry out a review of the Directive no sooner than 7 June 2026. 
It is therefore too early to provide details on its effects.  
 
6. Please further clarify how the Directive and Regulation to implement the Marrakesh 
Treaty can really make prints more accessible to blind and visually impaired or otherwise 
print -disabled people from an operational level.  
 
EU reply: Directive (EU) 2017/1564 introduces an exception to copyright and certain related rights 
that has a cross -border effect within the internal market. Due to this exception, i) an authorised 
entity (AE) can make and distribute an accessible format copy for / to a beneficiary person or another 
AE established in any Member State, and ii) a beneficiary person or a AE established in one Member 
State may obtain or have access to an accessible format copy from an AE established in any Member 
State.  
Regulation (EU) 2017/1563 provides for a copyright exception that permits the cross -border 
exchange of accessible format copi es of certain works and subject matter that are ordinarily 
protected by copyright and related rights, for the benefit of persons who are blind, visually impaired 
or otherwise print -disabled. The Regulation permits the cross -border exchange of copies made u nder 
the exception between the EU and third countries that are parties to the Treaty.  
More information is provided on the following homepage: https://ec.eu ropa.eu/digital -single -
market/en/implementation -marrakesh -treaty -eu-law. 
 
Page 42  (Para 2.34)  
"Some innovative features of the EU -Japan EPA include the express reference to the Paris Agreement 
on Climate Change, a chapter aimed at supporting the use of the  Agreement by small and medium -
sized enterprises (SMEs), and provisions on corporate governance." …  
 
Question  
7. Please elaborate on the contents of the SMEs Chapter of the EU -Japan EPA and its 
impact on Japanese and European SMEs since its implementation?  
 
EU reply:  Chapter 20 of the EU -Japan EPA aims at enhancing cooperation on matters of relevance 
to SMEs or that may otherwise be of particular benefit to SMEs.  
Firstly, it includes provisions on information sharing. Each party shall establ ish or maintain its own 
publicly accessible website containing information, or links to information, considered useful for SMEs 
interested in benefitting from the opportunities provided by the EU -Japan EPA. Such websites shall 
include links to inter alia  legislation and procedures related to customs, intellectual property rights, 
sanitary and phytosanitary measures, notices for government procurement, business registration, 
taxes collected during the importation. Besides, the website shall also include an e lectronically 
searchable database by tariff nomenclature that includes rates of custom duty, fees, other tariff 
measures, rules of origin, duty drawback, etc.  
Secondly, the EU and Japan designate SME Contact Points whose functions are notably:  WT/TPR/M/395/Add.1  
 
- 133 - 
 
  - to ensure that the needs of SMEs are taken into account in the implementation of the Agreement, 
and  
- to consider ways for strengthening the cooperation on matters of relevance to SMEs.  
As the EU -Japan EPA entered into force less than a year ago (February 2019), it  is premature to 
comment on the impact of the SME chapter since its implementation.  
 
Page 43 (Para2.40)  
The United States and the EU adopted a Joint Statement in July 2018, in which they agreed to work 
towards elimination of tariffs, non -tariff barriers, and subsidies on non -auto industrial goods, and 
towards the reduction of barriers to trade in services, chemicals, pharmaceuticals, medical products 
and soybeans.  
 
Question  
8. Please brief on the latest developments of the trade negotiations with  the United States.  
 
EU reply: In July 2018, President Juncker and President Trump agreed on the EU -US Joint 
Statement. On 15 April 2019, the Council adopted a mandate to open talks for a horizontal 
agreement on conformity assessment and to open talks on the elimination of tariffs on in dustrial 
goods.  
 
Page 47 -50 (Para 2.59 -2.67)  
"A key development during the review period was the preparation and adoption of legislation 
providing for the establishment of an EU framework for the screening of FDI.…...and the Commission 
to cooperate with r esponsible authorities of third countries on issues relating to the screening of FDI 
on the grounds of security and public order."  
 
Questions  
9. The Regulation of the European Parliament and of the Council establishing a framework 
for the screening of fore ign direct investments into the Union stipulates that "The 
implementation of this Regulation by the Union and the Member States should comply 
with the relevant requirements for the imposition of restrictive measures on grounds of 
security and public order in the WTO agreements, including, in particular, Article XIV(a) 
and Article XIV bis of the General Agreement on Trade in Services (GATS). It should also 
comply with Union law and be consistent with commitments made under other trade and 
investment agreemen ts to which the Union or Member States are parties and trade and 
investment arrangements to which the Union or Member States are adherents."  
 
Question:  Are the security considerations included in this EU Regulation limited to genuine 
and sufficiently seri ous threats that are posed to the fundamental interests of society?  
 
EU reply : In accordance with the Regulation, Member States may maintain, amend, or adopt 
mechanisms to screen foreign direct investments in their territory on the grounds of security or 
public order. Although the Regulation does not define security or public order, it lays down in Article 
4 the factors Member States may take into consideration. By way of example, in determining whether 
a foreign direct investment is likely to affect securi ty or public order, Member States and the 
Commission may consider its potential effects on critical infrastructure, including energy, transport, 
water, health communications, data processing or storage, aerospace, defense, electoral of financial 
infrastruc ture. The Regulation, in its Recital 13 further mentions that one element to be taken into 
account is whether the disruption, failure loss or destruction of the critical infrastructure or 
technology would have a significant impact in a Member State or the Union.  
 
10. Is the principle of the free movement of capital within the EU market applicable to the 
Regulation of the European Parliament and of the Council establishing a framework for 
the screening of foreign direct investments into the Union? Does the R egulation follow the 
rules established by the Court of Justice of the European Union (CJEU) in accordance with 
case law concerning the strict interpretation of public security or public order, and is 
proportionality test applicable to the Regulation? Is th e list of security -related factors of 
the Regulation in pursuit of pure economic purposes?  
 
EU reply : The legal basis of the Regulation is Article 207 TFEU laying down the EU 's common 
commercial policy. At the same time, the Regulation is without prejudice to the right of Member WT/TPR/M/395/Add.1  
 
- 134 - 
 
  States to derogate from the free movement of capital provided in point (b) of Article 65(1) TFEU 
(Recital (4) of the Regulation).  
Pursuant to the inter national commitments undertaken in the WTO, in the OECD, and in the trade 
and investment agreements concluded with third countries, it is possible for the Union and the 
Members States to adopt restrictive measures relating to foreign direct investment on t he grounds 
of security or public order, subject to certain requirements.  
As reaffirmed by Recital (35), the Regulation will be implemented in consistency with the WTO 
agreements and other commitments made under other trade and investment agreements to whi ch 
the Union or Member Stats are adherents. Against this background, factors introduced in pursuit of 
pure economic purposes are not supported by the Regulation.  
 
11. Why does the EU adopt a special legislation on the screening of FDI from state -owned 
enterprises? Does this legislation cause discrimination against state -owned enterprises? 
Will it impede normal investment and trade?  
 
EU reply : The Regulation applies to all foreign direct investments, irrespective of whether the 
foreign investor is a state -owned enterprise or a private undertaking. It is therefore fully in line with 
the principle of non -discrimination.  
The question whether a foreign investor is directly or indirectly controlled by the government 
(including through ownership structure or signi ficant funding) is, nonetheless an important element 
for the assessment of a potential effect of FDI on security or public order of the Union or EU Member 
States. Therefore, it has been included as one the factors that may be taken into consideration 
pursu ant to Article 4 of the Regulation.  
The Regulation was designed not to impede investments into the Union. The scope of the Regulation 
is limited to Member States ' screening on grounds of security or public order only. The timelines 
provided for the coopera tion between the Member States and Commission are limited to the 
minimum to ensure a minimal impact on the investor and the investment.  
 
12. Please elaborate on the detailed content, standards and review method regarding the 
"security and public order" stipulated in the EU's newly established framework for FDI 
screening. Please explain how the above standards will be disclosed to potential investors, 
so that the latter can fully understand the review procedures may be required to perform.  
 
EU repl y: What is new about the Regulation is that it provides for cooperation between Member 
States and between Member States and the Commission on certain FDI. Article 4 guides Member 
States and the Commission in the application of this Regulation by providing a list of factors that 
may be taken into consideration when determining whether a FDI is likely to affect security and 
public order. By way of example, in determining whether a foreign direct investment is likely to 
affect security or public order, Member States and the Commission may consider its potential effects 
on critical infrastructure, including energy, transport, water, health, communications, data 
processing or storage, aerospace, defence, electoral or financial infrastructure.  
 
13. As the newly p roposed Framework for FDI screening only establishes the cooperation 
mechanism between the EU and its member States, which is not an EU -level review 
mechanism, please elaborate on the specific duties of the EU in terms of the cooperation 
mechanism, includi ng whether the EU has a veto on the reviews conducted by its member 
States.  
 
EU reply : As mentioned, the Regulation indeed sets up a cooperation mechanism between Member 
States and between Member States and the Commission. As regards the Commission, it may  issue 
an opinion to the Member State where it considers that an investment is likely to affect security or 
public order in more than one Member State or when it has relevant information in relation to that 
investment. A Member State may also request an op inion by the Commission. The Member State 
shall give due consideration to the opinion. The final decision shall however be taken by the Member 
State.  
The Commission may also issue an opinion to the Member States when the investment is likely to 
affect a p roject or programme of Union interest. In such case, the Member State concerned shall 
take the utmost account of the Commission 's opinion and provide an explanation to the Commission 
if its opinion is not followed.  
 
14. The Report by the Secretariat indic ates that the reviews will focus on foreign 
acquisitions in cases involving state -owned enterprises and strategic sectors in countries WT/TPR/M/395/Add.1  
 
- 135 - 
 
  outside the Union. Please elaborate on the EU's definition of state -owned enterprises and 
strategic sectors and explain w hether the relevant definitions apply to all member States.  
 
EU reply : The Regulation applies to all foreign direct investments and does not use or define the 
term "State Owned Enterprises " or "strategic sectors ". The assessment by the Member States or the 
Commission will focus on assessing whether FDI is likely to affect security or public order. To guide 
Member States and the Commission in this assessment, Article 4 of the Regulation provides an open 
list of factors that may be considered. Among those are factors concerning potential effects on critical 
infrastructures, critical technologies, supply of critical inputs, access to sensitive information or the 
freedom and pluralism of the media, as well as factors related to the foreign investor (such as c ontrol 
by the government, including through ownership structure or significant funding; a serious risk that 
the investor engages in illegal or criminal activities; or others).  
 
15. Please elaborate on the application conditions of the framework and prove t hose 
conditions will not constitute a means to restrict FDI from specific countries or sectors.  
 
EU reply : Article 3 of the Regulation lays down the minimum requirements for Member States ' 
screening mechanisms. Article 3 also explicitly states that that th e rules and procedures related to 
the screening mechanism shall be transparent and not discriminate between third countries. Article 
4 provides a non -exhaustive list of factors that may be taken into consideration by Member States 
or the Commission in orde r to determine whether a FDI is likely to affect security or public order. It 
is also recalled that it is possible for the Union and the Member States to adopt restrictive measures 
relating to FDI on the grounds of security and public order, subject to the  requirements set by 
Articles XIV and XIV bis of the GATS.  
 
16. A uniform mechanism at the EU level has not yet been established at present. Is there 
any plan to establish such a uniform mechanism in the future?  
 
EU reply : There are no such plans at this stage. The Regulation itself shall apply only from 
11 ctober  2020. The first evaluation and effectiveness of the Regulation is due by 12 October 2023 
pursuant to Article 15.  
 
17. How to ensure that the state -owned enterprises of third countries are not 
discriminated against during the FDI review? How to ensure that public security is not 
subject to generalized or random discretion and thus trigger protectionism?  
 
EU reply : The Regulation complies with the EU commitments under the WTO agreements. Article 
3(2) stipulates that rules and procedures related to screening mechanisms, including relevant 
timeframes, shall be transparent and not discriminate between third countries. Article 4 provides a 
non-exhaustive list of factors that may be taken into considerati on by Member States or the 
Commission in order to determine whether a FDI is likely to affect security or public order.  
The implementation of the Regulation by the EU and its Member States should comply with the 
relevant requirements for the imposition of restrictive measures on grounds of security and public 
order in the WTO agreements, including, in particular, Article XIV(a) and Article XIV bis of the GATS. 
It should also comply with Union law and be consistent with commitments made under other trade 
and investment agreements to which the Union or Member States are parties and trade and 
investment arrangements to which the Union or Member States are adherents.  
 
18. What specific measures will the EU take to ensure the transparency and 
non-discrimination of the screening mechanism relate to security? Will there be an open 
and predictable institutional arrangement for time limit of the screening? At present, the 
coverage of screening is wide -ranging. Will there be clearer limit or areas in th e future?  
 
EU reply : Article 3 of the Regulation provides that Member States that maintain, amend or adopt 
mechanisms to screen foreign direct investment shall carry out such screening on the basis of rules 
and procedures that are transparent and non-discriminatory. The circumstances triggering the 
screening, the grounds for screening and the applicable detailed rules are set out by the Member 
States, subject to the requirements set out in the Regulation. The screening is not wide ranging but 
limited to grounds of security and public order.  
 
19. How to determine whether an FDI investor is controlled by the government of a third 
country?  WT/TPR/M/395/Add.1  
 
- 136 - 
 
  EU reply:  As described above, the Regulation offers guidance by referring to ownership structure 
or significant fu nding as possible factors to assess (Article 4(2)(a) of the Regulation).  
 
20．Does the European Commission have the right to issue relevant opinions to member 
States without an FDI review mechanism?  
 
EU reply : Article 7(2) of the Regulation stipulates that,  where the Commission considers that a 
foreign direct investment planned or completed in a Member State which is not undergoing screening 
in that Member State is likely to affect security or public order in more than one Member State, or 
has relevant infor mation in relation to that foreign direct investment, it may issue an opinion 
addressed to the Member State in which the foreign direct investment is planned or has been 
completed.  
 
21. If so, how can a member State without an FDI review mechanism follow the European 
Commission's objection opinion to a certain FDI?  
 
EU reply:  Where a Member State does not have a screening mechanism, it should give such an 
opinion due consideration through, where appropriate, measures available under its national law, or 
in its broader policy -making, in line with is duty of sincere cooperation laid down in Article 4(3) TEU.  
 
P83 Chart 3.3  
 
Questions:  
22. The Chart shows that Asian area is the main target of EU trade remedy measures. 
According to statistics, 87% of trade remedy investigations initiated by the EU in 2016 -18 
targeted developing countries. Please explain how to protect the interests of developing 
countries within the EU framework of trade remedy?  
 
EU reply: The EU does not target any countries in the applicat ion of the trade defence instruments. 
The EU opens trade defence investigations where it receives duly substantiated complaints from 
industry alleging dumping/subsidization and relating injury. The EU is obliged to initiate an 
investigation if all the evid ence is provided, regardless of the country of export. Only after the 
completion of a full investigation confirming the allegations are measures imposed.  
In accordance with Article 15 of the Agreement on Implementation of Article VI of the General 
Agreeme nt on Tariffs and Trade 1994 (the WTO anti -dumping Agreement), the EU takes into account 
the status of developing countries when considering the application of anti -dumping measures, 
where they would affect the essential interests of the country. In that c ontext, the EU considers any 
constructive remedy that may be identified and/or offered i.e. undertakings.  
As regards the imposition of anti -subsidy measures Article 14(5) of the EU 's Basic Regulation 
provides for the termination of an investigation where the amount of the countervailable subsidies 
is de minimis. In the case of developing countries, this amount is 2%, whereas for all other countries 
the amount is 1%.  
 
Page 96 (para 3.126)  
The EU provides incentives in the form of subsidies and state aid. I t notified its subsidies programmes 
to the WTO in 2019.  
 
Question:  
23. What are the differences between subsidies and state aid?  
 
EU reply:  Under EU law, State aid is defined as a selective advantage in any form whatsoever 
conferred on a selective basis to an undertaking through state resources. Under WTO a subsidy is a 
financial contribution by a government or any public body within the terri tory of a Member which 
confers a benefit. The main difference between the two regimes is that WTO rules apply to goods, 
but EU rules include services too.  
 WT/TPR/M/395/Add.1  
 
- 137 - 
 
  Page 99 (Para 3.138)  
As previous Secretariat reports point out, member States are, in principle, re quired to notify state 
aid measures to the Commission, which must approve the measures before they can be 
implemented. State aid measures are exempted from the notification requirement if they meet the 
requirements of regulations defining ex ante compatibi lity conditions, for example the Commission's 
General Block Exemption Regulation (GBER), which was renewed in July 2014, and updated in 2017.  
 
Questions:  
24. As stated by the EU, some state aid measures are exempted from the notification 
requirements if they meet the requirements, eg. GBER. How can the EU ensure the 
compliance of those notification —exempted measures with the State aid rules, i.e. the 
compatibility with the internal market?  
  
EU reply:  EU ensure compliance as follows: Transparency (nationa l public registers of individual aid 
awards will ensure peer review and greater accountability) and Monitoring (ex post -controls of 
compliance with the formal conditions for exemption). Any non -compliance with any of the 
compatibility conditions means that  the measure is illegal (i.e. implemented in breach of the general 
notification requirement). Following the jurisprudence, national courts as well as national 
administrative authorities are required to order recovery of any aid that was implemented under t he 
GBER without being in compliance with the compatibility conditions laid down in it. Lastly, interested 
parties (e.g. competitors of the beneficiary) can lodge complaints with the Commission for alleged 
breaches of State aid rules. This is also possible for cases allegedly falling under the GBER.  
Chapter II of the GBER (Articles 10 -12 GBER) lays down the relevant rules, including obligations for 
Member States to report to the Commission on measures implemented under the GBER and to keep 
detailed records on all such measures to enable an effective ex post monitoring. Article 10 GBER 
provides for a possibility for the Commission to withdraw the benefit of the GBER from a Member 
State, when it has provided aid under the GBER without complying with its condit ions. 
For more details on the GBER please refer to:  
http://ec.europa.eu/competition/state_aid/legislation/block.html . 
 
25. Is there any ex post investigation for the notifica tion—exempted measures? If yes, 
how does the EU conduct such investigations?  
 
EU reply:  The Commission carries regular ex -post monitoring of aid measures to ensure compliance 
with the conditions laid down in the GBER. If it detects irregularities, it can order recovery of the 
aid. In addition, the Commission can open investigations ex officio as well as following a complaint 
by an interested party (e.g. a competitor of the beneficiary).  
 
Page 100 (Table 3.14 Non -crisis related state aid, 2013 -17) 
 
Questio ns:  
26. Could the EU please specify what is "closure aid"?  
 
EU reply: Closure aid refers to aid to facilitate the closure of uncompetitive coal mines.  
 
27. Could the EU please explain why "the railway support includes a significant amount 
that is not clas sified as state aid"?   
 
EU reply:  The public financing granted under the railway support category reported in the 
Scoreboard can constitute State aid. However, a significant part of railway support, as shown in 
Table 3.14, does not qualify as state aid. The Commission considers that an ef fect on trade between 
Member States or a distortion of competition is normally excluded as regards the construction of the 
infrastructure in cases where at the same time (i) an infrastructure typically faces no direct 
competition, (ii)  private financing is  insignificant in the sector and Member State concerned and 
(iii) the infrastructure is not designed to selectively favour a specific undertaking or sector but 
provides benefits for society at large.  
For further information refer to Commission Notice on t he notion of State aid as referred to in 
Article  107(1) of the Treaty on the Functioning of the European Union (2016/C 262/01), para 211. 
(https://eur -lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:52016XC0719(05)&from=EN)   
 WT/TPR/M/395/Add.1  
 
- 138 - 
 
  Page 102  (Para 3.148)  
In 2017, the level of state aid to the financial sector, both approved and used, was at its lowest level 
since the beginning of the financial crisis, except for capital aid instruments where around 
EUR 12.1 billion were employed to address legacy cases requiring recapitalization aid.  
 
Question:   
28. According to Table 3.15 "Use of crisis -related state aid, 2008 -17", it seems that 
EUR 11.3 billion were employed  for recapitalization in 2017. Could the EU please explain 
why, as mentioned in paragraph 3.148 of the secretariat report, "around EUR 12.1 billion 
were employed to address legacy cases requiring recapitalization aid"? Please provide 
detailed information o n "legacy cases".  
 
EU reply:  The amount of EUR 11.3 billion relates to State aid measures in Italy, involving banks 
that showed their weaknesses in the previous years. These weaknesses were finally addressed with 
measures (involving State aid) implemented in 2017.  
With regard to legacy cases, we broadly indicate banking crisis measures that did not arise during 
the years of crisis, but that were ultimately caused by the financial crisis. This is the case, for 
instance, of institutions that, although were no t struck by sudden crisis of liquidity in the years of 
the crisis, they were nonetheless weakened by the economic decline, and measures aiming at 
preserving the financial stability were needed.  
 
Page 102 (Table 3.15 Use of crisis -related state aid, 2008 -17) 
 
Question:   
29. Please give specific examples to illustrate the aid instruments, including 
"Recapitalizations", "Impaired asset measures", "Guarantees on liabilities", "Liquidity 
measures, other than guarantees on liabilities".  
 
EU reply:  A list o f examples of state aid decisions taken in the context of the financial crisis including 
"Recapitalizations", "Impaired asset measures", "Guarantees on liabilities", "Liquidity measures", 
can be found on the State aid register: 
https://ec.europa.eu/competition/recovery/banking_case_list_public_en.pdf .  
 
Page 110 （Para 3.165 ） 
"In the absence of EU harmonized technical regulations, member States may develop and apply 
national technical regulations subject to specific procedures."  
 
Question:  
30. This paragraph states that in the absence of EU harmonized technical regulations, 
member States may develop and apply national technical regulations subject to specific 
procedures. How can other WTO members obtain information on the technical regulations 
independently developed by EU member States?  
 
EU reply:  EU Member States are subject to the notification requirements laid down under the TBT 
Agreement when it comes to the technical regulations that they may adopt in the absence of EU 
harmonized legislation. As a consequence, WTO Members can have access to the se notified 
measures through their domestic TBT enquiry points in accordance with Article 10 of the TBT 
Agreement.  
 
Page 112 （Para 3.184 ） 
"In addition to the three ESOs, the Commission plays a role in standardization by funding 
participation in the standar dization process by SMEs and non -governmental organizations (NGOs), 
such as environmental and consumer groups and trade unions. The Commission issues 
standardization requests for harmonized standards in support of EU policy and legislation, and 
financially  supports the work of the ESOs, but is not involved in the process of standard -setting, 
which is carried out by the ESOs."  
 
Questions:  
31. This paragraph states that, in addition to the three ESOs, the Commission plays a role 
in standardization by funding participation in the standardization process by SMEs and 
non-governmental organizations (NGOs), such as environmental and consumer groups 
and trade unions. The Commission issues standardization requests for harmonized WT/TPR/M/395/Add.1  
 
- 139 - 
 
  standards in support of EU policy and legislation, and financially supports the work of the 
ESOs, but is not involved in the process of standard -setting. How is the Commission's 
annual public budget input for standardization determined? How much is the budget each 
year? Where is the budget use d, and how to assess the input -output ratio?  
 
EU reply:  The budget is planned one year in advance, regularly during January of year n -1 for 
year 1, and a financing decision is approved through a legislative process by the College of 
Commissioners. Budget lines are in place per each main activity of the relevant Directorate General 
and a global amount is loaded per each budget line after approval of the EU budget.  
Concerning standardisation, one single budget line is dedicated to grant s for ESOs and to 
procurement related to technical assistance/studies. The yearly budget is around 20 Mio. 
One separate single budget line is dedicated to the standardization process by SMEs and 
non-governmental organizations (NGOs), such as environmental and consumer groups and trade 
unions. The yearly budget is around 4,4 Mio. The execution for both budgets is usually up to 100%.  
 
32. What channels through which can Chinese enterprises (especially SMEs) and NGOs 
participate in the revision of European sta ndards?  
 
EU reply:  The European Commission does not draft standards, the private and independent 
European standardisation organisations CEN, CENELEC and ETSI do.  
The Regulation on Standardisation 1025/2012 encourages the ESOs to allow the participation of 'all 
relevant stakeholders ' in European standardisation (Art. 5.1). The ESOs and the NSBs (National 
Standards Bodies) are alone responsible for managing the rules of participation, without any 
interference from the European Commission. If the European Comm ission received a complaint from 
a stakeholder that he/she was prevented from participating in European standardisation, it would 
then refer to the ESOs. All stakeholders from anywhere in the world can comment on European draft 
standards when the commentin g period is open. However, the participation of foreign stakeholders 
in EU standard setting is already possible, not only for foreign companies established in the EU, but 
also for any expert that asks to participate in a personal capacity to a national sta ndard body in the 
EU. To be noted that EU companies do not have themselves a right for direct participation. 
Participation is established through the national standardisation bodies of the Member States.  
 
Page 112 (Para 3.194)  
Creating the right conditions  for digital networks and services to flourish is one of the three pillars 
of the EU Digital Single Market Strategy. Standardization is supporting it in 2019 by focusing on the 
IoT, big data, blockchain, cooperative intelligent transport systems and autono mous driving, 
eHealth, smart cities, accessibility, e -Government and artificial intelligence (AI). Good progress has 
been made in the harmonization of the 5G spectrum, and the first global 5G standards are now 
available, as foreseen in the 5G Action Plan. However, further work in global 5G standardization is 
needed in the next few years, notably to promote investments in 5G networks supporting industrial 
applications. The planned European partnership on Smart Networks and Services under Horizon 
Europe is ex pected to be instrumental in driving this standardization agenda.  
 
Questions:  
33. Please elaborate on the specific implementation plan of the European partnership in 
smart networks and services under Horizon Europe and its role in promoting the 
development  of 5G standards.   
 
EU reply: The European partnership in smart networks and services under Horizon Europe will follow 
and extend the 5G PPP (public private partnership) by developing research & innovation for networks 
and services beyond 5G and later 6G, and by supporting 5G deployment. The mode of 
implementation is currently subject to an impact assessment.  
 
The European partnership in smart networks and services under Horizon Europe has been presented 
by the Commission in the 6th ITU Workshop on Network 2030 (Lisbon, 13 -14 Jan 2020): 
https://www.itu.int/en/ITU -T/Workshops -and-
Seminars/20200113/Documents/Berna rd_Barani.pdf . 
 
34. Please introduce the policy development situation of 5G security and the main 
considerations.  
 WT/TPR/M/395/Add.1  
 
- 140 - 
 
  EU reply: On 26 March 2019, the Commission published a Recommendation for Member States to 
take concrete actions to assess cybersecurity risks of 5G networks and to strengthen risk mitigation 
measures. The Recommendation set out a series of operational measures:  
 
- At national level, each Member State completed a national risk assessment of 5G network 
 infrastructures and tran smitted the results to the Commission and the European Union 
 Agency for Cybersecurity (ENISA).  
- At EU level, Member States, with the support of the European Commission and ENISA, 
 completed a coordinated risk assessment which was published on 9 October 2 019. This EU -
 wide risk assessment focuses on threats and threat actors, on assets and their level of 
 sensitivity and on the main vulnerabilities. The report also presents different risk scenarios.  
- On this basis, Member States, in cooperation with the C ommission, are currently finalizing 
 a toolbox of mitigating measures to address the identified cybersecurity risks at national and 
 Union level.  
- By 1 October 2020, Member States, in cooperation with the Commission, should assess the 
 effects of the Reco mmendation in order to determine whether there is a need for further 
 action. This assessment should take into account the outcome of the coordinated European 
 risk assessment and of the effectiveness of the measures.  
 
On 3 December 2019, the Council adopt ed conclusions on the security of 5G networks, endorsing 
the ongoing work related to the implementation of the Recommendation.  
 
Page  115 (Para 3.200)  
On a mandate from the European Commission, the ESOs completed the first phase at the beginning 
of 2017; th is resulted in a shortlist of 12 standards to be revised and 1 standard to be written under 
the second phase, which started at the beginning of 2018 and is expected to take about four years.  
 
Questions:  
35. Please introduce the shortlist of 12 standards to  be revised and the new standard to 
be written under the second phase.  
 
EU reply:  Standards under consideration for revision:  
1. EN ISO 52000 -1: Energy performance of buildings – overall energy use and definitions of 
 energy ratings  
2. EN ISO 15927 -4 Hygrothermal performance of buildings – calculation and presentation of 
 climatic data  
3. EN 16798 Energy performance of buildings -  
Part 1: Indoor environmental input parameters for design and assessment of energy 
performance of buildings addressing indoor air quality, thermal environment, lighting and 
acoustics - Module M1 -6.  
Part 3: Ventilation for non -residential buildings - Perfor mance requirements for ventilation 
and room -conditioning systems (Modules M5 -1, M5 -4) 
4. EN 16309 Sustainability of construction works. Assessment of social performance of 
 buildings. Calculation methodology  
5. EN 50125 Railway applications - Environmental  conditions for equipment  
 Part 1: Equipment on board rolling stock  
 Part 2: Fixed electrical installations  
 Part 3: Equipment for signalling and telecommunications  
6. EN 1915 Aircraft ground support equipment - General requirements  
 Part 1: Basic safety  requirements  
 Part 2: Stability and strength requirements, calculations and test methods  
7. EN 16348 Gas infrastructure - Safety Management System (SMS) for gas transmission 
 infrastructure and Pipeline Integrity Management System (PIMS) for gas transmis sion 
 pipelines – Functional requirements  
8. EN 15399 Gas Supply Systems - Guidelines for Management systems for Gas Distribution 
 Networks  
9. EN 1473 Installation and equipment for liquefied natural gas - Design of onshore installations  
10. EN 50600 serie s Information technology - Data centre facilities and infrastructures  
 Part 2 -3: Environmental control  
 Part 2 -5: Security systems  
11.  EN 300 019 series Environmental Engineering (EE); Environmental Conditions (Part 1) and 
 Environmental Tests (part 2) for Telecommunications Equipment  WT/TPR/M/395/Add.1  
 
- 141 - 
 
  After consideration, standard EN 15723 "Closing and locking devices for payload protecting devices 
against environmental influences - Requirements for durability, operation, indication, maintenance, 
recycling " has been remo ved from the work programme of the second phase.  
New standard under standardisation committee CEN TC 350:  
New WI 0035028 "Sustainability of construction works — civil engineering works sustainability 
assessment methodology " 
 
36. Please explain why the revi sion and writing of relevant standards will not constitute 
non-tariff trade barriers.  
 
EU reply:  The application of the standards is voluntary, as is the case with all harmonised standards 
in the EU. Therefore, they do not constitute non -tariff trade barri ers.  
 
Page 124 （Para 3.247 ） 
"In October 2018, the Commission commenced the review of the Vertical Block Exemption 
Regulation (VBER), which will expire in May 2022. In order to decide whether the VBER should be 
amended, prolonged or lapsed, the Commission is conducting an evaluation of the functioning of the 
existing rules."  
 
Question:  
37. This paragraph states that, in October 2018, the Commission commenced the review 
of the Vertical Block Exemption Regulation (VBER), which will expire in May 20 22. In order 
to decide whether the VBER should be amended, prolonged or lapsed, the Commission is 
conducting an evaluation of the functioning of the existing rules. Please elaborate on the 
implementation effect of the VBER and what will be included if it i s amended.  
 
EU reply:  The prohibition of Art. 101(1) of the Treaty covers, amongst others, agreements entered 
into between two or more undertakings operating at different levels of the production or distribution 
chain, and relating to the conditions under which the parties may purchase, sell or resell certain 
goods or services (so -called "vertical agreements "). The aim of the VBER is to make use of the 
empowerment in Council Regulation 19/65/EEC to block exempt certain categories of vertical 
agreements and corresponding concerted practices falling within Art. 101(1) TFEU for which it can 
be assumed with sufficient certainty that they satisfy the conditions of Art. 101(3) TFEU. The 
objective of the evaluation phase is to gather evidence on the functioning of the current Vertical 
Block Exemption Regulation and the accompanying Guidelines on Vertical Restraints. The objective 
of the impact assessment phase is to inform and support the decision of the Commission to 
determine whether it should let the Regulation l apse, prolong its duration or revise it on the basis of 
the evidence gathered during the evaluation phase. It will verify the existence of any problem, 
explore the underlying causes, analyse the advantages and disadvantages of available solutions and, 
if necessary, propose amendments. The review of the VBER is currently in its evaluation phase.  
 
Page 126 （Para 3.251 ） 
"The above table shows that the national competition authorities are actively engaged in the 
enforcement of competition rules. As evidenced by  it, a majority of cases are investigated or 
submitted by the competition authorities of the member States. The Directive further supporting the 
role of national competition authorities in enforcing European competition law can thus be expected 
to contribu te to the effective investigation of anti -competitive behaviour and merger cases in the 
EU." 
 
Question:  
38. This paragraph states that the national competition authorities of EU member States 
are actively engaged in the enforcement of competition rules... a majority of cases are 
investigated or submitted by the competition authorities of the member States. The 
Directive further supporting the role of national competition authorities in enforcing 
European competition law can thus be expected to contribute to  the effective investigation 
of anti -competitive behaviour and merger cases in the EU. Please introduce the problems 
existing in the enforcement of European competition law by EU member States and the 
measures taken by the Commission to improve the effecti veness of the case transfer 
mechanism with member States.  
 
EU reply:  Directive 2019/1 ( "ECN+ Directive ") does not affect merger control. The Directive 's scope 
covers only the enforcement of Articles 101/102 TFEU by national competition authorities. Contrar y WT/TPR/M/395/Add.1  
 
- 142 - 
 
  to merger control, where competence is clearly split between the Commission and the national 
competition authorities on the basis of turnover thresholds, the EU enforcement system for Articles 
101/102 TFEU is a system of parallel competences and flexible  case allocation rules. The relevant 
work-sharing rules are designed to be flexible, so that work can be shared according to the features 
of the sector and the case under investigation. This system easily adjusts to circumstances, 
e.g. whether the markets are national or broader or whether the conduct is national or wider -spread 
etc. For example, when it comes to cartels the Commission typically deals with those with a global 
scale, and the national competition authorities mostly tackle cartels with  their main effect in one 
Member State. Experience has shown that this system has worked very well. Issues of case allocation 
between the members of the European Competition Network arise very rarely and are resolved 
satisfactorily. This is why the Commiss ion's Proposal for the ECN+ Directive did not revisit the case 
allocation system within the European Competition Network.  
 
P133  (Para 3.272)  
"3.272.  State -owned enterprises (SOEs) continued to play an important role in the EU economy in 
terms of revenue, value added, and employment, although their importance varies from one member 
State to another. According to a 2018 report by the European Commission, EU member States owned 
about EUR  16.5 trillion of public assets in 2015, mostly in services and public ut ilities (i.e.  water, 
electricity, energy, and transports) and in financial institutions, employing more than 4  million 
people. At the individual country level, in absolute terms, the number of SOEs covered in the report 
ranged from 35 or below (in Cyprus a nd Malta) to over 3,000 (in Germany, Italy, Bulgaria, and 
Poland) in 2015. "  
 
Questions:  
39. The 2018 Report by the EU, titled European Commission Public Assets: Please 
elaborate on what's at Stake? An Analysis of Pubic Assets & their Management in the 
European Union, is not accessible with the link provided. Please provide the document at 
an earlier date in order for members to look into it. According to the above Report, EU 
member states owned about EUR 16.5 trillion of public assets in 2015 and employed more 
than 4 million people. Can EU provide the respective data in 2018? As there are over 
3,000  SOEs in Germany, Italy, Bulgaria and Poland, can the list of major SOEs be 
provided?  
 
EU reply:  The European Commission report is available via the following li nk: 
https://ec.europa.eu/info/sites/info/files/economy -finance/dp089_en_public_assets.pdf  
It provides an overview and discussion of state asset management  in the EU based on a 
comprehensive study conducted by a private consultant and managed by the Commission. The 
various deliverables of that study are available via the following link.  
https://ec.europa.eu/info/evaluation -reports -economic -and-financial -affairs -policies -and-spending -
activities/analysis -public -assets -and-their-management -european -union_en  
During the preparation of the study the most recent data year available was 2015. The EU does not 
have 2018 data that was collected and/or calculated according to the same methodology used in the 
study.  
The EU does not mainta in regular records or lists of SOEs. The above -mentioned Commission report 
was a one -off initiative, conducted by a consultant under the management of the European 
Commission.  
 
40. According to The Size and Sectoral Distribution of SOEs, published by OECD in 2017, 
there are 1476 SOEs among 20 member states, with less than EUR 1 trillion of assets. It 
seems there might be huge discrepancies from the 2018 Report by EU. Could EU give more 
details about the size and sectoral distribution of SOEs across all  28 member states?  
 
EU reply:  For details about the size by Member State and sectorial distribution we refer to Figure D 
and Table C in Appendix I to the EU summary report of Pillar I of the study. Please find a direct link 
to that document below. https://ec.europa.eu/info/sites/info/files/economy -
finance/dg_ecfin_am_final_report_pillar_1_eu28_summary_report.pdf  
Please note th at the definition of Public Sector Holding (PSH) that is used in the European 
Commission report and underlying study includes all companies in which the government has a 
non-zero share. This definition is likely to be more inclusive than the definition of SOEs used in the 
OECD document, which would explain the larger number and higher value of entities covered in the 
European Commission documents.  
 WT/TPR/M/395/Add.1  
 
- 143 - 
 
  41. As mentioned, that there is no specific EU legislation to regulate SOEs at the EU level, 
each member stat e has its own legal provisions and retains competence for SOEs. Please 
provide the major legal provisions applied in Germany, France, Italy, Bulgaria and Poland.  
 
EU reply:  Irrespective of nationality, all SOEs are bound by EU legislation. The EU rules on  
competition, freedom of establishment and non -discrimination generally apply in the same manner 
for all enterprises, irrespective of whether they are publicly or privately owned.  
As a result, the legislation of the member states concerns only the ownersh ip and management 
arrangements of the SOEs. The national laws cannot affect the functioning of the SOEs in the EU 
common market.  
Table A3.4 on page 292 of the Secretariat Report provides an overview of each national situation, 
including definitions and in stitutional setup. The table contains a reference document with more 
specific information on the national arrangements.  
 
42. As the Chart 3.7 shows the liabilities of public corporations at 2017, with Germany 
and France data of 2016, can the 2018 data be p rovided? If not, could the EU explain why 
Germany and France data is dated in 2016 instead of 2017 or 2018?  
 
EU reply:  The database is publicly available at the Statistical Office of the European Union 
("Eurostat "), at the following link:  
http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=gov_cl_liab&lang=en   
Data from the year 2018 is not yet available, so 2017 is the most recent available year. Most EU 
Member States have provided the data from 2017. For France and Germany, the published data is 
the most recent data provided by the French and German (year 2016).  
 
Page  137 (Para 3.293)  
"To address some of the procurement challenges, the new EU strategy foc uses on six policy priorities, 
including "improve access to non -EU procurement markets through trade agreements".  
 
Questions:  
43. Please explain the route of implementation and the operation of this policy priority.   
 
EU reply: One of the strategic priorit ies of the EU with regard to government procurement is to 
further improve access to non -EU procurement markets through plurilateral and bilateral trade 
agreements. On the one hand, the European Union has been supporting the accession of new parties 
to the WTO Government Procurement Agreement (GPA). On the other hand, the European Union is 
engaging in bilateral trade agreements that include comprehensive chapters on government 
procurement in view of further opening the procurement markets in third countries.   
 
44. Please elaborate on the application conditions of the above -mentioned priorities and 
prove that it will not constitute a non -tariff trade barrier in case of an inconsistency or 
unequivalence with the procurement policy of a third country.   
 
EU reply: The six policy priorities on which the new EU strategy focuses set wide objectives that 
the EU intends to achieve in order to improve its public procurement system and deliver better value 
for money, by ensuring increased competition and better c hoice for public buyers. For each policy 
priority, the Commission created a series of soft tools, which are meant to help achieve these 
objectives. These tools do not establish new conditions or rules regarding the functioning of public 
procurement procedu res in the EU. Such rules, in fact, are outlined in the EU 2014 Public 
Procurement Directives, which laid down the following basic principles: transparency, equal 
treatment, non -discrimination and open competition. In addition, the EU 2014 Public Procureme nt 
Directives are designed to implement the EU's obligations under the revised Government 
Procurement Agreement (GPA). The six policy priorities, therefore, will have to be implemented in 
accordance with the above -mentioned basic principles and with the GP A. 
 
Page  150（Para 3.342 ） 
Following up on a Commission proposal of 28 May 2018, the EU co -legislators adopted Regulation 
(EU) 2019/933 amending Regulation (EC) No. 469/2009 concerning the supplementary protection 
certificate for medicinal products, introduc ing an exception to let firms established in the EU 
manufacture certain pharmaceutical products for export to non EU markets during the term of the 
SPC. It also permits the making and stockpiling of a pharmaceutical product six months prior to the WT/TPR/M/395/Add.1  
 
- 144 - 
 
  expiry o f the certificate, in order to place it on the market of EU member States immediately after 
expiry of the certificate …  
 
Question:  
45. In May 2019, the EU adopted an amendment to the Regulation concerning the 
supplementary protection certificate for medicinal products. Has the amendment been 
formally implemented? What is about the implementation effect?  
 
EU reply:  Regulation (EU) 2019/933 is in force and does not require further implementation. It is 
still too early to assess the effects of this Regul ation.  
 
Page  151（Para 3.343 ） 
"No 'unitary SPC' that would apply to future unitary patents is foreseen in the regulatory package 
adopted and awaiting entry into force. The Commission is working on the relationship between 
unitary patent protection and SPC l egislation."  
 
Question:  
46. Please elaborate on the current progress of the Commission's research on the 
relationship between unitary patent protection and SPC legislation.  
 
EU reply:  The Commission is currently conducting an evaluation of the SPC framework based on 
the studies, desk research and public consultations/surveys conducted during the last years.  
 
Page 152 （Para 3.352 ） 
"During the review period, the EUTM regime witnessed the implementation of a substantive 
trademark reform package, adopted  in December 2015 in the form of a regulation modernizing the 
rules on EU -wide trademarks administered by the EU, and a directive further harmonizing national 
trademark law…"  
 
Question:  
47. What are the specific contents of modernizing rules on EU -wide tra demarks 
administered by the EU?  
 
EU reply:  Information on the specific contents of the recent trade -mark reform in the EU is available 
on the relevant website of the European Commission following the link 
https://ec.europa.eu/growth/industry/intellectual -property/trade -mark-protection_en.  
 
Page 154 （Para 3.362 ） 
"With regard to non -agricultural products, the EU commissioned a study on economic aspects of GI 
protection at the EU level, in order to (i) evaluate the effectiveness of specific GI protection in limiting 
the availability of non -authentic products; (ii) assess the value of this specific GI protection to 
consumers, and the impact on consumer search costs for authentic products with and without explicit 
GI protection; and (iii) identify  the value of this specific GI protection to producers of authentic 
geographically -rooted products. The results of the study are planned for publication in 2020. GIs for 
non-agricultural products may also be protected as collective EU  trademarks, and under  unfair 
competition laws."  
 
Question:  
48. Please elaborate on the current status and legal requirements of GI protection of 
nonagricultural products in the EU.  
 
EU reply: The current status of GI protection for non -agricultural products in the EU remains 
unchanged. The final version of the study on the economic aspects of GI protection at the EU level 
will soon be published. Based on all the evidence collected, the EU will decide on concrete further 
steps.  
 
Page 155 （Para 3.363 ） 
"EU member States had until J une 2018 to implement the Directive on the Protection of Undisclosed 
Know -How and Business Information (Trade Secrets) Against Their Unlawful Acquisition, Use and 
Disclosure (the Trade Secrets Directive)."  
 WT/TPR/M/395/Add.1  
 
- 145 - 
 
  Questions:  
49. This paragraph states that EU memb er States had until June 2018 to implement the 
Directive on the Protection of Trade Secrets. Please elaborate on the main content of the 
Directive on the Protection of Trade Secrets.  
 
EU reply: The Directive lays down rules on the protection against the un lawful acquisition, use and 
disclosure of trade secrets (civil redress). More information on the content of the Directive can be 
found on the website of the European Commission at:  
https://ec.europa.eu/growth/industry/intellectual -property/trade -secrets_en . 
 
50. Please introduce the typical cases (including the subjects of illegal and the types of 
infringement) investigated by member States after the implementation o f the Directive.  
 
EU reply:  An intermediate report on the application of Directive 2016/943 was foreseen for 2022 
but it will only take place in 2024, due to the late transposition of the Directive. It is still too early 
to report on cases investigated by Member States after the transposition of the Directive.  
 
Page 167 (Para 4.12)  
"Member States can exempt farmers from the definition of active farmer if they received direct 
payments below a certain level of threshold not exceeding EUR 5,000 ." 
 
Questions:  
51. Please explain the standards for the EU to determine farmers receiving less than EUR 
5,000 under the direct payment framework.  
 
EU reply:  In order to minimise the administrative burden of the active farmer provision especially 
for smalle r part -time farmers that contribute to the vitality of rural areas, the EU legislator decided 
that applicants who receive less than a certain amount of direct payments in the previous year are 
considered de facto active farmers (except for the farmers fall ing under Article 9(1) of Regulation 
(EU) No . 1307/2013). This amount is set by Member States on the basis of objective criteria such 
as their national or regional characteristics, but may not be greater than EUR 5000 (Article 9(4) of 
Regulation (EU) No . 1307/2013). Article 12(3) and (4) of Regulation (EU) No . 639/2014 specify how 
Member States should calculate this amount in specific cases, e.g. if the farmer did not submit an 
aid application for the previous year.  
 
52. Are the sizes of farm households in different members of the EU related to the amounts 
and proportions of direct payments? If so, please elaborate on the relationship.  
 
EU reply:  Direct payments are granted to farmers in the form of a basic income sup port (the Basic 
Payment Scheme/Single Area Payment Scheme), complemented by a series of other supports 
targeting specific objectives or types of farmers (the "green" direct payment, the redistributive 
payment, the voluntary coupled support, the payment to young farmers and the payments for areas 
with natural constraints).  
Therefore, the total size of the support has some relationship to the size of the holding of the 
applicant, but not to the size of the farm household as such. The decoupled payments are d ifferent 
in different Member States, in particular due to implementation decisions they take.   
 
Page 176 (Para 4.50)  
"The butter and skimmed milk powder stocks accumulated during the period 2015 -17, with total 
public and private stocks of skimmed milk powd er reaching more than 415,000 tonnes at the end of 
2016; public intervention stocks reached 380,000 tonnes at the end of 2017. The intervention stocks 
were progressively put back on the market through a tendering process, and decreased regularly in 
2018 an d in the first half of 2019, down to zero in July 2019"  
 
Questions:  
53. How does the EU deal with the milk powder stocks?  
 
EU reply:  The sale of intervention stocks by the Commission is governed by Regulation (EU) 
No. 1308/2013, which sets the framework for the cautious approach adopted by the Commission 
when disposing of SMP intervention stocks. Sales did not take place until the market had recovered. 
The prices at which the SMP in public intervention was sold in 2018 and 2019 were in line with 
market reality, taking into account the ageing of the product and therefore its relative loss of WT/TPR/M/395/Add.1  
 
- 146 - 
 
  commercial value (not the intrinsic quality of the product). In the period during which the bulk of 
the SMP intervention stocks were  disposed of (April 2018 – January 2019) EU SMP milk prices 
increased by more than 30% and Oceania SMP prices increased by more than 20%.  
 
54. Are there any stocks exported to the international market or used in grant aid? If so, 
please specify the respect ive quantities.  
 
EU reply:  Intervention stocks are sold without any condition of further use. They can find their 
destination on the internal market, can be further processed and/or exported in powder form. The 
Commission does not have information about th e further use of stocks released from intervention. 
If exported, these quantities are not differentiated and are counted together with other exports from 
the EU.  
 
Page 212 (Para4.178 and 4.179)  
"4.178.  The European Council adopted Conclusions on 22 March 2 019 inviting the Commission to 
"present, by the end of 2019, a long -term vision for the EU's industrial future, with concrete 
measures to implement it. It should address the challenges European industry faces, touching upon 
all relevant policy areas". Addi tionally, following up on previous Council Conclusions, on 
27 May 2019, the Competitiveness Council adopted "An EU Industrial Policy Strategy: Vision 2030", 
reiterating the Council's call for a comprehensive and long -term EU industrial policy strategy with  a 
clear vision for 2030 and stressing the importance of mobilizing all EU policies to strengthen the 
competitiveness of EU industry. Weakness in the manufacturing sector has contributed to the 
slowdown of GDP growth since the second half of 2018."  
 
Questi ons: 
55. The EU will develop concrete measures to implement the long -term vision for the EU's 
industrial future. Please brief on the specific progress made on the concrete 
implementation measures.  
 
EU reply:  The long -term vision for the EU's industrial fut ure is under preparation. The 
European  Commission will adopt in March 2020 an EU industrial strategy setting out this long -term 
vision. Progress with the implementation of this strategy will be communicated publicly by the 
European Commission.  
 
56. Can third country enterprises have access to the EU's Industrial Policy Strategy?  
 
EU reply: The content of the strategy can be accessed by everybody, as it will be documented 
publicly. The EU Industrial Strategy has been announced to cover a broad range of as pects that 
affect the competitiveness of industry in the EU Single Market. The strategy will hold therefore for 
all enterprises established in the European Union.  
 
57. What kind of impact on industry intervention imposed by this EU policy?  
 
EU reply: The industrial policy strategy can be expected to address the twin challenge of green and 
digital transformation, as announced in the European Green Deal, that the European Commission 
adopted on 11 December 2019. The strategy for the EU's industr ial future would cover aspects that 
affect the competiveness of industry in such aspects as investment and public procurement, trade, 
skills, innovation and small and medium -sized enterprises. The detailed impact, notably of any 
possible future regulatory measures, that might be announced in the strategy, will be the object of 
impact assessments during the preparation of such measures.  
 
58. How to prevent non -market behaviours and distorted market competition?  
 
EU reply: The EU industrial policy aims at cre ating a favourable business environment for a 
competitive and sustainable EU industry in line with the principles of the Treaty on the functioning 
of the EU, which includes avoiding distortion of competition in the EU Single Market.  
 
59. How to ensure that  overcapacity will not be caused by strengthened intervention?  
 
EU reply:  Production capacity is decided upon by enterprises based on their expectations on demand 
and the future evolution of markets. The EU Industrial policy aims at improving the market co nditions 
for a competitive industry in a functioning market economy.  WT/TPR/M/395/Add.1  
 
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  Page  210（Para 4.170 ） 
…Several policies, programmes and initiatives, covering a wide variety of fields, contribute to 
EU industrial policy. Examples of initiatives with a budget envelope i nclude: the ESIF; Horizon 2020; 
the CEF; and the programme for the COSME. In addition, the Investment Plan for Europe and the 
EFSI aim to mobilize at least EUR  408.4  billion in private and public investment by 2020. Two 
recurring priorities across these pr ogrammes and initiatives are SMEs and innovation."  
 
Questions:  
60. Please elaborate on the effectiveness of the aforementioned initiatives in promoting 
the development of SMEs.  
 
EU reply:  As far as European SMEs are concerned, several figures can be quoted regarding their 
recent development: SME value added and employment grew in all Member States in 2018 for the 
first time in years. Overall, in 2018 EU -28 SME value added grew by 4.1% and EU -28 SME 
employment by 1.8%. Those figures can be explained, a t least partly, by the effectiveness of EU 
programmes and initiatives.  
 
61. Do these initiatives benefit other SMEs outside the EU?  
 
EU reply:  Developing in the EU an overall environment which is conducive to the development of 
SMEs is benefiting to all S MEs operating in the EU market. EU SME Policy principles are also a source 
of inspiration for third countries in their own policies, particularly for EU neighbourhood countries. 
The EU is also developing SME Policy dialogues with some of its partners to sh are best practices in 
that policy area.  
 
Page 226 （Para 4.238 ） 
"New rules that will facilitate financing through capital markets for small businesses were agreed by 
co-legislators in March 2019. They aim to ensure that smaller businesses in the EU have access to 
diversified sources of financing at each stage of their development. They are expected to make it 
cheaper and simpler for SMEs to access public markets through the "SME Growth Markets", a new 
category of trading venue dedicated to small issuers."  
 
Questions  
62. Please elaborate on the specific arrangements of SME Growth Markets. Do these 
arrangements benefit other SMEs outside the EU?  
 
EU reply:  
SME growth markets are a type of multilateral trading facilities (alternative trading venues) that 
were introduced by the Markets in Financial Instruments Directive (MiFID II) specifically to make it 
easier for small companies to raise financing on public markets. Companies choosing to list their 
securities on an SME growth market benefit from less burdensome regulatory requirements than 
those listing on a r egulated market or another type of multilateral trading facility, such as a lighter 
prospectus. Regulation 2019/2115 on the promotion of SME growth markets further alleviated those 
requirements (e.g. reduced market abuse reporting obligations, facilitated transfer to a regulated 
market, etc.). In order for a multilateral trading facility to be able to register with a national authority 
as an SME growth market, at least 50% of the companies listed on it must be SMEs (defined as a 
company with a market capita lization of less than EUR 200 million). Non -EU companies that would 
choose to list on a European SME growth market would be entitled to the same conditions as 
European companies.  
 
Page 253 (Para 4.342)  
The EU Cybersecurity Act entered into force on 27 June  2019. It reinforces the role of the EU Agency 
for Cybersecurity (ENISA) by expanding its mandate and providing it with more resources. The 
revised mandate of ENISA is to: contribute to the development and implementation of EU policy and 
law in the field o f cybersecurity; support capacity building and preparedness across the EU; promote 
operational cooperation at the EU level; support and promote the development and implementation 
of EU policy on cybersecurity certification; provide analysis and advice, and  raise awareness and 
identify research needs in the field of cybersecurity; and contribute to the EU's  international 
cooperation in this field. The Act also establishes a European cybersecurity certification framework 
in order to increase the level of cybe rsecurity and enable a harmonized approach to cybersecurity 
certification within the EU, with a view to creating a single digital market for ICT products, services 
and processes.  WT/TPR/M/395/Add.1  
 
- 148 - 
 
  Question ： 
63. Please introduce the European cybersecurity certification frame work and the role of 
ENISA in it. Will the above certification framework constitute a barrier to entry of products 
outside Europe into the EU market?   
 
EU reply:  
EU Cybersecurity Act  
The Cybersecurity Act, which entered into force in June 2019, brings two  major changes: a 
comprehensive reform of the European Union Agency for Cybersecurity (ENISA) and the creation of 
the European cybersecurity certification framework.  
 
Reform of ENISA  
The Agency has been granted a permanent mandate as well as additional fin ancial and human 
resources. The major novelties of the new mandate concern the key role that ENISA will play in: 
promoting operational cooperation among Member States, assisting them in effectively responding 
and preventing cyber -attacks; supporting the im plementation of the NIS Directive; establishing and 
maintaining the European cybersecurity certification framework.  
 
European cybersecurity certification framework  
The EU cybersecurity certification framework entered into force on 26 June, 2019 and will al low for 
the establishment of tailor -made EU certification schemes for ICT products and services. This will 
enable users to know what are the cybersecurity features of the ICT products and services, with a 
particular benefit for the operators of essential s ervices that are in need of tested cybersecure 
solutions. On the other hand, companies that want to certify their products will be able to obtain 
certificates that are valid across the whole EU. As such, the new framework does not constitute a 
barrier to e ntry of products outside Europe into the EU market.  
 
The schemes will be prepared by ENISA in consultation with stakeholders and will be adopted by the 
European Commission. The use of the new European certification schemes will remain voluntary. 
Neverthele ss, the Cybersecurity Act provides for the Commission to regularly assess whether an 
adopted European scheme is to be made mandatory through relevant Union law. The first 
assessment will be carried out no later than 31 December 2023, and subsequent assessm ents shall 
be carried out at least every two years. As the new European schemes will be recognized across the 
entire EU, there will be a strong incentive for companies to certify products, processes and services 
at EU level.  
 
Experts groups will help with the drafting and implementation of the certification framework, namely 
the European Cybersecurity Certification Group, comprised of representatives from Member States 
and the Stakeholder Cybersecurity Certification Group (SCCG).  
 
Next steps  
ENISA is currently preparing two candidate schemes. The first one concerns the transition of the 
Senior Officials Group – Information Systems Security (SOG -IS) Mutual Recognition Agreement 
(MRA) into the European cybersecurity certification framework. The second scheme concerns 
cybersecurity certification of cloud services.  
 
A public call for experts to become a member of the Stakeholder Cybersecurity Certification Group 
was launched and closed on 17 September 2019. The first meeting of the group will be h eld following 
the termination of the selection procedure.  
 
As regards planning, the "Union Rolling Work Programme for European Cybersecurity Certification " 
is a forward -looking document that will identify strategic priorities for the European Cybersecurity 
Certification Framework, as well as indicate future requests to ENISA for the preparation of schemes. 
In particular, it will include a list of ICT product s, services and processes or categories thereof that 
may benefit from being included in the scope of a European Cybersecurity Certification Scheme.  
 
The Union Rolling Work Programme is currently under preparation and should be published in 
June 2020.  
 WT/TPR/M/395/Add.1  
 
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  Page 266 Table  A2.2 
 
Question ： 
64. Please elaborate on the progress of DS549 and the EU's plan for the next step.  
 
EU reply:  On 1 June 2018 the EU filed a request for consultation with China with regard to certain 
Chinese measures related to the transfer of t echnology. On 20 December 2018 the EU filed a revised 
consultation request covering additional Chinese measures which are alleged to violate commitments 
of China in its Protocol of Accession on performance requirements. Consultations took place in 
Geneva o n 19 and 20 February 2019. Since then the process of consultations has continued. The EU 
notes that in the meanwhile China has amended or repealed some of the measures that were covered 
by the request for consultation in DS549. The EU continues to monitor the situation in relation to 
China 's legislative reforms with a view to assessing the next steps in the case.  
 
PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 6 (Para 3.7)  
"To further improve the free flow of goods, the European Commission adopted the Regulation on 
Compliance and Enforcement.[Regulation (EU) 2019/1020, OJ L 169, 25.06.2019, p. 1. The 
regulation will be applied as of 16  July 2021, except articles 29, 30, 31, 32, 33 and 36, which will 
be applied as of 1 January 2021 .] The aim is to create a fairer internal market for goods through 
more cooperation among national market surveillance authorities. The new regulation will strengthen 
the enforcement of EU health, safety and environmental protection rules and the applicati on of 
harmonised EU legislation in order to keep non -compliant products from being placed on the 
market."  
 
Questions:  
65. 1. As stated in this paragraph, "To further improve the free flow of goods, the 
European Commission adopted the Regulation on Complian ce and Enforcement. The aim 
is to create a fairer internal market for goods through more cooperation among national 
market surveillance authorities. The new regulation will strengthen the enforcement of 
EU health, safety and environmental protection rules and the application of harmonised 
EU legislation in order to keep non -compliant products from being placed on the market." 
However, in practice, SMEs usually gain compliance information from trade documents 
provided by their partners, and are unable to pay  attention to relevant regulations or 
information on non -compliant products due to cost or capability issues. What solutions 
does the European Union have to address the non -compliant products of SMEs due to 
asymmetric information?  
 
EU reply:  This issue wil l be addressed through the new tool for providing information to economic 
operators laid down in Article 8 of Regulation 2019 (EU) 2019/1020 on market surveillance and 
compliance of products. Economic operators will have easy online access through the Your  Europe 
portal that will provide information about EU product requirements. This will be operational at the 
end of this year. In addition, there will be contact points at Member State level to which further 
questions on the implementation of product requir ements can be addressed.  
 
66. 2. Is there any plan to carry out relevant compliance training for enterprises 
(especially foreign invested enterprises in the EU) before the implementation of the 
Regulation?  
 
EU reply: The European Commission will provide guidance that will help enterpr ises and could be 
used by anyone that might offer training. Most of the Regulation concerns rules under which market 
surveillance and customs authorities of EU member States will operate. These rules will be further 
explained in an update of the Commission  Notice "The Blue Guide on the implementation of EU 
product rules 2016 " (OJ C 272, 26.7.2016, p. 1). There will also be separate guidelines explaining 
the practical implementation of Article 4 of the Regulation, which requires an economic operator in 
the EU as contact point for the market surveillance authorities for certain types of products. The aim 
is to publish these guidelines in 2020.  
 
67. 3. Which EU agency will be responsible for implementing this Regulation? Does the 
agency have any interest in exc hanging and cooperating with China market administration 
agencies?   WT/TPR/M/395/Add.1  
 
- 150 - 
 
  EU reply:  The market surveillance and customs authorities of EU member States will be responsible 
for the implementation of the Regulation.  
 
Several market surveillance authorities are already engaging with Chinese authorities. In addition, 
cooperation at EU level is possible through the European Commission. Indeed, the European 
Commission (DG Internal Market, Industry, Entrepreneurship and SMEs) and China (the State 
Administration for Market Regulation, SAMR) already have a good longstanding cooperation 
established  in the framework of the "Consultation Mechanism on industrial products and WTO/TBT ", 
i.e. the "EU-China Regulatory Dialogue ". The platform notably consists of the Working Group on 
Conformity Assessment (WG), which along its horizontal scope across many in dustrial sectors, 
focuses on bilateral cooperation in the fields of conformity assessment and market surveillance with 
a view to facilitating trade and reducing burdens on enterprises.  
 
Page 12 (Para 3.34)  
"3.34.  The EU recognises the role of SMEs in the E U economy with the "Small Business Act" for 
Europe (SBA), an overarching framework for guiding SME policy -making for EU Member States. 
Every year the European Commission prepares an annual SME Performance Review, which is used 
to monitor and assess countri es' progress in implementing the SBA recommendations. The last 
annual report for 2017/2018 provides a synopsis of the size, structure and importance of SMEs to 
the European economy and an overview of the past and forecasted performance of SMEs from 2018 
to 2019. Comparisons with partner countries outside the EU and with the large enterprise sector are 
also included."  
 
Question:  
68. 4. Could the EU elaborate on 2017 -18 performance assessment results ？  
 
EU reply: The latest issue of the "Annual Report on European SMEs 2018/2019 " (SME Performance 
Review) provides a snapshot on the size, structure and importance of SMEs to the European 
economy:  
https://ec.europa.eu/growth/smes/business -friendly -environment/performance -review_en . 
The Report also focuses on the research and development (R&D) and innovation activities of SMEs.  
 
Page 16 (Para 4.2), Page 17 (Para 4.6), and Page 24 (Para 5.3)  
 
Question:  
69. 5. The EU attributes the crisis faced by the WTO and current international trade 
tensions to "non -market" policies and practices, and believes that the WTO should update 
rules to address these issues. Could the EU share it s view on the impact of unilateral and 
protectionist measures on the international economic and trade environment and the 
multilateral trading system and how to address long -standing issues in the WTO such as 
the misuse of agricultural subsidies and trade remedies? Does the EU agree that the WTO 
reform should focus on addressing the above issues, first and foremost?  
 
EU reply: As regards the impact of unilateral and protectionist measures on the international 
economic and trade environment and the multilat eral trading system, the EU does not condone such 
measures if they are incompatible with WTO rules. WTO reform should first and foremost focus on 
strengthening rules that aim at levelling the playing field, such as rules on industrial subsidies. The 
EU is not opposed to discussing agricultural subsidies and trade remedies in the WTO context.  
 
Page 22 (Para 4.45)  
"In 2018, the EU launched the "Responsible Supply Chains in Asia" pilot project funded under the 
EU Partnership Instrument for three years and developed by the EU together with the ILO and OECD. 
The EU launched a similar project to promote CSR/RBC and Business and Human Rights in selected 
Latin America countries. The project started in early 2019 for 4 years."  
 
Question:  
70. 6. Please update the progress, actual results and future plans of "Responsible Supply 
Chains in Asia" pilot project.  
 
EU reply:  Through the Responsible Supply Chains in Asia, the EU 's implementing partners - the 
International Labour Organisation (ILO) and the Organisation for Economic Development and 
Cooperation (OECD) - have joined their efforts to promote responsible business practices in the six WT/TPR/M/395/Add.1  
 
- 151 - 
 
  partner countries. The project had p ositive impact on enhancing cooperation with all government 
ministries concerned as well as with business associations planning and building up the capacity of 
business to develop responsible practices.  
All information about the project progress is availa ble on the implementing partners ' websites. The 
EU is has not taken a decision yet on a possible follow -up to this project.  
 
Page 23 (Para 4.53.b)  
"EU Regulation on Screening of Foreign Direct Investment…. The EU screening framework does not 
replace or du plicate existing national mechanisms, and hence does not add red tape for investors. 
It is not targeted against investors from any particular country: non -discrimination is a key principle 
of the new Regulation and screening mechanisms of EU Member States will need to respect this 
principle." …  
 
Questions:  
71. 7. How does the principle of non -discrimination apply to the EU Regulation on 
Screening of Foreign Direct Investment? Will the implementation of the Regulation 
constitute discriminatory treatment agai nst free capital flows within the EU and the free 
capital flow between EU Member States and any third country?  
 
EU reply:  Article 3(2) of the Regulation stipulates that Member States that screen foreign direct 
investments - the Regulation does not oblige t he Member States to screen investments - shall carry 
out the screening on the basis of transparent and non -discriminatory rules and procedures. The 
implementation of the Regulation by the EU and its Member States should comply with the relevant 
requirement s for the imposition of restrictive measures on grounds of security and public order in 
the WTO agreements, including, in particular, Article XIV(a) and Article XIV bis of the GATS. It should 
also comply with Union law and be consistent with commitments ma de under other trade and 
investment agreements to which the Union or Member States are parties and trade and investment 
arrangements to which the Union or Member States are adherents.  
 
72. 8. Under this Regulation, do the EU and its Member States require the investors to 
assume an obligation to disclose investment plans and report the sources of investment? 
Do the EU Member States directly impose the obligation of disclosing information on 
investors? How do the EU and its Member States guarantee that such information 
disclosure does not leave foreign investors in a relatively disadvantaged position 
comparing with internal investors in the EU?  
 
EU reply:  The Regulation lays down a minimum set of rules which Member States that apply 
screening mechanisms are r equired to comply with. Where a Member State screens foreign direct 
investment, it shall set out the circumstances triggering the screening, the grounds for screening 
and the applicable detailed procedural rules.  
The information that will be exchanged und er the new cooperation mechanisms is further detailed 
in Article 9(2) of the Regulation. This comprises the ownership structure of the foreign investor and 
of the undertaking in which the FDI is planned or has been completed, the approximate value of the 
FDI, the products, services and business operations of the investor and the FDI, the Member States 
concerned, the funding of the investment and its source, and the date when the investment is 
planned to be completed or has been completed. The Commission and  the Member States are 
required to ensure the protection of confidential information acquired in application of the Regulation 
pursuant to Article 10.  
 
73. 9. According to the definition and classification of "direct investment" in Annex 1 of 
the Directive  (EU) 88/362, direct investment also includes bank loans over five years and 
corporate reinvestments. Could the EU explain whether the classification in the Directive 
is applied to the definition of "foreign direct investment" in Article 2 of the EU Regula tion 
on Screening of Foreign Direct Investment, i.e. whether the definition of foreign direct 
investment stipulated in the Regulation covers bank loans over five years and corporate 
reinvestments?  
 
EU reply:  Foreign direct investment is defined in Article  2, point (1). That definition, which is based 
on settled case -law of the Court of Justice (see para 80, Opinion 2/15), requires that the investment 
"aims to establish or to maintain lasting and direct links between the foreign investor and the 
entrepreneu r to whom or the undertaking to which that capital is made available in order to carry 
out an economic activity ". WT/TPR/M/395/Add.1  
 
- 152 - 
 
  A determination of whether an investment is aimed at establishing or maintaining the type of links 
mentioned in Article 2, point (1) can only be done on a case -by-case basis. To this end, 
Directive  88/361/EEC , indeed includes expressly within the scope of the notion of "direct 
investments " long term loans with a view to establishing and maintaining lasting economic links (see 
Annex I to Co uncil Directive 88/361/EEC ).  
 
74. 10. Article 4 of the EU Regulation on Screening of Foreign Direct Investment 
authorizes that "The Member States and the Commission may also take into account, in 
particular, whether the foreign investor is directly or ind irectly controlled by the 
government, including state bodies or armed forces, of a third country, including through 
ownership structure or significant funding." Could the EU explain whether "directly or 
indirectly controlled" covers government subsidies, e nterprises research and 
development funding, and funding for encouraging innovation and green technology in 
line with the WTO rules and regulations?  
 
EU reply:  Each case will have to be examined on its own merits, taking into account the totality of 
the c ircumstances. Therefore, depending on such case -by - case analysis, the above quoted 
examples may be described as relevant factors to determine whether a foreign investor is 'directly 
or indirectly controlled by the government '. 
 
75. 11. Paragraph 10, Arti cle 7 of the EU Regulation on Screening of Foreign Direct 
Investment provides that, "This Article shall not apply to foreign direct investments 
completed before 10 April 2019." How could any investment be identified as "completed"? 
Including any investment  whose equity delivery agreement has been duly signed by and 
between the investor and the invested entity and approved by the government of the 
corresponding EU Member State but whose fulfilment is incomplete within the delivery 
period due to any reason be yond the investor's control?  
 
EU reply:  The Regulation does not define the term "completed ". Analysis on the date when a foreign 
direct investment is planned to be completed or has been completed will have to be done on a 
case-by-case basis and take into c onsideration domestic law, specific features of an investment, its 
type and schedule of execution, etc.  
 
Page 23 (Para 4.53.d)  
"Following the European Council conclusions of March 2019, the EU resumed discussions on the 
International Procurement Instrument  (IPI) and the legislative process is ongoing. IPI aims at 
improving access of EU economic operators to public procurement and concessions markets in third 
countries."  
 
Questions:  
76. 12.  Could the EU explain the legislative process and how this legislatio n will improve 
access of EU economic operators to public procurement and concessions markets in third 
countries?  
 
EU reply: The IPI Commission proposal is currently discussed by the co -legislators, the Council and 
the European Parliament: they review the proposal by the Commission and propose amendments. 
Eventually, if the two institutions agree on amendments, the proposed legislation can be adopted.  
 
If the Council and the Parliament cannot agree upon amendments, a second reading takes place. I n 
the second reading, the Parliament and Council can again propose amendments. Parliament has the 
power to block the proposed legislation, if it cannot agree with the Council. If the two institutions 
agree on amendments, the proposed legislation can be ado pted. If they cannot agree, a conciliation 
committee tries to find a solution. Both the Council and the Parliament can block the legislative 
proposal at this final reading.  
 
The International Procurement Instrument is a tool aiming at providing opportuniti es for EU 
companies in procurement markets of third countries through negotiations with such third countries.  
Once adopted, IPI would provide for the possibility to initiate investigations on discriminatory 
measures and practices existing in a third countr y. Such an investigation could be followed by 
consultations with the authorities of the third country with the objective of removing the identified 
barriers. Should the consultations not be conducive to the removal of the barrier(s) investigated, 
the IPI p roposal foresees the possibility of adopting an IPI implementing decision.  WT/TPR/M/395/Add.1  
 
- 153 - 
 
  13. Does the EU seek opinions from stakeholders during the legislative process, especially 
from stakeholders in third counties? If yes, please inform the results of public opinions .  
 
EU reply: Before the Commission proposes new legislative initiatives the Commission consults 
interested parties such as non -governmental organisations, local authorities and representatives of 
industry and civil society. In this preliminary phase, citi zens, businesses and organisations can 
participate in the consultation procedure via a dedicated website on public consultations. In this way, 
the Commission ensures that legislative proposals correspond to the needs of those most concerned 
and avoids unne cessary red tape. For past public consultation on IPI, please visit:  
https://ec.europa.eu/growth/content/consultation -access -third-countries -eu%E2%80%99s -public -
procurement -market_en.  
 
PART III: OTHER QUESTIONS  
 
Questions:  
77. 1. How will the EU maintain and expand trade relations with China after Brexit? 
Particularly for the allocation of tariff quotas of some important products between the EU 
and the UK, how will the EU ensure China's export interests to the EU not to be injured?  
 
EU reply:  The EU and UK through their "joint approach " intend to apportion the EU 's WTO bound 
tariff rate quotas (TRQs) based on observed trade flows into the EU27 and the UK in a representative 
period, so that the existing level of market access available to other WTO Members would be 
maintained. The negotiations under the GATT Article XXVIII procedure are confidential and are 
currently ongoing with the WTO Members whose rights the EU recognised. Any agreements will be 
notified in accordance with the applicable rule s. 
 
78. 2. In accordance with relevant WTO rules, members should submit their 2017 -2018 
subsidy notifications at the central and sub -central governmental levels by 30 June  2019. 
According to the information published on the WTO's website, the EU has not ye t 
submitted subsidy notifications for all member states, and EU -level subsidy notifications 
were submitted on 2 July 2019. China would like to know at what time that the EU intends 
to submit subsidy notifications of all member states. Meanwhile, what kind of 
improvements does the EU intend to make in order to increase the transparency of its 
subsidy notifications?  
 
EU reply:  The EU and Member States have already submitted their subsidy notifications to the WTO 
in respect of 2017 and 2018. These were submitt ed on 2 July 2019, one day after the deadline 
(given it fell on a weekend). The majority of these have already been circulated by the WTO. The 
remaining notifications which were reviewed by the WTO Secretariat will be circulated shortly.  
The EU would like  to thank China for pointing out the need for timely and complete subsidy 
notifications. The EU has always attached great importance to filing subsidy notifications in a 
complete and timely manner, as the record will show. In the context of the ASCM Commit tee 
meeting, the EU has continually called on other WTO Members, who have ignored their notification 
obligations consistently, to improve their record.  
 
79. 3. On 5 July 2018, the European Commission promulgated Regulation (EU) 2018/960, 
amending the resi due limits for lambda -cyhalothrin in certain products, and the limit on 
tea was revised from the previous lmg/kg to 0.01mg/kg (quantitative limit of analytical 
method). This Regulation enters into force on 26th January 2019. This amendment is not 
based on risk assessment results or continuing to implement the risk concerns caused by 
the original limit standards, but only because there is no relevant data available. Could 
the EU explain the relationship between this Regulation and the Article 5 of the SPS 
Agreement, and assess whether the implementation of the original residue limit standard 
(lmg/kg) exposes customers to health risks? If there is no risk, EU should continue to 
implement the original limit standard. If EU implements new limit standards, we 
recommend EU consider the tea planting and tea production period, and provide a 
transition period of at least one year for Chinese tea producers.  
 
EU reply: The European Union amended its legislation on maximum residue levels for lambda -
cyhalothrin in 2018. A  deferred application date of 6 months after entry into force was set to allow 
food business operators and third countries to adapt to the new provisions. The Regulation therefore 
only entered into force on 26 January 2019.  WT/TPR/M/395/Add.1  
 
- 154 - 
 
  The amendments to the maximum re sidue levels (MRLs) of lambda -cyhalothrin are based on two 
EFSA risk assessments for the review of the MRLs of lambda -cyhalothrin, published by the European 
Food Safety Authority (EFSA) on its website on 2 December 201521 and 26 July 201722, respectively.  
EFSA performed risk assessments for the MRLs of the products on which trials and information were 
submitted by the EU Member States, by non -EU countries or by any other stakeholders at the time 
of the finalization of the document. Availabl e Codex maximum residue levels (CXLs) were also 
assessed.  
In case of products for which no information was available to EFSA, the EU sets the MRLs at the limit 
of determination (LOD), the lowest limit, where analytical results can be quantified, which for  
lambda -cyhalothrin is 0.01* mg/kg. This was the case for herbal infusions for which no data were 
provided. For tea, the submitted data were insufficient to derive an MRL.  
European Union invites China to request import tolerances and to submit information  to revise the 
MRLs, if deemed appropriate.  
 
80. 4. On 18 January 2016, the European Commission promulgated the Regulation (EU) 
2016/156, providing that folpet residue is defined as the sum of folpet and phthalimide, 
expressed as folpet. On 17th April 2018 , the EFSA sought public opinions on folpet 
definition on its website, and was planning to change the definition of folpet residue based 
on the opinions. Up to the present, the European Commission has not changed the 
definition of folpet pesticide residue,  which still refers to the sum of folpet and 
phthalimide, expressed as folpet. Could the EU inform the time when the definition of 
folpet residue is changed?  
 
EU reply:  The approval of the fungicide folpet expires on 31 July 2020. The EU residue definitio n of 
the fungicide folpet (Sum of folpet and phthalimide, expressed as folpet equivalents) is currently 
under consideration as part of the on -going renewal procedure of the approval of this active 
substance. An important element of this process is the risk  assessment carried out by Member States 
of the European Union and the peer review carried out by the European Food Safety Authority. These 
procedures are still on -going. The EU assures China that it would report on any developments in due 
course.  
 
81. 5. Could the EU provide information on the sources of funds, forms and standards of 
collection for its special civil aviation fund, as well as the scope of support and subsidies 
of the special civil aviation fund? Could the EU provide information on its curre nt subsidy 
policies, forms and standards as well as the amount of subsidies in recent years for 
airlines and airports? Are there variations in the above aspects in different EU member 
States? If yes, please give a brief introduction.   
 
EU reply:   
On 7 December 2015, the Commission adopted an Aviation Strategy, in order to shape a 
comprehensive strategy for the whole EU aviation ecosystem. One of the goals of the strategy is to 
generate growth and let passengers reap the benefits from competition ac ross the whole air 
transport value chain.  
For more detailed information please refer to our website:  
http://ec.europa.eu/competition/sectors/transport/legislation_air_state_aid.html  
Information on the amounts of State aid approved by the Commission and implemented by EU 
Member States is publicly available on the dedicated web -page of the Direction General for 
Competition:  
http://ec.europa.eu/competition/state_aid/scoreboard/index_en.html.  
Information on individual State aid decisions adopted by the Com mission can be found under the 
following link: https://ec.europa.eu/competition/elojade/isef/.  
 
82. 6. Do the EU and its Member States impose access restrictions on foreign investment 
in such civil aviation transport services as public transport aviation,  general aviation, civil 
airports, air traffic control, aircraft maintenance, aviation ground services, passenger and 
freight transport agencies, aviation fuel, and online reservation systems? Please provide 
 
21 European Food Safety Authority, 201 5. Reasoned opinion on the revision of the review of the existing 
maximum residues levels for lambda -cyhalothrin. EFSA Journal 2015;13(12):4324. 
http://www.efsa.europa.eu/en/efsajournal/pub/ 4324 
22 European Food Safety Authority, 2017. Focussed review of the existing maximum residue levels for 
lambda -cyhalothrin in light of the unspecific residue definition and the existing good agricultural practices for the 
substance gamma -cyhalothrin. EFSA Journal  2017;15(7):4930.  WT/TPR/M/395/Add.1  
 
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  information on the legal basis for industry mana gement and foreign investment access 
management in the above fields. Are there any access restrictions and corresponding laws 
in other civil aviation sectors other than the above?  
 
EU reply: As regards legislation governing the provision of services in th e sectors mentioned, there 
exist in the EU no restrictions on foreign investment other than the following:  
Regulation 1008/2008 on common rules for the operation of air services in the Community provides 
that, in order for an undertaking to obtain an oper ating license from an EU Member State, it must 
comply inter alia with the condition that "Member States and/or nationals of Member States own 
more than 50% of the undertaking and effectively control it, whether directly or indirectly through 
one or more in termediate undertakings, except as provided for in an agreement with a third country 
to which the Community is a party". For the purposes of this Regulation, "operating licence " means 
an authorisation granted by the competent licensing authority to an unde rtaking, permitting it to 
provide air services as stated in the operating licence.  
As for ground -handling services, Directive 96/67/EC allows member States to restrict the number of 
service providers in certain airports and for certain services, and to li mit market access for foreign 
service providers on the basis of reciprocity.  
Access to the investment market for the remaining services is not regulated at EU level and some 
Member States may impose restrictions on foreign investors.  
 
83. 7. Could the EU  elaborate on the support from government departments on negotiating 
multilateral rules and commitments to promote global e -commerce and facilitate the 
development of enterprises, especially SMEs?  
 
EU reply:  The EU has always been supportive of multilatera l rules and commitments to promote 
global e -commerce. Such rules are key to ensure that businesses, and in particular SMEs, can take 
part in and benefit from global trade. The EU considers that, at present, the best way to achieve this 
is the successful co nclusion of WTO negotiations in the context of the e -commerce joint statement 
initiative.  
 
84. 8. Although the EU constantly strengthens its legislation in personal data protection 
in recent years, especially many GDPR rules stipulated in some regulations are not clear 
in the statement, and the Member States follow different standards in implementa tion. 
China would like to see that the EU and its Member States further improve their rules, 
impose same standards, and guarantee fair, transparent, and non -discriminatory GDPR 
enforcement.  
 
EU reply:  The EU rules on personal data protection are clearly d efined in the General Data Protection 
Regulation (GDPR). As its name suggests, the GDPR provides for a general data protection 
framework, based on clear and common principles, which are evenly applied across EU Member 
States and across sectors. In this reg ard, the fact that the GDPR is a Regulation implies that it is 
directly implemented in the same manner in all EU Member States which only retain very limited 
margins to adapt the text to their national specificities. The GDPR is implemented in a fair, 
predictable, transparent, and non -discriminatory manner.  
The EU has made a lot of efforts to explain this regulation to all stakeholders. To name a few concrete 
initiatives: the Commission has created a use -friendly website where practical information can be 
found based on concrete examples (see: https://ec.europa.eu/info/law/law -topic/data -
protection_en ), and it has organized consultations and conferences to review the one year 
implementation of the GDPR (see for example: 
https://ec.europa.eu/commission/presscorner/detail/en/IP_19_2956 ). Also, the European Data 
Protection Board (EDPB ) is regularly publishing opinions, guidelines, recommendations, best 
practices, etc. to provide guidance to stakeholders (see: https://edpb.europa.eu/our -work-
tools/general -guidance _en, https://edpb.europa.eu/our -work-tools/consistency -
findings/opinions_en ). In fact, more than 20 sets of guidelines have been adopted by the EDPB on 
all key aspects of the GDPR, each time following public consultation in which not  only EU but also 
many non -EU stakeholders participated.  
In addition, the EDPB is not only issuing guidelines on the interpretation of core concepts of the 
GDPR, but is also compet ent to rule by binding decisions on disputes regarding cross -border 
processing activities, ensuring therefore a uniform application of EU rules to avoid the same case 
potentially being dealt with differently across various jurisdictions. The consistency in  interpretation 
and application of EU data protection rules is also ensured as regard investigations/the treatment of 
individual cases through the one stop shop, cooperation and consistency mechanisms ensuring that WT/TPR/M/395/Add.1  
 
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  several hundreds of cross -border cases ha ve been dealt through those mechanisms (e.g.: by 
31/12/2020, 142 procedures under the one -stop-shop mechanism had been triggered, leading to 
79 final decisions). These new features of the GDPR benefit in particular non -EU companies operating 
in the EU  as they involve a significant reduction of compliance costs compared to the earlier, 
fragmented situation where companies had to deal with 28 national data protection laws.  
As an EU regulation, the GDPR is directly applicable in all EU Member States and can be  directly 
invoked by individuals. Aside from a few limited areas (mainly for data processing by public 
authorities, e.g. in the area of social security) where Member States may further specify the 
application of the data protection rules within the framewo rk set by the GDPR – which however do 
not concern the core principles, rights and obligations – implementing national laws are neither 
required nor allowed.  
The EU therefore maintain that the GDPR actually represents, in the international arena, an example 
of a transparent and inclusive process in adopting and applying data protection rules.  
 
CHINA  - FOLLOW -UP QUESTIO NS 
PART I: QUESTIONS REGARDING THE SECRETA RIAT REPORT  
 
Page 9 (Para. 2)  
"While discussions on an EU digital services tax regime were suspended, several EU member States 
introduced such a tax at the national level".  
 
Question:  
1. Could the EU  further provide more details about the  digital services tax regime , such as 
which member States introduced such a tax at the national level and what is the digital 
services tax regime comprised of?  
 
EU reply:  
The Report refers to the Member States that b elieve that an interim solution could be put in place 
at national level to ensure fair taxation of the digital economy in the short term, pending an 
agreement at the OECD. These measures are to be withdrawn once the agreement for a global 
solution is achie ved. These national measures take into account the design considerations set out in 
the OECD's interim report on the tax challenges arising from digitalisation, as the European 
Commission legislative proposal on a Digital Services Tax does.  
According to t he EU proposal for a Digital service tax COM(2018) 148 final, the following services 
can result in taxable revenues: (a) the placing on a digital interface of advertising targeted at users 
of that interface; (b) the making available to users of a multi -sided digital interface which allows 
users to find other users and to interact with them, and which may also facilitate the provision of 
underlying supplies of goods or services directly between users; (c) the transmission of data 
collected about users and ge nerated from users' activities on digital interfaces.  
The EU proposal model of taxation targets the revenues stemming from the supply of digital services 
where users contribute significantly to the process of value creation. The expected effects of the 
application of the tax are published in the Impact assessment accompanying the proposal SWD  
(2018).81final/2. https://ec.europa.eu/taxation_customs/sites/taxation/files/  
fair_taxation_digital_economy_ia_21032018.pdf . 
 
Page 10 (Para.13)  
"The EU 's Union Customs Code (UCC) for customs procedures at the border was implemented in 
2016, although the application of several elements remain ongoing pending the full functioning of 
several electronic systems, some of which have faced delays. The EU's single window  initiative 
continues to be gradually implemented. New provisions for low -value consignments are expected to 
be introduced in 2021."  
 
Question:  
2. Could the EU elaborate on the new provisions? For example, who are the targets and 
how the duty can be effect ively collected ? 
 
EU reply:  
As from the date of the entry into force of the new VAT e -commerce package and due to the abolition 
of the EUR  10/22 import VAT de minimis  threshold, all goods imported into the EU, irrespectively of 
their value, will be subject  to VAT payment. In order to ensure the correct collection of VAT, all WT/TPR/M/395/Add.1  
 
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  goods will need to be covered by an electronic customs declaration. Nevertheless, the EUR  150 
import customs duties de minimis  threshold is maintained.  
To alleviate the obligations entailing the abolition of the exemption threshold, the newly adopted 
legislation introduces two simplifications for all imports of goods supplied to consumers in the EU in 
consignments of an intrinsic value not exceeding EUR  150.  
The first simplification is the creation of an import one -stop shop system whereby the supplier (in a 
third country) can fulfil all the VAT obligations (reporting and payment) in one Member State through 
an intermediary appointed for this purpose. The n goods can be imported free of VAT and the VAT 
paid by the customer to the supplier at the time of sale is declared and paid on a monthly basis by 
this intermediary.  
A second simplification is foreseen specifically for postal operators, express carriers and customs 
agents, when the IOSS is not used. Under that scheme, called the special arrangements, VAT due 
on import is collected from the customer upon delivery and the postal operator, express carrier or 
customs agent pays the amount of VAT collected in the course of a given month by the 20th day of 
the following month to the customs authorities.  
In order to provide a fair balance between ensuring customs controls and facilitating legitimate trade 
whilst implementing the customs aspects of the VAT E -commerce package, a new customs 
declaration with a 'super reduced dataset (SRDS)' was created, conta ining three times less data 
elements than the standard customs declaration. This customs declaration will be available for any 
declarant and for any goods that benefit from a customs duty relief in accordance with Article 23(1) 
or 25(1) of Council Regulati on 1186/2009 and which are not subject to prohibitions and restrictions.  
 
Page 11  (Para.17)  
"There were several important legislative developments with respect to the Eu's value -added tax 
(VAT) regime. For example, one set of amendments to the VAT Directi ve of 2006, which aims to 
simplify VAT for e -commerce transactions, entails the removal of the VAT threshold of EUR 22, which 
means that all commercial goods entering the EU will be subject to VAT from 1st January 2021. The 
amendments also introduce two al ternative VAT collection mechanisms".  
 
Question s: 
3. Could the EU elaborate on the important legislative developments with respect to the 
Eu's VAT regime?  
EU reply:  
Please see reply to question two above.  
 
4. Could the EU elaborate on amendments to the VAT Directive of 2006 including but not 
limited to the amendments to VAT for e -commerce transactions?  
 
EU reply:  
Please see reply to question two above for e -commerce. For other VAT developments, please refer 
to paragraphs 3.153. to 3.158. (pages 104 -106).  
 
5. Could the EU elaborate on the major considerations regarding the removal of the VAT 
threshold of EUR 22 in the VAT Directive of 2006 and on the two alternative VAT collection 
mechanisms?  
 
EU reply:  
The removal of the of the VAT threshold was to bring the level playing field to EU business that are 
obliged to apply VAT on their sales irrespective of their value. In addition, it will ensure the taxation 
of goods at the place of destination which is the international principle applicable in the field of V AT. 
 
6. Could the EU elaborate on VAT for e -commerce transactions (including scope of 
taxation, applicable tax rate, tax declaration, tax payment, and related operational 
procedures)?  
 
EU reply:  
Scope of taxation – all import of goods into the EU without a ny exemption depending on their value. 
The VAT rate is the one applicable in the Member State of the final destination of the goods in the 
EU (where such goods are dispatched/transported). Table 3.17 "VAT in the EU -28" provides the 
situation of the VAT rat es in 2019. EU Member States may update the level of the VAT rates 
depending on their national policies.  
 WT/TPR/M/395/Add.1  
 
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  7. Could the EU elaborate on the Eu's VAT policy for agricultural products, including 
applicable tax rate and tax incentives? In cases where certain a gricultural products are 
subject to the tax -free policy, how would the downstream taxpayers who purchase the 
tax-free agricultural products to claim an input tax credit?  
 
EU reply:  
Member States may apply a reduced rate not lower than 5% to the supply of goods and services of 
a kind normally intended for use in agricultural production but excluding capital goods such as 
machinery or buildings. Specific derogations allow a few Member States to apply a VAT rate lower 
than 5% (the so -called super re duced rate) to such goods and services.  
Apart from that, Member States may put in place a scheme whereby farmers who are allowed not 
to charge VAT on the sale of products will be compensated for the burden of input VAT.  
 
Page 12 (Para.25)  
"In the area of c ompetition policy, the main legislative development during the review period was 
the adoption of a directive that strengthens the competences of national competition authorities in 
the enforcement of EU competition law. The Commission commenced the review of the Vertical Block 
Exemption Regulation, which will expire in May 2022. In relation to anti -competitive agreements 
and abuse of dominant position, the Commission adopted several decisions concerning large firms 
in the digital services market, and took a ction to ensure competition in gas supply markets. It also 
adopted several important decisions in merger cases."  
 
Questions:  
8. What are the highlights of the series of changes to the Eu's competition policy?  
 
EU reply:  
The importance of promoting a level  playing field and continuing to ensure fair competition means 
that the EU competition framework continues to adapt to new technological and global market 
developments. In April 2019, the Commission published the Report "Competition policy for the digital 
era", by three Special Advisers, designed to provide input to the Commission's ongoing reflection 
process about how competition policy can best serve European consumers in a digital, fast -changing 
world. Moreover, in 2019, the Commission started a broad re view exercise, covering the antitrust 
regulations that will expire in the course of the next Commission mandate, as well as a number of 
State aid rules and guidance, and continued the ongoing evaluation of merger control.  
For more detailed information: htt ps://ec.europa.eu/competition/publications/annual_report/.  
 
Page 13 (Para.28)  
"as part of the broader revised EU -28 Schedule certification exercise, the EU submitted the changes 
to its WTO commitments to revise its export subsidy commitment levels pursuant  to the Nairobi 
Ministerial Conference Decision".  
 
Question:  
9. Could the EU offer further description on the Eu's export subsidy commitment levels 
prior to and after the changes ? What impact will such changes have on exporters and the 
national export at large?  
 
EU reply:  
The previous EU export subsidy commitments can be consulted in the document WT/Let/1220, Part 
IV, Section II. The EU submitted in September 2017 a draft EU -28 schedule that includes the 
elimination of all export subsidy commitme nts, as provided for in the Nairobi Ministerial decision. In 
practice, the EU has not granted any export subsidies since July 2013 and has already set all export 
subsidy amounts in internal legislation to zero. Therefore, the elimination of commitments in the EU 
schedule would not have any impact in practice on EU exporters.  
 
Page 13 (Para.31)  
"In September 2017, the EU formulated a renewed Industrial Policy Strategy. The Strategy proposed 
measures relating to: cybersecurity; the free flow of non -personal d ata; a EU framework for the 
screening of FDI; the secure, sustainable and affordable supply of critical raw materials; and the 
exploitation of key enabling technologies. Many of the measures envisaged in this Strategy were 
adopted in 2018 -19. In March 2019 , the European Council invited the Commission to present, by 
the end of 2019, a long term -vision for the Eu's industrial future."  
 WT/TPR/M/395/Add.1  
 
- 159 - 
 
  Question:  
10. Could the EU elaborate on its industrial policy and clarify how policies can prevent 
market distortion?  
 
EU reply:  
The EU industrial policy aims at creating favourable business environment conditions for a 
competitive and sustainable EU industry in line with the principles of the Treaty on the functioning 
of the EU, including avoiding distortion of competition i n the EU Single Market. Fair competition in 
the EU Single Market is a major driver of companies' competitiveness, because it requires companies 
to innovate and invest. This allows to establish an efficient, competitive and innovative EU industry.  
 
Page 14  (Para.34)  
"During the review period, the EU adopted legislative measures under the first pillar of the Digital 
Single Market (DSM) Strategy launched in 2015 that address different types of barriers to the growth 
of cross -border e -commerce. These measures deal with: cross -border portability of online content 
subscriptions; cooperation between national consumer protection agencies; VAT aspects of 
e-commerce…"  
 
Question:  
11. Could the EU offer further description on specific legislative measures in regards to 
VAT for e -commerce transactions and their effectiveness?  
 
EU reply:  
See replies to questions above, in particular question 2. The rules will enter into force on 
1 January  2021, hence no assessment yet of their effectiveness. Based on the impact assessment 
carried out for the proposal of the rules, they are expected to bring up to 7 billion EUR additional 
revenues per year.  
 
Page 41  (Para. 2.28) and Page 264 (Table A2.2)  
… The EU was a complainant (EU v. US, China, India, Turkey) in five new dispu te settlement cases 
and a respondent (US v. EU) in one new case…  
 
Question:   
12. As for the case concerning certain measures on compulsory technology transfer 
launched by the EU on 1 June 2018 against China under the WTO dispute settlement 
mechanism, could  the EU offer examples.  
 
EU reply:  
The EU filed a consultation request against China on Certain measures concerning the transfer of 
technology on 1 June 2018 and a revised consultation request on 20 December 2018. The latter is 
available on the WTO website and outlines in detail the EU's claims, including through references to 
specific measures by China.  
 
Page  43（Para.  2.40） 
"The United States and the EU adopted a Joint Statement in July 2018, in which they agreed to work 
towards elimination of tarif fs, non -tariff barriers, and subsidies on non -auto industrial goods, and 
towards the reduction of barriers to trade in services, chemicals, pharmaceuticals, medical products 
and soybeans. " 
 
Question s:  
13. What kind of subsidies on non -auto industrial prod ucts will be eliminated? Please 
provide some examples. Are these subsidies complying with the WTO rules?  
 
14. Any progress has been made in respect to the elimination of subsidies on non -auto 
industrial goods ? If any, please provide details.  
 
EU reply to questions 13 and 14:  
The EU and the US have not yet started discussing what types of subsidies will be eliminated in the 
context of a bilateral agreement. However, the issue of illegal subsidies is currently being discussed 
by the EU, the US a nd Japan in the context of the Trilateral process.  
 WT/TPR/M/395/Add.1  
 
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  Page 48 （Para.2.63 ） 
"In addition, the Regulation defines the factors that may be taken into consideration by member 
States (or the Commission) in determining whether FDI is likely to affect security or pub lic order."  
 
Questions ： 
15. How to make sure that the Regulation on Framework for Screening Foreign Direct 
Investment in the EU  is not inconsistent with the principle of free establishment and free 
movement of capital upheld by TFEU?  
 
EU reply:  
The Member States are bound by the rules of the Treaty on the Functioning of the European Union, 
including when they apply the Regulation. The Commission will oversee the application of the 
Regulation under the control of the European Court of Justice, in line  with its role as a guardian of 
the EU Treaty set out in Article 17(1) of the Treaty on the European Union.  
 
16. How many notifications of investment project screening from the member States have 
been received by the EU since the implementation of the Regu lation in April  2019? How 
many comments have been made by the EU on such screening? Which countries are the 
major sources of investment projects notified by the member States? Are there any 
investment projects that the EU recommends its member States not t o approve? Could 
the EU disclose the source countries of the investment projects?  
 
EU reply:  
As explained in paragraph 4.53 in the EU Government's report, the Regulation entered into force on 
10 April 2019. However, it will only become fully applicable as  of 11 October 2020. This implies that 
so far, Member States have not notified any investments to the Commission. Member States will 
start doing so after 11 October 2020. It is also noted that the individual notifications as well as any 
potential comments by Member States or an opinion by the Commission are confidential and will be 
protected from disclosure according to applicable rules.  
 
Page  49 (Para.  2.62 and 2.64)  
The Regulation on Framework for Screening Foreign Direct Investment in the EU  entered into force 
in April 2019, and will be implemented on 11th October 2020, which requires member States to take 
account of whether the foreign direct investor is directly or indirectly controlled by the government 
of a third country with respect to t he FDI screening. The principle of non -discrimination is also 
provided.  
 
Question:  
17. On the one hand, the regulation requires the European Commission and member 
States to take account of whether the foreign investor  is directly or indirectly controlled 
by the government of a third country and encourage them to take into consideration the 
state -led FDI projects . On the other  hand , it requires member States to follow  the 
non-discrimination principle. Does this mean that it is an unfair treatment to foreign 
investors directly or indirectly controlled by the government of a third country? What are 
the differences in FDI screening procedures, investment areas, and submission of 
materials  between such foreign investors and private investor s? Will this increase t he cost 
or uncertainty  on such foreign direct investors? In this regard , will the EU  plan to solve 
such problems?  
 
EU reply:  
It should be recalled that the Regulation applies to all foreign investments, irrespective of whether 
a foreign investor is a stat e-owned or a private enterprise. The Regulation is therefore fully in line 
with the principle of non -discrimination. The question whether a foreign investor is directly or 
indirectly controlled by the government is however an important element for the asse ssment of a 
potential effect of FDI on security or public order of the Union or the EU Member States. By way of 
example, the links to a foreign government may increase the risk of espionage, notably if the foreign 
investor would receive access to sensitive  information, or sabotage of critical infrastructure. 
Therefore, whereas the screening procedure as such is the same for each and every foreign direct 
investment, the fact that an enterprise is indirectly or directly controlled by a government is a factor 
that may be taken into  consideration pursuant to Article 4 of the Regulation. The EU screening 
framework does not replace or duplicate existing national mechanisms, foreign investors continue WT/TPR/M/395/Add.1  
 
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  to be subject to the national screening mechanism, if there is one, and oversight by the Member 
State s' competent authorities. Hence, it does not add red tape for investors.  
 
Page 69 （Para.  3.55） 
"During the review period, there were a number of legislative developments with respect to VAT, 
and the EU put forth many proposals to amend different VAT provisions. One of the more recent 
changes was described as four quick fixes, pending a more substantial overhaul of the VAT  Directive. 
Scheduled to enter into force in 2020, these amendments allow for a simplified and uniform 
treatment for call -off stock arrangements; require the VAT identification number of the customer to 
be communicated to the supplier in order for the supplier to apply the VAT exemption for intra -EU 
supply of goods; introduce rules to facilitate trader proof that the intra -EU transport  (a condition for 
the exemption for intra -EU supplies of goods to apply) has taken place; and provide uniform criteria 
to assign the transport to a concrete supply in the case of chain transactions involving a single intra -
EU transport. Another set of rule s, amending the main VAT Directive, are set to enter into force in 
2021, and aim to simplify VAT for e -commerce transactions."  
 
Question s: 
18. What are the reasons for the cancellation of VAT exemption in the EU?  
 
EU reply:  
Please see reply to question 5 above.  
 
19. Is there any other measure for e -commerce transactions in the future?  
 
EU reply:  
On 18 February 2020, the Council adopted a legislative package23 to request payment service 
providers to transmit information on the beneficiary ("the p ayee") of cross -border payments 
originating from Member States. Under this proposal, payment service providers providing payment 
services in the EU will have to monitor the payees of cross -border payments and transmit to Member 
States information on those who receive more than 25 cross -border payments per quarter. This 
information will then be centralised in a central European database where it will be processed and 
made available to Member States' anti -fraud experts.  
 
The new rules will provide tax author ities with a powerful tool to improve the fight against VAT fraud 
in e-commerce. They will enter into force on January 2024.  
 
Page 79 (Para.3.76)  
"The EU has emphasized the importance of WTO trade remedy rules as a legitimate tool to combat 
trade distortio ns and unfair trade practices by others"(section 3.76); and "this allows for the normal 
value to be determined by another method where there are state -induced distortions in the exporting 
country"  
 
Question s: 
20. The targets of anti -dumping investigation i n the WTO Anti-Dumping Agreement  are 
the enterprises that may have carried out unfair trade practice of dumping. But the EU 
has taken anti -dumping as a tool not only to offset unfair trade, but to balance the so -
called "market distortion", which has gone beyond the scope of functions for  anti-
dumping specified in the Anti-Dumping Agreement .The Eu's act of expanding the scope of 
the targets of anti -dumping investigation to include the governments of exporting 
countries and their macro policies in addition to enterprises  contradicts with th e principle 
set forth in Article 6.1 of the GATT that stipulates anti -dumping applies to the practices of 
dumping products of one country to another. Please clarify  the consistency between the 
legislation and its purpose  and the WTO  rules .  
 
21. Three exce ptions are specified in Article 2.2 of the Anti-Dumping Agreement  as to 
deviating from the general method of determining the normal value: (1) there are no sales 
of the like product in the ordinary course of trade in the domestic market of the exporting 
 
23 Council Directive (EU) 2020/284 of 18 February 2020 amending Directive 2006/112/EC as regards 
introducing certain requirements for payment service providers (OJ L 62, 2.3.2020, p. 7).  
Council Regulation (EU) 2020/283 of 18 February 2020  amending Regulation (EU) No. 904/2010 as 
regards measures to strengthen administrative cooperation in order to combat VAT fraud (OJ L 62, 2.3.2020, 
p. 1).  WT/TPR/M/395/Add.1  
 
- 162 - 
 
  country; (2) such sales do not permit a proper comparison because of the particular 
market situation; (3) and such sales do not permit a proper comparison because of the 
low volume of the sales in the domestic market of the exporting country. The WTO 
Appella te Body has made further confirmation in this regard in the DS219. Please explain 
the consistency between the "market distortion" and the three exceptions and confirm 
which one of the three exceptions it belongs to?  
 
EU reply to questions 20, 21, 23 and 27 :  
The purpose of the current Trade Policy Review is not for the EU to offer interpretations or views 
regarding the meaning of the provisions of the 1994 Anti -Dumping Agreement. In any event, the EU 
is of the view that the EU's Anti -dumping legislation is in conformity with the Agreement on 
implementation of Article VI of the General Agreement on Tariffs and Trade 1994.  
 
22. In light of the Eu's legislation, data of representative countries or international market 
data will be selected as the data to determine the normal value if there is market 
distortion. How does the EU select the data? Is it from the official data of a rep resentative 
country or the data of specific enterprises in the country? How does the EU select the data 
if the country has different types of data? Does the EU replace all the elements of cost, or 
just partial elements of cost or selling and administrative  expense that are distorted?  
 
EU reply:  
The EU only replaces those costs which are distorted. Where distortions are found, normal value 
shall be constructed using undistorted prices and benchmarks for each distorted production factor, 
and for SGA and profit, on the basis of:  
 
o readily available data in an appropriate representative country at a similar level of economic 
 development, or if more than one country qualifies, preference will be given to the one with 
 adequate level social and environmental protection  
o undistorted international prices, costs and benchmarks  
o domestic costs if positively established that they are not distorted  
 
23. The WTO Appellate Body explicitly denied the use of other costs other than the book 
cost of the exporter to calcula te the normal value in EU biodiesel case. Regarding the 
Article  2.2.1.1 in the Anti-Dumping Agreement , the WTO Appellate Body  explicitly pointed 
out that the cost records kept by exporters or producers shall reasonably reflect the costs 
associated with the  production and sale of the product under consideration. Although 
there is no limit to "confirmation of sources of information or proof that may be adopted 
for the cost of production of the country of origin", the investigatory agency shall 
guarantee the u se of such information to produce the cost of production of the country of 
origin.  How d oes the EU obtain  the cost of production of the country of origin with 
reasonable adjustments to the price or cost of a representative third country when the 
provision 2.6(a) is applied?   
 
EU reply:  
Please see reply to question 21.  
 
24. It is stipulated in the Article 32.1 of the Agreement on Subsidies and Countervailing 
Measures  that no specific action against a subsidy of another Member can be taken except 
in accordance with the provisions of GATT 1994 as interpreted by this Agreement. But the 
Eu's new regulation 2017/2321 stipulates that subsidies are involved in measuring the 
standard of market distortion. Please explain the consistency between the EU and the 
Article 32.1 in the Agreement on Subsidies and Countervailing Measures.  
 
EU reply:  
The purpose of the current Trade Policy Review is not for the EU to offer interpretation s or views 
regarding the meaning of the provisions of the Agreement on Subsidies and Countervailing 
measures. In any event, the EU is of the view that the EU's Anti -subsidy legislation is fully in 
conformity with WTO rules.  
 
25. Since the enactment of the  Eu's new regulation 2017/2321, the EU only releases 
reports on China and applies the new method of determining the normal value based on 
market distortion structures to Chinese exports only. Do the Eu's legislation, reports, and WT/TPR/M/395/Add.1  
 
- 163 - 
 
  investigatory practices on  the whole constitute substantive discrimination  against China? 
Does the EU plan to release similar market distortion reports to any other third countries?  
 
EU reply:  
As explained at the time the report of China was published, China was selected because it  is the 
country subject to most trade defence actions in the EU.  The Russia n Federation  was selected as the 
country for the second report given it accounts for the second highest number for trade defence 
actions by the EU.  
 
26. According to the Eu's new regulation 2017/2321, the complainant  can present claims 
against market distortion based on the report released by the EU, and the respondent 
enterprise has to provide materials for disproof. This reflects serious imbalances of th e 
rights and obligations between the complainant and the respondent. How does the EU 
balance their rights and obligations and prevent the complainant from presenting 
malicious claims against market distortion?  
 
EU reply:  
A complainant must support any allegations of distortions by providing prima facie evidence. The 
existence of distortions is verified by the Commission services in the course of the investigation, 
where relevant.  
 
27. According to the Agreement on Impleme ntation of Article VI of the General Agreement 
on Tariffs and Trade 1994 , a.k.a. the Anti-Dumping Agreement , when there are no sales 
of the like product in the ordinary course of trade in the domestic market of the exporting 
country ，or because of the parti cular market situation ，or the low volume of the sales in 
the domestic market of the exporting country, proper comparison of such sales is not 
allowed, the margin of dumping shall be determined by comparison with the cost of 
production in the country of ori gin plus a reasonable amount for management, sales, 
general costs and profits. Which provision of the Anti-Dumping Agreement  or the WTO 
rules is the Eu's method based on which the EU determines the normal value with costs 
of production and sale reflecting undistorted prices or of benchmarks on the grounds of 
market distortions?  
 
EU reply:  
Please see reply to question 21.  
 
28. What are the legal procedures of the EU in identifying market distortions caused by 
countries in the exporting country? How to ensure the right of interested parties to 
comment and demur in this process? And how does the investigatory agency make sure 
that no unreasonable burden of proof is imposed on interested parties?  
 
29. The EU added the definition of "normal value" when amending the regulations. In 
essence, this allows for the "normal value" to be determined by another method where 
there are stat e-induced distortions in the exporting country. In the meantime, a different 
methodology for determining the "normal value" is set out for non -WTO  Members. Is 
there any standard to determine whether or not there are state -induced distortions in the 
exporti ng country? Please elaborate on the rationality of determining whether or not 
there is dumping in the exporting country with the new methodology of determining the 
"normal value".  
 
EU reply to questions 28 and 29:  
As regards the existence of distortions, the Commission may find indications in any number of 
sources including primary sources (legislation of exporting country, policy documents etc.), studies 
by authoritative organisations (WB, IMF, OECD etc.), findings in previous trade defence 
investigations  (not only in the EU), authoritative academic studies, and others such as EU  industry, 
expert papers, economic consultants, law -firms etc.  
 
As stated in Article 2(6а)(c) of the Basic Regulation, "Such reports and the evidence on which they 
are based shall  be placed on the file of any investigation relating to that country or sector. Interested 
parties shall have ample opportunity to rebut, supplement, comment or rely on the report and the 
evidence on which it is based in each investigation in which such re port or evidence is used. In WT/TPR/M/395/Add.1  
 
- 164 - 
 
  assessing the existence of significant distortions, the Commission shall take into account all the 
relevant evidence that is on the investigation file."  
The reasons for the adoption of Regulation (EU) 2017/2321 are detailed in the recitals of that 
regulation. For instance, Recital 3 explains that, in light of experience gained in past proceedings, it 
was appropriate to clarify the circumstances in which significant distortions affecting to a 
considerable extent free market force s may be deemed to exist. In that respect, recital 3 stipulates 
that this is the case when reported prices or costs, including the costs of raw materials and energy, 
are not the result of free market forces because they are affected by substantial governme nt 
intervention.  
 
Page 80（Para.3.79 ） 
"For example, in calculating the non -injurious price, a minimum profit of 6% is included."  
 
Question ： 
30. Please explain  the basis for setting the minimum profit  margin  at 6%? For industries 
with a profit margin of less than 6%, d oes the setting of the minimum limit artificially 
increase the  injury ? Does an interested party have the right to demur against it?  
 
EU reply:  
The minimum target profit of 6% was selected on the basis of historical information on profitability 
for the industrial sector from financial databases, such as Bloomberg and BACH. Article 7 para 2c of 
the basic regulation states that the 6% is the minimum profit level.  
 
Page  81（Para.  3.80） 
 "In 2019, a new regulation on safeguarding competition in air transport entered into force…The new 
legislation aims to address concerns about unfair practices…".  
 
Question ： 
31. The EU applies trade remedy to the trade in service beyond the trade in goods . Could 
the EU explain the provisions in the new legislation corresponding under  the WTO rules 
framework and the basis for the new legislation ? Could the EU explain the consistency of 
this legislation with the multilateral rules of the International A ir Services Agreement 
(ASA) and the International Civil Aviation Organization (ICAO)?  
 
EU reply:  
The Regulation concerns air services which are excluded from the GATS and is fully compatible with 
the Union's and the Member States' international commitments . 
 
Page 83 (Para.3.88)  
It mentioned that  "whereas in 2018, this  (expiry reviews) had increased to 100%". To the knowledge 
of China, the longest implementation of anti -dumping measures by the EU exceeds 30 years.  
 
Question:  
32. Does it indicate that the EU has provided  related industries with excessive remedy and 
protection?  
 
EU reply:  
Trade defence measures are imposed, maintained or extended, only after investigations have been 
completed which show the existence of dumping or t he likelihood of recurrence of dumping and 
ongoing injury or threat of recurring injury. Where the conditions to continue measures are not met, 
the measures are terminated. The continuation of measures is an indication of continued unfair 
injurious trade p ractice by the exporting producers in the countries concerned.  
 
Page 84 (Chart 3.4)  
In accordance with the Chart 3.4 , it indicates that steel is the most important area that the EU has 
taken trade remedy measures to protect.  
 
Question:  
33. According to th e strategic document – Steel: Preserving sustainable jobs and growth 
in Europe  – released by the EU on 16th March 2016, greater trade remedy measures shall 
be taken for imported steel products to offer protective support to the Eu's steel industry. 
At least 52 anti -dumping and anti -subsidy measures that have been taken by the EU are WT/TPR/M/395/Add.1  
 
- 165 - 
 
  related to steel products. T he EU also initiated investigations on the measures protecting 
imported steel products and took measures to protect 26  types of steel products on a 
large scale. Some products are even involved in anti -dumping, anti -subsidy, and 
protection measures at the s ame time. Given that the Eu's trade remedy policy and its 
objectives are targeted at industrial protection, could the EU explain how fairness and 
justice are reflected in the trade remedy system and how excessive remedy (the aforesaid 
triple remedies) can be avoided when anti-dumping, anti -subsidy, and protection 
measures  are taken for the same product at the same time?  
 
EU reply:  
As regards the imposition of anti -dumping and countervailing measures simultaneously, the EU 
ensures that anti -dumping and countervailing measures are not imposed to address one and the 
same situation arising from dumping and subsidization, where this is s hown to be the case.  
 
With reference to the application of safeguard measures on certain steel products, Commission 
Implementing Regulation (EU) 2019/1382 of 2 September 2019 prevents the concurrent application 
of the anti -dumping and/or countervailing me asures with the safeguard measures that might be in 
place at the same point in time.  
 
Page  100（Table 3.14） 
Table 3.14 shows all the state aid from 2013 to 2017, but excludes the agricultural and transport 
state aid.  
 
Question:  
34. Given that there is no transport state aid in Table 3.14, does this mean that there is 
no state aid in transport ation sector ? Please elaborate on the footnote to "Railway 
support" in Table 3.14 – "The Commission notes that railway support includes a signif icant 
amount that is not classified as state aid."  
 
EU reply:  
The public financing granted under the railway support category reported in the Scoreboard can 
constitute State aid. Only part of the railway support shown in Table 3.14 does not qualify as sta te 
aid.  
When assessing if a support measure constitutes state aid or not (including in the transport sector), 
we refer to the Commission Notice on the notion of State aid as referred to in Article  107(1) of the 
Treaty on the Functioning of the European Un ion (2016/C 262/01), para 211. (https://eur -
lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:52016XC0719(05)&from=EN).  
 
Page 103  (Para. 3.26 and 3.27)  
"… eliminating tax barriers to cross -border economic activity, and combatting harmful tax 
competition, tax evasion, and tax fraud. To this end, in 2016, the European  Commission proposed 
a directive currently under discussion with member States on a "common consolidated corporate tax 
base".  
 
Question:  
35. According to the Treaty on the Functioni ng of the European Union , the EU  institutions 
have the authority of coordinating customs duty and indirect tax, and direct tax is in the 
realm of sovereign rights of the Eu's member States, for which the EU institutions can 
only take coordinated measures p ursuant to the principle of subsidiarity. As a type of 
direct tax, corporate tax is extremely unlikely to reach consensus at the EU level. Even if 
the consensus reached, the member States could still maintain the right to set tax rates. 
The EU first came u p with the Common Consolidated Corporate Tax Base (CCCTB) in 2011, 
but it eventually failed as the member States couldn't reach consensus on it. How likely 
does the EU expect the CCCTB to be approved this time? If approved, what are the specific 
impacts (i n terms of tax, etc.)?  
 
EU reply:  
The European Commission re -launched the common consolidated corporate tax base (CCCTB) as a 
two-step process. The Council of the European Union adopted conclusions confirming the view that 
the work should first focus on t he proposal to establish a common corporate tax base step of the 
proposal. The work on this step of the CCCTB is ongoing. The Council published on 25 November 
2019 its latest Presidency compromise on the CCCTB. When this step of the proposal is completed WT/TPR/M/395/Add.1  
 
- 166 - 
 
  the work will then focus on the consolidation step of the CCCTB. The exact timeframe for finalising 
the work on the CCCTB is not known at this moment.  
In the political guidelines for the new European Commission, the President of the Commission 
Ms Ursula von  der Leyen included the CCCTB proposal as part of the Commission's agenda for fair 
taxation and confirmed she will fight to make it a reality. In his mission letter, the Commissioner for 
Economy Paolo Gentiloni has been tasked with leading the efforts to m ake the CCCTB a reality. It is 
evident that the new College is willing to continue the work on the CCCTB.  
The CCCTB will provide concrete benefits to the EU's single market. In the long -run it would both 
increase investment in the EU by up to 3.4% and lea d to an increase in growth by up to 1.2% 
(corresponding to about EUR 180 billion). Time spent on annual compliance activities should 
decrease by 8% while the time spent for setting up a subsidiary would decrease by up to 67%, 
making it easier for companies , including SMEs, to set up abroad. It would also increase tax certainty 
by providing a stable and transparent EU -wide system for corporate taxation. Further information 
can be found in the CCCTB Impact assessment  
https://ec.europa.eu/taxation_customs/site s/taxation/files/swd_2016_341_en.pdf.  
 
Page 109 ( Para. 3.168)  
"Pursuant to the new Regulation (EU) 2019/515, member States that use existing technical 
regulations to restrict market access for products lawfully said in another member State must justify 
their position with technical and scientific evidence and must gr ant other affected  economic 
operators an opportunity to  comments, and the new  dispute settlement mechanism is expected to 
allow for a faster resolution of disputes between companies and national authorities.  
 
Question:  
36. What is the procedure with respec t to the new mechanism for disputes resolution?  
 
EU reply:  
As a general rule, any administrative decision taken by the competent authorities of an EU  Member 
State pursuant to Regulation (EU) 2019/515 that restricts or denies market access to products 
lawfu lly marketed in another EU Member State must specify the remedies available to economic 
operators, so that they are able, in accordance with national law, to appeal against the decision or 
bring proceedings before the competent national court or tribunal. The decision must also refer to 
the possibility for economic operators to use the Internal Market Problem Solving Network (SOLVIT).  
 
SOLVIT is a service provided by the national administration in each EU Member State that allows 
effective solutions for eco nomic operators wishing for a business friendly alternative when 
challenging administrative decisions restricting or denying market access, so as to ensure the correct 
and consistent application of the principle of mutual recognition. SOLVIT is a non -judicial, problem -
solving mechanism that is provided free of charge. It works under short deadlines and provides 
practical solutions to individuals and businesses when they are experiencing difficulties in the 
recognition of their EU rights by public authoritie s in other Member States.  
 
Where the economic operator, the relevant SOLVIT national centre and the Member States involved 
all agree on the appropriate outcome, no further action is required. However, where this SOLVIT's 
informal approach fails, and doubt s remain regarding the compatibility of a decision of an EU Member 
State with the principle of mutual recognition, the national SOLVIT centre involved will request the 
European Commission to look into the matter. Following its assessment, the Commission sh all issue 
an opinion to be communicated through the relevant SOLVIT centre to the economic operator 
concerned and to the competent national authorities, which must be taken into account during the 
SOLVIT procedure. The Commission's intervention is subject to a time -limit of 45 working days, 
which does not include the time necessary for the European Commission to receive any additional 
information and documents that it considers necessary. The opinion of the Commission shall only 
address whether the administ rative decision taken by a Member State is compatible with the 
principle of mutual recognition and with the requirements of Regulation (EU) 2019/515. If the case 
is solved between the parties during this assessment period, the Commission will not be requir ed to 
issue an opinion any more.  
 
Page 110 （Para. 3.165 ） 
"......In the absence of EU harmonized technical regulations, member States may develop and apply 
national technical regulations subject to specific procedures."  
 WT/TPR/M/395/Add.1  
 
- 167 - 
 
  Question:  
37. How can other WTO members obtain the information regarding technical regulations 
developed by EU member States on their own?  
EU reply:  
EU Member States are full WTO members and they are responsible for the notification to the TBT 
Committee of technical r egulations that they might adopt in the areas in which there is no EU 
harmonization legislation. These notifications allow other WTO members - through their TBT enquiry 
points - to obtain information and have access to these proposed domestic regulatory me asures.  
 
Page 116 （Para.  3.209） 
It mentioned that "the EU made 200 notifications to the TBT Committee in the WTO". (TBT)  
 
Question:  
38. The Chinese government has noticed that the EU is prepared to reduce the daily 
maximum intake level of Monacolin K  (an active ingredient in red yeast rice) from 10mg 
to 3mg and that the standard for it is under formulation which is expected to be put to 
vote and come into effect in the near future. What are the reasons for the EU to change 
this standard? And has the EU conducted any risk assessments and obtained any scientific 
evidence or verification?  
 
EU reply:  
The Commission initiated the procedure under Article 8 of Regulation (EC) No 1925/2006 on the 
addition of vitamins and minerals and of certain other substances to foods24, for monacolins in red 
yeast rice (RYR) as the Member States raised concerns regarding a potential risk to consumer s linked 
with the consumption of this substance. On 25 June 2018, the European Food Safety Authority 
(EFSA) adopted a scientific opinion on the safety of monacolins in red yeast rice25. In this opinion, 
EFSA considered that monacolin K in lactone form is id entical to lovastatin, the active ingredient of 
several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. 
Furthermore, intake of monacolins from RYR via food supplements could lead to estimated exposure 
to monacolin K with in the range of the therapeutic doses of lovastatin. EFSA concluded that 
monacolins from RYR when used as food supplements were of signiﬁcant safety concern at the use 
level of 10 mg/day. EFSA further considered that individual cases of severe adverse reac tions have 
been reported for monacolins from RYR at intake levels as low as 3 mg/day, and that exposure to 
monacolin K from RYR could lead to severe adverse effects on musculoskeletal system, including 
rhabdomyolysis, and on the liver.  
In the light of the  above and in accordance with the Article 8 procedure, the Commission will adopt 
a measure to include monacolins from red yeast rice in Annex III to Regulation (EC) No.  1925/2006. 
However, internal discussions are still ongoing to decide on the most approp riate risk management 
response on the basis of the scientific opinion of EFSA and discussions with interested parties.  
 
39. The Chinese government has noticed that European Food Safety Authority (EFSA) 
submitted a proposal to the European Commission to mo dify the standard of tartaric acid, 
suggesting that only tartaric acids with natural sources can be added to food and synthetic 
ones cannot be used. The European Commission has required the EFSA to provide 
scientific evidence and a risk assessment report i n regards to the safety. Thus the EFSA 
unreasonably required China's tartaric acid enterprises to offer  relevant  proof. What is 
reason to change the standard of tartaric acid? According to the WTO  Agreement on the 
Application of Sanitary and Phytosanitary Measures  (SPS Agreement ), it is the EFSA or 
the complainant , rather than the Chinese tartaric acid enterprises , shall bear the burden 
of proof regarding risk assessment and scientific evidence, because  it would incur 
unreasonable burden on the Chinese side . Can the EU guarantee that such measures will 
not restrict trade beyond the limits required to achieve an appropriate lev el of sanitary 
and phytosanitary protection? Can the EU guarantee that such measures will not restrict 
trade beyond the limits required to achieve an appropriate level of sanitary and 
phytosanitary protection?  
 
EU reply:  
The Commission services are not awa re of any advice from the European Food Safety Authority 
(EFSA) that would suggest modifying the legislation to restrict the use of tartaric acid to that 
 
24 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32006R1925&from=EN . 
25 EFSA Journal 2 018;16(8):5368.  WT/TPR/M/395/Add.1  
 
- 168 - 
 
  obtained from natural sources. Tartaric acid (L(+) -) (E 334) is an authorised food additive which, as 
all additives permitted in the EU before 20 January 2009, is subject to a new risk assessment 
performed by EFSA. The re -evaluation programme is managed in an open, transparent and inclusive 
way allowing any interested party to submit, as a reply to calls f or data, the relevant information to 
EFSA for further consideration. Among the interested parties that submitted the documentation to 
EFSA were also the Chinese business operators and the documentation provided was taken into 
account in the scientific risk  assessment.  
As already outlined, we are not aware of any recommendation suggesting restricting the use of 
tartaric acid (E 334) to tartaric acid from natural sources only. For further details please consult the 
EFSA opinion which shall be published in th e coming days at http://www.efsa.europa.eu/.  
 
Page 133 -134 (Para.3.272 to 3.275)  
The s tate-owned enterprises (SOEs) continued to play an important role in the EU economy in terms 
of revenue, value added, and employment, although their importance varies fro m one member State 
to another. The EU does not have a legal definition of the SOEs, but several articles of the TFEU 
refer to "public undertakings". Article 345 is neutral on the issue of ownership (including ownership 
of public undertakings). However, Art icle 106 states that general EU rules are applicable to the SOEs, 
including rules on non -discrimination and competition policy.  
 
Question:  
40. How does the EU maintain its neutrality on the issue of ownership of public 
undertakings? And Could the EU provid e a list of public undertakings of its member States 
so that the WTO member States can have a deeper understanding of the operations and 
management of public undertakings and learn from them?  
 
EU reply to Q40 and 47:  
The EU Treaty establishes neutrality in terms of ownership. General EU rules (e.g. on competition, 
freedom of establishment and non -discrimination) apply to all enterprises in the EU, including the 
public undertakings. Competitive neutrality is guaranteed by the fact that all enter prises are subject 
to the same laws as privately -owned companies, in terms of taxation, competition and governance.  
 
A report on State -owned enterprises in the EU is available via the following link:  
https://ec.europa.eu/info/evaluation -reports -economic -and-financial -affairs -policies -and-spending -
activities/analysis -public -assets -and-their-management -european -union_en  
It provides an overview and discussion of state asset management in the EU based on a 
comprehensive study.  
 
Each country report contains a table of the largest SOEs in the Member State (Pillar 1, Table E):  
https://ec.europa.eu/info/evaluation -reports -economic -and-financial -affairs -policies -and-spending -
activities/analysis -public -assets -and-their-management -european -union/country -fiches -pillars-1-
3_en.  
 
Page 150 (Para.3.344)  
The EU legal framework offers supplementary protection certificates (SPCs) for medicinal products 
(Regulation (EC) No. 469/2009) and plant protection products (Regulation (EC) No.  1610/96) as a 
sui generis IP category that only applies after expiry of the basic patent. In other words, they are 
considered as legally distinct from patent protection, including international obligations in this 
regard, and may therefore be subject to wider exceptions than patent rights themselve s… 
 
Question:  
41. a) Is a third party allowed to provide comments in the procedures of screening SPC 
application?  
 
EU reply:  
The large majority of national patent offices in the EU allow for the submission of third -party 
observations.  
b) And is there any opposition procedure following the SPC authorization?  
 
EU reply:  
Article 19(2) of Regulation 469/2009 stipulates that the pro cedure for opposition to the granting of 
a certificate shall be excluded.  
 WT/TPR/M/395/Add.1  
 
- 169 - 
 
  42. What is the standard of innovation with respect to innovative medicinal products that 
can obtain supplementary protection?  
 
EU reply:  
The substantive conditions for obtaining the SPC are laid down in Article 3 of Regulation 469/2009. 
It stipulates that a certificate shall be granted if, in the Member State in which the application is 
submitted and at the date of that application: (a) the product is protected by a basi c patent in force; 
(b) a valid authorisation to place the product on the market as a medicinal product has been granted 
in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product 
has not already been the subject of a c ertificate; and (d) the authorisation referred to in point (b) is 
the first authorisation to place the product on the market as a medicinal product. Article 1(b) lays 
down that 'product' means the active ingredient or combination of active ingredients of a  medicinal 
product.  
 
Page 151 (Para.3.346)  
"Plant varieties can be protected either under national plant variety right systems or as a Community 
Plant Variety Right (CPVR). As regards the latter, Council Regulation (EC) No.  2100/94 on CPVRs 
established a s eparate regime that provides for a unitary right to exploit a plant variety with effect 
across the EU via a single application to the Community Plant Variety Office (CPVO). The term of 
protection is 25 years, and 30 years in the case of potato, vine and tr ee varieties, extendable for a 
further 5 years in certain cases. National plant variety rights or patents cannot coexist with CPVRs; 
when a CPVR is granted, the corresponding national title becomes ineffective as long as the CPVR is 
in force."  
 
Question:  
43. If a plant variety with a CPVR of 25 or 30 years of protection that has already been 
granted a national plant variety right in a certain member State, is the term of protection 
for the plant variety calculated by subtracting the term of protection that it enjoyed in the 
member State from that of 25 or 30 years? If there is no such subtraction, then does 
means that the plant variety obtains an extended term of protection of over 25 or 
30 years.  
 
EU reply:  
There is a prohibition on cumulative protection i n the EU according to Article 92 of Regulation 
2100/94 on Community Plant Variety Rights (CPVR). So any variety that has been subject to CPVR 
shall not be subject of a national plant variety right.  
 
Page 154 (Para.3.365)  
"Furthermore, a special study was also carried out regarding trade secret litigation. It provides a 
description of all 28 EU member States' legal systems for the protection of trade secrets, prior to 
the implementation of the Trade Secret Directive , and a comparative overview of national case law 
is provided in a dedicated section. Overall, it finds that there is considerable divergence between 
member States in terms of their national definition of trade secrets, the scope of protection, the 
sources of law, and the availability of  case law."  
 
Question:  
44. With respect to the development and implementation of the Trade Secret Directive  in 
2018, how the standards of determining trade secrets, their infringements, and indemnity 
that vary from one member State to another can be unified, is the Directive being actually 
implemented in practice, and eliminated the divergence?  
 
EU reply:  
At the time of writing this reply, the Directive has been transposed by 26 out of 27 EU Member 
States. The European Commission is currently conducting a study on the transposition of the Trade 
Secrets Directive which assesses the completeness and conformity of national transposition 
measures. The European Commission intends to issue a report on the impact of the Directive which 
is foreseen for 2022.  
 WT/TPR/M/395/Add.1  
 
- 170 - 
 
  Page 170  (Para. 4.34 and Table 4.5)  
"Out of the 27 member States that apply the voluntary coupled support (all bu t Germany), 9  have 
allocated to the scheme up to the baseline ceiling of 8% of their national ceiling for direct payments, 
3 have allocated between 8% and 13% (plus 2% to support protein crops), 11 have allocated the 
maximum percentage of 13% (+ 2%) and 3 received the Commission's approval to provide more 
than 13% (+ 2%) (Table 4.5).One member State is using the derogation allowing member States 
to use EUR 3 million for voluntary coupled support."  
 
Question:  
45. Following the Doha Round negotiations, the EU  pledged to slash agricultural subsidies 
and control proportion of the output -linked subsidies (yellow box subsidies) within 8% of 
the total expenditure of its common agricultural policy (CAP). But since the latest round 
of CAP reforms in 2013, there has b een "reverse recovery" of linked subsidies in the 
member States, in spite of the Eu's commitment to promoting the subsidies decoupling 
from agricultural production (green subsidies). As the Report shows, the overall 
proportion of the yellow box subsidies w ithin the EU is still controlled within 8% due to 
the Eu's regulation, the subsidized areas are very concentrated, mostly targeting at the 
advantageous products of the EU, such as beef, dairy products and sugar. Take the beef 
yellow box subsidies for examp le, the budget exceeds 6 billion Euros from 2017 to 2020, 
will this cause market distortions?  
 
EU reply : 
The EU has been, and remains fully committed to non - or minimally trade -distorting forms of 
support. This is why around 90% of direct payments have alr eady been decoupled. Part of the 
remainder is used for production limiting (coupled) support that meets Blue Box criteria.  
Voluntary coupled support (VCS) does not aim to increase production. In fact, VCS is 
production -limiting support that aims at aiding sectors that undergo difficulties. It is Blue Box and 
so subject to strict conditions (e.g. the importance and the difficulty of the sector) and limits 
(budgetary limit at Member State level) in order to minimise its effects on the markets.  
A substa ntial share of the VCS allocations target beef and veal (40.4% in claim year 2018), dairy 
(21.2% in claim year 2018) and sugar beet (4.2% in claim year 2018). However, this is justified by 
the substantial difficulties that these sectors undergo. To illustr ate this, the number of supported 
animals/hectares in claim year 2018 remained respectively by 13.9% (beef and veal), 24.9% (dairy) 
and 13.6% (sugar beet) below the historical number of animals/hectares in these sectors 
(i.e. 2009-13) in those Member State s that decided to grant VCS. The rules include various 
safeguards against market distortion, and the data on implementation also justifies their efficiency.  
 
Page 231 (Table 4.21)  
According to the data about trade in construction services listed in column s C and D of Table  4.21, 
in 2017, the proportion of goods and services provided by foreign contractors was 28.3%, while the 
proportion of projects undertaken by foreign contractors was only 8.4%.  
 
Question:  
46. Why the foreign enterprise significantly less  active than those in the EU, or 
construction services are significantly less imported than exports in the construction 
industry of the EU?  
 
EU reply:  
Construction markets are very different across the EU -27, with often significant regional and local 
realities even within a specific country in terms of local construction traditions, linguistic aspects, 
access to finance, trade credit, building permits and licenses, insurance and liability regimes. 
Moreover, the construction sector operates as a network of c ompetences rather than a vertical 
structure. Construction activities are also highly regulated at many levels (e.g. the products, works, 
professional qualifications, occupational health and safety, environmental impact) and many aspects 
are Member States' competences. This makes that initial costs to take advantage of market 
opportunities could be substantial for EU construction enterprises and even more for 
non-EU companies. Despite continuous efforts form the European Union, European market 
integration re mains low for construction services (i.e. only 1% of the total sector turnover for 
builders and specialized construction contractors). International turnover of EU contractors is rather 
moderate compared to the total turnover of the sector (about 2%).  
 WT/TPR/M/395/Add.1  
 
- 171 - 
 
  PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Page 3 (Para.1.3)  
"EU competitiveness against distortions induced by state capitalist practices and lower standards"  
 
Question:  
47. Could the EU elaborate on the data, management models, and other basic information 
pertaining to its state -owned enterprises (SOEs)? What do the Eu's SOEs do to avoid 
disrupting market competition as they get involved in the management of enterprises and 
the operations of public listed ones in particular? How can the EU  make sure that other 
enterprises including the foreign ones get fair market treatments with those with equity 
participation from its state capitals?  
 
EU reply:  
Please see reply to question 40.  
 
Page 7  (Para.3.10)  
"On 24 July 2019, the European Commission adopted the Communication Guidance on the 
participation of third country bidders and goods in the EU procurement market."  
 
Question:  
48. Is there an adequate period for public comments when making legislation on the 
International Procurement Instrument?  
 
EU reply:  
Before the Commission proposes new legislative initiatives, the Commission consults interested 
parties such as non -governmental organisations, local authorities and representatives of industry 
and civil society. In this preliminary phase, citizens , businesses and organisations can participate in 
the consultation procedure via a dedicated website on public consultations.  In this way, the 
Commission ensures that legislative proposals correspond to the needs of those most concerned and 
avoids unnecess ary red tape. For past public consultation on IPI, please visit: 
https://ec.europa.eu/growth/content/consultation -access -third-countries -eu%E2%80%99s -public -
procurement -market_en . 
 
Page 16  (Para.4.4)  
"The EU's priority in its reform efforts has been to pre serve and strengthen the main features of the 
dispute settlement system, which risked paralysis, at the time of writing, by the end of 2019 if the 
appointment of Appellate Body members remained blocked. To that end, the EU, together with a 
coalition of 13 WTO Members, submitted proposals to the WTO in November  2018, which addressed 
concerns of the Members blocking appointments."  
 
Question:  
49. The European Commission proposed an amendment on 12 December 2019, allowing 
the EU to take trade measures only based on a panel report in the case of the paralysis of 
the WTO appellant mechanism, and indicating that the EU must strengthen trade 
enforcement so that it can make resolute responses in the case of obstruction of dispute 
settlement by trade partners incl uding impediment to selection of the Appellate Body 
members. Could the EU elaborate on its trade measures as well as the specific scope of 
application and procedures thereof?   
 
EU reply:  
The EU is committed to the multilateral trade system and continues its efforts to find a permanent 
solution to the Appellate Body crisis. In the meantime, the EU proposed a temporary solution 
pursuant to Article 25 DSU in the form of an interim appeal arbi tration arrangement and multiparty 
interim appeal arbitration arrangement. Such arrangements allows for two -step resolution of 
disputes and until the Appellate Body functions again, the EU will always seek adjudication through 
it. The proposed amendment of  the Enforcement Regulation is for ensuring that other Members 
respect their WTO obligations and that the EU can effectively protect its economic interests when 
they do not. The Enforcement Regulation is only applicable at the end of adjudicative procedure s. 
The new amendments would allow the EU to act if the other party to the dispute blocks such 
procedures, thereby depriving the Union of its ability to enforce international commitments which 
its partners have previously agreed to. International law recogn ises that countermeasures are WT/TPR/M/395/Add.1  
 
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  allowed where the other party blocks effective dispute settlement (cf. the Articles on State 
Responsibility of the International Law Commission and commentaries thereto).  
 
PART III: OTHER QUESTIONS  
 
Questions:  
50. a) Could th e EU offer an overview of the implementation of the Directive on Copyright 
in the Digital Single Market ? 
 
EU reply:  
For a directive to take effect at national level, EU Member States must adopt implementing measures 
to transpose it. In the case of Directiv e (EU) 2019/790, the transposition must take place by 
7 June 2021. 
 
b) And could the EU elaborate on the Unitary Patent package and the latest developments 
in the Unitary Patent Court?  
 
EU reply:  
There have not been recent developments as regards the unitary patent system (The website of the 
European Commission provides information and links to the unitary patent package at: 
https://ec.europa.eu/growth/industry/policy/intellectual -property/patents/unitary -patent_en). A 
legal challenge is still pending before the German Constitutional Court concerning the Unified Patent 
Court Agreement.  
 
51. The EU passed the Patents (Supplementary Protection Certificate for Medicinal 
Products) (Amendment) Rules  in May 2019, introducing an exception to the 
Supplementary Protection Certificate for Medicinal Products. What is the reason for 
putting forward this Amendment and what are the objectives of the Amendments?  
 
EU reply:  
Regulation 2019/933 aims to restore the level playing field for manufacturers of generics and 
biosimilars operating in the EU vis -á-vis manufacturers operating in non -EU countries where SPC 
protection is shorter, weaker or does not exist. It allows makers of generics and biosimilars 
established in the EU to make in the EU products, or medicinal produc ts containing those products, 
for the purpose of export to third -country markets in which protection does not exist or has expired, 
thereby also helping those makers to compete effectively in those third -country markets. This 
Regulation should also allow s uch makers to make and store products, or medicinal products 
containing those products, in a Member State for a defined period pending the expiry of the 
certificate, for the purpose of entering the market of any Member State upon expiry of the 
correspondin g certificate, thereby helping those makers to compete effectively in the EU immediately 
after protection has expired ('EU day -one entry').  
 
52. What are the background, considerations, and visions as to the substantive trademark 
reforms? What are the spec ific contents of the EU Regulation on Modernization of 
Trademark Legal Framework  and the Directive on Further Harmonization of Trademark 
Law in particular? Is there any specific judicial policy in these reforms in regards to 
abusive trade mark registration ? 
 
EU reply:  
In its Communication of 16 July 2008 the Commission announced that it would carry out a 
comprehensive evaluation of the overall functioning of the trade mark system in Europe as a whole, 
covering EU and national levels and the interrelation be tween the two. Within this evaluation 
exercise, a Study on the overall functioning of the European Trade Mark System, carried out by the 
Max Planck Institute for Intellectual Property and Competition Law, at the request of the 
Commission, was published in March 2011. This was followed by a process of public consultation 
and impact assessment, which concluded in the Commission issuing two  legislative proposals (for 
the reform of the Directive 2008/95/EC and Regulation (EC) No . 207/2009) in March 2013. 
Therea fter, the proposals went through the ordinary legislative procedure (including trilogue 
negotiations between the institutions) and a political compromise was reached in April 2015, with 
final approval by the Council and by the plenary of the European Parli ament at the end of 2015.  
The revision of Directive 2008/95/EC included measures to make it more consistent with Regulation 
(EC) No . 207/2009, which would thus reduce the areas of divergence within the trade mark system WT/TPR/M/395/Add.1  
 
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  in Europe as a whole, while maintai ning national trade mark protection as an attractive option for 
applicants. The revision of the Regulation (EC) No 207/2009 sought to build on the success of the 
Community trade marks system by making it more efficient and consistent as a whole and adaptin g 
it to the internet era.  
The main features of the reform include:  
a) Modernised provisions, such as to facilitate the registration of new types of trade marks 
(e.g. sound, motion or hologram marks) in the digital age, and thereby supporting corporate 
branding strategies;  
b) Streamlined and harmonised registration procedures, including at national levels, which will, 
inter alia, make trade mark applications across the EU subject to the same filing date and other 
formality requirements, and permit businesses to easily oppose trade mark applications and to seek 
for revocation or invalidity of existing registrations directly before the national IP offices concerned 
without need to go to court (i.e. faster and less costly);  
c) More effective means to fight against counterfeit goods, in particular when they are in transit 
through the Union territory so as to prevent that this territory and its transit routes are misused as 
central hub for the world -wide distribution of counterfei t goods;  
d) Enhanced legal certainty by removing ambiguities, clarifying trade mark rights in terms of their 
scope and limitations, including the introduction of a certification mark at Union level;  
e) Legal and financial framework to foster cooperation be tween the Member States' offices and the 
European Union Intellectual Property Office for the purpose of converging examination practice 
across the EU and developing common search tools and databases;  
f) More flexible and tailor -made fee structure for Europ ean Union trade marks to better meet user 
needs, implying significant savings;  
g) Improved efficiency, transparency and accountability as far as the governance of the European 
Union Intellectual Property Office in Alicante is concerned;  
h) Strengthened co -existence and complementarity between the EU and national trade mark 
systems by providing a legal base to offset Member States costs for their contributions to the efficient 
functioning of the EU trade mark system.  
The reform package has reinforced the pro tection against bad faith trade mark filings in that it is 
now mandatory for Member States to ensure that trade mark registrations applied for in bad faith 
are able to be declared invalid. In addition, Member States may provide that such a trade mark is 
not to be registered.  
 
53. What are the latest developments in the area of trade secret litigation following the 
enactment of the Trade Secret Directive ? Are judgements in the member States 
consistent?  
 
EU reply:  
The European Commission intends to issue a r eport on the impact of the Directive that is foreseen 
for 2022. Due to the late transposition in several Member States, it is still too early to draw 
conclusions.  
 
54. Please provide further information in regards to the Patents (Supplementary 
Protection C ertificate for Medicinal Products) (Amendment) Rules, protection of 
geographical indications for agricultural products, and policies on cross -border 
e-commerce?  
 
EU reply:  
Further detailed information regarding SPCs can be found at the dedicated website of  the European 
Commission's Directorate General for Internal Market, Industry, Entrepreneurship and SMEs: 
https://ec.europa.eu/growth/industry/policy/intellectual -property/patents/supplementary -
protection -certificates_en.  
Further information on the protecti on of agricultural GIs can be found on the following website: 
https://ec.europa.eu/info/food -farming -fisheries/food -safety -and-quality/certification/quality -
labels/quality -schemes -explained#howareproductsprotected.  
Under the European Union's Digital Single  Market strategy, the European Commission has introduced 
30 legislative proposals, of which 28 have already been adopted by the EU  co-legislators (the directly 
elected European Parliament and the Council representing EU  Member States). Many of those 
initiatives are relevant for ecommerce and platforms. The factsheet "A Digital Single Market for the 
benefit of all Europeans"  summarizes the achievements of the Digital Single Market strategy, please 
see the following link: https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=53056.  
 WT/TPR/M/395/Add.1  
 
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  55. Could the EU clarify how to avoid green protectionism and trade barriers in violation 
of the WTO rules while attaining the ambitious objectives of the climate change policy?  
 
EU reply:  
To create a level playing field for businesses across Europe, EU law sets out minimum harmonised 
public procurement rules. However, their implementation remains a responsibility of national 
authorities as well as contracting entities.  
In general, the 2014 Proc urement Directives enable public authorities to take environmental 
considerations into account. Contracting entities may apply environmental award criteria, provided 
those criteria:  
- are linked to the subject -matter of the contract;  
- do not confer an unrestricted freedom of choice on the contracting authority;  
- ensure the possibility of effective competition;  
- are expressly mentioned in the contract notice and tender documents, together with their 
 weightings and any applicable sub -criteria; and  
- comply w ith the EU Treaty principles.  
 
Contracting entities may allocate points during the award stage to recognise environmental 
performance beyond the minimum requirements set in the specifications. There is no set maximum 
on the weighting one can give to enviro nmental criteria.  
Additional information is available in the European Commission's "Buying Green!" Handbook at 
https://ec.europa.eu/environment/gpp/pdf/Buying -Green -Handbook -3rd-Edition.pdf.  
 
56. Could the EU make further clarifications on the specific us e of the 365 billion euros of 
agricultural fund and on how to avoid disrupting the international market of agricultural 
products?  
 
EU reply : 
The amount of EUR  365 billion is the total budget for the years 2021 -2027. It is a reduction of 5% 
compared to the years 2014 -2020 (which was the amount for the EU -27). This amount will be spen t 
on decoupled direct payments and rural development, of which more than 90% is notified as Green 
Box. 
 
57. The European Commission released a  concept paper on WT O reform in Sep 2018. The 
suggestions in the paper were clustered in three areas: 1) updating the rule book on 
international trade to capture today's global economy; 2) strengthening the monitoring 
role of the WTO; 3) overcoming the imminent deadlock on th e WTO dispute settlement 
system. What actions have been taken and what progress has been made since then? 
Does EU have any new proposals on how to deal with the crisis that the WTO is facing or 
any plan to do that?  
 
EU reply:  
The WTO is facing its deepest  crisis since its inception. The EU sees a genuine risk of demise of the 
multilateral trading system, which can only be prevented by a concerted effort to reform the WTO. 
The EU has continued and accelerated work outlined in its concept paper of September  2018, 
submitting textual proposals and working on future proposals, to reform all three main functions of 
the WTO of dispute settlement, rulemaking and monitoring/consultation.  
The proposals by the EU and others in relation to the Appellate Body have brou ght about the 
dedicated process that became to be known as the Walker Process. Whilst pursuing this avenue to 
reinstate an impartial, two -step dispute settlement system as a priority, the EU is also working with 
partners towards safeguarding its rights und er a future Multiparty Interim Arrangement.  
As the WTO's negotiating arm has been unable to update the WTO rulebook in order to address the 
causes of today's trade tensions, the EU is working with key partners – including China – on 
developing possible ap proaches and solutions. The EU aims to turn these into proposals in the near 
future. Moreover, the EU is working towards tangible results in ongoing multilateral and plurilateral 
negotiations which should demonstrate that the WTO is able to deliver results . 
Regarding the WTO's monitoring function, the EU co -sponsored two proposals. One is aimed at 
improving compliance with notification obligations on trade in goods; the second aims to improve 
WTO councils and committees work in addressing Members' trade con cerns and now also enjoys co -
sponsorship by China.  
 WT/TPR/M/395/Add.1  
 
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  58. The EU notified the Proposed Regulation on In Vitro Diagnostic Medical Devices (IVDs) 
(G/TBT/N/EU/72) to the WTO on 23 October 2012. After amendment to the proposed 
Regulation, EU issued G/TBT/N/EU/72  Add. l on 23 March 2017. On 5 May 2017, the EU 
officially completed the legislation on in vitro diagnostic medical devices and released the 
In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, which aims to 
establish the regulatory framewo rk and safety standards for in vitro diagnostic medical 
devices. It is scheduled to enter into force on 26 May 2022. IVDR covers all kinds of in 
vitro diagnostic medical devices. However, necessary preparation such as notified bodies, 
authorized laboratori es and other aspects are lagging far behind. Thus, the Chinese 
enterprises are not able to proceed from their product transfer reviews on a solid basis or 
via well -connected channels, which will lead to high risk against their exports in a rule -
compliant m anner.  
Will practical and effective measures be adopted to accelerate the preparation of relevant 
laboratories? Will the opinions of members be taken into account on launching a simplified 
certification process for CE -certified devices? Will the opinions of members be considered 
to postpone the deadline to May 2024?  
 
EU reply:  
Preparations to designate reference laboratories for in vitro diagnostics are ongoing. In particular, 
implementing acts on tasks and criteria of the laboratories and on fees  they may levy are expected 
to be adopted in the first half of 2020. The call for applications for designation is also in preparation. 
The EU notes that, according to Article 113(d) of the IVDR, reference laboratories may be designated 
only after 25 Novemb er 2020.  
CE certification will follow the provisions of the IVDR. The EU is not aware about requests to change 
the legislation on which we at this stage have very little experience as it has not become applicable 
yet.  
The EU is not aware about any reques ts to postpone the application deadline and see no reasons to 
do so.  
 
59. On 9 October 2018, the EU notified the Draft Regulation on Ecological Design 
Requirements for Electronic Displays, setting minimum energy performance requirements 
for electronic disp lays such as televisions, monitors and sign displays entering the EU 
market. In November 2018, China submitted its comments on it. On 8  February 2019, the 
EU published a new version of this Regulation, which entails significant changes compared 
with the original version and establishes stricter requirements for relevant products. First, 
the scope of control is expanded. Second, energy effi ciency requirements are still too 
stringent. Third, new requirements for halogen flame retardants are added; fourth, the 
newly -added requirements for the maximum delivery time for spare parts are not feasible. 
The considerable changes, expanded the scope o f control, established stricter 
management and control rules, thus exerts substantial influence on international trade.  
Given the significant changes made to new version, will the EU re -notify to the WTO and 
give members opportunity to comment according t o transparency rules of 
TBT Agreement? Members' main comments are: 1. to exempt or further relax the 
requirements for energy efficiency limits on OLED displays; 2. to delete the requirement 
that "halogen flame retardants shall not be used in display housin g and support"; 3. to 
review the requirements that "after the last product is sold, external power and remote 
control shall be provided for at least seven years" and "the maximum delivery time for 
spare parts is 15 days". Will the EU adopt members' opinion s? 
 
EU reply : 
The EU supports the engagement and active participation of WTO Members in the discussion of 
specific trade concerns in the TBT Committee. The EU considers the concerns raised by other 
Members as follows.  
With respect to WTO Members' written c omments on TBT notifications, they are received and 
collected through the EU TBT Enquiry Point and shared with the Commission's competent services, 
who prepare and draft and individual reply to the comments made, which is subsequently 
communicated to the M ember concerned.  
 
As regards specific trade concerns raised in the context of the TBT Committee meetings, an 
articulated system of reporting is in place within the Commission, whereby the EU TBT team reports 
internally on all STCs and related issues raise d during bilateral meetings to the competent WT/TPR/M/395/Add.1  
 
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  Commission services. The comments, information and views gathered during the TBT  Committee 
meetings are shared with them for their subsequent assessment and consideration.  
 
60. From October 2018 to October 2019,  the EU successively notified ecological design 
requirements for a variety of products, including servers, data storage products, domestic 
dishwashers, etc. Those requirements have posed several obstacles on trade such as 
vague technical requirements, shor t transition period etc. The requirements were 
officially published on 5 December 2019. Will EU take effective measures and further 
accept opinions from members?  
 
EU reply : 
Please see answer to question 59 above.  
 
61. In July 2011, French Energy Regulator y Commission (CRE) introduced Photovoltaic 
Project Bidding Mechanism. Different from common practice in global market which 
mainly bid electricity price and module technology, the CRE focuses on the impact of 
carbon emissions in addition to the price of ph otovoltaic modules. It means less carbon 
dioxide generated and emitted during the production of photovoltaic modules, the greater 
chance one party will possess in winning the bid. In a 100 -point bid evaluation system, 
the carbon footprint accounts for 18 -30% of final bid score. In cases where the prices of 
photovoltaic modules of suppliers from different countries are similar to each other, the 
carbon footprint becomes a key factor in winning the bid.  
China is aware that the CRE is a public agency under DGE C, this biding rule may be covered 
by government procurement. However, China believes that this rule is obviously unfair. 
We hope EU would consider: 1. to adjust the biding rule to create a level playing field for 
members; 2. to refer to common practices i n global market by focusing on the bidding 
electricity price and modules technology; 3. to consider the fact that China has a greatly 
varied electricity structure on Chinese vast territory, and to divide China into different 
regions to determine global war ming index correspondingly according to its practice on 
Canada and other members.  
 
EU reply : 
Please refer to the reply to question 55.  
 
62. In December 2018, the EU notified the Third -country Operators of Unmanned Aircraft 
(UA) and Unmanned Aircraft System s (UAS) in the 'open' category , providing 
requirements for the risk management on unmanned aircraft in the "Open" category. In 
January 2019, China submitted comments. In March 2019, the EU extended the 
management and control requirements for unmanned airc raft in the "Open" category to 
unmanned aircraft in all categories and published COMMISSION DELEGATED REGULATION 
(EU) "on unmanned aircraft systems and on third -country operators of unmanned aircraft 
systems." providing the management system for the design , production, inspection, 
certification and sale of unmanned aircraft in all categories exported to the EU.  
The tests results indicate that as long as the mechanical strength of tethered UAS is not 
less than 4 times, the safety requirements can be fulfilled. Will the EU consider changing 
the existing mechanical strength of tethered UAS from not less than 10 times of the 
maximum take -off weight to 4 times thereof? Will the EU change the extension length 
limit of C3 UAS of the tethered from 50 meters to 120 meters? According to existing EU 
inspection rules, "UAS shall be hovered 0.5 meter above the reflective plane." However, 
the scaffolding size of some industry -class UAS is too long, unable to take off at the height 
of 0.5 meter above the reflective plane, not to mention hovering at 0.5 meter above the 
reflector. China suggests the EU to revise the above requirements to "UAS should hover 
0.5 meters above the reflection plane" to "the lowest point of UAS should hover 0.5 meters 
above the reflector".  
 
EU reply : 
As previously communicated, the safety factor of 10 for the tether strength is derived from the 
published certification specification for tethered gas balloons (EASA CS -31TGB). The figure of 10 
was obtained by combining the following elements (2*3 .5*1.5=10.5):  
 
• CS 31TGB.23 requires to consider an ascent load factor, the AMC recommends to use load 
factor 2 based on an ascent speed below 1m/s  WT/TPR/M/395/Add.1  
 
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  • CS 31TGB.25(a) requires a factor of safety on 3.5 for fibrous or non -metallic tether  
• CS 31TGB.25(c) requires for single tether to multiply the factor of safety by a factor of 1.5  
• A maximum tether length of 50m was chosen for the following reasons:  
• A longer tether would take too long to safely recover in case of incoming low -flying aircraft 
(e.g. helicopter emerge ncy medical service)  
• Occurrences of such low -level helicopter operations are much rarer at 50m than 120m 
from the ground . 
China will be pleased to read that the upcoming amendment to (EU) 2019/945 (planned to be 
published in Q2 2020) will address their con cern regarding the test method for the measurement of 
UA noise and remove the requirement of hovering 0.5m above the reflecting plane.  
 
 
  WT/TPR/M/395/Add.1  
 
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  COLOMBIA  
INFORME DE GOBIERNO - Documento WT/TPR/G/395  
 
3.4 Mercado único para los servicios  
En la página 8, numeral 3.14, se indica que: "Se ha adoptado un Reglamento sobre el entorno 
europeo de ventanilla única marítima que reunirá todas las obligaciones de información relativas a 
las escalas portuarias, incluidas las formalidades aduaneras para  la entrada y la salida de las 
mercancías. Este Reglamento comenzará a aplicarse en 2025 y se prevé que tendrá un importante 
efecto de facilitación del comercio, ya que reducirá a la mitad el tiempo necesario para la 
presentación de información en el secto r del transporte marítimo";  
 
Q1 ¿Podría la UE ampliar la información, indicando con mayor detalle las aplicaciones que 
reunirá este Reglamento, qu é procesos unifica y cuáles elimina, qué beneficios en tiempos 
y costos se tienen previstos, por qué se comenzará a aplicar solo hasta el 2025? ¿Así 
mismo, qué aspectos se espera que genere en los acuerdos comerciales suscritos por la 
UE?  
 
EU reply:   
Regul ation 2019/1239/EU establishing a European Maritime Single Window environment entered 
into force on 15 August 2019 and includes a set of measures to achieve harmonisation and 
simplification in maritime reporting. It will create a single entry point per Mem ber State and will 
minimise duplicate reporting requests for static data by appropriate data re -use mechanisms.  
A corner stone of the new regulation is the harmonisation of data definitions and formats and 
measures to improve data flows for increased effi ciency. The shipping operators will have the 
opportunity to report to customs using the same interface. It is also envisaged that national and 
local reporting requirements will be rationalised and harmonised.  
Authorities will use the Maritime National Single Windows to share some information with the 
providers of port services, like pilots, tugs, terminals, etc. Relevant information will be also available 
to operators along the logistic chain.  
The new rules are expected to cut in half the repor ting times, saving about 2.5 million hours every 
year, and hence reduce administrative costs by up to EUR 725 million for the shipping sector by 
2030. As a facilitation measure, the regulation will apply to all ships calling at European ports, 
including no n-European vessels. The new Regulation is not expected to raise any specific aspect in 
trade agreements signed by the EU.  
 
3.8. Prescripciones sanitarias y fitosanitarias  
Desde el último examen, la UE ha adoptado tres actos legislativos importantes en la e sfera de las 
medidas sanitarias y fitosanitarias (MSF), que son los siguientes: Reglamento sobre controles 
oficiales26, Reglamento sobre medicamentos veterinarios27 y Reglamento sobre la transparencia y la 
sostenibilidad de la determinación o evaluación del riesgo en la cadena alimentaria28. 
El Reglamento sobre controles oficiales establecerá un marco único para los controles oficiales a lo 
largo de toda la cadena agroalimentaria. Las empresas y las autoridades se beneficiarán de una 
reducción de la carga admi nistrativa, de procesos más eficaces y de controles reforzados. Gracias al 
Reglamento sobre medicamentos veterinarios la UE podrá intensificar su lucha contra la resistencia 
a los antimicrobianos, que representa una amenaza mundial para la salud pública. E n él se establece 
un amplio abanico de medidas para tal fin y para promover el uso prudente y responsable de los 
antimicrobianos, aplicando el enfoque del Plan de Acción Europeo "Una sola Salud" para luchar contra 
la resistencia a los antimicrobianos.  
La nueva legislación sobre la transparencia y la sostenibilidad de la determinación o evaluación del 
riesgo en la cadena alimentaria constituye un avance importante hacia la modernización de la política 
de inocuidad de los alimentos de la UE; asegurará una may or transparencia, reforzará la gobernanza 
y la cooperación científica, y facilitará el desarrollo de un sistema exhaustivo de comunicación del 
riesgo.  
Durante el período objeto de examen, la UE ha venido elaborando medidas de ejecución para esos 
reglamento s, así como para dos actos legislativos, sobre sanidad vegetal29 y sobre sanidad animal30, 
que habían sido adoptados en el período de examen anterior.  
 
26 Reglamento (UE) 2017/625, DO L 95, de 7 de abril de 2017, página 1.  
27 Reglamento (UE) 2019/6, DO L 4, de 7 de enero de 2019, página 43.  
28 Reglamento (UE) 2019/1381, DO L 231, de 6 de septiembre de 2019, página 1.  
29 Reglamento (UE) 2016/20 31, DO L 317, de 23 de noviembre de 2016, página 4.  
30 Reglamento (UE) 2016/429, DO L 84, de 31 de marzo de 2016, página 1.  WT/TPR/M/395/Add.1  
 
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  En el desarrollo de las nuevas medidas adoptadas por la UE en materia MSF, Colombia quisiera 
consultar:  
 
Q2 ¿La Unión Europea dispone de información técnica que sustente la prohibición de 
antimicrobianos en animales de producción para consumo humano? En c aso afirmativo 
¿dónde se pueden consultar las referencias correspondientes?  
 
EU reply:   
The European Commission constantly follows scientific and policy developments, which support the 
fight against antimicrobial resistance. As an example, the report to th e Secretary -General of the 
United Nations (UN) published by the Interagency Coordination Group (IACG) on antimicrobial 
resistance, entitled "No Time to Wait: Securing the future from drug -resistant infections ", is of great 
interest. The report was drafted with input from partners across the UN, international organizations 
and individuals with expertise across human, animal and plant health, as well as the food, animal 
feed, trade, development and environment sectors, to formulate a blueprint for the fight a gainst 
antimicrobial resistance.  
 
Q3 ¿Para la prohibición de uso de antimicrobianos se tiene en cuenta el estatus sanitario 
de los países?  
 
EU reply:  
The Commission will lay down the detailed rules as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January 2022.  
 
Q4 ¿La Unión Europea dispone de herramientas de control para verificar la 
implementación de la norma? Ejemplo comercio de medicamentos por vía web.  
 
EU reply:  
The Commission is currently reflecting on the most suitable approach for the various aspects of the 
implementation measures relating to Article 118. In order to ensure that the draft delegated acts 
are comprehensive, further reflection is warranted by Commission services in upcoming months.  
 
Q5 ¿En l a Unión Europea disponen de criterios generales para que sean tenidos en cuenta 
por los médicos veterinarios para la definición de tiempos de retiro en prescripción en 
cascada (off label)?  
 
EU reply:  
We understand this question relates to withdrawal periods for medicinal products used outside the 
terms of a marketing authorization in food -producing animal species. In accordance with Article 115 
of Regulation 2019/6, unless a medicinal product used has a withdrawal period provided in its 
summary of the product characteristics for the animal species in question, a withdrawal period shall 
be set by the veterinarian in accordance with criteria set out in Article 115(1) of the Regulation.  
 
Q6 Teniendo en cu enta medicamentos, autorizaciones de comercialización y registros 
existentes, ¿A partir de qué fecha se hará efectiva el cumplimiento de la lista de 
antimicrobianos de uso exclusivo en humanos?  
 
EU reply:   
The implementing acts designating antimicrobials or groups of antimicrobials reserved for treatment 
of certain infections in humans under Article 37(5) are to be adopted by 27 January 2022 and to 
apply as of 28 January 2022.  
 
Q7 Si el antimicrobiano es de uso exclusivo en humanos, y no hay otra alternati va 
terapéutica en animales ante una enfermedad, ¿la UE podría autorizar el uso de éste 
antimicrobiano?  
 
EU reply:  
The Commission will lay down the detailed rules as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January  2022.  
 
Respecto de los cambios normativos en materia de LMR de sustancias activas:  
 WT/TPR/M/395/Add.1  
 
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  Q8 ¿Dónde se puede tener acceso a los comentarios remitidos por los países y a las 
respuestas emitidas por la UE a dichos comentarios en el marco del proceso de consulta 
internacional de la OMC?  
 
EU reply:   
Within the framework of the international consultation process of the WTO, comments are submitted 
and responded to on a bilateral basis and cannot be accessed on a public database. However, 
countries can make a  request to access such documents. Regulation (EC) 1049/2001 lays down the 
basic principles regarding the right of the public to access documents held by the Commission. Under 
this Regulation the public can request access to any document that is not alread y publicly available. 
The Commission applies a maximum level of transparency and can only refuse access in specific 
cases (see Exceptions in Art. 4 on page 3 of the Regulation mentioned above).  
 
Q9 ¿Por qué la UE no realiza una evaluación de impacto frente  a cada sustancia activa (o 
por lo menos las más importantes)? ¿Cuál es la orientación de la Comisión Europea con 
respecto a la gestión de riesgos en los países productores de frutas, una vez que no se 
renueva una sustancia activa o simplemente se reduce e l LMR al 0,01 Mg/Kg?.  
 
EU reply:   
Regulations approving active substances for plant protection products and setting maximum residue 
levels for pesticides residues are routine measures for which clear procedures are laid down in the 
respective legislation a nd for which no impact assessment is necessary. EU legislation on pesticides 
focusses on protection of consumers and the environment and requires that the active substance 
approved poses no risk to humans or the environment and that a MRL is safe for consu mers.  
 
Q10 ¿Por qué en los casos en los que por la falta de información EFSA no realiza una 
recomendación sobre el LMR, no se mantiene provisionalmente los LMR conforme lo 
establecido por Codex Alimentarius, hasta que reúna la información necesaria que 
permitirá a EFSA proponer unos LMR seguros?  
 
EU reply:   
In order to set a maximum residue level (MRL) a risk assessment from the European Food Safety 
Authority must demonstrate that the MRL is safe for consumers. This requires that a minimum of 
supporting dat a is provided in line with the EU's data requirements allowing EFSA to reach a 
conclusion on the safety of the MRL. If such supporting evidence is lacking or insufficient, EFSA 
cannot conclude that the MRL is safe. The situation as regards supporting data and the possibility to 
establish tentative MRLs is evaluated on a case by case basis.  
 
Q11 Respecto del nuevo Green Deal ¿Cómo tiene previsto la UE brindar cooperación a los 
terceros países productores de frutas y vegetales para que se puedan preparar frente a 
los cambios normativos de reducción de LMR en sustancias indispensables para la 
producción y el control de plagas?  
 
EU reply:   
The EU will continue to provide assistance to non -EU countries through its international cooperation 
programmes  and instruments.  
 
Respecto de las propuestas sobre "Cumulative Risk Assement":  
En los últimos años, la Comisión ha estado trabajando en una metodología para tener en cuenta los 
efectos acumulativos de los productos de protección de las plantas. El sitio oficial de la UE informa 
que se ha desarrollado una herramienta en línea basada en la web (Acropolis) para el cálculo de la 
exposición acumulativa a los residuos de dichos productos. También establece que el proyecto se 
está coordinando estrechamente  por parte de la Comisión Europea, que ha establecido un grupo de 
trabajo con los expertos de los países de la UE y la EFSA para garantizar que el proyecto satisfaga 
las necesidades de los gestores de riesgos.  
Podría la UE explicar:  
 
Q12 El estado de desar rollo de tales metodologías y herramientas.  
 WT/TPR/M/395/Add.1  
 
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  EU reply:   
EU legislation for pesticides31,32 and biocides33 requires that their cumulative and synergistic effects 
on consumer exposure should be taken into account when setting MRLs, when approving active 
substan ces and when authorising biocidal products, once the methodology is developed by the 
European Food Safety Authority (EFSA). Since 2008 EFSA has published several scientific opinions 
regarding the development of such a methodology, while the Acropolis proje ct resulted in the MCRA 
(Monte Carlo Risk Assessment) Tool, currently in version 8.3 .34 
 
Based on those developments, EFSA published its first pilot reports on the cumulative risk 
assessment of pesticide residues and their effects on the thyroid and the ner vous system .35 Those 
reports comprise 3 parts: the first part consists in grouping pesticides into Cumulative Assessment 
Groups (CAGs) (hazard identification), the second part includes calculating the cumulative exposure 
for those CAGs based on consumption data and on 2014 -2016 monitoring data and the third and 
final part assesses the uncertainty associated with the methodology and the data, thus finalising the 
risk evaluation. The first two parts where published in October 2019, while for the third part the re 
was a public consultation until mid -November 2019, with a view to finalise and publish it in 
April 2020.  
 
The methodology will be applied in the near future in a retrospective manner, thus assessing acute 
and chronic consumer exposure based on monitorin g results, as part of the EFSA Annual Monitoring 
Report on pesticide residues. At the same time, the working group of EU and EFSA experts will meet 
in 2020 with a view of expanding the method development towards the prospective (MRL -setting) 
scenario, whil e EFSA will continue its work on retrospective assessments for other CAGs.  
 
Q13 Las oportunidades para que los miembros y las partes interesadas participen en el 
proceso regulatorio de creación de tales metodologías y herramientas.  
 
EU reply:   
The development of the methodology is not really a regulatory process, as the regulatory 
requirements are already set. Stakeholders participate in those advancements via inputs in public 
consultations and through their national contact points, which are repres ented in EFSA's Advisory 
Board, in the Working Group of Experts and in the Standing Committee for Plants, Food, Feed and 
Animals, both chaired by DG SANTE.  
 
Q14 Las ideas de la Comisión sobre los límites previstos en el tiempo y el número de 
factores que s e podrían tener en cuenta para tal acumulación.  
 
EU reply:   
As already mentioned in our reply to question 12, the methodology for cumulative risk assessment 
will be included in the near future in the EFSA annual report for pesticide residues, without 
influencing the setting of MRLs. As of early 2020, EFSA and DG SANTE will start working on 
developing a method for the MRL -setting aspect . 
 
Q15 Las ideas de la Comisión sobre cómo garantizar la menor restricción al comercio de 
tales metodologías y herramientas.  
 
EU reply:   
Our priority is to ensure methodological advancement in the field of mixtures of pesticide residues, 
as this is a topic of major concern to European citizens. Similar discussions are ongoing already at 
international level, e.g. in  OECD and JMPR. The EU will make sure that its expertise in this area is 
shared and is willing to constructively contribute to such discussions. Before implementing the 
methodology into regulatory practice, more work is still needed, including the consider ation of 
possible trade impacts.  
 
 
31 Available at: https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396.  
32 Available at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex%3A32009R1107 . 
33 Available at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32012R0528 . 
34 Available at: https://mcra.rivm.nl/Account/LoginMcra# . 
35 Available at: https://www.efsa.europa.eu/en/consultations/call/public -consultation -draft-efsa-
scientifi c-reports . WT/TPR/M/395/Add.1  
 
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  INFORME DE LA SECRETARÍA - Documento WT/TPR/S/395  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS  
 
3.1 Medidas que afectan directamente a las importaciones  
3.1.1 Procedimientos y requisitos aduaneros y valoración en aduana  
3.1.1.2 Facilitación del comercio  
 
En el párrafo 3.16 indica la Secretaria que "… A partir del 1º de octubre de 2019 entrará en 
funcionamiento un portal para comerciantes armonizado de la UE, el eAEO. A través de ese portal 
se podrá in tercambiar información, es decir, notificaciones entre las administraciones de aduanas y 
los OEA con respecto a los procedimientos de este programa relativos a la solicitud y la gestión de 
la autorización. Se espera que el sistema esté plenamente operativo  a partir del 15 de diciembre de 
2019".  
 
Por otra parte, en el párrafo 3.18 señala que "la Comisión sigue racionalizando y mejorando los 
procedimientos que se utilizan en los puertos y en el transporte marítimo. El 15 de agosto de 2019, 
entró en vigor el R eglamento 2019/1239 por el que se crea un entorno europeo de ventanilla única 
marítima (EMSWe). Su establecimiento obedece a la necesidad de reducir la carga administrativa de 
las compañías de navegación, agilizar el transporte marítimo y mejorar la intero perabilidad de los 
flujos de información. Así pues, el nuevo Reglamento, que reemplaza al anterior, de 2010, armoniza 
en mayor medida las normas para la presentación de información cuando los buques entran en un 
puerto de la UE o salen de él. Se aplicará p lenamente a partir de 2025 y se espera que permita 
reducir a la mitad el tiempo necesario para llevar a cabo las formalidades aduaneras requeridas para 
hacer una escala portuaria".  
 
Q16 Agradecemos a la Unión Europea ampliar la información relativa a: (i) la entrada en 
funcionamiento del portal para comerciantes armonizado de la UE, eAEO, prevista para el 
15 de diciembre de 2019, y si el mismo permite que otros países realicen consultas sobre 
los operadores económicos autorizados; y (ii) sobre la ventanilla  única marítima, EMSWe 
(con la que se espera reducir a la mitad, el tiempo necesario para llevar a cabo las 
formalidades aduaneras requeridas para hacer una escala portuaria), respecto de sus 
funcionalidades y de las entidades que la integran.  
 
EU reply:   
(i) The eAEO Customs trader portal is fully operational since 16/12/2019. It is not designed to be 
consulted by third countries.  
But, if the AEO company gave its formal consent to be included in the EU AEO database, they can 
be found using the link below:   
https://ec.europa.eu/taxation_customs/dds2/eos/aeo_consultation.jsp?Lang=en  
 
If the AEO did not give its consent, the AEO status of a company can then only be verified by 
contacting this company directly and ask for proof of AEO authorisation (AEO certif icate).  
 
(ii) Regulation 2019/1239/EU establishing a European Maritime Single Window environment entered 
into force on 15 August 2019 and includes a set of measures to achieve harmonisation and 
simplification in maritime reporting. It will create a single entry point per Member State and will 
minimise duplicate reporting requests for static data by appropriate data re -use mechanisms.  
A corner stone of the new regulation is the harmonisation of data definitions and formats and 
measures to improve data flows  for increased efficiency. The shipping operators will have the 
opportunity to report to customs using the same interface. It is also envisaged that national and 
local reporting requirements will be rationalised and harmonised.  
Authorities will use the Maritime National Single Windows to share some information with the 
providers of port services, like pilots, tugs, terminals, etc. Relevant information will be also available 
to operators along the logistic chain.  
The new rules are expected to cut in half the reporting times, saving about 2.5 million hours every 
year, and hence reduce administrative costs by up to EUR 725 million for the shipping sector by 
2030. As a facilitation measure, the regulation will apply to all ships calling at European ports, 
including non -European vessels.  
 WT/TPR/M/395/Add.1  
 
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  3.3 Medidas que afectan a la producción y al comercio  
3.3.1 Incentivos  
3.3.1.1 Subvenciones a nivel de la UE  
 
En el párrafo 3.128 se informa que "el objetivo del FEDER es fortalecer la cohesión socioeconómica 
dentro de la Unión Europea corrigiendo los desequilibrios entre sus regiones. El FEDER centra sus 
inversiones en cuatro áreas prioritarias clave: la innovación e investigación; el programa digital; el 
apoyo a las pymes; y la economía de bajas emisiones de carbono. Los recursos del FEDER asignados 
a estas prioridades dependen de la categoría de la región: en las regiones más desarrolladas, al 
menos un 80% de los fondos debe centrarse en dos de estas prioridades como mínimo; en las 
regiones en transición, el 60%; y en las  regiones menos desarrolladas, el 50%. Además, parte de 
los recursos del FEDER deben destinarse a proyectos de economía de bajas emisiones de carbono; 
en concreto, el 20% en las regiones más desarrolladas; el 15% en las regiones en transición; y el 
12% en las regiones menos desarrolladas".  
 
Q17 Podría la Unión Europea explicar cómo funciona este fondo de subvenciones en 
economías menos desarrolladas de la UE y, si bien son distintos los objetivos con el fondo 
de cohesión, ¿cómo coexisten éstos?  
 
EU reply:  
In 2014 -20, Cohesion Policy consists of three funds: the European Regional Development Fund 
(ERDF), the European Social Fund (ESF) and the Cohesion Fund (CF). The ERDF addresses regions 
(i.e. at a regional, not national level) and calibrates its aid intens ity depending on their level of 
development. As opposed to the ERDF, the Cohesion Fund intervenes at national (not regional) level, 
namely in Member States with a per capita GNI of less than 90% of the EU average. It focuses on 
environment and energy inves tments.  
 
The ERDF's focus of support is on the so -called less developed regions (with a GDP per capita of 
<75% of the EU average), but transition regions (GDP per capita >75%, but <90% of the EU 
average) and more developed regions (GDP per capita >90% of t he EU average) are also supported. 
(Please note that the percentages for the categories of regions change for 2021 -2027.)  
 
In 2014 -20, EU Cohesion Policy addresses eleven thematic objectives, to which all the three funds 
mentioned above are expected to con tribute. Particular importance is given to the first four thematic 
objectives: (1) strengthening research, technological development and innovation; (2) enhancing 
access to, and use and quality of, ICT; (3) enhancing the competitiveness of SMEs, (4) suppor ting 
the shift towards a low -carbon economy in all sectors. These are the four thematic objectives that 
the ERDF is supposed to focus on, and it does so through the so -called thematic concentration:  
 
• In more developed regions, at least 80% of the total ERD F resources at national level shall 
be allocated to two or more of these four thematic objectives. At least 20% of the total ERDF 
resources at national level shall be allocated to the fourth thematic objective, i.e. to move 
towards a low -carbon economy (an d thereby tackle climate change);  
• In transition regions, at least 60% of the total ERDF resources at national level shall be 
allocated to two or more of these four thematic objectives. At least 15% of the total ERDF 
resources at national level shall be al located to the fourth thematic objective;  
• In less developed regions, at least 50% of the total ERDF resources at national level shall 
be allocated to two or more of these four thematic objectives. At least 12% of the total ERDF 
resources at national level shall be allocated to the fourth thematic objective.  
 
Through thematic concentration, the policy aspires to have real impact and critical mass of 
interventions. More developed regions are in many cases better prepared to focus their investments 
on thematic  objectives 1 -4 (incl. innovation, research etc.) than less developed regions, which are 
often still in need of more basic infrastructure. This explains the different concentration 
requirements.  
 
For 2021 -2027, the Commission has proposed to replace the 1 1 thematic objectives by five policy 
objectives (among which "a smarter Europe", "a greener, low -carbon Europe" and "a more connected 
Europe"). The thematic concentration requirements will also be adjusted, but will fundamentally 
continue to follow a very similar logic.  
 WT/TPR/M/395/Add.1  
 
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  4 POLÍTICAS COMERCIALES, POR SECTORES  
4.1 Agricultura y pesca  
4.1.1 Agricultura  
4.1.1.2 Políticas agrícolas  
4.1.1.2.1 Ayuda interna  
4.1.1.2.1.1 Pagos directos  
 
Régimen de pago a los jóvenes agricultores  
 
En el párrafo 4.24 se señala que "c ada Estado miembro está obligado a aplicar el régimen de jóvenes 
agricultores, en cuyo marco se conceden pagos adicionales a agricultores que se beneficien de pagos 
básicos o de pagos únicos por superficie, que tengan 40 años de edad o menos e n el año en que 
presenten la solicitud correspondiente al régimen y que se instalen por primera vez en una 
explotación agraria como jefe de explotación, o que lo hayan hecho ya dentro de los cinco años 
anteriores a la aplicación del régimen. Los Estados mi embros pueden definir otros criterios de 
admisibilidad, por lo que respecta a conocimientos adecuados y/o requisitos formativos".  
 
Q18 ¿Podría la Unión Europea explicar cómo funciona este pago y según la experiencia de 
la UE, para los últimos años, los Est ados miembros han logrado "retener" población joven 
en este sector?  
 
EU reply:   
The Young Farmer Payment (YFP) is a compulsory scheme for Member States to implement. The 
payment is additional to other direct payments and is limited to a maximum period of 5  years 
following the setting -up. Member States had to make a number of policy choices in implementing 
the YFP. In particular, the method for calculating the payment for young farmers. Article 50(6) to 
(8) and Article 50(10) of Regulation (EU) No 1307/2013 provide for several calculation methods for 
calculating the payment per farmer. When a Member State chose one of the methods provided in 
Article 50(6) to (8), a single maximum limit has been set for the number of payment entitlements 
activated by the farme r or to the number of eligible hectares declared by the farmer. In addition, 
Member States may define additional eligibility criteria regarding appropriate skills and/or training 
requirements that have to be met when submitting his first application for th e YFP.  
 
In 2017, almost 410 000 young farmers, benefited from the YFP in the EU: an increase of about 5% 
in comparison to 2015. The share of YFP beneficiaries varies among Member States: between 1% 
and approximately 13% of total decoupled direct payment be neficiaries.  
 
4.3 Manufacturas  
Industria del automóvil  
 
En el párrafo 4.184. la Secretaria informa que "se prevé que aproximadamente el 80% del 
crecimiento del sector del automóvil se producirá fuera de la UE, de modo que, si la UE aspira a 
conservar e incrementar en el futuro su cuota de mercado, resultará cada vez más importante que 
mantenga el liderazgo en cuanto a costos y en las nuevas esferas tecnológicas. Un factor clave que 
contribuirá a la competitividad en el futuro será la evolució n del entorno normativo, tanto dentro 
como fuera de la UE. Gracias a una reglamentación rigurosa, la UE se asegura de que la industria 
del automóvil siga creando productos sostenibles, de gran calidad y tecnológicamente avanzados, y 
de que al mismo tiempo ocupe una posición sólida de liderazgo normativo en lo que se refiere a 
proteger el mercado interno y potenciar al máximo las oportunidades de acceso a los mercados 
extranjeros".  
 
Q19 Qué cambios normativos (ambientales, de seguridad, etc.) impulsará la UE  con el fin 
de mantener el liderazgo y su cuota y manejo en este sector?  
 
EU reply :  
The automotive regulatory framework in the EU is mature and strongly aligned with the regulations 
that are put forward by the international regulatory body in this area: UNECE World Forum for 
Harmonization of Vehicle Regulations (WP. 29). The competitiveness of the EU automotive sector 
results from significant investments of the sector on Research and Innovation ( EUR 57 billion in 
2019), long experience in production  and high quality of output. The demanding EU regulatory 
framework on safety and environment requirements is a result of consumer and societal needs and 
serves to ensure that cars placed in the market provide for safety of vehicle occupants in case of WT/TPR/M/395/Add.1  
 
- 185 - 
 
  accident, have features to reduce probability of accidents to occur and have a reduced air quality 
impact (reduced CO2 and pollutants emissions).  
 
2. Régimen de Comercio e Inversiones  
Marco general  
 
"2.6. El Consejo adopta la decisión de celebrar el acuerdo una vez obtenida la aprobación del 
Parlamento. Este último ratifica los acuerdos comerciales internacionales por mayoría simple. Las 
decisiones del Consejo sobre la negociación y celebración de acu erdos comerciales internacionales 
se adoptan por mayoría cualificada, salvo en determinados casos. En primer lugar, el Consejo deberá 
pronunciarse por unanimidad para negociar y celebrar acuerdos en materia de servicios, aspectos 
comerciales de los derecho s de propiedad intelectual e inversiones extranjeras directas, cuando esos 
acuerdos contengan disposiciones relativas a la adopción de normas internas para las que se 
requiera la unanimidad. En segundo lugar, el Consejo deberá pronunciarse por unanimidad p ara 
negociar y celebrar acuerdos en el ámbito del comercio de servicios culturales y audiovisuales, 
cuando dichos acuerdos puedan perjudicar a la diversidad cultural y lingüística de la Unión, o 
acuerdos en el ámbito de servicios sociales, educativos y san itarios, cuando dichos acuerdos puedan 
perturbar gravemente la organización nacional de dichos servicios y perjudicar a la responsabilidad 
de los Estados miembros en la prestación de los mismos."  
 
Q20 ¿Cuándo se considera que un acuerdo de servicios audiovisuales perjudica la 
diversidad cultural y lingüística de la Unión? Existen parámetros establecidos por el 
Consejo al respecto?  
 
EU Reply:   
The assessment of whether the Council must act unanimously fo r the negotiation and conclusion of 
agreements in the field of trade and audiovisual services on the grounds that they risk prejudicing 
the Union's cultural and linguistic diversity is not subject to pre -set criteria. The Council acts on the 
basis of recom mendations or a proposal by the Commission and the decisions the Council takes may 
be subject to review by the European Court of Justice.  
 
2.4.1 Inversión y mercado interno de la UE  
 
2.57. En el período objeto de examen se produjeron importantes novedades en lo que respecta a la 
situación de los acuerdos bilaterales de inversión entre los Estados miembros de la UE en el marco 
de la legislación de la Unión Europea. Muchos de los acuerdos bilaterales de inversión intra -UE se 
concluyeron cuando una de las dos partes aún no era miembro de la UE.95 La Comisión siempre ha 
considerado que esos acuerdos son incompatibles con la legislación de la Unión, y en 2016 instó a 
determinados Estados miembros a ponerles fin. La Comisión "intensificó su diálogo" con los Estado s 
miembros a este respecto a raíz de una sentencia del TJUE de 2018 en la que se confirmó que las 
cláusulas arbitrales de los acuerdos bilaterales de inversión intra -UE entre un inversor y el Estado 
son contrarias a la legislación de la UE.96 En enero de 2 019, todos los Estados miembros firmaron 
declaraciones políticas en las que se comprometían a poner fin a sus acuerdos bilaterales de 
inversión intra -UE a más tardar a finales de 2019.97  
 
2.72. La política de inversión extranjera de la UE incluye disposiciones transitorias sobre los acuerdos 
bilaterales de inversión firmados por los Estados miembros de la UE con terceros países antes de la 
entrada en vigor del Tratado de Lisboa o de la fecha de su adhesión a la UE. Según una comunicación 
de la Comi sión de junio de 2019121, estaban en vigor más de 1.400 acuerdos bilaterales de inversión 
entre Estados miembros de la UE y terceros Estados, lo que representa más de la mitad de los 
2.353  acuerdos bilaterales de inversión vigentes en todo el mundo, según cifras de la base de datos 
de la UNCTAD sobre acuerdos internacionales de inversión.122 El Reglamento (UE) Nº 1219/2012 
establece las condiciones en las que esos acuerdos pueden mantenerse en vigor hasta que sean 
sustituidos progresivamente por acuerdos de  inversión celebrados por la UE.123. También dispone 
que la Comisión podrá autorizar a los Estados miembros a negociar con terceros Estados para 
modificar los acuerdos existentes o concluir otros nuevos, con sujeción a determinadas condiciones.  
 
Q21 ¿Podrí a la UE informar el estado de cumplimiento de las declaraciones políticas que 
firmaron los Estados miembros en enero de 2019, en la que se comprometieron a finalizar 
sus acuerdos bilaterales de inversión intra -UE a más tardar a finales de 2019? ¿Ya la 
totalidad de estados miembro le puso fin a todos los acuerdos bilaterales de inversión 
intra -UE? WT/TPR/M/395/Add.1  
 
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  EU reply:   
On 24 October 2019, EU Member States reached an agreement on a plurilateral agreement for the 
termination of intra -EU bilateral investment treaties. The  agreement is in line with EU and 
international law.  
On the same day, the European Commission released a public statement (available at 
https://ec.europa.eu/info/sites/info/files/business_economy_euro/banking_and_finance/document
s/191024 -bilateral -investme nt-treaties_en.pdf).  
The signature of the plurilateral agreement is expected in spring 2020, depending on the Member 
States' internal empowerment procedures. Once the agreement is signed and ratified, it will have 
the legal value of an international treat y. It will terminate the intra -EU BITs between the Member 
States that are parties to the plurilateral agreement.  
 
Q22 ¿Qué estados miembros están actualmente negociando acuerdos bilaterales de 
inversión y con qué países?  
 
EU reply:   
Under Regulation EU 1219/12 the Commission has so far issued 322 authorisations to EU Member 
States for the negotiation and conclusion of bilateral investment agreements with third countries all 
over the world. Such authorisations entitle the Member State concer ned to negotiate, but do not 
create a formal obligation to do so. It is therefore not possible to give an exact figure for how many 
negotiations are currently ongoing. The Commission, however, publishes each year a full list of all 
bilateral investment agr eements that each Member State has actually signed with a third country. 
The most recent version of this list can be found in the EU's Official Journal of 13 June 2019 
(OJ 2019/C 198/01).  
 
Q23 ¿Podría la UE indicar cuáles son las condiciones a las que están sujetos los Estados 
miembros en caso de que la Comisión les autorice negociar con terceros Estados para 
modificar los acuerdos de inversión existentes o concluir otros nuevos? ¿Deben velar por 
que los nuevos Acuerdos cumplan con todas las condiciones  para su compatibilidad con el 
ordenamiento jurídico europeo que estableció el TEUJ en la revisión del Capítulo de 
Inversiones del CETA? Qué pasa con los acuerdos antiguos con terceros países que NO 
cumplen con dichas condiciones? Planea la Unión europea u n Reglamento similar al 
Reglamento (UE) Nº 1219/2012 en el que se establezcan orientaciones para el caso de 
los Acuerdos con terceros países?  
 
EU reply:   
Regulation 1219/2012 lays down the conditions under which EU member States can conclude new 
or amend o ld investment agreements. An authorisation cannot be granted if an EU -level investment 
negotiation is already ongoing with the same third country (or if the Commission has recommended 
the opening of such a negotiation). Other key conditions include compati bility with Union law and 
consistency with the Union's principles and objectives for external action. To ensure consistency 
between bilateral investment agreements and the EU's reformed investment policy, the Commission 
in its decisions to EU member State authorising new or amendments to old agreements sets out the 
relevant modernised standards and rules to be included in agreements with third countries. These 
include, inter alia , the right to regulate; a clear circumscription of the fair and equitable trea tment 
standard; definition of direct and indirect expropriation; and a reference to human rights and 
sustainable development. As regards investment dispute settlement, it also includes: transparency 
requirements; a code of conduct for tribunal members; com mitments to make disputes subject to a 
future multilateral investment court; and provisions on the applicable law ensuring preservation of 
the autonomy of the EU legal order.  
 
3.1.6 Medidas antidumping, compensatorias y de salvaguardia  
3.1.6.1 Medidas ant idumping y antisubvenciones  
 
3.80. También ha habido cambios en otras normas de la legislación de la UE relativas a las medidas 
comerciales correctivas. La UE dispone de legislación sobre la protección contra las subvenciones y 
las prácticas tarifarias desleales en los servicios aéreo s desde 2004, que se estaba revisando cuando 
se realizó el anterior examen.126 En 2019 entró en vigor un nuevo reglamento sobre la defensa de 
la competencia en el transporte aéreo, que sustituyó al reglamento anterior de 2004.127 La nueva 
legislación tiene  por objeto responder a las preocupaciones suscitadas por las prácticas desleales de 
terceros países y de entidades de terceros países, en particular aquellos que se benefician de 
subvenciones o de otras formas de ayuda estatal. Una investigación puede ser  iniciada por un Estado WT/TPR/M/395/Add.1  
 
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  miembro, una línea aérea de la UE, una asociación de líneas aéreas de la UE o la propia Comisión. 
En cuanto al procedimiento, se siguen las principales normas relativas a las medidas comerciales 
correctivas para la apertura y realiz ación de una investigación, la determinación del perjuicio o la 
amenaza del perjuicio y la adopción de medidas correctoras. Las medidas correctoras pueden ser 
obligaciones financieras o cualquier medida operativa de igual o menor valor, de servicios debido s o 
de otros derechos de la compañía aérea del tercer país.  
 
Q24 ¿Podría la UE indicar cuál ha sido el impacto en términos de aumento o disminución 
del número de investigaciones abiertas a partir de la entrada en vigor del nuevo 
reglamento sobre la defensa  de la competencia en el transporte aéreo? ¿Podría la UE dar 
a conocer las primeras evaluaciones que se hayan realizado sobre la aplicación de la nueva 
legislación?  
 
EU reply:   
The Commission did not open any investigations yet under the new Regulation 201 9/712.  
 
4.4 Política comercial para un comercio abierto y equitativo  
 
4.53 La UE ha adoptado varias medidas importantes para lograr un comercio abierto y al 
mismo tiempo equitativo:  
 
a. Reglamento sobre el control de las inversiones extranjeras directas[1]: este Reglamento entró en 
vigor el 10 de abril de 2019. Se aplicará plenamente a partir del 11 de octubre de 2020. En algunos 
casos excepcionales (inversiones extranjeras que afectan a tecnologías críticas, a infraestructuras 
críticas, al sumin istro de insumos fundamentales o al acceso a datos sensibles), ayudará a la Unión 
Europea a proteger sus intereses en materia de seguridad frente a las inversiones extranjeras cuyo 
objetivo sea adquirir activos europeos críticos. El marco de control de la UE no reemplaza ni duplica 
ningún mecanismo nacional ya existente, por lo que no añade trámites administrativos para los 
inversores. No está dirigido a los inversores de ningún país en concreto; la no discriminación es un 
principio fundamental del nuevo re glamento, y los mecanismos de control de los Estados miembros 
de la UE deberán respetar ese principio. Además, las prescripciones aplicables a los mecanismos 
nacionales de control incluyen normas sobre la transparencia, la confidencialidad de la informació n 
intercambiada y la posibilidad de recurrir las decisiones de control, y medidas para determinar y 
evitar la elusión de los mecanismos y las decisiones por parte de los inversores extranjeros.  
 
Q25 ¿Podría la UE explicar en mayor detalle cómo aplicarán es te reglamento y por qué se 
vieron en la necesidad de implementar unas medidas de este tipo? ¿Cuáles fueron los 
principales cambios con respecto a cómo se controlaban las inversiones antes de esta 
reglamentación?  
 
EU Reply:   
The EU created this new framewor k to be able to respond to the changing trends in foreign direct 
investments ('FDI') into the Union and to increase awareness of possible threats to security or public 
order related to certain foreign direct investments in the Union. At the same time, the Regulation 
was also designed to not impede foreign investments into the Union which contribute to the Union's 
growth, create jobs, bring in capital, technology, innovation and expertise.  
The Regulation (i) sets out some essential elements for the screenin g mechanisms of Member States 
(such as transparency, non -discrimination and factors to be taken into consideration when assessing 
whether a FDI is likely to affect security or public order) and (ii) establishes a new cooperation 
mechanism between Member St ates and the Commission on certain FDI. A Member State may issue 
comments where it considers that FDI in the territory of another Member State is likely to affect its 
security or public order. As regards the Commission, it may issue an opinion to the Membe r State 
where it considers that an investment is likely to affect security or public order in more than one 
Member State or when it has relevant information in relation to that investment. A Member State 
may also request an opinion by the Commission. The M ember State shall give due consideration to 
the comments from other Member States or the Commission's opinion. The final decision shall 
however be taken by the Member State.  
The Commission may also issue an opinion to the Member States when the investment  is likely to 
affect a project or programme of Union interest. In such case, the Member State concerned shall 
take utmost account of the Commission's opinion and provide an explanation to the Commission if 
its opinion is not followed. This exchange of info rmation and cooperation between the Member States 
and the Commission did not exist before and will become applicable on 11 October 2020.  WT/TPR/M/395/Add.1  
 
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  4.4.2 Servicios de construcción  
4.4.2.2 Marco jurídico y de políticas  
 
4.264. Recientemente se ha formulado una propuesta de Directiva y Reglamento sobre una tarjeta 
electrónica de servicios.353 Lo que se propone es elaborar un formulario de notificación armonizado 
para obtener una suerte de "pasaporte de servicios", que perm ita acceder a la actividad de que se 
trate en el Estado miembro receptor, lo que potenciaría la cooperación entre los Estados miembros 
de origen y los Estados miembros receptores, y ayudaría a los proveedores de servicios 
transfronterizos. Este procedimien to armonizado totalmente electrónico reducirá los obstáculos 
administrativos y simplificará los trámites para que los proveedores de servicios puedan prestarlos 
de una manera más eficiente en el extranjero. En marzo de 2018 se dejó en suspenso el proceso 
legislativo de la iniciativa.  
 
Q26 ¿Podría la UE informar las razones de la suspensión del proceso legislativo de la 
iniciativa?  
 
EU reply:  
The services e -card initiative has been on hold since 21 October 2019 because the European 
Parliament expressed the view that the legislative proposal should be withdrawn. As announced on 
29 January 2020, the Commission has decided to include it in its Wor k Programme for 2020. Different 
options for the way forward are currently explored.  
 
Q27 ¿Podría la UE explicar cuál es el proceso de implementación del "pasaporte de 
servicios" y si se prevé ampliar su aplicación a los socios comerciales?  
 
EU reply:   
As a proposal, the services E -card initiative (formerly called services passport initiative) foresaw 
various possible steps regarding transposition and implementation. In line with the Treaty freedoms, 
the initiative would have benefitted only companies consti tuted in accordance with the laws of a 
Member State and having their registered office, central administration or principal place of business 
within the EU. The initiative is currently on hold.  
 
4.272. The DSM Strategy was launched in 2015 as part of the E urope 2020 Strategy. It aims to 
create a market "in which the free movement of goods, persons, services and capital is ensured and 
where individuals and businesses can seamlessly access and exercise online activities under 
conditions of fair competition, and a high level of consumer and personal data protection, irrespective 
of their nationality or place of residence".  The Strategy rests on three main pillars: (i) better access 
for consumers and businesses to online goods and services across E urope; (ii) creating the right 
conditions for digital networks and services to flourish; and (iii) maximizing the growth potential of 
the European digital economy.  
 
Q28 Podría informar la UE ¿Cuáles fueron los obstáculos más difíciles de afrontar para 
lograr un Mercado Digital consolidado e integral en la Unión Europea?  
 
EU reply:   
Developing a Digital Single Market in the EU had a number of challenges. An important one was the 
existence of national markets in the telecoms sector. This was addressed e.g. b y the elimination of 
roaming charges in the EU  (https://ec.europa.eu/digital -single -market/node/28785), and new 
common rules in the European Electronic Communications Code (https://ec.eu ropa.eu/digital -
single -market/en/news/european -electronic -communications -code-updating -eu-telecom -rules). 
There were also barriers limiting cross -border portability of online content services. The main 
reasons behind those barriers were related to licensin g practices of right holders and the commercial 
practices of service providers. To overcome them a regulation for ensuring cross -border portability 
of online content services  was adopted (https://ec.europa.eu/digital -single -
market/en/news/regulation -cross-border -portability -online -content -services -internal -market). This 
means that, since September 2018, consumers in the EU can use online services, they have acc ess 
to in their home country (e.g. watching films or sporting events, listening to music, reading e -books 
or playing games) also, wen they travel to other EU Member States.  
 
Other obstacles concerned geoblocking practices used by traders and preventing co nsumers from 
freely shopping across EU countries. To address these obstacles, a regulation on addressing 
geoblocking  (https://ec.europa.eu/digital -single -market/en/geo -blocking -digital -single -market) WT/TPR/M/395/Add.1  
 
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  and other forms of discrimination based on customers' nationality, place of residence or place of 
establishment was adopted. The regulation e.g. bans blocking of access to websites and automatic 
re-routing, if the consumer has not given prior consent. The regulation also sets a non -discrimination 
rule in payments. The new rules have been in place since December 2018 and consumers can now 
be treated equally when buying online in another EU country.  
 
4.276. The Europe an Commission's communication on the DSM Strategy identified five types of 
regulatory barriers to the growth of cross -border e -commerce within the EU: (i) the complexity and 
disparity of national contract and consumer protection laws; (ii) the cost and ine fficiencies of high 
quality cross -border parcel delivery services; (iii) practices used by online sellers that result in the 
denial of access to websites based in other member States; (iv) obstacles to the cross -border access 
to copyright -protected content  and services; and (v) the burdens on businesses arising from 
different VAT systems.  
 
Q29 ¿Cómo se logró tener un consenso entre el sector público y el privado sobre qué 
medidas implementar para lograr resolver las barreras anteriores?  
 
EU reply:   
An extensive consultation process, during which the Commission consulted interested parties, such 
as non -governmental organisations, local authorities and representatives of industry and civil 
society, took place. Groups of experts also gave advice on tech nical issues. This process helped 
identify possible obstacles across a wide range of issues and build the necessary consensus.  
 
4.281. Reform of VAT rules is an important dimension of the DSM Strategy. In December 2017, the 
EU adopted new VAT rules as par t of a modernization of VAT for e -commerce. The new rules comprise 
three legal acts, a Council Directive, a Council Regulation  and a Council Implementing 
Regulation.  Some of the rules became applicable on 1 January 2019, while others will become 
applicable  on 1 January 2021.  
 
Q30 Desde la perspectiva del Gobierno, las entidades aduaneras y los actores privados 
que participan en la cadena de valor del comercio electrónico, ¿cómo se ha visto, sentido 
y asimilado la implementación de la nueva normativa del IVA ? 
 
EU reply:   
The implementation work on the VAT e -commerce package is still ongoing, as the measures will 
enter into force only on 1 January 2021. The implementation is a complex project, as it required 
further legal amendments of the VAT legislation, IT developments and considerable impact on the 
customs legislation and procedures. Given this, tax and customs authorities from all EU Member 
States, including IT people, as well as concerned businesses (online sellers, marketplaces, postal 
and courier operat ors, customs agents) are permanently consulted and providing input to the 
Commission. This dialogue began already in 2014 (when the Commission started its preparatory 
work for the proposal) and will continue at least until the full deployment of the packag e in 2021.  
 
4.329. As at 15 June 2017, roaming charges were abolished for customers travelling periodically 
within the EU, in accordance with a Regulation adopted in November 2015.  In order to avoid negative 
effects of abusive use of regulated retail roam ing services by roaming customers, the Regulation 
allows roaming providers to apply a "fair use" policy. Detailed rules and conditions on this "fair use" 
policy are laid down in an Implementing Regulation adopted in December 2016.  
 
Q31 ¿Cómo fue la reacci ón y acople de los operadores a la medida de referencia?  
 
EU reply:   
The review report of 29 November 2019 from the Commission to the European Parliament and the 
Council on the functioning of the roaming market in Europe, following the introduction of Roam Like 
at Home (RLAH) – COM(2019) 616 final36 reflects the main reactions of the market to the introduction 
of RLAH:  
 
 
36 Available at: https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1581331782808&uri=CELEX:52019DC0616 . WT/TPR/M/395/Add.1  
 
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  • Operators in general have complied with the new rules. Where a breach of the rules was detected 
in a Member State, the r egulatory authority (NRA) swiftly solved the issue with the operator 
concerned, often before starting any formal proceedings or in the course of such proceedings.  
• Operators report having maintained the overall availability of their tariff plans under RLAH . 
According to an opinion by the Body of European Regulators on Electronic Communications 
(BEREC), no significant changes occurred to the overall structure of the domestic tariff plans. 
Similarly, one does not observe any negative consequences to retail ro aming prices of EU/EEA 
mobile operators in non -EU/EEA countries. Many operators include some popular non -EU/EEA 
destination countries in their RLAH offering or apply a reduced roaming fee to those countries.  
• As allowed by Commission Implementing Regulation  (EU) 2016/2286 of 15 December 2016 
laying down detailed rules on the application of fair use policy and on the methodology for 
assessing the sustainability of the abolition of retail roaming surcharges and on the application 
to be submitted by a roaming p rovider for the purposes of that assessment37, to prevent abusive 
or anomalous use of roaming services at domestic prices, the vast majority of operators have 
applied a fair use policy (95% of MNOs and 78% of MVNOs). However, the proportion of 
customers who  actually exceed the limits of any fair use policy remains very limited and traffic 
that is subject to a small surcharge because it exceeds fair use limits remains very low, with 
surcharges that are below the ones applied prior to 16.6.2017.  
• Very few mobil e operators have made use of the sustainability derogation. The roaming 
regulation gives this option to operators who can demonstrate that they are not able to recover 
their actual and projected roaming costs without increasing their domestic prices. In it s Opinion 
on the roaming market, BEREC notes that the derogation mechanism concerns a small and 
shrinking part of the market and that NRAs expect the number of derogations to further decrease 
in the coming years.  
 
In the wholesale roaming market, regulati on has triggered considerable reductions in wholesale 
prices that have benefited net outbounder operators. Net inbounder operators have benefited from 
increased roaming demand.  
 
3.2 Measures Directly Affecting Exports  
3.2.1 Customs procedures and requireme nts 
 
En la página 86, numeral 3.2.1, se indica que: "Prior to exportation, the exporter is required, in 
most circunstances, to file a pre -departure declaration with the customs authorities",  
 
Q32 ¿Podría la UE ampliar esta información de la Secretar ía, indican do con mayor detalle 
en qué circunstancias se requiere presentar y cuáles no, una declaración previa a la salida 
ante las autoridades aduaneras?  
 
EU reply:   
There are derogations to the obligation to lodge a pre -departure declaration, which are established  
in Article 271(2) UCC (i.e. for goods passing through the customs territory of the Union without 
stopping there) and in Article 245 UCC -Delegated Act (e.g. goods leaving the EU by pipeline or items 
of correspondence).  
 
En la página 90, numeral 3.112, se d escribe que; "There was also further progress towards the 
development of the Dual -use e -System (DUeS), an electronic system from the Commission to 
support the exchange of information between member State export control authorities and the 
Commission, in pa rticular on enhanced functionality and better online management",  
 
Q33 ¿Podría la UE ampliar esta información de la Secretar ía sobre este sistema, en 
particular los beneficios de la implementación del Sistema electrónico Dual -use e -System?  
 
EU reply:   
The Dual Use electronic System (DUeS) is a secure and encrypted system for the Exchange of 
information between Member States and t he Commission. It was set up according to Article 19(4) 
of the Council regulation (EC) No 428/2009. The system supports the secure exchange of information 
with regards to the denials issued by the Member States, or to any modification to the export 
authori sations already granted by the Member States. The recent developments of the system are 
 
37 OJ L 344, 17.12.2016, p. 46 –62. Available at: https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1581330848910&uri=CELEX:32016R2286.  WT/TPR/M/395/Add.1  
 
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  related to the implementation and the improvement of the consultation mechanism between the 
Member States, foreseen by the Regulation in some specific case. This mechan ism is now 
implemented within the Dual Use electronic System, so to have a quicker and more secure and 
efficient process of consultation. The main benefits of these implementations are related to the 
security of the information exchanged, to the efficiency  of the process of consultation, to a more 
efficient application of a no -undercut policy within the EU.  
 
3.1.3.2 Tipos aplicados  
 
"3.40. También llama la atención el número de aranceles no ad valorem  de la UE, ya que alrededor 
del 10% de las líneas arancelarias están sujetas a derechos no ad valorem , y su número aumentó 
en el período objeto de examen. Además, aproximadamente un tercio de los aranceles no ad valorem  
son derechos compuestos, mixtos u ot ros, lo cual significa que en muchos casos es difícil determinar 
el tipo del derecho o calcular el efecto real del arancel."  
 
Q34 Teniendo en cuenta que los derechos compuestos no generan previsibilidad a los 
operadores comerciales ¿cuál es la política de la UE en relación a los mismos y por qué en 
lugar de disminuir han aumentado?  
 
EU reply:   
The EU's import regime for agricultural products is fully transparent and predictable and is contained 
in the EU's WTO schedule. The apparent small increase in the nu mber of non -ad valorem  tariffs is in 
fact due to the nomenclature change from HS2012 to HS2017. In substance, there has been no 
change compared to the previous exercise. Concerning the non -ad valorem tariff lines, it affects 
specific duties with an increase from 652 to 674, i.e. 22 tariff lines, mainly concerning wine 
(HS 2204). Specific duties are as transparent as ad valorem  tariffs.  
 
3.1.3.3 Contingentes arancelarios y su administración  
 
"3.45. La Lista de la UE en el marco de la OMC contiene 107 categorías de contingentes arancelarios, 
de las cuales 79 (el 74%) se refieren a productos agrícolas y 28 (el 26%) a productos no agrícolas 
(cuadro A3.1).60 Los contingentes arancelarios agrícolas abarcan diversos productos, entre ellos los 
siguientes: carne, frutas, cereales, hortalizas, queso, vino y chocolate; mientras que los 
contingentes arancelarios no agrícolas se aplican principalmente a los siguientes productos: pescado, 
determinados productos metálicos, determinados productos de la ma dera, hilados de lino y cuentas 
de vidrio. En el período representativo más reciente, la utilización de los contingentes arancelarios 
varió considerablemente: en el caso de algunos de ellos se registraron tasas de utilización del 100% 
y en otros casos, del  0%, pero el promedio global fue del 52%. Un número bastante importante de 
contingentes (24%) no se utilizó en absoluto (tasa de utilización nula) y alrededor del 30% se utilizó 
en su totalidad (tasas de utilización del 100%)"  
 
Q35 ¿Tiene la Comisión Europea una evaluación de las razones por las cuales el 24% de 
los contingentes registran una tasa de utilización nula?  
 
EU reply:   
The EU does not consider that the management system for any of its TRQs causes low fill rates or 
no use.  Even some TRQs managed on a "first -come, first -served" basis have low fill rates. Fill rates 
are determined by prevailing economic conditions. In addition, the EU has concluded FTAs providing 
additional or better market access conditions, weakening the at tractiveness of scheduled TRQs. The 
EU seeks to apply the TRQ management method most appropriate to each TRQ to ensure smooth 
trade flows and the lowest possible administrative burden.  
 
3.1.6 Medidas antidumping, compensatorias y de salvaguardia  
 
3.1.6.1  Medidas antidumping y antisubvenciones  
 
"3.79. Los cambios introducidos en 2018 en la segunda modificación son más numerosos y variados; 
los elementos principales se describen en el recuadro 3.2.125 Como se muestra, los cambios 
guardan relación con aspect os de procedimiento, como la reducción del plazo para la imposición de 
medidas provisionales, y otros aspectos más sustanciales, como el método para calcular el margen 
de perjuicio. Por ejemplo, al calcular el precio no perjudicial se incluye un beneficio mínimo del 6%. 
Otra novedad es la posibilidad de tener en cuenta los costes presumiblemente superiores a los que WT/TPR/M/395/Add.1  
 
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  la industria de la UE Unión tenga que hacer frente para poder cumplir las normas sociales y 
medioambientales."  
 
Q36 ¿Podría la UE indicar cómo va la Comisión a medir y cuantificar el factor ambiental y 
social para efectos de determinar los costes, según la nueva reglamentación del 2018 
sobre medidas de defensa comercial?  
 
EU reply:   
The changes to the calculation of the non -injurious  price used to calculate an injury margin mean 
that the non -injurious price will reflect:  
 
- Actual  costs resulting from compliance with multilateral environmental agreements and 
International Labour Organisation Conventions to which the European Union is a party as 
well as any future  cost increases in that respect that would occur during the lifetime of TDI 
measures.  
- With regard to the actual costs the Commission identifies and verifies the cost in the financial 
records of the Union producer. As regards fut ure costs, these are based on clear evidence 
that the conventions to which the Union is party will impose a measureable and quantifiable 
future cost to the company.  
 
3.3.2.1 Nuevo Marco Legislativo  
 
"3.168. Con objeto de agilizar, simplificar y asegurar l a correcta aplicación, de manera 
individualizada, del principio del reconocimiento mutuo de las mercancías, el 19 de marzo de 2019 
se adoptó el Reglamento (UE) 2019/515212, que entrará en vigor el 19 de abril de 2020 en 
sustitución del Reglamento (CE) Nº 7 64/2008. De conformidad con el nuevo Reglamento, los Estados 
miembros que apliquen reglamentos técnicos para restringir el acceso a los mercados para productos 
comercializados legalmente en otro Estado miembro deberán justificar su posición mediante prueba s 
técnicas y científicas y brindar a los agentes económicos afectados por la restricción la oportunidad 
de formular observaciones. Con arreglo al nuevo Reglamento, las empresas sabrán si sus productos 
se pueden vender en otro país de la UE en unos pocos me ses, en lugar de años. Además, podrán 
usar declaraciones voluntarias para demostrar que sus productos cumplen todos los requisitos 
pertinentes en su país. De esta forma las autoridades podrán determinar más fácilmente si debe 
aplicarse el principio del rec onocimiento mutuo. Además, se espera que un procedimiento de 
resolución de problemas permita una resolución más rápida de los litigios entre empresas y 
autoridades nacionales.  
 
Q37 ¿Los productores de terceros países podrán beneficiarse de este nuevo reglamento?  
 
EU reply:   
Yes, Regulation (EU) 2019/515 does not provide for any criterion of establishment with respect to 
the economic operators that fall under its scope of application.  
 
Q38 ¿Cómo lograr que haya completa armonización en los OTC como se ha logrado en los 
MSF?  
 
EU reply:   
In the EU the adoption of technical regulations within the meaning of the TBT Agreement is in many 
areas a shared competence between the EU and its Member States in accordance with the European 
Treaties. This prevents a full harmonization of le gislation at EU level since both the EU and its 
Member States are able to legislate and adopt legally binding acts. EU Member States exercise their 
own competence where the EU does not exercise, or has decided not to exercise, its own 
competence. In accord ance with Article 4 of the Treaty on the Functioning of the European Union 
(TFEU), shared competence between the EU and its Member States applies, among others, in areas 
such as the internal market, agriculture, environment, consumer protection, transport,  energy, or 
common safety concerns in public health matters. In other areas, the EU only has supporting 
competence, that is, competence to carry out actions out to support, coordinate or supplement the 
actions of EU Member States. That is for instance the case in areas such as the protection and 
improvement of human health, or industry (Article 6 of the TFEU).  
 
Q39 ¿Existen planes dentro de la UE para que la Comisión tenga competencia exclusiva 
también en OTC?  WT/TPR/M/395/Add.1  
 
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  EU reply:   
No. This is so to the extent that th e EU operates under the principle of conferral of competences and 
it has only the competences conferred on it by the European Treaties. Under this principle, the EU 
may only act within the limits of the competences conferred upon it by the EU countries in the 
Treaties to attain the objectives provided therein. Competences not conferred upon the EU in the 
European Treaties remain with EU Member States.  
 
"3.169. En el marco del "paquete sobre mercancías" y con miras a abordar la cuestión de la 
comercialización en el mercado de la UE de productos no conformes con los requisitos de la UE, y 
que ponen así en peligro a los consumidores, la Comisión propuso tam bién un nuevo reglamento 
relativo a la conformidad y la observancia, con objeto de crear un mercado interior de mercancías 
más justo, merced a un refuerzo de la cooperación entre las autoridades nacionales de vigilancia del 
mercado. Este nuevo instrumento,  el Reglamento (UE) 2019/2020213, fue adoptado el 20 de junio 
de 2019 y deroga en parte el Reglamento (CE) Nº 765/2008. Prevé mecanismos destinados al 
intercambio de información entre las autoridades nacionales de vigilancia del mercado en materia 
de produ ctos ilícitos e investigaciones en curso. También ayudará a las autoridades nacionales a 
mejorar las comprobaciones de los productos que entren en la UE. Dado que en la UE el 30% de las 
mercancías son importadas, el Reglamento prevé también el refuerzo de las inspecciones en los 
puertos y las fronteras exteriores.  
 
Q40 ¿Podría la Comisión Europea ahondar en este asunto y explicar a qué tipo de refuerzo 
se refiere? ¿en qué cambia al sistema actual?  
 
EU reply:   
Regulation (EU) 2019/1020 strengthens cooperati on and effectiveness of market surveillance 
authorities in the EU in different ways.  
 
(i) At national level the Regulation provides for the setting up of a single liaison office per 
Member State to coordinate the activities of all national market surveillance  authorities, 
as well as the formulation of national market surveillance strategies - at least every 4 
years - that must consider all product sectors and set priorities. Regulation (EU) 
2019/1020 also recognises a minimum set of powers to market surveillan ce authorities 
in terms of investigation, enforcement and imposition of penalties, as well as systemic 
cooperation and risk information exchange with customs authorities.  
(ii) Between Member States, the Regulation provides for cross -border mutual assistance 
obligations between market surveillance authorities, as well as the introduction of 
voluntary peer reviews of these authorities.  
(iii) At EU -wide level, Regulation (EU) 2019/1020 introduces enhanced cooperation 
mechanisms between market surveillance authorities o f EU Member States and the 
European Commission by setting up a Union Product Compliance Network. This Network 
is to serve as a platform for structured coordination and cooperation between 
enforcement authorities of EU Member States and the Commission, and to streamline 
the practices of market surveillance within the EU, thereby making market surveillance 
more effective. The Network will set priorities for common market surveillance work. It 
will also facilitate joint control campaigns, including testing, an d will help Member States 
carry out their market surveillance strategies.  
 
Regulation (EU) 2019/1020 also addresses the challenges of e -commerce, and it introduces a 
requirement on manufacturers not established in the EU to appoint a responsible person to  act as 
contact point for national market surveillance authorities for certain types of products placed on the 
EU market. The Regulation provides flexibility on who can be this responsible person. Manufacturers 
not established in the EU can appoint an impo rter or an authorized representative, but the 
responsible person can also be a fulfilment centre in the EU as laid down in Article 4 of the Regulation. 
The Commission will provide guidelines explaining the practical implementation of this provision. 
The ai m is to publish them in 2020.  
 
Information on compliance with EU product rules will also be made easily accessible to economic 
operators through the new tool laid down in Article 8 of the Regulation. In particular, economic 
operators will have easy online access through the Your Europe portal that provides information 
about EU product requirements. This will be operational at the end of this year. In addition, there 
will be contact points at Member State level to which further questions on the implem entation of 
product requirements can be addressed.  WT/TPR/M/395/Add.1  
 
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  3.3.2.2 Marco institucional  
 
"3.189. El 30 de abril de 2019, la Comisión publicó sus recomendaciones para la próxima Agenda 
Estratégica de la UE para 2019 -2024. El CEN y el CENELEC quieren mejorar la comp etitividad de las 
industrias europeas y contribuir a eliminar los obstáculos al comercio en el mercado mundial. En 
2018, sus miembros determinaron los países y regiones prioritarios en los cuales la cooperación en 
el proceso de normalización podía reforzar  las relaciones comerciales con Europa. El ejercicio se 
potenció con la puesta en marcha de un diálogo con la Comisión a fin de coordinar las prioridades 
en materia de normalización e incluirlas en los acuerdos comerciales de la UE."  
 
Q41 ¿Está Colombia o algún país latinoamericano priorizado?  
 
EU reply:   
CEN and CENELEC are private and independent organisations, so their decisions to prioritise this or 
that region in the world does not affect in any way the priorities of the European Commission.  
Saying that, this is the CEN CENELEC website describing the priorities: 
https://www.cencenelec.eu/news/articles/Pages/AR -2019-004.aspx.  
 
3.3.2.3 Papel de la normalización para las tecnologías digitales  
  
"3.195. El 1º de febrero de 2018, la Com isión puso en marcha el Observatorio y Foro de la Cadena 
de Bloques de la UE, cuyo grupo de trabajo sobre política de la cadena de bloques y condiciones 
marco se propone abordar, entre otras, cuestiones relacionadas con la evolución tecnológica y de 
ecosis temas, como la interoperabilidad, en la que la normalización podría aportar soluciones.220 
También se propone determinar las posibles necesidades de la UE en materia de armonización de 
las cadenas de bloques. El Observatorio y Foro ha terminado cinco grand es informes de investigación 
sobre políticas en los ámbitos siguientes: i) las cadenas de bloques y la identidad digital; ii) la 
escalabilidad, interoperabilidad y sostenibilidad de las cadenas de bloques; iii) las cadenas de 
bloques para los servicios púb licos gubernamentales; iv) las cadenas de bloques y el Reglamento 
general de protección de datos (RGPD); y v) la innovación en la cadena de bloques en Europa.221  
 
Q42 Teniendo en cuenta que el blockchain y la inteligencia artificial son fenómenos 
globales  que se están desarrollando en otras latitudes (ie. Centro para la Cuarta 
Revolución Industrial del Foro Económico Mundial en Medellín), ¿cómo está este trabajo 
integrándose con investigaciones y trabajos realizados en otras latitudes?  
 
EU reply:  
The EU Blockchain Observatory and Forum is already taking into account works and developments 
done at international level. However, more European Players have naturally been engaged in the 
forum and the European context is indeed predominant for  some reports. The EU Blockchain 
Observatory and Forum is going to be renewed through a new contract, with more attention to be 
paid to the international situation. Moreover, the European Commission has facilitated the creation 
of the International Associa tion for Blockchain Applications (INATBA – inatba.org) which aims at 
bringing together all stakeholders committed to promote interoperability, transparent governance, 
legal certainty and trust in services enabled by blockchain and DLT, worldwide. As first concrete 
achievement, INATBA organised, with the Spanish network Alastria and the European Commission, 
the Convergence – 1st Global Blockchain Congress (Malaga, November 2019) where a high number 
of international participants, including from Colombia, wher e involved. The EC will continue to help 
reinforcing such a dialogue with international stakeholders, in particular through INATBA.  
 
3.3.3 Prescripciones sanitarias y fitosanitarias  
 
"3.218. La Comisión se encarga de elaborar las propuestas de actos de ej ecución. El Comité 
Permanente de Vegetales, Animales, Alimentos y Piensos es el principal organismo de 
reglamentación encargado de emitir dictámenes sobre los proyectos de medidas de aplicación. El 
Comité comprende 14 secciones, cada una de ellas responsab le de diferentes aspectos de las 
MSF.236. Además, hay otros cinco comités encargados de cuestiones específicas relacionadas con 
las MSF:  
 
Q43 Teniendo en cuenta la importancia del Comité Permanente de Vegetales, Animales, 
Alimentos y Piensos, ¿qué medidas  ha establecido la Comisión Europea para volverlo más 
transparente y permitir mayor control por parte de la sociedad civil y los 3ros países? WT/TPR/M/395/Add.1  
 
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  ¿Qué procedimientos están establecidos para garantizar por parte de la UE que las 
decisiones son lo más informadas  y discutidas posibles y se toman con base en evidencias 
científicas y no por otras razones?  
 
EU reply:   
To ensure transparency of the discussions taking place in the different sections of the Standing 
Committee of Plants, Animals, Food and Feed, all meetings (i.e. agenda and minutes) are published 
on the Commission's website.  
Moreover, the draft measures de livered by the Committee and that the Commission intends to adopt 
are made available in the Comitology Register. This register contains background information and 
documents relating to the work of the committees, including all documents forwarded to the EU  
Parliament for information or scrutiny.  
In addition, the Better Regulation principles provides for a feedback mechanism that allows 
stakeholders and citizens to provide feedback on each roadmap (including for evaluations) or 
inception impact assessment (i nception IA), on legislative proposals adopted by the College and on 
draft conferred legislation, namely draft implementing and delegated acts of a general application 
as well as on draft measures subject to regulatory procedure with scrutiny.  
 
Finally, t he Commission would like to note that risk management decisions take into account not 
only the results of risk assessment but also other legitimate factors where relevant.  
 
"3.221. En la UE se ha llevado a cabo una importante armonización de las MSF, y la  mayoría de las 
medidas se adoptan a nivel de la Unión. Sin embargo, en aquellos casos en que la UE carece de 
prescripciones armonizadas, los Estados miembros pueden adoptar medidas específicas, facultad 
que ejercen de vez en cuando.  
 
Q44 ¿Qué instrumento s tiene la Comisión Europea para asegurar y garantizar que los 
Estados miembros cumplen con los compromisos internacionales cuando deciden adoptar 
medidas a nivel nacional? existe algún tipo de control? ¿cuál es el mecanismo para 
controvertir alguna medida  nacional que no esté alineada con los compromisos 
internacionales?  
 
EU reply:   
According to EU rules, Member States are allowed to adopt national legislations in very limited 
circumstances in the SPS area, e.g. if they have a serious health concern and/or  there are no 
harmonized rules. Member States are obliged to notify any such measure to the European 
Commission and the other Member States. The Commission, together with the EU Member States, 
assesses whether the conditions for taking such measures are fu lfilled and whether harmonised 
action at EU level is needed.  
 
Measures taken by EU Member States are notified by the EU notification authority both in case of 
non-harmonized standards and when seeking a higher level of protection. These measures are 
discus sed between the EU Commission and the EU Member States within the relevant regulatory 
committees, taking into account also the EU international obligations. The EU legal framework 
provides tools for the Commission to take legal action where necessary.  
 
"3.222. Los Estados miembros de la UE son miembros de la Comisión del Codex Alimentarius y de 
la Organización Mundial de Sanidad Animal (OIE), y partes contratantes en la Convención 
Internacional de Protección Fitosanitaria (CIPF). La propia UE es miembro del  Codex y parte 
contratante en la CIPF."  
 
Q45 ¿Cómo se coordina la posición UE si cada estado miembro tiene voz y voto en el 
Códex? ¿Existe algún tipo de coordinación interna para que el voto de los 28 estados 
miembro sea coherente con la posición de la Co misión Europea?  
 
EU reply:   
All EU Member States are members of the Codex Alimentarius Commission. In 2003, the EU also 
joined, sharing competence with the Member States depending on the level of harmonisation of the 
respective legislation. Council Decision 2003 2003/822/EC of 17 November on the accession of the 
European Community to the Codex Alimentarius Commission  describes relevant working procedures 
and constitutes a legal basis for the accession of the EU to Codex. The Directorate -General Healt h & 
Food Safety is the EU Codex contact point.  WT/TPR/M/395/Add.1  
 
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  Member States and EU actors coordinate their action in Codex to the fullest extent possible. Prior to 
each Codex Committee or the Codex Alimentarius Commission, the Member States meet to 
coordinate the EU posi tion on all the agenda items of a Codex Committee taking into account existing 
EU legislation and policy. Also, on the spot in the margins of Codex Committee meetings, the 
European Commission and the Member States meet in order to coordinate, fine -tune and  determine 
the EU common positions to be presented in Codex.  
 
3.3.3.4 El Comité MSF de la OMC  
 
"3.239. En 2017 y 2018, la UE presentó un total de 153 notificaciones al Comité de Medidas 
Sanitarias y Fitosanitarias de la OMC (107 en el período 2015 -2016). A demás, en el período 
2017-2018, Finlandia presentó una notificación ordinaria, Francia presentó dos notificaciones de 
medidas de urgencia y España presentó dos notificaciones ordinarias.254 Durante los nueve 
primeros meses de 2019 la UE presentó 108 notifi caciones."  
 
Q46 Agradecemos a la Comisión Europea que nos informe los casos de propuestas 
regulatorias en las cuales los comentarios de los miembros de la OMC fueron 
efectivamente tenidos en cuenta en la regulación final, de manera que se generó algún 
cambio entre la propuesta inicial y la finalmente expedida.  
 
EU reply:   
All the comments received are systematically discussed with the EU Member States within the 
framework of the regulatory process. The EU always provides a reply to all the comments submitted 
by another WTO Member on an EU notification and explains in details the planned measures and 
their rationale.  
 
3.3.6 Contratación pública  
 
3.309. El 29 de enero de 2016, la Comisión presentó una propuesta revisada relativa a un 
instrumen to de contratación pública internacional (ICPI).365 El origen del ICPI, que se remonta a 
2012, nace de la preocupación de larga data de la UE por el desequilibrio en los mercados de 
contratación pública a nivel internacional.366 Según la Comisión, el ICPI promovería un acceso 
abierto a los mercados de contratación pública de todo el mundo. Permitiría a la Comisión iniciar 
investigaciones públicas en los casos de supuesta discriminación contra las empresas de la UE en 
los mercados de contratación. Según la C omisión, los compromisos actuales de la UE, en especial 
los contraídos en el marco del ACP y los acuerdos comerciales bilaterales, no se verían afectados 
por el ICPI. Recientemente, el Consejo Europeo pidió la reanudación de los debates sobre ese 
instrumen to. 
 
Q47 ¿Qué medidas concretas ha tomado la UE para incrementar la participación de 
empresas no europeas en la contratación europea? ¿qué porcentaje de empresas no 
europeas participan en la contratación pública europea?  
 
EU reply :  
One of the strategic priorities of the EU with regard to government procurement is to further improve 
access to non -EU procurement markets through plurilateral and bilateral trade agreements. Our 
agreements are based on the principle of ambitious and mutual market op ening. On one hand, the 
European Union has been supporting the accession of new parties to the WTO Government 
Procurement Agreement (GPA). On the other hand, the European Union is engaging in bilateral trade 
agreements that include comprehensive chapters o n government procurement in view of further 
opening the procurement markets in third countries. As regards statistics on contract awards in the 
EU, the data is available on EU Open Data Portal https://data.europa.eu/euodp/en/data/dataset/ted -
1. 
 
3.3.7.1  Derecho de autor y derechos conexos  
  
3.331.  En la Directiva también se aborda la utilización de contenidos protegidos por prestadores de 
servicios en línea, como YouTube, Twitter, etc. Cabe destacar que, con arreglo al artículo 17 de la 
Directiva, los pres tadores de servicios para compartir contenidos en línea son considerados 
responsables de la comunicación al público, por usuarios, de materiales protegidos por derechos de 
autor, y están obligados a solicitar las autorizaciones pertinentes a los titulares de los derechos. 
Esas autorizaciones deberán también incluir a los usuarios no comerciales. En caso de difusión no WT/TPR/M/395/Add.1  
 
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  autorizada, los prestadores de servicios están exentos de responsabilidad si demuestran que han 
hecho los mayores esfuerzos por obtener una a utorización del titular de los derechos; y que han 
hecho los mayores esfuerzos por garantizar la indisponibilidad de las obras basándose en la 
información facilitada por el titular de los derechos y/o retirar los contenidos infractores (y por evitar 
que se  carguen en el futuro) al recibir una notificación del titular de los derechos a estos efectos. 
Los nuevos proveedores de servicios (menos de tres años prestando servicios) cuyo volumen de 
negocios anual sea inferior a 10 millones de euros serán sometidos a requisitos menos exigentes. 
La Directiva, más que imponer una obligación general de supervisión, establece que los prestadores 
de servicios en línea deben proporcionar a los titulares de derechos, previa solicitud por parte de 
estos, información adecuada  y prever mecanismos de reclamación y recurso para los usuarios. 
También se establecen expresamente excepciones y limitaciones, por ejemplo, para la utilización de 
contenidos en citas, críticas o reseñas; o a efectos de caricatura, parodia o pastiche.  
 
Podría la UE informar con mayor detalle cómo se va a aplicar esta directiva específicamente en los 
siguientes puntos:  
 
Q48 La forma como van a establecer los estándares que permitan determinar que un 
prestador de servicios en línea ha hecho los mayores esfue rzos para la obtención de la 
autorización del titular del derecho en los casos de difusión no autorizada que dé lugar a 
que quede exento de responsabilidad.  
 
EU reply:   
As required in Article 17(10) of Directive (EU) 2019/790 (https://eur -
lex.europa.eu/eli/dir/2019/790/oj), the Commission has launched a stakeholder dialogue to discuss 
best practices for cooperation between online content -sharing services and right holders. Taking into 
account the results of such dialogue, the C ommission will issue guidance on the application of Article 
17, in particular regarding the cooperation referred to in Article 17(4). Where online content -sharing 
service providers meet the conditions in Paragraph 4, they will not be liable. The conditions  are: 
(i) demonstrating best efforts to obtain an authorisation, (ii) demonstrating best efforts to ensure 
the unavailability of unauthorised content, regarding which right holders have provided necessary 
and relevant information and (iii) acting expeditio usly to remove any notified works following a notice 
received, and making also their best efforts to prevent future uploads.  
 
Q49 La forma como van a funcionar los mecanismos de reclamación y recurso que los 
prestadores de servicios en línea deben proporci onar a los usuarios, en los casos que se 
presente una presunta difusión no autorizada.  
 
EU reply:   
According to Article 17(8), EU Member States are required to provide that online content -sharing 
services provide for an effective and expeditious complaint and redress mechanism for their users, 
in case of disputes regarding the removal of works uploaded by them. Where rightholders request 
to have access to their specific works  or other subject matter disabled, or to have those works or 
other subject matter removed, they need to duly justify the reasons for their requests. Complaints 
submitted under this mechanism will be processed without undue delay, and decisions to disable 
access to or remove uploaded content shall be subject to human review.  
Article 17(8) also provides that "Member States shall also ensure that out -of-court redress 
mechanisms are available for the settlement of disputes. Such mechanisms shall enable disputes  to 
be settled impartially and shall not deprive the user of the legal protection afforded by national law, 
without prejudice to the rights of users to have recourse to efficient judicial remedies. In particular, 
Member States shall ensure that users have access to a court or another relevant judicial authority 
to assert the use of an exception or limitation to copyright and related rights".  
 
3.3.7.2 Propiedad industrial  
3.3.7.2.1 Patentes  
 
3.339. En 2012, como parte de un paquete de medidas relativas a la  patente unitaria410, se aprobó 
un reglamento que permite que los titulares de derechos puedan disfrutar en casi todos los Estados 
miembros de la UE de la protección que ofrece una patente, sobre la base de una solicitud única.411 
Este reglamento será apli cable a partir de la fecha de entrada en vigor del Acuerdo internacional 
sobre un Tribunal Unificado de Patentes (Acuerdo sobre el TUP), el tercer componente del paquete. 
El Acuerdo sobre el TUP fue firmado por 25 Estados miembros de la UE a principios de 2013.412 
Para su entrada en vigor es necesaria la ratificación de 13 Estados miembros, incluidos los 3 con el WT/TPR/M/395/Add.1  
 
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  mayor número de patentes europeas en vigor (Alemania, Francia y Reino Unido). El 30 de septiembre 
de 2019 el Acuerdo había sido ratificado por 16 Estados miembros de la UE, entre ellos Francia y el 
Reino Unido, pero no Alemania.  
 
Q50 ¿Los titulares de derechos gozarían de la protección, así no sean europeos? y gozarían 
de la protección en toda la UE o solamente en los países que ratifiquen el acuer do? 
 
EU reply:   
The unitary patent system can be used by any applicant for a European patent irrespective of 
nationality (i.e., including non -European applicants). The unitary patent protection can be extended 
to those EU Member States which are both part of the enhanced cooperation established by 
Regulation (EU) No . 1257/2012 and which have ratified the Unified Patent Court Agreement.  
 
Q51 Dada la importancia de Alemania para que el acuerdo entre en vigor, ¿tiene interés 
Alemania en ratificar el Acuer do sobre el TUP?  
 
EU reply:   
Germany and other EU MSs are committed to the entry into operation of the unitary patent system 
(including the UPC), considering the benefits it would bring in terms of patenting costs and patent 
litigation.  
 
3.3.7.2.4 Indicaci ones geográficas  
 
"3.360. En abril de 2019 empezó a funcionar la base de datos pública "eAmbrosia - registro de 
Indicaciones Geográficas de la UE". Está previsto que sustituya a las bases de datos actuales 
correspondientes al vino (e -Bacchus), las bebidas espirituosas (e -Spirit -Drinks) y los productos 
alimenticios (DOOR).447 A través de ella se puede acceder a información sobre todas las indicaciones 
geográficas registradas, por ejemplo, a información sobre su país de origen, sobre su situación 
(solicitada, publicada o registrada), la especificación de los productos abarcados o un enlace directo 
con el fundamento jurídico en caso de que estén oficialmente protegidas.448 El registro contiene 
1.605 indicaciones geográficas registradas de vinos y 23 9 indicaciones geográficas registradas de 
bebidas espirituosas. En la base de datos eAmbrosia se enumeran todas las indicaciones geográficas 
de vinos y de bebidas espirituosas registradas directamente a través de la reglamentación de la UE, 
incluidas las i ndicaciones geográficas de terceros países.449 Las indicaciones geográficas de 
productos agrícolas y productos alimenticios (actualmente en la base de datos DOOR) estarán 
incorporadas en eAmbrosia para finales de 2019.  
 
Q52 Colombia celebra el avance en l a publicidad de las IG de los terceros países protegidas 
a través de acuerdos comerciales, sin embargo sigue sin entender la razón por la cual 
estas IG no pueden estar en la base de datos general con una nota, en caso de ser 
necesario, que señale el proced imiento por el cual es protegida.  
 
EU reply:   
The e -Ambrosia database is composed of the electronic registers of geographical indications 
established by Regulation (EU) No . 1308/2013, Regulation (EU) 2019/787 and Regulation (EU) 
No. 1151/2012. The geograph ical indications registered in accordance with the requirements, forms 
and procedures established in the relevant legal bases are entered into the registers (e.g. Café de 
Colombia).  
 
Q53 Colombia agradece a la UE la explicación de las razones que justifica n un tratamiento 
distinto entre las IG protegidas mediante un ALC y las que surten el trámite ordinario.  
 
EU reply:   
The level of protection of GIs provided by EU legislation includes:  
 
• any direct or indirect commercial use of a name in respect of products not covered by the 
registration;  
• any misuse, imitation or evocation, even if the true origin of the products or services is 
indicated or if the protected name is translated or accompanied by an expression such as 
'style', 'type', 'method', 'as pro duced in', 'imitation' or similar, including when those products 
are used as an ingredient;  WT/TPR/M/395/Add.1  
 
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  • any other false or misleading indication as to the provenance, origin, nature or essential 
qualities of the product and any other practice liable to mislead the con sumer as to the true 
origin of the product.  
 
In the agreements concluded with third -country partners, the EU aims at ensuring the level of 
protection similar to the one above while the outcome depends on each negotiation and could involve 
certain adaptatio ns, which take into account the specificities of the other contracting party's system.  
 
3.362. En lo que respecta a los productos no agrícolas, la UE encargó un estudio de los aspectos 
económicos de la protección de las indicaciones geográficas a escala de  la UE, con objeto de: 
i) evaluar la efectividad de la protección específica de las indicaciones geográficas como forma de 
limitar la disponibilidad de productos no auténticos; ii) estimar el valor para los consumidores de 
esta protección específica de las  indicaciones geográficas, y la repercusión que tiene en los costos 
que genera al consumidor la búsqueda de productos auténticos el hecho de que los productos estén 
protegidos expresamente por indicaciones geográficas o no; y iii) identificar el valor que tiene la 
protección específica de las indicaciones geográficas para los productores de productos auténticos 
de las zonas geográficas pertinentes.453 Está previsto que los datos del estudio se publiquen en 
2020. Las indicaciones geográficas de productos no agrícolas también pueden estar protegidas en 
calidad de marcas colectivas de la UE454, así como en virtud de la legislación sobre competencia 
desleal.  
 
Q54 Colombia celebra el avance en esta materia, que es particularmente relevante para 
nuestra riqueza a rtesanal. ¿Tiene contemplada la Comisión Europea una regulación 
comunitaria para proteger las IG de artesanías en toda la UE?  
 
EU reply :  
The EU currently provides Geographical indication protection for non -agricultural products through 
legislations availa ble at national level in its Member states and at EU level through the EU collective 
trade mark rules. As regards protection at EU level, the EU will soon publish the final version of a 
2019 external "study on the economic aspects of geographical indicatio n protection for 
non-agricultural products at EU level" designed to assess the added value of a special (sui generis) 
protection regime for geographically rooted non -agricultural products as compared to other kinds of 
protection in particular trade marks. Based on all the evidence collected, the Commission will decide 
on concrete further steps.  
 
4.1.1.2.1.2 Medidas de sostenimiento del mercado interior  
 
Otros productos  
 
"4.67. Para responder a la rápida evolución del sector de la agricultura ecológica, en mayo de 2018 
se adoptó un nuevo Reglamento sobre producción ecológica y etiquetado de los productos 
ecológicos82, que se comenzará a aplicar el 1º de enero de 2021. Segú n la Comisión83, ese 
Reglamento se concibió para modernizar el sector, armonizar las normas y garantizar una 
competencia leal para los agricultores y, al mismo tiempo, evitar el fraude y mantener la confianza 
de los consumidores. Se simplificarán las norma s de producción y se reforzará el sistema de control. 
Se pasará también del principio de equivalencia al principio de conformidad: los productores de 
países no pertenecientes a la UE tendrán que cumplir las mismas normas que se apliquen en la UE. 
La nueva normativa prevé asimismo elementos de simplificación, como el establecimiento de un 
procedimiento para eximir a los operadores de bajo riesgo del control anual y la introducción de un 
sistema de certificación de grupo para los pequeños productores, con mir as a reducir los costes 
administrativos y de certificación. La reforma incluye además una ampliación de la gama de 
productos que pueden recibir la certificación ecológica84, así como nuevas normas para facilitar la 
conversión a la producción ecológica.85  
 
Q55 Teniendo en cuenta las grandes diferencias climáticas que existen entre los países 
tropicales (no europeos) y los estados miembros de la UE, ¿cómo justifica la UE el nuevo 
enfoque de la UE según el cual deja a un lado el principio de equivalencia y lo  reemplaza 
por el de "full compliance"?  
 
EU reply:  
Article 45 (1) of Regulation (EC) No . 2018/848 provides that an organic product can be imported 
into the EU if the product complies with Chapter II, III and IV of the Regulation. However, under WT/TPR/M/395/Add.1  
 
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  Article 45(2) of Regulation (EU) No . 2018/848 the European Commission may grant specific 
authorisat ion for the use of products and substances in third countries and in the outermost regions 
of the European Union. The specific authorisation takes into account differences in the ecological 
balance in plant or animal production, specific climatic condition , tradition and local condition in 
those areas.  
 
Q56 ¿Cuenta la Comisión Europea con recursos económicos para apoyar a los agricultores 
en países en desarrollo para que puedan entender el impacto del nuevo reglamento y 
adaptarse a las nuevas normas de la U E? 
 
EU reply:   
The EU does not provide financial support for this specific issue.  
 
2.6 Energía  
Realizar el mercado interior de la energía  
 
4.143. La UE sigue afrontado dificultades en la realización de su mercado interior de la energía. Por 
ejemplo, a juicio de la Comisión, la digitalización de la infraestructura energética requerirá mejorar 
la ciberseguridad y la protección de la infraestructura crítica. Además, aunque las inversiones 
realizadas han permitido la integración de sectores, la C omisión considera que aún queda trabajo 
por hacer para integrar los sectores de generación de energía y uso final.218 Según la Comisión, es 
una labor necesaria para incorporar al sistema energético la cuota cada vez mayor de energías 
renovables variables, de calefacción y refrigeración, y de vehículos eléctricos. Esta será una esfera 
clave de atención en el futuro, ya que la demanda de vehículos eléctricos variará según las regiones 
y dependerá de factores tales como el desarrollo de la infraestructura para  combustibles alternativos.  
 
Q57 ¿Cómo planea la UE gestionar las baterías de los vehículos eléctricos una vez 
terminan su vida útil?  
 
EU reply:   
Under the current Directive on batteries and waste batteries (2006/66/EC) EU Member States are 
required to co llect waste batteries, including Electric Vehicles batteries. All collected batteries have 
to be treated and recycled, the disposal and incineration being prohibited. The Directive lays down 
specific targets for the efficiency of the recycling processes of  lead-acid and nickel -cadmium 
batteries.  
 
The EU Directive on batteries is under revision. It is likely that, as a result, current obligations on 
collection and recycling are strengthened. In particular, efficiency targets for recovery of materials 
contai ned in lithium -ion batteries, like lithium or cobalt, could be established.  
 
4.2 Energía  
Descarbonizar la economía y convertirse en líder mundial de las energías renovables  
 
"4.152. Según la Comisión, los Estados miembros también pueden utilizar transferencias 
estadísticas, tal como se prevé en la Directiva sobre energías renovables, bien para garantizar la 
consecución del objetivo en caso de déficit, bien para vender sus excedentes. La Comisión adoptó 
la Directiva sobre energías renovables para: fomentar el uso de energía renovable en el sector de la 
electricidad; integrar las energías renovables en el sector de la calefacción y refrigeración; 
descarbonizar y diversificar el sector de transportes (con un objetivo de energía renovable para 2030 
de al menos el 14% de consumo total de energía en el transporte); informar a los consumidores y 
promover su participación; reforzar los criterios de sostenibilidad de la UE; y asegurarse de que se 
alcance a tiempo y de manera eficiente en términos de costes e l objetivo vinculante para el conjunto 
de la UE.  
 
Q58 En Colombia consideramos que el Acto Delegado se equivoca al clasificar el aceite de 
palma, a nivel global, como un cultivo de alto riesgo de ILUC y por lo tanto limitar la 
contabilización de los biocom bustibles producidos a partir de esta materia prima para las 
metas de reducción de emisiones. ¿En este contexto, Colombia agradecería que la UE 
explicara las razones por las cuales el Acto Delegado establece un criterio global y no 
tiene en cuenta las part icularidades y realidades de las diferentes regiones del mundo?  
 WT/TPR/M/395/Add.1  
 
- 201 - 
 
  EU reply :  
The markets for commodities such as palm oil are global, which therefore requires a global 
assessment of the ILUC phenomenon. Given the high share of global palm oil expansion onto land 
with high carbon stock, the use of palm oil for producing biofuels can only be expected to aggravate 
the situation - unless measures preventing displacement effects, such as those recognised by low 
ILUC certification, are applied.  
 
Q59 Además, agradeceríamos que la UE aclarara cómo concilia el trato injustificado a 
aquellos países con menos del 10% de deforestación relacionada con la expansión de la 
palma aceitera y que, por tanto, no cumplen los criterios establecidos en el Acto Del egado 
para ser clasificados como de alto riesgo de ILUC?.  
 
EU Reply:   
Please see reply to question 58.  
 
4.3 Manufacturas  
 
Productos químicos  
 
"4.195. De la evaluación del Reglamento REACH efectuada en 2018 se desprende que ahora se 
dispone de más información sobre las propiedades y los usos de las sustancias químicas para evaluar 
y gestionar sus riesgos, lo que indica que el Reglamento está contribuyendo a mejorar 
progresivamente la protección de la salud humana y del medio ambiente en la UE. En la  evaluación 
se constató que los beneficios están empezando a materializarse, y que la estimación de estos es 
del orden de EUR 100.000 millones en un período de 25 a 30 años. Se detectaron varias deficiencias 
y posibilidades de mejora en relación con la fal ta de conformidad de los expedientes de registro, 
problema de considerables dimensiones, el insuficiente flujo de información a lo largo de la cadena 
de suministro, así como la necesidad de simplificar el proceso global de autorización y de establecer 
unas condiciones de competencia equitativas entre las empresas comunitarias y extracomunitarias 
a través de restricciones y medidas de ejecución eficaces.278 Tras la evaluación, y en cooperación 
con los Estados miembros y la ECHA, la Comisión propuso diversas medidas encaminadas a reforzar 
el cumplimiento y reducir la carga que supone, por ejemplo, la cumplimentación de los expedientes 
de registro, las fichas de datos de seguridad ampliadas y el proceso de solicitud de autorización y 
las restricciones, todo lo cual no debe conllevar la disminución del nivel de protección de la salud 
humana y el medio ambiente.  
 
"4.196. Cuando se adoptó el Reglamento REACH, se prestó atención a que las empresas nacionales 
y extranjeras de fabricación o importación de productos qu ímicos en la UE recibieran el mismo trato. 
Sin embargo, terceros países han planteado reiteradamente ante el Comité OTC de la OMC su 
preocupación de que el Reglamento cree obstáculos al comercio y beneficie a la industria química 
de la UE en detrimento de los competidores extranjeros.280 No obstante, según la Comisión no hay 
pruebas de que eso ocurra.  
 
Q60 Teniendo en cuenta la gran resistencia que el sistema REACH generó para la 
membresía de la OMC, agradeceríamos a la Comisión Europea nos indique cuándo piensan 
implementarse las medidas propuestas para mejorar las deficiencias que ha mostrado la 
aplicación del sistema, especialmente para que las empresas no europeas estén en 
igualdad de condiciones que las europeas.  
 
EU reply:  
As it is standard in every TBT notification to the WTO, every time that there is a change or a new 
measure in the REACH regulation, the European Commission notifies the expected time to be 
adopted and the expected time to be fully applicable of this new measure. Once the new measure  is 
adopted, the EU official journal reflects the measure. Moreover, the European Chemical Agency 
website ( https://echa.europa.eu/es/home ) provides timely information on the development and 
processes of these measures.  
 
4.4.1.2.3.4 Medidas de financiación sostenible  
 
"4.245. Por último, se están llevando a cabo negociaciones sobre una propuesta de reglamento de 
la Comisión relativa al sistema de clasificación unificado de la UE. El objetivo de esta propuesta de 
reglamento es ofrecer a los inver sores un lenguaje común para determinar qué actividades WT/TPR/M/395/Add.1  
 
- 202 - 
 
  económicas pueden considerarse sostenibles desde el punto de vista medioambiental. También 
servirá de base para la creación de normas y etiquetas destinadas a los productos financieros 
sostenibles.  
 
Q61 Agradecemos a la Comisión Europea especificar si en estas negociaciones se están 
discutiendo temas relacionados con el aceite de palma y si se ha discutido en alguna 
medida la posibilidad de considerar la producción de aceite de palma como no sostenibl e 
per se.  
 
EU reply:   
The EU Taxonomy Regulation lays down a framework that allows for the progressive development 
of an EU taxonomy of environmental sustainable economic activities. For an economic activity to be 
considered as environmental sustainable, it needs to: (1) Contri bute substantially to at least one of 
the six environmental objectives set out in the taxonomy regulation. (2) Do no significant harm to 
any of the other environmental objectives. (3) Comply with minimum social safeguards.  
The 6 environmental objectives r eferred to above are: (i) climate change mitigation, (ii) climate 
change adaptation, (iii) sustainable use and protection of water and marine resources, (iv) transition 
to a circular economy, (v) pollution prevention and control, (vi) protection and restor ation of 
biodiversity and ecosystems.  
The technical screening criteria, which will determine when an economic activity can be considered 
to make a substantial contribution and do no significant harm, will be developed by the EU through 
delegated acts, usin g a thorough technical and science -based assessment. Work on the delegated 
acts is ongoing.  
For more information, please refer to: 
https://ec.europa.eu/commission/presscorner/detail/en/QANDA_19_6804.  
 
4.4.2.2 Marco jurídico y de políticas  
 
"4.264. Recientemente se ha formulado una propuesta de Directiva y Reglamento sobre una tarjeta 
electrónica de servicios.353 Lo que se propone es elaborar un formulario de notificación armonizado 
para obtener una suerte de "pasaporte de servicios", que per mita acceder a la actividad de que se 
trate en el Estado miembro receptor, lo que potenciaría la cooperación entre los Estados miembros 
de origen y los Estados miembros receptores, y ayudaría a los proveedores de servicios 
transfronterizos. Este procedimie nto armonizado totalmente electrónico reducirá los obstáculos 
administrativos y simplificará los trámites para que los proveedores de servicios puedan prestarlos 
de una manera más eficiente en el extranjero. En marzo de 2018 se dejó en suspenso el proceso 
legislativo de la iniciativa.  
 
Q62 La propuesta de tarjeta electrónica es de interés para Colombia. ¿Tiene pensado la 
Comisión volver a presentar una nueva propuesta teniendo en consideración las 
observaciones presentadas durante el proceso?  
 
EU reply:   
The services e -card initiative has been on hold since 21 October 2019 because the European 
Parliament expressed the view that the legislative proposal should be withdrawn. As announced on 
29 January 2020, the Commission has decided to include it in its Work  Programme for 2020. Different 
options for the way forward are currently explored.  
 
4.4.3.2.3 Prohibición del bloqueo geográfico injustificado y de otras formas de 
discriminación por razón de la nacionalidad, el lugar de residencia o el lugar de 
establecimiento de los clientes  
 
"4.287. En el marco del paquete de medidas concebidas para reducir los obstáculos al comercio 
electrónico transfronterizo dentro de la UE, la Estrategia para el Mercado Único Digital preveía la 
prohibición de las prácticas que entrañaran el bloqueo geográfico injustificado y otras formas de 
discriminación geográfica. La expresión "bloqueo geográfico injustificado" designa las prácticas 
utilizadas por razones comerciales por los vendedores en línea que dan lugar a la denegaci ón del 
acceso a sitios web en otros Estados miembros  
 
Q63 ¿Todas estas medidas que prohíben la discriminación beneficia también a los 
compradores de terceros países que no están radicados dentro de la Unión Europea?  
 WT/TPR/M/395/Add.1  
 
- 203 - 
 
  EU reply:   
The Geo -blocking Regulation (EU) 302/2018, see information in https://ec.europa.eu/digital -single -
market/en/geo -blocking -digital -single -market , provides for an obligation to treat EU customers 
(including consumers and other end -users) in the same manner when they are in the same situation, 
regardless of their nationality, place of residence or place of establishment (s.c. shop -like-a-local). 
In principle, the trader remains free to define the geographical area in which he or she provides 
delivery services, provided that he does no t discriminate vis -à-vis a foreign EU customers seeking 
to buy goods shipped within the area served by the trader. Hence, the Regulation does not introduce 
an obligation to deliver across the EU in areas not served by the trader.  
 
The Regulation bans the b locking of access to websites and re -routing without the customer's prior 
consent. This increases price transparency by allowing customers to access different national 
websites. However, the prohibition of discrimination with respect to access to online in terfaces 
should not be understood as creating an obligation for the trader to engage in transactions with 
customers. On the basis of the Geoblocking Regulation a trader does not have an obligation to sell 
a specific service he does not provide. The Regulat ion's prohibition of discrimination should not be 
understood as affecting the application of any territorial limitation or other existing limitations to 
services the trader provides.  
 
With regard to the territorial scope of the Regulation, the Regulation applies to all traders offering 
their goods or services to consumers in the EU, regardless of whether they are established in the EU 
or in a non -EU country. Therefore, traders established in non -EU countries that operate in the EU 
are subject to  this Regulation.  
 
Regarding whether the Regulation benefits all customers in Europe including non -EU customers in 
Europe, the term "customer " means a consumer who is a national of, or a resident in, a Member 
State, or an undertaking that is established in  a Member State, and receives a service or purchases 
a good, or seeks to do so, within the EU, for the sole purpose of end use. In other words, the 
Regulation applies to the provision of goods or services to EU nationals or residents in all EU Member 
State s. As a result, non -EU nationals who have their residence in the EU will also benefit from the 
Regulation within the EU.  
 
On application of this Regulation to third countries, it applies only on the basis of bilateral 
agreements. The Geo -blocking Regulati on is therefore not directly applicable to customers outside 
the EU. This is without prejudice to the general non -discrimination obligations concerning natural 
persons that are applicable to EU -third countries relations under existing international arrange ments. 
However, as explained above, the Regulation will also apply to traders established in non -EU 
countries who operate in the EU.  
 
Please also see the Questions & Answers document published at https://ec.europa.eu/digital -single -
market/en/news/geo -blocking-regulation -questions -and-answers.  
 
4.4.5.1.1 Reglamento sobre la Ciberseguridad de la UE  
 
"4.342. El Reglamento sobre la Ciberseguridad de la UE entró en vigor el 27 de junio de 2019.461 
Refuerza el papel de la Agencia de la Unión Europea para la Ciber seguridad (ENISA) ampliando su 
mandato y dotándola de mayores recursos. El mandato revisado de la ENISA consiste en: contribuir 
a la elaboración y ejecución de la política y del Derecho de la UE en el ámbito de la ciberseguridad; 
prestar apoyo a la creació n de capacidades y a la preparación en toda la UE; promover la cooperación 
operativa en la UE; apoyar y promover el desarrollo y la aplicación de la política de la Unión en 
materia de certificación de la ciberseguridad; realizar análisis, prestar asesorami ento, sensibilizar y 
determinar las necesidades de investigación en el campo de la ciberseguridad; y contribuir a la 
cooperación internacional de la UE en este ámbito. El Reglamento establece también un marco 
europeo de certificación de la ciberseguridad, a fin de incrementar el nivel de ciberseguridad y hacer 
posible un planteamiento armonizado de la certificación de la ciberseguridad en la UE, con el objetivo 
de crear un mercado único digital para los productos, servicios y procesos de TIC.  
 
Q64 ¿Podrían empresas no europeas obtener la certificación que se está planteando 
desarrollar en la UE en materia de ciberseguridad?  
 WT/TPR/M/395/Add.1  
 
- 204 - 
 
  EU reply:   
Yes, any company may apply to get a certificate in accordance with the provisions of a particular 
scheme.  
 
4.4.6 Se rvicios audiovisuales  
 
4.343. En el marco de la Estrategia para el Mercado Único Digital, la Comisión presentó en mayo de 
2016 una propuesta para la reforma amplia de la Directiva de servicios de comunicación audiovisual 
vigente. La Directiva de servicios de comunicación audiovisual revisada fue adoptada en noviembre 
de 2018 y entró en vigor en diciembre de 2018.462 Dispone que los Estados miembros incorporarán 
las disposiciones de la Directiva a la legislación nacional el 19 de septiembre de 2020 a más tar dar.  
 
Q65 ¿Esta nueva directiva modificó en alguna medida el procedimiento de negociación de 
acuerdos de coproducción entre la UE y terceros países? cuántos acuerdos de 
coproducción audiovisual tiene la UE con terceros países? tiene planeado negociar algu no 
en los próximos años?  
 
EU reply:   
The choice, negotiation and conclusion of bilateral co -production agreements with third countries is 
under the full responsibility of the EU Member States.  
 
On this topic, you may be interested in a 2018 publication of the Council of Europe´s European 
Audiovisual Observatory on the analysis of the legal framework for co -productions 
(https://rm.coe.int/iris -plus-2018-3-the-legal-framework -for-international -co-
productions/168090369b ), but which does not include a country by country analysis.  
 
At EU level, two "Cultural Co -operation Protocols" wer e negotiated with Cariforum and Korea. These 
protocols are based on the provisions of the UNESCO Convention on the Protection and Promotion 
of the Diversity of Cultural Expressions adopted in Paris 20/10/2005, which entered into force 
18/03/2007. They are attached to the respective Free Trade Agreements, and set up a framework 
for the parties to co -operate in cultural activities including in the audiovisual sector.  
 
At this point in time, no negotiations of other similar protocols are envisaged. The recent  revision of 
the Audiovisual Media Services Directive (AVMSD) has not brought any changes in this regard. Please 
see https://ec.europa.eu/digi tal-single -market/en/revision -audiovisual -media -services -directive -
avmsd . 
 
  WT/TPR/M/395/Add.1  
 
- 205 - 
 
  COSTA RICA  
Informe de la Secretaría  
 
2.4. Régimen de inversión  
 
Página 46 (párrafo 2.54)  
2.54. As a general rule, the TFEU prohibits all restrictions on capital movements and on payments 
among EU member States, and between EU member States and non -members. The free movement 
of capital may be restricted based on the exceptions89 provided for in the TFEU or for overriding 
reasons of general interest as defined in th e case law of the CJEU, provided that the restrictions are 
necessary and proportionate to the achievement of the public objective pursued. Under the TFEU, 
no restrictions are in principle allowed on the freedom of establishment of an EU national in the 
territory of another member State. Freedom of establishment extends to EU subsidiaries affiliated 
to non -EU companies90, but not to branches or agencies of non -EU companies.  
 
Pregunta:  
1. Puede por favor la Unión Europea proporcionar más información sobre lo s motivos por 
los que no se extiende la libertad de establecimiento a sucursales o agencias de empresas 
no pertenecientes a la UE, y si existen otras limitaciones que les aplican a ellas?  
 
EU reply:  
According to Article 54 TFEU, Chapter 2 of the TFEU (right of establishment) applies to companies 
or firms formed in accordance with the law of a Member State of the EU and having their registered 
office, central administration or principal place of business within the Union. These are the conditions 
for a juridical person to benefit from the freedom of establishment as guaranteed by the TFEU. A 
non-European company not fulfilling both conditions can therefore not invoke the freedom of 
establishment based on Article 54 TFEU.  
 
Página 48 (párrafo 2.62)  
 
2.62. Regarding the first pillar – the establishment of a framework – it is important to note that the 
Regulation does not require member States to adopt screening mechanisms or to harmonize them. 
Rather, it provides that member States may maintain, amend or ado pt mechanisms to screen FDI 
in their territory on the grounds of security or public order106, and lays down certain requirements 
that these screening mechanisms must satisfy with respect to the following factors: transparency 
and non -discrimination between  third countries; the application of time -frames; the protection of 
confidential information; the right of foreign investors and the undertakings concerned to seek 
recourse to screening decisions; the avoidance of circumvention of screening mechanisms and 
screening decisions; and the notification to the Commission of existing screening mechanisms and 
of the adoption of new screening mechanisms or amendments to existing ones.107  
 
Preguntas:  
2. Costa Rica agradece la información sobre los criterios para la adopción de mecanismos 
de detección. ¿Puede por favor la Unión Europea aclarar si los criterios y procedimientos 
estarán a disposición del público en cada miembro de la UE, para que los inversores 
comprendan mejor cuándo se puede evaluar su inversión?  
 
EU Reply:   
The Regulation leaves the decision whether or not to put in place a screening mechanism to the 
Member States. The Regulation indeed confirms that Member States may maintain, amend or adopt 
mechanisms to screen foreign direct investment in their territory on the grounds of security or public 
order and lays down the essential requirements that Member States shall adhere to when screening 
foreign direct investments, such as transparency of those rules and procedures and non -
discrimination. Whe ther a foreign direct investment is screened in a given Member State thus 
depends on the national legislation of the Member States. The applicable national legislation needs 
to be transparent for investors and the Commission made the existing rules publicl y available.  
 
3. La Unión Europea indica que existen requisitos de notificación de los mecanismos de 
detección existentes o nuevos/modificados. ¿Puede por favor la Unión Europea aclarar si 
la Comisión también realizará revisiones de tales mecanismos y su c umplimiento con el 
marco?  WT/TPR/M/395/Add.1  
 
- 206 - 
 
  EU Reply:  
Pursuant to Article 3 of the Regulation, Member States had to notify the Commission of their existing 
screening mechanisms by 10 May 2019. Any newly adopted screening mechanism or any 
amendment to an existing screening m echanism also has to be notified. Article 3 also lays down the 
essential requirements for screening and the Member States are required to comply with these 
essential requirements. As for any other measure adopted by the Union institutions pursuant to the 
Treaties, the Commission will oversee the application of the Regulation under the control of the 
European Court of Justice, in line with its role as the guardian of the EU Treaties set out in Article  17 
TEU. 
 
Página 50 (párrafo 2.68)  
 
2.68. As noted above, following the advisory opinion of the CJEU of May 2017, the treatment of 
investment matters in EU agreements bifurcated. Trade agreements that deal only with matters 
within exclusive EU competence, and are concluded only by the EU, include market access pr ovisions 
with respect to FDI. Investment protection issues are addressed in separate investment protection 
agreements that include matters that fall within EU -exclusive and shared EU and member State 
competences and that are concluded by both the EU and th e member States. These mixed EU 
investment protection agreements will replace bilateral investment agreements between individual 
EU member States and third countries.  
 
Pregunta:  
4. Costa Rica agradece más información sobre las disposiciones que rigen la re lación entre 
las disposiciones de establecimiento en los acuerdos comerciales y las normas de 
protección de inversiones en los acuerdos de protección de inversiones. En particular, 
cómo aborda el nuevo esquema una inversión cubierta tanto por el cronograma  de 
compromisos específicos en un acuerdo como por la definición amplia de inversión en el 
otro acuerdo.  
 
EU reply:  
The EU 's trade agreements cover the liberalisation of foreign direct investment including market 
access in services and non -services and cl auses on NT and MFN. In certain cases, investment 
protection is covered in investment protection chapters of the EU 's trade agreements, or in separate 
investment protection agreements. Under those chapters or agreements, investment is indeed 
defined in a b roader manner (asset -based investment) and typically includes rules and standards on 
NT post -establishment, fair and equitable treatment, indirect expropriation etc.  
 
3.1.6. Medidas antidumping , compensatorias y de salvaguardia  
 
Página 79 (párrafo 3.78)  
3.78. The first set of changes were introduced in 2017, and added language with respect to "normal 
value". In essence, this allows for the normal value to be determined by another method where 
there are state -induced distortions in the exporting coun try. In such circumstances, normal value is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of 
benchmarks such as international prices or costs in another representative country.124 A different 
methodology for dete rmining the normal value is set out for non -WTO Members.  
 
Preguntas:  
5. ¿Podría la Unión Europea proporcionar más información sobre cómo la Comisión 
determina cuándo existe una distorsión inducida por parte de un Estado?  
 
EU reply:  
Sub-paragraph (b) of the Article 2(6)(a) of the EU 's Basic Anti -dumping Regulation lists in a non -
exhaustive manner circumstances which may result in significant distortions, as follows:  
 
— the market in question being served to a significant extent by enterprises which operate under 
the ownership, control or policy supervision or guidance of the authorities of the exporting country;  
— state presence in firms allowing the state to interfer e with respect to prices or costs;  
— public policies or measures discriminating in favour of domestic suppliers or otherwise influencing 
free market forces;  
—the lack, discriminatory application or inadequate enforcement of bankruptcy, corporate or 
prope rty laws;  WT/TPR/M/395/Add.1  
 
- 207 - 
 
  — wage costs being distorted;  
— access to finance granted by institutions which implement public policy objectives or otherwise 
not acting independently of the state.  
 
The presence of significant distortions is examined on a case -by-case basis  taking into account cross -
cutting distortions, distortions in the factors of production as well as distortions in the relevant 
sector.  
 
6. ¿A la fecha, han sido aplicadas estas nuevas disposiciones para la estimación del valor 
normal? ¿En cuáles casos esp ecíficos?  
 
EU reply:  
The new dumping calculation method was used in the following expiry reviews initiated after the 
date the legislation entered into force.  
 
Case number  Initiation date  Product  Country  
R683 14-03-2018 Organic coated steel  P.R. China  
R684 13-03-2018 Aluminium foil (rolls of less than 10 kg)  P.R. China  
R685 31-05-2018 Tungsten electrodes  P.R. China  
R687 15-05-2018 Ceramic tableware and kitchenware  P.R. China  
R688 04-06-2018 Bicycles  P.R. China  
R692 08-05-2018 Threaded tube or pipe cast fittings of malleable cast iron  P.R. China  
R693 19-07-2018 Ironing boards  P.R. China  
R697 17-12-2018 Peroxosulphates  P.R. China  
 
3.3.2 Normas y reglamentos técnicos  
 
Página 108 (párrafo 3.161)  
3.161. During the review period, there were some important changes to the basic legislative 
framework regarding technical requirements, standards, conformity assessment and accreditation. 
They include new rules on the mutual recognition of goods lawfully m arketed in member States and 
a new EU framework on market surveillance.  
 
Pregunta:  
7. Con el propósito de tener mayor claridad sobre los alcances de las nuevas regulaciones 
sobre acuerdos de reconocimiento mutuo y vigilancia de bienes en el mercado, solic itamos 
amablemente a la Unión Europea que por favor nos brinde un resumen sobre los 
principales elementos de las regulaciones a las que se hace referencia en este párrafo.  
 
EU reply:   
The EU Goods Package has brought forward the adoption of Regulation (EU) 2019/515 on the mutual 
recognition of goods lawfully marketed in another Members State, and (EU) 2019/1020 on market 
surveillance and compliance of products. Both Regulations improve the rules under which products 
can be marketed in the EU by economic operators.  
Regulation (EU) 2019/515 will start to apply on 19 April 2020 and it is a step forward when it comes 
to transparency of decisions taken by the competent authorities of the EU Member States in the area 
of mutual recognition. Decisions by an EU Member State restricting or denying market access to 
goods which have been lawfully marketed in other Member States will be notified to the European 
Commission and to other EU Member State s through the "information and communication system 
for the pan -European market surveillance " (ICSMS). ICSMS will also be used for exchange of 
information among the competent authorities and domestic product contact points, which will 
facilitate their comm unication in the area of mutual recognition of goods lawfully marketed in other 
EU Member States.  
ICSMS is not a new system. It was established by Regulation (EC) No . 765/2008 on accreditation 
and market surveillance, as a general archiving and exchange of  information system, on issues 
relating to market surveillance activities, programmes and related information on non -compliance WT/TPR/M/395/Add.1  
 
- 208 - 
 
  with EU harmonization legislation. ICSMS will be adapted to its new role, which is extended by 
Regulation (EU) 2019/515, and wil l also be used in regard of non -harmonized goods.  
As regards new Regulation (EU) 2019/1020, it introduces a new requirement whereby manufacturers 
not established in the EU will have to appoint a responsible person to act as contact point for national 
marke t surveillance authorities for certain types of products. The Regulation provides flexibility on 
whom can be this responsible person. Manufacturers not established in the EU can appoint an 
importer or an authorized representative, but the responsible perso n can also be a fulfilment centre 
in the EU as laid down in Article 4 of the Regulation. The Commission will provide guidelines 
explaining the practical implementation of Article 4. The aim is to publish them in 2020.  
 
Information on compliance with EU pro duct rules will also be made easily accessible to economic 
operators through the new tool laid down in Article 8 of Regulation (EU) 2019/1020. In particular, 
economic operators will have easy online access through the Your Europe portal that provides 
information about EU product requirements. This will be operational at the end of this year. In 
addition, there will be contact points at Member State level to which further questions on the 
implementation of product requirements can be addressed.  
Further, Regu lation (EU) 2019/1020 introduces enhanced cooperation mechanisms between market 
surveillance authorities of EU Member States and the European Commission by setting up a Union 
Product Compliance Network.  
 
Página 108 (párrafo 3.162)  
3.162. The principal legi slation setting the basis for these measures is described in Table 3.20. The 
EU framework of technical requirements, standards and conformity assessment is described in the 
Blue Guide on the implementation of EU product rules. This document provides guidan ce on the 
application of product -related directives and regulations, which serve as harmonization legislation 
for non -food and non -agricultural products destined for the EU market. The latest update to the 
Guide was published in July 2016.208  
 
Preguntas:  
8. ¿Qué porcentaje de las reglamentaciones técnicas aplicadas por los países miembros 
de la Unión Europea se encuentran armonizadas?  
 
EU reply:   
There are no formal statistics as to the percentage of harmonised technical regulations at EU level. 
Neverthel ess, the vast majority of industrial products are harmonised fully or partially by EU 
harmonization legislation.  
A recent list of EU harmonisation legislation can be found in Annex I to Regulation (EU) 2019/1020 
on market surveillance and compliance of pr oducts.  
 
9. ¿Cuáles son los principales elementos de la jurisprudencia de la CJEU sobre el principio 
general de libertad de movimiento de productos y reconocimiento mutuo?  
 
EU reply:   
The free movement of goods is one of the four fundamental freedoms of th e EU – together with the 
free movement of services, capitals and people – and a cornerstone of the EU single market. The 
rationale of an open market throughout the EU has always been to assist economic growth and 
competitiveness and therefore promote emplo yment and prosperity. Legislation on the single market 
for goods aims at ensuring that products placed on the EU market conform to high health, safety 
and environmental requirements. Once a product is sold legally in the EU, it should circulate without 
barriers to trade.  
 
The free movement of goods is ensured through EU harmonisation legislation and the principle of 
mutual recognition:  
 
- EU harmonization legislation entails that the same product rules applies across the EU, thereby 
preventing EU Member States from adopting national laws or regulations which might differ or 
go against EU harmonised rules. Under the New Legislative Framework, harmonisation is 
limited to the setting up "essential requirements" that products must meet (e.g. health, safety, 
and environmental protection).  
 
- In the case of non -harmonised products, the principle of mutual recognition applies. 
In these areas Member States may adopt national rules, but the EU ensures that they do not WT/TPR/M/395/Add.1  
 
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  constitute undue barriers to trade. Goods that ma y benefit from the principle of mutual recognition 
are those that have been lawfully marketed in one of the EU Member State. This condition 
encompasses two criteria: i) the goods have to comply with the relevant rules applicable in a Member 
State or not to  be subject to any such rules in that Member State; and ii) the goods were made 
available to end users in that Member State. 'Making available on the market ' is defined in Regulation 
(EU) 2019/515 as 'any supply of goods for distribution, consumption or us e on the market within 
the territory of a Member State in the course of a commercial activity, whether in return for payment 
or free of charge '. Goods that are imported from a third countries to an EU Member State, which 
comply with the technical rules of that Member State and were made available to end users there, 
are also eligible for mutual recognition in other EU Member States.  
 
EU Member States can however restrict or deny market access to goods that have already been 
lawfully marketed in another Memb er State provided that this restriction or denial is aimed at 
attaining one of the public interest objectives listed in Article 36 of the Treaty on the Functioning of 
the European Union ( "TFEU"). These public interest objectives are: (i) public morality, ( ii) public 
policy or public security; (iii) the protection of health and life of humans, animals or plants; (iv) the 
protection of national treasures possessing artistic, historic or archaeological value; or (v) the 
protection of industrial and commercial property. In addition to the grounds listed in Article 36 TFEU, 
there are 'overriding reasons of public interest ' or 'mandatory requirements ' developed by the Court 
of Justice of the EU that might also be raised by EU Member States, such as protection of 
fundamental rights (e.g. the protesters ' freedom of expression and freedom of assembly), consumer 
protection, child protection or the protecti on of the environment.  
 
Irrespective of whether a decision by an EU Member State denying or restricting market access is 
based on one of the grounds listed in Article  36 TFEU or of those developed by the Court of Justice 
of the EU, the decision must comply  with the principle of proportionality. Consequently, the 
administrative decision has to be appropriate for the purpose of achieving the objective pursued and 
not go beyond what is necessary to attain that objective  
 
Página 110 (párrafo 3.173)  
3.173. Other  key regulatory elements governed by the NLF are conformity assessment, product 
marking and accreditation. Conformity assessment is carried out before the product is placed on the 
EU market. A manufacturer can only place a product on the EU market when it meets all the 
applicable requirements. The Commission's main objective is to help ensure that unsafe or otherwise 
non-compliant products do not find their way on to the EU market. The purpose of conformity 
assessment is to ensure consistency of compliance from design to production, and to allow 
acceptance of the final product. Conformity assessment procedures in the EU product legislation 
range from a self -certification examination and production quality control system, to a full quality 
assurance system, d epending on the impact of the product on the protection of public interest 
(health, safety, environment, etc.). Several pieces of EU legislation require the involvement of a 
notified body in the conformity assessment process.  
 
Pregunta:  
10. ¿Cuáles son lo s criterios para determinar cuál procedimiento de evaluación de la 
conformidad es más apropiado para garantizar el cumplimiento de un determinado 
requisito técnico?  
 
EU reply:   
In the EU the choice of a particular conformity assessment procedure is influenced by a number of 
factors that EU regulators take into account, such as (i) the nature of the risks entailed by the 
product and the extent to which conformity assessment corres ponds to the type and degree of risk; 
(ii) whether the procedure concerned is appropriate to the type of product, including its complexity, 
nature, way of production and its intended use; (iii) the need to avoid imposing procedures which 
would be too burde nsome for the manufacturers in relation to the risks covered by the technical 
regulations concerned; (iv) the size and the structure of the manufacturers in the sectors concerned; 
(v) or the specificities of these sectors.  
Taking into account these overal l factors aiming at providing a high level of confidence as regards 
the conformity of products, while avoiding the imposition of heavier procedures than necessary and 
minimising the burden on manufacturers to the extent possible, EU regulators select the l east 
onerous and proportionate procedure.  
The EU system on conformity assessment provides for a menu of conformity assessment procedures 
(the so -called "modules") which are pre -defined and regulated in a horizontal decision addressed to WT/TPR/M/395/Add.1  
 
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  the EU legislators (i.e. Decision 768/2008 of 9 July 2008, on a common framework for the marketing 
of products). Out of this menu, each sector -specific harmonisation legislation must specify which 
one(s) of those procedures is or are applicable to the products which fall und er its scope of 
application. This modular approach is based on the conformity assessment toolbox developed by 
ISO CASCO, and provides for a wide range of conformity assessment solutions from which the 
legislator can make a choice in relation to its specifi c regulatory needs. That ensures a coherent 
approach to the extent that the legislator cannot deviate from the specified conformity assessment 
procedures.  
 
Conformity assessment procedures in the EU are grouped in two main categories which include:  
 
- First-party conformity assessment, whereby the manufacturer declares conformity on his/her 
sole responsibility as assurance of conformity to technical regulations. This is the preferred 
procedure for low to medium risk products, which are the vast majority  of products covered by 
EU harmonisation legislation (e.g. electrical equipment, machinery, toys, some medical devices, 
cosmetics, personal protective equipment, radio equipment, textiles, some equipment for 
explosives atmospheres, some construction produc ts, or consumer products).  
- For products presenting a higher -risk to the relevant public policy objectives, the intervention of 
an independent third -party conformity assessment body is required, including cases where the 
assessment is performed by specified  governmental bodies.  
 
3.3.2.3. El rol de la normalización para las tecnologías digitales  
 
Preguntas:  
11. ¿Este apartado hace referencia a bienes relacionados con tecnologías digitales o a 
servicios digitales?  
 
EU Reply:   
This paragraph relates to all pr oducts (goods) and services placed on the EU market, including digital 
ones, like for example eAccessibility.  
 
12. ¿Los principios de normalización de bienes de las tecnologías digitales aplican también 
a la normalización de servicios digitales?  
 
EU Reply:   
The principles also apply to digital technologies. Additional regulations (for example the General 
Data Protection Regulation, copyright) may also apply.  
 
 
Página 114 (párrafo 3.199)  
3.199. Since 2013, the Commission has been implementing an EU Strategy on Adaptation to Climate 
Change, setting out a framework and mechanisms for the EU's preparedness for current and future 
climate impacts (Section 4.2). The Commission invited the ESOs t o contribute to EU efforts to make 
Europe more climate -resilient. In 2018, the Commission published an evaluation of the initial five 
years of the implementation of the Strategy, encompassing, among others, the progress on 
standardization.  
 
Preguntas:  
13. ¿Cuáles son los efectos actuales y potenciales del cambio climático en los países de la 
UE? ¿Afectan estos efectos la producción o comercialización de bienes europeos o 
importados específicos?  
 
EU reply:  
The European Commission carried out an extensive a nalysis of the current and potential effects of 
climate change on EU countries in support to its Communication "A Clean Planet for All - A European 
long-term strategic vision for a prosperous, modern, competitive and climate neutral economy " ref. 
COM(2018) 773 - https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52018DC0773 ). The 
analysis underlines that unconstrained climate change without appropriate adaptation "would also 
have severe consequences on the productivity of Europe's economy, infrastruc ture, ability to produce 
food, public health, biodiversity and political stability. " 
 WT/TPR/M/395/Add.1  
 
- 211 - 
 
  14. ¿Cuáles son los avances que se han alcanzado en materia de normalización e 
incorporación de la variable cambio climático?  
 
Página 114 (párrafo 3.200)  
3.200. On a mandate from the Commission, the ESOs completed the first phase at the beginning of 
2017; this resulted in a shortlist of 12 standards to be revised and 1 standard to be written under 
the second phase, which started at the beginning of 2018 and  is expected to take about four years. 
CEN-CENELEC will then consider whether the process should be extended to other standards. The 
technical committees are currently asking for more detailed information on climate change projection 
data.  
 
Pregunta:  
15. ¿De qué manera se incorpora la data sobre la proyección del cambio climático en la 
elaboración de normas, reglamentos o evaluación de la conformidad? ¿Cómo y a partir de 
cuáles variables se obtiene esa data?  
 
Página 114 (párrafo 3.202)  
3.202. In 2016, CEN and CENELEC developed and published a "Guide for addressing climate change 
adaptation in standards". The Guide is intended to help standard writers address the consequences 
and implications of climate change. It includes a simple checklist to help establis h whether climate 
change adaptation is relevant to a particular standardization activity and a decision tree to help 
identify which actions should be taken.224  
 
Preguntas:  
16. ¿Cuáles son los principales elementos establecidos en la Guía para la adaptació n del 
cambio climático en la normalización?  
 
17. ¿Pueden por favor brindar ejemplos de normas a las que se les haya aplicado esta guía 
y los elementos específicos en los que se detalla la adaptación al cambio climático?  
 
 
EU reply (Q14 -15-16-17): 
The work on updating selected European harmonised standards to take into account the impacts of 
climate change is still ongoing, it will finish probably in 2022. A shortlist of 12 priority standards 
considered for revision was established.  
Standards under consideration for revision:  
1. EN ISO 52000 -1: Energy performance of buildings – overall energy use and definitions of 
energy ratings;  
2. EN ISO 15927 -4 Hydrothermal performance of buildings – calculation and presentation of 
climatic data  
3. EN 16798 Energy performance of buildings -  
Part 1: Indoor environmental input parameters for design and assessment of energy performance 
of buildings addressing indoor air quality, thermal environment, lighting and acoustics - Module 
M1-6.  
Part 3: Vent ilation for non -residential buildings - Performance requirements for ventilation and room -
conditioning systems (Modules M5 -1, M5 -4) 
4. EN 16309 Sustainability of construction works. Assessment of social performance of buildings. 
Calculation methodology  
5. EN 50125 Railway applications - Environmental conditions for equipment  
Part 1: Equipment on board rolling stock  
Part 2: Fixed electrical installations  
Part 3: Equipment for signalling and telecommunications  
6. EN 1915 Aircraft ground support equipment - General requirements  
Part 1: Basic safety requirements  
Part 2: Stability and strength requirements, calculations and test methods  
7. EN 16348 Gas infrastructure - Safety Management System (SMS) for gas transmission 
infrastructure and Pipeline Integrity Management System (PIMS) for gas transmission pipelines – 
Functional requirements  
8. EN 15399 Gas Supply Systems - Guidelines for Management systems for Gas Distribution 
Networks  
9. EN 1473 Installation and equipment for liquefied natural gas - Design of onshore installations  
10. EN 50600 series Information technology - Data centre facilities and infrastructures  WT/TPR/M/395/Add.1  
 
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  Part 2 -3: Environmental control  
Part 2 -5: Security systems  
11. EN 300 019 series Environmental Engineering (EE); Environmental Conditio ns (Part 1) and 
Environmental Tests (part 2) for Telecommunications Equipment  
 
After consideration, standard EN 15723 "Closing and locking devices for payload protecting devices 
against environmental influences - Requirements for durability, operation, ind ication, maintenance, 
recycling " has been removed from the work programme of the second phase.  
New standard under standardisation committee CEN TC 350:  
New WI 0035028 "Sustainability of construction works — civil engineering works sustainability 
assessment  methodology " 
 
The Adaptation to Climate Change Coordination Group (ACC -CG) of the European Standardisation 
Organisations, operating with financial support from the European Commission, advises and 
coordinates the technical committees in charge of the stan dards in their revision work. The revision 
is at various stages of advancement, with nothing finalised yet, so there is no example that could 
be described.  
The work is carried out using the Guide for addressing climate change adaptation in standards, 
available on the website of the European Standardisation Organisations CEN/CENELEC.  
https://www.cencenelec.eu/standards/Sectorsold/ClimateChange/Pages/default.aspx.  
 
The Guide is intended to help standard writers address the consequences and implications of c limate 
change. It includes a simple checklist to help establish whether climate change adaptation is relevant 
to a particular standardization activity and a decision tree to help identify which actions should be 
taken. A complementary tailored guidance doc ument for infrastructure standards is currently under 
development by the ACC -CG, it will include more specific information on which climate data can be 
used in preparing the standards to climate change.  
In the coming months, the ACC -CG will also attempt to  identify together with the technical 
committees further standards to revise or to adopt in order to take into account current and future 
climate impacts on assets.  
 
Página 115 (párrafo 3.210)  
3.210. During the review period, the TBT Committee received 13 new specific trade concerns 
regarding measures taken by the EU or its member States: eco -design requirements for electronic 
displays; chlorothalonil (pesticide active substance); transitional periods for minimum residue limits 
(MRLs) and international cons ultations; organic production and labelling - maté (erva -mate); 
labelling requirements of the origin of grains used in the preparation of dried pasta; non -renewal of 
approval of the active substance picoxystrobin; titanium dioxide: Regulation (EC) No. 1272 /2008 
(CLP Regulation), Annex VI, Part 2; amendments to Directive 2009/28/EC, Renewable Energy 
Directive; application of Regulation No. 1169/2011 and Regulation (EC) No. 1924/2006 as regards 
the labelling of food products, in not prohibiting or examining t he use of "palm oil free" labels; 
Regulation of the European Parliament and of the Council laying down rules and procedures for 
compliance with and enforcement of Union harmonization legislation on products and amending 
relevant regulations; establishment and operation of a traceability system for tobacco products; 
Radio Equipment Directive; and laws, regulations, procedures and guidelines on marketing 
authorization for medicinal products.229  
 
Preguntas:  
En relación con la preocupación comercial presentada  contra la Unión Europea por la propuesta de 
no renovación del ingrediente activo clorotalonil:  
 
18. ¿Cuál es la visión de la Unión Europea sobre la labor que realiza el Codex Alimentarius  
como organismo internacional de referencia para el establecimiento de Límites Máximos 
de Residuos (LMR) de sustancias que se consideran – dentro de los límites definidos – 
inocuas para el ser humano?  
 
EU reply:  
The EU fully supports the activities of the international standard setting bodies, notably the 
OIE/CODEX/IPPC, and works assiduously in the three sisters to help reach the objective of providing 
a comprehensive framework of standards at an international le vel. EU measures on maximum 
residue levels (MRLs) are regularly and systematically aligned with Codex MRLs (CXLs), provided 
that these CXLs are higher than existing EU MRLs, are related to commodities for which the EU sets WT/TPR/M/395/Add.1  
 
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  MRLs, and are acceptable in terms  of consumer protection, supporting data and extrapolation rules. 
This is systematically assessed by the European Food safety Authority (EFSA). In accordance with 
Article 3.3 of the SPS Agreement, the EU can deviate from international standards based on EF SA's 
scientific advice when EFSA raises concerns for consumer protection. Any measures that are taken 
on the basis of EFSA's risk assessments, are not more trade restrictive than necessary and are 
applied in a non -discriminatory manner both to intra -EU tra de as well as to imports from third 
countries.  
In practice, before each meeting of the relevant Codex Committee (Codex Committee on Pesticides 
Residues - CCPR) EFSA carries out a systematic assessment of the draft proposed JMPR CXLs and 
delivers an opinion  that will form the basis of the EU common position. If no concerns are identified 
by EFSA, the CXLs are systematically taken over in the EU legislation. If the EU has concerns, it 
makes a reservation at the CCPR meeting, thus transparently informing the o ther delegations at an 
early stage that the MRL will not be taken over.  
 
19. ¿Considera la Unión Europea que las sustancias activas con un LMR establecido a nivel 
de Codex Alimentarius pueden ser utilizadas en la producción agrícola siempre que el 
producto  final no las contenga en porcentaje superior al LMR definido a nivel de Codex?  
 
EU reply:  
The EU acknowledges the role of Codex Alimentarius in setting international standards for pesticide 
residues in food and feed, to ensure the safety of consumers and facilitate trade. Codex Alimentarius 
is however not a body with competence for the authorisation of active substances and/or plant 
protection products.  
The EU legislation provides for a two -step system: it requires that each active substance to be used 
in the European Union in a Plant Protection Product (PPP) is approved at EU level38. PPPs containing 
EU approved active substances can only be placed on the EU market after prior authorisation. The 
authorisation of PPPs is granted by individual EUMS39. Both app rovals and authorisations are granted 
following the submission of applications supported by the required data to ensure the protection of 
human health, animal health and the environment. Along with the approval of the active substance 
and subsequent author isation of PPPs, maximum residue levels (MRLs) need to be established for 
each crop on which the active substance is intended to be used.  
It is for non -EU countries to decide on their own system to regulate pesticides used in agricultural 
production.  
Food products placed on the EU market must comply with EU -MRLs. Existing Codex MRLs are taken 
into account when setting EU -MRLs, and it is an EU policy to systematically and proactively align its 
MRLs with Codex MRLs if they are acceptable to the EU with respe ct to areas such as consumer 
protection, supporting data and extrapolations.  
When a Codex MRL is not included in the EU legislation, an exporting country can still provide the 
necessary data and follow the procedure for setting an 'import tolerance '. This approval procedure 
is laid down in Regulation (EC) No 396/2005 and includes an evaluation of the submitted data by 
EFSA. An import tolerance may be granted by the EU under the condition that there is no health risk 
for consumers and that t he requested MRL is not higher than the one established in the third country.  
Products imported into the EU should respect MRLs established at EU level and listed in the EU 
pesticide database:  
https://ec.europa.eu/food/plant/pesticides/eu -pesticides -
database/public/?event=homepage&language=EN  
 
20. ¿La decisión de la Unión Europea de no renovar la autorización de uso de un 
ingrediente activo se basa en un análisis de riesgo específico por productos?  
EU reply:  
Decisions to approve or to revoke the authoris ation of active substances and decisions on MRLs are 
taken after a rigorous risk assessment carried out jointly by European Union Member States and the 
European Food Safety Authority (EFSA) with the first and foremost objective to protect consumers ' 
health . 
 
21. ¿Qué es un análisis de riesgo para la UE?  
 
 
38 https://ec.europa.eu/food/plant/pesticides/approval_active_substances_en.  
39 http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/index_en.htm.  WT/TPR/M/395/Add.1  
 
- 214 - 
 
  EU reply:  
According to the EU 's general food law laid out in REGULATION (EC) No 178/2002, "risk analysis " 
means a process consisting of three interconnected components: risk assessment, risk management 
and risk communication. As a consequence, EU risk assessment is carried out independently from 
risk management. As the EU's risk assessor, the European Food Safety Authority (EFSA) is an 
independent source of scientific advice and communication on risks associ ated with the food chain. 
The risk managers (European Commission, the European Parliament and the EU Member States), 
acting on the basis of EFSA's risk assessments, adopt the risk management decisions. Thanks to 
EFSA's independence and broad remit – which covers food and feed safety, nutrition, animal health 
and welfare, plant protection and plant health – the EU risk managers can rely on solid scientific 
advice on the basis of which to determine their chosen level of protection. It is also on this basis 
that the EU establishes its contribution to the standard -setting process at international level.  
 
22. ¿Considera la Unión Europea que la labor del Codex Alimentarius es útil a nivel 
internacional en relación con la facilitación del comercio y la protección d e la salud 
pública?  
 
EU reply:  
Please refer to the answer to question 18.  
 
23. ¿Por qué considera la Unión Europea que es necesario trabajar de manera unilateral 
en el análisis y evaluación de sustancias cuya confiabilidad ha sido establecida a nivel del 
Codex Alimentarius?  
 
EU reply:  
Pesticide residues resulting from the use of plant protection products (PPPs) on crops or food 
products that are used for food or feed production may pose a risk for public health. For this reason, 
a comprehensive legisla tive framework has been established in the EU, which deﬁnes strict rules for 
the approval of active substances used in PPPs and the authorisation of such PPPs, for the sustainable 
use of pesticides, and for pesticide residues in food. The EU legislation re quires that each active 
substance to be used in the European Union in a PPP is approved at EU level . The process is strictly 
science based and approval is given only when a risk assessment shows that there are no risks to 
human health or the environment. EU legislation further requires that EU risk managers, when 
setting MRLs, take account of i.a. the available scientific and technical knowledge and the results of 
an assessment of any potential risks to consumers  
Nonetheless, in accordance with Article 5(3 ) of Regulation (EC) 178/2002 of the European Parliament 
and of the Council , where international standards exist or their completion is imminent, they are to 
be taken into consideration in the development or adaptation of food law, except where such 
stand ards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the 
legitimate objectives of food law or where there is a scientific justification, or where they would 
result in a different level of protection from the one deter mined as appropriate in the Community. 
Moreover, in accordance with Article 13(e) of that Regulation, the Union is to promote consistency 
between international technical standards and food law while ensuring that the high level of 
protection adopted in the  Union is not reduced.  
 
24. Las sustancias activas que han sido aprobadas por la Unión Europea y que contienen 
LMR establecidos a nivel de Codex Alimentarius son utilizadas en la producción de un 
amplísimo número de productos agrícolas. La producción agríc ola, el planeamiento, la 
rotación de las sustancias, el cambio climático y otra serie de elementos hacen difícil que 
los agricultores puedan eliminar en un corto plazo el uso de una sustancia activa 
previamente aprobada. ¿La Unión Europea toma en cuenta es tos elementos al momento 
de establecer períodos de transición para la aplicación de nuevas regulaciones que 
eliminan la aprobación previa de una sustancia activa?  
 
EU reply:  
The EU regularly notifies its trading partners through the appropriate WTO channel s all the planned 
measures related to plant protection products ' active substances and MRLs. Information and 
comments received in response to these notifications are duly considered and taken into account 
before a final decision is taken. Detailed replies are sent to all trading partners that submit 
comments.  
Following the formal adoption, publication and entry into force of an act lowering MRLs, a deferred 
date of application is set. The date of application is the date from which the new/lower MRLs are WT/TPR/M/395/Add.1  
 
- 215 - 
 
  effectively enforced. The length of the deferral is 6 months after entry into force, in the vast majority 
of cases. This deferral of the application date allows third countries and food business operators to 
make the necessary arrangements to meet the new req uirements. Products produced in the EU or 
imported into the EU before the aforementioned application date may continue to benefit from the 
old/higher MRLs and remain on the market, if information shows that a high level of consumer 
protection is maintained . This is not the case where MRLs are lowered because the safety of 
consumers could not be demonstrated.  
Similar procedures to what described above apply when a decision to withdraw (or amend) the 
approval of a substance is taken. If and when the EU takes a decision of non -renewal (or restricted 
renewal), and following formal adoption, publication and entry into force, a period of time is given 
to EU Member States to withdraw authorisations for PPPs containing that active substance. The 
length of the deferr al is usually a maximum of 6 months after entry into force, in the vast majority 
of cases. In addition, the EU would like to underline that non -renewal measures provide for a grace 
period for placing on the market and use of plant protection products, duri ng which there is no 
disruption of trade in food and feed commodities as there is no modification of existing MRLs. The 
grace period is taken into account when proposing changes to existing MRLs.  
Recent concrete cases show that at least 2 years elapse bet ween the first notification of a proposed 
non-approval or restriction of approval under the WTO/TBT system, and the application of a measure 
lowering MRLs to the limit of determination.  
 
25. ¿Cuál es la relación entre la no autorización de una sustancia ac tiva y la revisión de 
los LMR específicos por producto?   
 
EU reply:  
Following the non -approval of an active substance at EU level, EU Member States must withdraw 
the authorisations for PPPs containing that active substance (see Question 24 for details). In line 
with the principle that MRLs should be set as low as reasonably achievable (ALARA), MRLs are 
lowered if the underlying Good Agricultural Practices become obsolete, which is the case when the 
MRL was set based on a (now withdrawn) use in a n EU Member State.  
However, it remains possible to maintain the MRL at the same level or set it at an appropriate 
different level, based on existing Codex MRLs or based on a use authorised in a non -EU country 
(import tolerance; see Question 19 for details) , under the condition that there is no health risk for 
consumers.  
 
26. ¿Puede un país de la Unión Europea rechazar un producto por identificación de un 
residuo de una sustancia activa cuya autorización no se ha renovado, aún y cuando los 
LMR se mantienen s in variación?  
 
EU reply:  
Food and feed placed on the market in the EU must comply with the MRLs set in the Annexes to 
Regulation (EC) No 396/2005. It is the responsibility of EU Member States to enforce those MRLs. 
Following a decision to non -approve an a ctive substance in the EU, MRLs are modified through a 
separate act (see the reply to Question 25).  
 
27. El clorotalonil tiene LMR a nivel del Codex para más de 40 productos agrícolas. 
¿Considera la Unión Europea que la armonización a nivel internacional e n relación con las 
normas de referencia es importante para efectos de facilitar el comercio?  
 
EU reply:  
Please refer to the answer to Question 18.  
 
3.3.3 Requisitos sanitarios y fitosanitarios  
 
Página 119 (párrafo 3.222)  
 
3.222. EU member States are members of the Codex Alimentarius Commission, and the World 
Organization for Animal Health (OIE), and are contracting parties to the International Plant 
Protection Convention (IPPC). The EU itself is a member of Codex and a cont racting party to the 
IPPC.  
 WT/TPR/M/395/Add.1  
 
- 216 - 
 
  Preguntas:  
28. ¿Considera la Unión Europea que la labor del Codex Alimentarius  es útil a nivel 
internacional en relación con la facilitación del comercio y la protección de la salud 
pública?  
 
EU reply:  
Please refer to the answer to Question 18.  
 
29. ¿Qué porcentaje de medidas sanitarias de la Unión Europea utilizan como referencia 
o se basan en las  normas del Codex Alimentarius ?  
 
EU reply:  
The EU fully supports the activities of relevant international standard setting bod ies, notably the 
OIE/CODEX/IPPC, and works assiduously with the three sisters to help reaching a comprehensive 
framework of standards at an international level. EU public, animal and plant health measures are 
generally based on those relevant international  standards.  
For instance, between 2012 and 2019, a total of 2567 CXLs for food commodities were adopted by 
Codex. In that period, the EU has taken on board 1833 MRLs out of these 2567 CXLs. Taking into 
account EU -MRLs that are set at the same or higher lev el than the CXLs for the same food products, 
the EU is aligned with more than 70% of the CXLs established in this period.  
 
Página 119 (párrafo 3.225)  
3.225. As from 14 December 2019, all plants (including living parts of plants) will need to be 
accompanied  by a phytosanitary certificate to enter into the EU, unless they are listed in Commission 
Implementing Regulation (EU) 2018/2019 as exempted from this general requirement. Currently, 
the list of exempted plants are the following: pineapples, coconuts, dur ians, bananas and dates.  
 
Preguntas:  
30. ¿Cuál es el razonamiento de la Unión Europea para excluir la importación de piña, 
coco, banano y dátiles, entre otros productos, del requisito de presentación de un 
certificado fitosanitario?  
 
EU reply:  
The reason for the exclusion of the importation of pineapple, coconut, bananas and dates, among 
other products, from the requirement for the submission of a phytosanitary certificate is based on 
Article 73 of Regulation (EU) 2016/2031. According to that articl e, an assessment can be carried out 
for a specific commodity, based on evidence about pest risks and experience with trade, taking into 
account the criteria set out in Annex VI of that Regulation. When that assessment demonstrates that 
such a certificate i s not necessary, that commodity can be proposed to be exempted from the 
obligation to be accompanied by a phytosanitary certificate.  
 
31. La Regulación de Implementación de la Comisión (EU) 2018/2019 establece una lista 
de plantas consideradas de alto ries go fitosanitario. ¿La Unión Europea realizó un análisis 
de riesgo de plagas para cada una de las plantas incluidas en esa categoría? ¿si no es así, 
se trata de una medida provisional bajo los términos del Acuerdo de Medidas Sanitarias y 
Fitosanitarias (AMS F) de la OMC?  
 
EU reply:  
The list of high risk plants included in the Annex to Regulation 2018/2019 was established on the 
basis of a preliminary assessment, in accordance with paragraph 1 of Article 42 of regulation (EU) 
23016/2031. That preliminary asse ssment took into account the criteria set out in Annex III of the 
same Regulation. The prohibition is only preliminary because the full risk assessment is not yet 
available. It will be carried out on request and can only be done after submission of a dossi er for 
risk analysis.  
 
32. ¿La Regulación de Implementación de la Comisión (EU) 2018/2019 toma en cuenta 
las disposiciones de la NIMF 2 de la Convención Internacional de Protección Fitosanitaria 
según la cual cuando exista comercio no deberán aplicarse nue vas medidas hasta que el 
examen o el ARP haya concluido? ¿El  listado de plantas de alto riesgo constituye una 
medida de urgencia en los términos del AMSF? Según la NIMF 2 cuando exista comercio 
es posible revisar las medidas o realizar un análisis de ries go, pero el comercio debe 
mantenerse mientras se realiza esta evaluación. ¿Acepta la Unión Europea este principio?  WT/TPR/M/395/Add.1  
 
- 217 - 
 
  EU reply:  
The risk assessment carried out in order to establish the list of high -risk plants is a commodity risk 
assessment while ISPM 2 refe rs to pest risk analysis. The decision to establish that list is based on 
the precautionary principle deriving as a result of that preliminary risk assessment.  
 
Página 119 (párrafo 3.226)  
3.236. Provisions within Regulation (EU) 2016/2031 are in place for the listing of "high risk plants, 
plant products and other objects" (Article 42), based on a scientific preliminary assessment by the 
EFSA. Commission Implementing Regulation (EU) 2018/201 9 establishes the list of high -risk plants 
the introduction of which into the EU territory will be provisionally prohibited from 14 December 
2019 until a full risk assessment has been carried out.  
 
Pregunta:  
33. ¿Puede un país miembro de la Unión Europea emitir una alerta RASFF por detección 
de un LMR que  aún no ha sido variado? Ver adjunto la notificación 2019.4453 en relación 
con clorpirifos en banano de Costa Rica. Se menciona como referencia un comunicado de 
prensa de EFSA cuyo enlace no funciona.  
 
EU reply:  
Yes, a RASFF member can send a notification when " …(it) has any information relating to the 
existence of a serious direct or indirect risk to human health deriving from food or feed" (Article 50 
of Regulation (EC) No 178/2002), and they can justi fy this fact on a risk assessment. On the 
mentioned notification 2019.4453 (chlorpyrifos in bananas from Costa Rica), the notifying country 
reported the level of chlorpyrifos below MRL on the basis of the scientific advice of EFSA due to the 
genotoxicity p otential of chlorpyrifos, as it is fully explained in the text of the RASFF notification. If 
the evidence provided is proven incorrect, such notifications can be withdrawn. The correct link to 
the EFSA publication "Chlorpyrifos: assessment identifies human  health effects" is:  
https://www.efsa.europa.eu/en/press/news/chlorpyrifos -assessment -identifies -human -health -
effects  
Only to highlight that the official document where the approval of the active substance chlorpyrifos 
is not renewed has been notified to both the SPS Agreement (G/SPS/N/EU/360, on 12/Dec/2019) 
and TBT Agreement (G/TBT/N/EU/682, on 3/Oct/2019) and the trade partners had the option to 
send comments for their consideration.  
 
Página 122 (párrafo 3.240)  
3.240. During the review period, WTO Membe rs used the SPS Committee to raise 11 new specific 
trade concerns about measures taken in the EU or a member State: EU non -recognition of 
regionalization for Avian Influenza; France's dimethoate -related restrictions on imports; EU MRLs 
for acrinathrin, met alaxyl and thiabendazole; EU maximum level of cadmium in foodstuffs; EU 
restrictions on poultry meat due to Salmonella detection; EU Commission Decision 2002/994/EC on 
animal products; EU restrictions on poultry meat preparations (Regulation (EU) No. 2018/ 700); EU 
review of legislation on veterinary medicinal products; new EU definition of the fungicide folpet; EU 
MRLs for buprofezin, diflubenzuron, ethoxysulfuron, ioxynil, molinate, picoxystrobin and 
tepraloxydim; and CJEU Opinion 528/16 on organisms obtai ned by mutagenesis.  
 
Preguntas:  
34. ¿Cuál es la visión de la Unión Europea sobre la labor que realiza el Codex Alimentarius  
como organismo internacional de referencia para el establecimiento de Límites Máximos 
de Residuos (LMR)?  
 
EU reply:  
Please refer to the answer to Question 18.  
 
35. ¿Considera la Unión Europea que las sustancias activas con un LMR establecido a nivel 
de Codex Alimentarius pueden ser utilizadas en la producción agrícola siempre que el 
producto final no las contenga en porcentaje superior al LMR definido a nivel de Codex?  
 
EU reply:  
Please refer to the answer to question 19.  WT/TPR/M/395/Add.1  
 
- 218 - 
 
  36. ¿La decisión de la  Unión Europea de establecer LMR más estrictos que los acordados 
a nivel del Codex Alimentarius se basa en un análisis de riesgo específico por productos? 
¿Por ejemplo, existe un análisis  de riesgo para banano de Costa Rica que justifique un 
LMR para bupr ofecina más estricto que el  acordado a nivel del Codex Alimentarius?  
 
EU reply:  
Regulation (EC) No 178/2002 on General Food Law (hereinafter, the "General Food Law ") establishes 
certain general principles underpinning the development of EU food law. The most important of these 
is the risk analysis principle consisting of three separate but interrelated components: risk 
assessment, risk management and risk communication. Risk assessment at EU level is carried out 
by an autonomous agency – EFSA – , separate ly from the EU risk management function, exercised 
mainly by the European Commission (but also by the European Parliament and the EU MS). Risk 
management decisions are to take into account the results of the risk assessment (EFSA 's scientific 
output) but a lso other legitimate factors.  
As laid down in the Fitness Check of the General Food Law – a comprehensive policy evaluation of 
this Regulation to be found at: 
https://ec.europa.eu/food/safety/general_food_law/fitness_check_en, the EU has made 
considerable efforts to ensure alignment of EU food law with international standards, following its 
introduction in 2002. This is also reflected in other EU secondary food legislation, where specific 
reference to international standards in the development of food law i s made; as a consequence, 
adaptation of EU law takes place in line with international standards. There are few cases, however, 
where EU measures are stricter than the international standards established. In those cases, EU risk 
managers have considered app ropriate that other legitimate factors had also to be considered in 
addition to the EU risk assessment findings. In the absence of an exhaustive list of legitimate factors 
in the General Food Law Regulation , the EU risk managers have in the past considere d as legitimate 
factors nutritional advantages and disadvantages, societal factors, ethical considerations, impact on 
non-communicable diseases (e.g. obesity), lack of mitigation measures, animal welfare as well as 
economic factors. The use of legitimate f actors in the EU decision -making process is not static; the 
exact range of factors and the weight attributed to them varies on a case -by-case basis depending 
on the subject matter and the measure concerned.  
The lowering of MRLs for buprofezin in banana wa s necessary to protect European consumers, as a 
risk assessment of buprofezin by the European Food Safety Authority (EFSA) identified important 
consumer health concerns. Available information showed in fact that under high -temperature 
processing conditions  buprofezin is degraded into several metabolites, including aniline. Aniline is a 
carcinogen for which a genotoxic mechanism cannot be excluded and therefore no threshold for 
acceptable exposure can be assumed.  
 
37. ¿Qué es un análisis de riesgo para la UE ? 
 
EU reply:  
Please refer to the answer to Question 21.  
 
38. ¿Considera la Unión Europea que la labor del Codex Alimentarius es útil a nivel 
internacional en relación con la facilitación del comercio y la protección de la salud 
pública?  
 
EU reply:  
Please refer to the answer to Question 18.  
 
39. ¿Por qué considera la Unión Europea que es necesario trabajar de manera unilateral 
en la definición de LMR más estrictos que los acordados a nivel multilateral por el Codex 
Alimentarius?  
 
EU reply:  
Please ref er to the answer to Question 23.  
 
40. Las sustancias activas que han sido aprobadas por la Unión Europea y que contienen 
LMR establecidos a nivel de Codex Alimentarius son utilizadas en la producción de un 
amplísimo número de productos  agrícolas. La prod ucción agrícola, el planeamiento, la 
rotación de las sustancias, el cambio climático y otra serie de elementos hacen difícil que 
los agricultores puedan eliminar en un corto plazo el uso de una sustancia activa 
previamente aprobada. ¿La Unión Europea toma en cuenta estos elementos al momento WT/TPR/M/395/Add.1  
 
- 219 - 
 
  de establecer períodos de transición para la aplicación de nuevas regulaciones que 
reducen las tolerancias de sustancias activas previamente permitidas?  
 
EU reply:  
Please refer to the answer to Question 24.  
 
41. ¿Cuál es la relación entre la no autorización de una sustancia activa y la revisión de 
los LMR específicos por producto?  
 
EU reply:  
Please refer to the answer to question Q5.  
 
42. ¿Considera la Unión Europea que la armonización a nivel internacional en relació n con 
las normas de referencia es importante para efectos de facilitar el comercio? ¿Por qué los 
países que deseen exportar a la Unión Europea productos agrícolas tienen que utilizar 
sustancias activas alternativas a aquellas que utilizan para la exportaci ón al resto del 
mundo sobre la base de LMR acordados multilateralmente en el Codex Alimentarius?  
 
EU reply:  
Please refer to the answer to Question 18.  
 
Página 136 (párrafo 3.285)  
 
3.285. According to the Commission, the creation of a single EU procurement market has helped to 
improve and integrate further procurement markets of member States, as reflected in the fact that 
cross-border procurement (direct and indirect) has increased in recent years, to around 23% of the 
total value of procurement  in the EU.339 Some 55% of procurement procedures use lowest price as 
the only award criterion for public contracts, which may indicate that public buyers are not yet paying 
enough attention to quality, sustainability and innovation. Similarly, only 11% of  procedures are 
carried out by cooperative procurement, which may result in lost opportunities to benefit from 
economies of scale and exchange of know -how. Overall, it is estimated that efficiency gains of 10% 
could save EUR 200 billion per year, without c utting the level of service offered.  
 
Pregunta:  
43. Costa Rica reconoce el progreso realizado por la Unión Europea para mejorar e integrar 
más mercados de compras de los Estados miembros. ¿Puede por favor la UE explicar 
brevemente qué están haciendo para revertir este porcentaje y hacer que las autoridades 
públicas presten más atención en otros criterios para adjudicar contratos como los 
mencionados anteriormente?  
 
EU reply:   
According to the EU Public Procurement Directives, quality consider ations such as environmental 
and social elements, related to the products, works or services procured, can be integrated at 
different stages of the procurement process, and not only through award criteria. Such elements 
can be taken into account at selecti on stage, in the technical specifications, through award criteria 
and contract performance clauses. The figure of 55% using the lowest price as an award criterion, 
therefore, does not necessarily mean that quality elements have not been considered, as they  might 
have been incorporated in other stages of the procurement process (e.g. the technical specifications 
might have already set a high environmental standard as regards the products purchased, and the 
evaluation is later on based on the lowest price).  
 
Nevertheless, the European Commission is working on promoting further the above -described 
possibilities through support for practitioners, concretely through different guidances and tools, 
trainings and other efforts in the area of professionalisation. Re spective information is available on 
the web page of the European Competence Center for Public Buyers: 
https://ec.europa.eu/info/policies/public -procurement/support -tools-public -buyers_en.  
 
Página 136 (párrafo 3.290)  
3.290. To harmonize procedures and proc esses, the Commission introduced the European Single 
Procurement Document (ESPD), which is a self -declaration form simplifying the participation of 
suppliers in procurement procedures.343 The next step is ESPD integration with national databases 
or eTender ing platforms.344 WT/TPR/M/395/Add.1  
 
- 220 - 
 
  Pregunta:  
44. ¿Podría por favor la Unión Europea informar brevemente qué tipo de información se 
requiere en el ESPD y cómo ayuda en la práctica a simplificar la participación de los 
proveedores?  
 
EU reply:   
The European Single Procurement Document (ESPD) is a self -declaration form used in public 
procurement procedures as preliminary evidence when submitting a bid. It covers exclusion grounds 
and selection criteria as defined in the EU Public Procurement Direc tives 2014/24/EU and 
2014/25/EU.  
 
The ESPD simplifies the participation of companies in procurement procedures by easing 
documentary requirements at the time of bidding. Only the winner of the tender then needs to 
provide the actual documents. As an addit ional simplification, companies in some EU Member States 
do not even need to provide any more data themselves, as public buyers have access to it thanks 
to the "Once Only Principle ". There is an increasing trend in the Member States to connect 
eProcurement  systems to the national databases.  
 
Página 142 (párrafo 3.309)  
 
3.309. On 29 January 2016, the Commission presented a revised proposal for an International 
Procurement Instrument (IPI).365 The genesis of the IPI goes back to 2012, and is rooted in a 
longstanding EU concern about international imbalance in public procurement markets.366 According 
to the Commission, the IPI would promote open access to public procurement markets around the 
world. It would allow the Commission to initiate public investigations in cases of alleged 
discrimination against EU companies in procurement markets. According to the Commission, the 
existing EU commitments, including in the GPA and bilateral trade agreemen ts, would remain 
unaffected by the IPI. Recently, the European Council called for resuming discussions on the IPI.  
 
Pregunta:  
45. Costa Rica reconoce los esfuerzos realizados por la Unión Europea para mejorar el 
acceso a los mercados de adquisiciones, siendo el Instrumento de Adquisiciones 
Internacionales (IPI) un ejemplo de este objetivo de política. En este sentido, ¿podría la 
Unión Europea proporcionar más detalles sobre el IPI y cuál es el esta do actual de los 
debates sobre la implementación de este mecanismo?  
 
EU reply : 
Discussions on the Commission proposal on the International Procurement Instrument have resumed 
in the Council in 2019 and are ongoing. The European Parliament also restarted it s work on the 
International Procurement Instrument. As the legislative process is not yet completed, the EU cannot 
provide any information as to what measures the International Procurement Instrument will provide 
for. 
 
The International Procurement Instrum ent as proposed by the European Commission would allow 
the Commission to initiate investigations in cases of alleged discrimination of EU companies in 
procurement markets. In case such an investigation would find discriminatory restrictions vis -à-vis 
EU go ods, services and/or suppliers, the Commission would invite the country concerned to 
consultations. Such consultations could also take place in the form of negotiations on an international 
agreement. As a last resort, the Commission could, after consultati on with EU Member States, apply 
the new tool.  
 
4. Políticas comerciales por sector  
4.4.1.2.3.4. Medidas sobre finanzas sostenibles  
 
Página 226 (párrafo 4.242)  
4.242. Three CMU legislative proposals of the Commission pertain to measures that seek to promote 
environmentally sustainable activities, through, inter alia , resource -efficient and circular economy 
approaches.  
 WT/TPR/M/395/Add.1  
 
- 221 - 
 
  Preguntas:  
46. Costa Rica aplaude los esfuer zos de la Unión Europea para promover la financiación 
sostenible. ¿Puede por favor la Unión Europea proporcionar más información sobre esta 
política?  
 
EU reply:  
The Commission adopted the 'action plan on financing sustainable growth " in March 2018, with ten 
actions in order to (1) mobilise private capital to finance climate -related and environmental 
investments; (2) make climate and sustainability risks more transparent in financial markets and 
(3) foster longer -term, more responsible  decision -making in financial institutions and companies.  
Major actions are currently being implemented, including legislative proposals on transparent 
disclosure requirements for the financial sector on sustainability matters and new EU climate 
benchmark s to help steer private capital to low -carbon investments. Finally, in December 2019, a 
political agreement was reached to establish an EU -wide classification system for environmentally 
sustainable economic activities ( 'EU taxonomy '). 
 
47. ¿Puede por favor  la Unión Europea describir algunos de los desafíos que anticipa en 
la implementación de su política de finanzas sostenibles?  
 
EU reply:  
In its Communication on the European Green Deal, the European Commission has announced that 
the EU will increase is climate ambition for 2030 and 2050. The private sector will be key to financing 
the green transition, alongside public spending. Long -term s ignals are needed to direct financial and 
capital flows to green investment and to avoid stranded assets.  
For this purpose, the Commission will present a renewed sustainable finance strategy aiming at 
(i) strengthening the foundations for sustainable investment (e.g. corporate governance 
frameworks, non -financial reporting); (ii) increasing opportunities for investors and companies by 
making it easier for them to identify sustainable investments and ensuring that they are credible 
(e.g. sta ndards and labels); (iii) better integrating climate and environmental risks into the EU 
prudential framework.  
 
Página 227 (párrafo 4.244)  
 
4.244. Political agreement was also reached, in February 2019, on a proposal for a regulation on 
low-carbon and posi tive-carbon impact. It creates new market standards which will reflect 
companies' carbon footprint, and give investors clearer information on how their investments 
contribute to fighting climate change.  
 
Pregunta:  
48. En el marco de la propuesta del regla mento sobre impacto bajo en carbono y carbono 
positivo, ¿alguna de estas disposiciones sería aplicable a productos, servicios o 
inversiones provenientes de terceros mercados? ¿Cuál sería la disposición y el efecto que 
tiene?  
 
EU reply:  
The Benchmark Regul ation entered into application on 1 January 2018. It applies to benchmarks 
that are used in the European Union.  
For what concerns EU climate benchmarks, they are voluntary labels that benchmark administrators 
may decide to have as an offering of climate -conscious investment strategies. The benchmark 
Regulation, together with its secondary legislation to be adopted soon, lays down a number of criteria 
to be met to be able to use the label. On the constituents of the benchmarks, they may include 
companies loc ated inside or outside of the EU.  
 
Página 229 (párrafo 4.257)  
  
4.257. […] Construction services are mainly provided through commercial presence, and cross -
border provision is not technically feasible for a wide range of the covered services.  
 
Pregunta:  
49. ¿Puede por favor la Unión Europea proporcionar más información sobre los servicios 
de construcción para los que se considera factible la provisión transfronteriza y si su 
suministro está abierto a proveedores de servicios extranjeros?  WT/TPR/M/395/Add.1  
 
- 222 - 
 
  EU repl y:  
All types of construction services can be exchanged across the single market. They are covered by 
the Treaty provisions on free movement of services and freedom of establishment as well as 
secondary EU law, notably the Services Directive. Recital 36 of  the Services Directive clarifies that, 
in line with Article 54 of the Treaty,  the freedom of establishment and free movement of services 
may benefit only companies constituted in accordance with the laws of a Member State and having 
their registered offic e, central administration or principal place of business within the Community.  
 
To do so, construction companies can use a range of different modes of supply in their 
internationalisation strategies. This can involve providing temporary cross -border servi ces but also 
setting up a more permanent presence in the host Member State, possibly in partnership (joint 
venture) with a local operator.  
 
Página 232 (párrafo 4.263)  
4.263. The EU construction sector is an important contributor to the economy and a creato r of jobs; 
it also plays an important role in sustainability, quality of life, and climate change.351 However, it 
faces a number of challenges and structural issues. Some of these include, the shortfall of skilled 
workers, the sharp decline as a result of the financial crisis, the productivity and resource efficiency 
of the sector, and the capacity for innovation. Thus, the EU has put forth a number of policy initiatives 
or strategies in recent years to address some of these issues. As part of its Europe 20 20 Strategy, 
the EU issued a Communication on Strategy for the sustainable competitiveness of the construction 
sector and its enterprises in 2012.352 This Strategy focuses on stimulating favorable investment 
conditions; improving the human -capital basis of  the construction sector; improving resource 
efficiency, environmental performance and business opportunities; strengthening the internal 
market for construction; and fostering the global competitive position of EU construction enterprises. 
As part of the last point on the global competitive position, the EU indicated it would seek to secure 
ambitious market access commitments from partner countries in trade negotiations, regarding 
access to both commercial and procurement markets.  
 
Pregunta:  
50. Costa Rica reconoce los desafíos que enfrenta el sector de la construcción en la UE. 
¿Puede indicar la Unión Europea si las políticas y estrategias vigentes consideran la 
facilitación del movimiento de personas, en particular trabajadores y profesionales 
calificados, de países no pertenecientes a la UE?  
 
EU reply:  
The EU continues to improve admission channels for skilled and qualified professionals and their 
families. Of particular relevance to trade policy is the introduction of an EU -wide scheme (coveri ng 
25 EU Member States)40 for the admission of intra -corporate transferees, either as specialists, 
managers or trainees, as well as their families. These rules were adopted in 2014 and implemented 
in subsequent years.  
 
Página 232 (párrafo 4.264)  
4.264. One recent development was a proposed Directive and Regulation on a Services E -card.353 
This initiative proposes a harmonized notification form in order to obtain a type of "services  
passport", securing access to the activity in a host member State,  enhancing cooperation between 
home and host member States, and aiding service providers operating across borders. This 
fully-electronic harmonized procedure will reduce administrative obstacles, simplifying formalities so 
that service providers may provid e the necessary services abroad more efficiently. Since March 
2018, the initiative's legislative process has been put on hold.  
 
Preguntas:  
51. Costa Rica aplaude y está muy interesado en la propuesta de Directiva y Reglamento 
sobre la tarjeta electrónica d e servicios, así como en los beneficios que podría cosechar 
para los servicios de construcción. ¿Puede por favor la Unión Europea compartir las 
razones para suspender el proceso legislativo y si hay planes para reanudarlo?  
52. ¿Puede por favor la Unión Eur opea aclarar si el procedimiento armonizado totalmente 
electrónico estará disponible para los proveedores de servicios no pertenecientes a la 
Unión Europea en un Estado miembro anfitrión?  
 
40 Directive 2 014/66/EU on the conditions of entry and residence of third -country nationals in the 
framework of an intra -corporate transfer . WT/TPR/M/395/Add.1  
 
- 223 - 
 
  EU reply to Q51 and Q52:   
The services e -card initiative has been on hold since 21 October 2019 because the European 
Parliament expressed the view that the legislative proposal should be withdrawn. As announced on 
29 January 2020, the Commission has decided to include it in its Work Programme for 2020. Different 
options for the way forward are currently explored.  
 
Página 250 (párrafo 4.337)  
4.337. Firstly, "online intermediation services" within the meaning of this Regulation are defined as 
information society services that allow business users to offer goods or serv ices to consumers with 
a view to facilitating the initiating of direct transactions between the business users and consumers, 
and which are provided to business users on the basis of contractual relationships between the 
business users and the providers of  those services. The Regulation applies to providers of online 
intermediation and search engine services, irrespective of whether they are established in a member 
State or outside the EU, if the business users or corporate website users are established in the EU  
and offer their goods and services to consumers located within the EU at least for part of the 
transaction.  
 
Preguntas:  
53. Con respecto a la regulación adoptada en junio de 2019 (aplicable a partir del 12 de 
julio de 2020) que establece normas para  mejorar la equidad y la transparencia de las 
plataformas en línea, ¿puede por favor la Unión Europea aclarar si los proveedores de 
servicios de intermediación en línea y motores de búsqueda establecidos fuera de la 
Unión  Europea tienen que cumplir con este reglamento, solo si los usuarios comerciales o 
los usuarios del sitio web corporativo están establecidos en la Unión Europea y ofrecen 
sus bienes y servicios a consumidores ubicados dentro de la UE?  
 
EU reply:   
The Regulation covers online platform intermediaries and general online search engines that provide 
their services to businesses established in the EU and that offer goods or services to consumers 
located in the EU.  
 
54. ¿Puede por favor la Unión Europea propo rcionar más información sobre las medidas 
de ejecución previstas en el presente Reglamento?  
 
EU reply :  
Articles 14 and 15 of Regulation 2019/1150 provide two sets of complementary enforcement 
frameworks. Article 14 enables qualified entities to instigate private litigation to remedy structural 
breaches of the Regulation, whereas Article 15 imposes upon Member States an obligation to provide 
measures applicable to infringements. The precise form of the enforcement measures that will 
ultimately be provided under these frameworks will however depend to an extent on the 
implementation that is given to these two Articles by Member States as well as by industry. Under 
Article 14(5), Member States may for example voluntarily opt to designate qualified en tities for 
instigating private litigation against providers of online intermediation services or online search 
engines. Article 15 establishes a principles -based obligation for Member States to provide effective, 
proportionate and dissuasive measures for t he enforcement of the Regulation. Given that the 
implementation process is on -going, it is therefore too early to provide a comprehensive overview 
of enforcement measures.  
 
Página 252 (párrafo 4.343)  
4.343. As part of the DSM Strategy, the Commission prese nted a proposal for the comprehensive 
reform of the existing Audiovisual Media Services Directive (AVMSD) in May 2016. The revised 
AVMSD was adopted in November 2018 and entered into force in December 2018.462 It requires 
member States to transpose its pro visions into national legislation by 19 September 2020.  
 
Pregunta:  
55. Costa Rica aplaude los esfuerzos de la Unión Europea para actualizar el marco de los 
servicios audiovisuales a las realidades digitales actuales. ¿Puede por favor la Unión 
Europea proporcionar más información sobre si este nuevo marco ofrece oportunidades 
para el trabajo conjunto entre la Unión Europea y los proveedores de servicios 
audiovisuales extranjeros, dada la naturaleza de las cadenas de valor en esta industria?  
 
 WT/TPR/M/395/Add.1  
 
- 224 - 
 
  EU reply:   
The Member States of the European Union have established a dense network of co -production 
agreements with a large number of third countries. Works produced in the framework of those 
agreements will be considered as European works if they comply with the c onditions in Article 1.1 . 
(n) of the Audiovisual Media Services directive (AVMSD).  
 
As regards any joint -venture between audiovisual service providers in the EU and in third countries, 
as long as such undertaking would have a base in an EU Member State th e provisions of AVMSD 
would fully apply to it.  
 
Informe de la Unión Europea  
 
3. Evolución del mercado interno  
3.7 Política agrícola común  
 
Página 10 (párrafo 3.22)  
3.22. The Council and European Parliament also adopted the important legislative initiative on Unfair 
Trading Practices strengthening the position of small and medium -sized enterprises in the food 
supply chain. They also agreed on new rules for organic pro duction and labelling of organic products 
to ensure an update of EU regulations for this growing segment of the agricultural market.  
 
Preguntas:  
56. ¿Podría la Unión Europea indicar el estado actual de la implementación de dicha 
legislación?  
 
EU reply:  
Member States must transpose Directive (EU) No 2019/633 on unfair trading practices in business -
to-business relationships in the agricultural and food supply chain into national law by 1 May 2021.  
 
57. ¿Podría la Unión Europea indicar qué cambios habrá para los países que tienen su 
producción y sistema de etiquetado orgánico homologado con los de la Unión Europea?  
 
EU reply:  
Article 48 of Regulation (EU) No 2018/848 on organic production and labelling of organic products 
provides that a third country that has been recognised for the purpose of equivalence under 
Article  33(2) of Regulation No 834/2007, continues to be recognised. This provision will expire on 
31 December 2025. This provision allows for a transition period to a new scheme of recognition 
under  an international agreement with a third country that has a system of production that meets 
the same objectives and principles and with the same level of assurance of conformity. Before the 
expiry of the current administrative arrangements, the EU should r enegotiate a bilateral international 
agreement on the recognition of the organic system of third countries.  
 
58. ¿Podría la Unión Europea indicar si se han establecido limitaciones en la configuración 
de entidades que se dedican a la producción orgánica, t ales como asociaciones o 
cooperativas?  
 
EU reply:  
No limitations have been established concerning the setting up of entities engaged in organic 
production.  
 
Página 10 (párrafo 3.23)  
 
3.23. Based on the Commission proposal for the Multiannual Financial Fram ework (MFF) for 2021 -27, 
which sets the budgetary framework, and main orientations for the CAP, the Commission adopted 
proposals for a set of regulations laying down the framework for the CAP during the period 2021 -27. 
For the 2021 -27 period, the European Commission is proposing a total CAP budget of EUR 365 billion, 
a reduction of 5% of annual amounts compared to 2020. The CAP will account for just under 
one-third of the overall EU budget. The proposed CAP budget will be divided between its two 
traditional "pillars": direct support for farmers/market measures and rural development. The EU 
aims to use 40% of the overall financial envelope of the CAP in support of climate objectives.  
 WT/TPR/M/395/Add.1  
 
- 225 - 
 
  Pregunta:  
59. ¿Qué pasos y acciones ha tomado e implementado la Unión Europea para reducir los 
niveles de subsidios y protección a la agricultura conforme a los compromisos realizados 
en la reunión Ministerial de la OMC de Nairobi?  
 
EU reply:  
The EU has not granted  any export subsidies since 2013. The EU also submitted a draft schedule 
CLXXV in October 2017 inter alia  incorporating the Nairobi Decision. In internal law, Articles 196 -
204 of Regulation (EU) No . 1308/2013 were the legal base in internal EU law for the payment of 
export refunds. All amounts had already set to zero in this chapter, which was also in any event 
explicitly subject to the international obligations of the EU such as the Nairobi Decision. The 
legislative proposal for the CAP post -2020 now clean s up the legislation by repealing these provisions 
as well as the reference in Article 219(1) of the same Regulation.  
 
3.8 Requisitos sanitarios y fitosanitarios  
 
Página 11 (párrafo 3.26)  
3.26. The Regulation on Official Controls will provide a single framework for all official controls along 
the agri -food chain. Businesses and authorities will benefit from reduced administrative burdens, 
more efficient processes and strengthened controls. The Regula tion on Veterinary Medicines will 
strengthen the EU action in fighting antimicrobial resistance (AMR), which a global threat to public 
health. It lays down a wide range of measures to fight AMR and to promote the prudent and 
responsible use of antimicrobia ls, following the approach of the European One Health Action Plan 
against AMR.  
 
Pregunta:  
60. A la luz del reporte científico que ha publicado la "European Medicines Agency", 
¿podría la Unión Europea desarrollar el estado de implementación del proceso del  
Artículo  37 (4), así como los próximos pasos para el Artículo 37 (5) relacionados con la 
creación de la lista en sí, y el Artículo 118 en lo que respecta a los actos delegados para 
su aplicación a terceros países?  
 
EU reply:  
• The state -of-play as regards the preparation of the various draft legal acts aforementioned 
is as follows:  
o Delegated Acts under Article 37(4): the Commission received end of 2019 the scientific 
advice it had requested from the European Medicines Agency (EMA) as a basis for its 
preparatory work in November 2019. It is now consulting EU Member States as well as 
targeted stakeholders on the advice received.  
o Implementing Acts under Article 37(5): upon the request from the European 
Commission, the EMA has set up an expert group at the end of 2019 to start preparing 
its scientific advice. An indicative date anticipated for the publication of the relating 
scientific advice report is November 2020.  
o Delegated Acts under Article 118: the European Commission is currently reflecting on 
the most suitable approach for the various aspects of the implementation measures 
relating to Article 118. In order to ensure that the draft delegated acts are 
comprehensive, further reflection is warranted by Commission services  in upcoming 
months.  
 
• The preparation of the draft legal acts will continue to follow its course, according to the 
institutional process. During this time, there will be several occasions on which the 
Commission will be able to receive external input:  
o during targeted stakeholders consultations, which may be launched by Commission 
services shortly after the publication on its website of the scientific advice reports 
prepared by the European Medicines Agency (EMA). Stakeholders -such as 
representatives of th e pharmaceutical industry, of farmers, of veterinarians, of 
consumers - will be invited to provide comments on the scientific advice reports.  
o during the feedback mechanism, as foreseen under the Commission 's Better Regulation 
agenda 41, for a period of 4 wee ks. Legal acts subject to the feedback mechanisms are 
published at regular intervals on the 'Have your say ' webpage of the Commission 's 
 
41 https://eur -lex.europa.eu/legal -content/ĽN/TX't7PDF/?uri"CĽLEX:520l5DC02l5&fľom; -'-EN. WT/TPR/M/395/Add.1  
 
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  website42 and open to citizens and stakeholders for feedback. The Commission welcomes 
any feedback from Third Country rep resentatives during this period.  
o during the notification of the draft acts by the Commission to the members of the WTO 
SPS Committee. On this occasion, Third Countries will also have an opportunity to 
provide feedback on the draft acts.  
 
• The delegated acts  under Article 37(4) are to be adopted at the latest by 
27 September  2021, while the implementing acts under Article 37(5) as well as the 
delegated acts under Article 118 are to be adopted by 27 January 2022.  
• The Commission remains committed to engage wit h its trading partners and other 
countries, both in the context of multilateral international fora and bilaterally, to promote 
and support effective strategies to prevent and contain the global threat of AMR.  
 
3.9 Nuevas medidas para una justa fiscalizació n 
 
Página 11 (párrafo 3.29)  
3.29. In recent years, the EU adopted several legislative proposals ensuring the proper allocation of 
taxing rights, limiting profit -shifting and securing, at the same time, a stable business environment 
for trade by avoiding d istortions and double taxation. With the Anti-Tax Avoidance Directive , the 
amendments of the Directive on Administrative Cooperation and the EU list of non -cooperative tax 
jurisdictions, the EU has achieved significant outcomes in recent years to fight against tax avoidance. 
Rules, such as controlled foreign company provisions, exit tax rules, interest limitations rules and 
provisions t o tackle hybrid mismatches, are efficient tools for ensuring a minimum level of protection 
against tax avoidance.  
 
Pregunta:  
61. La Unión Europea ha informado de sus intenciones de crear un nuevo impuesto en 
frontera sobre la huella de carbono. ¿Podría la  Unión Europea indicar el estado actual del 
diseño de dicho impuesto y de qué manera garantizará su compatibilidad con las normas 
de la Organización Mundial de Comercio y de los acuerdos comerciales preferenciales que 
mantiene actualmente con terceros país es? 
 
EU reply:  
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in leve ls of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address t he risk of carbon leakage in the EU 's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way ". 
A Carbon Border Adjustment mechanism is not designed to protect European industry from open 
competitions but rather to ensure the environmental integrity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the border measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU 's climate policies. The internal market of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Trade Organisation and our trade agreements in 
particular.  
There is  a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financia l impacts and legal feasibility, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
 
42 https://ec.europa.eu/info/law/better -regulation/have -your-say. WT/TPR/M/395/Add.1  
 
- 227 - 
 
  The EU will continue to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the e conomies of the G20 that are responsible for 80% of global greenhouse gas 
emissions ". 
 
3.11 La implementación del programa de acción medioambiental de la UE  
 
Página 13 (párrafo 3.40)  
3.40. Furthermore, the European Commission adopted the Communication on Stepping up EU Action 
to Protect and Restore the World's Forests .67 The overall aim is to protect and grow the world's forest 
cover to improve public health and livelihoods. This is in line with the EU's broader objective to halt 
global forest cover loss by  2030 and with the EU's existing international commitments. Halting 
deforestation and forest degradation, combined with sustainable restoration, re - and afforestation 
activities, provide opportunities for economic development. This requires putting a parti cular 
emphasis on the sustainable production and consumption of agricultural and forest -based products.  
 
Pregunta:  
62. Respecto a la Comunicación sobre la intensificación de la acción para proteger y 
restaurar los bosques del mundo, ¿se implementarían medidas adicionales a lo ya 
dispuesto en el Plan de Acción de aplicación de la Ley Forestal, Gobernanza y Comercio de 
la Unión Europea (FLEGT, por sus siglas en  inglés) para la importación de la madera y 
productos de madera?  
 
EU reply:  
Protecting biodiversity and fighting global warming are top priorities for Commission President Ursula 
von der Leyen. In its Communicatio n on deforestation from July 2019 ( "Stepping up EU Action to 
Protect and Restore the World 's Forests "), the Commission committed to assess different measures 
to curb deforestation associated with the EU 's footprint. It is included in the Commission Work Plan 
for 2021. This assessment will take into account experience in implementing the EU Timber 
Regulation. Looking forward, in the European Green Deal communication adopted in December, the 
Commission stat ed that "Building on the Communication on Stepping up EU Action to Protect and 
Restore the World 's Forests, the Commission will take measures, both regulatory and otherwise, to 
promote imported products and value chains that do not involve deforestation an d forest 
degradation ". The European Parliament has also made the fight against deforestation one of its 
priorities and plans a legislative initiative on "an EU legal framework to halt and reverse EU -driven 
global deforestation ". 
 
3.12 Las acciones de la Un ión Europea sobre el cambio climático  
 
Página 13 (párrafo 3.41)  
3.41. The EU has put climate action as a central policy objective. The EU is on track to keep its 2020 
greenhouse gas emissions well below the target and finalized the legislative framework to  deliver on 
its objectives for 2030. This should allow the EU to adopt an ambitious long -term strategy, striving 
for climate neutrality in line with the Paris Agreement and confirming Europe's commitment to lead 
in global climate action to the UNFCCC by 20 20. Transitioning to a low greenhouse gas emission, 
resource efficient, and climate resilient economy will require a transformative effort demanding a 
fundamental shift in technologies, energy systems, business and investment behavior, and 
ultimately, in s ociety as a whole.  
 
Pregunta:  
63. La Unión Europea ha anunciado que bajo la nueva Comisión Europea será nombrado 
un "Chief Trade Enforcement Officer ". ¿Podría la Unión Europea explicar los alcances, 
funciones y responsabilidades de esta nueva figura en la administración e implementación 
de los acuerdos comerciales preferenciales que mantiene con terceros países y, 
particularmente, el rol de esta nueva figura en la implementación de los capítulos de 
comercio y desarrollo sostenible que se han establecido en dichos acuerdos comerciales?  
 
EU reply:  
The Chief trade enforcement officer will be a new deputy Director General in the directorate general 
for trade of the European Commission. As a deputy Director General, this person will supervise 
several directora tes including the trade defense directorate. The work of this high -level Commission WT/TPR/M/395/Add.1  
 
- 228 - 
 
  official will be also to monitor and improve the compliance of EU trade partners with the 
commitments made in multi -lateral or bilateral trade agreements. This work will in clude a close 
monitoring of the implementation of commitments related to climate, environmental and labour 
protection enshrined in EU bilateral trade agreements. The Chief trade enforcement officer will also 
regularly report on those issues to the European  Parliament and the Council.  
 
3.13 Paquete de energía limpia para todos los europeos  
 
Página 14 (párrafo 3.46.c)  
3.46.c. The revised Renewable Energy Sources Directive  introduces a new approach to address 
emissions from indirect land -use change ("ILUC") associated to the production of biofuels, bioliquids 
and biomass fuels. It includes a binding renewable energy target for the European Union for 2030 
of 32% with an upwa rds revision clause by 2023. The rules also serve also to create an enabling 
environment to accelerate the penetration of renewable energy, as well as public and private 
investment in innovation and modernization in all key sectors. The criteria determinin g high 
ILUC-risk feedstock for biofuels and the criteria for certifying low ILUC –risk biofuels, bioliquids and 
biomass fuels are detailed in Commission Delegated Regulation (EU) 2019/807.  
 
Preguntas:  
64. ¿Podría la Unión Europea explicar las razones por las cuales el Acto Delegado de la 
Comisión 2019/807 estableció criterios globales de alto riesgo de ILUC y no consideró las 
particularidades y realidades de las diferentes regiones del mundo? Además, 
agradeceríamos la aclaración de la Unión Europea sobre cómo concilia el tratamiento a 
los países con menos del 10% de deforestación relacionado con la expansión de la 
producción de aceite de palma y que no cumplen los criterios establecidos en el acto 
delega do para ser clasificados como alto riesgo de ILUC.  
 
EU reply:  
The markets for renewable energy commodities such as palm oil are global, which therefore requires 
a global assessment of ILUC for the purpose of qualifying as renewable energy under the Renew able 
Energy Directive.  
 
65. ¿Qué elementos se tomaron en cuenta para la definición de una fórmula para el cálculo 
el ILUC en relación con biocombustibles?  
 
EU reply:  
The formula establishes whether the expansion of a producing area of a certain feedstock has to be 
considered as significant. The threshold level set for the significant expansion of a relevant feedstock 
into high carbon stock land is set with the aim of ensuring that all biofuels that count towards the 
2030 renewable energy target a chieve net GHG emission saving, also looking at potential indirect 
impacts. The formula takes into account the share of the feedstock expansion into high carbon stock 
areas as defined in the recast Renewable Energy Directive (Directive (EU) 2018/2001) and the 
productivity factor of different feedstocks.  
 
66. ¿De qué manera esa fórmula toma en cuenta las diferentes condiciones ambientales y 
de producción de los distintos países donde se produce la materia prima a partir de la cual 
se elaboran los  biocombusti bles?  
 
EU reply:   
The formula determines the ILUC risk at global scale. The specific situation can be taken into account 
if the criteria for low ILUC risk certification are met.  
 
67. ¿El biocombustible elaborado a partir de aceite de palma producido en co ndiciones 
ambientales adecuadas, puede calificar como de bajo de riesgo de ILUC?  
 
EU reply:   
Yes, if the specific criteria for low ILUC -risk certification are met. Low ILUC certification allows to 
mitigate the risk even if the feedstock in question generally qualifies as high ILUC risk feedstock 
(Commission Delegated Act 2019/807).   
 WT/TPR/M/395/Add.1  
 
- 229 - 
 
  68. ¿Bajo qué condiciones el biocombustible elaborado a partir de aceite de palma puede 
ser considerado para el cumplimiento de la meta de un 32% de energía ren ovable para el 
2030?  
 
EU reply:  
Two scenarios  would need to be distinguished. 1) In the scenario where palm oil would cease to 
qualify as a high ILUC -risk feedstock, biofuels produced from palm oil would count in the same ways 
and under the same conditions as any other biofuels produced from food and feed crops, including 
the requirement to meet the sustainability and greenhouse gas saving criteria. 2) In the scenario 
where palm oil would continue to qualify as a high ILUC risk feedstock, biofuels produced from palm 
oil would count toward s the target only if they fulfil the certification criteria for low ILUC –risk fuels.  
 
3.14 El retiro del Reino Unido de la Unión Europea  
 
Página 15 (párrafo 3.47)  
3.47. On 29 March 2017, the United Kingdom notified the European Council of its intention t o leave 
the European Union. To provide for an orderly withdrawal and give legal certainty to businesses, 
citizens, and stakeholders as to how the disentanglement of the United Kingdom from the EU will 
work, a Withdrawal Agreement was negotiated between the  EU and the United Kingdom. On 
25 November 2018, the European Council endorsed the Withdrawal Agreement. Before it can enter 
into force, the Withdrawal Agreement needs to be ratified.  
 
Pregunta:  
69. ¿Podría la Unión Europea indicar, si a la luz del retiro del Reino Unido de la Unión 
Europea tiene planificado realizar una adecuación a una UE -27 de los acuerdos 
comerciales preferentes que actualmente mantiene vigentes con terceros países?  
 
EU reply : 
The EU 's trade policy will not change due to the withdrawal of the UK. The EU does not considers it 
necessary to amend the current EU agreements, including the EU 's FTAs. The references to the UK 
in EU international agreements will simply become obsolete  after the end of the transition period.  
In addition, it should be noted that the Political Declaration that accompanied the Withdrawal 
Agreement sets out the framework for the future relationship between the European Union and the 
United Kingdom. It estab lishes the parameters of 'an ambitious, broad, deep and flexible partnership 
across trade and economic cooperation with a comprehensive and balanced Free Trade Agreement 
at its core, law enforcement and criminal justice, foreign policy, security and defenc e and wider 
areas of cooperation. In the Political Declaration, the EU and UK have stated their intent to begin 
the formal process of negotiations of their future relationship as soon as possible after the 
UK's withdrawal, such that it can come into force by the end of 2020.  
 
4.4. Política Comercial para el comercio abierto y justo  
 
Página 23 (párrafo 4.53.b)  
4.53.b. The EU took several significant measures to achieve open but fair trade: Regulation on 
Screening of Foreign Direct Investment : The regulation entered into force on 10 April 2019. It will 
become fully applicable as of 11 October 2020. In some except ional cases (foreign investment 
affecting critical technologies, infrastructure, supply of critical inputs or access to sensitive data), it 
will help European Union safeguard its security interests from foreign investment targeting the 
acquisition of criti cal European assets. The EU screening framework does not replace or duplicate 
existing national mechanisms, and hence does not add red tape for investors. It is not targeted 
against investors from any particular country: non -discrimination is a key princip le of the new 
Regulation and screening mechanisms of EU Member States will need to respect this principle. In 
addition, requirements applying to national screening mechanisms include rules on transparency, 
confidentiality of information exchanged, possibil ity of recourse against screening decisions, and 
measures to identify and prevent circumvention by foreign investors.  
Pregunta:  
 
70. ¿Podría indicar la Unión Europea el estado actual de la implementación del nuevo 
sistema para el escrutinio de la Inversió n Extranjera Directa?  
 WT/TPR/M/395/Add.1  
 
- 230 - 
 
  EU reply:   
Member States that maintain screening mechanisms have notified these mechanisms to the 
Commission (cf. Article 3) and expert meetings pursuant to Article 12 with the Member States and 
the Commission are being organised on a regular basis. The Commission is preparing further the 
application of the cooperation mechanism between the Member States and the Commission. To this 
end, it is recalled that the Commission needs to provide a secured and encrypted system thr ough 
which the exchange of confidential information under the cooperation mechanism can be carried out 
(cf. Articles 11.2 and 10). In the Commission, the Directorate –General for TRADE is responsible to 
coordinate the implementation and notably the applica tion of the cooperation mechanism. This 
requires close cooperation with several relevant other services and agencies of the Commission, 
notably in view of the programmes and projects of Union interest. Lastly, the Commission and the 
Member States have enga ged with the responsible authorities of third countries to exchange best 
practices on screening of foreign direct investments on grounds of security and public order.  
 
  WT/TPR/M/395/Add.1  
 
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  DOMINICAN REPUBLIC  
DOCUMENTO WT/TPR/G/395  
PREGUNTAS DEL INFORME DE LA UNIÓN EUROPEA  
 
3 EVOLUCIÓN DEL MERCADO INTERIOR  
 
Pág. 6  
Párrafo 3.5. " El balance del Programa concluyó en abril de 2019, y reconoció los logros relacionados 
con las medidas clave introducidas en el Programa de Mejora de la Legislación:  
a. mejora de la participac ión de las partes interesadas a través de i) oportunidades de formular 
observaciones y hacer propuestas durante la totalidad del ciclo de vida de las políticas, incluidos los 
proyectos de actos delegados y de ejecución; ii) el compromiso de celebrar consul tas durante un 
período de 12 semanas sobre todas las nuevas propuestas y evaluaciones; y iii) un nuevo portal de 
Internet común en el que todas las partes interesadas puedan obtener información sobre las nuevas 
iniciativas y expresar sus puntos de vista;  
b. directrices integradas y un conjunto de herramientas completo para el personal de la Comisión 
Europea sobre cómo legislar mejor a lo largo del ciclo político;  
c. un compromiso renovado para evaluar la legislación vigente antes de proponer cambios ("evalu ar 
primero");  
d. un Comité de Control Reglamentario independiente que revise la calidad de todas las evaluaciones 
de impacto y de las principales evaluaciones, compuesto por siete miembros a tiempo completo que 
no participan en el proceso de elaboración de  las políticas, incluidos tres miembros ajenos a las 
instituciones de la UE;  
e. un nuevo compromiso de verificar sistemáticamente las oportunidades de conseguir una 
simplificación y una mayor eficiencia a la hora de revisar la legislación vigente, todo ell o sin socavar 
su objetivo;  
f. una Plataforma REFIT para proporcionar a la Comisión un apoyo ascendente en la mencionada 
tarea; y  
g. una propuesta que sirvió de fundamento para que, el 13 de abril de 2016, se alcanzase un nuevo 
Acuerdo Interinstitucional so bre la Mejora de la Legislación entre el Parlamento Europeo, el Consejo 
de la Unión Europea y la Comisión Europea."  
 
1. En cuanto al Programa de Mejora de la Legislación, podrían darnos mayores detalles y 
explicar el alcance del componente e. (conseguir una s implificación y una mayor 
eficiencia a la hora de revisar la legislación vigente).  
 
EU reply:  
More information can be found in the communication itself:  
https://ec.europa.eu/info/publications/better -regulation -taking -stock-and-sustaining -our-
commitment_en   
 
All the Commission's better regulation instruments (consultations, impact assessments, evaluation) 
are addressing simplification and efficiency issues.  The aim is to ensure that policy choices come 
with the lowest possible cost to society. However, the EU is a multi -layered system and legislation 
proposed by the Commission has to go through negotiations (and potentially changes) in Parliament 
and Council . Furthermore, Member States are mostly responsible for the implementation and they 
often complement EU law with national preferences potentially imposing further requirements. 
Hence, the task of ensuring that EU regulation is efficient is shared with the other institutions and 
with Member States.  
 
The Commission also applies other tools, such as the 'Lighten the load' website, where stakeholders 
can announce concerns over burdensome legislation, and the REFIT platform, which is a stakeholder 
forum adopting opinions on existing EU laws on the extent to which these are fit for purpose. On 
this basis – and on its evaluations carried out - the Commission identifies areas for simplification 
proposals.  
 
The new Commission, which came into office in December 2019, has furthermore announced to 
apply a 'one in, one out' approach to its regulatory agenda. This is envisaged to further intensify 
efforts to streamline, simplify and digitalise EU laws.  
 WT/TPR/M/395/Add.1  
 
- 232 - 
 
  Pág. 7  
Párrafo 3.10. "El 24 de julio de 2019, la Comisión Europea adoptó la comunicación "Directrices 
sobre la p articipación de licitadores y bienes de terceros países en el mercado de contratación pública 
de la UE"  
 
2. Con respecto a las Directrices sobre la participación de terceros en los procesos de 
compras públicas, nos pueden precisar el alcance de esta medida y si la misma opera 
en consonancia con los compromisos del EPA y otros Tratados sobre contratación 
pública?  
 
EU reply :  
The purpose of the Guidance on the participation of third -country bidders and goods in EU 
procurement is to offer assistance to public buy ers by improving their understanding of certain 
practical aspects of the public procurement procedures laid down in the relevant EU legislation when 
dealing with third -country bidders' participation in tenders. By recalling and clarifying applicable 
legal provisions, the Guidance contributes to ensuring compliance with the EU's international 
commitments.  
 
Pág. 7  
Párrafo 3.12. " Tras las modificaciones aportadas a la Directiva sobre cualificaciones profesionales, 
que inició un proceso de evaluación de todas las reglamentaciones nacionales de las profesiones de 
los Estados miembros de la UE, la Comisión Europea adoptó una comunicac ión que contenía 
recomendaciones sobre las reformas nacionales destinadas a mejorar el entorno reglamentario para 
una serie de servicios profesionales con un gran potencial de crecimiento y creación de empleo (por 
ejemplo, arquitectos, ingenieros y abogado s)."  
 
3. En relación a la Directiva sobre el test de proporcionalidad para nuevas regulaciones 
de servicios profesionales, que impacto se espera que tenga la misma con respecto a 
los compromisos del EPA en materia de servicios profesionales?  
 
EU reply:   
Directive (EU) 2018/958 on a proportionality test before adoption of new regulation of professions 
has no direct impact on EPA commitments under professional services. However, it will streamline 
the domestic regulation with regard to these commitments. Firstl y, the Directive will ensure that the 
introduction of new, or amendment of existing, provisions restricting access to or pursuit of regulated 
professions follows the principle of proportionality. Member States will be required to assess whether 
these provi sions are necessary and suitable for attaining the objective pursued and do not go beyond 
what is necessary to attain that objective, and the criteria applicable to such analysis will be clarified, 
contributing to reliability and comparability across Membe r States.  
 
Secondly, the Directive will bring about more transparency to the regulation of professions. Before 
introduction of new measures, interested parties will have to be informed and given a possibility to 
express their views, while the final propor tionality assessments conducted by Member States will be 
publicly available in the regulated professions database  (https://ec.europa.eu/growth/tools -
databases/reg prof/index.cfm?action=homepage).  
 
Pág. 13  
Párrafo 3.30. " La Directiva sobre el IVA y su Reglamento de Ejecución se han modificado 
recientemente para abordar los problemas de impuestos en el comercio electrónico transfronterizo. 
Se ha restaurado la igualdad  de condiciones entre los comerciantes establecidos dentro y fuera de 
la UE mediante la eliminación de la exención para los pequeños envíos de mercancías importadas. 
Asimismo, se han simplificado las obligaciones de las empresas con respecto al IVA al ampl iar el 
campo de aplicación de la ventanilla única del IVA, que ha resultado ser un medio eficaz para 
recaudar este impuesto. Se ha introducido una "responsabilidad del mercado" para que, en 
determinadas situaciones, las plataformas que faciliten el suminis tro de mercancías estén obligadas 
a pagar el IVA en lugar del vendedor. Esta medida simplificará la recaudación del impuesto en los 
casos en que a las administraciones tributarias les resulte difícil recaudarlo de las empresas no 
establecidas en la UE. Al mismo tiempo, esta función ampliada de los mercados para recaudar el 
IVA reducirá la carga para las pequeñas empresas, pues estas no tendrán que cumplir todas las 
obligaciones relativas al IVA que se derivan de la venta de mercancías en línea a clientes si tuados 
en la UE. Estas modificaciones ayudarán a subsanar las pérdidas en concepto de IVA ocasionadas WT/TPR/M/395/Add.1  
 
- 233 - 
 
  tanto por el incumplimiento como por la declaración de un valor inferior al valor real de las 
mercancías importadas. Las medidas entrarán en vigor el 1º d e enero de 2021."  
 
4. ¿Nos pueden dar mayores datos e informaciones sobre la exención para los pequeños 
envíos de mercancías importadas?  
 
EU reply:  
Presently, the import of low value goods not exceeding 10/22 EUR (depending on Member States) 
is exempt from VAT upon importation. Goods exceeding 10/22 EUR are subject to VAT but no 
customs duties are due. Goods exceeding 150 EUR are subject to customs du ties and VAT. To note 
that goods subject to excise duties (mainly alcohol, tobacco or oil products) do not benefit from 
either VAT or customs duty reliefs upon importation in the EU.  
 
From 1 January 2021, the 10/22 EUR VAT exemption on importation of low value goods is abolished. 
Thus all goods imported in the EU, irrespective of their value, will be subject to VAT. The customs 
duty relief of 150 EUR remains in place.  
For the collection of VAT of goods not exceeding 150 EUR, there are two special collecti on models 
next to the normal rules provided in the EU VAT Directive, both of them being optional for economic 
operators:  
 
- The vendor registers electronically for VAT in one EU Member State, in the so -called Import 
One Stop Shop (IOSS). This IOSS registrati on is valid for distance sales of imported goods 
made to customers in the entire EU. With this registration, the vendor will be liable to collect 
the VAT from the customer in the EU at the moment the payment for the goods is made. 
The vendor reports and pa ys the VAT collected on a monthly basis to the tax authority of 
the EU Member State of IOSS registration. Upon registration for the IOSS, the vendor 
receives an IOSS number. After checking that this IOSS number is valid, the customs 
authorities will exempt  the importation of the goods when they arrive at the EU border (to 
avoid double taxation);  
- Special arrangements for payment of VAT intended for postal and courier operators in the 
EU that declare the goods to customs if the IOSS is not used for those good s. The postal or 
courier operator who brings the goods in the EU and declares them for release into free 
circulation will need to collect the VAT from the customer, but will only pay it to the customs 
authorities monthly.  
 
The new VAT rules introduce also  increased VAT liabilities on the electronic interfaces (such as 
marketplaces, platforms, etc.) that facilitate the distance sales of imported goods to customers in 
the EU. In this respect, if a distance sale is carried out via such an electronic interface , it is the 
electronic interface that is deemed to be the seller, is therefore liable to pay VAT of the goods and 
can use the IOSS.  
 
Pág. 17  
3.14 La retirada del Reino Unido de la Unión Europea  
Párrafos 3.47 -3.53.  
 
5. A raíz de los últimos acontecimientos pol íticos en Reino Unido y el resultado de las 
elecciones de diciembre, que vías espera la Unión Europea se materialicen a futuro?  
 
EU reply:  
The Political Declaration that accompanied the Withdrawal Agreement sets out the framework for 
the future relationship between the European Union and the United Kingdom. It establishes the 
parameters of 'an ambitious, broad, deep and flexible partnership across trade and economic 
cooperation with a comprehensive and balanced Free Trade Agreement at its core, l aw enforcement 
and criminal justice, foreign policy, security and defence and wider areas of cooperation. In the 
Political Declaration, the EU and UK have stated their intent to begin the formal process of 
negotiations of their future relationship as soon as possible after the UK's withdrawal, such that it 
can come into force by the end of 2020.  
 
Pág. 19  
Párrafo 4.7. " La UE considera que, para modernizar la normativa de la OMC, es fundamental 
actualizar las normas sobre subvenciones industriales enunciadas en el Acuerdo sobre Subvenciones 
y Medidas Compensatorias. Las normas vigentes no son suficientes para hacer frente a las prácticas WT/TPR/M/395/Add.1  
 
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  que han ido apareciendo desde la redacción del Acuerdo y que han dado lugar a graves distorsiones. 
Con miras a preparar las negociaciones en esta esfera en el marco de la OMC cuando llegue el 
momento, la UE ha emprendido conversaciones exploratorias con distintos Miembros en diferentes 
formatos."  
 
6. Podrían enumerar o referir alguna documentación sobre las nuevas prácticas que h an 
ido surgiendo en materia de subvenciones industriales?  
 
EU reply:  
The EU for example refers to recent extensive trade policy papers published by the OECD:  
• Measuring distortions in international markets: the aluminium value chain;  
• Measuring distortions in international markets: the semiconductor value chain.  
 
The EU also refers to the overcapacity existing in certain industries, such as steel, to which subsidies 
contributed significantly. This was recognised by G20 Trade Ministers and by G20 Leaders in 2016. 
Paragraph 31 of the Hangzhou Summit communiqué clearly underscores and acknowledges the 
importance of collective action: "[…] We also recognize that subsidies and other types of support 
from governments or government -sponsored institutions  can cause market distortions and 
contribute to global excess capacity and therefore require attention."  
 
Pág. 20  
4.2 El programa de negociaciones bilaterales de la UE  
Párrafos 4.17 -4.30.  
 
7. La UE se encuentra aplicando el principio NMF contenido en el EPA c on respecto a estos 
nuevos TLCs que ha venido firmando con terceros países y regiones?  
 
EU reply:  
The MFN clause in the EPA is indeed applicable where the EU has become party to a free trade 
agreement with third parties after the signature of the EPA.  
 
Reporte de la secretaría  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.5 Import Prohibitions, Restrictions, and Licensing  
 
Pág. 73  
Párrafo 3.65. " In 2019, the EU codified Regulation (EC) 1236/2005 on trade in certain goods which 
could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or 
punishment, and its subsequent amendments, into Regulation (EU) 2019/125 (which applies to both 
imports and exports). The codified Regulatio n does not make any changes; it merely consolidates 
the previous amendments. It is also noted that, prior to the codification, during the review period, 
Commission Delegated Regulation (EU) 2018/181 amended the list of relevant third countries in the 
Union  General Export Authorisation (UGEA), adding the Dominican Republic, Saõ Tome and Principe, 
and Togo to the list of relevant countries."  
 
8. ¿Pueden aclarar el alcance de esta inclusión para la República Dominicana? ¿A qué 
productos exportados por el país se refiere la citada regulación?  
 
EU reply:  
The Commission Delegated Regulation (EU) 2018/181 of 18 October 2017 2 added the Dominican 
Republic, Sao Tome and Principe and Togo to the list of countries of destination to which the EU 
General Export Authorisation (EU GEA) applies. The EU General Export Authorisation covers the 
goods listed in in Annex IV to the Regulatio n (EU) 2019/125, i.e.: products which could be used for 
the execution of human beings by means of lethal injection. The EU GEA applies to Union exports to 
countries (destinations are listed in part 2 of Annex V to the Regulation (EU) 2019/125) that have 
abolished capital punishment for all crimes and confirmed that abolition through an international 
commitment, if the conditions and requirements for using that authorisation are met. As regards 
countries that are not members of the Council of Europe, that li st comprises the countries that have 
not only abolished capital punishment for all crimes, but also ratified the Second Optional Protocol 
to the International Covenant on Civil and Political Rights without reservation.  WT/TPR/M/395/Add.1  
 
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  DOMINICAN REPUBLIC - ADDITIONAL QUEST IONS  
REPORTE DE LA SECRET ARÍA  
 
3 TRADE POLICIES AND  PRACTICES BY MEASUR E 
3.3 Measures Affecting Production and Trade  
3.3.3 Sanitary and phytosanitary requirements  
 
Pág. 116  
Table 3.21 Principal SPS legislation, 2019  
Legislation  Note  
Regulation (EC) No. 178/2002 of the European 
Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements 
of food law, establishing the European Food Safety 
Authority (EFSA) and laying down procedures in 
matters of f ood safety  The General Food Law.  
Regulates the safety of food and feed produced or 
consumed in the internal market; established a 
framework for controlling and monitoring the risks 
and their prevention and management; and created 
the EFSA for the control  and evaluation of food and 
feed. The amendment of the Law by Regulation (EU) 
No. 2019/1381 of the European Parliament and the 
Council on the transparency and sustainability of the 
EU risk assessment in the food chain, amending 
Regulations (EC) 178/2002, 1 829/2003, 1831/2003, 
2065/2003, 1935/2004, 1331/2008, 1107/2009, 
Regulation (EU) 2015/2283 and Directive 
2001/18/EC. Regulation (EU) 2019/1381 aims to 
improve the transparency of the EU risk assessment 
process carried out by the EFSA, strengthen the 
long-term sustainability of the EFSA, and improve 
risk communication.  
Regulation (EC) No. 852/2004 of the European 
Parliament and of the Council of 29 April 2004 on 
the hygiene of foodstuffs  General rules for food business operators on the 
hygiene of foodstuf fs, putting primary responsibility 
on the operators; implementation of procedures 
based on Hazard Analysis and Critical Control Point 
(HACCP) principles and good hygiene practice; and 
ensuring that imported foods are at least the same 
as, or equivalent to,  the hygiene standards of food 
produced in the EU.  
Regulation (EC) No. 853/2004 of the European 
Parliament and of the Council of 29 April 2004 laying 
down specific hygiene rules for food of animal origin  Supplementing Regulation (EC) No. 852/2004.  
Setting out specific rules on hygiene for food of 
animal origin, for food business operators, and 
applying to unprocessed and processed products of 
animal origin.  
Regulation (EC) No. 854/2004 of the European 
Parliament and of the Council of 29 April 2004 laying 
down specific rules for the organization of offic ial 
controls on products of animal origin intended for 
human consumptiona  Setting out specific rules on the organization of 
official controls on products of animal origin intended 
for human consumption.  
The Regulation applies in addition to Regulation (E C) 
No. 882/2004.  
Regulation (EC) No. 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on 
official controls performed to ensure the verification 
of compliance with feed and food law, animal health 
and animal welfare rulesa  On offic ial controls for verification of compliance with 
feed and food law, animal health, and animal welfare 
rules. The Regulation sets out general rules for the 
performance of official controls to verify compliance 
with rules aiming, in particular, at: (a) preve nting, 
eliminating or reducing to acceptable levels risks to 
humans and animals, either directly or through the 
environment; and (b) guaranteeing fair practices in 
the feed and food trade, and protecting consumer 
interests, including feed and food labellin g and other 
forms of consumer information.  
Regulation (EU) 2017/625 of the European 
Parliament and of the Council of 15 March 2017 on 
official controls and other official activities performed 
to ensure the application of food and feed law, and 
rules on a nimal health and welfare, plant health and 
plant protection products (Official Controls 
Regulation)  On official controls for the verification of compliance 
with the feed and food law, and rules on animal 
health and animal welfare rules, plant health and 
plant protection products.  
It amends Regulations (EC) No. 999/2001, (EC) 
No. 396/2005, (EC) No. 1069/2009, (EC) 
No. 1107/2009, (EU) No. 1151/2012, (EU) 
No. 652/2014, (EU) No. 2016/429 and (EU) 
No. 2016/2031 of the European Parliament and of WT/TPR/M/395/Add.1  
 
- 236 - 
 
  Legislation  Note  
the Council, Co uncil Regulations (EC) No. 1/2005 
and (EC) No. 1099/2009 and Council Directives 
No. 98/58/EC, No. 1999/74/EC, No. 2007/43/EC, 
No. 2008/119/EC and No. 2008/120/EC, and repeals 
Regulations (EC) No. 854/2004 and (EC) 
No. 882/2004 of the European Parliament an d of the 
Council, Council Directives No. 89/608/EEC, 
No. 89/662/EEC, No. 90/425/EEC, No. 91/496/EEC, 
No. 96/23/EC, No. 96/93/EC and No. 97/78/EC and 
Council Decision No. 92/438/EEC (Official Controls 
Regulation).  
Directive 2002/99/EC of 16 December 2002 laying 
down the animal health rules governing the 
production, processing, distribution and introduction 
of products of animal origin for human 
consumptionb, c  Setting out rules for the production, processing, 
distribution, and introduction of products of animal 
origin for human consumption. The Directive lays 
down the general animal health rules governing all 
stages of the production, processing and distribution  
within the EU and the introduction from third 
countries of products of animal origin and products 
obtained therefrom intended for human 
consumption.  
Regulation (EU) 2016/429 of the European 
Parliament and of the Council of 9 March 2016 on 
transmissible animal diseases, amending and 
repealing certain acts in the area of animal health 
(Animal Health Law)  Repeal of Council Directives 64/432/EEC, 
77/391/EEC, 78/52/EEC, 80/1095/EEC, 82/894/EEC, 
88/407/EEC, 89/556/EEC, 90/429/EEC, 91/68/EEC, 
92/35/EEC, 92/65/ EEC, 92/66/EEC, 92/118/EEC, 
92/119/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 
No. 2002/99/EC, and 2003/85/EC; Council Decisions 
91/666/EEC, 95/410/EC, and 2000/258/EC; Council 
Regulation (EC) 21/2004, Council Directives 
2004/68/EC, 2005/94/EC, 2006/88/EC, 20 08/71/EC, 
2009/156/EC, and 2009/158/EC, and Regulation 
(EU) 576/2013 of the European Parliament and of 
the Council. Inter alia , the Law consolidates animal 
health legislation and aims to simplify and clarify the 
rules relating to the prevention and eradica tion of 
diseases.  
Regulation (EU) 2016/2031 of the European 
Parliament of the Council of 26 October 2016 on 
protective measures against pests of plants, 
amending Regulations (EU) 228/2013, (EU) 
652/2014 and (EU) 1143/2014 of the European 
Parliament and of the Council and re pealing Council 
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 
98/57/EC, 2000/29/EC, 2006/91/EC and 
2007/33/EC  Repeal of Directive 2000/29/EC.  
Protective measures against the introduction of 
organisms which are harmful to plants or plant 
products.  
Regul ation (EU) 2019/4 of the European Parliament 
and of the Council of 11 December 2018 on the 
manufacture, placing on the market and use of 
medicated feed  Amending Regulation (EC) No. 183/2005 of the 
European Parliament and of the Council and 
repealing Counc il Directive No. 90/167/EEC  
Regulation (EU) 2019/6 of the European Parliament 
and of the Council of 11 December 2018 on 
veterinary medicinal products, repealing Directive 
2001/82/EC  This Regulation sets up an up -to-date legal 
framework for the authoriza tion, distribution and use 
of veterinary drugs in the EU, and strengthens the 
fight against antimicrobial resistance (AMR). It will 
apply from 28 January 2022.  
a To be replaced by Regulation (EU) 2017/625, which will apply from 14 December 2019.  
b In addition to Directive 2002/99/EC, there are many other legislative acts in the EU relating to 
animal health (see the directives repealed by Regulation (EU) 2016/429).  
c To be replaced by Regulation (EU) 2016/429 which will apply from 21 April 2021.  
Source:  European Commission and Eur -Lex. Access to European Union law . Viewed at: http://eur -
lex.europa.eu/homepage.html . 
9. ¿Cuál es el estatus de la justificación científica que sustentan el anteproyecto de 
Reglamento de la Comisión por el que se modifican los anexo II y III del Reglamento (CE) 
N°396/2005 del Parlamento Europeo y del Consejo en lo que respecta a la disminución de 
los Límites Máximos de Residuos (LMR) de Imazalil en ciertos productos alimenticios?  WT/TPR/M/395/Add.1  
 
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  EU reply:  
Decisions to approve or t o revoke the authorisation of active substances and decisions on MRLs are 
taken after a rigorous risk assessment carried out jointly by European Union member states and the 
European Food Safety Authority (EFSA) with the first and foremost objective to prot ect consumers’ 
health.  
 
The lowering of the MRLs for imazalil was necessary to protect European consumers, as an 
assessment of imazalil carried out by EFSA in 2017 identified consumer health concerns. Subsequent 
assessments of MRLs for imazalil did not le ad to more favourable results.  
 
The EU further considered that for none of the good agricultural practices on bananas for which 
information was available to EFSA, was it demonstrated that an MRL could be established that would 
be sufficiently protective fo r consumers. In this regard, EFSA also included the current Codex MRL 
for bananas of 2 mg/kg in its assessment. For all good agricultural practices evaluated in the MRL 
review, a possible acute risk for at least one group of European consumers could not be  excluded, 
as the calculated short -term exposure exceeded the Acute Reference Dose (157% ARfD for EU uses, 
184% for the use underlying the current Codex MRL of 2 mg/kg).  
 
The EU considered that it has not been demonstrated that residues of imazalil followi ng application 
in accordance with the evaluated good agricultural practices in bananas are safe for EU consumers. 
As information on alternative practices was not available to EFSA, the EU therefore proposed to 
lower the MRL for bananas to the limit of anal ytical determination.  
 
  WT/TPR/M/395/Add.1  
 
- 238 - 
 
  ECUADOR  
Informe de la Secretaría:  
 
Página 40, párrafo 2.14  
"La Comisión está aplicando una recomendación sobre comercio y género formulada por el Comité 
Mixto, constituido al amparo del ALC entre la UE y Canadá (Acuerdo Económico y Comercial Global 
(CETA))". Podría informarnos la Unión Europea:  
 
Preguntas 1:  
¿En la práctica, en sus ALC cómo se llevan a cabo esas recomendaciones?  
¿En qué ámbito de las distintas disciplinas abarcadas en los Acuerdos Comerciales se 
aplican dichas recomendaciones? Se aplican en forma de excepciones, disciplinas de 
mejor esfuerzo, u otras medidas.  
¿Podría otorgarnos un ejemplo al respecto?  
 
EU reply:  
The recommendation on trade and gender, agreed by the Joint Committee of the Comprehe nsive 
Economic and Trade Agreement (CETA) between EU and Canada, launches a cooperation between 
the EU and Canada on improving the capacity and conditions for women (including workers, 
businesswomen and entrepreneurs) to access and fully benefit from the C ETA. This includes 
exchange of experience and best practice on the collection of gender -disaggregated data, on 
gender -based analysis of trade policies, or on developing gender responsive trade agreements 
(Please see: https://trade.ec.europa.eu/doclib/press /index.cfm?id=1811).   
 
Página 52, párrafo 258  
Referente a uno de los objetivos de la política de inversión de la UE sobre preservar el derecho de 
los países de origen y receptores a reglamentar sus economías en aras del interés público.  
Podría indicarnos la Unión Europea:  
 
Preguntas 2:  
¿Cómo se define el interés público, bajo qué consideraciones?  
¿Cómo se armonizan las distintas reglamentaciones entre los países de la UE, país de 
origen y receptores?  
 
EU reply:   
In its trade and investment agree ments, the EU aims to strike a balance between ensuring the 
protection of investors and investments while fully recognising and preserving the right of the 
respective Parties to regulate within their territories to achieve legitimate policy objectives. In the 
Union's investment agreements, it is clarified that such legitimate policy objectives include public 
policy objectives such as the protection of public health, social services, public education, safety, 
the environment including climate change, public morals, social and consumer protection, privacy 
and data protection, or the promotion and protection of cultural diversity. The EU has also included 
specific language on the right to regulate, for example, in the annexes on indirect expropriation to 
provid e interpretative guidance and further clarity (e.g. CETA, EU -Singapore FTA).  
 
Página 58, párrafo 2.60  
En relación al reforzamiento de la gestión de riesgos aduanera. Podría indicarnos la UE:  
 
Pregunta 3:  
¿Cómo se llevará a cabo el reforzamiento de la gesti ón de riesgo, en cuanto a la primera 
acción del objetivo específico No . 2.2: "Reforzar la gestión de riesgos aduanera"?  
Es de interés del Ecuador conocer cómo se implementará esa acción, respecto de la 
concentración del control aduanero en los envíos de alto riesgo y la selección aleatoria en 
la gestión del riesgo, en el marco del régimen multilateral y bilateral sobre facilitación del 
comercio.  
 WT/TPR/M/395/Add.1  
 
- 239 - 
 
  EU reply:  
According to the EU Customs Action Plan to combat intellectual property rights (IPR) infringements 
for the years 2018 to 2022, the European Commission together with the Member States created a 
specific project group for the "Development of a common risk ma nagement based control strategy 
including risk information needs, common risk criteria and standards and implementation of EU 
priority control actions (PCAs) as appropriate, targeted at detection of IPR infringements for small 
and large consignments".  
The objective is to improve customs' capabilities to detect IPR infringing goods in different kinds of 
consignments, by determining the most appropriate place for effective customs controls on IPR in 
the supply chain, and by improving cooperation between risk  analysis and IPR specialists within the 
Member States Customs administrations. The work will start in 2020 with an analysis of the existing 
risk criteria to assess their effectiveness. Analysis of this information may then lead to the inclusion 
of additio nal common risk criteria, the gathering of the relevant information on how the risks are 
addressed and its analysis.  
 
Página 71, párrafo 3.42  
"Hay tres categorías principales de contingentes arancelarios: i) preferenciales, en virtud de ALC u 
otros acuerd os concluidos por la UE; ii) autónomos, para la suspensión de derechos 
(sección  3.1.3.4), determinados productos pesqueros y acceso no preferencial de otro tipo; y 
iii) convencionales, que comprenden los contingentes arancelarios en el marco de la OMC".  
Reglamento (UE) 2018/1977 del Consejo de 11 de diciembre de 2018.  
Podría informarnos la Unión Europea:  
 
Preguntas 4 -7: 
Si para la apertura del volumen contingentario con arancel cero ¿se consideran otros 
aspectos diferentes al de no poner en peligro la prod ucción de productos de la pesca y 
garantizar el adecuado suministro de la industria de la transformación de la UE?  
 
EU reply:  
In order to determine the level of autonomous tariff quotas for fisheries products, the EU takes into 
account quota intake, competition with EU production, other existing preferences (unilateral or trade 
agreements) and added value of the product.  
 
¿Cómo se distribuye ese volumen, qué variables, comerciales y no comerciales, se utilizan 
para la asignación del contingent e con arancel cero?  
 
EU reply:  
The allocation is on a first come first served basis.  
 
¿Se incluyen también a los países que mantienen un ALC con la UE en esa asignación de 
contingentes?  
 
EU reply:  
The origin of the product is not taken into account for t he autonomous tariff quotas.  
 
¿Considera la UE que la apertura de contingentes autónomos, para la suspensión de 
derechos, estaría –quizás - erosionando las ventajas de sus socios comerciales con los 
cuales mantiene un acuerdo comercial?  
 
EU reply:  
The existence of trade agreements and consequent possible preference erosion is part of the analysis 
for each product.  
 
Página 77, párrafo 3.59  
En relación a las variaciones en la aplicación de los impuestos especiales por los distintos Estados 
Miembros. Podría indicarnos la UE:  
 
Preguntas 8 -11: 
¿Qué medidas ha tomado para que esas variaciones se enmarquen en las disposiciones en 
materia de trato general de la nación más favorecida?, debido a que, según lo expuesto, 
los impuestos especiales que t ambién se aplican a las importaciones de productos 
similares, podrían ser diferentes dependiendo del Estado Miembro.  WT/TPR/M/395/Add.1  
 
- 240 - 
 
  EU reply:  
EU countries agreed on common EU rules to make sure that excise duties are applied in the same 
way and to the same products ever ywhere in the Union. These rules must be applied to the same 
imported products.  
 
Respecto de la Directiva del Consejo por la que se modifica la Directiva 92/83/CEE sobre la 
armonización de las estructuras de los impuestos especiales sobre el alcohol y las bebidas 
alcohólicas:  
 
1. ¿El aumento del umbral para la aplicación de las tarifas reducidas a la cerveza de baja 
concentración también se adoptaría para las cervezas similares importadas?  
 
EU reply:  
Directive 92/83/EEC allows Member States to grant reduced e xcise rates to beer with an actual 
alcoholic strength by volume not exceed 2,8% (article 5). If Member States use this provision, they 
must ensure that any reduced rates they introduce apply equally to beer with an actual alcoholic 
strength by volume not e xceed 2,8% delivered into their territory. These provisions cannot only 
apply to domestic beers.  
 
In May 2018, the Commission proposed to amend Directive 92/83/EEC. The proposal included an 
increase in the threshold of 2,8% to 3,5%. Member States are still  negotiating this proposal, 
therefore the threshold remains at 2,8%.  
 
2. Sobre las tarifas reducidas a los pequeños productores, ¿cómo la medida se ajusta a 
las disposiciones de trato nacional en el caso de productos similares, directamente 
competidores o sustitutos?  
 
EU reply:  
Directive 92/83/EEC allows Member States to grant reduced excise rates to small producers of beer 
(article 4) and ethyl alcohol (article 22). Member States must ensure that any reduced rates they 
introduce apply equal ly to beer delivered into their territory from independent small breweries and 
distilleries situated outside of their territory. These provisions cannot only apply to domestic 
producers.  
 
3. En cuanto a los objetivos de reducir los costos de las pequeñas e mpresas productoras 
de alcohol, ¿se implementaría únicamente con la reducción de tarifas de impuestos 
especiales o se utilizaría otro instrumento de política comercial para alcanzar dicho 
objetivo?  
 
EU reply:  
The proposal was not directly aimed to reduce excise costs or the present large variations of excise 
duty amongst Member States, the main objective of the proposal was to alleviate the 
disproportionate administrative and compliance costs for economic operators that restrict the 
participation of  small and medium -sized enterprises in intra -EU trade in alcohol and alcoholic 
beverages. The proposal is still being negotiated by the Member States. Therefore these measures 
have not been adopted yet.  
 
Página 77, cuadro 3.6  
Tipos mínimos de los impuestos  especiales sobre los productos armonizados en la UE, 2020. Podría 
informarnos la UE:  
 
Pregunta 12:  
¿En qué casos se aplica uno u otro tipo mínimo de impuestos? En el caso de la categoría 
de productos como la cerveza, en donde se informan dos valores del i mpuesto especial. 
Quizás, esa posibilidad se vincularía con la aplicación de tarifas reducidas a la cerveza, 
según la Directiva del Consejo por la que se modifica la Directiva 92/83/CEE.  
 
EU reply:  
Directive 92/84/EEC sets out minimum rates that must applied to each category of alcoholic 
beverage. The minimum rate for beer is expressed in two different measurements: degree Plato and 
degree of alcohol. Degree of alcohol measures how much alcohol is contained in a given volume of 
a beverage. Degree Plato  is used to quantify the concentration of extract as a percentage by weight.  WT/TPR/M/395/Add.1  
 
- 241 - 
 
  It is not possible to create an exact conversion table between degree Plato and degree of alcohol as 
the conversion is not linear. However we understand the industry norm is one d egree Plato is 
equivalent to 0.4% degree of alcohol. Therefore the rates for the two measurements provided for in 
Directive 92/84/EEC mean that a beer is taxed the same regarding how the alcoholic content of the 
beer is measured.  
 
Página 81, Cuadro 3.8  
Productos sujetos a licencias de importación, 2019:  
"La UE solo mantiene prescripciones en materia de licencias para los siguientes productos: arroz; 
semillas de cáñamo para siembra, cáñamo en bruto, semillas de cáñamo no destinadas a la siembra; 
alcohol etí lico de origen agrícola".  
Según la información contenida en el indicado cuadro, ese régimen buscaría el control de las 
corrientes comerciales y gestión de los contingentes arancelarios.  
En el Reglamento (CE) Nº 1342/2003 de la Comisión, por el que se estab lecen disposiciones 
especiales de aplicación del régimen de certificados de importación y de exportación en el sector de 
los cereales y del arroz, se establecieron normas complementarias o excepciones respecto de las 
disposiciones del Reglamento (CE) Nº 1291/2000 de la Comisión, de 9 de junio de 2000, por el que 
se establecen disposiciones comunes de aplicación del régimen de certificados de importación, para 
tener en cuenta las prácticas comerciales propias del sector de los cereales y el arroz.  
 
Preguntas  13-14: 
El sustento normativo multilateral que justifica la aplicación de esta medida, según el 
informe de la Secretaría tendría el carácter de una licencia de importación no automática. 
De ser el caso, ¿qué objetivo persigue la medida cuando se habla del control de las 
corrientes comerciales?  
¿Cómo se considera esa variable para autorizar las importaciones y en qué casos se 
otorgaría la licencia de importación?  
 
EU reply (Q13 and Q14):   
Import licences still required for certain products, other than licences for the management of tariff 
rate quotas, are automatically delivered on request by importers and are used for statistical trade 
monitoring.  
 
Import licences within the framework of the management of tariff rate quotas are distributed 
following a process of simultaneous examination of all operators' applications. Within the 
simultaneous examination process, import licences are distributed based on a pro -rata allocation 
coefficient, which is calculated taking into account the volume available within  the quota and total 
volume applied for by the operators. The delivery of import licences is mandatory following the 
publication of this allocation coefficient. To ensure the effective use of import licences operators 
lodge a security, which is released th e operator upon proof of importation.  
 
The EU fully respects WTO rules in relation to licences, including the Import Licensing Agreement 
and the Bali MC9 Ministerial Decision on TRQ Administration.  
 
Results of the allocation process for tariff rate quotas are made public via the following website: 
https://ec.europa.eu/info/food -farming -fisheries/key -policies/common -agricultural -policy/market -
measures/trqs_en . 
 
Página 88, Recuadro 3.2  
Principales elementos de la modernización de las medidas comerciale s correctivas, 2018.  
Según el documento de la Secretaría, la aplicación de normas sociales y medioambientales se tiene 
en cuenta al determinar el precio indicativo para la industria de la UE; y al considerar la aceptación 
de ofertas.  
En el Reglamento (UE) 2018/825 del Parlamento Europeo y del Consejo, relativo a las reformas al 
Reglamentos de defensa contra las importaciones que sean objeto de dumping e importaciones 
subvencionadas de países no miembros de la Unión Europea, se señala que la Comisión debe in iciar 
reconsideraciones provisionales, en su caso, cuando la industria de la Unión deba hacer frente a un 
incremento de los costes como consecuencia del establecimiento de normas sociales y 
medioambientales más estrictas. De igual manera en el caso de que se produzcan cambios en las 
circunstancias de los países exportadores en materia de normas sociales y medioambientales; como 
ejemplo, si un país que está siendo objeto de medidas se retira de acuerdos medioambientales 
multilaterales y de sus protocolos, de  los que es parte la UE, o de los Convenios de la Organización WT/TPR/M/395/Add.1  
 
- 242 - 
 
  Internacional del Trabajo (OIT). La reconsideración provisional deberá tomar en cuenta la naturaleza 
exacta del cambio.  
 
Preguntas 15 -16: 
¿Podría explicarnos la UE cómo se aplicaría la reconsid eración en el cálculo y uso del 
precio indicativo en el proceso de investigación tomando en cuenta el aumento de costes 
de la industria nacional, cómo se ajustaría el precio indicativo, sería más bajo quizás?  
 
EU reply:   
The Commission could initiate inter im reviews, where appropriate, in cases where the Union industry 
faces increased costs resulting from higher social and environmental standards. In this context, the 
review could examine whether these higher costs have an impact on the target price and, as  the 
case may be, on the duty level necessary to remove the injury.  
 
As regards the calculation of the non -injurious price used to calculate an injury margin, it will reflect:  
 
- Actual costs resulting from compliance with multilateral environmental agreements and 
International Labour Organisation Conventions to which the European Union is a party as 
well as any future cost increases in that respect that would occur during the life time of TDI 
measures.  
- With regard to the actual costs, the Commission identifies and verifies the cost in the 
financial records of the Union producer. As regards future costs, these are based on clear 
evidence that the conventions to which the Union is pa rty will impose a measureable and 
quantifiable future cost to the company.  
 
De igual manera, ¿Cómo se aplicaría esa reconsideración, si un país se retira de 
determinados acuerdos medioambientales multilaterales?  
 
EU reply:   
In examining the acceptability of price undertaking offers from exporters, social and environmental 
standards in the exporting country concerned may also be a consideration. The circumstances would 
be examined in the context of each individual case based on its own merits. The relevant disciplines 
in that respect are those to be found in the multilateral environmental agreements, and protocols 
thereunder, to which the Union is a party, and in the International Labour Organisation (ILO) 
Conventions listed in Annex Ia to the Regulations. W here an exporting country withdraws from such 
essential social and environmental agreements, this may also be a consideration in deciding whether 
an undertaking should continue.  
 
Página 131, párrafo 3.224  
 
Preguntas 17 -20: 
Podría indicarnos la UE ¿qué indicadores evalúa o la metodología que utiliza para 
establecer las plagas cuarentenarias que tendrían los efectos más graves, y su 
clasificación como plaga prioritaria?  
Según el documento G/SPS/GEN/1541 de 10 de marzo de 2017, existe la posibilidad de señ alar 
determinadas plagas cuarentenarias como "plagas prioritarias", cuando éstas entrañen un mayor 
riesgo de impacto económico, medioambiental o social para el territorio de la UE.  
 
EU reply:   
As communicated in document G/SPS/GEN/1541 of 10 March 2017, the possibility of identifying 
certain quarantine pests as "pests priority" is foreseen when these entail a higher risk of economic, 
environmental or social impact for the EU territory. Through a scientific study by the European 
Commission's Joint Re search Centre, the economic, environmental and social impact for individual 
regulated pests have been calculated. The ones with the combined highest rates were subsequently 
listed as priority pests.  
 
¿En ese contexto, podría informarnos la UE qué disposici ones normativas de la OMC y las 
directrices de la Convención Internacional de Protección Fitosanitaria se han estimado 
para incluir la evaluación del impacto económico, medioambiental o social para la 
adopción de medidas sanitarias y fitosanitarias? ¿Cómo se vincula a la evaluación de 
riesgos en ese análisis?  
 WT/TPR/M/395/Add.1  
 
- 243 - 
 
  Según el Reglamento (UE) 2016/2031, se establecería el concepto de los vegetales, productos 
vegetales y otros objetos de alto riesgo, que abarca los productos cuya importación en la UE se 
prohibirá ha sta que una evaluación completa del riesgo confirme su condición fitosanitaria.  
 
EU reply:   
The extra analysis resulting in the priority pest list allows the EU to focus its resources for 
surveillance of the EU territory and import control of the regulated  pests with the highest potential 
impact on the EU. It has no direct consequences for import or import restrictions.  
The concept of high -risk plants, plant products and other objects, according to Regulation (EU) 
2016/2031, covers products that are prohib ited to be imported into the EU until a complete risk 
assessment confirms their status as plant protection status.  
 
Sobre la base de lo expuesto, podría señalarnos la UE ¿bajo qué criterios el concepto de 
alto riesgo y la prohibición de importaciones se a justa a las disposiciones del Acuerdo 
sobre Medidas Sanitarias y Fitosanitarias, Artículo 2.2 y 2.3 y la aplicación del nivel 
adecuado de protección?  
 
EU reply:   
In the framework of the revision  of the existing plant health legislation and the implementati on of 
Regulation (EU) 2016/2031, several preliminary assessments have been carried out concerning 
whether plants and plant products from third countries  present a pest risk of an unacceptable level 
for the Union territory. Those assessments concluded that because certain plants and plant products 
fulfil one or more of the criteria set out  in Annex III to that Regulation, they could qualify as 'high 
risk plants' or 'high risk plant products' within the meaning of Article 42 of that Regulation. The 
import is subsequently prohibited on a preliminary basis.  
A complete risk assessment is first required in order to conclude whether those plants or plant 
products pose a risk of and unacceptable level or whether that risk can be reduced to an acceptable 
level by ap plying certain measures. This risk assessment is carried out on the basis of a dossier 
submitted by the applicant country. The preliminary ban can – if technically justified – eventually be 
lifted, possibly linked to specific import requirements.  
 
¿Qué suc ederá con aquellos productos cuya importación se encuentra habilitada al 
momento de adoptar la medida?  
 
EU reply:  
The list of high risk plants and plant products whose importation is provisionally banned was 
published one year before the entry into application of Regulation (EU) 2016/2031 to allow third 
countries to submit dossiers and the EU to carry out the risk assessment and decide about the risk 
management in due time to limit the trade consequences as much as possible.  
 
Página 145, párrafo 3.27 1 
"El artículo prohíbe toda discriminación respecto de las importaciones o las exportaciones de 
productos entre los Estados miembros si un Estado, directa o indirectamente, controla, dirige o 
influye sensiblemente en el comercio intra -UE. Como se indicó en  el examen anterior, estas 
disposiciones se aplican al mercado interno de la UE, pero no al comercio exterior".  
 
Pregunta 21:  
¿Podrían indicarnos qué medidas ha tomado la UE para que sus empresas se ajusten a las 
disposiciones del Artículo XVII del GATT de 1994, principios generales de no 
discriminación?  
 
EU reply:   
General EU rules (e.g. on competition, freedom of establishment and non -discrimination) apply to 
all enterprises in the EU, including the state monopolies. EU has notified its state tradi ng enterprises 
under the obligations set in Article XVII of the GATT 1994 and its Understanding.  
 
Página 186, párrafo 4.19  
"Cada Estado Miembro está obligado a asignar el 30% del límite máximo nacional anual a pagos 
directos para prácticas agrícolas benefi ciosas para el clima y el medio ambiente (ecologización)".  
Según la notificación de la UE sobre medidas de ayuda interna para la campaña 2016 y 2017, estos 
pagos estarían justificados bajo compartimiento verde, "ayuda a los ingresos desconectada".  
 WT/TPR/M/395/Add.1  
 
- 244 - 
 
  Preguntas 22 -23: 
¿Podría indicarnos la UE bajo qué criterios las prácticas agrícolas beneficiosas para el 
clima y el medio ambiente o sus equivalentes se ajustan a los criterios establecidos en el 
Anexo 2 del Acuerdo sobre la Agricultura?  
 
EU reply:  
Green ing payments are part of the EU's decoupled income support and fulfil the requirements set 
out in paragraph 5 or 6 of Annex II of the WTO Agreement on Agriculture. Beneficiaries of the 
decoupled Basic Payment Scheme or Single Area Payment Scheme receive gr eening payments when 
observing agricultural practices beneficial for the environment as defined in Article 43 of Regulation 
(EU) Nº 1307/2013. The payment amount is not related to or based on the type or volume of 
production. Farmers are free to produce an y crop or may decide not to produce at all and they will 
get the same payment as farmers producing.  
 
En el párrafo 4 del Artículo 43 se establece que las prácticas equivalentes que cita el apartado 3 no 
estarán sujetas a doble financiación (Reglamento (UE)  Nº 1307/2013 del Parlamento Europeo y del 
Consejo).  
 
Podría informarnos la UE ¿si los productos incluidos en la ayuda interna bajo el criterio de 
prácticas agrícolas beneficiosas para el clima y el medio ambiente se benefician también 
de doble financiació n y, de ser el caso, cómo se estaría registrando esos valores en virtud 
de los compromisos en materia de ayuda interna?  
 
EU reply:   
Double funding of practices is excluded, including for greening payments.  
 
Página 187, párrafo 4.27  
En relación a los pagos  redistributivos. Según la notificación de la UE a la OMC sobre ayuda interna, 
correspondiente a la campaña de comercialización de 2016/2017, el pago redistributivo se informó 
como ayuda a los ingresos desconectada.  
En el Reglamento (UE) No 1307/2013 del P arlamento Europeo y del Consejo , párrafo 3 del artículo 
41 establece que el "pago redistributivo se concederá anualmente previa activación de los derechos 
de pago por el agricultor o, en los Estados miembros que aplican el artículo 36 del presente 
Reglamento, previa declaración de las hectáreas admisibles por el agricultor." En el artículo 36, 
párrafo 2, se menciona que "el régimen de pago único por superficie se concederá sobre una base 
anual para cada hectárea admisible declarada por el agricultor ". 
 
Pregunta 24:  
¿Podría informarnos la UE cómo se determinan el número de hectáreas admisibles, qué 
parámetros cuantitativos o cualitativos se empelan y cómo el factor de la producción se 
incluye en ese cálculo?  
 
EU reply:   
To receive direct support, a farmer should have agricultural land at his/her disposal and the 
agricultural land should be used for an agricultural activity. Each year the farmer has to submit an 
aid application for Direct Payments, whereby they declare, inter alia , all agricultural parcels of the 
holding.  
As a general rule, "eligible hectare" refers to any agricultural area of the holding that is used for 
agricultural activity. The agricultural area can also be used for non -agricultural activities, as long  as 
the agricultural activities are predominant. In general, only land suitable for agricultural production 
is considered as agricultural area. This includes arable land, permanent crops, permanent grassland 
and permanent pasture.  
 
In order to be eligible  to payments, any single part of the agricultural area should be utilised for an 
agricultural activity each year .43 In the framework of direct support, the agricultural activity is 
defined as: either (i) production, rearing or growing of agricultural produc ts, including harvesting, 
milking, breeding animals, and keeping animals for farming purposes, or (ii) maintaining an 
agricultural area in a state which makes it suitable for grazing or cultivation without preparatory 
 
43 However, areas which may no longer be used for an agricultural activity as a result of specific 
commi tments (e.g. afforested, set aside, or converted in the framework of Natura 2000 Directives) may also be 
eligible for direct payments under certain conditions.  WT/TPR/M/395/Add.1  
 
- 245 - 
 
  action going beyond usual agricultural  methods and machineries. Therefore, farmers always have 
the choice to produce on the land or to maintain the land without production.  
 
Página 199, párrafo 4.67  
"Se simplificarán las normas de producción y se reforzará el sistema de control. Se pasará tam bién 
del principio de equivalencia al principio de conformidad: los productores de países no pertenecientes 
a la UE tendrán que cumplir las mismas normas que se apliquen en la UE".  
 
Preguntas 25 -26: 
Podría informarnos la UE si en el caso de la equivalencia sería necesario establecer un 
acuerdo previo, y el procedimiento a seguir para la conformidad. ¿La certificación de grupo 
será aplicable a los productos importados también?  
 
EU reply:   
Article 48 of Regulation (EU) No 2018/848 on organic produ ction and labelling of organic products 
provides that a third country that has been recognised for the purpose of equivalence under 
Article  33(2) of Regulation No. 834/2007, continues to be recognised. This provision will expire on 
31 December 2025. It all ows for a transition period to a new scheme of recognition under an 
international agreement with a third country that has a system of production that meets the same 
objectives and principles and with the same level of assurance of conformity. Before the ex piry of 
the current administrative arrangements, the EU should renegotiate a bilateral international 
agreement on the recognition of the organic system of third countries.  
 
The principle of compliance refers to the rules applied to producers certified by Control bodies when 
their product complies with Chapter II, III and IV of the Regulation (Article 45 (1) of Regulation (EU) 
No. 2018/848).  
 
The group certification will be applicable to producers operating in an EU Member State or a third 
country that whi ch are certified to export to the EU. The group certification applies to groups of 
operators, not to groups of products.  
 
¿Desde cuándo iniciaría el proceso de simplificación de normas a la producción?  
 
EU reply:   
The European Commission Implementing Regu lation is being drafted and should enter into force on 
1 January 2021.  
 
Página 87, párrafo 3.78  
Respecto a "En la primera modificación, que se introdujo en 2017, se añadió información con 
respecto al "valor normal". A grandes rasgos, se permite que el valo r normal se determine mediante 
otro método cuando haya distorsiones introducidas por el Estado en el país exportador. En tales 
circunstancias, el valor normal se calcula a partir de costes de producción y venta que reflejen 
precios o valores de referencia no distorsionados o a partir de referencias como los precios 
internacionales o los costes en otro país representativo. En el caso de los países que no son Miembros 
de la OMC, se establece una metodología específica para determinar el valor normal".  
 
Pregunta 27:  
¿Se han presentado casos en los que se haya aplicado el método del valor normal (cuando 
haya distorsiones introducidas por el Estado en el país exportador) y/o se ha aplicado la 
metodología específica a algún país no Miembro de la OMC?  
 
EU re ply:  
The new dumping margin calculation methodology has been used in the following cases:  
 
Case 
number  Initiation 
date Product  Country  
R683 14-03-2018 Organic coated steel  P.R. China  
R684 13-03-2018 Aluminium foil (rolls of less than 10 kg)  P.R. China  
R685 31-05-2018 Tungsten electrodes  P.R. China  WT/TPR/M/395/Add.1  
 
- 246 - 
 
  Case 
number  Initiation 
date Product  Country  
R687 15-05-2018 Ceramic tableware and kitchenware  P.R. China  
R688 04-06-2018 Bicycles  P.R. China  
R692 08-05-2018 Threaded tube or pipe cast fittings of malleable cast 
iron P.R. China  
R693 19-07-2018 Ironing boards  P.R. China  
R697 17-12-2018 Peroxosulphates  P.R. China  
 
The methodology has not been used in any cases concerning imports from a non -WTO country.  
 
Página 88, recuadro 3.2  
Principales elementos de la modernización de las medidas comerciales correctivas, 2018.  
En lo que respecta a los cambios introducidos en 2018 en la segunda modificación de dichos 
reglamentos, podría la UE explicar:  
 
Preguntas 28 -29: 
¿El servicio de asistencia destinado a las PYMES es para la investigación antidumping?  
 
EU reply:   
Article 5 (1a) of the basic anti -dumping Regu lation sets out the details as regards the assistance 
available to SMEs in the context of investigations:  
 
'The Commission shall facilitate access to the trade defence instrument for diverse and fragmented 
industry sectors, largely composed of small and me dium-sized enterprises (SMEs), through a 
dedicated SME Helpdesk, for example by awareness raising, by providing general information and 
explanations on procedures and on how to submit a complaint, by releasing standard questionnaires 
in all official langua ges of the Union and by replying to general, non -case-specific queries.  
The SME Helpdesk shall make available standard forms for statistics to be submitted for standing 
purposes and questionnaires.'  
 
Small and medium -sized companies (SMEs) benefit from st reamlined procedures and the support of 
an SME Helpdesk to make it easier for them to participate in trade defence investigations.  
The Commission has created a dedicated web page for SMEs which provides relevant information to 
help navigate the system, including a guide to filing complaints as well as standard questionnaires 
for Union producers, importers and users.  
 
The dedicated we bpage can be found here:  
https://ec.europa.eu/trade/policy/accessing -markets/trade -defence/actions -against -imports -into-
the-eu/help -for-smes/ . 
 
¿Qué tipo de intereses que convengan a la UE deben existir para aplicar la regla de derecho 
inferior en las investigaciones sobre derechos compensatorios?  
 
EU reply:   
In deciding on the application of the lesser duty rule in anti-subsidy investigations, the Commission 
examines the interests of stakeholders that may be affected by the measures including, for example, 
downstream industries, upstream suppliers, consumers users etc.  
 
Página 92 y 93, párrafo 3.92  
"En marzo de 2018,  la UE inició los procedimientos para abrir una investigación en materia de 
salvaguardias en relación con 26 categorías de productos siderúrgicos, con arreglo a las normas 
sobre salvaguardias previstas en los Reglamentos (UE) 2015/478 y (UE) 2015/755; el a lcance de la 
investigación se amplió posteriormente hasta abarcar 28 categorías de productos. La Comisión 
esgrimió como razones para iniciar la investigación la tendencia creciente de las importaciones de 
esos productos, la situación de la industria siderú rgica de la UE y el riesgo de desvío comercial de 
las medidas de los Estados Unidos, además del exceso de capacidad y el mayor uso de prácticas 
comerciales restrictivas. Se aplicaron medidas provisionales de salvaguardia en julio de 2018 y 
medidas definiti vas en febrero de 2019. El Reglamento de Ejecución se modificó en noviembre de 
2018 para excluir del ámbito de aplicación de las medidas a varios países (Botswana, Camerún, WT/TPR/M/395/Add.1  
 
- 247 - 
 
  Eswatini, Fiji, Ghana, Côte d'Ivoire, Lesotho, Mozambique, Namibia y Sudáfrica). La s medidas de 
salvaguardia definitivas aplicadas abarcan 26 categorías de productos siderúrgicos para las que se 
han establecido contingentes arancelarios sobre la base del nivel de las importaciones de los tres 
años anteriores (2015 -2017) más el 5%. En alg unos casos, los contingentes se asignaron 
específicamente a un país, es decir, en función de su historial de importaciones; en los demás casos, 
se asigna un contingente general según el orden de recepción de las solicitudes. Se aplica un derecho 
adicional del 25% a las importaciones fuera del contingente. Se espera que la medida de 
salvaguardia esté en vigor durante algo menos de tres años; su expiración está prevista para el 
30 de junio de 2021. La medida se ha notificado a la OMC".  
 
Pregunta 30:  
Se indica que se excluyeron a ciertos países en la aplicación de las medidas provisionales. 
¿Podría explicarnos la UE cuáles son los criterios utilizados para realizar dichas 
exclusiones?  
 
EU reply:   
The criteria used for exclusions are laid down in recital 8 0 of Commission Implementing Regulation 
(EU) 2018/1013 of 17 July 2018 imposing provisional measures with regard to imports of certain 
steel products for the explanation regarding the exclusion from the measures of the countries part 
of the European Econom ic Area; and in recitals 2 to 4 of Commission Implementing Regulation (EU) 
2018/1712 of 13 November 2018 amending Implementing Regulation (EU) 2018/1013 for the 
exclusions of Botswana, Camerún, Eswatini, Fiji, Ghana, Côte d'Ivoire, Lesotho, Mozambique, 
Namibia y Sudáfrica).  
 
Párrafo 3.359  
En relación con este párrafo, en el que se indica que las IG de productos no europeos pueden ser 
protegidas por aplicación directa o por inclusión en sus acuerdos comerciales, y a la luz de los 
Artículos 3 y 4 del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados 
con el Comercio (ADPIC) sobre Trato Nacional  y Trato de Nación Más Favorecida  con respecto a la 
propiedad intelectual:  
 
Pregunta 31:  
¿Podría indicarnos la UE cómo es consistente con estos artículos la disposición respecto 
del uso del símbolo de la UE para productos protegidos al que se refiere el artículo 12, 
apartado 3, del Reglamento (UE) No 1151/2012, que permite el uso de este sello 
únicamente a "productos originarios de la Unión comercializados con una denominación 
de origen protegida o indicación geográfica protegida registrada de acuerdo con los 
procedimientos establecidos en el presente Reglamento"?  
Esto teniendo en cuenta que los productos reconocidos por la UE como indicacio nes geográficas o 
denominaciones de origen deberían gozar de las mismas ventajas una vez que hayan sido 
reconocidos como tales, más allá del mecanismo utilizado para su registro y protección.  
 
EU reply:   
Regulation (EU) No . 1151/12 provides for the possibi lity to use the EU symbols for  designations of 
origin and geographical indications  originating in third countries. In particular, such a possibility is 
set out in Articles 11(2) and 12(6) of this Regulation. Article 11(2) provides that geographical 
indicat ions pertaining to products of third countries that are protected in the EU under an 
international agreement to which the EU is a contracting party may be entered in the register. 
Article  12(6) provides that in the case of products originating in third countries marketed under a 
name entered in the register, the EU symbols may appear on the labelling.  
 
 
ECUADOR  – ADDITIONAL QUESTIONS  
Informe de la Secretaría, Secciones de Obstáculos Técnicos al Comercio y Medidas 
Sanitarias y Fitosanitarias:  
 
Additional questions FROM ECUADOR  
 
Report by the Secretariat, Technical Barriers Section for Trade  
and Sanitary and Phytosanitary Measures:  
 WT/TPR/M/395/Add.1  
 
- 248 - 
 
  Página 132, párrafo 3.230  
"La Legislación sobre Sanidad Animal se aplicará a partir del 21 de abril de 2021. Establece nuevas 
prescripciones sobre sanidad animal aplicables a la importación de animales y sus productos en la 
UE, pero no introduce cambios significativos en el sistema existente". Podría la UE explicar:  
 
Pregunta 1:  
¿Cuáles son los detalles de los cambios más relevantes que se realizan a esta norma, las 
modificaciones realizadas en las prescripciones sobre sanidad animal que aplicará a partir 
del 21 de abril del 2021?  
 
EU reply:  
The revised detailed animal health import requirements stemming from the Animal Health Law are 
contained in a draft Delegated Regulation which was notified to the WTO SPS in 2019 as 
G/SPS/N/EU/329 (https://mem bers.wto.org/crnattachments/2019/SPS/EEC/19_3746_00_e.pdf), 
That Delegated Regulation was adopted since and expected to be published in the coming months 
in the Official Journal of the EU.  
 
Página 199, párrafo 4.67  
"Para responder a la rápida evolución del  sector de la agricultura ecológica, en mayo de 2018 se 
adoptó un nuevo Reglamento sobre producción ecológica y etiquetado de los productos ecológicos, 
que se comenzará a aplicar el 1º de enero de 2021. Según la Comisión, ese Reglamento se concibió 
para mo dernizar el sector, armonizar las normas y garantizar una competencia leal para los 
agricultores y, al mismo tiempo, evitar el fraude y mantener la confianza de los consumidores. Se 
simplificarán las normas de producción y se reforzará el sistema de contro l. Se pasará también del 
principio de equivalencia al principio de conformidad: los productores de países no pertenecientes a 
la UE tendrán que cumplir las mismas normas que se apliquen en la UE. La nueva normativa prevé 
asimismo elementos de simplificació n, como el establecimiento de un procedimiento para eximir a 
los operadores de bajo riesgo del control anual y la introducción de un sistema de certificación de 
grupo para los pequeños productores, con miras a reducir los costes administrativos y de 
certificación. La reforma incluye además una ampliación de la gama de productos que pueden recibir 
la certificación ecológica, así como nuevas normas para facilitar la conversión a la producción 
ecológica".  
Ecuador inició su proceso de reconocimiento de país ter cero en normativa de productos orgánicos, 
ecológicos o biológicos con el Reglamento (CE) No. 834/2007 del Consejo de la Unión Europea y el 
mandato para este tipo de instrumentos finalizó en 2017; sin embargo, la reciente normativa 
promulgada para productos  orgánicos mediante Reglamento (UE) 2018/848 en su Artículo 58, 
establece que la Comisión de la Unión Europea finalizará el examen de las solicitudes de terceros 
países que se hayan presentado de conformidad con el Artículo 33, apartado 2, del Reglamento ( CE) 
834/2007, y que aún estén en trámite el 17 de junio de 2018. Podría la UE confirmar:  
 
Pregunta 2:  
Según lo expuesto, ¿se continuará trabajando sobre la base del Reglamento anterior, en 
virtud del trabajo iniciado?  
 
EU reply:  
The implementation of Article 58 of Regulation (EU) 2018/848 is being discussed between the 
European Commission and EU Member States. The EU will be able to inform other members including 
Ecuador once these discussions are finalised.  
 
Página 128, cuadro 3.21, Principal legislación sanitaria y fitosanitaria en 2019.  
El Ecuador reconoce la importancia de proteger la salud humana y el ambiente. Sin embargo, 
estimamos que las decisiones regulatorias tomadas sobre la base de criterios fundados en peligro 
no son cons istentes con la práctica internacional de evaluación de riesgos, debido a que no se 
considera el tema de la exposición. A nuestro criterio, el enfoque precautorio, debido a la falta de 
información durante la elaboración de los análisis de riesgo, ha llevad o a que las aprobaciones de 
ingredientes activos se dirijan a reducir los LMR a un nivel mínimo de detección, como principio de 
precaución, causando una afectación muy alta para la economía de los pequeños, medianos y 
grandes productores de los países prov eedores, y a los consumidores en la Unión Europea, en 
relación a la oferta de productos. Podría la Unión Europea indicarnos:  
 WT/TPR/M/395/Add.1  
 
- 249 - 
 
  Pregunta 3:  
¿En qué se basa el enfoque precautorio que está utilizando y cómo se está procediendo 
cuando falta información en el proceso de elaboración de los análisis de riesgo?  
 
EU reply:  
The EU body of law foresees the possibility to resort to the precautionary principle and, more 
specifically, it refers to the precautionary principle as part of the risk managem ent process that leads 
to the development of EU and national food law. The precautionary principle, as laid down in the 
General Food Law Regulation, Regulation (EC) No 178/2002, allows the adoption of provisional risk 
management measures necessary to ensur e a high level of health protection when, following an 
assessment of available information, the possibility of harmful effects on health is identified but 
scientific uncertainty persists. It therefore requires a scientific evaluation as well as an evaluati on 
and balancing of the risks involved, i.e. whether the potential risks identified exceed the threshold 
of what is acceptable for consumers as well as the consequences of non -action by the risk managers. 
The EU always bases its decision on a thorough risk  assessment carried out by the EFSA in 
conjunction with EU Member States as the basis to assess an import tolerance request, or to set or 
amend maximum residue limits. This is product -specific and fully in line with SPS Agreement 
provisions.  
 
Página 119, p árrafo 3.164  
"En líneas generales, en el caso de las mercancías no sujetas a una legislación de armonización y 
comercializadas legalmen te en un Estado miembro de la UE es aplicable el principio del 
reconocimiento mutuo, en virtud del cual estas pueden come rcializarse en otro Estado miembro 
aunque no se ajusten a los reglamentos técnicos del segundo Estado miembro. Las únicas 
excepciones a ese principio son las restricciones introducidas por las razones especificadas en el 
artículo 36 del TFUE o por otras ra zones primordiales de interés público que guarden proporción con 
el objetivo perseguido". Podría indicarnos la Unión Europea:  
 
Pregunta 4:  
¿Con qué países mantiene acuerdos de reconocimiento mutuo, y los temas abarcados en 
los mismos?  
 
EU reply:  
The princi ple of mutual recognition in the EU is not based on mutual recognition agreements between 
Member States but stems directly from Articles 34 -36 of the Treaty on the Functioning of the 
European Union as interpreted by the case -law of the European Court of Ju stice. It has been further 
developed by EU legislation, i.e. Regulation (EU) 2019/515, of 19 March 2019, on the mutual 
recognition of goods lawfully marketed in another Member State.  
A separate issue unrelated to the principle of mutual recognition in the  EU are the mutual recognition 
agreements (MRAs) concluded between the EU and third countries, whereby the acceptance of 
conformity assessment results between the parties is facilitated. Currently the EU has concluded 
MRAs with Australia, Canada, Israel, J apan, New Zealand, Switzerland and the US. These MRAs are 
different in terms of their scope and cover different industrial products, ranging from machinery or 
low-voltage electrical equipment to medical devices or good manufacturing practices for 
pharmaceu tical products.  
 
The full list of MRAs concluded between the EU and third countries, including the text of the 
agreements, is available at:  
https://ec.europa.eu/growth/single -market/goods/international -aspects/mutual -recognition -
agreements_en . 
 
Página 123, párrafo 3.189  
"El 30 de abril de 2019, la Comisión publicó sus recomendaciones para la próxima Agenda Estratégica 
de la UE para 2019-2024. El CEN y el CENELEC quieren mejorar la competitividad de las industrias 
europeas y contribuir a eliminar los obstáculos al comercio en el mercado mundial. En 2018, sus 
miembros determinaron los países y regiones prioritarios en los cuales la coo peración en el proceso 
de normalización podía reforzar las relaciones comerciales con Europa. El ejercicio se potenció con 
la puesta en marcha de un diálogo con la Comisión a fin de coordinar las prioridades en materia de 
normalización e incluirlas en los acuerdos comerciales de la UE". Podría la Unión Europea 
informarnos:  
 WT/TPR/M/395/Add.1  
 
- 250 - 
 
  Preguntas 5:  
¿Qué parámetros se evaluaron para identificar los países y regiones prioritarias para la 
cooperación en los procesos de normalización? ¿Cuáles serían estos países y regiones ? 
 
EU reply:  
CEN and CENELEC are two independent private  organisations. The criteria for selecting their own 
priority areas for cooperation in standardisation are thus not dependant on the European 
Commission.  
Some information can be found on the CEN and CENELEC website: 
https://www.cencenelec.eu/news/articles/Pages/AR -2019-004.aspx  
 
Página 124, párrafo 3.194  
"Crear las condiciones adecuadas para que las redes y los servicios digitales prosperen es uno de 
los tres pilares de la Estrategia para el Mercado Único Digital. El proceso de normalización respalda 
la estrategia en 2019 centrándose en el Internet de las cosas, los macrodatos, las cadenas de 
bloques, los sistemas de transporte inteligentes cooperativos y la conducción automatizada, la 
sanidad electró nica, las ciudades inteligentes, la accesibilidad, la administración electrónica y la 
inteligencia artificial. Se han realizado grandes progresos en la armonización del espectro 5G, y ya 
están disponibles las primeras normas mundiales sobre tecnología 5G, conforme a lo previsto en el 
Plan de Acción 5G. Sin embargo, será necesario seguir trabajando en el proceso de normalización 
mundial de la tecnología 5G los próximos años, en particular para promover la inversión en redes 
5G para aplicaciones industriales.  Se espera que la asociación europea en materia de redes y 
servicios inteligentes en el marco del programa Horizonte Europa contribuya de manera importante 
a llevar adelante el programa de normalización". Podría la Unión Europea indicarnos:  
 
Pregunta 6:  
¿Cuándo entraría en funcionamiento la asociación europea sobre redes y servicios 
inteligentes?  
 
EU reply:  
The European Partnership for Networks and Smart Services should be operational under Horizon 
Europe with a starting date expected in 2021.  
 
Página 125, Cuadro 3.20 0 
"De conformidad con el mandato encomendado por la Comisión, las organizaciones europeas de 
normalización terminaron la primera fase a principios de 2017, como resultado de lo cual se elaboró 
una lista de 12 normas pendientes de revisión y  una norma pendiente de redacción en la segunda 
fase, que comenzó a principios de 2018 y debería durar unos cuatro años. El CEN y el CENELEC 
examinarán luego si el proceso debería hacerse extensivo a otras normas. Actualmente los comités 
técnicos están sol icitando información más detallada acerca de las proyecciones sobre el cambio 
climático".  
 
Pregunta 7:  
¿Cuáles son los 12 estándares que se revisarán y la norma pendiente de redacción?  
 
EU reply:  
The request for a new standard can be found in M/526 Commission Implementing decision C(2014) 
3451 final of 28.5.2014 on deciding to make a standardisation request to the European 
Standardisation Organisations pursuant to art 10 (1) of regulation(EU) no 10 25/2012 of the EP and 
of the Council in support of implementation of the EU strategy on adaptation to climate change  
(COM(2013) 216 final).  It can be found here:  
https://ec.europa.eu/growth/tools -
databases/mandates/index.cfm?fuseaction=search.detail&id=546   
 
The list of standards that will be reviews is as follows:  
 
1  CEN TC 89 / ISO TC 163 Thermal performance of buildings and building components  
 EN ISO 15927 1 -6 
2  CEN TC 156 Ventilation for buildings FprEN 16798 -1, 2, 3, 4  
3  CEN TC 350 Sustainability of Construction Works EN 16309  WT/TPR/M/395/Add.1  
 
- 251 - 
 
  4  CEN TC 371 Project Committee - Energy Performance of Building project group EN ISO 52000 -
 1 5 CEN TC 350 Sustainability of Construction Works NEW (Climate resilience of construction 
 works)  
6  CEN TC 234 Gas Infrastructur e EN 16348  
7  CEN TC 234 Gas Infrastructure EN 15399  
8  CEN TC 282 Installation and equipment for LNG EN 1473  
9  CLC TC 215 Electrotechnical aspects of telecommunication equipment EN 50600 -2-3 and -2-
5 
10  CEN TC 104 Concrete and related products EN 206  
11  CEN TC 256 Railway applications EN 15723:2010  
12  CLC TC 9X Electrical and electronic applications for railways EN 50125 -1, 2 and 3  
 
Página 126, párrafo 3.204  
"El RAPEX permite el intercambio rápido de información entre los Estados miembros de la UE/el EEE 
y la Comisión sobre los productos no alimentarios que suponen un riesgo para la salud y seguridad 
de los consumidores, así como la adopción de medidas para combatir ese riesgo". Podría la Unión 
Europea  indicarnos:  
 
Preguntas 8:  
Esta plataforma, ¿permite el acceso a terceros países exportadores de productos no 
alimenticios a la UE? De ser el caso, ¿cuál sería el procedimiento para acceder al mismo?  
 
EU reply:  
The EU Rapid alert system for dangerous non -food products (RAPEX) is currently open only to 
countries of the European Economic Area (EEA), i.e. EU Member States, Iceland, Liechtenstein and 
Norway. According to Article 12(4) of the General Product Safety Directive (2001/95/EC), access o f 
a non -EEA country to the RAPEX system would need to be based on an international agreement. At 
the same time, alert summaries and detailed statistics are publicly available on the European 
Commission 's Safety Gate website (https://ec.europa.eu/rapex).  
 
Página 130, párrafo 3.216  
"Asimismo, se introdujeron diversos requisitos específicos adicionales para la importación de 
moluscos bivalvos, productos pesqueros y productos compuestos. Los requisitos de importación que 
establece este Reglamento tienen en cuen ta las características específicas de determinados 
productos (tal como también hacen las normas vigentes que prevé el Reglamento (CE) 
Nº 854/2004). Además, contemplan la necesidad de aplicar una mayor flexibilidad a los productos 
que plantean menos riesgo para la salud pública y la de los animales". Podría la Unión Europea 
informarnos . 
 
Preguntas 9:  
a) Según el Reglamento (CE) Nº 854/2004, ¿los productos que plantean menos riesgo 
fueron determinados sobre la base de un análisis de riesgo? ¿Existen otras variables que 
se utilizaron para esa determinación? De no ser el caso, ¿qué principios se utilizaron 
diferentes del análisis de r iesgo?  
b) ¿Cuáles serían esos requisitos específicos adicionales definidos para la importación 
de moluscos bivalvos, productos pesqueros y productos compuestos y cómo se justifica 
bajo las disposiciones multilaterales en materia sanitaria y fitosanitaria?   
c) ¿Cuáles serían los productos que estarían considerados de menor riesgo para la 
salud pública y la de animales, qué flexibilidad se plantea para esos productos y si 
aplicaría también para los productos importados?  
 
EU reply:  
For fishery products and bivalve m olluscs, the new rules have not substantially changed.  
 
a) The main changes are related to the import of composite products. The implementation of the 
Official Controls Regulation offered an opportunity to adapt the public health requirements applicable 
to composite products. From 21 April 2021, controls of composite products will be subject to different 
requirements on the basis of the risk presented by the product itself from both an animal health and 
a public health point of view.  
For processed products o f animal origin contained in the composite products, the public health 
requirements remain the same as at present. They must be produced either in establishments WT/TPR/M/395/Add.1  
 
- 252 - 
 
  located in third countries authorised for the entry into the European Union of those processed  
products of animal origin, or in establishments located in EU Member States.  
 
b) A Delegated act based on the Animal Health Law will lay down animal health requirements for 
entry into the Union of animals and products of animal origin, including processed p roducts of animal 
origin contained in the composite products. The animal health guarantees required will change and 
will no longer be linked to the percentage of processed products of animal origin contained in the 
composite products but to the risk presen ted by the composite product itself. Implementing acts will 
establish the lists of third countries authorised to enter animals and products of animal origin into 
the Union from the animal health perspective.  
 
With regard to residues of veterinary medicine s and pesticides, the third country manufacturing the 
composite product must be listed in Commission Decision 2011/163/EU for each product of animal 
origin contained in the composite product. For example, a composite product that contains milk and 
eggs mus t be manufactured in a country that has an approved residue monitoring plan for milk and 
eggs (and be listed in the above Decision). This requirement actually corresponds to legal provisions 
which exist already but have never been fully enforced. Applying the same requirements on chemical 
residues for products of animal origin, whether there are imported as such or as an ingredient in a 
composite product, is essential for guaranteeing food safety. Fully applying the existing legislation 
will avoid that prod ucts of animal origin which originate from sources that cannot guarantee 
compliance with the EU residues requirements are marketed in the EU, disguised as composite 
products.  
 
Third countries may also source such processed products of animal origin either  from an EU Member 
State or another third country which is listed in the above Decision, provided they request such a 
possibility to the Commission which must then be expressly acknowledged in Decision 2011/163/EU. 
This possibility to source will also be s ubject to further animal health requirements that are under 
preparation and may be further limited depending on the animal health situation of the country 
manufacturing the composite product. The draft Regulation fixing such animal health requirements 
has been adopted by a Commission Delegated Regulation, notified to SPS/WTO and, is at present 
under scrutiny by the EP and the Council, and will be applicable as from 21 April 2021.  
 
As regards the public health requirements, composite products intended for entry into the Union will 
be categorised in the three following categories, sorted by decreasing level of risk, and therefore 
with corresponding less demanding guarantees:  
 
(1) non -shelf-stable composite products (which need to be transported or stored under controlled 
temperatures) will have to originate from countries authorised for entry into the European Union for 
each processed product of animal origin contained in the composite product (including for the control 
of residues) and be accomp anied by an official certificate signed by the competent authorities of the 
country where the composite product is produced;  
(2) shelf -stable composite products (which do not need to be transported or stored under controlled 
temperatures) that contain meat  products will have to originate from countries authorised for the 
entry into the European Union for the meat products contained in the composite product (including 
for the control of residues) and be accompanied by an official certificate signed by the co mpetent 
authorities of the country where the composite product is produced;  
(3) shelf -stable composite products (which do not need to be transported or stored under controlled 
temperatures) that do not contain meat products will have to originate from coun tries authorised 
for the entry into the European Union of either meat, dairy, fishery or egg products (including from 
the respective residues ' control aspect) and be accompanied by a private attestation provided by 
the importing food business operator.  
 
The model official certificate is still to be established in 2020. The attestation should include the 
information requested in Article 14(3) of Commission Delegated Regulation (EU) 2019/625 and the 
relevant documentation provided for in the above -mentioned a nimal health Regulation currently 
under scrutiny.  
 
c) From April 2021, all composite products will be subject to veterinary controls at the Border 
Control Posts before entry into the EU. In accordance with the Official Control Regulation, the 
Commission will list in a future delegated act those composite products that, due to their lower risk 
(for example bread, confectionery or chocolate), can be granted a derogation from veterinary control 
at the border and for which controls may be carried out by the Member  States ' competent Authorities WT/TPR/M/395/Add.1  
 
- 253 - 
 
  at the point of destination in the EU. A Delegated act including such a list is in preparation with 
adoption foreseen before the end of this year.  
 
Third countries are kept informed on the evolution of the requirements for co mposite products. The 
adopted measures were notified to WTO SPS in autumn 2018. A letter to all the Embassies of third 
countries was sent in autumn 2019. A further letter will be sent again in the course of 2020 as soon 
as the remaining elements, notably o n certification, are established.  
 
Página 130, párrafo 3.217  
"La Legislación sobre Sanidad Animal de 2016 empezará a aplicarse el 21 de abril de 2021, y la 
Legislación sobre Sanidad Vegetal de 2016 lo hará el 14 de diciembre de 2019, exceptuando las 
disposiciones referentes al certificado fitosanitario para la exportación, que comenzarán a aplicarse 
el 1º de enero de 2021. Mientras tanto, la Comisión deberá adoptar varias medidas para poner en 
práctica las nuevas normas". Podría la Unión Europea señal arnos:  
 
Preguntas 10:  
¿Qué medidas son las que adoptaría la Comisión para la entrada en vigor de las nuevas 
normas? ¿Qué ámbitos o aspectos abarcarían las propuestas de actos de la Comisión?  
 
EU reply:  
As regards the Animal health Law, legal acts in the f orm of Commission Implementing Regulations 
are planned to set out the future model import certificates containing the revised animal health 
import requirements which stem from the Animal Health Law and are contained in the future 
Delegated Regulation refer red to in Question 1 (G/SPS/N/EU/329). Those Implementing Regulations 
will cover live terrestrial animals and germinal products, products of animal origin for human 
consumption and live aquatic animals. Those certificates will contain other relevant import  
requirements too, related to food safety, animal welfare etc. Those Implementing Regulations are 
planned to be adopted in 2020, well before their date of application (21 April 2021). In addition, a 
Commission Implementing Regulation is planned to lay down  the list of the third countries authorized 
from animal health point of view for the entry of various food commodities, live terrestrial animals 
and germinal products, and aquatic animals, respectively. That is planned to be adopted later in 
2020 and will be duly notified to the WTO SPS Committee.  
 
The full phytosanitary system as described in Regulation (EU) 2016/2031 is in place. The main 
implementing act for this is Regulation (EU) 2019/2072, containing the lists of Union quarantine 
pests, protected zone  quarantine pests, RNQPs, prohibitions, import requirements and regulated 
commodities needing a phytosanitary certificate at  import.  
 
Página 131, párrafo 3.221  
"En la UE se ha llevado a cabo una importante armonización de las MSF, y la mayoría de las medidas 
se adoptan a nivel de la Unión. Sin embargo, en aquellos casos en que la UE carece de prescripciones 
armonizadas, los Estados miembros pueden adoptar medidas específicas, facultad que ejercen de 
vez en cuando". Podría indicarnos la Unión Europea:  
 
Preguntas 11:  
¿Para qué tipo de productos o medidas sanitarias y fitosanitarias no existe dicha 
armonización? En el caso de la adopción de medidas específicas por parte de los Estados 
Miembros, ¿qué mecanismo se emplea para vigilar que las mismas se ajuste n a los 
compromisos de la UE en el ámbito multilateral y bilateral?  
 
EU reply:  
As previously stated, SPS measures in the EU are largely harmonised. Nevertheless, in very specific 
cases or for products which are only relevant for one or a very limited numbe r of Member States, 
national rules can be applied. These exceptions are laid down in the related vertical legislation.  
For example, as regards animal health import requirements for live animals, germinal products and 
food of animal origin, national rules a re allowed pursuant to Article 234(3) of the EU Animal Health 
Law. EU  harmonised animal health import requirements have been laid down in the future Delegated 
Regulation referred to in Question 1 (G/SPS/N/EU/329). National rules are for the animals and 
commodities outside the scope of that Regulation. As regards animal by -products, national rules are 
allowed for imports pursuant to the last sentence of Article 41(3) of Regulation (EC) No . 1069/2009 
and pursuant to Annex XIV, Chapter IV, Section 2 of Regulation (EU) No . 142/2011.  
All these national legislations are notified as appropriate.  WT/TPR/M/395/Add.1  
 
- 254 - 
 
  Página 132, párrafo 3.227  
"De conformidad con la legislación aplicable actualmente al comercio de vege tales y productos 
vegetales (Directiva 2000/29/CE), se requiere un certificado fitosanitario expedido por las 
autoridades competentes del país exportador para los vegetales destinados a la plantación, 
determinadas frutas, las hortalizas, las semillas y las  flores cortadas. Tras su entrada en la UE, el 
certificado fitosanitario puede sustituirse por un pasaporte fitosanitario. Las importaciones en la UE 
de la mayor parte de los vegetales y los productos vegetales procedentes de casi todos los países 
no requi eren aprobación ni notificación previa, aunque están sujetas al cumplimiento de normas 
sobre inocuidad alimentaria y procedimientos e inspecciones de aduana. Deben notificarse a las 
autoridades competentes de los Estados miembros las importaciones de ciert os productos 
alimenticios y piensos de origen no animal procedentes de determinados terceros países, que han 
de entrar en la UE a través de los puntos de entrada designados, donde son sometidos a controles 
adicionales. La lista de los productos y países ex portadores se revisa trimestralmente". Podría 
informarnos la Unión Europea:  
 
Pregunta 12:  
¿Las listas revisadas son publicadas y notificadas en el marco de los compromisos en 
materia de notificación de la OMC? ¿Dónde se puede encontrar esta información?  
 
EU reply:  
Commission Implementing Regulation (EU) 2019/1793 established the lists of food and feed of non -
animal origin subject to a temporary increase of official controls and to emergency measures 
governing their entry into the Union. This regulation rep ealed Commission Regulations (EC) 
No. 669/2009, (EU) No . 884/2014, (EU) No . 2015/175, (EU) No 2017/186 and (EU) 2018/1660 and 
consolidated the lists of goods contained therein. The draft "Commission Implementing Regulation 
(EU) on the temporary increase of  official controls and emergency measures governing the entry 
into the union of certain goods from certain third countries implementing Regulations (EU) 2017/625 
and (EC) 178/2002 of the European Parliament and of the Council [...] " was notified under the SPS 
Agreement (G/SPS/N/EU/328). The lists contained in Regulation (EU) 2019/1793 will be reviewed 
biannually. In case an amendment to the lists will be published in the Official Journal of the European 
Union, it will also be notifie d under SPS measures. In addition, third countries concerned by planned 
amendments to those lists are informed thereof on a bilateral basis, before the formal adoption by 
the Commission of the amendments.  
 
Página 132, párrafo 3.229  
"A finales de septiembr e de 2019 se había autorizado la entrada de un OMG para cultivo (cuya 
autorización está actualmente pendiente de renovación) y de 139 para uso como alimentos y 
piensos. Además, estaban pendientes de autorización las solicitudes relativas a dos OMG para cul tivo 
(sin contar la que estaba en proceso de renovación) y a 51 para uso como alimentos y piensos. 
Asimismo, hay seis tipos de flores modificadas genéticamente cuya venta está aprobada en la UE". 
Podría la Unión Europea informarnos:  
 
Pregunta 13:  
¿Existe a lguna base de datos en dónde se pueda encontrar los GMOs aprobados para ser 
comerciados a la Unión Europea?  
 
EU reply:  
The EU GMO register contains the GMOs authorised for food and feed (GMFF) use under 
Regulation  (EC) 1829/2003, as well as GMFF withdrawn from the market. The EU GMO Register is 
accessible online through https://webgate.ec.europa.eu/dyna/gm_register/index_en.cfm. The 
GMOs authorised for deliberate release and placing on the market (e.g. GM carnation cut flowers) 
under Directive 2001/18/EC ar e also listed online at 
https://gmoinfo.jrc.ec.europa.eu/gmc_browse.aspx.  
 
  WT/TPR/M/395/Add.1  
 
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  EL SALVADOR  
• Informe de la Secretaría: WT/TPR/S/395 – página 124, párrafo 3.196.; página 125, párrafo 3.197.; 
página 234, párrafo 4.180.  
• Comunicación del Gobierno: WT/TPR/G/395 – página 11, párrafo 3.20  
 
Preguntas :  
Dada la importancia y la atención que se está d ando al desarrollo de inteligencia artificial (IA) en la 
UE, tanto en el marco de las políticas comerciales sectoriales, así como bajo el Mercado Único Digital, 
y a la luz del Plan Coordinado de Inteligencia Artificial:  
 
1. ¿Se cuenta con datos sobre la in cidencia o impacto de la IA en las innovaciones 
(p.ej.  porcentaje de productos protegidos por PI que reivindican su protección sobre IA, 
niveles de licenciamiento de IA para su uso en productos o servicios innovadores)?  
 
EU reply:  
 
The European Commission does not have reliable data on this at present.  
 
2. En el Plan Coordinado de IA, se plantea la ambición de llevar la visión de una IA ética a 
nivel global y se plantea la cooperación con países no Miembros de la UE que compartan 
la misma visión. ¿Se prevé a corto o mediano plazo, algún tipo de cooperación o asistencia 
técnica a países en desarrollo para promover la creación, desarrollo, uso y adopción de 
inteligencia artificial, ya sea a través de apoyo para la formulación de políticas de fomento 
de la IA o  a través de transferencia de tecnología y/o fortalecimiento de capacidades en 
este ámbito?  
 
EU reply:  
The EU is for the time being planning the international financial cooperation with our partners for 
the next financial period (2021 -2027). In this contex t, there is in principle room for cooperation 
projects on digital transformation.  
 
  WT/TPR/M/395/Add.1  
 
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  GUATEMALA  
Pregunta 1.  
2.2 Formulación y objetivos de la política comercial  
2.14. Una novedad digna de mención relacionada con este primer objetivo es el lugar más destacado 
que han empezado a ocupar en la política comercial de la UE los aspectos de género del comercio 
internacional. Por ejemplo, se han realizado análisis para comprender mejor la incidencia de los 
acuerdos comerciales internacionales en la igualdad e ntre hombres y mujeres. Las posibles 
repercusiones de los acuerdos comerciales en las mujeres se han analizado mediante evaluaciones 
del impacto del comercio en la sostenibilidad, así como en varias evaluaciones ex post de los 
acuerdos comerciales de la UE . 
 
¿Podría la Unión Europea ampliar información sobre las principales conclusiones que se 
han derivado de la aplicación del objetivo relacionado a la incidencia del género dentro de 
los acuerdos de comercio internacional y los resultados obtenidos dentro d e su política 
comercial?  
 
EU reply: Gender equality features high on the political agenda of the EU. In 2019, the European 
Commission presented a report on equality between women and men in the EU that provides an 
overview of the main EU policy and legal developments in gender equality durin g the last year, as 
well as examples of policies and actions in the EU Member States (see: 
https://ec.europa.eu/info/sites/info/files/aid_development_cooperation_fundamental_rights/annua
l_report_ge_2019_en.pdf).  
 
That report contains a specific section on  the actions by the EU for promoting gender equality through 
its trade policies. Trade and Sustainable Chapters continue to be negotiated in all trade agreements 
containing commitments to respect core ILO conventions, including on equal remuneration and 
non-discrimination in the workplace. Furthermore, a Recommendation on trade and gender was 
agreed at the Joint Committee of the Comprehensive Economic and Trade Agreement (CETA) 
between EU and Canada in September 2018. This recommendation launches cooperatio n between 
the EU and Canada on improving the capacity and conditions for women (including workers, 
businesswomen and entrepreneurs) to access and fully benefit from the CETA.  
 
A recent study by the European Commission shows that the EU's exports to the wor ld support 
36 million jobs across Europe, of which more than 13 million are held by women. Trade therefore 
provides substantial potential for empowering women across the EU (see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf).  
 
Furthermore, Sustainability Impact Assessments in support of the negotiations of trade agreements 
with Chile, Australia and New Zealand include a gender impact analysis. This contains an 
assessment, based on the latest methodology available — the UNCTAD Trad e and Gender Toolbox 
– of the impact on women in their roles as workers, entrepreneurs, traders, and consumers. For 
further information, please refer to the following website: https://ec.europa.eu/trade/policy/policy -
making/analysis/policy -evaluation/susta inability -impact -assessments/.  
 
Pregunta 2  
 
3.3.7 Derechos de propiedad intelectual  
3.327. Durante el período objeto de examen, la UE adoptó las siguientes medidas legislativas: i) la 
Directiva sobre los derechos de autor y derechos afines en el mercado único digital; ii) la Directiva 
sobre programas de radio y de televisión; iii) el Regl amento relativo a la portabilidad transfronteriza 
de los servicios de suscripción digital; y iv) una directiva y un reglamento sobre la aplicación del 
Tratado de Marrakech.  
 
¿Podría la Unión Europea ampliar información sobre sus principales estrategias qu e ha 
utilizado para la implementación del Tratado de Marrakech?  
 
EU reply: The Marrakesh Treaty is implemented in EU law through two legislative instruments:  
As regards the EU's internal market, Directive (EU) 2017/1564 introduces an exception to copyrigh t 
and certain related rights that has a cross -border effect within the internal market:  
 WT/TPR/M/395/Add.1  
 
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  • An authorised entity (AE) can make and distribute an accessible format copy for / to a 
 beneficiary person or another AE established in any EU Member State.  
• A benefici ary person or an AE established in one EU Member State may obtain or have 
 access to an accessible format copy from an AE established in any EU Member State.  
 
As regards relations with other parties to the Marrakesh Treaty, Regulation (EU) 2017/1563 provid es 
for a copyright exception that permits the cross -border exchange of accessible format copies of 
certain works and subject matter that are ordinarily protected by copyright and related rights, for 
the benefit of persons who are blind, visually impaired o r otherwise print -disabled. The Regulation 
permits the cross -border exchange of copies made under the exception between the EU and third 
countries that are parties to the Marrakesh Treaty.  
 
Reporte de Gobierno WT/TPR/G/395  
 
3.7 Política agraria común  
3.23 con relación a su propuesta de uti lizar el 40% de la dotación financiera global de la 
PAC para apoyar los objetivos relacionados con el clima.  
 
Q3. ¿se refiere a los programas para los productores biológicos?  
¿cuáles son las características y requisi tos de los productores bio para poder acceder a 
ayuda de la UE en su producción?  
 
EU reply: The proposals for reform of the Common Agricultural Policy provide for 40% of its budget 
be allocated to addressing climate action. This is linked to the higher lev el of climate and 
environment ambition required under the new CAP Strategic Plans to be prepared by Member States, 
in particular through the conditions attached to support (known as "conditionality"), as well as new 
'eco-schemes' as part of direct support for farmers and agri -environment -climate schemes under 
the EU's rural development policy.  
 
The provision that 40% of the future financial envelope be consecrated to climate action, includes 
expenditure on organic farming that a Member States decides to all ocate under rural development 
policy and under eco -schemes as part of direct support, as laid down in article 87 of the proposal 
for a regulation on CAP Strategic Plans.  
 
The CAP post -2020 proposal maintains the possibility for Member States to support or ganic farming 
methods and practices given the role of organic production methods in contributing to environmental 
and climate related objectives. Such support will be possible under the environmental, climate and 
other management commitments under rural de velopment. Member States can grant support for 
both conversion to and maintenance of organic farming methods as defined by the EU rules on 
organic farming. Other rural development measures, such as investments, can also support 
interventions linked to orga nic production.  
 
In the framework of direct payments, the proposal provides that Member States will be obliged to 
set up schemes beneficial for the climate and the environment (eco -schemes), which will be 
voluntary for farmers. Farmers applying organic far ming methods and practices may also benefit 
from the support provided under such schemes. It is up to Member States to propose a tailor -made 
support to organic farming based on their specific conditions, in accordance with the needs 
assessment of the Membe r State.  
 
3.8 Prescripciones sanitarias y fitosanitarias  
 
3.27 la nueva legislación sobre transparencia y sostenibilidad de la determinación o 
evaluación de riesgo en la cadena alimentaria, menciona que asegura una mejor 
transparencia, reforzará la gobernanza y cooperación cient ífica. 
 
Q4. ¿podría la Unión Europea, compartir que tipo de cooperaci ón científica se refiere para 
poder fortalecer la evaluación de riesgo en la cadena alimentaria?  
 
EU reply: The new Transparency Regulation (Regulation (EU) 2019/1381) intends to improve the 
transparency of the EU risk assessment process carried out by the European Food Safety Authority 
(EFSA), strengthen the governance of EFSA and the scientific cooperation. To this end, it mainly 
amends Regu lation (EC) No . 178/2002 [General Food Law Regulation] and – as far as transparency WT/TPR/M/395/Add.1  
 
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  is concerned – eight other sectoral acts, i.e. Regulation (EC) 1829/2003 [GM Food and Feed], 
Regulation (EC) No . 1831/2003 [Feed Additives], Regulation (EC) No . 2065/2003 ( Smoke 
flavourings), Regulation (EC) No . 1935/2004 [Food Contact materials], Regulation (EC) 
No. 1331/2008 [common authorisation procedure for food additives/enzymes/flavourings], 
Regulation (EC) No . 1107/2009, Regulation (EU) 2015/2283 [Novel Foods] and Di rective 
2001/18/EC [GMO cultivation].  
 
As regards the strengthening of the scientific cooperation, Article 28 paragraph 5(e) empowers EFSA 
to:  
 "[…] support the tasks of the Scientific Committee and Scientific Panels by organising their work, in 
particula r the preparatory work to be undertaken by the Authority's staff or by designated national 
scientific organisations referred to in Article 36, including by organising the possibility for preparing 
scientific opinions to be peer -reviewed by the Scientific P anels before they adopt them."  
 
This new provision is expected to strengthen the support provided by EFSA and the Member States 
to the work of the EFSA's Scientific Committee and the Scientific Panels. In particular, EFSA will be 
able to organise the prepa ratory work supporting the tasks of the Scientific Panels, including by 
requesting national scientific organisations networking with the Authority to draft preparatory 
scientific opinions to be peer -reviewed and adopted by those Scientific Panels. This wor k however 
would be without prejudice to the independence of the EFSA's scientific assessments (see also recital 
18 of the new Transparency Regulation).  
 
Moreover, all scientific data, studies and other information supporting any request for a scientific 
output from EFSA (including in the area of authorisation procedures) shall be made publicly available 
proactively, with the exception of duly justified confidential information, early on in the EU risk 
assessment process. Following public disclosure, EFSA w ill be launching public consultations on the 
submitted data, studies and other information to ensure access to the widest evidence -base possible 
before it delivers its scientific output. The general public, stakeholders but also risk assessment 
bodies will  have the opportunity to take part in these public consultations. This action is also 
expected to strengthen scientific cooperation.  
 
3.9 nuevas medidas para una fiscalidad justa  
 
3.30 la Directiva sobre el IVA en referencia al impuesto al comercio electró nico.  
 
Q5. ¿Puede la Unión Europea compartir que porcentaje de las ventas en línea han logrado 
controlar el pago de impuesto? Y que medidas han tenido que implementar para mejorar 
el sistema de recaudación en comercio electrónico.  
 
EU reply: The EU does not have a direct role in controlling tax payments; this is in the remit of EU 
Member States. The VAT collection system falls also within the competence of EU Member States. 
Thus, the Commission does not have the information asked by Guatemala concern ing online sales.  
 
The Commission published aggregated statistics for the VAT collected at EU level via the Mini -One-
Stop-Shop (MOSS) with regards to telecommunications, broadcasting and electronically supplied 
services (TBE services):  
The TBE services are  an important component of online sales, for which the VAT treatment changed 
in 2015. The new VAT rules for concerning online sales of goods will only enter into force in 2021.  
 
3.13 Paquete de "Energía limpia para todos los europeos"  
3.46.C. paquete de va rias propuestas legislativas. "Directiva sobre fuentes de energías 
renovables"  
Varios países han presentado en el Comité de Obstáculos Técnicos al Comercio de la OMC, 
preocupación por esta medida y su enfoque del cambio indirecto del uso de la tierra. La p reocupación 
se enfoca porque no se realiza una diferenciación en la producción entre las regiones y países, 
condenando el aceite de palma a nivel mundial, en comparación con los aceites vegetales producidos 
por la Unión Europea.  
 
Q6. ¿La Unión Europea pue de realizar diferenciación en la producción de aceite de palma, 
conforme las condiciones productivas? ¿cuál es su base científica para establecer los 
límites y el cambio indirecto del uso en la tierra como un daño al medio ambiente? ¿La WT/TPR/M/395/Add.1  
 
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  Unión Europea recon oce el esfuerzo de los productores para establecer una producción 
sostenible?  
 
EU reply: The markets for renewable energy commodities such as palm oil are global, which 
therefore requires a global assessment of ILUC for the purpose of qualifying as renewab le energy 
under the Renewable Energy Directive.  
The recast Renewable Energy Directive recognises measures taken to mitigate the risk of 
displacement effects, and establishes that, even if the feedstock in question generally qualifies as 
high ILUC risk feedstock, specific production can be certified as l ow ILUC -risk if mitigation measures 
are applied, according to the criteria set out in the Commission Delegated Regulation 2019/807.  
 
4 Evolución de la Política Comercial y de Inversión  
4.10 propuesta en el Consejo General  
 
Q7. ¿La Unión Europea puede ofrecer soluciones alternativas en la práctica a las 
preocupaciones comerciales presentadas por una reglamentación en proceso de consulta 
pública, con el objetivo de reducir las preocupaciones comerciales en los Comités 
pertinentes?  
 
EU Reply: The EU has a  very transparent process of public consultation on EU policy initiatives and 
draft legislation, which is also described in paragraph 3.1 of the EU Government report.  
 
El Informe de la Secretaria WT/TPR/S/395,  
 
3.3.2.6 Comité de Obstáculos Técnicos al Comercio de la OMC  
3.210, sobre etiquetado "libre de aceite de palma"  
 
Q8. Agradecemos a la Unión Europea indicar como se realiza el control en el tema de 
etiquetas, para garantizar que no se realice una mal información al consumidor sobre el 
etiquetado. En particular por la situación con la etiqueta de "libre de aceite de palma". 
Comprendemos que el etiquetado no viola el Reglamento Nº 1925 de 2006, relacionado 
con etiquetado de productos alimenticios, sin embargo, existe un espacio en donde el  
reglamento permite que se mal informe o confunda al consumidor, sin existir una base 
científica o técnica que aclare el tema.  
 
Q9. Agradecemos a la Unión Europea pueda aclarar ¿cuál es su línea de acción y reacción 
ante estos casos, en materia de etiquetado?  
 
Q10. ¿Así como aclarar que acciones se pueden seguir para finalizar este tipo de campañas 
que no tienen respaldo técnico, pero si genera un impacto negativo?  
 
EU reply (Questions 8 -10): Regulation (EU) No 1169/2011 on the provision of food information 
to consumers does neither require nor regulate any form of negative labelling, such as "palm oil 
free". The Regulation allows manufacturers to provide information on a voluntary basis such as to 
indicate that a product ingredient has not been u sed in a food product, provided that this is not 
ambiguous, confusing, nor misleading for the consumer.  
The statement "palm oil free" per se/alone is not considered as a nutrition claim according to the 
term's definition in Regulation (EC) No 1924/2006 on nutrition and health claims.  
The EU Member States are responsible to enforce, monitor and verify that the relevant EU food law 
requirements are fulfilled by food business operators. The European Commission's Directorate -
General for Health and Food Safety ( DG SANTE), Directorate F carries out audits, inspections aimed 
at ensuring that EU legislation on food and feed safety is properly implemented and enforced. In this 
context, an audit project for food labelling and nutrition and health claims was performed in eight 
Member States during 2017 -2018.  
The reports are available at: http://ec.europa.eu/food/audits -analysis/audit_reports/index.cfm  
Moreover, the European Commission meets regularly with the Member States' competent authorities 
on food labelling to di scuss food labelling claim issues and ensure harmonised implementation of 
both Regulations. A "Questions and Answers" document on the application of Regulation (EU) 
1169/2011 is regularly updated and is available to help food business operators to comply w ith EU 
labelling requirements.  
 WT/TPR/M/395/Add.1  
 
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  3.2.10 sobre clorotalonil  
El reglamento establece que no se "puede afirmar la presencia de los metabolitos de clorotalonil en 
las aguas subterráneas no va a tener efecto inaceptables en las aguas subterráneas ni efectos 
nocivos para la salud humana.." debido a que no existe certeza en los niveles de metabolitos para 
un daño a la salud.  
 
Q11. ¿existe algún reporte médico y cientifico que pueda analiza el riesgo para los 
consumidores para el clorotalonil?  
 
EU reply: In 2018, EFSA published its Conclusion on the peer review of the pesticide risk assessment 
of the active substance chlorothalonil, which can be found using the following link:  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5126 . 
 
Q12. ¿la Unión Europea puede proporcionar el listado de sustancias alternativas para el 
clorotalonil, para poder proporcionar una solución a los productores, en particular a los 
pequeños productores?  
 
EU reply: Decision to approve or to revoke the authorisation  of active substances and decisions on 
MRLs are taken after a rigorous risk assessment carried out jointly by European Union Member 
States and the European Food Safety Authority (EFSA) with the first and foremost objective to 
protect consumers' health.  
 
The EU risk assessment does not cover alternative substances that could be used to replace 
substances for which the MRL has been brought down to the Level of Quantification.  
 
Please see also replies to questions 14 and 15.  
 
3.3.3.1 vegetales y productos ve getales  
3.225 Actualmente, los vegetales exentos de esta exigencia son la piña, los cocos, los 
duriones, los plátanos y los dátiles.  
 
Q13. ¿podría explicar a qué se debe la exoneración del certificado fitosanitario únicamente 
para la piña, cocos, duriones, plátanos y dátiles?  
 
EU reply: The reasoning to exclude the importation of pineapple, coconut, bananas and dates, 
among other products, from the requirement for the submission of a phytosanitary certificate is 
based on Article 73 of Regulation (E U) 2016/2031. According to that article, an assessment can be 
carried out for a specific commodity, based on evidence about pest risks and experience with trade, 
taking into account the criteria set out in Annex VI of that Regulation. When that assessment 
demonstrates that such a certificate is not necessary, that commodity can be proposed to be 
exempted from the obligation to be accompanied by a phytosanitary certificate.  
 
En los numerales 3.210 y 3.240  menciona las diferentes preocupaciones comerciales qu e los 
países han presentado en los Comités de Obstáculos Técnicos al Comercio y sobre Medidas Sanitarias 
y Fitosanitarias por las reglamentaciones notificadas y aplicadas por la Unión Europea.  
 
En el Comité MSF se ha manifestado nuestra preocupación por las revisiones periódicas y 
modificación de los límites máximos de residuos LMR.  
 
Q14. Agradecemos a la Unión Europea indicar como esta medida no afectará el comercio 
de países tropicales en desa rrollo.  
 
EU reply: Decision to approve or to revoke the authorisation of active substances and decisions on 
MRLs are taken after a rigorous risk assessment carried out jointly by European Union Member 
States and the European Food Safety Authority (EFSA) with the first and fo remost objective to 
protect consumers' health.  
 
The EU regularly notifies its trading partners through the appropriate WTO channels all the planned 
measures related to plant protection products' active substances and MRLs. Information and 
comments receive d in response to these notifications are duly considered and taken into account 
before a final decision is taken.  WT/TPR/M/395/Add.1  
 
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  The EU would like to remind that following the formal adoption, publication and entry into force of 
an act lowering MRLs, a deferred date of application is set. The length of the deferral is usually a 
maximum of 6 months after entry into force, in the vast majority of cases.  This deferral of the 
application date allows third countries and food business operators to make the necessary 
arrangemen ts to meet the new requirements. Products produced in the EU or imported into the EU 
before the aforementioned application date may continue to benefit from the old/higher MRLs and 
remain on the market, if information shows that a high level of consumer pr otection is maintained. 
This is not the case where MRLs are lowered because the safety of consumers could not be 
demonstrated.  
Similar procedures to what described above apply when a decision to withdraw (or amend) the 
approval of a substance is taken. If and when the EU takes a decision of non -renewal (or restricted 
renewal), and following formal adoption, publication and entry into force, a period of time is given 
to EU Member States to withdraw authorisations from the market. In addition, the EU would li ke to 
underline that non -renewal measures provide for a grace period for placing on the market and use 
of plant protection products, during which there is no disruption of trade as there is no modification 
of existing MRLs. The grace period is taken into a ccount when proposing changes to existing MRLs.  
Recent concrete cases show that 2 years elapse between the first notification under the WTO/TBT 
system and the application of a measure lowering MRLs to the limit of determination.  
The EU is very attentive t o developing countries' concerns and several technical assistance programs 
have been put in place to help trading partners' to face import requirements that might affects the 
trade of specific agricultural commodities.  
 
Q15. ¿Qué soluciones brinda a los pa íses con clima tropical, en donde las sustancias 
activas son efectivas para el combate de plagas que son propias del país por su humedad, 
suelo y clima, en particular por el cambio climático?  
 
EU reply: When the existing EU -MRL is not sufficient to cover t he residues from the use of a plant 
protection products authorised in an exporting country, an interested party can still provide the 
necessary data and follow the procedure for setting an 'import tolerance'. This procedure is laid 
down in Regulation (EC) No 396/2005 and includes an evaluation of the submitted data by EFSA. An 
import tolerance may be granted by the EU under the condition that there is no health risk for 
consumers and that the requested MRL is not higher than the one established in the third  country.  
 
Por otro lado, el Codex Alimentarius establece normas armonizadas que permite a los países en 
desarrollo trabajar con estándares internacionales y la armonización de estándares a nivel mundial  
 
Q16. ¿Siendo el CODEX un órgano especializado, nos gustaría saber a qué obedece que la 
Unión Europea se aparte de los niveles establecidos por este órgano y establezca límites 
más estrictos que los acordados por el CODEX, como es el caso del IMAZALIL, y que és tos 
no sean fundamentados científicamente?  
 
EU reply: The EU and its Member States actively participate in the work of the "three sisters" (OIE, 
IPPC and Codex Alimentarius). Regulation (EC) No . 178/2002 on General Food Law (hereinafter, the 
"General Food Law") stipulates that relevant international standards need to be taken into account 
in the legislation making process. This is also reflected in other EU secondary food legislation, where 
specific reference to international standards in the development of  food law is made. The relevant 
provisions of the EU legislation are in fact generally based on the standards, guidelines and 
recommendations of these international standard setting bodies.  
 
It is to be noted that decisions to approve or to revoke the auth orisation of active substances and 
decisions on MRLs are taken after a rigorous risk assessment carried out jointly by European Union 
member states and the European Food Safety Authority (EFSA) with the first and foremost objective 
to protect consumers' he alth.  
 
The lowering of the MRLs for imazalil was necessary to protect European consumers, as an 
assessment of imazalil carried out by EFSA in 2017 identified consumer health concerns. Subsequent 
assessments of MRLs for imazalil did not lead to more favour able results.  
The EU further considered that for none of the good agricultural practices for which information was 
available to EFSA, it was demonstrated that an MRL could be established that would be sufficiently 
protective for consumers. In this regard, EFSA also included the current Codex MRL of 2 mg/kg in 
its assessment. For all good agricultural practices evaluated in the MRL review, a possible acute risk 
for at least one group of European consumers could not be excluded, as the calculated short -term WT/TPR/M/395/Add.1  
 
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  exposure exceeded the Acute Reference Dose (157% ARfD for EU uses, 184% for the use underlying 
the current Codex MRL of 2 mg/kg).  
The EU considered that it had not been demonstrated that residues of imazalil following application 
in accordance with the eval uated good agricultural practices were safe for EU consumers. As 
information on alternative practices was not available to EFSA, the EU therefore proposed to lower 
the MRL to the limit of analytical determination.  
Guatemala is invited to submit an applicat ion for an import tolerance.  
 
Q17. ¿Agradecemos a la Unión Europea indique que porcentaje de su reglamentación 
utilizan como base el CODEX?  
 
EU reply: The EU policy is to systematically align its MRLs with Codex MRLs if they are acceptable 
to the EU with r espect to areas such as consumer protection, supporting data and extrapolations. 
Between 2012 and 2019, a total of 2567 CXLs for food commodities were adopted by Codex. In that 
period, the EU has taken on board 1833 MRLs out of these 2567 CXLs. Taking into  account EU -MRLs 
that are set at the same or higher level than the CXLs for the same food products, the EU is aligned 
with more than 70% of the CXLs established in this period.  
 
Q18. ¿La Unión Europea puede informar y compartir sus estudios y testimonios c ientíficos 
para catalogar el pesticida Imazalil como carcinógeno?   
 
EU reply: The classiﬁcation of imazalil has been proposed in the pesticides peer review by EU 
Member States and the European Food Safety Authority. The proposal has been evaluated by the 
European Chemicals Agency (ECHA), following submission of a classification dossier by Germany. 
The current harmonised classiﬁcation and labelling in the EU of the active substance now includes 
Carcinogenicity Cat. 2 (H351, Suspected of causing cancer).  
 
EFSA Conclusion on the pesticides peer review of imazalil:  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2010.1526 . 
 
ECHA's substance information for Imazalil:  
https://echa.europa.eu/fr/substance -information/ -/substanceinfo/100.047.817 . 
 
Opinion of ECHA's Committee for Risk Assessment:  
https://echa.europa.eu/documents/10162/479698f6 -7224-e19e-4f6a-d44fcd2ee860 . 
 
Q19. ¿Existen estudios médicos que demuestren el po tencial carcinógeno del imazalil?  
Podría favor indicarlos y compartirlos.  
 
EU reply: Please refer to the answer to question 18.  
 
Q20. Agradecemos a la Unión Europea pueda proporcionar el listado de las próximas 
sustancias que serán revisadas en el año 2020 en adelante, para revisar sus niveles 
máximos de residuos y su renovación en la Unión Europea.  
 
EU reply:  
For reviews of maximum r esidue levels:  
The on -going review process of EU -MRLs is carried out on basis of a provision foreseen in the EU 
legislation (Article 12 of Commission Regulation (EC) No 396/2005). During this so -called "Article 
12 revision", on -going since 2012, most exist ing maximum residue levels are reviewed to assess the 
consumers' safety. In order to explain this review process more in detail, the EU prepared a specific 
note that was also submitted to all WTO members in June 2016 (G/SPS/GEN/1494). The note 
includes the  list of substances, which were meant to be reviewed in the following two years' time 
and the "rapporteur member state" designated for each substance. The EU highly recommends 
non-EU countries authorities and stakeholders to check this note regularly, in o rder to know in 
advance for which substances the EU -MRLs are going to be revised in the near future.  
The note can be found on the EU website at:  
http://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl -review_en.pdf.  
 
Furthermor e, EFSA publishes on its website the updated list of the substances, which will be subject 
to the reviewing process. This list is updated on a quarterly basis and can be found at 
http://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -report.pdf . WT/TPR/M/395/Add.1  
 
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  For renewals of approvals of active substances:  
The expiry dates of all active substances approved in the EU can be consulted in the EU Pesticides 
database. The advanced search function provides a filter i.a. for defined expiry dates:  
https://ec.europa.eu/food/plant/pesticides/eu -pesticides -
database/public/?event=activesubstance.selection&language=EN . 
 
An application for renewal of approval must be submitted three years before the expiry of the 
approval period. The supporting dossier mu st be submitted 30 months before expiry of the approval.  
 
Asimismo, dentro de los Comités de MSF y OTC Guatemala y otros países han solicitado la necesidad 
de tener periodos de transición más amplios, requiriendo un período mínimo de 24 meses después 
de la entrada en vigor de la medida, a efecto de otorgar a los productores un tiempo prudencial para 
ajustarse y a adecuar estos cambios a los ciclos productivos, cada producto agrícola maneja 
diferentes tiempos y períodos de cosecha. Adicionalmente, se debe de  buscar períodos alternativos 
que no es posible tenerlo en 6 meses.  
 
Q21. ¿Por qué la Unión Europea no puede otorgar el plazo de 24 meses requerido por los 
países en desarrollo, si lo que se busca también es no afectar el comercio?  
 
EU reply: The EU regularly notifies its trading partners of all the planned measures related to  active 
substances and MRLs. Information and comments received in response to these notifications are 
duly considered and taken into account before a final decision is taken. Detailed replies are sent to 
all trading partners that submit comments.  
 
Followin g the formal adoption, publication and entry into force of an act lowering MRLs, a deferred 
date of application is set. The date of application is the date from which the new/lower MRLs are 
effectively enforced. The length of the deferral is 6 months after  entry into force, in the vast majority 
of cases. This deferral of the application date allows third countries and food business operators to 
make the necessary arrangements to meet the new requirements. Products produced in the EU or 
imported into the EU before the aforementioned application date may continue to benefit from the 
old/higher MRLs and remain on the market, if information shows that a high level of consumer 
protection is maintained. This is regularly not the case where MRLs are lowered because  the safety 
of consumers could not be demonstrated.  
 
Measures deleting MRLs are often also the consequence of the non -renewal of active substance 
approvals in the EU. Regulations non -renewing approval are notified under the WTO/TBT notification 
system and should be understood as early warnings that MRL changes are possible. This is clearly 
mentioned in the notifications under the TBT.  
 
Similar procedures to those described above apply when a decision to withdraw (or amend) the 
approval of a substance is tak en. If and when the EU takes a decision of non -renewal (or restricted 
renewal), and following formal adoption, publication and entry into force, a period of time is given 
to EU Member States to withdraw authorisations from the market. In addition, the EU w ould like to 
underline that non -renewal measures provide for a grace period for placing on the market and use 
of plant protection products, during which there is no disruption of trade as there is no modification 
of existing MRLs. The grace period is taken  into account when proposing changes to existing MRLs. 
Recent concrete cases show that 2 years elapse between the first notification under the WTO/TBT 
system and the application of a measure lowering MRLs to the limit of determination.  
 
Q22. ¿Cuál es la ba se para no otorgar un período de transición real para el comercio, 
cuando no está fundamentando en un análisis de riesgo?  
 
EU reply: All EU measures related to plant protection products and the establishment of MRLs are 
based on a risk analysis. Please al so refer to the answer to question 21.  
 
Q23. ¿Cuál es la solución que la Unión Europea brinda a los países tropicales, para lidiar 
con los efectos del cambio climático y es por ello el uso de ciertas sustancias para 
contrarrestar las excesivas lluvias o se quías extremas?  
 
EU reply: Please refer to the answers to questions 14, 15.  
 WT/TPR/M/395/Add.1  
 
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  Q24. La Política de la Unión Europea identifica los criterios de disruptores endocrinos, 
basándose en el peligro, sin una base científica. En ese sentido, solicitamos a la UE aclare 
las opciones que están considerando para no obstaculizar el comercio y las exp ortaciones 
agrícolas.  
 
EU reply: The European Union is aware of the potential trade and agricultural impacts the identified 
criteria might have. Those potential impacts were analysed in the impact assessment report that 
was published on 15 June 201644.  
The criteria ensure a high level of protection of human health and the environment, are based on 
science, and are proportionate. Furthermore, the criteria are based on the internationally agreed 
WHO definition of endocrine disruptors (EDs) which is widely su pported by governments, scientists 
and stakeholders. They identify only EDs (neither suspected EDs, nor endocrine active substances).  
 
Q25. La Unión Europea podría compartir información sobre el proceso interno de análisis 
y discusión interna, entre los Es tados Miembros e instituciones de la Comisión Europea, 
con relación a las preocupaciones comerciales presentadas por los países en el Comité de 
Medidas Sanitarias y Fitosanitarias, y el de Obstáculos Técnicos al Comercio.  
 
EU reply: The European Union and  its Member States are members of the WTO SPS and TBT 
Committee. The European Union speaks on behalf of the EU Member States at the WTO Committee 
meetings. In preparation of the SPS Committee meetings, the European Commission services discuss 
internally an d conduct preparatory meetings with the Member States in order to form the EU position 
on all the points of the agenda, including STCs. After each WTO SPS meeting, a similar process 
applies to discuss and analyse the outcome.  
 
  
 
44 http://ec .europa.eu/health/endocrine_disruptors/impact_assessment_en . WT/TPR/M/395/Add.1  
 
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  HONDURAS  
Informe de la Secretaria  
 
3.3.2.5 Sistema de alerta rápida para los productos peligrosos no alimentarios (RAPEX)  
 
Parrafo 3.207  ¿Podría la UE informarnos, bajo que formato, en qué fecha y con qué países 
fuera de la UE, han firmado acuerdos de cooperación para intercambi o de información 
sobre el sistema de alerta rápida para productos peligrosos?  
 
Question 1  
EU reply:   
The EU is currently exchanging selected information from the EU's Rapid Alert System (RAPEX) with 
China (as regards dangerous products of Chinese origin) and with Canada. In addition, the possibility 
to exchange information on market surveillance and enforcement activities is mentioned in the 
Economic Partnership Agreement with Japan (entered into force in 1 February 2019), and in the Free 
Trade Agr eements with Singapore and Viet  Nam (signed in October 2018 and June 2019, 
respectively).  
 
3.3.3 Requisitos sanitarios y fitosanitarios.  
 
Párrafo 3.222. ¿Podrían la UE proporcionarnos estadísticas sobre las medidas sanitarias 
en proyecto y/o vigentes, que se han fundamentado en las normas del Codex 
Alimentarius?  
 
Question 2  
EU reply:   
The EU fully supports the activities of relevant interna tional standard setting bodies, notably the 
OIE/CODEX/IPPC, and works assiduously with the three sisters to help reaching a comprehensive 
framework of standards at an international level. EU public, animal and plant health measures are 
generally based on t hose relevant international standards.  
In accordance with article 13 of Regulation (EC) 178/2002, the EU contributes to the development 
of international technical standards for food and feed and sanitary and phytosanitary standards and 
promotes consistenc y between international technical standards and food law while ensuring that 
the high level of protection adopted in the Community is not reduced.  
Pursuant to Article 5(3) of Regulation (EC) 178/2002, where international standards exist or their 
completion  is imminent, they are to be taken into consideration in the development or adaptation of 
food law, except where such standards or relevant parts would be an ineffective or inappropriate 
means for the fulfilment of the legitimate objectives of food law or where there is a scientific 
justification, or where they would result in a different level of protection from the one determined 
as appropriate in the Community.  
Moreover, Regulation (EC) 396/2005 stipulates that MRLs set at international level by the Code x 
Alimentarius Commission should be considered when EU MRLs are being set, taking into account 
corresponding good agricultural practice. When deciding on the setting, modification, or deletion of 
a MRL, the European Commission is bound to take into account  existing CXLs.  
For instance, between 2012 and 2019, a total of 2567 CXLs for food commodities were adopted by 
Codex. In that period, the EU has taken on board 1833 MRLs out of these 2567 CXLs. Taking into 
account EU -MRLs that are set at the same or highe r level than the CXLs for the same food products, 
the EU is aligned with more than 70% of the CXLs established in this period.  
Article 12 of Regulation (EC) No 396/2005 provides for a review of the existing MRLs of all approved 
and certain non -approved pes ticides. This review process has been on -going since 2008. An overview 
of progress in the MRL review is available on the EFSA website  
(http://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -report.pdf ) and 
regularly updated. Notably, this allows interested parties to anticipate the future launch of an MRL 
review of a given substance and prepare the contribution of in formation, e.g. on relevant 
authorizations in non -EU countries, into the process.  
 
Párrafo 3.240. ¿A que aspira la UE, sobre la labor del Codex Alimentarius de servir como 
organismo internacional de referencia para el establecimiento de Límites Máximos de 
Residuos (LMR)?  
 WT/TPR/M/395/Add.1  
 
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  Question 3  
EU reply:   
The EU fully supports the activities of the international standard setting bodies, notably the 
OIE/CODEX/IPPC, and works assiduously in the three sisters to help reach the objective of providing 
a comprehensive framew ork of standards at an international level. EU measures on maximum 
residue levels (MRLs) are regularly and systematically aligned with Codex MRLs (CXLs), provided 
that these CXLs are higher than existing EU MRLs, are related to commodities for which the EU  sets 
MRLs, and are acceptable in terms of consumer protection, supporting data and extrapolation rules. 
This is systematically assessed by the European Food safety Authority (EFSA). In accordance with 
Article 3.3 of the SPS Agreement, the EU can deviate f rom international standards based on EFSA's 
scientific advice when EFSA raises concerns for consumer protection. Any measures that are taken 
on the basis of EFSA's risk assessments, are not more trade restrictive than necessary and are 
applied in a non -discriminatory manner both to intra -EU trade as well as to imports from third 
countries.  
 
In practice, before each meeting of the relevant Codex Committee (Codex Committee on Pesticides 
Residues - CCPR) EFSA carries out a systematic assessment of the draft pr oposed JMPR CXLs and 
delivers an opinion that will form the basis of the EU common position. If no concerns are identified 
by EFSA, the CXLs are systematically taken over in the EU legislation. If the EU has concerns, it 
makes a reservation at the CCPR mee ting, thus transparently informing the other delegations at an 
early stage that the MRL will not be taken over.  
 
  WT/TPR/M/395/Add.1  
 
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  HONG KONG, CHINA  
PART I: QUESTIONS REGARDING THE Secretariat Report  
 
Trade Policies and Practices by Measures  
 
Anti-dumping and anti-subsidy measures  
(WT/TPR/S/395 pages 78 -83, paras 3.76 -3.88) 
 
The EU basic antidumping and anti -subsidy regulations were amended by two new regulations. The 
first set of changes introduced in 2017 allows for the normal value to be determined by altern ative 
methods where there are state -induced distortions in the exporting country. The amendments made 
by the second regulation adopted in 2018 form part of a comprehensive modernization of EU trade 
remedy legislation. For example, in calculating the non -injurious price, a minimum profit of 6% is 
included. Another new development is the ability to take into account the presumably higher costs 
of EU industry compliance with social and environmental standards.  
 
Questions : 
1. In calculating the "non -injurious pri ce", under what circumstances would a higher 
profit margin be adopted?  
 
EU Reply:  
The target profit of 6% is a floor profit level. Thus, the target profit is a profit established taking into 
account various factors such as, the level of profitability before the increase of imports from the 
country under investigation, the level of profitability needed to cover full costs and investments, 
research and development and innovation, and the level of profitability expected under normal 
conditio ns of competition. If the target profit so established is higher than 6%, the higher percentage 
will be used as the target profit. Otherwise, the target profit will be set at 6%.  
 
2. Please provide information on how the EU would take into account the social and 
environmental considerations in application of trade defence measures.  
 
EU Reply:  
The European Union will take account of social and environmental standards in the application of the 
trade defence instruments in the following ways:  
 
• In the context of selecting a representative country, when establishing normal value under the 
alternative dumping calculation methodology, from a group of several potentially suitable countries, 
an assessment of the level of social and environmental protection in the co untries under 
consideration may be used in the decision.  
 
• Injury margins will reflect the cost of social and environmental standards within the European 
Union. The cost of production also includes costs that EU producers incur when complying with 
multil ateral environmental agreements and with important International Labour Organisation 
conventions. It means that actual costs incurred by EU manufacturers as well as future cost increases 
during the lifetime of TDI measures resulting from compliance with th ese standards will be taken 
into account, in calculating a non -injurious price.  
 
Trade Policies by Sector  
 
Financial Services  
(WT/TPR/S/395, page 222, para 4.222)  
 
As one of the three pillars of the Banking Union, it was proposed that a European Deposit Insurance 
Scheme (EDIS) be established to protect covered deposits up to EUR 100,000 against the 
consequences of insolvency of a credit institution. The legislative proposal envisages the 
establishment of an EDIS in three successive stages: a reins urance scheme for participating national 
Deposit Guarantee Schemes (DGSs) for a first period of three years, a co -insurance scheme for 
participating national DGSs for a second period of four years, and full insurance for participating 
national DGSs in the final stage.  
 WT/TPR/M/395/Add.1  
 
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  Question:  
3. What is the timetable for the establishment of EDIS? What are the major differences 
of the proposed EDIS compared to the existing measures on deposit protection?  
 
EU reply:  
On 24 November 2015, the European Commission proposed a Regulation to Establish a European 
Deposit Insurance Scheme (EDIS). The proposal is intended to help establish a common deposit 
insurance system in the Banking Union, to supplement existing common supervision and bank 
resolution frameworks. The contents of the EDIS proposal are well summarised in the question put 
to the Commission by Hong Kong.  
On 11 October 2017, the Commission suggested new ideas to introduce EDIS more gradually 
commensurate to progress achieved with regard to risk reduction an d the tackling of legacy issues, 
starting with a more limited re -insurance phase and moving gradually to co -insurance. The timetable 
for the establishment of EDIS depends on further progress in these negotiations. The new European 
Commission, which began i ts mandate of 1 December 2019, remains committed to EDIS.  
In the absence of a common deposit insurance scheme, the protection of depositors in the EU is 
regulated by the Deposit Protection Scheme Directive of 2014 providing for partial harmonisation at 
national level. For example, covered deposits in the EU are protected up to EUR 100,000. The 
Directive provides for Member States to ensure by 3 July 2024 that the available financial means of 
a DGS shall reach a minimum target level of 0.8% of the amount of covered deposits of its members. 
A legislative review of this directive is ongoing.  
 
Construction Services  
(WT/TPR/S/395, pages 228 -233, paras 4.255 -4.265)  
 
The EU construction sector is an important contributor to the economy and a creator of jobs. 
Accor ding to the report, the administrative costs of construction services formalities imposed on 
providers establishing or providing services across internal market borders ranged from EUR 35 
million to EUR 1.2 billion. The construction sector is also noted as  the least -digitized sector in Europe.  
 
Question:  
4. A Directive and Regulation on a Services E -card was proposed to reduce 
administrative obstacles and simplify formalities through a fully -electronic 
harmonized procedure, but its legislative process was put on hold since 2018. What 
have hindered the legislative process? How would the EU follow up on the Services 
E-card initiative? What is the timetable?  
 
EU reply:   
The European Parliament was unable to reach a majority on its report regarding the Service E -Card 
initiative, effectively putting the initiative on hold until further notice.  
 
The Service E -Card initiative is not part of the 'unfinished business' of the 8th legislature that the 
European Parliament has decided to pursue in the 9th legisla ture. 
 
No timetable has been proposed as regard the Service E -Card Initiative.  
 
E-commerce  
(WT/TPR/S/395, pages 237 -238, paras 4.281 -4.285)  
 
Reform of VAT rules is an important dimension of the Digital Single Market (DSM) Strategy. Among 
the changes, the new VAT rules adopted in December 2017 that will become applicable in January 
2021 will subject distance sales of goods imported from third countries/territories to VAT in the 
Member State of the consumer and abolish the VAT exemption for low value consign ments.  
 
Question:  
5. What are the current VAT rules and VAT exemption for low value consignments 
applicable to distance sales of goods imported from third countries/territories? How 
do non -EU suppliers comply with the VAT payment requirement under the new rules?  
 
EU Reply:  
Presently, the import of low value goods not exceeding 10 -22 EUR (depending on Member States) 
is exempt from VAT upon importation. Goods exceeding 10 -22 EUR are subject to VAT but no WT/TPR/M/395/Add.1  
 
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  customs duties are due. Goods exceeding 150 EUR are subject to customs duti es and VAT. To note 
that goods subject to excise duties (mainly alcohol, tobacco or oil products) do not benefit from 
either VAT or customs duty reliefs upon importation in the EU.  
From 1 January 2021, the 10 -22 EUR VAT exemption on importation of low val ue goods is abolished. 
Thus all goods imported in the EU, irrespective of their value, will be subject to VAT. The customs 
duty relief of 150 EUR remains in place.  
For the collection of VAT of goods not exceeding 150 EUR, there are two special collection models 
next to the normal rules provided in the EU VAT Directive, both of them being optional for economic 
operators:  
 
- The vendor registers electronically for VAT in one EU Member State in the so -called Import 
One Stop Shop (IOSS). This IOSS registration i s valid for distance sales of imported goods 
made to customers in the entire EU. With this registration, the vendor will be liable to collect 
the VAT from the customer in the EU at the moment the payment for the goods is made. 
The vendor reports and pays t he VAT collected on a monthly basis to the tax authority of 
the EU Member State of IOSS registration. Upon registration for the IOSS, the vendor 
receives an IOSS number. After checking that this IOSS number is valid, the customs 
authorities will exempt the  importation of the goods when they arrive at the EU border (to 
avoid double taxation);  
- Special arrangements for payment of VAT intended for postal and courier operators in the 
EU that declare the goods to customs if the IOSS is not used for those goods. T he postal or 
courier operator that brings the goods in the EU and declares them for release in free 
circulation will need to collect the VAT from the customer, but will only pay it to the customs 
authorities monthly.  
 
The new VAT rules introduce also increased VAT liabilities on the electronic interfaces (such as 
marketplaces, platforms, etc.) that facilitate the distance sales of imported goods to customers in 
the EU. In this respect, if a distance sale is carried out via such an electronic interface, it is the 
electronic interface that is deemed to be the seller of the goods and can therefore use the IOSS. For 
such distance sales of imported goods, the actual vendor (the underlying supplier) cannot use the 
IOSS.  
 
(WT/ TPR/S/395, page 238, para 4.286)  
 
The Commission proposed in 2018 a legislative package to request payment service providers 
established in Europe to transmit VAT -relevant payment data to tax authorities. The proposal will 
require payment service providers  such as banks, companies responsible for card payments and e -
money institutions to provide tax authorities with information on the beneficiary of cross -border 
payments.  
 
Question:  
6. What is the latest status of the proposed legislation? What types of data w ill be 
collected and transmitted to tax authorities?  
 
EU Reply:  
The Commission legislative proposal is in its final phase of adoption by the Council and should be 
published soon.  
 
The data that will be collected concern the beneficiary of cross -border pay ments ("the payee") 
originating from EU Member States. Only data on payees receiving more than 25 cross -border 
payments per quarter will be transmitted to tax authorities.  
 
The full list of data transmitted is laid down in article 243d of the Council comp romise text to amend 
Directive (EU) 2006/112 and includes:  
 
− The Business Identification Code (BIC) of the payment service provider providing the data;  
− The name or business name of the payee;  
− Any VAT identification number or tax number if available to the payment service provider;  
− The IBAN or any identifier which unambiguously identifies the payee and his location;  
− The BIC or any business identifier code that unambiguously identifies the payment service 
provider acting on behalf of the payee and its location, when the payee receives funds 
without any payment account;  WT/TPR/M/395/Add.1  
 
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  − The address of the payee if available;  
− The date and time of the payment or payment refund;  
− The amount and the currency of the payment or payment refund;  
− The reference of the payment;  
− Information that the payment is initiated at the physical premises of the merchant;  
− The Member State of origin of the payment or the Member State of destination o f the refund.  
 
Telecommunication Services  
(WT/TPR/S/395, pages 242 -248, paras 4.304 -4.326)  
 
The EU adopted a new European Electronic Communications Code (recast) (EECC) in December 
2018. Among others, it promotes connectivity and access to very high capaci ty networks. To achieve 
the objective, the EECC creates incentives for private investment in such networks by providing for 
more flexible regulation in certain areas, such as exempting certain providers from access and 
interconnection obligations.  
 
Questi on: 
7. Would any of these flexibilities have an adverse impact on users' security? Apart from 
providing for regulatory flexibility, are there other measures to attract private 
investment?  
 
EU reply:   
In relation to users' security, the Code does not change the current obligations imposed on electronic 
communications providers to ensure adequate network security (Art 40). For example, Member 
States shall ensure that providers of public electronic communications networks or of publicly 
available electro nic communications services take appropriate and proportionate technical and 
organisational measures to appropriately manage the risks posed to the security of networks and 
services. The flexibility that you mention in your question does not therefore impl y less security, but 
is only referring to the flexibility of economic regulation on certain operators.  
 
Regarding your second question, as you mention, the Code includes some measures to attract 
private investment through more flexible regulation, such as by (i) promoting co -investments in 
certain areas, (ii) giving priority to access to physical infrastructure as a remedy to foster 
competition, (iii) the provision for wholesale -only operators, etc.  
 
Beyond economic regulation, the Code includes other meas ures that foster investment, such as the 
minimum duration of spectrum rights (at least 15 years while ensuring predictability for 20 years), 
coordinated assignment of 5G bands, consistency and certainty as regards the deployment of small 
cells, etc.  
 
  WT/TPR/M/395/Add.1  
 
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  ICELAND  
The European Union played an important role in the adoption and implementation of the Buenos 
Aires Declaration of Trade and Women 's Economic Empowerment adopted at the MC11. As is 
mentioned in chapters 4.3.4 of the report (WT/TPR/G/395) EU trade ag reements contain 
commitments on the implementation of fundamental ILO conventions targeting non -discrimination 
in employment and the EU has recently introduced specific provisions on trade and gender equality 
in the trade negotiations.  
 
The report of the secretariat (WT/TPR/S/395) mentions that gender issues have begun to figure 
more prominently in EU trade policy, including analysis on how to improve the understanding of the 
impact of international trade agreements on gender equality. It mentions  inter al ia a study on the 
gender balance of the employment opportunities supported by extra -EU exports.  
 
Iceland would like to ask the European Union the following questions:  
 
1. What is the participation of women in the economy of the European Union, and 
particu larly in external trade?   
 
EU reply:  
A recent study "From Europe to the World: Understanding Challenges for European Businesswomen " 
found that women are largely under -represented in extra -EU trade in the agricultural and 
manufacturing sectors. Only one in five exporting companies in the EU is led (i.e. owned and/or 
managed) by a woman. In almost half of companies surveyed, women account for 30% or less of 
the total workforce. For further information, please see: 
http://www.intracen.org/publication/Europe -to-world/ . 
Furthermore, another recent study by the European Commission "Female Participation in EU 
exporting activities: jobs and wages " shows that the EU 's exports to the world support 36  million 
jobs across Europe, of which more than 13.5 million are women. The share of women in jobs related 
to exports has remained constant at 38% in the time period analysed. The female share of export -
supported jobs is smaller than the share of women in t otal employment of the EU economy, which 
stands at 46%. For further information, please see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf . 
 
2. Have particular barriers that limit women 's participation in trade been identified, an d 
if so how have they been addressed?   
 
EU reply:  
A recent study "From Europe to the World: Understanding Challenges for European Businesswomen " 
(see reply to question 1 above) found that both women and men -led companies  report scarcity in 
legal, marketing /communication, IT/digital, and language skills, but women -led companies are more 
likely to be negatively affected. Women -led companies are also less likely to identify commercial 
banks as the most important source of funding, with significant disparity co mpared to men -led 
companies. Both skills and finance -related challenges impact women more, irrespective of size.  
For further information, please see: http://www.intracen.org/publication/Europe -to-world/ . 
 
3. Are there any best practices that the EU can sh are with the WTO membership as regards 
women 's economic empowerment and trade?  
 
For example, are there particular lessons to be drawn from the EUs experience so far of 
analysis to improve the understanding of the impact of international trade agreements on 
gender equality.  
 
EU reply:  
The EU assesses gender impacts of its trade agreem ents. For example, Sustainability Impact 
Assessments in support of the negotiations of trade agreements with Chile, Australia and New 
Zealand includes a gender impact analysis. This contains an assessment, based on the latest 
methodology available — the UN CTAD Trade and Gender Toolbox – of the impact on women in their 
roles as workers, entrepreneurs, traders, and consumers. For further information, please refer to 
the following website: https://ec.europa.eu/trade/policy/policy -making/analysis/policy -
evaluat ion/sustainability -impact -assessments/ . WT/TPR/M/395/Add.1  
 
- 272 - 
 
  A recent study "From Europe to the World: Understanding Challenges for European Businesswomen " 
(please also see reply to question 1 above) is based on the first -of-its kind survey on women and 
trade. The survey looke d at the linkages between gender, company characteristics and international 
trade, across firms in manufacturing and agriculture exporting outside the EU. For further 
information, please see: http://www.intracen.org/publication/Europe -to-world/ . 
Furthermor e, another recent study by the European Commission "Female Participation in EU 
exporting activities: jobs and wages " (please also see reply to question 1 above) sheds new insights 
on the gender -balance of the employment opportunities supported by extra -EU exports.  
For further information, please see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf . 
 
4. What has been the experience of the EU in negotiating specific trade and gender 
chapters in trade agreements?   
 
EU reply:  
The EU is negotiating specific provisions on trade and gender equality in the context of the 
modernisation exercise on EU Chile Association Agreement. Such provisions will help acquiring a 
better understanding of the constrains and opportunities faced by women in  trade, as well as sharing 
best practices aimed at facilitating women 's participation in international trade and benefitting from 
it. For further detail, please see the EU proposal: 
https://trade.ec.europa.eu/doclib/docs/2018/june/tradoc_156962.pdf . 
Negoti ations with Chile are ongoing, for more information please see: 
https://trade.ec.europa.eu/doclib/docs/2019/december/tradoc_158512.pdf . 
 
  WT/TPR/M/395/Add.1  
 
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  INDIA  
Secretariat  Report ( WT/TPR/S/395)  
 
Page 93, Paragraph –3.121  
Background  
The EU has several provisions on export credit, insurance or guarantee instruments but does not 
have any all -encompassing legislation, except on short -term official export -credit support, i.e. with 
a repayment time of up to two years. The various instruments that impose rules in this area  are 
outlined in Table 3.12. Regulation (EU) No. 1233/2011 provides certain guidelines in the field of 
officially -supported export credits for EU member States. It basically has two functions: it legally 
incorporates the Arrangement on Officially Supported  Export Credits (the Arrangement) of the OECD 
into EU law, and it provides for annual reporting of export -credit activities to the Commission in 
order to increase transparency.  
 
Questions 1:  
 
a) What are the relevant EU regulations on short -term official exp ort-credit support? 
On what lending terms, short term export credit support, with repayment time of up to 
2 years, is granted by commercial banks or other financial institutions?  
 
EU reply:  
The Commission laid down the principles for State intervention i n the area of short -term 
export -credit insurance in the Communication from the Commission to the Member States on the 
application of Articles 107 and 108 of the Treaty on the Functioning of the European Union to 
short-term export -credit insurance (OJ C 392 , 19.12.2012, p. 1 –7). When insuring temporarily 
non-marketable short -term export -credit risks, public or publicly supported insurers (usually Export 
Credit Agencies) must adhere to the rules set out in the Communication for the insurance of such 
risks. Th ose rules concern quality of cover, underwriting principles, adequate pricing and 
transparency and reporting.  
 
b) What is the extent of such short -term official export credit support and whether 
such short -term export credit support can be treated as subsidy  under Article 1 of ASCM? 
If so, how such short term concessional credit is covered under clause (k) "the safe haven 
clause" of Annex I of ASCM?  
 
EU reply:  
Short -term export -credit insurance covers commercial and political risks connected with the 
export --credit transactions. The Communication on short -term export -credit insurance only applies 
to export -credit transactions with a risk period of less than two years. That risk period includes the 
manufacturing period plus the period given to the buyer  to pay for the delivered goods and services.  
 
ASCM illustratively lists provision of insurance by governments as subsidy. When insuring 
temporarily non -marketable short -term export -credit risks, public or publicly supported insurers 
must apply safe -harbo ur premiums. To minimise the crowding out of private credit insurers, average 
premiums under publicly supported schemes must be higher than the average premiums charged 
by private credit insurers for similar risks.  
 
Page – 97, Table –3.132  
Background  
The EM FF helps fishermen in the transition towards sustainable fishing; supports coastal 
communities in diversifying their economies; finances projects that create new jobs and improve 
quality of life along European coasts; supports sustainable aquaculture devel opments; and makes it 
easier for applicants to access financing. It is used to co -finance projects, along with national 
funding. Each member State is allocated a share of the total EMFF budget, based on the size of its 
fishing industry. Once the Commission  approves this fund, it is up to the national authorities to select 
the operations eligible for funding. The national authorities and the Commission are jointly 
responsible for the implementation of the fund.  
 
Question 2: The EU has stated that the EMFF he lps fishermen in the transition towards 
sustainable fishing; supports coastal communities in diversifying their economies etc. WT/TPR/M/395/Add.1  
 
- 274 - 
 
  Please provide the details of EMFF in terms of annual support to the fishermen, the 
eligibility criteria and the purpose for whic h the support has been provided?  
 
EU reply:   
All details about the EMFF can be found at: https://ec.europa.eu/fisheries/cfp/emff_en . 
 
Page – 191-192, Paragraph 4.107 & Table 4.12  
Background  
(Para. 4.107) The EU has demonstrated its fishing effort management, which is an essential part of 
ensuring sustainable fishing, one of the main objectives of the CFP. Fleet capacity continued to 
decline, in number, capacity and power; the number of vessels decreased from some 84,000 in 2015 
to 82,000 in 2017.  
 
(Table 4.12) The Member States are required to adjust their fishing capacities to bring them into 
line with fishing opportunities.  
 
Question 3 :  
a) The fishing fleet capacity of EU has been shown as 82000 in 2017. Could the EU 
provide details of the fishing v essels in terms of size of the vessels, engine capacity and 
gross tonnage?  
 
EU reply:   
All information is available at https://op.europa.eu/en/publication -detail/ -/publication/ca63ab82 -
c3bf-11e9-9d01-01aa75ed71a1 . 
 
b) In Table 4.12 against the column Fishing effort, it has been stated that member 
States are required to adjust their fishing capacity to bring them into line with fishing 
opportunities. Could the EU share information as regards the fishing capacity of EU vessels 
and information about the f ishing opportunities?  
 
EU reply:  
Total allowable catches (TACs) or fishing opportunities, are catch limits (expressed in tonnes or 
numbers) that are set for most commercial fish stocks. The Commission prepares the proposals, 
based on scientific advice on t he stock status from scientific advisory bodies such as the International 
Council for the Exploration of the Sea and the Scientific, Technical and Economic Committee for 
Fisheries. Some multi -annual plans contain rules for the setting of the TACs. TACs are  set annually 
for most stocks (every two years for deep -sea stocks) by the Council of fisheries ministers. For 
stocks that are shared and jointly managed with non -EU countries, the TACs are agreed with those 
(groups of) non -EU countries.  
 
c) What is the perce ntage of fishermen who can be categorised as subsistence 
fisheries, artisanal fisheries and small -scale fisheries under the EU Regulations?  
 
EU reply:  
75% of vessels are small -scale coastal fisheries, employing 51% of the workforce.  
 
Page – 196, Paragraph  – 4.116  
Background  
In exchange for access rights to the Exclusive Economic Zone (EEZ), the EU provides these partners 
with a financial contribution for sectoral support for, inter alia , small -scale fisheries, science and 
research, institutional capacities , and reinforcement of monitoring and control capacities. SFPAs 
contribute to fighting and eradicating IUU by providing these partners with various tools such as 
capacity building and monitoring and control of surveillance actions by the Vessel Monitoring System 
(VMS).  
 
Question 4:  
a) It has been mentioned that in exchange for access rights to the EEZ, the EU provides 
these partners with a financial contribution for sectoral support. Could the EU provide full 
details of the sectoral support for each SFPA in f orce with the quantum of financial 
contribution made say in the latest financial year for which figures are available.  
 WT/TPR/M/395/Add.1  
 
- 275 - 
 
  EU reply:  
All figures available at https://ec.europa.eu/fisheries/cfp/international/agreements_en.  
 
b) Whether this financial contribution  is to be considered as a subsidy as per Article  1 
of ASCM? Further, what is the total allowable catch under each of the SFPA in force? Who 
reports such catches and where are these reported?  
 
EU reply:  
Government to government agreements are not subsidies as per Article 1 of ASCM. For straddling 
stocks and highly migratory species, the EU and its partners follow the recommendations of relevant 
RFMOs or RFBs and relevant scientific advice for each agreement, also respecting the principle of 
access to surplus, as per Article 62 of UNCLOS. The EU reports the catches to the partner country 
and the partner country reports them to RFMOs and RFBs as appropriate.  
 
Page -197-198, Paragraph - 4.119  
Background  
In addition to the EMFF, the member States may provide state aid to the fisheries and aquaculture 
sector, pursuant to the guidelines on state aid ... Moreover, tax exemptions from indirect taxes 
(e.g. excise duties) for energy products used for water navigation (including fishing) in the territorial 
waters of EU member States are granted in accordance with Article 14(1)(c) of the Council Directive 
2003/96/EC. For example, fuel tax exemption for inland fisheries and commercial marine fishing in 
Estonia was notified to the WTO during the review period.  
 
Question 5:  
a) In addition to the EMFF, member States may provide state aid to the fisheries and 
aquaculture sector, pursuant to the guidelines on state aid. Could the EU give full details 
of state aid provided to fishers by each member State?  
 
EU reply:  
Detailed information can be found via the following link: 
https://webgate.ec.europa.eu/comp/redisstat/databrowser/view/COMP_MARE_SA_X$COMP_MARE
_SA_01/default/table?category=COMP_FISH.  
 
b) Whether this state aid to the fishers is notified to the WTO under the Sub sidies 
agreement and if so, details of the notification may be provided.  
 
EU reply:  
State aid is notified to the WTO by EU Members States individually in the form of addendum to the 
EU notification G/SCM/N/343/EU.  
 
c) In what form is fuel tax exemption for c ommercial marine fishing vessels provided 
by each EU member State and what is the total value of such fuel tax exemption for the 
year 2018? Can EU mention the criteria and documentation requirement to avail such fuel 
tax exemption?  
 
EU reply:  
The European  Commission does not keep separate data on the amount of support provided under 
fuel tax exemptions. Further information regarding fuel tax exemptions could be extracted from the 
text of the decisions concerning such measures. https://ec.europa.eu/competit ion/elojade/isef/.  
 
See also Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework 
for the taxation of energy products and electricity, Article 14 and 15 via https://eur -
lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:320 03L0096&from=EN#d1e332 -51-1. 
 
Page – 219, Paragraph – 4.212  
 
Background  
Following the financial crisis, the EU developed rules designed to create a safer financial sector for 
the Single Market that apply to all financial actors in the EU -28. These rules, collectively known as 
the Single Rulebook, include, in particular, strong er prudential requirements for banks, improved 
protection for depositors, and rules for managing failed banks. The key legal acts that constitute the WT/TPR/M/395/Add.1  
 
- 276 - 
 
  Single Rulebook are the Capital Requirements Regulation and Capital Requirements Directive IV; the 
amended  Directive on Deposit Guarantee Schemes; and the Bank Recovery and Resolution Directive.  
 
Question 6:  
The EU is requested to inform whether rules for financial sector are same for both 
domestic service suppliers and foreign service suppliers or discrimina tory. If 
discriminatory, the EU is requested to provide the details of such discrimination.  
 
EU reply:  
The Capital Requirements Regulation and Capital Requirements Directive (CRR/CRD), as well as 
Investment Firms Regulation (IFR) and the Investment Firms  Directive (IFD) (which are applicable 
as of June 2021) set out the prudential framework applicable to, respectively, credit institutions and 
investment firms established in the EU. This includes subsidiaries of non -EU undertakings established 
in the EU, r egardless of the country of establishment of their parent. Such rules are therefore the 
same for domestic service suppliers and foreign service suppliers, insofar as they fall within the 
scope of application of CRR/CRD, and they are not discriminatory.  
 
Page – 221, Paragraph – 4.218  
Background  
The Banking Union is an essential complement to the Economic and Monetary Union (EMU) and the 
internal market, which aligns responsibility for supervision, resolution and a single resolution fund 
at EU level. It oblig es banks across the euro area to abide by the same rules. While the Single 
Rulebook applies to all EU countries, the Banking Union applies to countries in the euro area. 
EU non-euro area countries can also join.  
 
Question 7: The EU is requested to inform about conditions, if any, on joining Single 
Rulebook by non -euro area countries.  
 
EU reply:   
EU Member States which are not part of the euro -zone can join the Banking Union by entering into 
a close cooperation agr eement with the European Central Bank (ECB). These countries may notify 
the ECB of their intention to join the Single Supervisory Mechanism (SSM) by establishing close 
cooperation with their competent authorities. They will have to take all necessary measu res to 
ensure that their national competent authorities abide by and implement the relevant EU legislation 
and ECB acts.  
 
Where all the conditions for establishing close cooperation are met, the ECB has to take a decision 
to establish it. This would allow  the non -euro area country to join the Single Resolution Mechanism 
(SRM) and to take part in deliberations of the SSM supervisory board, gaining access to all 
information available within the SSM.  
 
More details on the specific conditions, as defined in th e SSM Regulation and in the ECB Decision 
on close cooperation (ECB/2014/5), can be found at: 
https://www.bankingsupervision.europa.eu/press/publications/newsletter/2018/html/ssm.nl18111
4_1.en.html.  
 
Page – 232, Paragraph – 4.263  
Background  
The EU construct ion sector is an important contributor to the economy and a creator of jobs; it also 
plays an important role in sustainability, quality of life, and climate change. However, it faces a 
number of challenges and structural issues. Some of these include, the shortfall of skilled workers, 
the sharp decline as a result of the financial crisis, the productivity and resource efficiency of the 
sector, and the capacity for innovation.  
 
Question 8: Considering the shortfall of skilled workers, could the EU please inform if there 
is any plan to ease entry of foreign (non -EU) workers) in the construction services in the 
EU?  
 
EU reply:   
The EU continues to improve admission channels for ski lled and qualified professionals and their 
families. Of particular relevance to trade policy is the introduction of an EU -wide scheme (covering 
25 EU Member States) for the admission of intra -corporate transferees, either as specialists, WT/TPR/M/395/Add.1  
 
- 277 - 
 
  managers or traine es, as well as their families. These rules were adopted in 2014 and implemented 
in subsequent years.  
 
Page – 227, Paragraph – 4.4.1.2.3.5  
Background  
Other measures pertaining to the CMu . 
 
Question 9:  The EU is requested to provide details of applicable reg ulations for 
cryptocurrencies and fintech companies operating in EU area.  
 
EU reply:  
Presently, the EU financial services regulatory framework does not cover pure cryptocurrencies 
(e.g. Bitcoin). However, the broader category of crypto -assets can exhibit  many different features 
and as such only a case -by-case approach can determine whether a specific crypto -assets would fall 
under the existing EU financial services regulatory framework. Additionally, the recently adopted 
Directive (EU) 2018/843 (the 5th Anti-Money Laundering Directive) introduces into law a definition 
of virtual currencies (covering e.g. Bitcoin), and by extension includes providers of virtual currency 
to fiat currency exchange services as well as custody services for virtual currencies. F inally, the 
European Commission is currently consulting stakeholders on crypto -assets with a view to potentially 
proposing legislation that would bring all crypto -assets within the scope of the EU financial services 
regulatory framework.  
 
Fintech cannot be  defined as any one specific type of company or business model. In general, the 
EU financial services regulation has been found to accommodate most innovative business models 
that fintech has enabled, but the European Commission is continuously considering  the regulatory 
perimeters.  
 
Page – 233, Paragraph – 4.265  
Background  
The EU construction industry has been working towards further digitization and promoting the digital 
transformation of the construction sector through its Construction 4.0 initiative, in order to utilize 
more efficient processes and eliminate errors and delays. As such, it aims to make the construction 
sector a priority sector in the Digitising European Industry initiative.  
 
Question 10: Could the EU please inform about stat us and its plan for implementation of 
3D printing in construction services in the EU?   
 
EU reply:  
Currently, there is no specific EU construction legislation or policy directly affecting 3D printing. It is 
most likely one of the aspects to be considered i n the future revision of the EU CPR (Construction 
Products Regulation).  
 
Page – 248, Paragraph – 4.327  
Background  
The European Commission's communication on the DSM Strategy stressed the importance of the 
694-790 MHz ("700 MHz") frequency band for ensuring  the provision of broadband services in rural 
areas, and announced that the Commission would make specific proposals for the coordinated 
release of the 700 MHz band, while accommodating the specific needs of audio -visual media 
distribution. A Decision on t his subject of the European Parliament and of the Council, dated 
17 May 2017, requires member States to allow the use of the 700 MHz frequency band for wireless 
broadband electronic communications services by June 2020, subject to the possibility of a dela y of 
up to two years for certain justified reasons. The availability of this band in 2020 for broadband 
wireless services is seen as a critical step in the deployment of 5G.  
 
Question 11: Could the EU please inform about the status and 5G trial and its adoption in 
the EU area?   
 
EU reply:   
The implementation of 5G for vertical industries will mostly rely on the availability of 3GPP release 
16 and 17 at product level, which is not yet the case. The EU is however preparing extensively for 
5G deployment in verticals, with more than 180 trials taking place in a multiplicity of domains. The 
most trialled verticals are media and entertainment (35 trials), followed by transport (30 trials) and WT/TPR/M/395/Add.1  
 
- 278 - 
 
  automotive (22 trials). Trials are the most numerous in Spain, German y, France and Italy. 39% of 
trials are in these top -4 countries.  
 
The release of the 700 MHz band in the EU is progressing. So far, six EU Member States have 
assigned the 700 MHz band. Three Member States have announced justified delays of full assignment 
by mid -2022. Most remaining Member States are in the process of planning or proceeding with the 
authorisation of the 700 MHz band. The Commission is closely monitoring the implementation by 
Member States of the binding deadline of mid -2020 for allowing use  of this band. More information 
on the status of assignments for the 700 MHz and other 5G pioneer bands for the EU can be found 
in the 5G observatory, see http://5gobservatory.eu/.  
 
Page – 249, Paragraph – 4.4.5.1  
Background  
Online platforms  
 
Question 12: The EU is requested to inform about how abuse of dominance power is taken 
care of w.r.t. online platforms and it ensures competition in the online space.  
 
EU reply:   
The EU case enforcement record over the years demonstrates that EU competition law is sound and 
sufficiently flexible for protecting competition in the digital era. In the past few years, the 
Commission enforced the competition rules in the digital sector with regard to:  
a) New leveraging strategies (i.e. better positioning and display) [Googl e Shopping, 2017];  
b) Pre-installation through e.g. tying [Google Android, 2018];  
c) Exclusivity requirements (including on placement) [Google Android 2018; Google AdSense 
 2019]  
d) Concerns about collusion on business models [E -books, 2012 and 2013],  
e) Standard -essential patents [Motorola, 2014, and Samsung, 2014],  
f) Most-favoured -nation clauses, not only with regard to price MFNs, but also with regard to 
 business model MFNs [Amazon E -books, 2017],  
g) Restrictions on using brand names and trademarks for the purposes of  online search 
 advertising [Guess, 2018]; and  
h) Consumer electronics case, involving algorithms, 2018.  
 
Within this generally fit for purpose framework, the Commission has been scrutinizing the 
effectiveness of its tools throughout the past years to provide higher legal certainty by means of 
clear rules that reflect today's business realities, including the impact of digitalisation. For instance, 
the Commission – like other enforcers elsewhere – is actively reflecting on the challenges of 
digitisation  for competition policy and on how to make fuller use of existing tools to ensure that we 
can preserve or restore effective competition. As part of this process, the Commission has conducted 
a consultation with stakeholders among others resulting in an ind ependent report on "Competition 
policy for the digital era". It is available at:  
https://ec.europa.eu/competition/publications/reports/kd0419345enn.pdf.  
 
Page – 176, Paragraph – 4.5 
Background  
In para 4.5, it is mentioned that stocks of skimmed milk powder  had accumulated over the years 
and the same was put in the market through a tendering process. As per its latest notification, 
G/AG/N/EU/55, for the year 2016 -17, the EU provided market price support for skimmed milk 
powder, however what constitutes eligi ble production i.e. total production or quantity procured, is 
not mentioned in the notification.  
 
Question 13: With regards to the market price support to skimmed milk powder -  
1. The EU is requested to shed more light on the process of putting the intervent ion 
stocks skimmed milk powder on the market  
 
EU reply:  
Details on sales of skimmed milk powder from EU intervention stocks were provided to WTO 
members in the Regular Committee on Agriculture (see AGIMS ID 92006) in relation to a question 
asked by the US . Additional information is available on the Milk Market Observatory via the following 
links:  WT/TPR/M/395/Add.1  
 
- 279 - 
 
  https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf.  
https://ec.europa.eu/info/sites/info /files/food -farming -fisheries/farming/documents/eu -dairy-
historical -stocks -series.pdf  
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -dairy-
commodity -prices_en.pdf  
Intervention stocks of skimmed milk powder were sold back to the market through a tendering 
process, opened by Regulation (EU) No 2016/2080, and which ran from December 2016 to June 
2019 (see: https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:02016R2080 -
20190222&qid=1580494098870)  
 
2. What were  the prices at which the stocks of skimmed milk powder were procured 
and the subsequently sold?  
 
EU reply:  
During the tender period between December 2016 and June 2019, the minimum selling prices 
accepted in the tenders for SMP ranged between EUR  1,050 an d EUR  2,051 per tonne. The sale of 
intervention stocks by the Commission is governed by Regulation (EU) No 1308/2013, which sets 
the framework for the cautious approach adopted by the Commission when disposing of SMP 
intervention stocks. Sales did not take  place until the market had recovered. The prices at which the 
SMP in public intervention was sold in 2018 and 2019 were in line with market reality, taking into 
account the ageing of the product and therefore its relative loss of commercial value (not the  intrinsic 
quality of the product).  
 
3. The EU is requested to clarify how it has calculated the eligible production.  
 
EU reply:  
Intervention buying -in is opened every year from 1 March to 30 September, for a maximum of 
109,000 tonnes at the pre-established reference price of EUR  1,698 per tonne. Due to the dairy 
market situation in 2016 -2017, this ceiling was removed. The intervention stocks totalled 380,000 
tonnes for the full intervention period (2015 -17). 
 
4. The EU is also requested to provi de the value of production of skimmed milk 
powder.  
 
EU reply:  
Such a figure is not available as Eurostat does not hold data on the value of production for SMP. The 
value of production of milk was EUR  48,992.9 million in the EU's 2016/2017 DS:1 notificatio n 
(G/AG/N/EU/55).  
 
Page – 169, Paragraph – 4.33- 4.37 
Background  
The Voluntary Coupled Support is a Blue Box programme that covers 21 sectors and regions and 
payments under the programme is made on fixed areas and yields and on number of livestock basis.  
 
Question 14: With regards to the Voluntary Coupled Scheme (VCS), the EU is requested:  
1. To provide the rationale to shift from Article 68 payments in the previous iteration 
of CAP, to VCS in the current CAP.  
 
EU reply:  
Support under Article 68 allowed the  granting of support for 9 different objectives (e.g. improving 
the quality/marketing of an agricultural product; enhanced animal welfare standards; 
agri-environmental support; compensation for disadvantages in economically vulnerable or 
environmentally se nsitive areas in the dairy, beef and veal, sheep meat and goatmeat, or rice 
sectors; contribution to insurance premiums; etc). Some of these payments were coupled, others 
decoupled, with certain (limited) possibilities for cross -financing.  
VCS aimed to st reamline and simplify coupled support. It allows the Member States to use a limited 
share of their national ceiling for direct payments for the purpose of coupled support, provided that 
the targeted sector is important from an economic, environmental, or s ocial point of view, and 
undergoes certain difficulties. This streamlined the support scheme and maintained a degree of 
flexibility. Member States can tailor their support decisions to local circumstances and needs.  WT/TPR/M/395/Add.1  
 
- 280 - 
 
  VCS remains an optional feature of direct payments. If applied, it is subject to various strict 
conditions (closed list of sectors, importance, difficulty) and limits (budgetary limit at Member State 
level). Furthermore, coupled support shall meet the prod uction limiting criterion (based upon a fixed 
area and yields or on a fixed number of animals for each VCS measure). These criteria make VCS 
Blue Box compatible.  
 
2. In response to India's question, the EU in the 92nd meeting of the Committee on 
Agriculture expressed its intention to move away from Blue Box support in the next CAP 
reform. Could EU explain the rationale for this move, especially on the issue of 
"red-tapism" . 
 
EU reply:  
The EU aims to minimise administr ative burden for farmers and EU Member State administrations. 
Applying Blue Box criteria for Coupled Income Support, due to the high level of administrative burden 
and restrictions it involves was not considered justified, especially in the light of propos als in the 
Committee on Agriculture in Special Session to treat the Blue Box the same as the Amber Box in 
terms of caps.  
 
3. Does the EU plan to replace the VCS with any other Blue Box support? If no, how 
will the present support under the Blue Box be notifie d in the future and how and what 
will be the mechanism of support that will be given to producers in place of the VCS.  
 
EU reply:  
The CAP reform proposal does not include any other Blue Box programme to replace VCS. The 
current cotton and bananas Blue Box  programmes will continue. The proposal is to replace VCS with 
Coupled Income Support (CIS), which could be notified as Amber Box. Similar to VCS, CIS would 
remain optional for the Member States, and its use would remain subject to strict conditions and 
limits. As a new element, CIS would aim to address the targeted sector's difficulty with the aim to 
improve its competitiveness, quality, or sustainability. At the moment, the proposal is still under 
discussion by the legislators. It is too early to tell if and how CIS will be implemented. It is not the 
aim of the new policy to increase production, but certain growth may be possible (e.g. through an 
improvement in competitiveness). It would thus be notified to the WTO under Amber Box. However, 
nothing would p revent Member States from implementing their coupled support in a way that 
respects the Blue Box requirements.  
 
Page – 170, Paragraph – Table 4.5  
Background  
The EU has initiated the voluntary coupled support, which is a Blue box programme under Article  6.5. 
Under this Article, the payments have to be made for 'production -limiting' programmes and must be 
based on sub -conditions laid therein. The Omnibus Regulation amended the VCS, making changes 
to the production limiting requirements as erstwhile mandated u nder Article 52 of the CAP 2013 
Regulation.  
 
Question 15:  In the EU, "over half of the total agricultural output value came from four 
producers, namely France, Italy, Spain and Germany". Germany and France together 
contribute 29% of the total EU agricultural output but have no mechanism for reduction 
of payments,  as opposed to other Members. How does the VCS (as amended by the 
Omnibus Regulation) then ensure that the 'production -limiting' condition of Article 6.5 is 
respected and VCS does not serve as a means to increase production?  
 
EU reply:  
As stated in the E U's DS:2 notification G/AG/N/EU/35, EU Member States may only grant VCS in 
clearly defined cases where specific types of farming or specific agricultural sectors that are 
particularly important for economic and/or social and/or environmental reasons underg o certain 
difficulties in terms of risk of decline or of abandonment of production. Payments shall be granted 
to the extent necessary to create an incentive to maintain current levels of production. VCS takes 
the form of an annual payment granted within de fined quantitative limits and based on fixed areas 
and yields or on a fixed number of animals. It shall also respect financial ceilings at measure level. 
Moreover, the support is also subject to further strict conditions (e.g. closed list of potentially el igible 
sectors, the importance and the difficulty of the sector) and limits (budgetary limit at Member State 
level) in order to minimalize its effects on the markets.  
 WT/TPR/M/395/Add.1  
 
- 281 - 
 
  The changes introduced by the 2017 "Omnibus" Regulation have not changed the criteria of  the 
scheme. They were further clarified, including a specific mentioning of the "production limiting " 
character in accordance with the WTO criteria with retrospective effect from 2015. All Member States 
that (voluntarily) decide to use VCS have to respect  these criteria, whether or not the Member State 
concerned applies a reduction of payments.  
 
The reduction of payments is an entirely separate issue which aims to fulfil a different policy 
objective, namely fairer and more effective use of direct payments  in general. For those farms whose 
annual basic decoupled payments (the Basic Payment Scheme, or the Single Area Payment Scheme) 
would exceed a certain monetary threshold, a pro -rata reduction shall be applied on the excess 
amount. Though this is in princi ple an obligatory feature of direct payments in all Member States, a 
derogation allows to replace reduction of payments: using at least 5% of the national ceiling for 
direct payments for the purpose of (the otherwise optional) redistributive payments.  
 
The four Member States mentioned in the question represent a substantial share in the 
EU's agricultural output value, which this is fully proportional to their share in the EU's population 
(257 million citizens, i.e. 50% of the total EU28 population in 201 8). Germany and France use a 
derogation, but this does not preclude the application of the conditions and limits of VCS, in case a 
Member State decides to grant coupled support. Indeed, Germany decided not to grant VCS.  
 
 
Page – 144, Paragraph – 3.319  
Back ground:  
In a world of increasingly knowledge -based economies, in which companies heavily rely on 
innovation and creativity, as well as quality, the adequate protection and enforcement of intellectual 
property rights (IPRs) continue to play a key role for E U business to maintain its competitiveness. 
The economic importance of IPRs, both in terms of employment and contribution to GDP, was 
confirmed by a joint report by the European Patent Office (EPO) and the European Union Intellectual 
Property Office (EUIPO ), released in September 2019.  385 An overview of its main findings is 
provided in Table 3.30. It shows that an important share of total GDP, amounting to 44.8% on 
average during the period 2014 -16, was generated by IPR -intensive industries. The 
trademark -intensive industry made by far the biggest contribution both to employment and the EU's 
GDP, followed by the design and patent -intensive industries.  
 
Question 16:  What was the methodology used in determining the contribution of IPR 
intensive indu stries?  
If pharmaceutical is categorized as a n IP intensive industry, will the direct employment 
in the pharmaceutical industry as a whole be categorized as employment in IPR intensive 
industry?  
 
EU reply:  
In order to determine which industries are IPR -intensive, the register databases of the EUIPO, EPO 
and Community Plants Varieties Office (CPVO) were matched with the firm level data. Using this 
database, the number of trade marks, designs, patents and CPVRs (Community plant variety rights) 
per employee was calculated for each industry, and the industries which were above average 
according to this measure were considered to be IPR -intensive (for details see Section 3.4 
Methodology and data in the Report: https://euipo.europa.eu/tunnel -
web/secure/webdav/gu est/document_library/observatory/documents/IPContributionStudy/IPR -
intensive_industries_and_economicin_EU/WEB_IPR_intensive_Report_2019.pdf). According to this 
measure, the pharmaceutical industry is classified as IPR intensive.  
 
When it comes to the calcu lation of the IPR intensive industry to the whole economy, direct 
employment in the whole industry is taken into account.  
 
Page – 146, Paragraph – 3.327 -3.328  
Background:  
In the period under review, the EU adopted the following legislative measures: (i) the Directive on 
copyright in the Digital Single Market; (ii) the Directive on television and radio programmes; (iii) the 
Regulation on cross -border portability of online subscriptions; and (iv) a Directive and a Regulation 
on the implementat ion of the Marrakesh Treaty. Member States are due to implement the first two 
Directives by June 2021. The deadline for them to transpose the Directive implementing the 
Marrakesh Treaty into national law was 11 October 2018.  WT/TPR/M/395/Add.1  
 
- 282 - 
 
  The Directive on copyright in t he Digital Single Market is designed to further harmonize copyright 
and related rights in the EU, in particular with regard to digital and cross -border uses of protected 
content. It lays down exceptions and limitations to copyright and related rights to al low, with 
appropriate safeguards, text and data mining, in particular for scientific purposes, and to facilitate 
digital and cross -border teaching activities, and the preservation and dissemination of European 
cultural heritage.  
 
Question 17:   
Has there be en any legislative measure attempted or implemented by EU granting any IP 
rights to "data"? if yes, kindly provide details. Has there been any judicial precedent or 
judgement on IP rights to data collected by Govt, companies or any other organizations? 
If yes, kindly provide details.  
 
EU reply:   
EU law does not grant IP rights on data as such. Directive 96/9/EC provides that certain databases 
may be protected by copyright and/or a sui generis right, provided that they fulfil the conditions laid 
down in the Directive. But such protection does not c over the data included in the databases.  
 
Page – 147, Paragraph – 3.330  
Background  
Importantly, the Directive introduces new measures to achieve a well -functioning marketplace for 
copyright. In that context, it protects the rights of publishers of press p ublications regarding the 
online use of their publications by information society service providers (as opposed to 
non-commercial uses of them by individual users, hyper linking, and use of individual words or very 
short extracts).  
 
Question 18:  
Under Art icle 15 of Copyright Directive, the publishers are given right over the press 
publication regarding the online use of their publications by information society service 
providers. Although acts of hyper linking, use of individual words or very short extract s 
have been treated as exceptions, has there been any deliberation or attempt to define 
"very short extracts"?  
 
EU reply:   
Recital 57 of Directive (EU) 2019/790 specifies that "The rights granted to publishers of press 
publications should not extend to acts of hyperlinking". Recital 58 of Directive (EU) 2019/790 
provides guidance on the meaning of "use of individual words or very short extracts" by recalling 
that "The use of press publications by information society service providers can consist of the u se of 
entire publications or articles but also of parts of press publications.  Such uses of parts of press 
publications have also gained economic relevance. At the same time, the use of individual words or 
very short extracts of press publications by infor mation society service providers may not undermine 
the investments made by publishers of press publications in the production of content. Therefore, it 
is appropriate to provide that the use of individual words or very short extracts of press publications 
should not fall within the scope of the rights provided for in this Directive. Taking into account the 
massive aggregation and use of press publications by information society service providers, it is 
important that the exclusion of very short extracts be interpreted in such a way as not to affect the 
effectiveness of the rights provided for in this Directive."  
 
Page – 148, Paragraph – 3.338  
Background  
With 166,585 new patent applications in 2017, the EPO was among the top five offices that 
accounted for a combined share of 84.5% of global patent applications. While China saw the fastest 
growth (+14.2%), the increase in filings at the EPO (+4.5%) exceeded those in other patent offices, 
such as the United States (+0.2%) and Japan (+0.03%). In 2018, the EPO gr anted 127,580 patents, 
and received 173,958 applications. Most patent applications were in the fields of medical technology, 
digital communications, and computer technology. Applications granted by the EPO result in a bundle 
of national patents.  
 
Question 20: kindly provide a detailed breakup of patents that have been filed in EU in 
the field of Artificial Intelligence (AI) machine learning. What are the major trends 
emerging in patent filing in AI?  
 WT/TPR/M/395/Add.1  
 
- 283 - 
 
  EU reply:   
A recent report of WIPO (WIPO Technology Tren ds 2019. Artificial Intelligence) outlines trends in AI 
patenting both in the EU and beyond. See:  
https://www.wipo.int/edocs/pubdocs/en/wipo_pub_1055.pdf . 
 
For recent trends in patent applications related to the so -called 4th  industrial revolution, including 
artificial intelligence, reference is made to the  study "Patents and the Fourth Industrial Revolution " 
published by the EPO, which is available at: https://www.epo.org/news -issues/issues/ict/fourth -
industrial -revolution.html . 
 
Page – 152, Paragraph – 3.352 - 3.356  
 
Question 21: Post the review period European Union Trade Mark (EUTM) regime went 
through major overhauling. What additional measures are mandated to curb the menace 
of counterfeiting goods distributed through online trading platforms?   
 
EU reply:  
 On 29 November 2017, the Commission adopted a comprehensive package of  measures to further 
improve the application and enforcement of IPRs within the EU Member States, at our borders and 
internationally [COM(2017) 707 final]. The actions set out in this package include the stepping up 
of EU -wide voluntary industry -led initia tives to prevent and combat IP infringements.  
 
The main ongoing industry -led initiative is the Memorandum of Understanding on the sale of 
counterfeit goods via the Internet (MoU), for which the Commission acts as facilitator. This MoU 
helps build cooperati on between the signatories – rights holders of products for which counterfeit 
versions are often sold online, internet platforms and business associations – and contributes to the 
prevention of counterfeit goods being sold online. The November 2017 package  includes a positive 
evaluation of the functioning of the MoU.  
 
The MoU complements the initiatives in the Commission Communication on Tackling illegal content 
online: towards enhanced responsibility of online platforms adopted on 28 September 2017 [COM 
(2017) 555 final] and the Commission Recommendation on measures to effectively tackle illegal 
content online, adopted on 1 March 2018 [C(2018) 1177 final], which intend to increase the 
(proactive) prevention, detection and removal of all illegal content in t he online environment, 
including the infringements of IPR.  
 
Page – 147, Paragraph – 3.331  
 
Question 22:  
Under Article 17 of Copyright Directive, the online service providers such as YouTube, 
Twitter, etc have been held responsible for the sharing by users  of copyright -protected 
materials with the public, and are obliged to seek relevant authorizations from 
right -holders. These authorizations then also cover non -commercial users. Considering 
the magnitude of online content posted by the users on a daily bas is, such obligation is 
onerous. Does Article 17 seek greater responsibility on part of the online service providers 
than provided under Notice and take down measure?  
 
EU reply:  
According to Article 17, EU Member States are required to provide that online content -sharing 
services covered by the new rules perform an act of communication or making available to the 
public, for which they need to obtain an authorisation from the right holders concerned. Article 17 
provides that where an authorisation is obtained, for instance, by concluding a licence agreement, 
it shall also cover the acts carried out by users of the services, under certain conditions. In situations 
where no authorisation is granted, the online content sharing service provider will need t o take 
certain actions in order to avoid liability for unauthorised uses of content. In particular, where they 
meet the conditions in Article 17(4), they will not be liable. The conditions are: (i) demonstrating 
best efforts to obtain an authorisation, (ii ) demonstrating best efforts to ensure the unavailability of 
unauthorised content regarding which right holders have provided necessary and relevant 
information and (iii) acting expeditiously to remove any notified works following a notice received 
and mak ing also their best efforts to prevent future uploads. Article 17 also provides for a number 
of safeguards for users, through mandatory exceptions and a complaint and redress mechanism in 
case of disputes on the removal of content uploaded by users.  WT/TPR/M/395/Add.1  
 
- 284 - 
 
  Questi on 23:  
How are enforcement agencies tracking the effective enforcement of Article 17? Whether 
enforcement agencies have named specific technologies (standard technologies) to 
ensure that no copyright -infringing material is uploaded by the users. Kindly pro vide 
details, if any.  
 
EU reply:   
Article 17 provides that, where no licensing agreements have been concluded and where right 
holders have provided online content -sharing services with the necessary and relevant information, 
online content -sharing service s need to make best efforts to ensure the unavailability of 
unauthorised content. In addition, online content -sharing services have to act expeditiously to 
remove any unauthorised content following a notice received from right holders and make best 
efforts  to prevent future uploads. As required in Article 17(10), the Commission has launched a 
stakeholder dialogue  to discuss best practices for cooperation between online content -sharing 
services and right holders. Taking into account the results of such dialo gue, the Commission will 
issue guidance on the application of Article 17.  
 
Page – 160, Paragraph – 3.384  
Background  
In the Council for TRIPS, the enforcement of IPRs pursuant to the EU's legislation was considered at 
its meeting on 8 -9 November 2018. (referring to IP/C/M/90/Add. 1 dated 15 January 2019 
(Para.  22-25) In that meeting, the EU took note of the questions from the Indian delegation on the 
enforcement of IPRs regarding goods in transit (referring to IP/C/W/636; IP/C/W/636 Add.1). The 
EU also submitted updated responses to the Checklist of issues on enforcement in July 2019 
(Referring to IP/N/6/EU/1).  
 
Question 24: Kindly clarify whether goods in transit through the EU will be subjected to 
suspension of release or detention on suspicion o f trademark infringement?  
If yes, please clarify whether the procedure of suspension of release or detention will be 
initiated based upon any information received in this regard from the relevant authorities 
in the country of destination? If that is not th e basis of initiating the procedure for 
suspension of release or detention, what alternative basis is used by EU?  
 
EU reply:  
Goods coming from a third country without being released for free circulation which are suspected 
of violating an intellectual property right protected in the European Union (e.g. a trade mark, a 
copyright or a related right, a design or a patent), may be classified as 'goods suspected of infringing 
an intellectual property right' where there is evidence that they are intended to be put on sale in the 
European Union (EU). Such evidence might indicate that the goods have been sold to a customer in 
the Europe an Union or offered for sale or advertised to consumers in the European Union (see, to 
that effect, the Philips/Nokia cases, paragraph 78 in the document under the following link: 
http://curia.europa.eu/juris/document/document.jsf;jsessionid=F89C8AB57328750E1173D61C148
7A875?text=&docid=115783&pageIndex=0&doclang=EN &mode=lst&dir=&occ=first&part=1&cid=
4718032 ).  
 
Regulation (EC) No 207/2009 as amended by Regulation (EU) 2015/2424 and Directive (EU) 
2015/2436 extends the rights of the proprietor of a trade mark registered at EU level as a European 
Union trade mark or a t EU Member State level as a national trade mark to prevent third parties from 
bringing, in the course of trade, into the EU without being released for free circulation, goods coming 
from third countries and bearing without authorisation a trade mark which  is identical with the trade 
mark registered in respect of such goods or which cannot be distinguished in its essential aspects 
from that trade mark (hereinafter referred to as 'identical or essentially identical trade mark goods') 
even if the goods are no t intended to be placed on the market of the EU. The detention of the 
suspected goods is a decision taken by the customs authorities based on reasonable indications that 
those goods are infringing intellectual property rights. Information and data received  from right 
holders are also an important basis for customs authorities to detain goods in transit.  
 
Page – 160, Paragraph – 3.384  
 
Background  
In the Council for TRIPS, the enforcement of IPRs pursuant to the EU's legislation was considered at 
its meetin g on 8 -9 November 2018. (referring to IP/C/M/90/Add. 1 dated 15 January 2019 WT/TPR/M/395/Add.1  
 
- 285 - 
 
  (Para  22-25) In that meeting, the EU took note of the questions from the Indian delegation on the 
enforcement of IPRs regarding goods in transit (referring to IP/C/W/636; IP/C/W/6 36 Add.1). The 
EU also submitted updated responses to the Checklist of issues on enforcement in July 2019 
(Referring to IP/N/6/EU/1).  
 
Question 25: Article 18 of the Regulation (EU) 608/2013 read with paragraph 3.1 of the 
Commission Notice (EU) 2016/C 244/ 03 provides for suo moto  detention of goods 
suspected for infringing intellectual property rights. Please clarify any and all criteria 
based upon which the customs authorities in the EU can proceed with suo moto  detention 
of the goods -in-transit suspected of trademark infringement? Further, in case the 
detention of goods is proved wrong subsequently, will there be compensation to the 
owner of the goods?   
 
EU reply:   
Customs authorities can ex officio detain or suspend the release for free circulation of goods that 
are suspected to infringe an intellectual property right. Customs controls are based on risk analysis 
and performed within a common risk management framework (Article 46 of Regulation (EU) 
No. 952/2013 laying down the Union Custom s Code (UCC)) which establishes common risk criteria. 
These criteria are used to select consignments based on existing and identified risks which are being 
shared between EU Member States to ensure an equal treatment of operators at the external border. 
Information exchanged and criteria used are confidential. Customs cannot act ex officio in the case 
of perishable goods. For the specific case of goods in transit, the answer provided to your question 
24 applies also here. Where the goods in question are sub sequently found not to infringe an 
intellectual property right, the holder of the decision shall be liable towards any holder of the goods 
or declarant, who has suffered damage in that regard, in accordance with specific applicable 
legislation (see Article  28 of Regulation (EU) No . 608/2013).  
 
 
Question 26:  
Please clarify the factors which are taken into consideration by the EU customs authorities 
while undertaking risk analysis criteria as provided in recital 16 of Regulation (EU) 
2015/2424 and recital  22 of Directive (EU) 2015/2436?  
 
EU reply:   
According t o Article 46 of Regulation (EU) No 952/2013 laying down the Union Customs Code (UCC), 
customs controls are based on risks analysis and performed within a common risk management 
framework. This framework, which is based on existing and identified risks shar ed between 
EU Member States, establishes common risk criteria and priority control areas (increased risk 
analysis and customs controls during a certain period). The European Commission has adopted a set 
of criteria to be applied in the EU Member States' ri sk analysis systems in order to continuously, 
electronically screen cargo information for security and safety purposes. The criteria are aimed at 
identifying high -risk consignments/goods that could have serious implications for the security and 
safety of t he EU and its citizens and providing equivalent protection throughout the external 
frontiers. A set of criteria was developed to systematically identify transactions that present potential 
financial risks. These criteria are set out in non -public implement ing acts based on Article 50(1) 
UCC. 
 
Page 9, Paragraph 2  
 
Question 27:  
i) What is the digital services tax which EU member states have introduced at national 
level?  
 
EU reply:   
The negotiation of EU proposals for digital tax are on hold given the internatio nal tax negotiations 
aimed at reaching a global solution are to be finalized in 2020.  
Some Member States believe that the interim solution could be put in place at a national level to 
ensure fair taxation of the digital economy in a short term. These meas ures are to be withdrawn 
once the agreement for the global solution is achieved.  
The EU is fully engaged in the debate with the international partners to achieve a long -term global 
solution for the taxation of digital economy and is encouraged by the progr ess being made at the 
Organisation for Economic Co -operation and Development in this respect.  WT/TPR/M/395/Add.1  
 
- 286 - 
 
  ii) It is understood that the EU has also initiated a process for taxing the intangible 
imports of goods and services (mainly online) from outside the EU. The EU is r equested 
to clarify whether such taxation of intangible imports is done on a discriminatory or a 
non-discriminatory basis.  
 
EU reply:   
In 2015, the EU fully harmonized the place of supply rules for VAT for telecommunications, 
broadcasting and electronicall y supplied services (TBE services). They are now taxable at the place 
where the consumer is located, in line with the OECD rules. All VAT taxation in the EU is done on a 
non-discriminatory basis, since the goods and services are subject to the same VAT rul es whether 
they come from within the EU or from outside the EU. More details on the new VAT rules are 
presented in Section 4.4.3.2.2 VAT aspects of e -commerce.  
 
Question 28:  
EU is requested to provide list of their policy initiatives aimed at exploiting the potential 
of the EU's single market in services, energy and the digital economy.  
 
EU reply:  
Services:  
The core principles governing the single market for services are the freedom to establish a company 
in another EU country (Article 49 Treaty on the Functioning of the European Union (TFEU)) and the 
freedom to provide or receive services in an EU country ot her than the one where the company or 
consumer is established (Article 56 TFEU).  
 
The adoption of the services directive in 2006 has codified into EU law several pieces of case law of 
the European Court of Justice regarding the application of these core p rinciples. This directive covers 
services activities accounting for around 46% of EU GDP, including in sectors like retail, tourism, 
construction and business services.  
 
In addition to the directive, a number of sector specific laws provide the rules for financial services 
(https://ec.europa.eu/info/business -economy -euro/banking -and-finance_en), transport 
(https://ec.europa.eu/transport/index_en), telecommunications (https://ec.europa.eu/digital -
single -market/en/telecoms), postal services  (https://ec.europ a.eu/growth/sectors/postal -
services_en) , broadcasting (https://ec.europa.eu/growth/sectors/postal -services_en) and patient 
rights (https://ec.europa.eu/health/cross_border_care/overview_en).  
 
Moreover, in 2017, the Commission proposed to the co -legislators  a services package 
(https://ec.europa.eu/growth/content/services -economy -works -europeans -0_en), containing 
measures that will make it easier for companies and professionals to provide services within the EU:  
 
• The package includes initiatives on the Europe an Services e -card (directive (https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016PC0823) and regulation 
(https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016PC0824)) and  
• An improved notification of draft national laws on services ( https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016PC0821).  
• A new proportionality assessment of national rules on professional services (https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016PC0822) has already been 
adopted.  
• Guidance f or national reforms in regulation of professions (https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016DC0820) was also issued.  
Energy : 
Since 2015, in the energy field, the European Commission has implemented "A Framework Strategy 
for a Resilient  Energy Union with a Forward -Looking Climate Change Policy," also known as the 
Energy Union Strategy. The strategy forms part of a collaborative approach to bringing the EU and 
the Member States' national efforts together under an EU wide governance framew ork along five 
key priorities:  
 
1) Security of supply, solidarity and trust through cooperation between Member States;  WT/TPR/M/395/Add.1  
 
- 287 - 
 
  2) An EU -wide fully integrated internal energy market with free flow of energy and best energy 
 deals for consumers;  
3) Putting energy ef ficiency first, to reduce emissions and the dependence on imports, and 
 to drive economic growth and employment;  
4) Climate action and decarbonisation of the economy, and;  
5) Promoting research, innovation and competitiveness.  
 
To implement the Energy Unio n Strategy, the "Clean Energy for All Europeans" package (also known 
as "Clean Energy Package") was adopted in 2019 and consists of eight legislative acts, all of which 
have been formally adopted and are in force, but still need to be implemented by the Me mber States. 
As for the Directives, EU Member States have time to transpose the new directives into national law.  
 
• Electricity Market Directive 2019/944/EU and Electricity Market Regulation 2019/943/EU 
ACER Regulation 2019/942/EU;  
• Regulation on Risk -Prepar edness in the Electricity Sector Regulation 2019/941/EU and 
Repealing the Security of Supply Directive;  
• Renewable Energy Directive 2018/2001/EU (RED II);  
• Energy Efficiency Directive 2018/2002/EU (EED II);  
• Energy Performance of Buildings Directive 2018/844/EU (EPBD); and  
• Regulation 2018/1999/EU on the Governance of the Energy Union.  
The European Green Deal provides a roadmap to deliver the transformative c hange to reach climate 
neutrality by 2050. Its core will be the first European Climate Law, with a binding climate neutrality 
target for 2050. Based on a comprehensive analysis of the national energy and climate plans of the 
Member States, the European Com mission will propose a new EU ambition to reduce greenhouse 
gas emissions by 2030. A strategy for smart sector integration will promote the smart integration of 
electricity, renewable and decarbonised gases, heating, transport, industry, agriculture and ot her 
sustainable solutions. A new approach for exploiting Europe's offshore renewable energy potential 
will contribute to secure energy supply and provide access to affordable clean energy. An overarching 
strategy for sustainable and smart mobility will hel p modernising and greening of the transport 
sector.  
 
Digital Single Market:  
The EU has continuously been working on policies shaping the Digital Single Market that is beneficial 
for the citizens and businesses. Please see the list of policy initiatives bre aking down digital barriers 
for consumers and businesses below:  
 
• Europeans can access their online subscriptions travelling to another Member State.  
• Europeans do not pay roaming charges when travelling within the EU.  
• EU updated consumer protection rules an d new digital contract rules.  
• The new rules against unjustified geoblocking ensure that consumers can access goods 
and services online without worrying about discrimination or geographically based 
restrictions.  
• Higher price transparency and increased regul atory oversight encourage lower prices.  
• New rules will make it easier for broadcasters to enrich their online output across borders.  
• New rules allow special formats of print material — such as Braille or Daisy — to be made 
and disseminated for people with print disabilities.  WT/TPR/M/395/Add.1  
 
- 288 - 
 
  • A single set of rules are due to make it easier to do business across borders in the EU, as 
cross-border data storage and processing becomes easier and follows one single set of 
rules all across the EU.  
• The first -ever rules on online p latforms' trading practices will create a fair, transparent 
and predictable business environment for businesses and traders when using online 
platforms.  
• To protect its democratic systems and public debates and in view of the 2019 European 
elections, as wel l as national and local elections, the EU has adopted an Action Plan to step 
up efforts to counter disinformation in Europe and beyond.  
For more information, please visit : 
https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=53056.  
 
Page 9, Paragraph 5  
 
Question 29:  
EU is requested to provide the latest update on status of United Kingdom leaving the 
European Union.  
 
EU reply:  
On 3 February 2020 the Commission adopted – and published – its proposal for the negotiating 
directives for a new p artnership with the United Kingdom. They cover all the areas outlined in the 
Political Declaration, including trade and economic cooperation, law enforcement and judicial 
cooperation in criminal matters, foreign policy, security and defence, participation in EU programmes 
and thematic areas of cooperation. EU Member States will discuss the Commission's proposal and 
once agreed, they will formally authorise the Commission to open the negotiations as 
Union  negotiator.  
 
Page 9, Paragraph 6  
 
Question 30:  
Can EU provide an insight on action plan it has adopted to improve sustainable 
development in its FTA's?  
 
EU reply:  
The EU has had in place since February 2018 a 15 -point Action Plan that aims to improve the 
implementation and enforcement o f the Trade and Sustainable Development (TSD) Chapters in 
EU bilateral trade agreements. Under this action plan, the Commission has stepped up monitoring 
and enforcement of TSD chapters through four axes: closer cooperation with the Member States, 
European  Parliament and international organisations; enabling civil society to play its role in the 
implementation of the chapter; ensuring results through a wide range of actions including assertive 
enforcement where needed and capacity building; and improving tr ansparency and communication. 
Concrete actions include two large projects to promote Corporate Social Responsibility (CSR) in Asia 
and Latin America, which are now under implementation. Additionally, the EU has established 
priorities with each FTA partner in order to better focus its TSD implementation efforts.  
 
Page 9, Paragraph 7  
 
Question 31:  
What is the rationale behind exclusive competence of EU in FTA while the competence of 
member states is only confined to its Investment Protection Agreement?  
 
EU reply:  
In its advisory opinion of 16 May 2017 (opinion 2/15 on the then envisaged EU -Singapore Free Trade 
Agreement), the Court of Justice of the European Union has analysed in detail which parts of the 
draft agreement were of exclusive EU competence and which parts were of shared competences. 
According to the Court of Justice, all parts of the agreement were of exclusive EU competence, 
except for non -direct investment and investor -to-state dispute settlement, for which the 
competences are shared between t he Union and its Member States. In line with the Court's opinion, 
EU agreements including provisions on investment protection and investor -to-state dispute WT/TPR/M/395/Add.1  
 
- 289 - 
 
  settlement have so far been concluded with the participation of the EU Member States, be it in form 
of stand -alone investment protection agreements (e.g. EU -Viet Nam IPA, EU -Singapore IPA) or in 
form of comprehensive free trade or association agreements which also cover investment protection 
and investor -to-state dispute settlement (e.g. CETA).  
 
Page 10, Paragraph 9  
 
Question 32:   
On what grounds EU is stipulating the fact that "FTAs have strategic benefits in an 
international trading environment that has become more uncertain and unstable"?  
 
EU reply:  
The sentence refers to the rise of protecti onism and the WTO crisis, notably the situation related to 
the appellate body. These create an uncertain and unstable situation for the multilateral trading 
system. In this respect, bilateral trade agreements contribute to maintaining a predictable 
rules-based system with like -minded partner countries.  
 
Page 10, Paragraph 11  
 
Question 33:  
What are those measures which EU takes to improve transparency and inclusiveness in 
GSP monitoring, both in the EU and in the beneficiary countries?  
 
EU reply:   
The EU is considering a number of practical actions to improve GSP+ monitoring and to further civil 
society involvement and raise awareness for businesses and civil society organisations, including 
social partners. To this end, a project is starting in 202 0 called 'GSP: analysis, awareness and 
engagement'. The European Commission is also working to publish more reports and statistics 
related to GSP on its website.  
 
Page 10, Paragraph 12  
 
Question 34:  
Can EU provide list of a framework for the screening by  member States of FDI into the EU 
on the grounds of security or public order?  
 
EU reply:  
The list of Member States' screening mechanisms (as notified by the Member States to the 
Commission) is available through the web pages of the European Commission 
(https://trade.ec.europa.eu/doclib/docs/2019/june/tradoc_157946.pdf).  
 
Page 11, Paragraph 17  
 
Question 35:  
Can EU provide the list of legislative developments with respect to the EU's value -added 
tax (VAT) regime?  
 
EU reply:  
The legislative developments with respect to the EU's VAT regime over the past years are listed in 
the following document:  
https://ec.e uropa.eu/taxation_customs/sites/taxation/files/vat_legislation_proposed_en.pdf.  
 
This link is mentioned in the Secretariat report under footnote (72) in paragraph 3.55.  
 
Page 11, Paragraph 19  
 
Question 36:  
EU is requested to provide the details of surveil lance measures it uses to protect steel and 
aluminium sector?  
 WT/TPR/M/395/Add.1  
 
- 290 - 
 
  EU reply:  
Pursuant to Regulation (EU) 2015/478 and Regulation (EU) 2015/755, the EU has currently in force 
surveillance measures on certain iron, steel and aluminium products. All details can be found in 
Commission implementing Regulation (EU) 2016/670 for iron/stee l surveillance, and Commission 
implementing Regulation (EU) 2018/640 for aluminium surveillance.  
 
Page 11, Paragraph 20  
 
Question 37:  
EU is requested to provide list of some export control measures which it has taken to 
improve its export control regime  
 
EU reply:  
To improve the effective implementation of its export control regime, in 2019 the EU Commission 
adopted a Recommendation on Guidelines for Industry Compliance45, to help exporters in the 
application and implementation of the Council regulation (EC) No . 428/2009, and Commission 
Delegated Regulation (EU) 2019/2199 to update the EU Dual Use control list in view of the changes 
occurred in the international export control regimes in 2018. Furthermore, in order to ensure 
transparency, the Commission p ublished an Annual Report46 on the implementation of Regulation 
(EC) No . 428/2009 and an Information Notice on measures adopted by Member States in conformity 
with the provisions of the Council Regulation (EC) No . 428/200947. 
 
Page 12, Paragraph 21 -22 
 
Quest ion 38:  
Does EU agree to the fact that officially supported export financing, credits, insurance or 
guarantees and incentives in the form of subsidies and state aid, granted both out of the 
EU budget and by member States may amount to prohibited subsidies  within the meaning 
of Agreement on Subsidies and Countervailing Measures?  
 
EU reply:  
Export subsidies are prohibited in Article 3.1.a. of Agreement on Subsidies and Countervailing 
Measures, and are described in more detail in Annex I of the Agreement. The EU fulfils the conditions 
of the letters (j) and (k) of the Annex that sets out the exemptions from prohibition. Accordingly, 
the export credit practices covered by that letter are not export subsidies prohibited by the 
Agreement.  
 
Page 12, Paragraph 21  
 
Question 39:  
Kindly elaborate on short term official export credit facility given to the EU member States 
for Export or trade promotion activities.  
 
EU reply:  
State insurers may offer short -term export -credit insurance for risks with a per iod of less than two 
years in line with the Short -term export -credit insurance Communication. Short -term credit -risks 
for exports within the EU and nine other countries are considered in principle marketable: there is 
sufficient capacity in the private mar ket to offer insurance for such risks. For all other countries they 
are considered non -marketable and Member States can insure such exports at terms they consider 
appropriate, i.e. the non -marketable risks are outside the scope of the Communication. Market able 
risks can in principle only be insured by Member States if they act as market economy operators.  
 
The Communication identifies cases of "temporarily non -marketable risks" that can be insured by 
State insurers. Member States must respect a set of rule s when insuring temporarily non -marketable 
risks, amongst other charge minimum safe -harbour premiums.  
 
 
45 Commission Recommendation (EU) 2019/1318 of 30 July 2019 on internal compliance programmes 
for dual -use trade controls under Council Regulation (EC) No. 428/2009.  
46 COM/2019/562 final published  on 4 November 2019.  
47 OJ C 16, 17.1.2020, pp. 4 –46. WT/TPR/M/395/Add.1  
 
- 291 - 
 
  Question 40:  
Does all categories of export credit being provided in EU fall under the gambit of 
WTO -compatible subsidies?  
 
EU reply:  
Export credit practices covered by letters (j) and (k) of Annex I are not export subsidies prohibited 
by the Agreement. Compatibility of all categories of export credits in the EU is verifiable on the basis 
of the notifications under the OECD Arrangement for Offi cially Supported Export Credits and/or 
WTO notifications and procedures. We are not aware of any government export credit practices that 
would infringe the applicable rules.  
 
Question 41:  
What are the rules under capital requirement to be followed by the EU financial 
institutions?  
 
EU reply:  
As per international standards, EU institutions (i.e. credit institutions or investment firms) are 
required to hold a minimum amount of capital compared to the amount of assets, sufficient to cover 
unexpected losses.  In the CRR, this is called 'own funds requirement' and is expressed as a 
percentage of risk weighted assets. In order to calculate the capital an institution needs to hold, CRR 
defines how to weigh an institution's assets according to their risk (e.g. cre dit risk, market risk, 
operational risk).  
 
Under the existing framework, banks and investment firms need to have a total amount of capital 
equal to at least 8% of risk -weighted assets. The share that has to be of the highest quality – 
common equity tier 1  (CET1) – is 4.5%. In addition the EU rules provide for capital buffers: the 
capital conservation buffer, the counter -cyclical buffer, the systemic risk buffer, the global systemic 
institutions buffer and the other systemic institutions buffer. On top of a ll these own funds 
requirements, supervisors may add extra capital to cover for other risks following a supervisory 
review (i.e. "Pillar 2").  
 
In addition to CRR, the Investment Firms Regulation and Directive (IFR/IFD) entered into force in 
December 2019 and will start applying as of June 2021. They set out a new prudential framework 
for investment firms whose assets are below 15 bn EUR (or 5bn if discretion is exercised by the 
relevant national competent authority). As a result, concerned firms will apply  a more proportionate 
prudential regime based on specific capital requirements. Capital requirements for those firms will 
be the highest of their (a) "fixed overheads" requirement, (b) "initial capital" requirement, and 
(c) "K-factors" requirement. Requirement (a) amounts to one quarter of their fixed overheads of the 
preceding year (i.e. total expenses after distribution of profits minus specific staff bonuses, fees and 
non-recurring expenses). Requirement (b) is either EUR 75 000, EUR 150 000, or EUR 750 000, 
depending on the type of activities performed by the firm (in particular, if the firm is dealing on own 
account, initial capital will be EUR 750 000). Requirement (c) is a simple capital requirement 
calculated based on several key business activity indicators or risks of the firm (such as daily trading 
flow, net position risk, amount of assets under management, amount of clients orders handled, 
amount of client money held, etc.).  
 
Investment firms beyond the EUR 15 bn (o r EUR 5 bn, see above) thresholds will continue applying 
the prudential framework applicable to credit institutions (CRR/CRD rules) even when the IFR/IFD 
will enter into application.  
 
Page 12, Paragraph 23  
 
Question 42:  
EU is requested to provide the impo rtant changes which were made during the review 
period to the basic legislative framework regarding technical requirements, standards, 
conformity assessment and accreditation.  
 
EU reply:  
The important changes made during the review period are included in  Regulation (EU) 2019/515 on 
the mutual recognition of goods lawfully marketed in another Members State, and Regulation (EU) 
2019/1020 on market surveillance and compliance of products. Both Regulations improve the rules 
under which products can be markete d in the EU by economic operators.  WT/TPR/M/395/Add.1  
 
- 292 - 
 
  Regulation (EU) 2019/515 will start to apply on 19 April 2020 and it is a step forward when it comes 
to transparency of decisions taken by the competent authorities of the EU Member States in the area 
of mutual recogniti on. Decisions by an EU Member State restricting or denying market access to 
goods which have been lawfully marketed in other Member States will be notified to the 
European  Commission and to other EU Member States through the "information and communication 
system for the pan -European market surveillance" (ICSMS). ICSMS will also be used for exchange 
of information among the competent authorities and domestic product contact points, which will 
facilitate their communication in the area of mutual recognition o f goods lawfully marketed in other 
EU Member States.  
ICSMS is not a new system. It was established by Regulation (EC) No 765/2008 on accreditation 
and market surveillance, as a general archiving and exchange of information system, on issues 
relating to mar ket surveillance activities, programmes and related information on non -compliance 
with EU harmonization legislation. ICSMS will be adapted to its new role, which is extended by 
Regulation (EU) 2019/515, and will also be used in regard of non -harmonized goo ds. 
 
As regards Regulation (EU) 2019/1020, it strengthens cooperation and effectiveness of market 
surveillance authorities in the EU in different ways.  
 
(i) Firstly, at national level the Regulation provides for the setting up of a single liaison office per 
Member State to coordinate the activities of all national market surveillance authorities, as well as 
the formulation of national market surveillance strategies - at least every 4 years - that must 
consider all product sectors and set priorities. Regulation (EU) 2019/1020 also recognises a minimum 
set of powers to market surveillance authorities in terms of investigation, enforcement and 
imposition of penalties, as well as systemic cooperation and risk information exchange with customs 
authorities.  
 
(ii) Between Member States, the Regulation provides for cross -border mutual assistance 
obligations between market surveillance authorities, as well as the introduction of voluntary peer 
reviews of these authorities.  
 
(iii) At EU -wide level, Regulation (EU) 2019/1020 introduces enhanced cooperation mechanisms 
between market surveillance authorities of EU Member States and the European Commission by 
setting up a Union Product Compliance Network. This Network is to serve as a p latform for structured 
coordination and cooperation between enforcement authorities of EU Member States and the 
Commission, and to streamline the practices of market surveillance within the EU, thereby making 
market surveillance more effective. The Network  will set priorities for common market surveillance 
work. It will also facilitate joint control campaigns, including testing, and will help Member States 
carry out their market surveillance strategies.  
 
Regulation (EU) 2019/1020 also addresses the challen ges of e -commerce, and it introduces a 
requirement on manufacturers not established in the EU to appoint a responsible person to act as 
contact point for national market surveillance authorities for certain types of products placed on the 
EU market. The Re gulation provides flexibility on whom can be this responsible person. 
Manufacturers not established in the EU can appoint an importer or an authorized representative, 
but the responsible person can also be a fulfilment centre in the EU as laid down in Arti cle 4 of the 
Regulation. The Commission will provide guidelines explaining the practical implementation of this 
provision. The aim is to publish them in 2020.  
 
Information on compliance with EU product rules will also be made easily accessible to economic 
operators through the new tool laid down in Article 8 of the Regulation. In particular, economic 
operators will have easy online access through the Your Europe portal that provides information 
about EU product requirements. This will be operational at the end of this year. In addition, there 
will be contact points at Member State level to which further questions on the implementation of 
product requirements can be addressed.  
 
Page 12, Paragraph 24  
 
Question 43:  
Regarding SPS measures, can the EU provide th e details of new regulation adopted in 
2017 on official controls on products of animal origin intended for human consumption 
along with requirements to be fulfilled for the entry into the EU of consignments of 
animals and goods from third countries  WT/TPR/M/395/Add.1  
 
- 293 - 
 
  EU rep ly:  
Regulation (EU) 2017/625 establishes a more integrated approach, as common rules now apply to 
controls carried out at borders on animals, products of animal origin, plants and other products and 
goods that must be checked before they enter the EU . 
The new import control system is even more risk -based, targeted and harmonised than before. 
Common requirements for facilities, equipment and staff qualifications will apply throughout all 
border control posts. All consignments to be presented at the border c ontrol posts must undergo 
documentary checks, while identity and physical checks will be carried out at a frequency depending 
on the risk linked to the specific animals or goods. The common criteria to determine and modify 
the frequency has been establishe d in Commission Implementing Regulation (EU) 2019/2129. 
https://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1579873070417&uri=CELEX:32019R2129 . 
 
In addition, a single standard document, the Common Health Entry Document (CHED), will be used 
by operators for  the prior notification of consignments. It will be transmitted to the border control 
post through a new integrated computerised system for official controls (Integrated Management 
System for Official Controls, IMSOC) which will optimise the handling and e xchange of information, 
data and documents necessary for the enforcement of agri -food chain rules.  
 
An overview on delegated and implementing acts adopted under Regulation (EU) 2017/625 can be 
found here:  
https://ec.europa.eu/food/sites/food/files/oc_qa_oc regulation_20191212_delegated_implemented
_acts_en.pdf . 
 
Page 12, Paragraph 25  
 
Question 44:  
Can EU provide links and name some of the important decisions adopted by the 
commission in anti -competitive agreements, abuse of dominant position and mergers?  
 
EU reply:   
European Commission's decisions concerning anti -competitive agreements, abuse of dominant 
position and mergers can be found at https://ec.europa.eu/competition/elojade/isef/.  
 
Page 12-13, Paragraph 27  
 
Question 45:  
What is the unitary patent package and can EU provide the details of its coverage? EU is 
also requested to provide list of measures taken during the review period to implement 
substantive reforms to EU trademark legisla tion. 
 
EU reply:   
The "Unitary patent package " consists of the following:  
 
• a regulation creating a European patent with unitary effect ('unitary patent') (see 
Regulation (EU) No 1257/2012)  
• a regulation establishing a language regime applicable to the unitary patent (see Council 
Regulation (EU) No . 1260/2012)  
• an agreement between EU countries to set up a single and specialised patent jurisdiction, 
i.e. the "Unified Patent Court " (see the Agreement on the Unified Patent Court, "UPCA ").  
• The unitary pate nt is a legal title that will provide uniform protection across all participating 
EU countries on a one -stop-shop basis, providing cost advantages and reducing 
administrative burden. The Unified Patent Court will offer a single, specialised patent 
jurisdic tion. Unitary patent will enter into operation with the entry into force of the 
Agreement on the Unified Patent Court and will cover the countries that have ratified the 
latter. The ratification procedure is currently still ongoing. Detailed information re garding 
the coverage of the unitary patent and the status of UPCA ratifications is available at:  
Coverage: https://www.epo.org/law -practice/unitary/unitary -patent/start.html  WT/TPR/M/395/Add.1  
 
- 294 - 
 
  • Ratifications: https://www.consilium.europa.eu/en/documents -publications/treaties -
agreements/agreement/?id=2013001 . 
• For general information regarding the unitary patent package, reference is also made to 
the dedicated websites of the European Commission, the European Patent Office and the 
Unified Patent Court.  
Page 13, Paragraph 29  
 
Question 46:  
Can EU provide a list of major fishery supplier countries to whom the EU grants 
preferences on a reciprocal or unilateral basis?  
 
EU reply:  
The major fishery and aquaculture supplier countries and territories to whom the EU grants 
preferences on a reciprocal or unilateral basis are Norway, Iceland, Morocco, Ecuador and the Faroe 
Islands.  
 
Question 47:  
Can EU provide the details of new regulation it has adopted in December 2017 on the 
sustainable management of external fishing fleets?  
 
EU reply:  
EU Regulation 2017/2403 on the sustainable management of external fishing fleets establishes a 
system concerning authorisations for fishing activities of Union fishing vessels outside Union waters 
and the access of third -country vessels to Union  waters. The full text of the Regulation is available 
at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32017R2403 . 
 
Question 48:   
Can the EU provide information as to how it has met the objective of restoring and 
maintaining fish stocks at s ustainable levels by 2020?   
 
EU reply:  
The general objective of the Common Fisheries Policy is to ensure that fishing and aquaculture 
activities are environmentally, economically and socially sustainable in the long term, contributing 
to the availability of food supplies. The main instruments to achieve these objectives of the Common 
Fisheries Policy are fishing opportunities, i.e. catch limits set at the EU level on the basis of scientific 
advice (in line with Fmsy, when there is analytical advice, or the  precautionary approach 
otherwise),the development of multiannual plans (MAPs) containing conservation measures to 
restore and maintain fish stocks above levels capable of producing maximum sustainable yield, and 
the implementation of the landing obligatio n to eliminate discards by avoiding and reducing, as far 
as possible, unwanted catches, and by ensuring that catches are landed.  
 
In the Northeast Atlantic area (including the North and Baltic Seas), the move towards sustainability 
is both widespread and v isible. While in the early 2000s most stocks were overfished, almost 100% 
of the landings are now from sustainable stocks managed at MSY. The sustainable fisheries are 
extended to new sea basins. With the fishing opportunities for 2020, the Commission has proposed 
fishing opportunities covering the Mediterranean Sea. In 2019, the co -legislators adopted a 
Multiannual plan for the demersal fisheries in the western Mediterranean and in line with the plan it 
was agreed to a 10% reduction of fishing effort for d emersal species in the Mediterranean Sea. In 
the Black Sea, a compromise was reached on quotas for the two most important commercial species, 
sprat and turbot. Continuous effort is necessary to rebuild the stocks and to strengthen the culture 
of compliance . 
Some examples show that stocks that have been overfished before can recover thanks to ambitious 
actions taken. This is the case for Northern hake where today fishers can catch twice as much as in 
2008. It also applies to Norther seabass where emergency m easures agreed in 2015 have led to 
maximum sustainable yield fishing after only three years.  
 
Question 49:   
Can the EU explain the reasons for maintaining high tariffs for fisheries?   
 WT/TPR/M/395/Add.1  
 
- 295 - 
 
  EU reply:  
EU tariffs for fisheries products are kept at an adequate le vel. Two thirds of the fisheries and 
aquaculture products consumed in the EU are imported. The EU has a trade deficit of more than 
20 billion euros in fisheries products. The EU grants preferences, on a reciprocal or unilateral basis, 
to major fishery supp liers. 
 
Page 13, Paragraph 30  
 
Question 50:  
Can EU provide the details and key elements of the new comprehensive legislative 
framework for energy and climate change policies which it has adopted?  
 
EU reply:   
The revised 2030 climate and energy framework (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:52014DC0015) sets three key targets for the year 2030: at least 40% 
cut in greenhouse gas emissions from the 1990 level, at least 32% share for renewable energy, and 
at least 32.5% improv ement in energy efficiency (to be reviewed in 2023). This framework was 
adopted by EU leaders in October 2014 and revised in December 2018. These targets are defined to 
implement the EU nationally determined contribution under the Paris Agreement and to pu t the EU 
on the way to achieve the transformation towards a low -carbon economy as detailed in the 
Communication "A Clean Planet for all A European strategic long -term vision for a prosperous, 
modern, competitive and climate neutral economy" (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:52018DC0773) , which the Commission presented in November 2018.  
 
The Commission presented a legislative proposal to the EU Parliament and Council in July 2015 to 
revise the EU Emission Trading System for a phase 4  (2021 -2030), including a reduction of the 
number of quotas by 2.2% per year from 2021, instead of 1.74% at present. The European 
Parliament plenary approved the ETS reform agreement on 6 February 2018 and the Council formally 
adopted it on 27 February 201 8 (https://eur -lex.europa.eu/eli/dir/2003/87). The EU Effort Sharing 
Regulation (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2018.156.01.0026.01.ENG) adopted on 30 May 2018 sets out 
binding annual greenhouse gas emission targets for M ember States for the period 2021 –30 for 
sectors outside the scope of the EU emissions trading system.  
The Commission presented the clean energy for all Europeans  package on 30 November 2016, with 
three main goals: putting energy efficiency first, achieving global leadership in renewable energies 
and providing a fair deal for consumers. The legislative proposals cover energy efficiency, renewable 
energy, the design of the electricity market, security of electricity supply and governance rules for 
the Energy Union.  
 
The EU's revised Renewable energy directive (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2018.328.01.0082.01.ENG&toc=OJ:L:2018:328:TOC) sets a 
binding target of 32% final energy consumption from renewable sources by 2 030, with a clause for 
an upwards revision by 2023. The Directive was published in the Official Journal on 
11 December  2018.  
 
The revised Directive on Energy efficiency (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2018.328.01.0210.01. ENG&toc=OJ:L:2018:328:TOC) includes 
a headline target of at least 32.5% for energy efficiency to be achieved collectively by the EU in 
2030, with a clause for an upwards revision by 2023. The Directive was published in the Official 
Journal on 11 December 2 018. 
 
The new Regulation on the Governance of the Energy Union and Climate Action was also adopted in 
December 2018 (https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2018.328.01.0001.01.ENG&toc=OJ:L:2018:328:TOC). It is the 
'umbrella' piec e of legislation that sets out planning, reporting and monitoring mechanisms intended 
to ensure that the EU's 2030 energy and climate targets are achieved in a coherent and coordinated 
approach.  
 WT/TPR/M/395/Add.1  
 
- 296 - 
 
  Page 13 -14, Paragraph 31  
 
Question 51:  
Does EU believe tha t its renewed Industrial Policy Strategy, "Investing in a smart, 
innovative and sustainable industry" has been successful in achieving its purpose?  
 
EU reply:  
All foreseen key actions under the renewed Industrial Policy Strategy were implemented. 
Stakeho lders joining forces to undertake the important efforts leads to a new dynamic with the 
objective of revitalising the EU economy.  
 
Page 14, Paragraph 32  
 
Question 52:  
India requests EU to provide the details of banking reform package it has adopted and 
legislative proposals submitted by the Commission which aims to develop deeper and 
more integrated capital markets across the EU.  
 
EU reply:  
In November 2016 the European Commission adopted a comprehensive package of reforms 
("EU banking reform package ") to further strengthen the resilience of EU banks. This package 
introduced amendments to various pieces of legislation, i.e. the Capital Requirements Regulation 
(CRR) Directive (CRD), the Bank Recovery and Resolution Directive (BRRD) and the Single 
Resolutio n Mechanism Regulation (SRMR).  
 
The new measures entered into force in June 2019. They incorporate the remaining elements of the 
regulatory framework already agreed at international level within the Basel Committee on Banking 
Supervision (BCBS) and the Financial Stability Board (FSB). They will increase the resilience of 
EU institutions and enhance financial stability, and improve banks' lending capacity to support the 
EU economy. They include the following key provisions:  
 
• A binding Leverage Ratio to p revent institutions from excessive leverage, as well as a 
leverage ratio buffer for all global systemically important institutions;  
• A binding Net Stable Funding Ratio to address the excessive reliance on short -term 
wholesale funding and to reduce long -term funding risk;  
• More risk -sensitive capital requirements, in particular in the areas of market risk, 
counterparty credit risk, and for exposures to central counterparties;  
• a requirement for third -country institutions having significant activities in the EU  to have 
an EU intermediate parent undertaking;  
• an updated macro -prudential toolkit;  
• Provisions to make CRD/CRR rules more proportionate and less burdensome for smaller 
and less complex institutions where some of the current disclosure, reporting and compl ex 
trading book -related requirements appear not to be justified by prudential considerations. 
This includes the exclusion of certain banks from the scope of application of CRR/CRD;  
• For non -complex, small banks, reduce the administrative burden linked to so me rules in 
the area of remuneration (namely those on deferral and remuneration using instruments, 
such as shares), which appeared disproportionate for these banks;  
• a new discount on capital requirements for investments in infrastructure and a more 
generou s discount on capital requirements for exposures to small and medium -sized 
enterprises;  
• targeted amendments to the credit risk framework to facilitate the disposal of non -
performing loans and to reflect EU specificities;  WT/TPR/M/395/Add.1  
 
- 297 - 
 
  • targeted amendments related to the incorporation of environmental, social and 
governance aspects into prudential rules;  
• enhanced prudential rules in relation to anti -money laundering;  
• a new total loss absorbing capacity requirement for global systemically important 
institutions;  
• enhanced Mi nimum Requirement for own funds and Eligible Liabilities (MREL) 
subordination rules for global systemically important institutions (G -SIIs) and other large 
banks referred to as top -tier banks;  
• a new moratorium power for the resolution authority;  
• restrictio ns to distributions in case of MREL breaches.  
Page 14, Paragraph 32  
 
Question 53:  
Why Directive and Regulation on a services e -card to enhance cooperation in member 
States is currently on hold?  
 
EU reply:  
The services e -card initiative has been on hold since 21 October 2019 because the 
European  Parliament expressed the view that the legislative proposal should be withdrawn. As 
announced on 29 January 2020, the Commission has decided to include it in its Work Programme 
for 2020. Different options for the way forward are currently explored.  
 
Page 14, Paragraph 33  
 
Question 54:  
What is digital single market? What are the legislative measures under it which addresses 
the barriers to the growth of cross border e -commerce?  
 
EU reply:  
Since the beginning of the Juncker Commission in 2014, 30 legislative proposals on the Digital Sin gle 
Market were made. The Digital Single Market Strategy outlined the path for the EU to build the right 
digital environment: one in which a high level of privacy, protection of personal data and consumer 
rights are ensured, businesses can innovate and com pete, and cybersecurity strengthens the fabric 
that weaves our societies together.  
 
The Commission has reported on its progress at midterm in May 2017, see information on 
https://ec.europa.eu/digital -single -market/en/news/digital -single -market -mid-term-review.  
 
At the end of the mandate, 28 of these legislative proposals have been agreed upon by the 
co-legislators. You can find a useful factsheet  "A Digital Single Market for the benefit of all 
Europeans" of November 2019 by following this link https://ec.europa.eu/digital -single -
market/en/news/digital -single -market -benefit -all-europeans, with details on what was achieved 
through the strategy.  
 
The aim of the e -commerce related package was to break down barriers to cross -border online 
activity and to define a comprehensive e -commerce framework focusing on three main objectives:  
 
(i) Ensuring better access to goods and services offered online;  
(ii) Building trust for consumers and greater certainty for businesses; and  
(iii) Reducing transaction costs and administrative burden for businesses when trading online 
 across borders.  
 
The package consisted of an inter -linked set of measures, aiming at fac ilitating the use of e -
commerce. These measures have all been adopted by the co -legislators, and are, or will become 
applicable in the coming months/years.  
 WT/TPR/M/395/Add.1  
 
- 298 - 
 
  For more information on the EU's Digital Single Market and related legal acts see 
https://ec.europ a.eu/digital -single -market/en/policies/shaping -digital -single -market . 
 
Page 17, Paragraph 1.8  
 
Question 55:  
Could EU please provide the details of investment plan it launched in 2014 and how it 
contributed in providing favourable financial conditions?  
 
EU reply:  
As a result of the impact of the financial and economic crisis that began in the US in 2008 and hit  
the EU economies with full force in 2010, investor risk aversion increased and the availability of 
financing through the banking system declined, which has particularly affected the access to finance 
for small and medium -sized enterprises.  
 
As a result, EU investment activity in 2013 was 15 percent (in real terms), below its pre -crisis peak. 
In the hardest hit Member States, the investment deficit is likely to have ranged between 25 and 
over 60 percent. The weakness reflected low demand growth, lo w capacity utilisation, increased 
economic and political uncertainty and, in some countries, the bursting of construction/residential 
construction bubbles, corporate debt reduction and financing bottlenecks. At that time, subdued 
investment activity threat ened Europe's long -term growth potential. It eroded the existing 
productive capital stock and worryingly meant that Europe was not making the productive 
investment in human and physical capital needed for future competitiveness, growth and 
employment. This  trend undermined the ability of European businesses to compete in the global 
economy and to create rewarding jobs and high living standards.  
 
As early as 2014, annual GDP growth in the EU was expected to be relatively moderate at 1.3%, 
while growth in the  euro area would be 0.8%. The expected GDP growth, which had already been 
relatively slow before the crisis due to low productivity gains, had declined further due to low 
investment and high structural unemployment. It was imperative to find ways to break this vicious 
circle and turn it into a virtuous circle in which investment projects could contribute to a stronger 
increase in employment and demand as well as to a sustainable increase in potential growth.  
 
The Investment Plan for Europe was announced in 2014 as a comprehensive investment promotion 
strategy to help restore the EU's competitiveness and boost growth and investment in the 
European  Union by removing barriers to investment, ensuring the visibility and technical support of 
investment projects an d using financial resources more wisely. As such, the plan consists of three 
pillars:  
 
First, the European Strategic Investment Fund (EFSI), which provides an EU guarantee to mobilise 
private investment. The Commission is working with its strategic partner , the European Investment 
Bank (EIB) Group.  
 
Secondly, the European Investment Advisory Centre and the portal for European investment 
projects, which provide technical assistance and greater visibility of investment opportunities, thus 
helping to make prop osed investment projects a reality. The Hub is a joint venture with the EIB 
Group.  
 
Third, to improve the business environment by removing regulatory barriers to investment at both 
national and EU level.  
 
Page 20, Point 1.15  
 
Question 56 :  
Please elaborate  on the measures the EU is planning to address the problem of high levels 
of public debt.  
 
EU reply:  
Please see the reply to Question 62.  
 WT/TPR/M/395/Add.1  
 
- 299 - 
 
  Page 21, Paragraph 1.16  
 
Question 57:  
Can EU provide an insight of its ongoing efforts to rationalize expenditures  including its 
tax related reforms and developments?  
 
EU reply:  
Spending reviews are becoming regular exercises across the EU and more and more EU Member 
States are conducting spending reviews tailored to country -specific needs. Some reviews are 
conducte d on an annual basis (e.g. in Germany), others span over a multi -year horizon (e.g. in 
Finland, France, Ireland and Portugal). In terms of the scope of expenditure subject to scrutiny, 
some reviews are comprehensive while others target key sectoral policie s such as education and 
healthcare (e.g. in Latvia, Lithuania and Slovakia) or very specific items (police force in Malta, 
business incentives in Germany and government subsidies in Spain). In September 2016, the 
Eurogroup called on euro area Member States  to actively use spending reviews and approved a set 
of common principles for improving expenditure allocation through their use .48. 
 
One way in which Member States can cut expenditures is by limiting the use or reducing the 
generosity of tax expenditures. Tax expenditures are generally reductions in government revenue 
through preferential tax treatment of specific groups of tax payers or specific economic activities. 
Some tax expenditures are recorded in the National Accounts as reductions on tax revenues while 
others (e.g. tax credits) as expenditures .49 EU Member States make ample use of tax expenditures 
with a wide variety of aims, including employment creation, innovation, education, entrepreneurship, 
home ownership and income redistribution . While tax expenditures may be motivated by relevant 
economic or social goals, they are not necessarily the most cost efficient instrument and may in 
some cases lead to severe economic impacts and distortions.  
 
Page 21 -22, Paragraph 1.18 -1.1.21  
 
Question 58:  
It is understood that monetary decisions in the euro area can only be taken by the 
Governing Council of the ECB consisting of the governors of the member states. Can EU 
please elaborate how does ECB deal with foreign exchange within the Euro system wi th 
different currencies among the EU member states?  
 
EU reply:  
According to the Article 282 of the Treaty on the Functioning of the EU (TFEU), the ECB, together 
with the national central banks of all the EU Member States constitute the European System of  
Central Banks (ESCB). The ECB and the national central banks whose currency is the euro constitute 
the Eurosystem. The ECB Governing Council, which consists of the six members of the Executive 
Board, plus the governors of the national central banks of the  19 euro area Member States, formulate 
the monetary policy for the euro area. Those EU Member States, whose currency is not the euro, 
and their central banks, retain their powers in monetary matters. Accordingly, they have full control 
of their exchange ra te policy, although they should treat it as a matter of common interest (please 
see article 142 of the TFEU). Furthermore, on the way to euro adoption, Member States whose 
currency is not the euro have to participate for at least two years in ERM II, which  is a special 
exchange rate policy framework (please see Resolution of the European Council on the establishment 
of an exchange -rate mechanism in the third stage of economic and monetary union, Amsterdam, 
16 June 1997). Currently, only Denmark participates  in ERM II.  
 
Page 22, Paragraph 1.23  
 
Question 59:  
EU is requested to provide an insight into the key changes it has made to its policy 
framework to address borrowing conditions of the Euro area private sector.  
 
48 Viewed at: http://www.consilium.europa.eu/en/press/press -releases/2016/09/09 -eurogroup -
statement/.  
49 The move from ESA 95 to ESA 2010 changed the classification of some tax expenditures. ESA 2010 
introduces among others explicit new rules for recording tax credits in national accounts. This treatment 
represents a clear difference as compared to the previous recording under the ESA 95. Tax credits that constitute 
non-contingent liability of government ar e now treated as expenditure instead of reduction of tax revenue and 
recorded at the moment when government recognises the obligation to pay.  WT/TPR/M/395/Add.1  
 
- 300 - 
 
  EU reply:  
As explained in the paragraph 1. 22 of the Secretariat report, the ECB cut its deposit facility rate 
(DFR) by 10 basis point (bps) from -0.40% to -0.50%. As this rate provides an anchor for short -
term market interest rates, which serve as the reference for many types of loans and financia l 
instruments, lowering the deposit facility rate helps to further improve the borrowing conditions of 
households and businesses. Negative policy rates also encourage banks to lend to the real economy 
instead of holding onto liquidity, thus supporting the portfolio -rebalancing channel of the asset 
purchase programme (APP). Moreover, the state -based forward guidance on policy rates helps to 
reduce uncertainty about the expected path of interest rates in the short to medium term, which 
should support credit c reation. The net purchases and longer reinvestment horizon help to keep 
down longer -term interest rates by mitigating the undue tightening that would otherwise 
mechanically arise from the reduction in the average maturity of the monetary portfolio. Finally , the 
changes in the modalities of the new series of targeted longer -term refinancing operations 
(TLTRO  III) should ensure that accommodative ECB monetary policy is passed through entirely to 
the funding costs of households and firms. In detail the changes have been the following: the ECB 
removed that previously announced 10bps spread above the average interest rate of the 
Eurosystem's main refinancing operations (MROs) and, for counterparties exceeding their lending 
benchmark, above the average inte rest rate on the deposit facility; the maturity of TLTRO III 
operations has been extended from two years to three years.  
 
Page 22, Paragraph 1.24  
 
Question 60:   
How EU is able to balance out the detrimental effect of Brexit to sustain its GDP growth?  
 
EU reply:  
Compared to the period under review, there is now more clarity about Brexit. Following the UK's 
withdrawal from the EU on 31 January 2020 and the entry into force of the Withdrawal Agreement, 
the UK entered a transition period lasting until 31 Dece mber 2020, during which EU law, with a few 
exceptions, continues to apply to and in the UK. At the same time, the question of future trading 
relations remains open.  
 
It is thus premature to discuss the effect of the UK leaving the EU on the EU's economic outlook. 
This impact will depend on the outcome of the negotiations on the future partnership between the 
EU and the UK. It can be said however that even if a free trade agreement is concluded, it will 
establish a different relationship in terms of market access than participating in the Internal Market 
and the Customs Union. Therefore, the end of the transition period means significant changes in the 
regulatory relationship between the United Kingdom and the European Union.  
 
Regardless of the modalities of  the future agreement, the results from various published studies on 
the economic impact of Brexit point to negative effects to the UK as well as the EU. However, the 
studies suggest that under any scenario the negative economic impact on the UK (as a shar e of 
GDP) will be significantly larger than the EU as a whole.  
 
Page 22 -23, Paragraphs 1.24 -1.25 
 
Question 61:  
Does EU agree to the fact that Brexit would not have significant overall impact on EU's 
economic outlook and the development in its labor market?   
 
EU reply:  
Following the UK's exit from the EU on 31 January 2020 and the entry into force of the Withdrawal 
Agreement, the UK entered a transition period during which EU law continues to apply to and in the 
UK. It is thus premature to discuss th e effect of UK leaving the EU on EU's economic outlook. The 
impact will depend on the outcome of the negotiations on the future partnership between the EU 
and the UK.  
 
Page 23, Paragraph 1.29  
 
Question 62 : 
Please describe the next steps that the EU intends  to undertake for structural reforms and 
fiscal policies.   WT/TPR/M/395/Add.1  
 
- 301 - 
 
  EU reply:  
On 5 February 2020, the Commission published a review of the application and the effectiveness of 
the EU economic governance framework,50 including the EU fiscal rules. The review revealed 
strengths as well as possible areas for improvement. It paid special attention to the current economic 
context. Some EU Member States, in particular in the euro area, have not reduced their high public 
debt. Many are challenged by weak potential growth, associated with persistently low inflation and 
interest rates. Economic growth may remain subdued for a longer period in the absence of policy 
action to boost potential growth. Also, the transition towards a climate -neutral and digital European 
economy will require significant private and public investments. However, the review does not make 
concrete reform proposals. Instead, the Commission invited stakeholders to provide their views on 
how strengthen the i mplementation of the EU economic governance. For instance, it will be important 
to consider whether and how Member States' fiscal and structural policies could contribute to the 
policy mix in the euro area and to raising potential growth without losing sig ht of fiscal sustainability. 
The Commission will consider all those views and on that basis complete its internal reflections on 
the scope for any possible future steps by the end of 2020.  
 
For next steps that the EU intends to undertake for structural re forms, please see reply to 
Question  64. 
 
Page 24, Paragraph 1.31  
 
Question 63:   
EU has gained maximum benefit from the single market as it allows free movement of 
goods, capital, services, and labour within the European Union. Does the EU has 
implications for its economy as a single market trade block due to UK's exit from EU? If 
yes, kindly elaborate on the same.  
 
EU reply:  
Following the UK's exit from the EU on 31 January 2020 and the entry into force of the Withdrawal 
Agreement, the UK entered a transi tion period during which EU law continues to apply to and in the 
UK. What is clear is that even if a free trade agreement is concluded, it will establish a very different 
relationship in terms of market access than participating in the Internal Market and the Customs 
Union. Therefore, the end of the transition period means significant changes in the regulatory 
relationship between the United Kingdom and the European Union. Whatever the shape of the future 
partnership with the UK, it will respect the integri ty of the Union's Single Market and of its Customs 
Union.  
 
Regardless of the outcome of the negotiations between the EU and the UK, the EU Single Market 
remains the EU's biggest asset – a market of 440 million consumers and a GDP of over 
EUR 15 trillion. This makes the EU the second largest economy after the USA and before China. The 
EU remains the largest trading bloc in the world, and the world's largest development aid donor.  
 
Page 24, Paragraph 1.32  
 
Question 64:   
Please describe the next steps that the EU intends to take in order to deliver the promise 
of inclusive and sustainable growth.  
 
EU reply:  
The twin objectives of inclusiveness and sustainability are at the heart of the EU's growth strategy.51 
These objectives are aligned with Article 3 Treaty on EU (TEU), which states that the EU's aim is to 
promote peace, its values and the well -being of its peoples. It inter alia  sets out that the EU shall 
work for the sustainable development of Europe based on balanced economic growth and price 
stability, a highly competitive social market economy aiming at full employment and social progress, 
and a high level of protection and improvement in the quality of the environment.  
 
 
50 European Commission, Economic governance review.  Viewed at: https://ec.europa.eu/info/business -
economy -euro/economic -and-fiscal-policy -coordination/eu -economic -governance -monitoring -prevention -
correction/stability -and-growth -pact/economic -governance -review_en.  
51 Viewed at: https://eur -lex.europa.eu/leg al-
content/EN/TXT/PDF/?uri=CELEX:52019DC0650&from=EN . WT/TPR/M/395/Add.1  
 
- 302 - 
 
  The EU has been at the forefront of formulating and putting in place a set of policies in view of 
delivering strong, inclusive, and sustainable growth. In particular, the EU2020 strategy put forward 
three mutually reinforcing priorities: developing an economy based on knowledge and innova tion, 
promoting a greener, more resource -efficient and competitive economy, fostering a 
high-employment economy delivering social and territorial cohesion.52 This strategy materialised 
through a set of policy initiatives, as well as an increasingly comprehe nsive monitoring of outcomes 
to assess EU achievements in the areas of prosperity, fairness, stability, and sustainability.53 The 
Annual Sustainable Growth Strategy (ASGS) builds upon these achievements while further 
underlining the need for a whole -of-government approach to deliver inclusive and sustainable 
growth.54  
 
On 11 December 2019, the European Commission adopted the European Green Deal, which aims to 
transform the EU into a fair and prosperous society, with a modern, resource -efficient and 
competiti ve economy, where there are no net emissions of greenhouse gases in 2050, and where 
economic growth is decoupled from resource use. It also aims to protect, conserve and enhance the 
EU's natural capital, and protect the health and well -being of citizens fr om environment -related risks 
and impacts. At the same time, it addresses the imperative for this transition to be just and inclusive 
by paying attention to the regions, industries and workers who will face the greatest challenges.  
 
The European Pillar of Social Rights55 is the EU's social strategy to make sure that the transitions of 
climate neutrality, digitalisation and demographic change are socially fair and just. The Commission 
Communication: A Strong Social Europe for Just Transitions56 outlines key pr iority areas and 
initiatives for the period 2020 -2021 to deliver in this area.  
 
The Communication on the European Green Deal provides an initial roadmap of the key policies and 
measures needed to achieve the European Green Deal57,58 - COM(2019) 640. In part icular, the 
European Green Deal puts forward a set of transformational policies that aim to increase the EU's 
climate ambition for 2030 and 2050, to preserve and restore ecosystems and biodiversity and to 
create a zero pollution ambition for a toxic -free e nvironment. This is coupled with a set of targeted 
policies for the sectors of the economy that are key for the transition towards sustainability, in 
particular, energy, industries, mobility, buildings and the food system. To accompany this change, 
the Eur opean Green Deal also addresses the economic and financial policy framework to mobilise 
both the public and private sectors at all levels – European, national and local. For example, on 
January 14, 2020, the European Commission launched the Investment Plan  for a Sustainable Europe, 
which is the investment pillar of the Green Deal. To achieve the goals set by the European Green 
Deal, the Plan will mobilise at least EUR 1 trillion in sustainable investments over the next decade. 
To ensure that the transition to carbon neutral society is just and inclusive, the Commission proposed 
the Just Transition Mechanism within the European Green Deal Investment Plan, mobilising 100 
million EUR over the period 2021 -27 to ensure tailored financial and practical support to workers 
and citizens of the regions most impacted by the transition59. 
 
The Green Deal is an integral part of this Commission's strategy to implement the United Nation's 
2030 Agenda and the sustainable development. As part of the Green Deal, the Commission will 
refocus the European Semester process of macroeconomic coordination to integrate the United 
Nations' sustainable development goals, to put sustainability and the well -being of citizens at the 
centre of economic policy, and the sustainable development goals at the heart of the EU's 
policymaking and action. Delivering an economy that works for the people and ensuring a just 
transition towards climate -neutrality while providing a high level of economic and political stability 
requires a strong and resilie nt social market economy that allows all to enjoy a high and sustainable 
level of prosperity. Delivering prosperity means raising living standards by increasing the efficiency 
 
52 Viewed at: https://ec.europa.eu/eu2020/pdf/COMPLET%20EN%20BARROSO%20%20%20007%20 -
%20Europe%202020%20 -%20EN%20version.pdf . 
53 Viewed at: https://ec.europa.eu/commission/publications/reflection -paper -towards-sustainable -
europe -2030_en . 
54 Viewed at: https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:52019DC0650&from=EN . 
55 Viewed at: https://ec.europa.eu/commission/priorities/deeper -and-fairer -economic -and-monetary -
union/european -pillar-social -rights_en . 
56 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1223 . 
57 Viewed at: https://ec.europa.eu/info/strategy/priorities -2019-2024/european -green -deal_en . 
58 About 50 legislative and non -legislative initiatives with a delivery date before the end of 2021 . 
59 Viewed at: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_17 . WT/TPR/M/395/Add.1  
 
- 303 - 
 
  of resource use, i.e. productivity growth. The growth strategy outlined in the m ost recent ASGS puts 
emphasis on structural reforms that unlock investment in innovation by delivering effectively 
regulated and integrated markets, so that firms compete on a level playing field, and 
entrepreneurship and innovation are rewarded. The growt h strategy underscores the importance of 
policies that deliver effective equality of opportunity, notably through the provision of equal access 
to high quality public goods. Initial education and lifelong learning play a critical role in equipping 
individu als with the right skills, so they can seize the opportunities of a knowledge -based economy.60 
Comprehensive regional development strategies tailored to the regional needs can deliver upward 
convergence in economic and social outcomes among regions, within and between EU Member 
States.61  
 
Question 65:   
Explain the measures taken by the EU to mitigate the risks and challenges faced by the 
EU outlined in the report.  
 
EU reply:  
The global and European outlook remains fragile with the prospect of a protracted period of subdued 
growth in a context of structural challenges and numerous downside risks. According to the 
Commission's Autumn 2019 forecast, the aggregate euro area fiscal stance is projected to be a 
broadly neutral to slightly expansionary in 2020 and 2021, which looks appropriate against the 
baseline scenario of subdued economic growth. However, using available fiscal space more actively 
and pre -emptively would allow Member States not only to provide a fiscal stimulus in case of a 
sharper slowdown, but  also to refresh and modernise the public capital stock, thereby boosting 
potential growth. Further boosting investment and other productive spending in Member States with 
a favourable budgetary situation would support their potential growth. Moreover, it is very important 
to improve the quality and composition of public finances in all Member States.  
 
The EU intends to implement policies that would support skill upgrading to harness the benefits of 
digitisation, and facilitate the transition toward a clima te-neural EU. In addition to boosting the 
growth outlook, improving human and physical capital through increased investment in education 
and key infrastructure could raise productivity growth. A targeted package of fiscal and structural 
policies could furt her contribute to the transition to an environmentally and socially sustainable 
economy that is at the centre of the European Green Deal, which the new Commission has put 
forward. Furthermore, the EU continues to put strong emphasis on investment through t he 
Sustainable Investment Plan and the InvestEU.  
 
The Commission has put forward several initiatives to help get more people into work. This includes 
the Youth Guarantee62, the Youth Employment Initiative63, the Recommendation on long -term 
unemployment64 and the Skills Agenda for Europe .65 The European Globalisation Adjustment Fund66 
provides support to people losing their jobs as a result of major structural changes in world trade 
patterns due to globalisation or as a result of the global econ omic and financial crisis. The 
Commission Communication: A Strong Social Europe for Just Transitions67 provides and overview 
and priority areas for the period 2020 -21 in this area.  
 
Page 25, Paragraph 1.33  
 
Question 66:   
What are the reasons behind the declining trend of EU's share in world trade in goods and 
services for two decades?  
 
 
60 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016DC0381; https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52019XG0605(01) . 
61 Viewed at: 
https://ec.europa.eu/regional_policy/sources/docgener/factsheet/new_cp/simplification_handbook_en.pdf . 
62 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1079 . 
63 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1176 . 
64 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1205&langId=en . 
65 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1223 . 
66 Viewed at: https://ec.europa.eu/social/main.jsp?catId=326 . 
67 Viewed at:  https://ec.europa.eu/social/main.jsp?catId=1223 . WT/TPR/M/395/Add.1  
 
- 304 - 
 
  EU reply:  
Europe's trade with the rest of the world is a major driver of economic prosperity, both at home and 
abroad. Even though the EU  share of world goods and services trade has decreased over the past 
few decades, the EU has remained the largest importer and exporter of goods and services in the 
world. It is also important to note that EU trade in goods and services has increased subst antially in 
absolute terms. Over the last ten years, the value of both EU exports and imports has grown by 
57% and 33%, respectively.68 
 
Page 25, Paragraph 1.34  
 
Question 67:   
Could EU explain the necessary steps to be undertaken in order to address the pro blem of 
the large deficit in the fuel products?  
 
EU reply:  
The EU has no policies with the objective of addressing the deficit on fuel products.  
 
Page 25, Paragraph 1.35  
 
Question 68:   
The share of manufacturing goods exports has decreased since 2016. Pl ease explain the 
steps taken in order to boost the manufacturing sector.  
 
EU reply:  
While the share of manufacturing goods in total goods exports has fallen slightly since 2016, in value 
terms they increased from EUR 1,429bn in 2016 to EUR 1,574bn in 201 8, a 10% increase. 
Competitive manufacturers are leading trade exports. The EU continue to work on improving 
EU's competitiveness focussing at three levels: the enabling environment, the ability of firms to drive 
and adapt to change, and the ultimate resul ts in terms of productivity growth, trade performance 
and economic well - being.  
 
Manufacturers are the backbone of the European economy. Yet companies face more and more 
challenges that put this strong position at risk. EU efforts converge on achieving the  fundamental 
longer -term goal of creating a highly competitive, inclusive and sustainable society to better enable 
Europe's economies to absorb shocks and ensure stable economic performance going into the future.  
 
The EU is elaborating a new comprehensive long-term strategy for Europe's industrial future. This 
should cover all aspects that affect industry and its competi tiveness, from investment and public 
procurement to trade, skills, innovation and supporting small and medium -sized businesses (SMEs).  
 
Page 36, Paragraph 2.14  
 
Question 69:   
In which sectors, is the EU focussing on, in order to generate employment opportunities 
for women supported by extra -EU exports?  
 
EU reply:   
A recent study by the European Commission "Female Participation in EU exporting activities: jobs 
and wages" shows that the EU's exports to the world support 36 million jobs across Europe, of which 
more than 13 million are held by women. Trade therefore provides substantial potential for 
empowering women across the EU. The study also includes data on women share in 
exports-supported employment per sector (Table 2). For further information, please see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf.  
 
In addition, another recent study "From Europe to the World: Understanding Challenges for 
Europea n Businesswomen" found that although women and men -led companies tend to export to, 
and import from similar markets, there are differences in their industry concentration. For example, 
women -led companies are most present in the clothing subsector, a secto r with lower growth 
 
68 Sources: Eurost at (Comext, Statistical regime 4), Eurostat (bop_its_tot; bop_its6_tot), IMF DOTS, 
WTO.  WT/TPR/M/395/Add.1  
 
- 305 - 
 
  potential, and under -represented in transport equipment, with higher export potential. For further 
information, please see: http://www.intracen.org/publication/Europe -to-world/ . 
 
Question 70:   
Could the EU provide the details of the ana lytical work done in order to understand the 
impact of trade on gender equality and women's participation in the economy?  
 
EU reply:   
EU reply: Sustainability Impact Assessments in support of the negotiations of trade agreements with 
Chile, Australia and New Zealand includes a gender impact analysis. This contains an assessment, 
based on the latest methodology available — the UNCTAD Trade and Gender Toolbox – of the impact 
on women in their roles as workers, entrepreneurs, traders, and consumers. For furth er information, 
please refer to the following website: https://ec.europa.eu/trade/policy/policy -
making/analysis/policy -evaluation/sustainability -impact -assessments/.  
 
In addition, please see the two abovementioned studies (please see reply to Question 69).   
 
Page 37, Paragraph 2.16  
 
Question 71:  
EU is requested to provide an account of some of its recent policy measures aimed at 
having robust trade and investment which protects EU's interest and ensures fairness and 
transparency as well.  
 
EU reply:   
Detailed information regarding EU's trade and i nvestment policy measures is available on DG 
TRADE's website https://ec.europa.eu/trade/ . 
 
Page 37, Paragraph 2.17  
 
Question 72:  
EU is requested to provide a link of its recommendations for negotiating directives for 
trade agreements.  
 
EU reply:   
This is the link to the draft negotiating directives for the future negotiations with the UK. 
https://ec.europa.eu/info/sites/info/files/ communication -annex -negotiating -directives.pdf . 
 
Page 37, Paragraph 2.18  
 
Question 72:  
Can EU please clarify the fact that in the case of investment protection agreement (where 
EU does not have an exclusive competence) if there is any inconsistency/confli ct between 
the share competences of EU and the member states which will prevail?  
 
EU reply:  
In the scenario where the EU decides to exercise its shared competences in form of so -called "mixed 
agreements" (i.e. agreement that are concluded by the EU and by  its Member States), the Union  and 
the Member State act together. No inconsistencies or conflicts between the competences of the EU 
and the competences of the Member States arise in such scenarios.  
 
Page 42, Paragraph 2.35 -2.36 
 
Question 73:  
Can EU pleas e clarify whether to enter into investment protection agreement is the sole 
prerogative of the EU member states? Is there any requirement of particular number of 
members for an investment protection agreement to be concluded by the EU with the 
country outs ide EU?   
 
EU reply: Foreign direct investment is an integral part of the common commercial policy, which falls 
under the exclusive competence of the European Union. Therefore, the Union is competent to 
negotiate and conclude new investment agreements with third countries. Suc h EU agreements are WT/TPR/M/395/Add.1  
 
- 306 - 
 
  binding on all EU Member States. Existing individual bilateral investment treaties (BITs) between 
EU Member States and third countries can be maintained in force until they are replaced by 
EU agreements  with the same third countries. Un der certain conditions, EU Member States can also 
be authorised by the European Commission to negotiate new or amend existing bilateral agreements 
until an EU agreement enters into force.  
 
Page 47, Paragraph 2.55  
 
Question 73:  
Which is the sector specifi c regulation which EU believes as a main obstacle to investment 
in growth of service and product market?  
 
EU reply:  
The EU is the world's main provider and the top global destination of foreign investment and is one 
of the most open places to invest in t he world. Since 2009 the EU investment policy aims to several 
objectives: - secure a level playing field so that EU investors abroad are not discriminated or 
mistreated; - make it easier to invest by creating a predictable and transparent business 
environm ent; - promote investment that supports sustainable development, respect for human 
rights and high labour and environmental standards. This includes encouraging corporate social 
responsibility and responsible business practices; - attract international inv estment into the EU, 
while protecting the EU's legitimate and essential interests, and; - preserve the right of home and 
host countries to regulate their economies in the public interest.  
 
Page 53 Paragraph 3.7  
 
Question 74:  
What are the transitional arrangements that are in place pursuant to UCC work 
programme?  
 
EU reply:  
The "transitional arrangements" that continue to apply until the new or upgraded UCC electronic 
systems are in place are essentially the ability to contin ue using pre -existing electronic and paper -
based national and EU -wide arrangements for the completion of customs formalities.  
For more information please consult: https://ec.europa.eu/taxation_customs/business/union -
customs -code/ucc -introduction_en . 
 
and this Regulation: https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2019.111.01.0054.01.ENG&toc=OJ:L:2019:111:TOC . 
 
The detailed rules regarding the transitional period are contained in a Transitional Delegated Act 
(https://ec.europa.eu/ taxation_customs/business/union -customs -code/ucc -
legislation_en#heading_4 ). and the planning for the deployment of the remaining UCC systems are 
set out in the UCC Work Programme (https://ec.europa.eu/taxation_customs/business/union -
customs -code/ucc -legislation_en#heading_5).  
 
Page 56 Paragraph 3.16  
 
Question 75:  
India request EU to apprise on whether EU harmonized trader interface, the eAEO, is 
operational as of now or not?  
 
EU reply:   
The eAEO Customs trader portal is fully operational since 16/12/2019. For more information, please 
consult https://ec.europa.eu/taxation_customs/general -information -customs/customs -
security/authorised -economic -operator -aeo/authorised -economic -operator -aeo_en . 
 
Page 56 Paragraph 3.17  
 
Question 76:  
India requests EU to provid e the detailed list of trade lane and maritime ports under Smart 
and Secure Trade Lanes (SSTL) Project which operates about 120 trade lanes involving WT/TPR/M/395/Add.1  
 
- 307 - 
 
  200 economic operators between 16 maritime ports in certain EU member States and 
China.  
 
EU reply:   
The Sm art and Secure Trade Lanes (SSTL) Project falls under a strategic framework for customs 
cooperation signed between the EU and China. Modalities and details of this project are the sole 
responsibility of the EU and China and are not to be disclosed to other  non-involved parties.  
 
Page 57 Paragraph 3.21  
 
Question 77:  
EU is requested to explain the implication of CJEU ruling which dealt with whether transfer 
prices can be used as the basis for the transaction value methodology of valuation.  
 
EU reply:   
In its judgement in the case C -529/16 the Court of Justice of the E uropean Union confirmed that the 
provisions of the EU customs legislation pertaining to the value of goods for customs purposes do 
not permit an agreed transaction value, composed of an amount initially invoiced and declared and 
a flat-rate adjustment made  after the end of the accounting period, to form the basis for the customs 
value, without it being possible to know at the end of the accounting period whether that adjustment 
would be made up or down.  
 
Page 57 Paragraph 3.24  
 
Question 78:  
EU is requested to provide an overview of the changes which have taken place both for 
preferential and non -preferential rules of origin as a result of the implementation of UCC.  
 
EU reply:   
Technical details of the changes relating to preferential origin can be found in implementing and 
delegated regulations entered into force in 2016:  
https://ec.europa.eu/taxation_customs/business/calculation -customs -duties/rules -origin/general -
aspects -preferential -origin/arrangements -list/generalised -system -preferences_e n. 
 
The main changes to the articles relating to non -preferential origin are:  
Inclusion of an article regarding products "wholly obtained in a single country ", inclusion of additional 
tariff lines in Annex 22 -01 creating for those products legally binding  rules for the interpretation of 
Art 60(2) of the UCC, a general article dealing with a list of 'minimal operations', deletion of 
provisions on the "universal certificate of origin ". 
 
Page 62, Table 3.3  
 
Question 79:  
As per the Table 3.3, kindly provide in formation on the tariff lines which have 
non-ad valorem  tariffs with no AVEs?  
 
EU reply:   
The EU invites India to contact the WTO Secretariat for the tariff items concerned as that report was 
prepared by them. India is alternatively invited to calculate AVEs itself, although the EU notes that 
there is no consensus on the methodology to be used.  
 
Page 62, Paragraph 3.39  
 
Question 80:   
Can the EU explain the reasons for maintaining usage of non -ad valorem  rates for 
agricultural products?  
 
EU reply:   
These tariffs were negotiated and agreed with the membership during the Uruguay Round. Changes 
would only occur as the result of comprehensive market access negotiations.  
 WT/TPR/M/395/Add.1  
 
- 308 - 
 
  Page 63, Table 3.4  
 
Question 81:  
Does the EU have any plans to replace the non -ad valorem  duties in agricultural products 
in order to increase transparency in trade?  
 
EU reply:   
The EU's import regime for agricultural products is fully transparent and predictable and is set out 
in the EU's WTO schedule. Changes would only occur as the  result of comprehensive market access 
negotiations.  
 
Page 66, Paragraph 3.46  
 
Question 82:  
EU is requested to provide the list of suspension which has been deleted as a result of 
implementation of the agreement on expansion of the Information Technology 
Agreement.  
 
EU reply:   
The details of the deleted suspensions can be found in the Official Journal of the EU (Council 
Regulation (EU) 2019/999 of 13 June 2019 amending Regulation (EU) No . 1387/2013 suspending 
the autonomous Common Customs Tariff duties on  certain agricultural and industrial products).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex:32019R0999 . 
 
Page 66, Paragraph 3.47  
 
Question 83:  
EU is requested to provide the details of new tariff quotas along with those with increased 
quota volumes  
 
EU reply:  
The details can be found in the Official Journal of the EU (Council Regulation (EU) 2019/998 of 
13 June 2019 amending Regulation (EU) No 1388/2013 opening and providing for the management 
of autonomous tariff quotas of the Union for certain agricultural and industrial products):  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex:32019R0998 . 
 
Page 66, Paragraph 3.48  
 
Question 84:  
What is the mechanism, process and requirement for granting/obtaining Air Worthiness 
certificate?  
 
EU reply:  
The requirements established for issuing airworthiness certificate are laid down in Regulation (EU) 
No. 748/2012 (SubPart H – points 21.A.171 to 21. A.181).  
 
Page 70, Paragraph 3.57  
 
Question 85:  
For goods not covered in the harmonized categories, what are the conditions under which 
member states may charge excise on other products?  
 
EU reply:  
Article 3(1) of Directive 2008/118/EC provides that Member States may levy taxes on products other 
than excise goods. However the levying of these taxes may not, in trade between Member States, 
give rise to formalities connected with the crossing of frontiers.  
 
Page 72, Paragraph 3.61  
 
Question 86:  
Could E U please explain the reason as to why there is rise in number of import 
prohibitions, restrictions, and licensing requirements on imports?  WT/TPR/M/395/Add.1  
 
- 309 - 
 
  EU reply:  
As indicated in the WTO Secretariat Report (section 3.1.5), the measures were adopted for 
environmental, consumer protection and other purposes, as well as to comply with the EU's 
international commitments.  
For example, as regards cultural goods, European Parliament and Council Regulation (EU) 
No. 2019/880 of 17 April 2019 (OJEU L No 151 of 7.6.2019) provides  for the following 
two prohibitions/restrictions of import in the Union:  
 
(1) A general prohibition to introduce into the EU customs territory cultural goods, which have been 
illegally exported from a third country . The aim of this provision is to prevent the illicit trade in 
cultural goods and to protect the cultural heritage of non -EU countries by mirroring their export 
prohibitions  when these objects are to be introduced in the EU. Its scope includes most of the cultural 
goods categories listed in Article 1 of the 1970 UNESCO Convention on the Means of Prohibiting and 
Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property . 
(2) A system of import licences or importer statements . The ai m of these provisions is, again, to 
prevent the illicit trade in cultural goods and to protect the cultural heritage of non -EU countries, by 
mirroring their export prohibitions  when these objects are to be imported in the EU. Because the 
import licence app lications and the submission of importer statements to customs is to be managed 
electronically, the relevant provisions will not apply before a centralised electronic system becomes 
operational , i.e. by 28 June 2025 at the latest . 
 
Page 79, Paragraph 3.78  
 
Question 87:  
Could EU please explain the rationale behind different method in determining the normal 
value?  
 
EU reply:  
The rationale is that when domestic prices and costs are distorted owing to state interference in the 
economy they do not provide a p roper basis to determine the normal value. In those cases other 
benchmarks reflecting undistorted costs of production and sale will be used. These could include 
benchmarks, or corresponding costs of production and sale in an appropriate representative coun try 
with a similar level of economic development as the exporting country. This dumping methodology 
allows the Commission to establish the actual magnitude of dumping where distortions exist.  
 
Page 85, Paragraph 3.96  
 
Question 88:  
Can EU please elucidate how restrictive measures and sanctions has helped in promoting 
its objectives of peace, democracy and respect for the rule of law, human rights and 
international law?  
 
EU reply:  
EU restrictive measures send a strong signal to the listed persons and entities that the EU is 
committed to international law, human rights, democracy and the rule of law. On more than one 
occasion, EU restrictive measures have been lifted or scaled back following a change in behaviour - 
for instance in the case of the Maldives or Iran in relation to the nuclear deal.  
 
Page 86, Paragraph 3.99  
 
Question 89:  
What does it mean by foreign decision based on foreign act? Can it be understood EU does 
not recognize foreign decisions?  
 
EU reply:  
The EU does not rec ognise the extra -territorial application of a third country's measures, since such 
application is contrary to international law. Consequently, the EU will not recognise nor enforce, in 
its territory, decisions based on extra -territorial legislation.  
 WT/TPR/M/395/Add.1  
 
- 310 - 
 
  Page 87, Paragraph 3.103  
 
Question 90:  
Can EU explain the provisions and procedures for the collection of export duties which the 
UCC contains?  
 
EU reply:  
In the EU, both import and export duties are based on the Common Customs Tariff (see Article 56(1)  
UCC). The provisions concerning the customs debt on export (see Articles 81 and 82 UCC) are very 
similar in substance to the provisions concerning the customs debt on import.  It should however be 
noted that the EU does currently not apply export duty.  
 
Page 93, Paragraph 3.122  
Question 91:  
How does the commission identify or determine the "marketable risk countries"?  
 
EU reply:   
Marketable risks means commercial and political risks with a maximum risk period of less than 
two years, on public and non -public buyers in the countries listed in the Annex to the Communication 
on short -term export -credit insurance; all other risks are considered non -marketable. Marketable 
risks are risks for which in principle a market exists, i.e. there is private insurance cap acity available 
to cover these risks.  
For further information on marketable risk countries see https://eur -lex.europa.eu/legal -
content/EN/TXT/HTML/?uri=CELEX:52012XC1219(01)&from=EN. The last page of the document 
includes the list of marketable risk count ries. 
 
Page 9, Paragraph 3.136  
 
Question 92:  
How does EU monitor or control the state aid which distorts competition?  
 
EU reply:   
The European Commission monitors State aid granted under block exempted schemes. This goes 
hand in hand with transparency (Article 9 of the General Block Exemption Regulation (GBER)) and 
reporting obligations by the Member States. Member States have to mai ntain detailed records with 
the information and supporting documentation necessary to establish that all GBER conditions are 
fulfilled and to provide information to the Commission to allow monitoring the application of the 
GBER (Article 11 GBER). The Europ ean Commission systematically follows up on irregularities and 
uses the means at its disposal, as appropriate, to address the competition distortions that these may 
have caused. In some cases, Member States offer to voluntarily redress the problems detecte d, for 
example to amend national legislation or to recover the excess aid granted. In other cases, the 
Commission may need to take formal action, such as opening the formal investigation procedure. 
Under certain circumstances, the European Commission may, fully or partially, withdraw the benefit 
of the block exemption (Article 10 GBER).  
 
For more details on the GBER please refer to 
http://ec.europa.eu/competition/state_aid/legislation/block.html . 
 
Page 108, Paragraph 3.161  
 
Question 93:  
Can EU provide a link to its new framework on market surveillance?  
 
EU reply:   
Regulation (EU) 2019/1020 is available at:  https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32019R1020&from=EN . 
 
Page 113, Paragraph 3.197  
 
Question 94:  
What are the seven key requirements that AI systems should meet in order to be 
trustworthy.  WT/TPR/M/395/Add.1  
 
- 311 - 
 
  EU reply:   
The 7 key requirements for Trustworthy AI defined by the EU's High Level Expert Group on Artificial 
intelligence are:  
 
1 Human agency and oversight: Including fundamental rights, human agency and human oversight  
2 Technical robustness and safety: Including resilience to attack and security, fall back plan and 
general safety, accuracy, reliability and reproducibility  
3 Priva cy and data governance: Including respect for privacy, quality and integrity of data, and 
access to data  
4 Transparency: Including traceability, explainability and communication   
5 Diversity, non -discrimination and fairness: Including the avoidance of unf air bias, accessibility and 
universal design, and stakeholder participation  
6 Societal and environmental wellbeing: Including sustainability and environmental friendliness, 
social impact, society and democracy   
7 Accountability: Including  auditability, mi nimisation and reporting of negative impact, trade -offs 
and redress.  
See also https://ec.europa.eu/futurium/en/ai -alliance -consultation/guidelines#Top . 
 
Page 204,  Paragraph 4.146  
 
Question 95:  
Can EU please elucidate legally binding rules for end - users and energy suppliers by the 
member states pursuant to the energy efficiency directive?  
 
EU reply:  
Relevant provisions for end - users and energy suppliers are lai d down in the Energy Efficiency 
Directive, the Energy Efficiency Directive 2012/27/EU, the Energy Performance of Buildings Directive 
2010/31/EU (EPBD), and in product related Regulations and Directives.  
 
In 2018, as part of the 'Clean energy for all Europeans package', the amending Directive on Energy 
Efficiency (2018/2002) was agreed to update the policy framework to 2030 and beyond. The key 
element of the Energy Efficiency Directive 2012/27/EU as amended by Directive (EU) 2018/2002 
("EED") is a head line energy efficiency target for 2030 of at least 32.5%.  
The EED as amended also includes an extension to the energy savings obligation in end use as 
provided in Articles 7, 7a, 7b and Annex V EED beyond 2020 with no end date. The obligation 
requires Memb er States to achieve cumulative end -use energy savings equivalent to new annual 
savings of at least 0.8% of final energy consumption from 2021 to 2030 and beyond (except for 
Cyprus and Malta, which have to achieve new savings of 0.24% of final energy consu mption). This 
provided a higher level than in the current period (2020 -2014).  
 
Under Article 7(10) EED as amended, Member States must achieve the required cumulative end use 
energy savings by:  
 
• establishing an energy efficiency obligation scheme (Article 7 a EED)  
• adopting alternative policy measures (Article 7b and Article 20(6) EED); or  
• a combination of the above.  
Member States have significant flexibility and broad discretion to choose, from various types of 
scheme, the system best suited to their particu lar situation and circumstances. Articles 7a(1) and 
7b(1) EED require that all policy measures be designed for the purpose of fulfilling the energy savings 
obligation under Article 7(1) EED and be eligible to contribute to 'end -use energy savings' that are  
"among final customers ". 
 
The key rationale of choosing to implement an energy efficiency obligation scheme to fulfil the energy 
savings obligation might be that energy suppliers, retailers and distributors are best placed to 
identify energy savings with their customers and will be able to achieve energy savings in business 
models for energy services. The designation of an obligated party must be based on objective and 
non-discriminatory criteria as provided in Article 7a(2) EED.  
 WT/TPR/M/395/Add.1  
 
- 312 - 
 
  Alternative measures to fulfil the energy savings obligation, relevant for end -users and energy 
suppliers, could be inter alia : 
 
• regulatory, financial, fiscal, voluntary or information provision instruments which have to 
be formally established and impleme nted in a Member State to create a supportive 
framework, requirement or incentive for market actors to provide and purchase energy 
services and to undertake other energy efficiency improvement measures.  
 
Energy suppliers could benefit from financing scheme s and instruments, and fiscal incentives. These 
are policy measures established by a Member State under which a monetary and fiscal incentive 
leads to the application of energy -efficient technology or techniques and which have the effect of 
reducing end -use energy consumption .69 
 
Other elements relevant for end - users and energy suppliers in the EED as amended include:  
 
• stronger rules on metering and billing of thermal energy by giving consumers - especially 
those in multi -apartment building with collective heating systems – clearer rights to 
receive more frequent and more useful information on their energy consumption, also 
enabling them to better understand and control their heating bills;  
• requiring Member States to have in place transparent, publicly avail able national rules on 
the allocation of the cost of heating, cooling and hot water consumption in multi -apartment 
and multi -purpose buildings with collective systems for such services;  
• monitoring efficiency levels in new energy generation capacities;  
Page  226-227, Paragraphs 4.242 -4.245  
 
Question 96:  
Can EU provide links to the regulation/proposals related to the measures pertaining to 
sustainable finance?  
 
EU reply:  
The Commission adopted the "action plan on financing sustainable growth" in March 2018, with ten 
actions in order to (1) mobilise priva te capital to finance climate -related and environmental 
investments; (2) make climate and sustainability risks more transparent in financial markets and 
(3) foster longer -term, more responsible decision -making in financial institutions and companies.  
Major actions are currently being implemented, including legislative proposals on transparent 
disclosure requirements for the financial sector on sustainability matters and new EU climate 
benchmarks to help steer private capital to low -carbon investments.  
https://ec.europa.eu/info/publications/180308 -action -plan-sustainable -growth_en . 
 
In its Communication on the European Green Deal, the European Commission has announced that 
the EU will increase is climate ambition for 2030 and 2050. The private sector wil l be key to financing 
the green transition, alongside public spending. Long -term signals are needed to direct financial and 
capital flows to green investment and to avoid stranded assets. For this purpose, the Commission 
will present a renewed sustainable finance strategy aiming at (i) strengthening the foundations for 
sustainable investment (e.g. corporate governance frameworks, non -financial reporting); 
(ii) increasing opportunities for investors and companies by making it easier for them to identify 
sustainable investments and ensuring that they are credible (e.g. standards and labels); (iii) better 
integrating climate and environmental risks into the EU prudential framework.  
https://ec.europa.eu/info/strategy/priorities -2019-2024/european -green -deal_en . 
 
 
69 The European Commission has published a Recommendation to help EU countries to transpose fully 
the different elements of the amended energy savings obligation into na tional law, putting forward a set of 
clarifications and practical implementation solutions, cf. https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1574946467190&uri=CELEX:32019H1658 . WT/TPR/M/395/Add.1  
 
- 313 - 
 
  Page 249, Paragraph 4.329  
 
Question 97:  
Why is the financial assistance for promotion of internet connectivity is kept confined to 
public bodies?  
 
EU reply:   
In the EU, investments in broadband connectivity come primarily from commercial investors. Some 
EU Member States use public financing to support the deployment of connectivity in market failure 
areas or to support take -up, in line with EU competition and State aid rules.  
 
Within the respect of such rules, Member States can choose diff erent models to implement 
broadband support measures, including publicly built and run networks. However, in the EU the 
model that has been more frequently used is the operator subsidy model, where the public authority 
decides not to become directly involv ed with the broadband deployment and limits itself to 
subsidising one market actor to build and operate the subsidised broadband infrastructure.  
 
Whenever the granting authorities select a third -party operator to deploy and operate the subsidised 
infrastru cture, the selection process shall be conducted in line with the spirit and the principles of 
the EU Public Procurement Directives that ensure that there is transparency for all investors wishing 
to bid for the implementation and/or management of the subsi dised project. Equal and 
non-discriminatory treatment of all bidders and objective evaluation criteria are indispensable 
conditions.  
 
Page 252, Paragraph 4.342  
 
Question 98:  
Can EU please throw some light on how Cyber Security Act 2019 will help in creat ing a 
single digital market for ICT products, services and processes.  
 
EU reply:  
EU Cybersecurity Act  
 
The Cybersecurity Act, which entered into force in June 2019, brings two major changes: a 
comprehensive reform of the European Union Agency for Cybersecurity (ENISA) and the creation of 
the European cybersecurity certification framework.  
 
Reform of ENISA  
 
The Agency has been granted a permanent mandate as well as additional financial and human 
resources. The major novelties of the new mandate conc ern the key role that ENISA will play in: 
promoting operational cooperation among Member States, assisting them in effectively responding 
to and preventing cyber -attacks; supporting the implementation of the Directive on security of 
network and information  systems (NIS Directive); establishing and maintaining the European 
cybersecurity certification framework.  
 
European cybersecurity certification framework  
 
The EU cybersecurity certification framework entered into force on 26 June 2019 and will allow for 
the establishment of tailor -made EU certification schemes for ICT products and services. This will 
enable users to know what the cybersecurity features of the ICT products and services are. 
Companies that want to certify their products will be able to obtai n certificates that are valid across 
the whole EU.  
 
The schemes will be prepared by ENISA in consultation with stakeholders and will be adopted by the 
European Commission. The European cybersecurity certification schemes are non -discriminatory and 
based o n European or international standards. The use of the new European certification schemes 
is voluntary. Companies established within the EU or elsewhere that choose to certify their products 
will be able to obtain certificates that are valid across the whol e EU, therefore providing a strong 
incentive for companies to certify products, processes and services on EU level.  
 WT/TPR/M/395/Add.1  
 
- 314 - 
 
  One of the aims of the European Cybersecurity Certification Framework is to avoid the fragmentation 
of cybersecurity certification schemes  across EU Member States, therefore further helping to create 
a single digital market. Within the EU, once a scheme is in force, under the framework, in a particular 
area, national schemes in the EU in that area will no longer be valid and EU Member States  shall not 
introduce new national cybersecurity certification schemes for ICT products, services and processes 
already covered by a European scheme that is in force.  
 
As regards cybersecurity standards, non -EU stakeholders will continue to contribute to t he 
development of both European and international standards as they do now. The development of 
cybersecurity standards does not take place within the framework but remains with the relevant 
standards development organisations.  
 
Page 303, Table A 3.6  
 
Question 99:  
Why EU does not consider giving trademarks to olfactory or smell marks?  
 
EU reply:  
Smell/olfactory or taste marks are currently not eligible for protection as EU trademarks (EUTM). 
This is because the representation must be clear, precise, s elf-contained, easily accessible, 
intelligible, durable and objective (Article 3(1) of Commission Implementing Regulation 2018/626 
(EUTMIR)), and the current state of technology does not allow these types of marks to be 
represented in such a way. Furthermo re, the EUTMIR does not recognise the submission of samples 
or specimens as suitable representation. A mark description cannot replace the representation, 
because a description of a smell or taste is neither clear, precise nor objective (12/12/2002, 
C-273/00, Sieckmann, EU:C:2002:748, § 69 -73; 04/08/2003, R 120/2001 -2, THE TASTE OF 
ARTIFICIAL STRAWBERRY FLAVOUR (gust.)). Therefore, any application for an olfactory or taste 
mark will not be treated as an application for an EUTM ('deemed not filed') by the Eu ropean Union 
Intellectual Property Office since it would not comply with the requirements for obtaining a filing 
date. 
 
Page 303, Table A 3.6  
 
Question 100:  
EU is requested to explain/list the criteria upon which it decides the distinctiveness of a 
mark?  
 
EU reply:   
According to settled case -law, distinctiveness of a trade mark within the meaning of Article 7(1)(b) 
of Regulation 2017/1001 on the European Unio n trade mark (EUTMR) means that the sign serves to 
identify the product and/or services in respect of which registration is applied for as originating from 
a particular undertaking, and thus to distinguish that product from those of other undertakings 
(29/04/2004, C -468/01 P – C-472/01 P, Tabs (3D), EU:C:2004:259, § 32; 21/10/2004, C -64/02 P, 
Das Prinzip der Bequemlichkeit, EU:C:2004:645, § 42; 08/05/2008, C -304/06 P, Eurohypo, 
EU:C:2008:261, § 66; 21/01/2010, C -398/08 P, Vorsprung durch Technik, EU:C:2010: 29, § 33). 
According to settled case -law, such distinctiveness can be assessed only by reference first to the 
goods or services in respect of which registration is sought and, second, to the relevant public's 
perception of that sign (12/07/2012, C -311/11 P , Wir machen das Besondere einfach, 
EU:C:2012:460, § 24 and case -law cited).  
According to the case -law of the European courts, a word mark that is descriptive of characteristics 
of goods or services for the purposes of Article 7(1)(c) EUTMR is, on that ac count, necessarily devoid 
of any distinctive character with regard to the same goods or services for the purposes of 
Article  7(1)(b) EUTMR (12/06/2007, T -190/05, Twist & Pour, EU:T:2007:171, § 39).  
In a similar vein, even though a given term might not be clearly descriptive with regard to the goods 
and services concerned, as to the point that an objection under Article 7(1)(c) EUTMR would not 
apply, the term would still be objectionable under Article  7(1)(b) EUTMR on the ground that it will 
be perceived by the relevant public as only providing information on the nature of the goods and/or 
services concerned and not as indicating their origin (12/07/2012, T -470/09, Medi, EU:T:2012:369, 
§ 22).  
An objec tion under Article 7(1)(b) EUTMR would also apply in those cases where the lexical structure 
employed, although not correct from a grammatical point of view, can be considered to be common WT/TPR/M/395/Add.1  
 
- 315 - 
 
  in advertising language and in the commercial context at issue (25/ 04/2013, T -145/12, Eco Pro, 
EU:T:2013:220, § 29 -32). 
 
Page 135, Para 3.3.6, Government procurement  
 
Question 101:  
As per the recent guidelines of the Commission, there are restrictions on the participation 
of Indian or foreign companies in the EU Public Pr ocurement. Does this mean that third 
countries like India which do not have such binding agreements with the EU, will not get 
any guaranteed access in the EU's public procurement tenders?  
 
EU reply:   
The purpose of the Guidance on the participation of thi rd-country bidders and goods in the EU 
procurement market  is to offer assistance to public buyers in the EU when dealing with third -country 
bidders' participation in tenders. The Guidance recalls that the international agreements concluded 
by the EU on pub lic procurement define who has secured access to the EU procurement market. It 
clarifies that economic operators from third countries, which do not have any agreement providing 
for the opening of the EU procurement market or whose goods, services and works  are not covered 
by such an agreement, do not have secured access to procurement procedures in the EU and may 
be excluded.  
 
Page 47, Section 2.4.2 Investment relations with third countries  
The Court of Justice of the European Union (CJEU) distinguishes bet ween Foreign Direct Investment 
(FDI) and other forms of investment (e.g., portfolio investment) and holds that only FDI falls within 
the exclusive competence of the EU. The criterion used by CJEU to define FDI, is the existence of 
lasting and direct links and the effective participation in the investment's management or control. 
This definition viz. an investment of any kind by a foreign investor aiming to establish or to maintain 
lasting and direct links between the foreign investor and the target company in order to carry out 
an economic activity in a Member State , now forms part of the definition of FDI in the Regulation 
(EU) 2019/452 establishing a framework for the screening of FDI into the Union.  
 
Question 102:  
On that basis, does it mean that Member States cannot, in principle, conclude investment 
agreements with third countries on their own (or amend existing ones), unless authorised 
by the Commission?  
 
EU reply:  
Since entry into force of the Lisbon Treaty, the EU has exclusive competence for foreign direct 
investment. Regulation 1219/2012 on the transitional arrangements for bilateral investment 
agreements lays down the conditions under which EU member States can conclude or amend 
bilateral investment agreements with third countries. The Regulation also sets out the mechanism 
under which the EU grants authorisations to EU member States to conclude such agreements. An 
authorisation cannot be granted by the Commissio n if an EU -level investment negotiation is already 
ongoing with the same third country (or if the Commission has recommended the opening of such a 
negotiation). Other key conditions include compatibility with Union law and consistency with the 
Union's prin ciples and objectives for external action.  
 
Page 58, Section 3.1.2.1 Non-preferential Rules of Origin  
 
Question 103:  
Paragraph 3.27 of document WT/TPR/S/395 states:  
"In order to determine their substantial transformation if more than one country is involv ed, the EU 
refers to Annex 22 -01 of the UCC Delegated Act, which lists the specific rules for many products. 
For example, each item may have its own rule specified or it refers to a change in tariff heading, for 
example. Annex 22 -01 sets out specific rules  for several products, at chapter, heading or subheading 
level, for 37 chapters. To determine the non -preferential origin of the products not explicitly 
mentioned in Annex 22 -01, the general rule applies (wholly obtained or last substantial 
transformation) ." 
 
With reference to the above paragraph, following clarifications are sought on the scope and 
application of Annex 22 -01 Union Customs Code (UCC) Delegated Act:  WT/TPR/M/395/Add.1  
 
- 316 - 
 
  i) Will the substantial transformation rule of Article 60 (2) UCC never apply in cases in 
which the product is listed in Annex 22 -01? 
 
EU reply:   
On the contrary, Art 60(2) UCC applies and Art. 32 UCC Delegated Act provides for a legally binding 
interpretation of the general principle of Art 60(2) UCC. Notably, goods listed in Annex 22 -01 UCC 
Delegated Act shall be considered to have undergone their last substantial processing or working, 
resulting in the manufacture of a new product or representing an important stage of manufacture, 
in the country or territory in which the rules set out in tha t Annex are fulfilled or which is identified 
by those rules.  
 
ii) There might be instances in which a process might not meet the primary and residual 
rules of Annex 22 -01 and yet comply with all the requirements of Article 60(2). How has 
the Commission determi ned that the rules inserted in Annex 22 -01 are indeed capable of 
covering all the instances in which substantial transformation actually occurs?  
 
EU reply:   
The residual rules are constructed in a way that the non -preferential origin can be determined whe re 
the primary rules would not be fulfilled.  
 
iii) Should not Annex 22 -01 UCCDA be read as establishing a "presumption" of 
substantial transformation while at the same time allow the "substantial transformation" 
test of Article 60(2) UCC to be carried out on a case-by-case basis?  
 
iv) How does the EU reconcile its reading of Annex 22 -01 with the ECJ judgement in C -
260/08 - HEKO Industrieerzeugnisse (2009 I -11571) in which the Court warned against 
(and prohibited) a determination of non -preferential origin simply bas ed on a mechanic 
reading of the List Rule?  
 
EU reply to iii) and iv):   
Article 32 UCC Delegated Act provides for a legally binding interpretation of the general principle of 
Art 60(2) UCC. Notably, goods listed in Annex 22 -01 UCC Delegated Act shall be considered to have 
undergone their last substantial processing or working, resulting in the manufacture of a new product 
or representing an important stage of manufacture, in the country or territory in which the rules set 
out in that Annex are fulfilled o r which is identified by those rules.  
Having binding non -preferential list rules is, besides fostering a harmonised application by 
MS customs authorities, also creating legal certainty and ensuring equal treatment of operators.  
 
ECJ judgement in C -260/08 r elates to the use of non -legally binding list rules. Provisions in Annex 
22.01 UCC Delegated Act are legally binding.  
 
Page 78 Section 3.1.6 Anti -dumping, countervailing and safeguard measures  
 
Question 104:  
The EU has emphasized the importance of WTO tra de remedy rules as a legitimate tool to combat 
trade distortions and unfair trade practices by others and, through its legislation, applies these 
measures with rigour and consistency. However, there have been instances when anti -dumping 
circumvention deter minations by DG TRADE and non -preferential origin investigations carried out 
by the European Anti -Fraud Office ("OLAF") reach radically different conclusions from DG TRADE's 
anti-circumvention investigations.  In such instances, the binding legal force of E U trade remedies 
determinations is jeopardized and nullified by an act of OLAF which is not appealable before the 
CJEU. 
 
Will EU please clarify its position in such cases, considering that such contradiction 
between conclusions of two organizations comprom ises the uniform application of trade 
remedies rules and customs practice across the Member states?  
 
EU reply:  
The legislative frameworks, procedures and rationale between the investigations carried out by the 
European Anti -Fraud Office ("OLAF") and the trade defence services in anti -circumvention cases are 
different.  
 WT/TPR/M/395/Add.1  
 
- 317 - 
 
  OLAF can investigate matters relating to frau d, corruption and any other illegal activity affecting the 
financial interests of the EU under the framework of Regulation (EU, Euratom) No . 883/2013. In the 
framework of its investigative mandate, OLAF exercises its powers in full independence.  
 
Inter ali a, when conducting investigations, OLAF applies Regulation (EU) No . 952/2013 (the Union 
Customs Code – (UCC)) with the aim of ascertaining the real origin of a certain imported product. 
To this end, OLAF applies the Union Customs Code and the Union Customs  Code Delegated Act 
provisions as regards the non -preferential origin rules. In other words, OLAF's investigation aimed 
at verifying the origin, under the Union Customs Code, of a specific set of products exported by 
specific economic operators in a specif ic timeframe.  
 
On the other hand, DG TRADE verifies if the conditions stipulated by Article 13 of Regulation (EU) 
2016/1036 are met. "Circumvention shall be defined as a change in the pattern of trade between 
third countries and the Union or between indivi dual companies in the country subject to measures 
and the Union, which stems from a practice, process or work for which there is insufficient due cause 
or economic justification other than the imposition of the duty, and where there is evidence of injury 
or that the remedial effects of the duty are being undermined in terms of the prices and/or quantities 
of the like product, and where there is evidence of dumping in relation to the normal values 
previously established for the like product, if necessary in accordance with the provisions of 
Article  2." 
 
These criteria have nothing to do with an origin determination under the UCC.  
 
Page 79, Para 3.78  
 
Question 105:  
EU has amended its anti -dumping legislation in respect to margin calculations to allow "for the  
normal value to be determined by another method where there are state -induced distortions in the 
exporting country. In such circumstances, normal value is determined on the basis of costs of 
production and sale reflecting undistorted prices, or of benchma rks such as international prices or 
costs in another representative country"  
Does the Commission consider the Industrial subsidy schemes operated by the 
Government of India as significant distortions? If yes then under which circumstances 
can Indian subsidy schemes be considered as "state -induced distortions" for the purpose 
of the alternative method for the calculation of the normal value?   
 
EU reply:  
Sub-paragraph (b) of the Article 2(6)(a) of the EU's Basic Anti -dumping Regulation lists in a 
non-exhaustive manner circumstances which may result in significant distortions, as follows:  
 
• the market in question being served to a significant extent by enterprises which operate 
under the ownership, control or policy supervision or guidance of the authori ties of the 
exporting country;  
• state presence in firms allowing the state to interfere with respect to prices or costs;  
• public policies or measures discriminating in favour of domestic suppliers or otherwise 
influencing free market forces;  
• the lack, dis criminatory application or inadequate enforcement of bankruptcy, corporate 
or property laws;  
• wage costs being distorted;  
• access to finance granted by institutions which implement public policy objectives or 
otherwise not acting independently of the state .  
The presence of significant distortions is examined on a case -by-case basis taking into account 
cross-cutting distortions, distortions in the factors of production as well as distortions in the relevant 
sector.  
 WT/TPR/M/395/Add.1  
 
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  Page 118, Regulation (EU) 2019/6  
 
Questi on 106:  
In November 2018, the EU passed new veterinary medicines legislation to lower the risk of 
antimicrobial resistance (AMR) spread through imports of animals or of products of animal origin. 
Article 118 of the concerned Regulation (2019/6) is of parti cular concern, as it may directly impact 
countries exporting animal products to the EU. This Article of the regulation stipulates that 
Article  107(2) shall apply, mutatis mutandis , to operators in third countries and those operators 
shall not use the designated antimicrobials referred to in Article 37(5), insofar as relevant in respect 
of animals or products of animal origin exported from such third countries to the Union.  
 
i) Would the Commission take into consideration the sanitary status/epidemiologica l 
situation of developing countries with huge livestock population like India when applying 
Article 118 for the prohibition of the use of antimicrobials? How would the sanitary status 
be considered?  
 
EU reply:  
The Commission will lay down the detailed rul es as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January 2022.  
 
ii) Given that animal disease conditions and therapeutic approaches vary across the 
globe, will the Commission consider the impact of extraterritorial application of EU risk 
management measures on international animal health?  
 
EU reply:  
The Commission will lay down the detailed rules as regards the implementation of Article 118 in the 
delegated acts to be adopted by 27 January 2022.  
 
iii) Did the Commission conduct an impact assessment on the implementation of Article 
118 with respect to the importation of animals or products of animal origin to the EU and 
its impact on EU business operators?  
 
EU reply:  
The Commission will be considering leg al requirements and obligations relevant human health, 
animal health, animal welfare, and food safety possible impacts as it proceeds with the preparation 
of delegated and implementing acts under Article 37(4) and (5) and with. Furthermore, the 
Commission will take into account the growing international consensus on the necessity to phase 
out the use of antimicrobials for growth promotion.  
 
Document – WT/TPR/G/395  
 
Page – 3, Paragraph – 1.4 
 
Background  
EU trade policy stays firmly grounded in universal fund amental rights and values – like promoting 
ambitious climate change mitigation, protecting the environment and guaranteeing food safety and 
security as well as the protection and promotion of labour rights. It does so by also actively 
promoting the mutual supportiveness between EU trade policy and the multilateral governance on 
such issues in the United Nations and the International Labour  Organisation context. As enshrined 
in the EU Treaty, the EU has an obligation to ensure a coherent approach in terms of foreign policy. 
EU trade policy therefore is consistent with its wider foreign policy objectives – that are to pursue a 
policy that benefits society as a whole – and promotes European and universal standards and values 
alongside core economic inte rests, putting a greater emphasis on sustainable development, human 
rights, consumer protection, and responsible and fair trade.  
 
Question 107:  
The EU is requested to inform about status and its plan for implementation of the trade 
policy of firmly groundi ng universal fundamental rights and values. Can the EU provide 
clarification on following queries by India:  
 
1. pursue a policy that benefits society as a whole;  WT/TPR/M/395/Add.1  
 
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  2. promotes European and universal standards and values alongside core economic 
interests;  
3. Putting a greater emphasis on sustainable development, human rights, consumer 
protection, and responsible and fair trade.  
4. How does the EU foresee to enforce commitments under the non -binding 
Agreements like the ILO and the UN?  
5. Lastly, does this indicate a  fundamental shift away from the preferential regime and 
the various preferential treatments accorded under.  
 
Please provide more clarity on the point 1 (EU or global) and other queries.  
 
EU reply:  
All recent free trade agreements negotiated by the EU con tain a chapter on trade and sustainable 
development (TSD), in which the parties commit to the implementation of fundamental labour rights 
and environmental conventions. As per the reply to Question 30 above, since 2018 the EU has also 
been working with a 1 5-point Action Plan to improve the implementation and enforcement of TSD 
chapters in EU bilateral free trade agreements. Another tool to promote this agenda is through the 
Generalised Scheme of Preferences (GSP). All GSP beneficiary countries are required to comply with 
the principles of 15 international conventions covering human rights and labour rights; in addition, 
beneficiaries of the Special Incentive Arrangement for Sustainable Development and Good 
Governance (GSP+) must ratify and effectively implem ent a total of 27 international conventions 
covering human rights, labour rights, environment and climate, and good governance. The EU works 
closely with each partner to ensure that these commitments are respected.  
 
The unilateral tariff preferences grante d under GSP have in recent years become more important, in 
absolute and relative numbers, as the scheme continues to be a cornerstone of the EU's trade and 
development policy. Despite the falling number of beneficiaries, the value of imports from GSP 
count ries grew by 16.2%, from EUR 158 billion in 2016 to EUR 183.6 billion in 2018 (meanwhile, 
overall EU imports increased by only 13.3%). Of these, EUR 68.9 billion were imported using GSP. 
Utilisation of trade preferences under GSP has gone up to 81.8% in 2018 (78.8% in 2016). For the 
Everything But Arms (EBA) preferential trade scheme, this was 93.4%.  
 
Page – 11, Paragraph – 3.27 
 
Question 108:  
Backgro und 
The new legislation on transparency and sustainability of risk assessment in the food chain 
is an important step towards the modernisation of the EU food safety policy ; it will ensure 
greater transparency, strengthen the governance and the scientific c ooperation and facilitate the 
development of comprehensive risk communication.  
 
The EU is requested to provide clarity on the conditions which would be enforced while modernisation 
of the food safety policy.  
 
1. What is the position of EU on the use of preca utionary principle for restricting trade 
based on measures which are mandatory and permanent in nature, like the MRLs ? This is 
legally not tenable under the SPS Agreement of WTO.  
 
EU reply:  
The EU always uses an EFSA risk assessment as basis to set or amend MRLs. This is always specific 
and risk based and fully in line with SPS Agreement.  
 
2. What does the EU mean by scientific cooperation and facilitate the development of 
comprehensive risk communication? Does this indicate towards more cooperation with 
third countries based on the scientific evidence or increased use of mutual recognition 
agreements (MRAs)?  
Please Clarify.  
 
EU reply:  
The new Transparency Regulation (Regulation (EU) 2019/1381) intends to improve the transparency 
of the EU risk assessment  process carried out by the European Food Safety Authority (EFSA), 
strengthen the governance of EFSA and the scientific cooperation. To this end, it mainly amends WT/TPR/M/395/Add.1  
 
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  Regulation (EC) No . 178/2002 [General Food Law Regulation] and – as far as transparency is 
concerned – eight other sectoral acts, i.e. Regulation (EC) 1829/2003 [GM Food and Feed], 
Regulation (EC) No . 1831/2003 [Feed Additives], Regulation (EC) No . 2065/2003 (Smoke 
flavourings), Regulation (EC) No . 1935/2004 [Food Contact materials], Regulation (E C) 
No. 1331/2008 [common authorisation procedure for food additives/enzymes/flavourings], 
Regulation (EC) No . 1107/2009, Regulation (EU) 2015/2283 [Novel Foods] and Directive 
2001/18/EC [GMO cultivation].  
As regards the strengthening of the scientific coop eration,  
Article 28 paragraph 5(e) empowers EFSA to:  
 "[…] support the tasks of the Scientific Committee and Scientific Panels by organising their work, 
in particular the preparatory work  to be undertaken by the Authority's staff or by designated 
nationa l scientific organisations referred to in Article 36, including by organising the 
possibility for preparing scientific opinions to be peer -reviewed by the Scientific Panels 
before they adopt them ." 
 
This new provision is expected to strengthen the support provided by EFSA and the Member States 
to the work of the EFSA's Scientific Committee and the Scientific Panels. In particular, EFSA will be 
able to organise the preparatory work supporting the tasks of the Scientific Panels, including by 
requesting nation al scientific organisations networking with the Authority to draft preparatory 
scientific opinions to be peer -reviewed and adopted by those Scientific Panels. This work however 
would be without prejudice to the independence of the EFSA's scientific assessm ents (see also recital 
18 of the new Transparency Regulation).  
Moreover, all scientific data, studies and other information supporting any request for a scientific 
output from EFSA (including in the area of authorisation procedures) shall be made publicly  available 
proactively, with the exception of duly justified confidential information, early on in the EU risk 
assessment process. Following public disclosure, EFSA will be launching public consultations on the 
submitted data, studies and other information  to ensure access to the widest evidence -base possible 
before it delivers its scientific output. General public, stakeholders but also risk assessment bodies 
will have the opportunity to take part in these public consultation s. This action is also expected  to 
strengthen scientific cooperation.  
 
  WT/TPR/M/395/Add.1  
 
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  INDONESIA  
1. Renewable Energy Directive (RED) II  
In June 2018, the EU adopted RED II (revised RED) which gradually eliminate the use of biofules 
from source that categorized as high indirect land -use change (ILUC) risk, to achieve the EU 
renewable energy target 2024 -2030.  
 
Questions:  
Please elaborate the scientific evid ence in determining the biofuels source that is 
categorized as ILUC. Please list the products that categorized as high -risk product.  
 
EU reply:  
The approach and scientific evidence used to determine high ILUC risk feedstock is described in the 
European Commission "Report on the status of production expansion of relevant food and feed crops 
worldwide"  (COM(2019) 142 final ). The Report reflects the best available scientific evidence on 
agriculture expansion since 2008 and identifies on that basis palm oil as feedstock qualifying as high 
ILUC-risk feedstock for which a significant expansion into land with high -carbon stock i s observed. 
The Commission will continue to assess the developments in the agricultural sector, including the 
status of expansion of agricultural areas, based on new scientific evidence when preparing the review 
of this report that will be carried out by 3 0 June 2021.  
 
2. ILUC (Indirect Land -Use Change) Draft EU PEFCR  
On the draft EU PEFCR (Product Environmental Footprint Category Rule), domestic paper industries 
are exempt from the obligation of Life Cycle Assessment (LCA).  
 
Questions:  
Please provide the sci entific justification regarding only the domestic paper industries 
exempt from LCA obligation.  
 
EU reply:  
The mentioned draft does not foresee any exemptions from the obligation of Life Cycle Assessment 
on domestic paper industries.  
 
3. Anti-Dumping and An ti-Subsidy Legislations  
• Government Report (page 22 -23, point 4.53 a):  
"Trade defence area: There were two changes to the EU's basic anti -dumping and anti -subsidy 
legislation in December 2017 and June 2018 respectively. The first of these changes to the 
antidumping rules introduced a new methodology to calculate the normal value of goods subject to 
investigation, in case of significant distortions induced by the authorities of the exporting country."  
On the new methodology to calculate the normal value of go ods subject to investigation, the change 
incorporated the calculation of social and environmental costs. In general practice of anti -dumping 
investigation, the main variable of cost calculation are production and retail price.  
 
Questions:  
Please provide the rationale in incorporating social and environmental costs as variable 
of cost calculation in calculating the normal value.  
 
EU reply:  
The rationale in including elements on social and environmental standards in trade defence 
legislation reflects the EU 's commitment to these standards.  
The inclusion of social and environmental costs is relevant in calculating a non -injurious price in 
order to establish the injury margin. Injury margins will reflect the cost of social and enviro nmental 
standards within the European Union. The cost of production also includes costs that EU producers 
incur when complying with multilateral environmental agreements and with important International 
Labour Organisation conventions. It means that actual  costs incurred by EU manufacturers as well 
as future cost increases during the lifetime of TDI measures resulting from compliance with these 
standards will be taken into account, in calculating a non -injurious price.  
 
4. MRLs for Anthraquinone (Aq) of 0,02 mg/kg in tea  
EU policy on the MRL of Aq (0.02 mg/kg) could hinder Indonesia tea export to the EU. This policy 
can be consider burdensome for tea producers as there are possibility of a very small Aq infiltration 
in the production process, even when the tea  is organic ally produced.  WT/TPR/M/395/Add.1  
 
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  The CODEX does not have any MRL standards for Aq, thus we believe it is requires further research 
on the effect of Aq to human body  
 
Questions:  
Please provide the scientific basis on the requirement of MRL for Aq of 0.02 mg/kg . 
 
EU reply:  
The MRLs for anthraquinone were reviewed by the European Food Safety Authority in 2012 
(Reasoned opinion on the review of the existing maximum residue levels (MRLs) for anthraquinone 
according to Article 12 of Regulation (EC) No 396/2005. EFSA Jo urnal 2012;10(6):2761. [6 pp.] 
doi:10.2903/j.efsa.2012.2761. Available online: www.efsa.europa.eu/efsajournal). Residues of 
anthraquinone are not expected to occur in any plant commodity or in any animal product because 
the pesticide use of anthraquinone i s no longer authorised within the EU, no Codex MRLs are 
available for this active substance and no uses authorised in third countries were notified in the 
context of the MRL review. The MRL for anthraquinone in tea was therefore set at 0.02 mg/kg, which 
is the limit of analytical determination for this substance -commodity combination.  
 
5. MRLs for Chlorpyrifos and Chlorpyrifos -Methyl  
 
In December 2019, the EU revoked the regulation on maximum residual limits for pesti cide with 
Chlorpyrifos and Chlorpyrifos -methyl on plants, including pepper. This is not in line with Codex 
standards that allowed maximum limits on residual for Chlorpyrifos (1,0 mg/Kg) and Chlorpyrifos -
methyl (0,3 mg/Kg).  
 
Questions:  
What is the scientific evidence for the policy? Could EU conside r a longer transition period 
for exporting countries to be aquinted?  
 
EU reply:  
Chlorpyrifos was last reviewed by JMPR more than 20 years ago, as it is also indicated in the General 
considerations (point 2.6) of 2019 Report of the Joint Meeting of the FA O Panel of Experts on 
Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide 
Residues in September 2019.  
 
During the 2019 EU Peer Review of the active substance, and based on the information available to 
the European Food Safety Authority, concerns were identified with regard to the genotoxic potential 
of chlorpyrifos that prevented the establishment of health based reference values and did not allow 
to carry out a dietary and non -dietary risk assessments In a ddition, developmental neurotoxicity 
(DNT) effects were observed, that suggested that the substance should be classified as toxic for 
reproduction, category 1B, according to Commission Regulation (EC) No . 1272/2008. (EFSA 
(European Food Safety Authority), 2019. Statement on the available outcomes of the human health 
assessment in the context of the pesticides peer review of the active substance chlorpyrifos. EFSA 
Journal 2019;17(8):5809, 23 pp. https://doi .org/10.2903/j.efsa.2019.5809) . 
 
Similar concerns were identified for chlorpyrifos -methyl. (European Food Safety Authority (EFSA), 
2019. Updated statement on the available outcomes of the human health assessment in the context 
of the pesticides peer review  of the active substance chlorpyrifos -methyl. EFSA Journal 
2019;17(11):5908, 21 pp. https://doi.org/10.2903/ j.efsa.2019.5908)  
 
Notwithstanding the serious health concerns identified, the relevant Regulation that lowers the MRLs 
for chlorpyrifos and chlorp yrifos -methyl to the level of analytical determination includes a period of 
deferral for the application of the lower MRLs and will only become applicable in October 2020. 
No further deferral periods are foreseen.  
 
6. VAT (Value -Added Tax) Directive on e -comm erce 
• Secretariat Report page 69 Poin t 3.55:  
"Another set of rules, amending the main VAT (Value -Added Tax) Directive, are set to enter into 
force in 2021, and aim to simplify VAT for e -commerce transactions . This is expected to have 
an impact on trade and customs procedures, as the VAT exemption threshold of EUR 22 has been 
removed, and this will be accompanied by the need to submit a customs declaration for small 
shipments. The customs exemption of EUR 150 remains in place. However, all commercial goods 
entering the EU will be subject to VAT from 1 January 2021, irrespective of their value."  WT/TPR/M/395/Add.1  
 
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  Questions:  
The VAT exemption threshold of EUR 22 has been removed, and this will be accompanied 
by the need to submit a customs declaration for small shipments, which results in adding 
time for customs clearance. Please provide detail explanation on this part.  
 
EU reply:  
With the purpose of a rapid release into free circulation of low value consignments a new customs 
declaration with a 'super reduced dataset (SRDS) ' was created, containing three times less data 
elements than the standard customs declaration. It is recommended to use such declaration as a 
pre-lodged declaration allowing customs to perform the risk analysis before the arrival of goods. 
Electronic advance  data (EAD) are crucial to implement the obligation to submit a formal customs 
declaration. The concept of electronic advance data for postal items has been endorsed by the UPU 
(Universal Postal Union) that elaborated a detailed roadmap to ensure the imple mentation of EAD 
exchange by all UPU members by end 2020.  
 
7. Green New Deal  
 
On the "Green New Deal" (GND) policy, EU plans to adjust import tariff based on carbon price 
differences between EU and exporting countries. We are of the view that the mechanism fo r 
calculating the carbon price differences will be very complex.  
 
Questions:  
Please provide the development on the draft policy of GND related to trade, and what are 
the plan for carbon border adjustment policy?   
 
EU reply:  
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This  would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way".  
A Carb on Border Adjustment mechanism is not designed to protect European industry from open 
competitions but rather to ensure the environmental integrity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the bo rder measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU 's climate policies. The internal market of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including  the rules of the World Trade Organisation and our trade agreements in 
particular.  
There is a breadth of considerations that need to be r eviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular  with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. I n the 
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 8 0% of global greenhouse gas 
emissions".  
 WT/TPR/M/395/Add.1  
 
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  8. EU Biodiversity Strategy 2030  
 
On June 2019, EU publi shed a n EU Communication (2019) on Stepping up EU Action to Protect and 
Restore the World's Forests, which will be implemented this year under EU Biodiversity Strategy for 
2030. One of the obligation s under this policy is the compliance on "deforest -proof" for co mmodities 
such as CPO, coffee, cocoa beans, spices and livestock.  
 
Questions:  
a) Regarding the compliance, will there be a certificate of compliance for each 
commodity that consider as forest -based risk product? Could EU clarify the relation of this 
requireme nt with Indonesia FLEGT (SVLK)?  
b) How will this regulation be affecting  the supply chains of raw materials to the 
manufacturing industries in the EU? What is the possible effect for EU consumers?  
 
EU reply to question 8 a) and b):  
Following the commitment  in the Commission 's Communication on 'Stepping up EU Action to Protect 
and Restore the World 's Forests ', adopted in July 2019, the Commission has launched an impact 
assessment of new measures to tackle global deforestation associated with the EU 's consump tion 
footprint. It is, however, too early to say what the consequences of these potential measures will be 
as regards supply chains or compliance requirements. The final impact assessment report and the 
related policy proposal of the Commission are planned  for the first quarter of 2021.  
 
9. MRLs for 3MCPD (3 – chloromonopropane 1, 2 -diol) in vegetable oil  
 
We are aware that under the proposed regulation, EU will increase the maximum limit of 3 -MCPD 
and 3 -MCPE on oil vegetables and animal fat to 1,25 µg/kg for 3-MCPD and 2,25 µg/kg for 3 -MCPE.  
 
Questions  
Could EU provide the scientific research which become the basis for determining the level 
of 1,25µg/kg? Will EU provide a cooperation programs with the vegetable oils suppliers 
to comply with the 3 -MCPD thre shold?  
 
EU reply:  
The question is not entirely clear, but we think it refers to the intention of the EU Commission to 
establish two maximum levels for different oils  
− for a list of certain named vegetable oils: 1.25 mg/kg, (the vegetable oils concerned: oils 
 and fats from coconut, maize, rapeseed, sunflower, soybean, palm kernel and olive oils  
− for the other vegetable oils, including palm oil: 2.5 mg/kg . 
 
An overview of the data on 3 -MCPD esters used for the setting of the maximum levels in vegetable 
oils available and used for the EFSA opinion can be found in table 11 of the EFSA opinion 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2016.442 6. 
 
10. Implementation Regulation on Market Surveillance and Compliance for Products 
Originating from Non – EU 
 
In 2019, EU issued a Market Surveillance and Compliance regulation for non -food products that 
regulate the non -EU products that marketed through on -line marketplace need to have the Only 
Representative (OR) to fully responsible for the products. This obliged the non -EU seller to have the 
OR in the EU te rritory.  
 
Questions:  
Please provide the detail mechanism for the OR for non -EU seller. Does the poli cy will be 
extend for non -food products?  
 
EU reply:  
Regulation (EU) 2019/1020 addresses the challenges of e -commerce, and it introduces a 
requirement on manufacturers not established in the EU to appoint a responsible person to act as 
contact point for n ational market surveillance authorities for certain types of products placed on the 
EU market. The Regulation provides flexibility on whom can be this responsible person. 
Manufacturers not established in the EU can appoint an importer or an authorized repr esentative, 
but the responsible person can also be a fulfilment service provider in the EU as laid down in Article  4 WT/TPR/M/395/Add.1  
 
- 325 - 
 
  of the Regulation. In this regard, fulfilment service providers are natural or legal persons offering, 
in the course of a commercial activi ty, at least two of the following services: warehousing, packaging, 
addressing and dispatching, without having ownership of the products involved.  
The requirement to appoint a responsible person is only foreseen for the following industrial non -food 
products and areas: construction products, personal protective equipment, gas appliances, noise 
emission in the environment by outdoor equipment, machinery, toys, eco -design requirements for 
energy -related products, restriction of hazardous substances in e lectrical and electronic equipment, 
pyrotechnics articles, recreational craft, simple pressure vessels, electromagnetic compatibility, 
non-automatic weighing instruments, measuring instruments, equipment for use in potentially 
explosive atmospheres, low -voltage electrical equipment, radio equipment, and pressure equipment.  
The Commission will provide guidelines explaining the practical implementation of this provision. 
The aim is to publish them in the third quarter of 2020.  
Regulation (EU) 2019/1020 is av ailable at the following:  
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1020&from=EN . 
 
11. Market Access for Hoof and Horn as Fertilizer Production  
 
Since 2017, Indonesia proposed a market access and request for information on the regulat ion for 
hoof and horn importation to Germany for fertilizer production.  
 
Questions:  
Please provide detail of regulation for hoof and horn importation for fertilizer production 
(EC Regulation 1069/2009 and other)  
 
EU reply:  
Regulation (EC) No . 1069/2009 o f the European Parliament and of the Council laying down health 
rules as regards animal by -products and derived products not intended for human consumption and 
repealing Regulation (EC) No . 1774/2002. The rules of importation of this product are harmonised . 
According to Article 41(3) of the above regulation, Member States may authorise imports of animal 
by-products if: The product is authorised, the third country is authorised, the establishment of origin 
is approved or registered in TRACES and the competen t authority of a third country certify that 
product comply with the EU animal health requirements.  
 
12. Smart and Secure Trade Lanes (SSTL)  
    Secretariat Report page 56 Poin t 3.17:  
• "Another trade -facilitating measure is the Smart and Secure Trade Lanes (SSTL) Pilot Project 
that was initiated in 2006 as a pilot to test end -to-end supply chain security instruments between 
the EU and China. The Project operates about 120 trade lanes involving 200 economic operators 
between 16 maritime ports in certain EU me mber States and China. The Project has now entered 
into a third phase, whereby traders will have faster customs clearance with enhanced logistical 
processes. This is expected to result in a higher share of goods traded under the SSTL, thereby 
improving sup ply chain security and trade facilitation. The Project is expanding to other modes of 
transportation, in particular air and rail, and to involve more partner countries."  
 
Questions:  
On the Smart and Secure Trade Lanes (SSTL) Pilot Project, what country wil l take part for 
the next project, and what are the roles of each participating country?  
 
EU reply:  
The Smart and Secure Trade Lanes (SSTL) Project falls under a strategic framework for customs 
cooperation signed between the European Union and China. Modalities and details of this project are 
the sole responsibility of the European Union and China and are not to be disclosed to other 
non-involved parties.  
 
  WT/TPR/M/395/Add.1  
 
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  ISRAEL  
3. TRADE POLICIES AND PRACTICES BY MEASURE  
3.3.2 Standards and technical requirem ents  
 
Question  
1. Could the European Union advise if it intends to hold a 3rd country stakeholder 
meeting in advance of the publication of the guidance, in order to make sure that 3rd 
country manufacturers' realistic concerns are understood and addressed in the guidance 
to the member states' market surveillance authorities?  
 
EU reply:  
The aim is to conduct a wide consultation for the guidelines, online and through a meeting open to 
all. 
 
3.3.2.1 New Legislative Framework Question  
 
2. Could the European Union elaborate what are the provisions for an additional direct 
notification to the manufacturer, considering that not all distributors, importers, and other 
economic operators are able or wi lling to notify the manufacturer in a timely manner? For 
example, if a distributor decides to stop offering a product after a non -compliance 
notification and does not pass on the notification either at all, or in a timely manner?  
 
EU reply:  
When a non -compliant product is found, the market surveillance authorities have the discretion to 
contact any economic operator concerned. In order to maximise the effectiveness of market 
surveillance in the EU, it has been recommended as a best practice that market sur veillance 
authorities should always request corrective actions from the economic operator (either the 
manufacturer or the importer) responsible for placing the non -compliant product on the EU/EEA 
market. This request should be made before or in parallel to  addressing the national distributor (i.e. 
any person in the supply chain, of the product other than the manufacturer or importer, who makes 
the product available on the market). Addressing the manufacturer or the importer should ensure 
that corrective act ions are taken at EU/EEA level. In this regard, please see the document "Good 
Practice for Market Surveillance" from July 2017 available at:  
https://ec.europa.eu/docsroom/documents/23041/attachments/1/translations/en/renditions/nativ
e. 
 
3. If there are no pro visions for direct notification to the manufacturer, and the 
distributor, importer, or economic operator does not respond in a timely manner to a 
market surveillance authority, and/or does not notify the manufacturer of the issue, could 
the European Union explain if there is any guidance for what the manufacturer can and 
should do to address a non -compliance notification from a Member State market 
surveillance authority once it comes to their attention?  
 
EU reply:  
Please see the reply to question 2. Furthermore, according to EU legislation, the manufacturer 
remains the responsible economic operator for the compliance of its products. Manufacturers who 
consider or have reason to believe that a product that they have placed on the market is not in 
conformity with the applicable EU legislation shall immediately take the necessary corrective 
measures to bring that product into conformity, to withdraw it or to recall it.  
 
4. Could the European Union explain what is the proc ess for 3rd country manufacturers 
who, through no fault of their own, were not notified in a timely manner, to redress the 
Member State market surveillance authority's non -compliance notification, if they have 
been dropped by their EU distributor, importer , or economic operator?  
 
EU reply:  
As mentioned before, the manufacturer remains the responsible economic operator for the 
compliance of its products. Also, it has been recommended as a best practice that market 
surveillance authorities contact the econom ic operator responsible for placing the non -compliant 
product on the market to take corrective actions (the manufacturer or the importer). Furthermore, 
EU legislation ensures that where a non -compliance is not limited to the territory of a Member State, WT/TPR/M/395/Add.1  
 
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  information is shared with other Member States market surveillance authorities in order to ensure 
that action against a non -compliant product is taken at EU level.  
 
5. Could the European Union advise if 3rd country manufacturer are able to directly ask 
questio ns of and directly receive responses from a Member State market surveillance 
authority regarding a notification of non -compliance?  
 
EU reply:  
Yes, a manufacturer, wherever is located, can contact directly a market surveillance authority in a 
Member State  
 
6. Could the European Union advise if 3rd country manufacturer are able to directly ask 
questions of and directly receive responses from a Member State market surveillance 
authority regarding a notification of non -compliance?  
 
EU reply:  
The basic principle  is that when a market surveillance authority in one Member States finds a product 
to be non -compliant, it is presumed to be non -compliant also by the authorities in other Member 
States. They do not need to do their own investigation. It is, however, possi ble for authorities in 
other Member States to reach a different conclusion based on an own investigation. In such case, 
the follow -up depends on the specific product legislation concerned. In most cases, the European 
Commission then makes a decision on whe ther the action taken by the first authority was justified. 
In other cases, informal discussions will take place between the relevant authorities across the EU 
to settle the issue.   
 
7.  Could the European Union advise if  there is a publicly available regi ster of recognized 
authorized representatives? Does the European Union  consider to facilitate access for 
third country manufacturers to EU authorized representation service providers?  
 
EU reply:  
There is no such register. The private sector has full freed om to facilitate this.  
 
4.4.3 E -commerce  
4.4.3.2.2 VAT aspects of e -commerce  
 
Question  
8.  Could the European Union elaborate if there are any guidelines on registration to the 
One Stop Shop scheme for third country vendors? What is the timeline for said  guidance?   
 
EU reply :  
The legislation setting up the details for the registration to the One Stop Shop scheme is being 
updated and will most likely be adopted in February 2020. The new registration details are similar 
to the one existing in the Mini One Stop Shop (MOSS) and fur ther explanations are available in the 
MOSS guide (https://ec.europa.eu/taxation_customs/business/vat/telecommunications -
broadcasting -electronic -services/content/guide -vat-mini-one-stop-shop-moss_en). This MOSS 
guide will also be updated by mid 2020.  
 
3. TRADE POLICIES AND PRACTICES BY MEASURE  
3.1.4. Other Charges affecting import  
 
Question  
9. Israel notes that the European Union applies lower value added tax rates on 
foodstuffs. Could the European Union elaborate on this policy?  
EU reply:   
The Common Agric ultural Policy (CAP) continued on the path towards market orientation and away 
from trade -distorting support measures. New CAP post -2020 in the making, proposals of 1/6/2018  
 
9.1 What is the rationale behind this practice?  
 
EU reply:   
The rational behind appl ying reduced rates of VAT is that applying reduced rates of VAT should lead 
to lower prices for final consumers compared to the applications of the standard rate of VAT.  WT/TPR/M/395/Add.1  
 
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  9.2 Is there a difference between fresh produce and processed food?  
 
EU reply:  
There is no  difference between produce and processed food. Member States can apply a reduced 
rate of VAT to both kind of foodstuffs.  
 
3.3.3 Sanitary and phytosanitary requirements  
3.3.3.1 Plants and plant products  
 
Question  
10. Article 42 of Regulation (EU) 2016/2031 on protective measures against plant pests 
introduced the new concept of "high risk plants, plant products and other objects". Israel 
understands that this concept was based on a scientific preliminary assessment by EFSA.  
10.1  Could the European Union specify the scientific basis on which these specific plant 
genera were selected?  
 
EU reply:  
The selection of the specific genera was based on a preliminary risk assessment, taking into 
consideration the preservation of impo rtant European crops and the environment, in accordance 
with Article 42 of Regulation (EU) 2016/2031, which is the legal basis. The preliminary risk 
assessment was carried out in accordance with the criteria set out in Annex III of that Regulation.  
 
10.2  Could the European Union specify the time frame given to EFSA to revise the 
requested dossiers for these "high risk plants, plant products and other objects" received 
from third countries?  
 
EU reply:  
EFSA is not bound to a specific timeframe to revise the dossi ers for "high risk plants, plant products 
and other objects" received from third countries. The length of the revision process is highly 
dependent on the quality of the dossier and whether it includes all the requested documents specified 
in EFSA's technic al report on "Information required for dossiers to support demands for import of 
high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 
2016/2031". If the dossier is incomplete, EFSA requests the applicant country f or the missing 
documents and the risk assessment process is put on hold until all the necessary information is 
submitted.  
 
10.3  Could the European Union specify the measures taken to minimize negative trade 
effects following the introduction of Regulation (EU) 2016/2031?  
 
EU reply:  
The European Union has taken the necessary actions to ensure that the whole process from the 
submission of the dossier until the publication of the relevant regulatory decision is finalized within 
a reasonable time. It has ensured th at EFSA has the necessary resources to carry out the risk 
assessment in a reasonable time and the regulatory proposal follows very soon after the publication 
of the EFSA opinion.  
EFSA published in October 2018 a Technical Report, detailing the information EU-trade partners 
need to include in the dossiers for the risk assessment to be carried out.  
To support the competent authorities of EU trade partners in the preparation of their dossiers, EFSA 
has also organised 2 webinars:  
 
• How to prepare dossiers to support demands for import of high -risk plants and plant 
products, on 12 February 2019, available online at:  
www.efsa.europa.eu/en/events/event/webinar -how-prepare -dossiers -support -demands -
import -high. 
• How to prepare a pest list for a commodity  and a dossier for Momordica fruits, on 
17 October 2019, soon available online at: 
www.efsa.europa.eu/en/events/event/webinar -how-prepare -pest-list-commodity -and-
dossier -momordica -fruits. 
 WT/TPR/M/395/Add.1  
 
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  4 TRADE POLICIES BY SECTOR  
4.1.1 Agriculture  
4.1.1.2.1.1 Direct Payments  
 
Question  
11. Israel appreciates the detailed description of the various payment schemes and their 
distribution among EU Member States. Could the European Union estimate what 
percentage of these payments is given through farmers' co operatives and what 
percentage of these payments is payed directly to farmers?  
 
EU reply:  
The EU does not collect any data on this particular matter.  
 
4.1.1.2.1.2 Internal market support measures  
 
Question  
12. Israel notes that the Amber Box support is now fo cused mainly on two sectors – 
cereals and dairy. Could the European Union elaborate on the adjustment aid to milk 
producers?  
 
EU reply:  
The majority of EU Amber Box support is indeed related to the public intervention system for cereals 
(common wheat only) , SMP, and butter. This is notified every year in accordance with the rules in 
the Agreement on Agriculture although in practice, it is rarely used. In the last ten years, SMP 
intervention was used once; it was never used for cereals or butter. The adjustm ent aid to milk 
producers was made available due to low milk prices in 2015/16. This was explained in detail in the 
Regular Committee on Agriculture – in particular see the EU response to question AGIMS ID 90026.  
 
ISRAEL – ADDITIONAL QUESTIONS  
3.3.2.3 The role of standardization for digital technologies  
 
1. What are the main operative recommendations of these reports and what is planned for the 
next phase? How does the EU envisage the implementation of these reports?  
 
EU reply:  
Regarding paragraph 3.193 of the Secretariat report: The main operative recommendations of the 
Rolling Action Plan for ICT Standardization are addressed to global standards development 
organisations, and monitored by the expert group "Multi Stakeholder Platform for ICT 
standardisation " (MSP), which is updating the Rolling Action Plan on an annual basis.  
 
Regarding paragraph 3.195 of the Secretariat report: Of the five thematic reports by the European 
Observatory & Forum for Blockchain referenced in section 3.3.2.3., only some contained  policy 
recommendations while others merely summarized the state of play on the market. The European 
Observatory & Forum is a think tank and its policy recommendations have no binding effect for the 
European Commission, the European Parliament or the Europ ean Council. That said, the European 
Commission will publish its blockchain strategy for the next five years shortly. The strategy may 
draw on some of the recommendations of the think tank, as well as on the outcome of public 
consultations and other source s. 
 
4.4.3.2.3 Prohibition of unjustified geoblocking and other forms of discrimination based 
on customers' nationality, place of residence or place of establishment  
 
2. What is the EU's experience with geoblocking so far? Have there been cases of non -compl iance 
and how have they been reported? How does the EU envisage the multilateralization of these 
non-discrimination provisions?  
 
EU reply:  
Regulation (EU) 302/2018 (please see below), applicable since 3 December 2018, addresses the 
problem of geo -blocking and unjustified discrimination of customers for reasons related to their 
nationality, place of residence or place of establishment. Informa tion on applicable national 
measures and the enforcement bodies and bodies providing assistance to consumers as appointed WT/TPR/M/395/Add.1  
 
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  by each EU Member State, questions and answers including in how far these rules apply to non -EU 
citizens and businesses are available at https://ec.europa.eu/digital -single -
market/en/policies/geoblocking. A report with all information on the assessment of the way the 
Regulation has been implemented and contributed to the effective functioning of the internal market 
so far. A substantive analysis of the feasibility and potential costs and benefits arising from any 
changes to the scope of the Regulation will also be available on that same website in the following 
months.  
 
Please find regulation and link: Regulation (EU) 2018/302 of the Euro pean Parliament and of the 
Council of 28 February 2018 on addressing unjustified geo -blocking and other forms of discrimination 
based on customers' nationality, place of residence or place of establishment within the internal 
market and amending Regulation s (EC) No 2006/2004 and (EU) 2017/2394 and Directive 
2009/22/EC ( DO L 60I de 2.3.2018, p. 1/15), https://eur -lex.europa.eu/eli/reg/2018/302/oj . 
 
3.3.7.2 Industrial property  
Supplementary protection certificates  
 
3. Based on the statements made in paragraph s 3.342 -4 does the EU take the position that SPCs 
are a form of IP, but that it does not come within the scope of IP as that term is defined in Article  1(2) 
of the TRIPS Agreement? And if so, then does the EU take the position that the TRIPS Agreement 
does not apply with respect to SPCs?  
 
EU reply:  
Supplementary protection certificates (SPCs) are a form of intellectual property. However, it is a sui 
generis IP right that is distinct from patents.  
 
4. Is it the EU's position that producing for stockpiling is allowed under the TRIPS or does it follow 
from the answer to question 1 because it is not covered?  
 
EU reply:  
SPCs are a sui generis IP right distinct from patents. Regulation (EU) 2019/933 is compatible with 
the TRIPS agreement.  
 
5. Does the EU take t he position that SPC are not a form of IP covered by Article 1 of the Paris 
Convention? For example, are SPCs subject to Paris Convention Article 5 ("compulsory licenses") 
and Article 5bis ("Period of Grace for Payment of Fees for the Maintenance of Rights ")?  
 
EU reply:  
SPCs are a form of intellectual property, and accordingly subject to relevant provisions of 
international conventions applicable to intellectual property.  
 
  WT/TPR/M/395/Add.1  
 
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  JAPAN  
Report by the Government (WT/TPR/G/395)  
 
3 DEVELOPMENTS IN THE INTERNAL MARKET  
3.9 New measures for fair taxation  
 
(Question 1: Paragraph 3.29, page 11)  
Japan would like to request the EU to provide with the details regarding its plans to 
introduce a carbon tax aimed at shielding European steel producers and other 
energy -intensive industries against cheaper imports from countries with less strict 
climate policies, particularly on ways to secure the new tax's concistency with WTO trade 
rules.  
 
EU reply:  
The EU has fully translated into legislation the steps t o meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambitio n, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU's Emissions 
Trading System.  
The Euro pean Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way".  
A Carbon Border Adjustment mechanism is not d esigned to protect European industry from open 
competitions but rather to ensure the environmental integrity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the border measure will complement the 
EU's c arbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU's climate policies. The internal market of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Trade Organization and our trade agreements, in 
particular.  
There is a breadth of considerations that need to be reviewed in the design and implementati on of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, trade agre ements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commiss ion pledged "to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 80% of global greenhouse gas 
emissions ". 
 
4 TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.1 Multilateral trade policy  
4.1.1 WTO reform  
(Question 2: Paragraph 4.2, page 16)  
Given the impasse of the Appellate Body, the European Commission presented a legislative 
proposal in December 2019 that would allow the EU to impose retaliatory tariffs on 
countries that block the resolution of a dispute at the WTO. Japan would like the EU to 
explain further how the EU ensures the consistency of the proposed amendment with 
international law, including the W TO agreement.  
 
EU reply:   
The EU is committed to the multilateral trade system and continues its efforts to find a permanent 
solution to the Appellate Body crisis. In the meantime, the EU proposed a temporary solution 
pursuant to Article 25 DSU in the form  of an interim appeal arbitration arrangement. Such WT/TPR/M/395/Add.1  
 
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  arrangement allows for two -step resolution of disputes and until the Appellate Body functions again, 
the EU will always seek adjudication through it. The proposed amendment of the Enforcement 
Regulation i s for ensuring that other Members respect their WTO obligations and that the EU can 
effectively protect its economic interests when they do not. International law recognises that 
countermeasures are allowed where the other party blocks effective dispute se ttlement (cf. the 
Articles on State Responsibility of the International Law Commission and commentaries thereto).  
 
Report by the Secretaria (WT/TPR/S/395 ) 
 
SUMMARY  
 
(Question 3: Paragraph 15, page 11)  
Japan would like to invite the EU to provide informatio n on recent development of the 
negotiations with U.K. both under Article XXVIII of the GATT and Article XXI of the GATS.  
 
EU reply:   
The EU and UK through their "joint approach" intend to apportion the EU's WTO bound tariff rate 
quotas (TRQs) based on observed trade flows into the EU27 and the UK in a representative period, 
so that the existing level of market access available to other WTO Members would be maintained. 
The negotiations under the GATT Article XXVIII procedure are confidential and are currently ongoing 
with the WTO Members whose rights the EU recognised. Any agreements will be notified in 
accordance with the applicable rule s. 
 
On 3 December 2018, the UK submitted to the WTO for certification its separate schedule of services 
commitments (S/C/W/380) and list of MFN exemptions (S/C/W/381). This notification followed the 
"joint approach" dating back to October 2017, setting the  EU's and UK's intentions with regard to 
the implications of the UK withdrawal from the EU within the WTO. As far as the EU is concerned, 
its schedules for services will remain applicable to its territory upon the withdrawal of the UK from 
the EU. If Japan  is interested in the process, it should engage bilaterally with the UK. It is for the UK 
to respond to questions on its proposed services schedule. The understanding is that the UK schedule 
of commitments would not enter into force before the end of the t ransition period agreed in the 
Withdrawal Agreement .70 
 
2 Trade and Investment Regimes  
2.3 Trade Agreements and Arrangements  
2.3.2 Regional and preferential agreements  
2.3.2.1 Reciprocal preferences  
 
(Question 4: Paragraph 2.25 -26, page 38)  
In the ongoing n egotiations with U.S., does the EU have any specific area for further 
discussion with regard to the reduction of barriers in trade in services?  
 
EU reply :  
The EU and the US continue to engage on a wide range of topics of mutual interest and have 
maintained dialogues in specific sectors, including on services.  
 
2.4 Investment Regime  
2.4.2 Investment relations with third countries  
2.4.2.1 Establishment of a cooperation mechanism for the screening of FDI  
 
(Question 5: Paragraph 2.59 -67, page 47 -50) 
Regarding the EU framework for FDI screening, how does the EU ensure that FDI 
screening mechanisms adopted by each member state are consistent with its obligations 
under comprehensive FTA or other international agreements that covers investment?  
 
EU reply:   
Pursuant to the international commitments undertaken in the WTO, in the OECD, and in the trade 
and investment agreements concluded with third countries, it is possible for the Union and the 
Members States to adopt restrictive measures relating to foreign  direct investment on the grounds 
of security or public order, subject to certain requirements.  
 
70 See the UK communication to the WTO (S/C/W/380 of 3 December) Part I, point 5.  WT/TPR/M/395/Add.1  
 
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  Although the Regulation does not harmonise the screening mechanisms of the Member States, it 
stipulates the essential elements that Member States screening for eign direct investments should 
adhere to (e.g. all screening Member States shall have rules and procedures in place that are 
transparent and do not discriminate between third countries). In any event, both the Member States 
as well as the EU remain bound b y the existing rules and commitments laid down in its multilateral 
and bilateral trade and investment agreements. As for any other measure adopted by the Union 
institutions pursuant to the Treaties, the Commission will oversee the application of the Regula tion 
under the control of the European Court of Justice, in line with its role as the guardian of the 
EU Treaties set out in Article 17 TEU.  
 
(Question 6: Paragraph 2.59, page 47 -48) 
According to the report by the Secretariat, 15 EU Member States' screeni ng mechanisms 
vary with respect to several factors. In this context, please provide a brief summary of 
these mechanisms and how the EU Commission valuates these variations.  
 
EU reply:  
The rules and procedures adopted by Member States that screen foreign direct investment vary 
indeed from one Member State to the other. The screening procedures carried out by Member States 
vary in scope (Member States may apply certain thresholds, may apply screening only to certain 
sectors), they are subject to different p rocedures (some Member States may impose mitigating 
measures, others do not) and involve different actors at Member State level. Nevertheless, the 
essential elements that Member States have to adhere to under the FDI screening regulation are 
laid down in A rticle 3 of the Regulation and apply to all Member States.  
According to Article 3(8) of the Regulation, the Commission publishes a list of Member States' 
screening mechanisms as they are being notified to it. The list is available at:  
https://trade.ec.eu ropa.eu/doclib/docs/2019/june/tradoc_157946.pdf . 
 
(Question 7: Paragraph 2.60, page 48)  
According to the report by the Secretariat, the EU regulation shall apply from 
11 October  2020. In this context, please elaborate updates on state of play of 
implementation of the EU legislation on work at EU Commission. For example, the 
management structure in which the EU Commission intends to establish 
(responsible/relevant persons, divisions or departments).  
 
EU reply:   
First of all, the Member States that maintain screening mechanism have notified these mech anisms 
to the Commission (Article 3). Expert meetings pursuant to Article 12 with the Member States and 
the Commission are being organised on a regular basis. Secondly, the Commission is preparing 
further the application of the cooperation mechanism between the Member States and the 
Commission. To this end, it is recalled that the Commission needs to provide a secured and encrypted 
system through which the exchange of confidential information under t he cooperation mechanism 
can be carried out (cf Articles 11.2 and 10). In the Commission, the Directorate –General for TRADE 
is responsible to coordinate the implementation and notably the application of the cooperation 
mechanism. This requires close coope ration with several relevant other services and agencies of the 
Commission, notably in view of the programmes and projects of Union interest. Lastly, the 
Commission and the Member States have engaged with the responsible authorities of third countries, 
including Japan, to exchange best practices on screening of foreign direct investments on grounds 
of security and public order.  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.3 Measures Affecting Production and Trade  
3.3.7 Intellectual property rights  
3.3.7.1 Copyright and related rights  
(Question 8: Paragraph 3.330, page 147)  
Regarding Article 15 of the Directive on copyright in the Digital Single Market, Japan 
would like to request the EU to a ddress the following questions.  
1) Please explain the background and purpose of the amendment of Article 15. In addition, 
what does the EU expect to be the specific effects of this Article?  
 
EU reply:   
The explanatory memorandum of the proposal for a Directive on copyright in the Digital Single 
Market pointed  out that "It is […] necessary to guarantee that authors and rightholders receive a WT/TPR/M/395/Add.1  
 
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  fair share of the value that is generated by the use of their works and other subject -matter. […] A 
fair sharing of value is also necessary to ensure the sustainability of the press publications sector. 
Press publishers are facing difficulties in licensing their publications online and obtaining a fair share 
of the value they generate. This could ultimately affect citizens' access to information. This proposal 
provides for a  new right for press publishers aiming at facilitating online licensing of their 
publications, the recoupment of their investment and the enforcement of their rights."  
Please refer to recitals 54 and 55 of Directive (EU) 2019/790 for further information on  the objectives 
of Article 15.  
 
2) Will Japanese publishers of press publications be subject to this Article and will the 
right be granted? Are there any conditions for providing rights to Japanese publishers of 
press publications? Is reciprocity adopted i n granting rights to publisher of press 
publications of foreign countries?  
 
EU reply:   
Article 15(1) of Directive (EU) 2019/790 provides new related rights to publishers of press 
publications established in an EU Member State. Therefore, the establishment of the press publisher 
in an EU Member State is a prerequisite to benefit from the rights provided for in Article 15(1). 
Article 15 does not govern the protection of press publications published by publishers established 
in third countries.  
 
3) Japan under stands that Google is one example of an "information society service 
providers". Will Japanese business operators also be subject to regulation under this 
article? If yes, under which conditions?  
 
EU reply:   
Member States will transpose Article 15 of Direc tive (EU) 2019/790 into their national laws. The 
rights provided for and the obligations laid down in Article 15 will therefore be subject to the general 
rules on applicable law and jurisdiction.  
 
4) What specifically does "use of individual words or very short extracts" of a press 
publication refer to?  
 
EU reply:   
Recital 58 of Directive (EU) 2019/790 provides guidance on the meaning of "use of individual words 
or very short extracts" by recalling that "The use of press publications by information society service 
providers can consist of the use of entire publications or articles but also of parts of press 
publications.  Such uses of parts of press publications have also gained economic relevance. At the 
same time, the use of individual w ords or very short extracts of press publications by information 
society service providers may not undermine the investments made by publishers of press 
publications in the production of content. Therefore, it is appropriate to provide that the use of 
individual words or very short extracts of press publications should not fall within the scope of the 
rights provided for in this Directive. Taking into account the massive aggregation and use of press 
publications by information society service providers, it is important that the exclusion of very short 
extracts be interpreted in such a way as not to affect the effectiveness of the rights provided for in 
this Directive."  
 
5) Is it allowed to conclude a license contract free of charge between publishers of pres s 
publications and information society service providers?  
 
EU reply:   
Recital 82 of Directive (EU) 2019/790 recalls that "Nothing in this Directive should be interpreted as 
preventing holders of exclusive rights under Union copyright law from authorising t he use of their 
works or other subject matter for free, including through non -exclusive free licences for the benefit 
of any users."  
 
(Question 9: Paragraph 3.331, page 147)  
Regarding Article 17 of the Directive on copyright in the Digital Single Market, J apan would like to 
know the following information:  
1) Please explain the background and purpose of the amendment.  
2) What is the specific effect of this Article?  
3) Please explain the rationale behind this amendment.  WT/TPR/M/395/Add.1  
 
- 335 - 
 
  EU reply:   
Article 17 aims to strengthen the position of the creative industries in their negotiations with major 
online content –sharing services and stimulate the conclusion of licences, so that creators and right 
holders are remunerated for the online use of their content. According to this Article, the online 
content -sharing services covered by the new rules are performing acts of communication or making 
available to the public for which they need to obtain an authorisation from the right holders 
concerned. Article  17 provides that the licences concluded between online content -sharing platforms 
and right holders also cover the uses carried out by users of the services, under certain conditions. 
In situations where there are no licensing agreements concluded with rig ht holders, the platforms 
will need to take certain actions in order to avoid liability for unauthorised uses of content. In 
particular, they will need to (i) make best efforts to obtain an authorisation, (ii) make best efforts 
to ensure the unavailability  of unauthorised content regarding which right holders have provided 
necessary and relevant information and (iii) act expeditiously to remove any unauthorised content 
following a notice received and make also their best efforts to prevent future uploads.  
Article 17 also provides for a number of safeguards for users, through mandatory exceptions and a 
complaint and redress mechanism in case of disputes on the removal of content uploaded by users.  
More information is provided under the following homepage: https://ec.europa.eu/digital -single -
market/en/modernisation -eu-copyright -rules. 
 
(Question 10: Paragraph 3.333, page 147)  
Regarding Article 3 paragraph 1 of the Dir ective on television and radio programmes, 
please explain the reason why only the broadcasts of sports events and works and other 
protected subject matter included in them are excluded from applying point (b).  
 
EU reply:   
Article 3 of Directive (EU) 2019/7 89 introduces the country of origin principle in order to facilitate 
the clearance of rights for ancillary online services of broadcasting organisations. This principle 
applies to radio programmes and only to certain  television programmes, which are (i) ne ws and 
current affairs programmes and (ii) fully financed own productions of broadcasting organisations. In 
addition, television broadcasts of sport events are excluded from the application of the country of 
origin principle in all cases, irrespective of w hether they fall under (i) or (ii).  
As explained in recital 10 of Directive (EU) 2019/789, the scope of application of the country of 
origin principle has been limited as regards television programmes in order to take into account the 
specificities of the  financing and licensing mechanisms for certain audiovisual works, which are often 
based on exclusive territorial licensing. The same rationale applies to television broadcasts of sport 
events.  
 
3.3.7.2 Industrial property  
3.3.7.2.1 Patents  
 
(Question 11: Paragraph 3.339, page 149)  
Japan would like to invite the EU to provide information on recent developments of the 
unitary patent system. Also, please let us know whether the UK will participate in the 
unitary patent system after Brexit.  
 
EU reply:   
The unitary patent package consisting of the unitary patent and the Unified Patent Court has not yet 
come into effect. It will come into effect when the Unified Patent Court (UPC) Agreement is ratified 
by the required number of EU Member States, inc luding three EU Member States with the highest 
number of European patents in force (currently Germany, France and the United Kingdom). Germany 
has not yet ratified the UPC Agreement.  
 
On 1 February 2020 the United Kingdom withdrew from the European Union.  The withdrawal took 
place according to the  arrangements  set out in the Agreement on the withdrawal of the United 
Kingdom of Great Britain and Northern Ireland ('the United Kingdom') from the European Union and 
the European Atomic Energy Community ('the Wi thdrawal Agreement)71. The Withdrawal Agreement 
provides for a transition period that will end on 31 December 2020, unless a one -time extension of 
the transition period for up to 1 or 2 years is agreed by the Parties. During transition, the full 
European Un ion "acquis" would apply to and in the UK. At the end of the transition period, EU law 
 
71 OJ C 384 I, 12.11.2019, p. 1.  
(https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=OJ:C:2019:384I:FULL&from=DE) . WT/TPR/M/395/Add.1  
 
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  will cease to have effect in the UK and the unitary patent protection will only extend to the EU 
Member States. According to Articles 1 and 84 of the UPC Agreement, it i s only open to EU Member 
States.  
 
(Question 12: Paragraph 3.342, page 150)  
The report by the Secretariat mentions "introducing an exception to let firms established in the EU 
manufacture certain pharmaceutical products for export to non -EU markets during t he term of the 
SPC", and "it also permits the making and stockpiling of a pharmaceutical product six months prior 
to the expiry of the certificate, in order to place it on the market of EU member States immediately 
after expiry of the certificate" in 3.342 . 
Please let us know the measures to prevent unnecessary litigation due to uncertainty of 
"SPC waiver". For example, whether an active ingredient (API) manufactured for export 
and API manufactured in order to place it on the EU market after expiry of the c ertificate 
can be clearly distinguished by a third party.  
 
EU reply:   
Under Regulation 2019/933, an API can be manufactured in order to be placed on the EU market 
after expiry of the certificate under the condition that it is not stored for more than 6 mon ths in the 
EU Member State where it was manufactured. Most importantly, if the API was manufactured earlier 
than those 6 months, the SPC holder might take infringement actions under the same conditions as 
any other potentially infringing act not covered by  Regulation 2019/933. Indeed recital 23 of 
Regulation 2019/933 states the following: "This Regulation does not affect the application of Union 
acts that aim to prevent infringements, and facilitate enforcement, of intellectual property rights, 
including Di rective 2004/48/EC and Regulation (EU) No . 608/2013 of the European Parliament and 
of the Council."  
 
(Question 13: Paragraph 3.342 -344, page 150 -151)  
There are several concerns about limitations on rights of protection conferred by 
supplementary protection  certificates (SPCs). Are there any plans to publish rules (such 
as guidelines) for clarification?  
 
EU reply : 
Regulation 2019/933, including its recitals, provides for the procedural aspects, including an annex 
with a template for the notification and anot her annex for the logo to be applied.  
 
Specific examples of the concerns are as follows:  
1) Will the act of importing active pharmaceutical ingredients (effective ingredients) from 
non-EU countries/regions to manufacture generic or biosimilar versions of SPC -protected 
medicines fall within the ambit of "any related act that is strictly necessary for the 
making" under Article 5 2. (a) (ii) and (iv) of the REGULATION (EU) 2019/933, if:  
(a) the act is exclusively for export to third countries wher e protection of the original 
medicines does not exist or has expired; or  
(b) for stockpiling during the last six months of the duration of the certificate?  
 
EU reply : 
Reference is made to recitals 9 to 11 which provide guidance on which acts and related acts are and 
are not covered by the exception.  
 
2) The condition of Article 5 2. (d) might not be enough to clearly distinguish whether the 
products were manufactured for the purpose of export to third countries. Therefore, is 
there any risk that s uch products will be diverted for marketing within the EU immediately 
after the expiration of the certificate?  
 
EU reply:  
That risk exists with and without Regulation 2019/933. The SPC holder can take infringement actions 
and recital (23) of Regulation 201 9/933 reads that this Regulation does not affect the application of 
Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual property 
rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Pa rliament 
and of the Council.  WT/TPR/M/395/Add.1  
 
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  3.3.7.2.4 Geographical indications  
 
(Question 14: Paragraph 3.359, page 153)  
Please elaborate how non -EU origin GIs have been effectively protected under FTAs/EPAs 
with third countries. We would appreciate information on admini strative measures being 
taken at the EU level and Member States level to protect non -EU origin GIs under 
FTAs/EPAs. For example, information on administrative actions of possible infringement 
cases after the EU Commission is notified under FTAs/EPAs, appro ximate timeline to solve 
cases, and any EU/Member States' actions ever taken. Additionally, in the event of 
suspected illegal cases, after national authorities of Member States are notified from the 
EU Commission, if the matter remains unresolved, what act ions will be taken by the EU 
Commission before seeking final decision by the European Court of Justice? We would be 
also interested in any uniform criteria for administrative actions among EU member 
states.  
 
EU Reply:  
In the EU, it is the responsibility of  Member States to ensure an adequate protection in the EU's 
territory, of GIs both of EU origin and of third country origin. Member States are obliged to have 
procedures in place to ensure the effectiveness and appropriateness of official controls and othe r 
official activities across their territories. In case of suspicion of non -compliance, the competent 
authorities of the Member State perform investigations in order to confirm or to eliminate that 
suspicion. Where necessary, actions shall include intensif ied official controls on goods and operators 
and/or the official detention of goods. Where the non -compliance is established, the Member State 
shall take the necessary action to determine the scope of non -compliance, to establish 
responsibilities, to ensur e that the non -compliance is remedied and to prevent further occurrences 
of such non -compliance. Infringements of the established rules are subject to effective, dissuasive 
and proportionate penalties at Member States' level throughout the Union. The Europ ean 
Commission verifies the Member States' control procedures, which include inter alia  in situ controls 
and audits. Detailed information on rules and enforcement are set up in Regulation (EU) 
No. 2017/625 (on official controls), Regulation (EU) No . 1151/2012 (on quality schemes for 
agricultural products and foodstuffs) and, Regulation (EU) No . 2019/787 (on spirit drinks).  
 
Several non -legally binding studies have been conducted on GI enforcement. These studies can be 
found on the EUIPO website:  
• https://euipo.europa.eu/tunnel -
web/secure/webdav/guest/document_library/observatory/documents/reports/Enforcement_of_GIs
/EUIPO_Geographical_Indications_full_report_en.pdf . 
• https://euipo.europa.eu/tunnel -
web/secure/webdav/guest/document_library/observatory/do cuments/reports/Enforcement_of_GIs
/Appendix_on_Good_Practices_in_National_Controls.pdf . 
• https://euipo.europa.eu/tunnel -
web/secure/webdav/guest/document_library/observatory/documents/reports/Enforcement_of_GIs
/Annex_Guide_for_Public_Authorities.pdf . 
 
(Question 15: Paragraph 3.362, page 154)  
According to the report by the Secretariat, the EU is working on a study on GIs for non -agri 
products at EU level. In this context, please elaborate on the system of GI protection for 
non-agri products under conside ration. For example, we would appreciate information on 
its scope discussed/planned, its responsible authorities, its possible 
administrative/judicial actions of infringement procedures at EU level and Member State 
level, its approximate timeline after the  result of the study for publication in 2020. We 
would be also interested in opinions/concerns/values received from stakeholders at any 
public hearing. Additionally, we would appreciate information on whether the approach 
chosen has been well received by t he market (both users and implementers). Does the EU 
have any plan to provide opportunities for non -EU stakeholders to submit their opinions 
in the future?  
 
EU reply   
For the time being no decision has been taken as regards a possible new system of GI prot ection for 
non-agricultural products. The EU will soon publish the final version of their 2019 external "study on 
the economic aspects of geographical indication protection for non -agricultural products at EU level" 
designed to assess the added value of a special (sui generis) protection regime for geographically WT/TPR/M/395/Add.1  
 
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  rooted non -agricultural products as compared to other kinds of protection in particular trade marks. 
Based on all the evidence collected, the Commission will decide on concrete further steps.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2 Agricultural policies  
4.1.1.2.1 Domestic support  
4.1.1.2.1.1 Direct payments  
 
(Question 16: Paragraph 4.9, page 165 -166)  
The report by the Secretariat mentions "Each member state has some flexibility to transfer 
some funding from direct payments to rural development, or vice versa". Does each 
member state have some flexibility to transfer funding between "national ceilings for 
direct payments" (Table 4.4) and "national  envelopes for rural development" (Table 4.9)?  
Or is the "national ceiling for direct payments" (Table 4.4) equal to the amount of each 
member state's direct payments?  
 
EU reply :  
According to Article 14 of Regulation (EU) No . 1307/2013, Member States can transfer a part of the 
funds for direct payments to rural development or vice versa. Member States that wish to use this 
possibility must notify the Commission of their decision by 1 August of the year preceding the 
financial year in question. Subsequently , the Commission will modify the national ceilings for the 
Member States concerned by a legal act. These ceilings then become binding: for each year, the 
direct payments granted shall not exceed the national ceiling for direct payments.  
 
(Question 17: Para graph 4.12 -13, page 166)  
The report by the Secretariat mentions "Member States can exempt farmers from the 
definition of active farmer if they received direct payments below a certain level of 
threshold not exceeding EUR 5,000". Does this mean that the act ive farmers who received 
less than threshold in the previous year can be exempted from active farmers in the next 
year?  
Also, the Secretariat report states, "Roughly 76% of beneficiaries receive less than 
EUR 5,000". Is the threshold each member state sets  far less than EUR 5,000?  
 
EU reply :  
Article 9(4) of Regulation (EU) No . 1307/2013 stipulates that applicants who received less than a 
certain amount of direct payments in the previous year are considered de facto active farmers 
(except for the farmers falling under Article 9(1) of Regulation 1307/2013). This amount is set by 
Member States on the basis of objective criteria such as their national or regional characteristics, 
but may not be higher than 5000 Euro (Article 9(4) of Regulation (EU) No . 1307/2013).  
Of the twelve Member States and regions applying the active farmer p rovisions as amended by 
Regulation (EU) No . 2017/2393 ("Omnibus" Regulation) , seven Member States have a threshold of 
EUR 5000, one Member State has a threshold of EUR 3000 and four Member States have thresholds 
between EUR 0 and EUR 1250.  
For more infor mation on the implementation of the active farmer provision, see 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/key_policies/documents/active -
farmer -ms-decsions -omnibus -regulation_en.pdf . 
For more information on eligibility, see https://ec.europa.eu/info/sites/info/files/food -farming -
fisheries/key_policies/documents/direct -payments -eligibility -conditions_en.pdf . 
 
(Question 18: Paragraph 4.37, page 172)  
Is there any diff erence in scheme betw een payments for cotton and voluntary coupled 
support?  
 
EU reply : 
Both are coupled support schemes that comply with the blue box criteria. Still, they are different 
schemes, each with its own set of rules for availability, pre -conditions and limits.  
Voluntary Coupled Support:  
 
• any Member States may (optionally) grant VCS;  
• granting it is subject to strict preconditions and limits:  WT/TPR/M/395/Add.1  
 
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  - only a closed list of (21) sectors may benefit from VCS;  
- it may only be granted to a sector that undergoes certa in difficulties;  
- the targeted sector must be important from economic/social/environmental point of view;  
- VCS is subject to a strict budgetary limit per Member State;  
- The support takes the form of an annual payment based upon fixed areas and yields,  or on 
 fixed number of animals for each VCS measure.  
 
Crop specific payment for cotton:  
 
• only four Member States (Bulgaria, Greece, Spain, Portugal) have access to the support. These 
 Member States are obliged to grant it, except in the case of no appli cations by farmers (which 
 is the case in Portugal);  
• the support may only target the cotton sector;  
• The annual payment per hectare is based upon fixed yields, reference amounts and national 
 base areas for each Member State.  
 
4.1.1.2.2 Export subsidi es and export measures with equivalent effect  
(Question 19: Paragraph 4.80, page 183)  
Is it possible to institutionally implement an export financing program at EU level? Are 
there any particular reasons why it is implementated at national levels?  
 
EU reply :  
The EU has exclusive competence over the financial terms and conditions of export credits. However, 
official export credits are provided by Member States' Export Credit Agencies (ECAs). There is no 
EU-wide ECA. Member States' ECAs are regulated by national rules, but the EU has played an active 
role in the harmonization of ECAs and the co -ordination of policy statements and negotiation 
positions, particularly at the OECD, where arrangements for export credits are negotiated. So far 
there has been no decision to implement an EU export credit scheme.  
 
4.1.1.3 Domestic support levels  
4.1.1.3.1 WTO notifications  
 
(Question 20: Paragraph 4.94 -95, page 187)  
According to the Secretariat report and the response at Committee on Agriculture (COA)  
mentioned in Note 120, the amounts for Blue Box was increased by reducing the amount 
for decoupled direct payments. Could EU explain the reason why the payment method was 
changed? Of what item payment was changed from "decoupled" to "coupled"?  
 
EU reply :  
The payment method did not change, the EU rules for direct payments have remained 
(fundamentally) the same. Therefore, any change of the coupled -decoupled ratio is only the result 
of interim re -shuffling by the Member States' of their support decisions w ithin the framework of the 
existing EU rules.  
 
To explain the annual coupled support allocations more in details:  
 
• Voluntary Coupled Support (VCS): At the level of the Member States' support decisions, the 
increase remained marginal (from EUR 4.13 million in 2015 to EUR 4.24 in 2019; or, in relative 
terms, from 9.924% of the national ceiling for direct payments in 2015  to 10.285% in 2019). This 
was due to the fact that some Member States reviewed their support decisions within the boundaries 
of their respective budgetary ceilings for VCS, which has been possible on an annual basis since 
2018.  
 
• Crop specific payment fo r cotton: The envelope is the same amount in each year. It is based 
upon the fixed national based areas, yields and reference amounts in the four Member States that 
may grant such support. Each of these are fixed in the direct payments Regulation (EU) 
No. 1307/2013, and remained unchanged.  
 WT/TPR/M/395/Add.1  
 
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  4.3 Manufacturing  
 
(Question 21: Paragraph 4.185, page 213)  
As one of a wide range of policy areas and initiatives which aim to work towards a clean, 
sustainable and competitive automotive industry, the EU is currently s tudying to prepare 
a potential directive or regulation on eco -design batteries, which will possibly be 
introduced in the coming year and beyond. As the battery is a key technology in 
automobiles, it could have a huge impact on the automotive industry and c ould be a trade 
restrictive meaure without fully considering the realities of business and inputs from 
stakeholders. Please let us know the current status of the study and the timing of the 
introduction of the new rule.  
 
EU reply:  
The European Commission is currently considering sustainability requirements for batteries to be 
placed in the EU internal market, including for electro -mobility applications.  Some of the potential 
requirements that will be further assessed relate to e.g. the carbon fo otprint associated to their 
manufacturing, the use of hazardous substances, or the responsible sourcing of raw materials going 
into battery production.  If such requirements were introduced, they would be the same regardless 
of where batteries will have bee n produced, and therefore would not constitute trade restrictive 
measures.  If appropriate, now or in the future, the EU may consider setting carbon thresholds for 
batteries to be placed in the EU internal market. In that case, the EU will ensure that such 
requirements are compatible with obligations under international trade rules.  
 
  WT/TPR/M/395/Add.1  
 
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  KAZAKHSTAN  
Report by the EU (WT/TPR/G/395)  
 
1) Pursuant to paragraph 3.6, one of the objectives of the Better Regulation Agenda 
was to improve participation of stakeholders in the policy - and law -making process. 
Please indicate if the objective has been reached?  
 
EU reply:  
For over a decade, the Commission has been developing its better regulation system to ensure 
high-quality legislation. 'Better regulation' means making sure legislation is evidence -based, 
cost-efficient and widely consulted with the relevant stakeholders. Commission 's commitment to 
listening more closely to stakeholders has translated into tangible results. According to our 2019 
Better Regula tion stocktaking exercise, the average number of replies to public consultations has 
increased from 461 in 2015 to 2.091 in 2018. The Commission improved and increased opportunities 
to contribute throughout the policy and law -making cycle. Interested citiz ens and stakeholders can 
share their views on the Better Regulation Portal, in place since 2016.  
 
2) Paragraph 3.8 states that the EU has made progress in the development of a full 
electronic procurement system. Please provide information on the results of th e system's 
effectiveness, i.e. how the electronic procurement system contributed to transparency 
and the reduced corruption factor, as well as to increased competition in the EU public 
procurement market?  
 
EU reply:  
With the entry into force of the 2014 EU Public Procurement Directives, electronic procedures became 
mandatory for several stages (eNotices, eAccess and eSubmission) of procurements above the 
applicable thresholds. The obligation was introduced gradually, from April 2016 to October 2018. 
The m andatory character of electronic procedures has contributed to an increased publication level, 
which is an important basis to increase competition and transparency in the EU public procurement 
market. In any case, the implementation of electronic procureme nt systems remains a responsibility 
of each EU  Member State.  
 
3) Paragraph 3.9 indicates that the Commission is working on updated guidance for the 
implementation of socially -responsible public procurement system. Could you elaborate 
on the main ideological provisions or principles of such public procurement system? In 
addition, how can the system improve the efficiency of the procurement? What was the 
main incentive for the adoption of the socially -responsible public procurement system?  
 
EU reply:  
Socially responsible public procurement (SRPP) is a means to achieve positive social outcomes in 
public contracts. Public and private stakeholders across the EU are increasingly interested in using 
public procurement to improve social and professional inclusion, to buy ethical products and services, 
and to create be tter conditions for disabled and disadvantaged people. By using their purchasing 
power to opt for goods and services that deliver positive social outcomes, public buyers can make a 
major contribution to sustainable development.  
 
4) Pursuant to paragraph 3.14,  three "Mobility Packages" aimed at improving the field 
of road transport and other transport modes were released in the field of transport 
services in 2017 and 2018. As of today, are there any improvements/outcomes following 
adoption of these packages?  
 
EU reply:  
On 11 -12 December 2019, the European Parliament and the Council reached a political agreement 
on the social and market aspects of Mobility Package I. Formal adoption should take place in 
July 2020 with entry into force in July/August 2020. Most of the new rules will not be applicable 
immediately, but rather from the beginning of 2022.  
Many of the new rules will benefit both workers and employers. Workers will have better working 
conditions through the application of posting rules, guarantee of r eturning home at least every 
4 weeks, prohibition from taking the regular weekly rest in the trucks, availability of safe and secure 
parking areas, etc. Employers will benefit from a more level playing field, with less letterbox WT/TPR/M/395/Add.1  
 
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  companies, further use of e lectronic transport documents, targeted controls focusing on high -risk 
operators, etc.  
On road charging (Eurovignette), which is part of Mobility Package I, while the European Parliament 
adopted an ambitious 1st reading position already in October 2018, d iscussions in Council are still 
ongoing. The recast of the Toll Interoperability Directive and the revision of the European Electronic 
Toll Service (EETS) Decision will allow making tolling systems interoperable across the EU, and thus 
reduce a lot of admi nistrative burden for the hauliers. The new legal framework will become 
applicable from the end of 2021. It will also make tolling fairer by ensuring that one cannot avoid 
paying.  
On the opening of domestic markets for bus and coach transport, the Europea n Parliament voted its 
first reading and discussions are continuing in the Council.  
The revision of the combined transport directive, which is part of Mobility Package III, is also 
outstanding.  
 
Report by the WTO Secretariat (WT/TPR/S/395)  
 
5) Paragraph 2.49  states that the Special Incentive Arrangement for Sustainable 
Development and Good Governance provides for complete elimination of duties on 66% 
of all tariff items for countries that are particularly vulnerable in terms of economic 
diversification and ex port volumes. Please specify what criteria are used to determine the 
special vulnerability of countries -beneficiaries of these preferences.  
 
EU reply:  
The vulnerability criteria used to determine a country 's eligibility for the EU 's Special Incentive 
Arrangement for Sustainable Development and Good Governance (GSP+) are found in Annex VII of 
Regulation (EU) 978/2012 (the "GSP Regulation"). One of these criteria has recently been adjusted 
to reflect the fact that the list of GSP beneficiaries has been subs tantially amended over the last 
years ( Commission Delegated Regulation (EU) 2020/129 of 26 November 2019 : https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:32020R0128 ). 
 
6) Paragraph 3.217 of the EU trade policy review prepared by the WTO Secretariat 
states that "...several measures are to be adopted by the Commission to implement the 
new rules". Please clarify whether the new rules will contain additional requirements for 
imports of products and goods, in addition to those already contained in the Animal Health 
Act 2016 and the Plant Health Act 2016.  
 
EU reply:  
The revised detailed animal health import requirements stemming from the Animal Health Law were 
contained in a dra ft Delegated Regulation which was notified to the WTO SPS in 2019 as 
G/SPS/N/EU/329 (https://members.wto.org/crnattachments/2019/SPS/EEC/19_3746_00_e.pdf), 
That Delegated Regulation was adopted since and expected to be published in the coming months 
in the  Official Journal of the EU.  
 
Further legal acts in the form of Commission Implementing Regulations are planned to set out the 
future model import certificates containing those revised animal health import requirements. Those 
Implementing Regulations will cover live terrestrial animals and germinal products, products of 
animal origin for human consumption and live aquatic animals. Those certificates will contain other 
relevant import requirements too, related to food safety, animal welfare etc. Those Implem enting 
Regulations are planned to be adopted in 2020, well before their date of application (21 April 2021). 
In addition, a Commission Implementing Regulation is planned to lay down the list of the third 
countries authorized from animal health point of vie w for the entry of various food commodities, live 
terrestrial animals and germinal products, and aquatic animals, respectively. That is planned to be 
adopted later in 2020 and will be duly notified to the WTO SPS Committee.  
 
The full phytosanitary system a s described in Regulation (EU) 2016/2031 is in place. The main 
implementing act for this is Regulation (EU) 2019/2072, containing the lists of Union quarantine 
pests, protected zone quarantine pests, RNQPs, prohibitions, import requirements and regulated 
commodities needing a phytosanitary certificate at  import.  
 
7) Paragraph 3.255 indicates that " [ ... ] the European court of auditors has launched 
an audit procedure, [ ... ] The publication of the report is scheduled for the end of WT/TPR/M/395/Add.1  
 
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  2019.[...]". Please provid e information whether this report has been published and 
whether it is publicly available.  
 
EU reply:  
The European Court of Auditors has not yet adopted its report on antitrust and merger control in the 
EU. 
 
8) Paragraph 3.276 indicates"[…]privatization is under the exclusive competence of 
the individual member States. […] General EU rules (e.g. on non -discrimination, freedom 
of establishment, and competition) apply if a member State decides to privatize a certain 
company[…]".Does this mean that a company ma y be privatized by a resident of any 
EU member State? What are the criteria to determine "a certain company"?  
 
EU reply:  
No discrimination can occur among residents of EU member States. A resident of any EU Member 
State may acquire assets being privatize d. 
The privatization of a certain company is decided by each individual member State.  
 
9) Pursuant to paragraph 3.285, "[…] Some 55% of procurement procedures use 
lowest price as the only award criterion for public contracts, which may indicate that 
public bu yers are not yet paying enough attention to quality, sustainability and 
innovation. […]".  
 
10) The OECD Recommendation of the Council on Public Procurement also contains 
public procurement policy objectives such as sustainable growth and innovation.  
 
11) Is there any methodology or other ways to assess and to prove the use of criteria of 
quality, susta inability and innovation in procurement process in the EU?  
 
EU reply to questions 9, 10 and 11:  
The use of quality, sustainability and innovation criteria is voluntary under the EU Public Procurement 
Directives. The Directives therefore do not include sp ecific provisions on monitoring the use of such 
criteria. The recently updated standard forms for e -procurement have a section where the 
contracting authority can indicate if green or social criteria have been used. This is expected to 
generate more data o n the use of green or socially responsible public procurement in the future.  
In 2016, the European Commission conducted a Study on the use of strategic public procurement in 
the EU , which is ava ilable at : https://ec.europa.eu/docsroom/documents/17261. In addition, under 
Article  83 of Directive 2014/24/EU, the Commission can request not more than every three years 
Member States to provide examples on the practical implementation of national strategic 
procurement policies. This reporting might include statistics on the use of quality criteria. The 
country reports received in 2018 are available at : https://ec.europa.eu/growth/single -
market/public -procurement/country -reports_en.  
 
12) Does the meaning of "cooperative procurement" match the meaning of the term 
"centralized purchasing" used within the OECD? Please provide information on the 
differences, if any.  
 
EU reply:  
Cooperation between contracting entities can take many different forms . The European 
Commission's approach to cooperative procurement and its benefits is presented in the 
Communication "Making Public Procurement work in and for Europe" available at 
https://ec.europa.eu/docsroom/documents/25612.  
 
13) According to paragraph 3.286,  "[…] according to the Commission, innovation 
procurement is hampered by various barriers. One way of improving the situation could 
consist of a wider use of the innovation partnerships procedure. […]".  What are the 
requirements for classifying procurement s as "innovative procurements|?  
 
EU reply:  
"Innovation procurement" refers to any procurement that has one or both of the following aspects: 
1. buying the process of innovation (research and development services) with (partial) outcomes; 
2. buying the ou tcomes of innovation created of others. In the first instance, the public buyer buys WT/TPR/M/395/Add.1  
 
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  the research and development services of products, services or processes, which do not exist yet. 
The public buyer describes its need, prompting businesses and researchers  to develop innovative 
products, services or processes to meet the need. In the second instance, the public buyer, instead 
of buying off -the-shelf, acts as an early adopter and buys a product, service or process that is new 
to the market and contains subst antially novel characteristics. Additional information is available in 
the European Commission 's Guidance on Innovation Procurement, 
https://ec.europa.eu/transparency/regdoc/rep/3/2018/EN/C -2018-3051-F1-EN-MAIN -PART-1.PDF.  
 
14) What methods of authentication o f market entities, which submitted tenders to 
contracting authorities, are used? In case of using electronic signature, how the EU 
member States recognize electronic signatures of the parties in electronic public 
procurement of the parties?  
 
EU reply:  
Authentication procedures vary across EU Member States, differing from "weak" to "strong" 
authentication. The most used authentication method is user name and password. Other methods 
include the use of eIDs. The use of eSignatures for the submission of bid s is not mandatory in the 
current EU legal framework.  
 
15) Do the conditions for obtaining an electronic signature differ in the EU member 
States?  
 
EU reply:  
Access to electronic signatures varies across EU Member States depending on the eSignatures 
provider s and on the respective country 's eSignature policy for eGovernment services. For example, 
some countries use ID cards with embedded electronic signature functionality, to access and process 
public services functions. One of these services can be electroni c public procurement.  
 
16) Pursuant to Рaragraph 4.6, the European Agriculture Guarantee Fund covers direct 
payments to farmers. Please elaborate on the mechanism for providing direct payments 
to farmers, including main conditions and criteria, types of commod ities covered, main 
beneficiaries.  
 
EU reply:  
All beneficiaries of direct support are farmers whose holdings are situated within the European Union 
and exercise an agricultural activity.  
 
To receive decoupled direct support, a farmer should have agricul tural land at his/her disposal and 
the agricultural land should be used for an agricultural activity. In order to get support, each year 
farmers have to submit an aid application for direct payments, whereby they declare, inter alia , all 
the agricultural p arcels of the holding. As a general rule, in the context of direct payments, eligible 
hectare means any agricultural area of the holding that is used for agricultural activity. In general, 
only land suitable to produce agricultural products is considered a s agricultural area and this includes 
one of the following: arable land, permanent crops, permanent grassland and permanent pasture.  
 
In order to be considered eligible to payments, any single part of the agricultural area should be 
utilised for an agricu ltural activity each year. In the framework of direct support, the agricultural 
activity is defined as: (i) production, rearing or growing of agricultural products, including harvesting, 
milking, breeding animals, and keeping animals for farming purposes O R (ii) maintaining an 
agricultural area in a state which makes it suitable for grazing or cultivation without preparatory 
action going beyond usual agricultural methods and machineries. Therefore, farmers always have 
the choice to produce on the land or to  maintain the land with no production. Decoupled direct 
support is not linked to a particular commodity.  
 
For further information on eligibility for direct payments, please consult 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/key_poli cies/documents/direct -
payments -eligibility -conditions_en.pdf . 
 
17) Рaragraph 4.14 indicates that the EU provides support for small farmers. Please 
provide more details on the mechanism for supporting small farmers, including main 
conditions and criteria, types  of commodities covered, main beneficiaries.  
 WT/TPR/M/395/Add.1  
 
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  EU reply:  
The Small Farmers Scheme (SFS) is a simplified direct payment scheme, which replaces all other 
direct payments of a farmer (including basic payment, redistributive payment, greening, young 
farmer payment and coupled support) that a farmer could be entitled to. The SFS includes simplified 
administrative procedures for farmers and national administrations. Participating farmers are 
exempted from greening obligations and from cross -compliance p enalties.  
The scheme is optional for Member States and is implemented by 15 of them. The annual payment 
per farmer is limited to a maximum of EUR 1,250 (a lower maximum can be fixed by the Member 
States). The Member States decide on the method to be applie d to determine the payment level. 
Depending on the method the Member State opted for, the expenditure for the SFS may be limited 
to a maximum of 10% of the direct payment envelope in the Member State.  
More information is available at https://ec.europa.eu/ info/sites/info/files/food -farming -
fisheries/key_policies/documents/small -farmers -scheme_en.pdf . 
 
18) Pursuant to Paragraph 4.263, the EU has put forth a number of policy initiatives or 
strategies to address a number of challenges, including the shortfall of s killed workers. 
Please specify what initiatives and strategies have been adopted and what measures have 
been proposed to address the shortfall of skilled workers.  
 
EU reply:  
The shortfall of skilled workers in the EU is addressed through the Skills Agend a for Europe72 adopted 
by the European Commission in 2016. It consists of ten actions designed to improve the quality and 
relevance of training and other ways of acquiring skills, make skills more visible and comparable and 
improve information and understan ding of trends and patterns in demands for skills and jobs (skills 
intelligence) to enable people make better career choices, find quality jobs and improve their life 
chances. These actions include modernisation of vocational education and training (VET)73 through 
promoting work -based learning, enhancing access through efficient and integrated guidance 
services, enabling the validation of non -formal and informal learning, and improving the 
attractiveness and image of VET.74 Another action – the blueprint for sectoral cooperation on skills75 
– improves skills intelligence and addresses skills shortages in specific economic sectors, including 
in construction.76 
 
19) Paragraph 4.311. Please elaborate on measures to effectively tackle illegal content 
online.  
 
EU reply:   
The Commission 's Recommendation on measures to effectively tackle illegal content online presents 
the general guidelines for such measures, both in what concerns online hosting service providers, in 
particular online platforms, and Member States of the U nion and their national authorities. 
Importantly, the Recommendation also clarifies a series of measures necessary to protect freedom 
of expression and information online. The Recommendation is available on the following website 
https://ec.europa.eu/digita l-single -market/en/news/commission -recommendation -measures -
effectively -tackle -illegal -content -online, and the main measures are summarised in paragraphs 
4.331 -4.333 of the Secretariat Report WT/TPR/S/395.  
 
20) Pursuant to Paragraph 15, the EU applies tariff ra te quotas (TRQs) for 712 products. 
However, according to the WTO notification (G/AG/N/EU/57) on imports under tariff rate 
quotas (table MA:2) for 2018/19 calendar year, there is a number of under filled TRQs.  
 
21) Please provide the reasons for under filled TR Qs, i.e. for live cattle (EECQ001) and 
meat of cattle (EECQ013).  Was the under filled TRQ caused by market circumstances, SPS 
measures or restrictive TRQ administration?  
 
 
72 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1223&langId=en . 
73 Viewed at: https://ec.europa.eu/education/policies/ eu-policy -in-the-field-of-vocational -education -
and-training -vet_en . 
74 Viewed at: https://ec.europa.eu/social/vocational -skills-week/about -skills-week_en . 
75 Viewed at: https://ec.europa.eu/social/main.jsp?catId=1415&langId=en . 
76 Viewed at: https://ec.europa .eu/programmes/erasmus -plus/projects/eplus -project -
details/#project/600885 -EPP-1-2018-1-ES-EPPKA2 -SSA-B. WT/TPR/M/395/Add.1  
 
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  EU reply to questions 20 and 21:  
Quota fill rates are determined by prevailing economic conditions. After successive reforms of its 
agricultural policy, prices of EU agricultural products are aligned with global market prices, making 
them internationally competitive. As a result, a number of TRQs have become less interesti ng 
economically speaking.  
 
 
  WT/TPR/M/395/Add.1  
 
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  KOREA , REPUBLIC OF  
PART I: Questions Regarding the Secretariat Report   
 
Page 47 (Para 2.57)  
The period under review saw important developments regarding the status under EU law of bilateral 
investment agreements between EU member States. Intra -EU bilateral investment agreements were 
often concluded at a time when one of the two parties was not yet an EU member. The Commission 
has consistently considered such agreements to be incompatible with EU law and, in 2016, requested 
certain member States to terminate them. The Commission "intensified its dialogue" with member 
States in this regard following a ruling of the CJEU in 2018, confirming that investor -state arbitration 
clauses in intra -EU bilateral investment agreements are c ontrary to EU law.96 In January 2019, all 
member States signed political declarations in which they committed to terminating their intra -EU 
bilateral investment agreements by the end of 2019.  
 
Question 1  
According to the declaration dated 15 January 2019 i n which all EU member states 
participated, EU  member states will discuss in the context of the plurilateral Treaty the 
settlement of intra -EU investment. When do you expect the plurilateral Treaty will go into 
effect? Could you please share any information  regarding the progress of the discussions?  
 
EU reply:  
On 24 October 2019, EU Member States reached agreement on a plurilateral agreement for the 
termination of intra -EU bilateral investment treaties. The agreement is in line with EU and 
international law.  
On the same day, the European Commission released a public statement (available at 
https://ec.europa.eu/info/sites/info/files/business_economy_euro/banking_and_finance/document
s/191024 -bilateral -investment -treaties_en.pdf).  
The signatur e of the plurilateral agreement is expected in spring 2020, depending on the Member 
States internal empowerment procedures. Once the agreement is signed and ratified, it will have 
the full legal value of an international treaty. It will terminate the intra -EU BITs between the Member 
States that are parties of the plurilateral agreement.  
 
Question 2  
If the dispute is not settled through the so -called "structured dialogue" known to be 
included in the plurilateral Treaty, will it have to be settled through the  national courts of 
EU member states or by the CJEU?  
 
EU reply:  
The plurilateral agreement takes account of the specific situation of intra -EU pending arbitration 
cases and provides possibilities to resolve the issues under the EU legal framework. These 
possibilities will be clear when the plurilateral agreement is mad e public in accordance with the 
applicable procedures.  
Together with the Court of Justice of the EU through the preliminary reference procedure, national 
judges must ensure in complete independence the full application of EU law and judicial protection 
of the rights of individuals in all Member States.  
The Communication on "Protection of intra -EU investments" of 19 July 2018 provides guidance on 
the investment protection standards applicable within the Union under EU law.  
 
Page 49 (Para 2.63)  
2.63. In addition, the Regulation defines the factors that may be taken into consideration by member 
States (or the Commission) in determining whether FDI is likely to affect security or public order. In 
this respect, it provides that account may be taken of the po tential effects of the investment on the 
following factors:  
"(a) critical infrastructure, whether physical or virtual, including energy, transport, water, health, 
communications, media, data processing or storage, aerospace, defence, electoral or financial  
infrastructure, and sensitive facilities, as well as land and real estate crucial for the use of such 
infrastructure;  
(b) critical technologies and dual use items as defined in point 1 of Article 2 of Council Regulation 
(EC) No. 428/2009, including artifi cial intelligence, robotics, semiconductors, cybersecurity, 
aerospace, defence, energy storage, quantum and nuclear technologies as well as nanotechnologies 
and biotechnologies;  WT/TPR/M/395/Add.1  
 
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  (c) supply of critical inputs, including energy or raw materials, as well as f ood security;  
(d) access to sensitive information, including personal data, or the ability to control such information; 
or 
(e) the freedom and pluralism of the media."108  
 
Question 3  
Regarding Article 4 in Regulation (EU) 2019/452, is it possible that duri ng the screening 
process some firms that are based in certain specific countries may be exempted or 
favored in the investigation procedures given that EUGEAs allow exports of dual -use items 
to certain destinations?  
 
EU reply:   
Article 3(2) of the Regulatio n stipulates that Member States that screen foreign direct investments 
shall carry out the screening in a transparent and non -discriminatory manner. Indeed, the Regulation 
does not exempt any third country investor from the scope of the Regulation nor favo ur any third 
country investor. Article 4(1)b only stipulates that the potential effect of a foreign investment on 
critical technologies and dual use items is a factor that a Member State may consider in determining 
whether a foreign direct investment is li kely to affect security or public order.  
 
Page 83 (Para 3.88) Chart 3.5  
3.88. Pursuant to EU trade remedy rules, anti -dumping and anti -subsidy measures generally expire 
after five years unless an expiry review demonstrates the need for the continuation of the measure.  
The number of expiry review investigations in any given year depends, to a large extent, on the 
number of measures that were imposed five years before. In 2016, about 71% of the measures 
were confirmed and extended, whereas in 2018, this had increased to 100% (Chart 3.5).  
 
Question 4  
Anti-dumping and anti -subsidy measures generally expire after five years unless an expiry 
review demonstrates the need for the continuation of the measure. In the case of the EU, 
as shown in Chart  3.5, the ratio of measures extended has continued to increase and in 
2018, actually reached 100%. What are the main reasons behind this trend in which 
measures that expire following a review are becoming rarer?  
 
EU reply:  
Expiry reviews examine if the expiry would be likely to lead to a continuation or recurrence of 
dumping/subsidisation and injury. The measures are extended only after there is a full investigation 
confirming that this is in fact the case. In the investigations referred to above, the Co mmission has 
found that the expiry of the measures would lead to the continuation or recurrence of 
dumping/subsidisation and injury. In accordance with the relevant legislation, the measures were 
therefore extended.  
 
Page 85 (Para 3.92) Chart 3.5  
3.92.  In March 2018, the EU initiated procedures for a safeguard investigation on 26 product 
categories of steel, pursuant to its safeguard rules in Regulations (EU) 2015/478 and (EU) 
2015/755137; the scope of the investigation was later expanded to 28 product cat egories. The 
Commission cited an increasing trend of imports of these products, the situation of the EU steel 
industry, and the risk of trade diversion from US measures besides overcapacity and increased use 
of trade -restrictive practices as the reasons fo r the initiation of the safeguard measure.138 
Provisional safeguard measures were put in place in July 2018, and definitive measures in 
February  2019.139  
The implementing regulation was amended in November 2018 to remove several countries 
(Botswana, Camero on, Eswatini, Fiji, Ghana, Côte d'Ivoire, Lesotho, Mozambique, Namibia, and 
South Africa) from the scope of the measures. 140 The final safeguard measures put in place involve  
26 categories of steel products whereby TRQs have been established based on the level of imports 
over the last three -year period (2015 -17) plus 5% . In some cases, the TRQs were specifically 
allocated to a country, i.e. based on historical imports; otherwise, a general TRQ is allocated on a 
first-come -first-served basis. An additional duty rate of 25% is applicable for out -of-quota imports.  
The safeguard measure is expected to be in place for slightly less than three years; it is set to expire 
on 30 June 2021. This measure was notified to the WTO.  
 
Question 5  
As the growth rate of the s teel quota has been lowered from 5% to 3% per last year, This WT/TPR/M/395/Add.1  
 
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  is the measurement against on the liberalization obligation of the WTO safeguard 
Agreement. We therefore hope that you would return to the 5% level originally in 
January 2019 in next review.  
 
EU reply:  
While this is a statement rather than a question, the Commission considers that this type of issue 
falls outside the scope of a Trade Policy Review and the Commission would therefore invite Korea to 
present its substantiated arguments w ithin the framework of a future review investigation.  
 
Page 110 (Para 3.170)  
3.170.  Under the NLF, one of the main tasks of the Commission is to bring harmonization legislation 
in line with the reference provisions of Decision No. 768/2008/EC. The followin g directives and 
regulations were aligned with these reference provisions since the last Review : Medical devices – 
Regulation (EU) 2017/745; In vitro diagnostic medical devices – Regulation (EU) 2017/746 ; 
Unmanned aircraft systems – Delegated Regulation (E U) 2019/945; Accessibility requirements for 
products and services – Directive (EU) 2019/882; and Fertilising products – Regulation (EU) 
2019/1009.  
 
Question 6  
The EU will put into effect MDR and IVDR to assure the safety and performance of all 
medical devices. However, many WTO members have expressed serious concerns 
regarding the implementation of these measures and foreign industries are worried about 
patient access to life savings and life enhancing medical technologies as well as their 
conti nued access to the EU market. I would thus like to ask the EU to elaborate on its plan 
to avoid such market impacts stemming from its measures.  
 
EU reply:  
In the interest of patient safety, there is a need to render the strengthened requirements of the tw o 
Regulations applicable as early as possible. This has led to an extremely short transition period for 
the preparations for this.  
The Commission and Member States are working closely together to ensure that patient access to 
medical technologies is at the  forefront of the implementation and that continued access to the 
EU market by WTO members is sustained.  
As regards notified bodies, important progress has been achieved. Twelve notified body designations 
have been completed with two more expected in earl y February and additional designations are in 
the pipeline. In addition, the notified bodies that are currently already designated under the Medical 
Devices Regulations are estimated to hold a significant share of the market (approximately more 
than half o f the existing certificates under the Directives). Additionally, most notified bodies have 
increased their resources, some with up to 50 %).  
Specific grace mechanisms to smoothen the transition are already foreseen in the legislation; in 
particular the ext ension of the validity of certificates issued under the existing legislation (up to 
May 2024) under certain conditions and the initial exemption of certain devices from the new, more 
strict clinical investigation requirements. In addition, the C orrigendum adopted in December 2019 
extends the grace period to certain up -classified Class I devices and will thus significantly alleviate 
pressure on notified bodies.  
 
Moreover, in duly justified cases and in the interest of public health or patient health or safety, 
national competent authorities may authorise within its territory the placing on the market of specific 
devices which have not fulfilled the relevant conformity assessment requirements; under exceptional 
cases, the Commission may decide to extend t hose national measures to the territory of the Union 
for a limited duration.  
 
Page 116 (Para 3.214) Table 3.21  
The amendment of the Law by Regulation (EU) No. 2019/1381 of the European Parliament and the 
Council on the transparency and sustainability of the EU risk  
assessment in the food chain, amending Regulations (EC) 178/2002,  
1829/2003, 1831/2003, 2065/2003, 1935/2004, 1331/2008,  
1107/2009, Regulation (EU) 2015/2283 and Directive 2001/18/EC.  
Regulation (EU) 2019/1381 aims to improve the transparency of the EU  
risk assessment process carried out by the EFSA, strengthen the longterm  
sustainability of the EFSA, and improve risk communication . 
 WT/TPR/M/395/Add.1  
 
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  Question 7  
The EU recently amended the Law of Regulation on the transparency and sustainability  of 
the EU risk assessment. What are the main changes and/or updates between the previous 
SPS legislation and the new legislation on the transparency and sustainability of risk 
assessment (2019/1381), and how might these affect the food trade?  
 
EU reply:  
The new Transparency Regulation (Regulation (EU) 2019/1381) intends to improve the transparency 
of the EU risk assessment process carried out by the European Food Safety Authority (EFSA), 
strengthen the long -term sustainability of EFSA and improve risk co mmunication. To this end, it 
mainly amends Regulation (EC) No . 178/2002 [General Food Law Regulation] and – as far as 
transparency is concerned – eight other sectoral acts, i.e. Regulation (EC) 1829/2003 [GM Food and 
Feed], Regulation (EC) No . 1831/2003 [F eed Additives], Regulation (EC) No . 2065/2003 (Smoke 
flavourings), Regulation (EC) No . 1935/2004 [Food Contact materials], Regulation (EC) 
No. 1331/2008 [common authorisation procedure for food additives/enzymes/flavourings], 
Regulation (EC) No . 1107/2009,  Regulation (EU) 2015/2283 [Novel Foods] and Directive 2001/18/EC 
[GMO cultivation].  
The new Regulation will enter into application on 27 March 2021.  
We do not consider that this amendment will have an impact on food trade as the new provisions 
mainly conc ern the transparency and the way EFSA will gather and manage the evidence needed to 
perform its tasks .  
 
The main changes brought about by the Regulation can be summarised as follows:  
 
Proactive public disclosure/Confidentiality/Public consultations of sub mitted studies  
All scientific data, studies and other information supporting any request for a scientific output from 
EFSA (including in the area of authorisation procedures) shall be made publicly available proactively, 
with the exception of duly justifie d confidential information, early on in the EU risk assessment 
process.  
To that effect, closed lists of clearly -defined information items for which confidentiality may be 
claimed under certain conditions, with the exception of safety relevant information, are set out in 
the General Food Law Regulation and complementarily – to address sectoral specificities - in seven 
other sectoral acts .  
More specifically: When an applicant submits a request for authorisation accompanied by scientific 
data, st udies and other supporting information, it may request certain parts of the submitted data, 
studies and other information to be kept confidential. This request must be duly justified (proof of 
"potential harm to a significant degree" in case of public disc losure). The applicant should submit a 
non-confidential version and a confidential version of the submitted data, studies and other 
information. Without delay and once an application is found valid or admissible, EFSA would make 
the non -confidential versio n of those studies, as submitted by the applicant, public. In parallel, EFSA 
would assess the confidentiality claim within 10 weeks. Once the assessment is completed, any 
additional data and information for which confidentiality requests has been considere d as unjustified 
would also be made public (final non -confidential version as assessed by EFSA). Upon receipt of the 
confidentiality decision by EFSA, applicants would have the right to make a confirmatory application 
asking EFSA to reconsider its decision . Following public disclosure, EFSA will launch public 
consultations on the submitted data, studies and other information to ensure access to the widest 
evidence -base possible before it delivers its scientific output.  
The public disclosure of all informat ion supporting applications or other requests for scientific output 
by EFSA shall be without prejudice to any existing rules concerning Intellectual Property Rights 
(which may set out limitations on certain uses of the disclosed documents on their content) , and 
'data exclusivity rules '. The disclosure to the public shall not be considered as an explicit or implicit 
permission or licence for the relevant data and information and their content to be used. EFSA shall 
ensure that clear undertakings or signed st atements are given to that effect by those accessing the 
relevant documents, prior to their disclosure.  
 
Notification of studies  
EFSA shall establish and manage a database of studies when commissioned or carried out (at pre -
submission phase) by business o perators to support a future application or notification in relation to 
which Union law makes provisions for EFSA to provide a scientific output. Business operators shall 
without delay notify EFSA on the title and the scope of the study, the laboratory or testing facility 
carrying out the study, and the starting and planned completion dates of any study commissioned 
or carried out by them to support an application or a notification. The notification obligation shall WT/TPR/M/395/Add.1  
 
- 351 - 
 
  also apply to laboratories and other test ing facilities located in the Union carrying out those studies, 
and also to laboratories and other testing facilities located in third countries insofar as set out in 
relevant agreements and arrangements. Certain procedural consequences of non -compliance w ith 
the notification requirement are also foreseen, e.g. an application or notification shall not be 
considered valid or admissible where it is supported by studies that have not been notified, unless 
the applicant or notifier provides a valid justificatio n for non -notification of such studies.  
 
Fact finding missions  
Within 4 years after the entry into application of the Regulation, Commission experts shall perform 
fact-finding missions in EU Member States to assess the application, by laboratories and other testing 
facilities of relevant standards for carrying out tests and studies submitted to EFSA as part of an 
application, as well as the compliance with the notification obligation. Commission experts shall also 
perform fact finding m issions to assess the application of relevant standards by laboratories and 
other testing facilities located in third countries insofar as set out in relevant agreements and 
arrangements. The Commission, EFSA and the Member States shall ensure the appropri ate follow -
up to these non -compliances. The outcome of the fact -finding missions shall be presented in an 
overview report, on which basis the Commission shall – if appropriate - submit a legislative proposal 
as regards any necessary control procedures, inc luding audits.  
 
Risk Communication  
A number of objectives that risk communication should pursue (while taking into account the 
respective tasks and responsibilities of risk assessors and risk managers), as well as the general 
principles of risk communicat ion are listed in the new Transparency Regulation. A general plan for 
risk communication will be adopted by means of implementing acts, in order to achieve the 
objectives of risk communication, in accordance with the general principles of risk communicatio n. 
 
Page 201 (Para 4.132)  
4.132. In 2018 and 2019, the EU adopted a new comprehensive legislative framework for energy 
and climate policies. The European Parliament and Council agreed on a revision of the EU's 
climate legislation , including the Emissions T rading System Directive199, both for stationary 
installations and for aviation , the Effort Sharing Regulation200, and the Regulation on Land Use, 
Land Use Change and Forestry.201 They also agreed on the eight legislative proposals in the "Clean 
Energy for All Europeans" package (all of which have entered into force)202, and on the ten mobility 
proposals following the Low -Emission Mobility Strategy.203 This framework is expected to put the 
EU on a good trajectory to a climate -neutral economy by 2050 (see bel ow). 
 
Question 8  
Could the EU please explain its revision of Directive 2003/87/EC in relation to its "carbon 
border adjustments" scheme to prevent carbon emissions and its compatibility with WTO 
law, as has been provided in paragraphs (24) and (33) of DIRE CTIVE (EU) 2018/410 OF 
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 March 2018 amending Directive 
2003/87/EC to enhance cost -effective emission reductions and low -carbon investments, 
and Decision (EU) 2015/1814?  
 
EU reply:  
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This  would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way".  
A Carb on Border Adjustment mechanism is not designed to protect European industry from open 
competitions but rather to ensure the environmental integrity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the bo rder measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone WT/TPR/M/395/Add.1  
 
- 352 - 
 
  of the EU 's climate policies. The internal market of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Trade Organisation and our trade agreements in 
particular.  
There is a breadth of considerations that need to be r eviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular  with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. I n the 
European Green Deal, the Commission pledged to "step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 80% of global greenhouse gas 
emissions".  
 
Page 222 (Para 4.222)  
4.222. A third pillar was proposed, in the form of a European Deposit Insurance Scheme (EDIS). 
However, it has not yet been established. The key objective of the EDIS is to protect covered 
deposits, i.e. up to EUR 100,000 against the consequences of insolvency of a credit institution. The  
relevant legislative proposal envisages the establishment of an EDIS in three successive stages: 
a reinsurance scheme for participating national Deposit Guarantee Schemes (DGSs) for a first period 
of three years, a co -insurance scheme for participating national DGSs for a second period of four 
years, and full insurance for participating national DGSs in the final stage.  
 
PART  Question 9  
The last pillar in establishing a Banking Union consists of setting up a European Deposit 
Insurance Scheme (EDIS). The proposed scheme has been introduced in 2015 and is being 
discussed. Can the EU elaborate upon the status of the negotiations,  and explain how the 
scheme is expected to be funded?  
 
EU reply:  
On 24 November 2015, the European Commission proposed a Regulation to Establish a European 
Deposit Insurance Scheme (EDIS). The proposal is intended to help establish a common deposit 
insura nce system in the Banking Union, to supplement existing common supervision and bank 
resolution frameworks. The main elements of the legislative proposal are correctly summarised in 
the question put to the European Union by the Republic of Korea.  
On 11 Octo ber 2017, the Commission suggested new ideas to introduce EDIS more gradually 
commensurate to progress achieved with regard to risk reduction and the tackling of legacy issues, 
starting with a more limited re -insurance phase and moving gradually to co -insurance. The precise 
nature of the funding of EDIS depends on further progress in ongoing negotiations between the 
European Union 's legislative institutions. The new European Commission, which began its mandate 
of 1 December 2019, remains committed to EDIS.  
In the absence of a common deposit insurance scheme, the protection of depositors in the EU is 
regulated by the Deposit Guarantee Scheme Directive of 2014 providing for partial harmonisation at 
national level. For example, covered deposits in the EU are pr otected up to EUR 100,000. The 
Directive provides for Member States to ensure by 3 July 2024 that the available financial means of 
a DGS shall reach a minimum target level of 0.8% of the amount of covered deposits of its members.  
 
III: Other Questions  
 
Question 10 : difficulties due to delayed air custom procedures in Greece  
The air customs authorities in Greece call for an excessive period and complicated 
procedures. Korean companies, therefore, are burdened with unnecessary costs for these 
additional proc edures. For example, small parcels like samples and brochures require 12 
to 35 days to pass through customs which results in lost sales, especially when they are 
due to go on the market. Is there any possibility to simplify this process for small parcels?  
 
EU Reply:  
According to customs legislation in force, all categories of postal items (letter post -small packets, 
registered, parcels, EMS -Express Mail Service etc.) arriving from third countries to the customs 
territory of the European  Union,  are presented  to customs. Items whose value exceeds the current WT/TPR/M/395/Add.1  
 
- 353 - 
 
  VAT threshold  (22 euros) are subject to customs clearance, with the submission of a customs 
declaration and the collection of taxes and duties.  Please note, that duties are levied on items whose 
value exceeds 150 euros.  Only items of correspondence (postcards,  letters),  brochures, periodicals 
and items for the blind are exempt from customs supervision.   
The customs procedures followed are the simplest possible in a ccordance with the European Union 
Customs Code.  
 
Priority postal service  items are  released within 24 hours from the submission of the Customs 
declaration  when such a declaration is needed, or immediately, when no declaration is needed 
and are exempted fro m customs supervision.  
Items arriving via the non-priority postal service , are submitted to  customs  inspection and the 
customs clearance process may indeed  take some  days.   
It is noteworthy that the designated postal operator proceeds to the customs cleara nce on behalf of 
the consignees, based on the information provided in the available postal labels CN22 / |CN23. 
Missing or inaccurate indications on these labels (as it is the case very often),  lead to delays in the 
clearance, as such cases require communi cation with the recipient (consignee) and provision of 
additional information for the correct classification and mainly the establishment of customs value 
for the goods (invoice, paypal, credit card receipt etc.).  
Furthermore, in special import cases, wher e permits/authorisations or documentation for the 
application of a duty and/or tax relief (i.e.  Commercial samples or imports by persons who are 
entitled to a relief) are required, additional time may be  needed for the clearance and customs 
approval of the  relief if the recipient did not provide for the submission of the required 
permits/licenses  etc. 
 
Question 11 : difficulties of entering the cosmetic market in the EU  
Korean cosmetic companies need to resister their products on CPNP in order to sell in the 
EU's market beforehand. However, Korean companies have a lack of information about 
the CPNP, in which regard it would be helpful if the EU held an explanatory session of this 
system. When it comes to the period for the procedures, it takes about 3 mont hs 
~12 months; this is highly disadvantageous for cosmetic products which are sensitive to 
trends. It is thus necessary to reduce this period.  
 
EU reply:  
The EU cosmetic products notification portal (CPNP) is a free of charge online notification system 
created for the implementation of Regulation (EC) No . 1223/2009 on cosmetic products 
(EU Cosmetics Regulation). The Regulation states that a cosmetic product that will be placed on the 
market in the European Union needs to be notified v ia the CPNP prior to being placed on this market. 
It does not specify a particular moment for such a notification, just before putting it on the market. 
However, for the notification of products containing nano -materials the notification must be done 
6 months prior to placing them on the EU market.  
 
Once all the required information is inserted in the CPNP, the notification is considered completed. 
There is no period for processing or validating this information and the product can be placed on the 
EU mark et immediately after the notification has been completed in the CPNP (except for products 
containing nano -materials for which a period of 6 months applies).  
 
When a product has been notified in the CPNP, there is no need for any further notification at na tional 
level of the EU Member States.  
 
All the necessary information about the notification requirement and the functioning of the CPNP, 
including CPNP user manuals, is publicly available on the European Commission 's website:  
https://ec.europa.eu/growth/s ectors/cosmetics/cpnp_en . 
 
Question 12 : difficulties of exporting organic fertilizers in Romania  
When bringing samples of organic fertilizer into Romania for CSR business, a 
RO-INGRASAMANT certification should be obtained. However, this requires a period of 
over one year as well as additional costs. Therefore, it is necessary to reduce this period 
or establish a mutual recognition arrangement between Romania and Korea.  
 
EU reply :  
Organic fertilisers are not covered by the scope of the current fertilisers regulation (2003/2003). 
Therefore, for Korea to enter the market for organic fertilising products in Romania they must either WT/TPR/M/395/Add.1  
 
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  import directly into Romania, or, as the rules for organic fertilising products are not harmonised by 
the current regulation, any other MS and then through the mutual recognition rules to Romania.  
 
The new Fertilising Products Regulation 2019/1009 opens the single market for organic fertilising 
products an d applies as of 16 July 2022. The Korean company can enter the single market through 
an EU distributor, and apply the new regulation, CE mark their organic fertilising products and place 
them in the European market as "EU fertilising products ", which can t hen move freely in the single 
market. Therefore, under 2019/2009, they are able to enter the European Market through a MS, 
comply with all legal requirements of this regulation, affix the CE marking and then circulate freely 
in the European market.  
 
KOREA , REPUBLIC OF  - ADDITIONAL QUESTI ONS 
PART I: Questions Regarding the Secretariat Report   
 
Page9 (Para 6)  
6. In addition, an Action Plan was adopted to improve the implementation and effectiveness of 
provisions on sustainable development in the EU's free trade agreements (FTAs).  
 
Question 1  
The new president of the European Commission announced that the Chief Trade 
Enforcement Officer will focus on ensuring compliance and enforcement of sustainable 
development in the EU's FTAs. Could you let us know when t he Chief Trade Enforcement 
Officer will be appointed, and elaborate upon the specifics of the Enforcement Officer's 
mandate?  
 
EU reply:  
The recruitment of the Chief trade enforcement officer is on -going in accordance with 
European  Commission 's internal rules and procedures which do not set dates for recruitment. The 
mandate of the Chief trade enforcement officer will be to monitor and ensure compliance with 
EU trade agreements, including the provisions related to labour rights and environmental and 
climate provisions.  
 
Page11(para 15)  
15. The EU maintains different categories of tariff rate quotas (TRQs) for both agricultural and 
non-agricultural products. As at 1 January 2019, there were 712 preferential TRQ 's in place pursuant 
to FTAs with 26 trading partners, mainly with respect to agricultural products, and 257  conventional 
TRQs, including WTO TRQs, and about 120 tariff lines for TRQs providing autonomous access. The 
EU adopted regulations on the apportionment of WTO TRQs quotas between the E U and the 
United  Kingdom, in anticipation of the latter 's eventual withdrawal from the EU.  
 
Question 2  
Many WTO members are concerned that the EU's suggestion to revise the TRQ may shrink 
access to the Market. We therefore ask that the EU proceeds in a fai r and transparent 
manner in accordance with WTO rules.  
 
EU reply:  
The 'apportionment ' of the EU 's WTO bound tariff rate quotas (TRQs) is based on observed trade 
flows in a representative period, so that the existing level of market access available to other 
WTO Members will be maintained.  
The negotiations under the GATT Article XXVIII procedure are confidential and are currently ongoing 
with the WTO Members whose rights the EU recognised. The EU has fully followed the applicable 
WTO rules.  The EU will continue to engage with trade partners in Geneva in an open and transparent 
manner.  
 
Page 47 (Para 2.59 ~ 2.65)  
2.59. A key development during the review period was the preparation and adoption of legislation 
providing for the establishment o f an EU framework for the screening of FDI. While no 
EU-wide mechanism exists for the review of inward investment from third countries based on 
considerations relating to security or public order99, 15 EU member States currently have national 
mechanisms en abling them to screen inward investment on that basis.100 These screening 
mechanisms vary significantly with respect to factors such as whether they apply only to extra  EU WT/TPR/M/395/Add.1  
 
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  investment or to both intra - and extra -EU investment; the type of criteria used to d efine the 
investment to be reviewed; the sectors covered by the screening mechanism; whether the grounds 
for screening are limited to defence -related national security interests or include the protection of 
broader public policy; and whether the screening is in the form of a prior authorization procedure or 
of an ex post mechanism.  
 
Question 3  
To our understanding, 15 EU member countries are currently implementing their own 
monitoring system in conjunction with the EU's FDI monitoring system that went into 
effect last year. Could you share with us cases or countries that operate the system most 
effectively? Do you think the system could have negative effects such as a contraction of 
foreign investment?  
 
EU reply:  
According to Article 3(8) of the Regulation, the Commission publishes a list of Member States ' 
screening mechanisms as they are being notified. The list is available at 
https://trade.ec.europa/doclib/docs/june/tradoc_157946.pdf . The Commission does not assess the 
different screening mecha nisms by the Member States, other than assessing their consistency with 
Union law.  
 
As explained in the government report (cf. paragraph 4.53), the Regulation will help the 
European  Union in some exceptional cases (foreign investment affecting critical te chnologies, 
infrastructure, supply of critical inputs or access to sensitive data), to safeguard its security interests 
from foreign investment targeting the acquisition of critical European assets. The EU screening 
framework does not replace or duplicate existing national mechanisms, and hence does not add red 
tape for investors. It was thus designed not to impede investments into the Union.  
 
Page 89 (Para 3.110)  
3.110. The EU continues to regulate the export of certain products, pursuant to its export c ontrol 
legislation on dual -use goods.158 This regulation, from 2009, and its amendments implement 
controls on the products as identified in various international agreements, i.e. the Wassenaar 
Arrangement, the Missile Technology Control Regime (MTCR), the Nuclear Suppliers' Group (NSG), 
the Australia Group, UN Security Council Resolution 1540, the Nuclear Non -Proliferation Treaty, the 
Biological Weapons Convention, and the Chemical Weapons Convention (CWC). The regulation sets 
out the customs procedures, co ntrol measures, and other provisions, and products covered are listed 
in its annexes. According to Commission estimates, exports of controlled dual  use products 
amounted to about 2.3% of total EU exports159 in 2017.  
 
Question 4  
According to the EU General Export Authorisations, each exporting country to the EU is 
classified in one of six categories, from EU001 to EU006. Currently, Korea is classified as 
EU002~EU006. Considering the close trade and investment partnership between Korea 
and the EU based on the  Korea -EU FTA, what are possible adjustments to be implemented 
to tend to a reclassification of Korea to EU001? And what are the necessary requirements 
to review them?  
 
EU reply:  
The EU export control system operates based on assessments of risks with respect to international 
security, including a graduation of control mechanisms for specific countries and items depending 
on associated risks. While the export of dual -use items to most countries is subject to individual 
licencing, authorisation proc edures, are simplified in the form of six different EU General Export 
Authorisations (EUGEAs), each of them referring to specific subset of items and to specific lists of 
countries of destination. Currently South Korea enjoys a simplification of most of co ntrols as 
destination listed on EU002, EU003, EU004, EU005 and EU006. The different numbering of the 
EUGEAs does not correspond to a ranking of the destination countries, but reflects the risk 
assessments carried out for the relevant items and destinations , at the time when the EU Dual -Use 
Regulation was adopted, and in light of the applicable security and trade considerations. Any decision 
to change the destinations on EUGEAs requires, under the current regulation, a legislative process.  
 
Page 110(para 3.1 70) 
3.170. Under the NLF, one of the main tasks of the Commission is to bring harmonization legislation 
in line with the reference provisions of Decision No. 768/2008/EC. The following directives and WT/TPR/M/395/Add.1  
 
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  regulations were aligned with these reference provisions  since the last Review: Medical devices – 
Regulation (EU) 2017/745; In vitro diagnostic medical devices – Regulation (EU) 2017/746; 
Unmanned aircraft systems – Delegated Regulation (EU) 2019/945; Accessibility requirements for 
products and services – Directive (EU) 2019/882; and Fertilising products – Regulation (EU) 
2019/1009 . 
 
Question 5  
The EU will put into effect MDR and IVDR to assure the safety and performance of all 
medical devices. However, many WTO members have expressed serious concerns 
regarding the implementation of these measures and foreign industries are worried about 
patient access to life savings and life enhancing medical technologies as well as their 
continued access to the EU market. I would thus like to ask the EU to elaborate on its pla n 
to avoid such market impacts stemming from its measures.  
 
1) Is there a clearer timeframe system for administrative review by the European CE 
Certification Authority (Notified bodies)? To date, there are no clear criteria or internal 
regulations for each  agency.  
i.e. Feedback period after basic audits, supplementary processing periods (if needed to 
supplement)  
 
EU reply:  
We understand the question is related to the time needed to get a device certified under the MDR. 
No deadline is established by the legislation in that respect, it depends on the notified bodies if they 
want to offer specific timeframes. In addition, there  is still very little experience with certification 
activities concluded under the new MDR which makes it difficult to do estimates.  
 
2) In addition to the CE audit checklist according to the Medical Device Regulations (MDR), 
considerable confusion exists due to the lack of a guide or public education other than the 
Medical Device Directive for manufacturers to carry out a voluntarily review. Is there at 
least an additional method of notification and plans for certified foreign companies?  
 
EU reply:  
We understand that the question if there are guidance documents/schemes for manufacturers to 
carry out a review of their technical documentation before applying to a notified body for certification. 
To our knowledge, no such documents are availa ble.  
Non-EU manufacturers are requested to designate an Authorised Representative located in the EU 
in order to place their devices on the market. We would recommend non -EU manufacturers to 
approach their authorised representatives to ask if they are awar e of, for instance, stakeholder 
associations having developed any useful documents in that respect.  
 
3) The time of establishment and related guidelines for EUDAMED (medical device 
database portal) are unsatisfactory. In particular, the MDR system is intro duced after the 
entry of the existing CE certified device registrations takes precedence, it is necessary for 
industries to enter markets quickly through verification of equivalence. However, there is 
uncertainty regarding the operation of the system. Does  any plan exist in this regard?  
 
EU reply:  
Development of guidance documents on the use of EUDAMED as well as on Equivalence is well 
advanced and intended to be endorsed by the MDCG (Medical Devices Coordination Group) and then 
published in the short term . Further information about guidance documents already endorsed or 
under development can be found on the Europa website 
https://ec.europa.eu/growth/sectors/medical -devices/new -regulations/guidance_en.  
 
PART II: Questions Regarding the Government Report   
 
Page 14 (Para 3.44)  
3.44. In 2018, the EU adopted a directive revising the EU Emission Trading System for the period 
2021-2030 (so -called "phase 4")68, including a reduction of the number of quotas by 2.2% per year 
from 2021, instead of 1.74% at present. I t includes strict, predictable and equitable rules to prevent 
risks of carbon leakage . 
 WT/TPR/M/395/Add.1  
 
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  Question 1 (6)  
Is the EU considering the introduction of a Carbon Border Tax? If such is the case, we 
would like to inquire as to the method, applicable fields, introdu ction process and 
timeframe of this tax.  
 
EU reply:  
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Gr een Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative  to the measures that currently address the risk of carbon leakage in the EU 's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing ef fective measures to tackle carbon 
leakage in a WTO compatible way".  
A Carbon Border Adjustment mechanism is not designed to protect European industry from open 
competition but rather to ensure the environmental integrity and effectiveness of EU climate pol icies 
as they apply to its trade -exposed industries. The design of the border measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU 's climate policies. The internal marke t of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Trade Organisation and our trade agreemen ts in 
particular.  
There is a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environ mental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continu e to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will co ntinue to 
engage with the economies of the G20 that are responsible for 80% of global greenhouse gas 
emissions"  
 
Page 19 (Para 4.21 & 4.22)  
4.21. As regards Africa, in September 2018, Commission President Juncker proposed to deepen the 
EU's economic and trade relationships with Africa through a new Africa -Europe Alliance for 
Sustainable Investment and Jobs. The European Commission proposes to boost trade and 
investment, further attract private investors, support education and skills developme nt for 
employability, as well as to improve the business climate.  
 
4.22. As of February 2018, the southern African Economic Partnership Agreement, already applied 
to other countries, entered into provisional application with Mozambique. In February 2019, C omoros 
ratified the Eastern and Southern African Economic Partnership Agreement and joined the Eastern 
and Southern Partnership already in implementation since 2012.  
 
Question 2 (7)  
The new EU Commission announced the implementation of the EU -Africa FTA an d the 
establishment of a free trade zone as part of the EU -Africa comprehensive strategy.  
 
In this regard, I wonder if the EC has any specific detailed contents and specific 
schedules to be included in this strategy and FTA.  
 
EU reply:  
A comprehensive A frica-Europe continent -to-continent free trade agreement remains a long -term 
perspective, building on the African Continental Free Trade Area 's implementation and existing trade 
agreements between the European Union and African countries and regions. No de tail is yet available 
on the detailed contents and specific schedules of a future Africa -Europe FTA.  WT/TPR/M/395/Add.1  
 
- 358 - 
 
  On 4 March 2020, the European Commission published a Communication entitled "Towards a 
comprehensive strategy with Africa." It is available at the followin g link: 
https://ec.europa.eu/commission/presscorner/detail/en/fs_20_374 . 
 
Page 19 (Para 4.23)  
4.23. The EU is also active with partners in Latin America. In November 2017, the EU and Chile 
launched negotiations for an Association Agreement – deepening and expanding the existing 
Agreement. In 2018, the EU reached a political agreement with Mexico on the modernisation of the 
current Association Agreement. In June 2019, the EU concluded negotiations with Mercosur for an 
ambitious, balanced and comprehensive tr ade agreement.  
 
Question 3 (8)  
Although the EU -Mercosur FTA negotiations were concluded in June last year, there are 
some predictions that ratification could be difficult due to negative opinions on sensitive 
areas such as environment and agricultural products.  
  
What is the current pr ogress on the ratification and the EU's plan to respond to these 
issues?  
 
EU reply:  
The negotiations of the trade part of the EU -Mercosur Association Agreement were concluded on 
28 June 2019. The texts of the trade part are published since July/August 20 19. We are currently 
working with Mercosur to consolidate and publish the market access schedules.  
The EU and Mercosur are currently also working on the legal revision of the trade part of the 
agreement. When the legal revision is completed, it will be tr anslated into all EU languages to allow 
for Commission proposals for signature and conclusion of the agreement to the Council and the 
European Parliament.  
The agreement is the subject of a vigorous democratic and societal debate including in the 
European  Parliament and with civil society stakeholders in the EU and Mercosur. It can be expected 
that this debate in the EU and Mercosur countries will continue as the Agreement progresses towards 
ratification.  
 
PART III: Other Questions  
 
Question 1 (9)  
Inquire about the possibility of stricter regulations on CO2 emissions for vehicles  
 
The EU has announced the European Green Deal in December last year, and it includes 
reviewing the CO2 emission regulations amendment for automobiles and vans to achieve 
zero emission routes in the transport sector by 2025. Is there any possibility that the 
current regulations will be tightened? (based on passenger cars, '95g/km or less in 2021 
and reducing 37.5% in 2030 less than 2021)  
 
EU reply:  
In the European Green Dea l, the Commission has indeed announced that it will propose more 
stringent air pollutant emissions standards for combustion -engine vehicles and that it will propose 
to revise by June 2021 the legislation on CO2 emission performance standards for cars and v ans, to 
ensure a clear pathway from 2025 onwards towards zero -emission mobility.  
 
Question 2 (10)  
Inquiry about the EC's in -depth investigation of subsidies from Hungarian government 
into Samsung SDI  
 
The EU launched an in -depth investigation of subsidies from the Hungarian government 
into Samsung SDI in October last year. In this regard, we hope that the Hungarian 
government's subsidy plan will proceed quickly on the originally promised scale and that 
Samsung SDI's investment will be processed smoothly.  
 
EU reply:  
https://ec.europa.eu/commission/presscorner/detail/en/IP_19_6078.  
 
No final decision has been taken yet on this case.  WT/TPR/M/395/Add.1  
 
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  Question 3 (11)  
Inquiry about the EU -UK trade negotiations  
 
As the possibility of Brexit increases, there is a strong interest among Korean local 
companies investing in the EU and the UK in the development of the trade negotiations to 
preside over future EU -UK relations. In this regard, I was hoping you could share  with us 
the main issues of the EU -UK trade negotiations and the expected schedule of the 
negotiations.  
 
EU reply:  
The first round of negotiations between the EU and the UK took place on 2 -5th March 2020, after 
the adoption on 25 February 2020 of the neg otiating directives by the Council.  
https://ec.europa.eu/info/ european -union -and-united -kingdom -forging -new-partnership/future -
partnership/guide -negotiations_en.  
 
The EU and UK negotiators have agreed on terms of reference for the negotiations, which esta blish 
the structure of the talks, including indicative dates and agendas.  
 
https://ec.europa.eu/info/european -union -and-united -kingdom -forging -new-partnership/future -
partnership/guide -negotiations_en#terms -of-reference.  
 
Question 4 (12)  
Exports of Korean S amgyetang  
 
The process for approving exports of Korean Samgyetang into the EU has been ongoing 
since 1996. We hope that this process will be wrapped up as soon as possible  
 
EU reply:  
The access to the EU market for the Sam -gye-tang is depending on the sa tisfactory actions being 
taken by Korea to rectify shortcomings identified during the EU audit on residues in 2018.  
To date, not all of the recommendations of this audit have been addressed satisfactorily by the 
Korean authorities and further concrete act ions are required, particularly in relation to laboratory 
performance.  
 
  WT/TPR/M/395/Add.1  
 
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  MALAYSIA  
SECRETARIAT'S REPORT  
 
2.3.2 - Regional and preferential agreements (page 40)  
 
Para 2.35  - The FTA between the EU and Singapore and the Investment Protection Agreement 
between the EU and its member States and Singapore were signed on 19 October 2018 and received 
the consent of the European Parliament on 13 February 2019. Once officially concl uded by the 
Council, the FTA can enter into force. The Investment Protection Agreement will firstly also have to 
be ratified by member States according to their respective internal procedures. The FTA with 
Singapore, the first EU FTA with a country in Sout heast Asia, is seen as a building block towards the 
conclusion of an FTA with ASEAN . It covers provisions on national treatment and market access; 
trade remedies; technical barriers to trade; sanitary and phytosanitary measures; customs and trade 
facilitat ion; non -tariff barriers to trade and investment in renewable energy generation; services, 
establishment and electronic commerce; government procurement; IP; competition and related 
matters; trade and sustainable development; and dispute settlement.  
 
QUEST ION 1  
• Appreciate if the EU could share its assessment on the prospect of the proposed FTA 
with ASEAN pointing to the fact that it has been more than 10 years (2007) after the 
official launch of the initiative.  
 
EU reply:  
Negotiations for an FTA between t he EU and ASEAN countries were launched in 2007 but were 
suspended by mutual agreement in 2009 due to a gap in respective ambitions. Since then, the EU 
has started negotiations of bilateral agreements with a number of ASEAN countries. The EU -
Singapore FTA entered into force on 21 November and the EU -Viet Nam FTA is expected to enter 
into force in summer 2020, subject to consent by the European Parliament in February and 
ratification by the Vietnamese National Assembly in May/ June. Negotiations are ongoing with 
Indonesia and temporarily on hold with Thailand, Malaysia and the Philippines. In fact, these bilateral 
trade and investment agreements were conceived as building blocks towards a future region -to-
region agreement. The bilateral FTAs establish a commo n base of highly ambitious comprehensive 
FTAs, which could also be beneficial in terms of ASEAN further integration efforts.  
 
The EU and ASEAN remain engaged through the creation, in 2017, of a Joint Working Group (JWG) 
to assess the respective ambitions concerning a future region -to-region FTA, which remains the 
long-term objective.  
 
3.1.3.2 - Applied rates (page 61)  
 
Para 3.40  - The number of non -ad valorem  tariffs in the EU also stands out, as about 10% of tariff 
lines are non -ad valorem , and their number increased over the review period. Further, of the 
non-ad valorem  tariffs, about one third are compound, mixed, or other, meaning that it is often 
difficult to determine the duty rate or calculate the real impact of the tariff . 
 
QUESTION 2 
• Does the EU have any plans to convert its non - ad valorem duties to ad valorem  in 
order to increase transparency and reduce distortion to trade? If no, how the EU could 
increase transparency related to the impact of non -ad valorem  tariffs on trade?  
 
EU reply:   
The EU does not consider that its tariff structure needs simplification. The EU's import regime for 
agricultural products, including the composition grid (Meursing table), is fully transparent and 
predictable, and is set out in the EU's WTO sche dule 
 
QUESTION 3  
• Could the EU explain the determination Agricultural products that are subjected to 
non-ad valorem  duties?  
 WT/TPR/M/395/Add.1  
 
- 361 - 
 
  EU reply:  
The EU understands that Malaysia would to know why certain agricultural products are subject to 
ad valorem  duties while other agricultural products are subject to specific or mixed or compound 
duties in the EU. This is the result of historical negotiations . Notably, during the Uruguay Round, the 
EU had to transform non -tariff measures into tariffs. During this process, it appeared that duties 
expressed in the form of specific, mixed or compound were more appropriate for these products 
taking into account (h istorical) trade patterns, sensitivity of certain products and their importance 
for the EU agricultural markets. These were agreed with members and certified in the EU schedule.  
 
3.1.5 - Import prohibitions, restrictions, and licensing (page 72)  
 
Para 3.67 - Another development during the review period s  and Trade (FLEGT) licensing scheme 
for imports of timber into the European Community, which is part of the FLEGT Action Plan . The Plan 
sets out the EU response to combatting illegal harvesting of timber  and associated trade, by 
improving forest governance, strengthening law enforcement and promoting trade in 
legally -harvested timber and timber products. Under the VPA, partner countries develop systems to 
verify the legality of their timber exports to the  EU and a licensing system to provide assurance that 
timber imported into the EU has been harvested in compliance with the legal requirements of the 
partner country, as set out in the relevant FLEGT VPA. To date, the EU has signed VPAs with Ghana, 
the Repu blic of Congo, Cameroon, Indonesia, the Central African Republic, Liberia, and Viet Nam. 
As of September 2019, Indonesia was the only VPA country with an operational FLEGT licensing 
scheme. The EU concluded negotiations and initialled VPAs with Honduras an d Guyana. It is in the 
process of conducting negotiations with a further six countries. Each VPA generally contains 
provisions on a list of products covered by the HS code, rules for the licensing scheme, monitoring 
and evaluation, and reporting and commun ication provisions.  
 
QUESTION 4  
• Could the EU share the results of the implemented FLEGT licensing scheme and 
indicate should there any plan to review the effectiveness of the policy in meeting the 
EU's objective of combatting illegal timbers?  
 
EU Reply:  
To date, two Commission reports on the implementation of the FLEGT licensing scheme (for year 
2016 and 2017) show that it has progressed well. The Commission reports as based on national 
reports from Member States (which are summarised in a Background Anal ysis) and which can all be 
found at: https://ec.europa.eu/environment/forests/FLEGT_Regulation_Reports.htm . 
Currently, the Commission is preparing the report on the implementation of the FLEGT licensing 
scheme for year 2018.  
A fitness check is planned during the course of 2020 to evaluate the functioning of the FLEGT 
Regulation and EU Timber Regulation (EUTR). The fitness check will look at the effectiveness, 
efficiency, coherence, relevance and EU added value of both regulations in contributing  to the fight 
against illegal logging globally.  
 
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.1.6.1 Anti -dumping and anti -subsidy measures (page 79)  
 
3.78. The first set of changes were introduced in 2017, and added language with respect t o "normal 
value". In essence, this allows for the normal value to be determined by another method where 
there are state -induced distortions in the exporting country. In such circumstances, normal value is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of 
benchmarks such as international prices or costs in another representative country.124 A different 
methodology for determining the normal value is set out for non -WTO Members.  
 
QUESTION 5  
• Please explain how different is the methodology of calculating normal value for non -
WTO members i.e. if the exporting country has a normal value which is reliable and not 
"distorted", would the EU Authorities still construct the normal value for exporters from 
the exporting countries?  
 WT/TPR/M/395/Add.1  
 
- 362 - 
 
  EU Reply:  
The provisions of Article 2.7 of the EU 's Basic anti -dumping regulation specify the methodology used 
in the case of anti -dumping investigations concerning non -WTO countries. The methodology for 
calculating normal value in case of distortions is spelled out in Article 2(6a) (a)  
 
(page 82)  
 
3.88. Pursuant to EU trade remedy rules, anti -dumping and anti -subsidy measures generally expire 
after five years unless an expiry review demonstrates the need for the continuation of the 
measure.  The number of expiry review investigations in any given year depends, to a large extent, 
on the number of measures that were imposed five years before. In 2016, about 71% of the 
measures were confirmed and extended, whe reas in 2018, this had increased to 100% (Chart 3.5).  
 
QUESTION 6  
• Please advise whether the duties imposed in the original investigation are merely 
extended for the next five years in an expiry review or are the duties revisited/ 
recalculated depending on  the current dumping margin established for the foreign 
producers / exporters?  
 
QUESTION 7  
• Will duties be revisited/ recalculated for foreign producers/exporters with nil duty in 
the original investigation?  
 
EU reply to Q6 -7:  
An expiry review can result only in the repeal or continuation of the duties in force. If measures are 
maintained, they  will normally remain in force for another five years. An expiry review cannot lead 
to a change in the level or form of the duties; these can only be changed by an interim review.  
 
3.1.6.2 Safeguards (page 84)  
 
3.92. In March 2018, the EU initiated procedu res for a safeguard investigation on 26 product 
categories of steel, pursuant  to its safeguard rules in Regulations (EU) 2015/478 and (EU) 
2015/755137; the scope of the investigation was later expanded to 28 product categories . 
The Commission cited an incr easing trend of imports of these products, the situation of the EU steel 
industry, and the risk of trade diversion from US measures besides overcapacity and increased use 
of trade -restrictive practices as the reasons for the initiation of the safeguard mea sure. 138 
Provisional safeguard measures were put in place in July 2018, and definitive measures in 
February  2019. 139 The implementing regulation was amended in November 2018 to remove several 
countries (Botswana, Cameroon, Eswatini, Fiji, Ghana, Côte d'I voire, Lesotho, Mozambique, 
Namibia, and South Africa) from the scope of the measures.140 The final safeguard measures put 
in place involve 26 categories of steel products whereby TRQs have been established based on the 
level of imports over the last three -year period (2015 -17) plus 5%. In some cases, the TRQs were 
specifically allocated to a country, i.e. based on historical imports; otherwise, a general TRQ is 
allocated on a first -come -first-served basis. An additional duty rate of 25% is applicable for 
out-of-quota imports. The safeguard measure is expected to be in place for slightly less than three 
years; it is set to expire on 30 June 2021. This measure was notified to the WTO.14  
 
QUESTION 8  
• Please explain whether it is an allowable practice to expand the scope of product under 
investigation/subject merchandise after the initiation OR during the course of the 
investigation?  
 
EU reply:   
We believe that it is in line with WTO requirements to ex pand the scope of product under 
investigation in the course of an investigation, provided that the investigation is actually conducted 
on the basis of this expanded scope, and that the rights of defence of the interested parties are fully 
preserved.  
 
3.3.2 .6 - Technical Barriers to Trade (TBT) Committee in the WTO (page 115)  
 
Para 3.210  - During the review period, the TBT Committee received 13 new specific trade concerns 
regarding measures taken by the EU or its member States: eco -design requirements for electronic WT/TPR/M/395/Add.1  
 
- 363 - 
 
  displays; chlorothalonil (pesticide active substance); transitional periods for minimum residue limits 
(MRLs) and international consultations; organic productio n and labelling - maté (erva -mate); 
labelling requirements of the origin of grains used in the preparation of dried pasta; non -renewal of 
approval of the active substance picoxystrobin; titanium dioxide: Regulation (EC) No. 1272/2008 
(CLP Regulation), Anne x VI, Part 2; amendments to Directive 2009/28/EC, Renewable Energy 
Directive; application of Regulation No. 1169/2011 and Regulation (EC) No. 1924/2006 as regards 
the labelling of food products, in not prohibiting or examining the use of "palm oil free" la bels; 
Regulation of the European Parliament and of the Council laying down rules and procedures for 
compliance with and enforcement of Union harmonization legislation on products and amending 
relevant regulations; establishment and operation of a traceabil ity system for tobacco products; 
Radio Equipment Directive; and laws, regulations, procedures and guidelines on marketing 
authorization for medicinal products.  
 
QUESTION 9  
• Could the EU share its opinion on the effectiveness of engaging Members through 
STC's mechanism during the Committee Meeting? In particular, we would like to know 
how Members' concerns and interests are being taken into consideration in the final 
regulations.  
 
EU reply:   
The EU supports the engagement and active participation of WTO Memb ers in the discussion of STCs 
in the TBT Committee. The EU considers the concerns raised by other Members as follows.  
 
With respect to WTO Members ' written comments on TBT notifications, they are received and 
collected through the EU TBT Enquiry Point and shared with the Commission 's competent services, 
who prepare and draft and individual reply to the comments made, which is subsequently 
communicated to the Member concerned.  
 
As regards STCs raised in the context of the TBT Committee meetings, an articula ted system of 
reporting is in place within the Commission, whereby the EU TBT team reports internally on all STCs 
and related issues raised during bilateral meetings to the competent Commission services. The 
comments, information and views gathered during the TBT Committee meetings are shared with 
them for their subsequent assessment and consideration.  
 
Table 3.21 Principal SPS legislation, 2019  
 
Regulation (EC) No. 852/2004 of the European Parliament and of the Council of 29 April 2004 on 
the hygiene of foodstuffs - General rules for food business operators on the hygiene of foodstuffs, 
putting primary responsibility on the operators; implementation of procedures based on Hazard 
Analysis and Critical Control Point (HACCP) principles and good hy giene practice; and ensuring that 
imported foods are at least the same as, or equivalent to, the hygiene standards of food produced 
in the EU.  
 
QUESTION 10  
• What is EU's acceptance for food business operators who are only certified with 
Good Manufacturing Practice (GMP)?  
 
EU reply:   
Good Manufacturing Practices as part of Good Hygiene Practices, are mandatory in all food business 
operators. Certification of s uch practices by a third party might help competent authorities to 
evaluate and, where required, to attest compliance with EU requirements in case of export to the 
EU but such third party certification is not mandatory: competent authorities might audit th emselves 
to provide guarantees on compliance with EU requirements.  
In addition, all food business operators, others than primary producers, must have procedures in 
place based on the Hazard Analysis and Critical Control Points (HACCP) principles. This incl udes that 
at least a hazard analysis needs to be carried out. If such hazard analysis demonstrates that there 
are no critical control points, Good Hygiene Practices suffice.  
 WT/TPR/M/395/Add.1  
 
- 364 - 
 
  GOVERNMENT REPORT  
 
3.6 Digital Single Market (page 8)  
 
3.18 The EU's Digital Single Market strategy adopted in 2015 and almost completed, represents a 
major step forward in improving the functioning of the EU's Single Market to the benefit of 
enterprises and consumers from both EU Member States and third countries . The measures create 
a level playing field and ensure equal treatment for all companies, and improve doing business 
through harmonising 28, previously different, laws in EU Member States into coherent EU wide legal 
acts, leading to both cost and timeline savings.  
 
QUESTION 11  
• What are the institutions involved in developing the Digital Single Market Strategy 
to ensure the measures and rules are streamlined across all EU member states  
 
EU reply:   
Under the European Union 's standard decision -making procedure ("Ordinary Legislative Procedure"), 
the directly elected European Parliament has to approve EU legislation together with the Council (the 
governments of the EU Member States). Before the European Commission proposes new  initiatives, 
it assesses the potential economic, social and environmental consequences that they may have (by 
preparing "impact assessments"). The Commission also consults interested parties such as non -
governmental organisations, local authorities and re presentatives of industry and civil society. 
Groups of experts give advice on technical issues. Citizens, businesses and organisations can 
participate in the consultation procedure via Internet: https://ec.europa.eu/info/consultations_en . 
 
QUESTION 12  
• Are there any initiatives by the European Union to promote the Digital Single Market 
to other regions? (i.e.: ASEAN)?  
 
EU reply:   
The European Union (European Commission and European External Action Service) undertakes 
outreach initiatives regarding the Digital Single Market and its initiatives in a number of partner 
countries. This is usually done via counsellors in the EU 's delegations in the respective countries, 
and in dialogue meetings on digital/ICT matters with those countries. The EU is one of the  'Digital 
Partners ' of ASEAN, and our ICT & digital dialogue with ASEAN is long -standing. The cooperation 
platform is the annual EU -ASEAN meeting that takes place in the context of the ASEAN Telecom 
Ministers and Senior Officials Meetings. The last meeting  took place in Vientiane in October 2019, 
which was the 12th occasion for such a dialogue, where we exchanged and discussed digital economy 
& connectivity and how to advance EU -ASEAN digital cooperation. In particular, there is an on -going 
joint initiative  aiming to develop a basis for an ASEAN digital benchmarking index. This project taps 
into the EU 's experience in measuring digital economy indicators, namely its world -class DESI index 
and its methodology.  
 
4.2 Trade Policy for open and fair trade (page 22 -23) 
 
4.52 While the EU is one of the most open economies in the world, it also believes in fair trade. The 
EU continued to stand against unfair and illegal practices and state subsidies, aiming at ensuring a 
level playing field to its economic ope rators.  
4.53 The EU took several significant measures to achieve open but fair trade:  
a. Trade defence area: There were two changes to the EU's basic anti -dumping and 
anti-subsidy legislation in December 2017 and June 2018 respectively . The first of thes e 
changes to the antidumping rules91 introduced a new methodology to calculate the normal 
value of goods subject to investigation,  in case of significant distortions induced by the 
authorities of the exporting country.  At the same time there was also a strengthening of the 
anti-subsidy rules92 , which allow the European Commission to better capture the full 
magnitude of subsidisation by making it possible to also address subsidies identified 
during the course of an investigation.  The second set of changes, i n June 2018, involved a 
modernisation of the trade defence instruments93 and introduced inter alia , shorter investigation 
deadlines , more transparent investigations as well as, rules more adapted to face the 
challenges of the global economy, i.e. the exist ence of raw materials distortions, which 
more and more plague today's commercial exchanges.  
 WT/TPR/M/395/Add.1  
 
- 365 - 
 
  QUESTION 13  
Appreciate if the EU could indicate examples of the new methodology to calculate the normal value 
of goods in case of significant distortions induced by the authorities of the exporting country in terms 
of: 
 
• What are characterised as "distortions" by exporting countries and how do we define 
"significant"?  
• In instances where there could be distortion in the normal value, how is the normal 
value then "constructed" or determined?  
• Any EU's trade defence measures/provisions are beyond the WTO Agreement (AD and 
safeguards)?  
 
EU reply:  
• Sub-paragraph (b) of the Article 2(6)(a) of the EU 's Basic Anti -dumping Regulation lists in a 
non-exhaustive manner circu mstances which may result in significant distortions, as follows:  
 
— the market in question being served to a significant extent by enterprises which operate under 
the ownership, control or policy supervision or guidance of the authorities of the exporting  country;  
— state presence in firms allowing the state to interfere with respect to prices or costs;  
— public policies or measures discriminating in favour of domestic suppliers or otherwise influencing 
free market forces;  
—the lack, discriminatory application or inadequate enforcement of bankruptcy, corporate or 
property laws;  
— wage costs being distor ted;  
— access to finance granted by institutions which implement public policy objectives or otherwise 
not acting independently of the state.  
 
The presence of significant distortions is examined on a case -by-case basis taking into account cross -
cutting d istortions, distortions in the factors of production as well as distortions in the relevant 
sector.  
 
Where distortions are found, normal value shall be constructed using undistorted prices and 
benchmarks for each production factor, and for SGA and profit, on the basis of:  
 
o readily available data in an appropriate representative country at a similar level of economic 
development, or if more than one country qualifies, preference will be given to the one with adequate 
level social and environmental pr otection  
o undistorted international prices, costs and benchmarks  
o domestic costs if positively established  that they are not distorted  
 
The EU 's Anti -dumping legislation is in full conformity with the Agreement on implementation of 
Article VI of the General  Agreement on Tariffs and Trade 1994.  
 
c. In the context of a growing number of trade tensions and protectionist measures , the 
EU continued defending interests of its companies in the global market and ensured95 
that European products are not blocked thro ugh barriers to trade.  The latest Trade and 
Investment Barriers Report96 shows that 123 barriers hindering EU exports opportunities have been 
removed since 2014. In the Report, the European Commission elaborated on the EU's wide toolbox 
to tackle market ac cess barriers, including dispute settlement where appropriate, providing specific 
examples from the report about cases which have led to the resolution of barriers.  
 
QUESTION 14  
With regards to emerging trade tensions globally, will the EU pursue protectionist 
measures?  
 
EU reply:   
The international trading order is indeed facing a severe crisis with a dramatic increase in trade 
tensions. The EU is convinced that protectionist measures are not the solution to these trade 
tensions. In this context, the EU is greatly concerned by the recourse of some Members to such 
protectionist measures. The EU continues to believe in the importance of openness, fairness and 
cooperation in international trade, which form the basis of sustainable economic de velopment. The 
reform and modernisation of the WTO has a key role to play in this regard.  WT/TPR/M/395/Add.1  
 
- 366 - 
 
  MEXICO  
PARTE I: INFORME DE LA SECRETARÍA (WT/TPR/S/395)  
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.1 Medidas que afectan 
directamente a las importaciones , 3.1.2 Normas de Origen  
 
Página 63, (párrafo 3.24)  
3.24. Al igual que en otros aspectos aduaneros, la aplicaci ón del CAU acarre ó cambios para las 
normas de origen de la UE, tanto preferenciales como no preferenciales, en los últimos a ños. En 
resumen, el  CAU dio lugar a cambios en las listas de operaciones de transformaci ón o elaboraci ón 
sustancial que confieren origen; en la designaci ón de las operaciones m ínimas que no pueden 
utilizarse para satisfacer el criterio de transformaci ón sustancial; y en  la autocertificaci ón de los 
exportadores registrados, un nuevo sistema para las normas de origen preferenciales.  
 
Pregunta:  
1. Podría la UE dar más información acerca de su propuesta de reforma de la PAC que 
incluye la derogación de todas las disposicio nes restantes en materia de subvenciones a 
la exportación. ¿Cuáles son dichas disposiciones restantes en materia de subvenciones a 
la exportación que estarían pendientes de derogar?  
 
EU reply: Articles 196 -204 of Regulation (EU) No 1308/2013 were the legal base in internal EU law 
for the payment of export refunds. All amounts had already been set to zero in this chapter, which 
was also in any event explicitly subject to the international obligations of the EU such as the Nairobi 
Decision. The legislati ve proposal for the CAP post -2020 now cleans up the legislation by repealing 
these provisions as well as the reference in Article 219(1) of the same Regulation.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES POR MEDIDAS, 3.1 Medidas que afectan 
directamente a las im portaciones , 3.1.3 Aranceles, 3.1.3.1 Nomenclatura y tipos 
consolidados y 3.1.3.2 Tipos aplicados  
 
Página 69 (párrafo 3.40)  
3.40. Tambi én llama la atenci ón el n úmero de aranceles no ad valorem de la UE, ya que alrededor 
del 10% de las l íneas arancelarias est án sujetas a derechos no ad valorem , y su n úmero aument ó 
en el per íodo objeto de examen. Adem ás, aproximadamente un tercio de los aranceles no ad valorem 
son derechos compuestos, mixtos  u otros, lo cual significa que en muchos casos es dif ícil determinar 
el tipo del derecho o calcular el efecto real del arancel.  
 
Pregunta:  
2. Considerando que el número de aranceles no ad valorem utilizados por la Unión 
Europea es de alrededor del 10% de  las líneas arancelarias, México desea conocer ¿Cuáles 
son las nuevas líneas sujetas a este tipo de aranceles? y; ¿a qué se debe este incremento 
en el número de líneas sujetas a aranceles no ad valorem ? ¿Estos cambios a los aranceles 
aplicados son compatib les con los compromisos de la UE en la OMC?  
 
EU reply: The EU's import regime for agricultural products is fully transparent and predictable and 
is contained in the EU's WTO schedule.  
Table 3.3 is compiled by the WTO Secretariat. The apparent small increa se in the number of 
non-ad valorem  tariffs is in fact due to the nomenclature change from HS2012 to HS2017. In 
substance, there has been no change compared to the previous exercise.  
For completeness, Mexico will note that according to table 3.3 the overall number of tariff lines has 
increa sed between the two exercises: from 9 414 to 9 533 affecting essentially ad valorem  tariff 
lines with an increase from 8416 to 8512, i.e. 96 additional tariff lines. Concerning the 
non-ad valorem  tariff lines, it affects specific duties with an increase fr om 652 to 674, i.e. 22 tariff 
lines, mainly concerning wine (HS 2204). Specific duties are as transparent as ad valorem  tariffs.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.1 Medidas que afectan 
directamente a las importaciones , 3.1.5 Prohibicion es, restricciones y licencias de 
importación  
 
Página 79 (párrafo 3.61)  
3.61. La UE sigue aplicando respecto a las importaciones varias prohibiciones, restricciones y 
prescripciones en materia de licencias; el n úmero de estas aument ó en el per íodo objeto de examen WT/TPR/M/395/Add.1  
 
- 367 - 
 
  y ninguna fue eliminada. Hay 12 grupos espec íficos de produ ctos sujetos a restricciones o 
prohibiciones (cuadro 3.7) y 11 sujetos a permisos o licencias de importaci ón (cuadro 3.8), y otras 
dos medidas aprobadas que a ún no han entrado en vigor. Adem ás de las nuevas medidas que 
entraron en vigor con respecto al aluminio (vigilancia), el wolframio y las especies invasoras, se 
introdujeron diversas modificaciones o cambios en varios de los reglamentos existentes que ya 
estaban en vigor.  
 
Pregunta:   
3.  El párrafo 3.61 menciona que existen 2 medidas aprobadas pero que aún no han 
entrado en vigor. En ese sentido, ¿Podría la UE proporcionar mayor información sobre el 
tipo de medidas de que se trata (prohibición, restricción, etc.)? Y de ser posible ¿cómo se 
justifican en el marco de reglas de la OMC (Acuerdo de Licenc ias, etc.)?  
 
EU reply: It is understood that the "two measures approved but not yet entered into force " referred 
to in para 3.61 of the Secretariat are (1) the cultural goods regulation (see also para. 3.75) and 
(2) the single -use plastics directive (see a lso para. 3.72).  
 
As regards cultural goods, European Parliament and Council Regulation (EU) No 2019/880 of 
17 April 2019 (OJEU L No 151 of 7.6.2019) provides for the following two prohibitions/restrictions 
of import in the Union:  
 
(1) A general prohibitio n to introduce into the EU customs territory cultural goods, which have been 
illegally exported from a third country  (for example, if that is the case from Mexico). To determine 
whether the export was legal or illegal, it is the laws and regulations of the third country - in this 
case, Mexico - that are taken into consideration . In other words, if a cultural object which was 
created and/or discovered in Mexico is protected by Mexican cultural heritage law  and its exit from 
the territory of  Mexico is prohibited, that same object cannot be legally introduced into the European 
Union (including the case where the good is only in transit through the Union 's customs territory). 
This prohibition will enter into force 18 months after the entry into  force of the Regulation, i.e. on 
28 December 2020 . 
 
The aim of this provision is to prevent the illicit trade in cultural goods and to protect the cultural 
heritage of non -EU countries by mirroring their export prohibitions  when these objects are to be 
introduced in the EU. Its scope includes most of the cultural goods categories listed in Article 1 of 
the 1970 UNESCO Convention on the Means of Prohibiting and Preventing the Illicit Import, Export 
and Transfer of Ownership of Cultural Property . 
 
(2) A syst em of import licences or importer statements  according to which the person who seeks to 
import in the EU ( import  = release for free circulation, but also temporary admission, customs 
warehousing, placement in a free zone and inward processing) cultural goo ds created and/or 
discovered in a third country will have to:  
- apply for an import licence  to a European competent authority, by proving that the export from 
the third country was in accordance with that country 's laws and regulations (for archaeological  
objects and parts of monuments that have been dismembered, of more than 250 years of age), or  
- submit an importer statement  to EU customs, declaring that the export from the third country was 
in accordance with that country 's laws and regulations (for c ollections of fauna and flora; historical 
objects; inscriptions, coins and seals; ethological objects; works of art; rare manuscripts and 
incunabula; rare books, of more than 200 years of age and of a value of more than 18,000 euro).  
 
The aim of this provi sion is, again, to prevent the illicit trade in cultural goods and to protect the 
cultural heritage of non -EU countries, by mirroring their export prohibitions  when these objects are 
to be imported in the EU. Because the import licence applications and the  submission of importer 
statements to customs is to be managed electronically, the relevant provisions will not apply before 
a centralised electronic system becomes operational , i.e. by 28 June 2025 at the latest . 
 
As regards the Single -Use Plastics Direct ive, the key elements of the directive comprise:  
Prevention measures : 
 
• A significant reduction for single -use plastic versions of drinks cups and food containers;  
• A ban of single -use plastic versions of cotton bud sticks, balloon sticks, cutlery, plates, 
straws, stirrers, cups and food containers made of extended polystyrene (for which both WT/TPR/M/395/Add.1  
 
- 368 - 
 
  single use and multi -use alternatives are available), as well as and all products made of 
oxo-degradable plastic;  
• Product design measures for caps and lids to remain con nected to drink containers, as well 
as targets for minimum recycled content of plastic bottles;  
• Marking requirements for sanitary towels, wet wipes (e.g. that they must not be flushed 
away) and balloons, and awareness -raising measures.  
Improved waste manag ement measures : 
 
• Extended Producer Responsibility schemes to cover the cost of prevention, waste 
management and cleaning up litter from food containers, packets and wrappers, beverage 
containers, drinks cups, tobacco filters, and light weight carrier bags; for wet wipes and 
balloons producer will have to contribute to the costs of clean -up, data gathering and 
awareness raising.  
• A 90% separate collection rate for waste single use plastic bottles.  
The items covered by the different measures are l isted in the Annex to the Directive.  
 
Schematic overview:  
 
 
 
 Consumption 
reduction  Market 
restriction  Product 
design 
requirement  Marking 
requirements  Extended 
producer 
responsibility  Separate 
collection 
objective  Awareness 
raising 
measures  
Food containers  X    X  X 
EPS food and 
beverage 
containers, cups   X      
Oxo-degradable 
products   X      
Cups for 
beverages  X   X X  X 
Cotton bud 
sticks   X      
Cutlery, plates, 
stirrers, straws   X      
Sticks for 
balloons  
 
Balloons   X      
    X  X 
Packets & 
wrappers      X  X 
Beverage 
containers, their 
caps & lids  
- Beverage 
bottles    X  X  X 
  X  X X X 
Tobacco product 
filters     X X  X 
Sanitary items:  
- Wet wipes  
- Sanitary 
towels   
    
X  
X   
X 
   X   X 
Plastic carrier 
bags     X  X 
Fishing  gear     X  X 
 WT/TPR/M/395/Add.1  
 
- 369 - 
 
  3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.1 Medidas que afectan 
directamente a las importaciones , 3.1.6 Medidas antidumping, compensatorias y de 
salvaguardia 3.1.6.1 Medidas antidumping y antisubvenciones  
 
Página 87, (párrafo 3.79)  
3.79. Los cambios introducidos en 2018 en la segunda modificación son más numerosos y variados; 
los elementos principales se describen en el recuadro 3.2.125 Como se muestra, los cambios 
guardan rel ación con aspectos de procedimiento, como la reducción del plazo para la imposición de 
medidas provisionales, y otros aspectos más sustanciales, como el método para calcular el margen 
de perjuicio. Por ejemplo, al calcular el precio no perjudicial se inclu ye un beneficio mínimo del 6%. 
Otra novedad es la posibilidad de tener en cuenta los costes presumiblemente superiores a los que 
la industria de la UE Unión tenga que hacer frente para poder cumplir las normas sociales y 
medioambientales.  
 
Preguntas:  
4. ¿Podría la Unión Europea (UE) explicar, en términos generales, cómo opera la 
presunción de los costos más altos que implica para la industria de la UE cumplir con los 
estándares sociales y medioambientales? ¿Es una presunción refutable? ¿Cómo se 
determina la  magnitud de esos costos supuestamente más altos? ¿Se realiza algún tipo 
de comparación? ¿Se tienen " benchmarks " predeterminados?  
 
EU reply: Please see reply under question 5.  
 
5. En caso de que se trate de una presunción refutable, ¿podría explicar cómo funciona 
el mecanismo desde el punto de vista procedimental?  
 
EU reply to question 4 and question 5: The changes to the calculation of the non -injurious price 
used to calculate an injury margin mean that the non -injurious price will reflect:  
 
- Actual  costs resulting from compliance with multilateral environmental agreements and 
International Labour Organisation Conventions to which the European Union is a party as 
well as any future  cost increases in that respect that would occur during the lif etime of TDI 
measures.  
- With regard to the actual costs, the Commission identifies and verifies the cost in the 
financial records of the Union producer. As regards future costs, these are based on clear 
evidence that the conventions to which the Union is p arty will impose a measureable and 
quantifiable future cost to the company.  
  
There are no rebuttable presumptions or predetermined benchmarks.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.1 Medidas que afectan 
directamente a las importaciones , 3.1.6 Medidas antidumping, compensatorias y de 
salvaguardia 3.1.6.1 Medidas antidumping y antisubvenciones  
Página 88 ( Recuadro 3.2 Principales elementos de la modernización de las medidas comerciales 
correctivas, 2018)  
- Mayor transparencia y previsibilidad  
Las partes interesadas reciben informaci ón sobre la imposici ón de medidas provisionales con tres 
semanas de antelaci ón.  
- Investigaciones antidumping m ás rápidas  
El plazo para la imposici ón de medidas provisionales se ha reducido de 9 a 7 meses (o a 8 meses 
como m áximo).  
- Más apoyo para las pymes de la UE  
Se han creado una p ágina web y un servicio de asistencia destinados a las pymes.  
- Cambio en el m étodo de c álculo del margen de perjuicio  
Se han adoptado nuevas normas c on respecto al precio no perjudicial que tienen en cuenta la 
rentabilidad y los gastos futuros, entre otros aspectos.  
- Inclusi ón de consideraciones sociales y medioambientales  
La aplicaci ón de normas sociales y medioambientales se tiene en cuenta:  
- al determinar el precio indicativo para la industria de la UE; y al considerar la aceptaci ón de 
ofertas.  
- Cambios con respecto al uso de la regla del derecho inferior  WT/TPR/M/395/Add.1  
 
- 370 - 
 
  - En las investigaciones antidumping, las distorsiones del mercado de materias primas  conllevar án 
una modulaci ón de la regla del derecho inferior.  
- En las investigaciones sobre derechos compensatorios, la regla del derecho inferior no se aplicar á 
a menos que ello contravenga los intereses de la UE.  
- Respuesta m ás eficaz ante las am enazas de represalias  
Se aclara que las amenazas de represalias a la industria se consideran una de las circunstancias 
especiales que justifican las investigaciones de oficio.  
- Participaci ón de los sindicatos en las investigaciones  
Las normas permiten ahora que los sindicatos sean partes interesadas en las investigaciones.  
- Nuevas normas aplicables a la plataforma continental y las zonas econ ómicas exclusivas de la UE  
Permiten aplicar medidas comerciales correctivas en esas regio nes de la UE.  
- Devoluci ón de derechos  
Se devuelven los derechos percibidos durante el per íodo de reconsideraci ón por expiraci ón si la 
reconsideraci ón concluye sin que se prorroguen las medidas.  
 
Preguntas:  
6. ¿Podría la UE explicar, de manera gene ral, en qué consiste el apoyo adicional que se 
otorga a las pequeñas y medianas empresas?  
 
EU reply: EU small and medium -sized companies (SMEs) benefit from streamlined procedures and 
the support of an SME Helpdesk to make it easier for them to participate in trade defence 
investigations.  
The Commission has created a dedicated web page for SMEs, which pr ovides relevant information 
to help navigate the system, including a guide to filing complaints as well as standard questionnaires 
for Union producers, importers and users. The dedicated webpage can be found here:  
https://ec.europa.eu/trade/policy/accessi ng-markets/trade -defence/actions -against -imports -into-
the-eu/help -for-smes/ . 
 
7. Podría la UE explicar de qué forma la distorsión en las materias primas resulta en la 
modulación de la regla del derecho inferior (LDR)?  
 
EU reply: The Commission may impose anti -dumping duties at the level of the dumping margin if:  
 
- the investigation fin ds that there are certain raw material distortions with regard to the 
product concerned which fulfil the conditions set in Article 7(2a) of the Basic Regulation; and  
- the investigation concludes that it is in Union interest to impose the higher duty in 
accordance with Article 7(2b) of the BR.  
 
The distortions on raw materials consist of the following measures: dual pricing schemes, export 
taxes, export surtax, export quota, export prohibition, fiscal tax on exports, licensing requirements, 
minimum export pr ice, value added tax (VAT) refund.  
 
A single raw material, whether unprocessed or processed, including energy, for which a distortion is 
found, must account for not less than 17 % of the cost of production of the product concerned. For 
the purpose of the calculation, an undistorted price of the raw material as established in 
representative international markets shall be used.  
 
Página 88 (Párrafo 3.81)  
3.81. En virtud de una decisión adoptada por el presidente de la Comisión Europea en 2019, se 
revisaron l a función y el mandato específicos del "consejero auditor" a fin de incrementar la 
transparencia y la equidad de los procedimientos comerciales.128 En concreto, el cometido del 
consejero auditor es salvaguardar los derechos procesales de las partes interes adas previstos en 
diversos reglamentos relativos al comercio, en especial las normas por las que se rigen las 
investigaciones antidumping, antisubvenciones y en materia de salvaguardias.129 Por ejemplo, el 
consejero auditor se encarga de la organizaci ón y la celebraci ón de las audiencias en nombre de las 
partes interesadas.  
 
Pregunta:  
8. Respecto al "consejero auditor" (hearing officer), ¿podría la Unión Europea dar más 
detalles acerca de cómo funciona ese mecanismo? ¿El "consejero auditor" forma parte 
permanente de la autoridad investigadora o se trata de un funcionario que interviene 
ad hoc cuando las circunstancias particulares lo ameriten?  WT/TPR/M/395/Add.1  
 
- 371 - 
 
  EU reply:  The role of the Hearing officer is to:  
 
• safeguard the effective exercise of the procedural rights of the interested parties;  
• ensure that trade proceedings are handled impartially, fairly and  within a reasonable time  
 
The Hearing officer acts on the basis of requests from interested parties in trade defence 
investigations. The Hearing Officer is attached, for administrative purposes, to the Cabinet of the 
Commissioner for Trade and works independently from Commission services and reports directly to 
the Commissioner for Trade. The Hearing Officer also provides independent policy advice on trade 
proceedings to the Commissioner and the Director General for Trade.  
General information regardin g the functioning of the Hearing Officer can be found on this webpage:  
https://ec.europa.eu/trade/trade -policy -and-you/contacts/hearing -officer/  
The full terms of reference of the Hearing Officer can be found in this link:  
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019D0339&from=EN . 
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.4 Política de competencia  
 
Página 136, (párrafo 3.246)  
3.246. Con el fin de facilitar la cooperaci ón con las autoridades nacionales de competencia, la 
Comisi ón adopt ó disposiciones sobre el funcionamiento del Comit é Consultivo en materia de 
prácticas restrictivas y posiciones dominantes. El Comit é Consul tivo debe ser consultado antes de 
adoptar decisiones al amparo de los art ículos 7, 8, 9, 10 y 23, p árrafo 2) del art ículo 24 y apartado 
1) del art ículo 29 del Reglamento 1/2003; en caso de que vayan a realizarse investigaciones 
sectoriales; y cuando ha ya reglamentos en proyecto. El Comit é está formado por representantes de 
las autoridades de competencia de los Estados miembros. Durante el per íodo objeto de examen, la 
Comisi ón, a la vista del Reglamento general de protección de datos de 2016264, adop tó una Decisi ón 
sobre el tratamiento de datos personales en relaci ón con la comunicaci ón de información a los 
interesados y la limitaci ón de determinados derechos. Seg ún la Comisi ón, la Decisión garantiza el 
equilibrio entre los derechos de los inte resados y la eficacia de las investigaciones en materia de 
competencia.  
 
Pregunta:  
9. ¿Se considera que la cooperación internacional en materia de aplicación de leyes de 
competencia económica es parte de la conducción eficiente de investigaciones de 
compe tencia? De ser así, ¿en qué circunstancias se considera que las garantías del sujeto 
titular de los datos están por encima del interés de la Dirección General de Competencia 
por cooperar con una agencia de competencia extranjera a fin de conducir eficiente mente 
una investigación en la materia?  
 
EU reply: On 5 December 2018, the Commission adopted a decision laying down internal rules 
concerning the processing of personal data by the European Commission in the field of competition 
in relation to the provisio n of information to data subjects and the restriction of certain rights (the 
decision).77 This decision was taken for the purpose of Article 25 of the Internal Data protection 
Regulation (EU) 2018/1725 (IDPR).78 
 
The decision recalls that the Commission cond ucts administrative investigations for the purpose of 
enforcing the competition rules in accordance with i.a. international agreements adopted for that 
purpose.79 If a restriction relating to personal data, contained in information exchanged with a third 
 
77 Commission Decision (EU) 2018/1927 of 5 December 2018 laying down internal rules concerning the 
processing of personal data by the European Commissio n in the field of competition in relation to the provision 
of information to data subjects and the restriction of certain rights (OJ L 313, 10.12.2018, p. 39).  
78 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, 
offices and agencies and on the free movement of such data, and repealing Regulation (EC) No . 45/2001 and 
Decision No . 1247/2002/EC (OJ L 29 5, 21.11.2018, p. 39). While the IDPR is applicable to Union Institutions like 
the Commission, the General Data Protection Regulation (GDPR) is the equivalent applicable to EU Member States 
and private operators (Regulation (EU) 2016/679 of the European Pa rliament and of the Council of 27 April 2016 
on the protection of natural persons with regard to the processing of personal data and on the free movement 
of such data, and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1).  
79 For the sake of clarity, the Advisory Committee on Restrictive Practices and Dominant Positions is 
composed of the representatives of the competition authorities of the EU Member States, which are consulted WT/TPR/M/395/Add.1  
 
- 372 - 
 
  country in the context of international cooperation, were necessary, the decision requires a case -
by-case analysis taking into account the concrete circumstances of the matter.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.4 Política de competencia ,3.3.4.1 Aplicación de la 
legislación de competencia (acuerdos anticompetitivos y abuso de posición dominante)  
 
Página 139 (Párrafo 3.252)  
3.252. Durante el per íodo objeto de examen, la Comisi ón ado ptó una serie de decisiones que 
afectaban a grandes empresas en el mercado de servicios digitales, como Google274, Amazon275 y 
Qualcomm.276 La Comisi ón tambi én adopt ó medidas para garantizar la competencia en los mercados 
de abastecimiento de gas, entr e las que destaca la adopci ón de una decisi ón en la que se establec ían 
unos compromisos que deb ía aceptar el proveedor ruso Gazprom.277 Entre los compromisos que 
Gazprom deb ía aceptar cabe mencionar la eliminaci ón de los obst áculos al libre flujo de  gas en 
Europa Central y Oriental; la integraci ón de los mercados de gas en Europa Central y Oriental; la 
garant ía de precios competitivos para el gas, especialmente en Bulgaria, Estonia, Letonia, Lituania 
y Polonia; y la supresi ón de las ventajas obten idas gracias a su posici ón dominante en el mercado.  
 
Pregunta:  
10. Respecto a las decisiones sobre grandes empresas en el mercado de servicios 
digitales, como Google, Amazon y Qualcomm en cuestiones de competencia, ¿se podría 
explicar de manera general cuáles fueron dichas medidas?  
 
EU reply: The European Commission stays committed to ensuring the full respect of European 
competition rules in digital markets. As regards the Commission's actions in relation to Google, 
Amazon and Qualcomm referred to in the question, all publicly available information on the relevant 
competition cases can be found under the following links:  
 
Google Search (Shopping) – case AT.39740: 
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_ 39740 . 
 
Google Android – case AT.40099:  
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_40099 . 
 
Amazon e -books (commitments decision) – case AT.40153:  
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_40 153. 
 
Qualcomm (exclusivity payments) – case AT.40220:  
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_40220 . 
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.4 Polític a de competencia, 3.3.4.2 Fusiones y adquisiciones  
 
Páginas 140, (párrafo 3.258)  
3.258. El control de las fusiones se basa en el Reglamento (CE) No 139/2004 del Consejo, de 
20 de enero de 2004. El documento de trabajo de los servicios de la Comisión que acompaña al 
informe sobre política de la competencia de 2017 confirma que, según se deduce de las consultas 
públicas, la legislación en esta esfera se considera efectiva en su conjunto, aunque la Comisión sigue 
analizando si para su posible me jora conviene proponer algunos cambios, legislativos o no, en el 
Reglamento de fusiones de la UE . 
 
Pregunta:  
11. ¿Existe alguna discrepancia en la tendencia se ha impuesto en el control de 
concentraciones en las jurisdicciones nacionales y aquella de la ju risdicción comunitaria? 
¿En qué sectores ha sido más visible la brecha en el control de concentraciones entre los 
niveles nacional y comunitario?  
 
 
prior to the adoption of certain Commission acts under competition law. It s functioning does not entail any 
international transfers of personal data under Chapter V of the IDPR.  WT/TPR/M/395/Add.1  
 
- 373 - 
 
  EU reply: The Commission, in line with its general Better Regulation principles, regularly 
re-examines its competition tools and processes, adapting them where appropriate to ensure that 
they continue to fulfil their role, in particular in light of evolving market conditions.  
 
For example, in 2016, the Commission launched an evaluation of certain p rocedural and jurisdictional 
aspects of EU merger control, which included a public consultation. This evaluation concerns 
potential improvements to further simplify merger control procedures and referrals between the 
Commission and the EU Member States. It  also focuses on the effectiveness of the current 
turnover -based jurisdictional thresholds to capture high -value acquisitions of firms with low 
turnover, including in the digital or pharma sectors. This work stream is on -going. Moreover, the 
Commission pla ns to review its Market Definition Notice used in antitrust and merger enforcement.  
 
These and other initiatives are part of the regular reflection process undertaken by the Commission 
to ensure effectiveness of EU competition enforcement. They have not be en prompted by "any 
discrepancy " in enforcement at national and EU levels. The Commission and EU Member States work 
in close cooperation and oftentimes deal with the similar challenges (e.g. digitisation, in response to 
which some EU Member States – i.e. A ustria and Germany – have recently introduced value -based 
notification thresholds, whereas the Commission has not done so at this stage).  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.4 Política de Competencia, 3.3.4.3 Investigaciones e 
informes sectoriales  
 
Páginas 142, (párrafo 3.262)  
3.262. Otros acontecimientos destacables son los relacionados con investigaciones sectoriales 
específicas realizadas por la Comisión.301 Esas investigaciones sirven de fundamento para la 
presentación de informes públicos y ayudan a la Comisión a decidir sobre si se inician procedimientos 
formales de investigación.  
 
Pregunta:  
12. En relación con la regulación que aborda cuestiones relacionadas c on el bloqueo 
geográfico en cuestiones de comercio digital, ¿qué medidas han ayudado a disminuir las 
prácticas discriminatorias que obstaculizan el comercio electrónico y mejorar la 
competencia transfronteriza en el comercio en línea?  
 
EU reply: As part of  the European Commission 's Digital Single Market strategy , the EU legislator 
adopted a regulation on unjustified geoblocking , which entered into force on 3 December 2018. It 
gives customers better access to goods and services in the Single Market, by preventing 
discrimination based on customers' nationality or place of res idence/establishment.  
 
Other major measures that have helped reduce discriminatory practices hindering e -commerce are 
the following:  
 
• The new VAT rules for electronic commerce, adopted in December 2017, which make it 
easier to collect VAT when consumers b uy goods and services online. They will also make it 
much simpler for online businesses to comply with VAT obligations.  
• Rules for more transparent and affordable cross -border parcel delivery prices. This allow 
consumers and small e -retailers to buy and se ll products and services online more easily 
and confidently across the EU.  
• The Digital Contracts rules, which aim at harmonising rules for the sale of digital content 
and online purchases for all 28 EU countries.  
• New rules for broadcasters to obtain more easily the authorisations they need from right 
holders to transmit online programmes in other EU Member States.  
• The revised Consumer Protection Cooperation Regulation, that improves the EU -wide 
cooperation mechanism for consumer protection. It entered int o force on 16 January 2018 
and started to apply on 17 January 2020.  
 
You can find all information under https://ec.europa.eu/digital -single -market/en/policies/shaping -
digital -single -market .  
 
On 10 May 2017, the Commission adopted the Final Report on the e -commerce sector inquiry. The 
insights gained from the sector inquiry  allowed the Commission to target EU antitrust enforcement WT/TPR/M/395/Add.1  
 
- 374 - 
 
  in European e -commerce markets on the  most widespread, problematic business practices that have 
emerged or evolved as a result of the growth of e -commerce and that may negatively impact 
competition and cross -border trade and hence the functioning of the EU's Digital Single Market.  
The Commiss ion opened several cases into e -commerce, relating to vertical restraints and territorial 
restrictions. See some examples below:  
 
• Guess: The Commission fined the clothing company Guess  for restricting retailers from 
online advertising and selling cross-border to consumers in other Member States, in breach 
of EU competition rules. 
[https://ec.europa.eu/commission/presscorner/detail/en/IP_18_6844]  
• Licensed merchandising: The Commission fined Nike and Sanrio   
 for restricting cross -border and online s ales of merchandising products such as bags, toys, 
school accessories and clothes, notably for children. 
[https://ec.europa.eu/commission/presscorner/detail/en/IP_19_1828; 
https://ec.europa.eu/commission/presscorner/detail/en/IP_19_3950  ] 
• PC video games: The Commission is investigating bilateral agreements concluded between 
Valve Corporation, owner of the Steam PC video game distribution platform, and five PC 
video game publishers, Bandai Namco, Capcom, Focus Home, Koch Media and ZeniMax . 
The investigation concerns geo -blocking practices, where companies prevent consumers 
from purchasing digital content, in this case PC video games, because of the consumer's 
location or country of residence.[  
https://ec.europa.eu/commission/presscorner/detail/en/IP_19_2010 ]  
 
For further information see also:  
Digital Single Market Strategy https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:52015DC0192 . 
Geo-Blocking Regulation https://eur -lex.europa.eu/content/news/geo -blocking -regulation -enters -
into-force.html   
E-commerce Sector Inquiry 
https://ec.europa.eu/compe tition/antitrust/sector_inquiries_e_commerce.html . 
 
Páginas 143, (párrafo 3.264)  
3.264. En relación con la digitalización, una de las principales conclusiones era que se utilizaba de 
forma muy amplia el bloqueo geográfico, que impedía que los compradores en línea adquirieran 
digitalmente bienes o servicios en función de su localización  geográfica (se constataba que cerca del 
60% de los proveedores de contenidos digitales entrevistados utilizaban el bloqueo geográfico). 
Estas practicas se traducen en restricciones fijadas en las licencias concedidas a los usuarios. En el 
informe se desta caba que las licencias son esenciales para los titulares de derechos de autor y se 
señalaba que para valorar en cada caso las consecuencias de las pr ácticas de concesi ón de licencias 
era preciso considerar las caracter ísticas espec íficas de la industri a de que se tratase. Para poner 
término a las pr ácticas discriminatorias que dificultan el comercio electr ónico y mejorar la 
competencia transfronteriza en el comercio en l ínea, la UE adopt ó un reglamento en que se abordan 
las cuestiones relacionadas con el bloqueo geográfico (sección  4.4.3.2).  
 
Pregunta:  
13. ¿Se prevén mayores barreras a la competencia derivadas del fortalecimiento de la 
protección a la propiedad intelectual en el espacio comunitario? ¿Existen otras áreas de 
la política de competenci a en las que la propiedad intelectual sea uno de los retos para el 
futuro de la política de competencia europea, por ejemplo, el control de concentraciones?  
 
EU reply: General approach towards IP: As it is explained in more detail in the Commission 's 
Guide lines on the application of Article 101 of the Treaty on the Functioning of the European Union 
to technology transfer agreements, DG Competition does not work under the presumption that 
intellectual property rights (and licence agreements) as such are a ba rrier to competition. The EU 
considers intellectual property rights ( "IPRs") as generally promoting dynamic competition by 
encouraging undertakings to invest in developing new or improved products and processes. Given 
that competition also puts pressure on undertakings to innovate, both IPRs and competition are 
necessary to promote innovation and ensure a competitive exploitation thereof.  
That being said, in exceptional circumstances the EU has found behaviour by IPR holders to be 
anticompetitive , e.g. the seeking of injunctions by the holder of a standard essential patent ( "SEP") 
for which a commitment to license on fair, reasonable and non -discriminatory has been given and 
the alleged infringer was willing to take a licence on these terms.  WT/TPR/M/395/Add.1  
 
- 375 - 
 
  Stren gthening of IP protection: As to any strengthening of IP protection, the Commission 's IPR policy 
for the next mandate has not been set.  
 
Future IP challenges: As to the second question, the digital industry and platforms are arguably the 
largest challenge s for competition policy at the moment. However, IP currently does not seem to 
play a major role for the business models of the GAFA. However, there are at least in two areas 
where competition law might face challenges with respect to IP, namely pharmaceut icals and 
standard -essential patents, in particular related to the Internet of Things.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.7 Derechos de propiedad intelectual, 3.3.7.1 Derecho de 
autor y derechos conexos  
 
Page 146 (Table 3.31 Status of participation in WIPO conventions and treaties)  
 
 
 
Pregunta:  
14. ¿Cuál es la razón por la cuál no se han aceptado los siguientes tratados: "Trademark 
law Treaty" y el "Beijing Treaty on Audiovisual Perfomances"?  
 
EU reply: The EU intends to accede to the Singapore Treaty on the Law of Trademarks. The 
preparatory work will be launched once the new trademark package (adopted in 2015) has been 
fully implemented.  
 
While the European Union sig ned the Beijing Treaty on Audiovisual Performances on 19 June 2013, 
internal discussions regarding the European Union 's accession are still ongoing.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.7 Derechos de propiedad intelectual, 3.3.7.1 Derecho de 
autor y derechos conexos  
 
Página 162 (Párrafo 3.331)  
3.331. En la Directiva tambi én se ab orda la utilizaci ón de contenidos protegidos por prestadores de 
servicios en l ínea, como YouTube, Twitter, etc. Cabe destacar que, con arreglo al art ículo 17 de la 
Directiva, los prestadores de servicios para compartir contenidos en l ínea son considera dos 
responsables de la comunicaci ón al p úblico, por usuarios, de materiales protegidos por derechos de 
autor, y est án obligados a solicitar las autorizaciones pertinentes a los titulares de los derechos. 
Esas autorizaciones deber án tambi én incluir a l os usuarios no comerciales. En caso de difusi ón no 
autorizada, los prestadores de servicios est án exentos de responsabilidad si demuestran que han 
hecho los mayores esfuerzos por obtener una autorizaci ón del titular de los derechos; y que han 
hecho los mayores esfuerzos por garantizar la indisponibilidad de las obras bas ándose en la 
informaci ón facilitada por el titular de los derechos y/o retirar los contenidos infractores (y por evitar 
que se carguen en el futuro) al recibir una notificaci ón del tit ular de los derechos a estos efectos. 
Los nuevos proveedores de servicios (menos de tres a ños prestando servicios) cuyo volumen de 
negocios anual sea inferior a 10 millones de euros ser án sometidos a requisitos menos exigentes. 
La Directiva, m ás que imp oner una obligaci ón general de supervisi ón, establece que los prestadores 
de servicios en l ínea deben proporcionar a los titulares de derechos, previa solicitud por parte de 
estos, informaci ón adecuada y prever mecanismos de reclamaci ón y recurso para  los usuarios. 
Tambi én se establecen expresamente excepciones y limitaciones, por ejemplo, para la utilizaci ón de 
contenidos en citas, cr íticas o rese ñas; o a efectos de caricatura, parodia o pastiche.  
 
WT/TPR/M/395/Add.1  
 
- 376 - 
 
  Pregunta:  
15. ¿Cuál es el procedimiento que sigue la autoridad correspondiente para bajar los 
contenidos que infringe derechos de autor y derechos conexos en internet?  
 
EU reply:  Article 17 provides that, where no licensing agreements have been concluded and where 
right holders hav e provided online content -sharing services with the necessary and relevant 
information, online content -sharing services need to make best efforts to ensure the unavailability 
of unauthorised content. In addition, online content -sharing services have to act  expeditiously to 
remove any unauthorised content following a notice received from right holders and make best 
efforts to prevent future uploads. As required in Article 17(10), the Commission has launched a 
stakeholder dialogue  to discuss best practices fo r cooperation between online content -sharing 
services and rightholders. Taking into account the results of such dialogue, the Commission will issue 
guidance on the application of Article 17.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas q ue afectan a la 
producción y al comercio, 3.3.7 Derechos de propiedad intelectual, 3.3.7.2 Propiedad 
industrial,  3.3.7.2.3 Marcas de fábrica o de comercio  
 
Página 168 (Párrafo 3.53)  
3.353. Entre otras cosas, el Reglamento de 2017 y sus normas delegadas y de ejecuci ón introdujeron 
la marca de certificaci ón de la UE.440 La marca de certificaci ón se define como aquella que permite 
"distinguir los productos o servicios que el titular de la marca certifica por lo que respecta a los 
materiales, el  modo de fabricaci ón de los productos o de prestaci ón de los servicios, la calidad, la 
precisi ón u otras caracter ísticas, con excepci ón de la procedencia geogr áfica, de los productos y 
servicios que no poseen esa certificaci ón". As í pues, ofrece la  garant ía de que determinadas 
mercanc ías y determinados servicios tienen caracter ísticas espec íficas, con independencia de la 
identidad de la empresa que produce realmente los bienes o presta realmente los servicios en 
cuesti ón. El papel del titular d e la marca de certificaci ón es controlar que unos bienes o unos servicios 
cumplen unos determinados criterios, que se establecen en las normas de uso de la marca de 
certificaci ón.  
 
Pregunta:  
16. ¿Cuántas y cuáles son las marcas de certificación? ¿Cuál e s el procedimiento para 
obtenerlas? ¿Cuáles son los beneficios de tenerla en los productos o servicios?  
 
EU reply:  The benefit of certification marks is that they guarantee specific characteristics of certain 
goods and services. They indicate that the goods or services bearing the mark comply with a given 
standard set out by the owner of the mark as a result of a cont rol set up by the certification mark 
owner, irrespective of the identity of the undertaking that actually produces or provides the goods 
and services at issue and uses the certification mark.  
 
In order to obtain an EU certification mark, applicants have to  include a statement in their 
applications to the effect that they are applying for an EU certification mark (Article 83(1) of 
Regulation (EU) 2017/1001 (EUTMR) and Article 2(1)(i) of Commission Implementing Regulation 
(EU) 2018/626 (EUTMIR). Applicants mu st also declare that they do not carry on a business involving 
the supply of goods or services of the kind certified (Article 83(2) EUTMR and Article 17(b) EUTMIR). 
They must not have any economic (business) interest in the relevant market.  
 
The regulation s of use constitute the essence of the certification mark. These must be filed within 
two months of the application (Article 84(1) EUTMR) and need to contain, in particular , the 
characteristics of the goods or services to be certified (e.g. the material, m ode of manufacture of 
goods or performance of services, quality or accuracy), the conditions of use of the certification 
mark, the persons authorised to use the EU certification mark and the testing and supervision 
measures to be applied by the certificati on mark owner (Article 84(2) EUTMR, Article 17 EUTMIR).  
 
Registered certification marks are searchable at 
https://euipo.europa.eu/eSearch/#advanced/trademarks ; the relevant field in the searching tool is 
the following: "kind of mark ". In order to know whic h marks are registered, one can in addition 
search for "trade mark status " and click on "registered " (the results will show all registered 
certification marks).  
 WT/TPR/M/395/Add.1  
 
- 377 - 
 
  Página 169 (Párrafo 3.356)  
3.356. Con objeto de armonizar m ás profundamente los reg ímenes na cionales de marcas de f ábrica 
o de comercio de los Estados miembros de la UE, que coexisten con el r égimen de marcas de f ábrica 
o de comercio de la UE, el Parlamento Europeo y el Consejo adoptaron la Directiva (UE) 2015/2436 
relativa a la aproximaci ón de las legislaciones de los Estados miembros en materia de marcas.443 La 
Directiva entr ó en vigor el 12 de enero de 2016; los Estados miembros dispon ían hasta el 14 de 
enero de 2019 para transponerla a la legislaci ón nacional. La mayor ía de los Estados miembros han 
notificado una transposici ón completa.  
 
Pregunta : 
17. ¿Cuáles son los países que ya implementaron el régimen de la Unión Europea en sus 
legislaciones nacionales y cuáles son los países que faltan?  
EU reply:  Most member States have not ified complete transposition and Cyprus, Greece, Latvia, 
Romania and Slovenia are expected to notify the transposition measures expeditiously.  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDAS, 3.3 Medidas que afectan a la 
producción y al comercio, 3.3.7 D erechos de propiedad intelectual, 3.3.7.2 Propiedad 
industrial , 3.3.7.2.3 Marcas de f ábrica o de comercio, 3.3.7.2.5.2 Datos de pruebas cl ínicas  
 
Página 173 (Párrafo 3.369)  
3.369. Los informes cl ínicos deben ser an ónimos para cumplir la legislaci ón europea sobre protecci ón 
de datos personales, y las empresas deben justificar la inclusi ón de cualquier informaci ón comercial 
confidencial. La EMA ofrece orientaciones a las empresas farmac éuticas sobre los requisitos para 
cumplir su pol ítica de publicaci ón de datos cl ínicos.  
 
Pregunta:  
18. Los informes clínicos a los que se hacen referencia en esta sección ¿Cuándo se deben 
publicar? ¿Cuál es la razón para publicarlos? ¿Se publican con la información necesaria 
para que los genéricos pued an empezar sus pruebas clínicas?  
 
EU reply: Clinical reports that are a part of the marketing authorisation application are published 
by the European Medicines Agency (EMA) 60 days after the European Commission decision, in line 
with EMA 's publication policy 0070 ( https://www.ema.europa.eu/en/documents/other/european -
medicines -agency -policy-publication -clinical -data-medicinal -products -human -use_en.pdf ). The 
main objective of the policy is to enable public scrutiny and the application of new knowledge in 
future research, all this in the interest of public health. This information does not a llow generics to 
start clinical trials.  
In the next couple of years (estimated by the end of 2021), the new Clinical Trials Regulation (CTR) 
increases the transparency of clinical trials related information. It states that all information in the 
EU CT Port al and Database (the IT tool that supports the submission and the assessment of the 
clinical trials application in the EU) is by default publicly available, unless one of the grounds of 
keeping it undisclosed is fulfilled. The CTR further specifies that cl inical study reports (CSR) would 
not be considered commercially confidential once a marketing authorisation has been 
granted/completed or the application withdrawn.  
 
Currently, there is no legal requirement on the publication of clinical reports but they are disclosed 
in compliance with the EMA transparency policy.  
 
4.4 Servicios , 4.4.2 Servicios de construcci ón, 4.4.2.1 Panorama general, 4.4.2.2 Marco 
jurídico y de pol íticas.  
 
Página 257 (Párrafo 4.264)  
4.264. Recientemente se ha formulado una propuesta de Directiva y Reglamento sobre una tarjeta 
electr ónica de servicios.353 Lo que se propone es elaborar un formulario de notificaci ón armonizado 
para obtener una suerte de "pasaporte de servicios", que permita acceder a la activida d de que se 
trate en el Estado miembro receptor, lo que potenciar ía la cooperaci ón entre los Estados miembros 
de origen y los Estados miembros receptores, y ayudar ía a los proveedores de servicios 
transfronterizos. Este procedimiento armonizado totalmen te electr ónico reducir á los obst áculos 
administrativos y simplificar á los trámites para que los proveedores de servicios puedan prestarlos 
de una manera m ás eficiente en el extranjero. En marzo de 2018 se dej ó en suspenso el proceso 
legislativo de l a iniciativa.  
 WT/TPR/M/395/Add.1  
 
- 378 - 
 
  Preguntas:  
19. ¿Podría la UE dar a conocer el estatus actual de esta iniciativa?  
 
EU reply:  The services e -card initiative has been on hold since 21 October 2019 because the 
European Parliament expressed the view that the legislative proposal should be withdrawn. As 
announced on 29 January 2020, the Commission has decided to include it in its Wo rk Programme 
for 2020. Different options for the way forward are currently explored.  
 
4 POLÍTICAS COMERCIALES, POR SECTORES, 4.4 Servicios, 4.4.4 Servicios de 
telecomunicaciones, 4.4.4.2 Reforma de las normas sobre telecomunicaciones: el Código 
Europeo de las Comunicaciones Electrónicas  
 
Página 271 (Párrafo 4.313)  
4.313. El CECE ampl ía el ámbito de aplicaci ón de la reglamentaci ón de la UE en materia de 
telecomunicaciones en consonancia con el principio de neutralidad tecnol ógica y para seguir el ritmo 
de la evoluci ón tecnol ógica. Rige los "servicios de comuni caciones electr ónicas", es decir, los 
"prestado[s] por lo general a cambio de una remuneraci ón a trav és de redes de comunicaciones 
electr ónicas", que comprenden, con arreglo a la definici ón del C ódigo, tres tipos de servicios: los 
servicios de acceso  a Internet; los servicios de comunicaciones interpersonales; y los servicios 
consistentes, en su totalidad o principalmente, en el transporte de se ñales.  
 
Pregunta : 
20. Sobre el principio de neutralidad tecnológica, ¿cómo ha sido su aplicación y cuáles 
son los desafíos a los que se ha enfrentado?  
 
EU reply:  Given that the Code will only be applicable from the end of 2020 and currently Member 
States are working towards its transposition, we are unable to provide at this stage further insights 
on the main implementation challenges. Generally speaking, however, the technological neutrality 
principle entails that only services ' functionality, rather than the underlying technology, should play 
a role when defining which services fall under a certain obligation  laid down by the Code.  
 
Página 273 (Párrafo 4.321)  
4.321. Adem ás de imponer a los Estados miembros la obligaci ón de cooperar entre s í en la 
planificaci ón estrat égica y coordinaci ón de la pol ítica sobre el espectro radioel éctrico, el CECE los 
obliga a promover la armonizaci ón del uso del espectro radioel éctrico por las redes y servicios de 
comunicaciones electr ónicas en el conjunto de la UE y a actuar con arreglo a determinados objetivos 
y principios a este respecto.439 El CECE dispone que los Estados miembros deber án facilitar la 
utilizaci ón del espectro radioel éctrico en el marco de autorizaciones generales, pero permite la 
concesi ón de derechos individuales en determinadas circunstancias. Establece normas detallada s 
sobre las condiciones que se pueden asociar a la concesi ón de derechos individuales, el 
procedimiento para la concesi ón de tales derechos y su duraci ón y renovaci ón. Los Estados miembros 
están obligados a velar por que los derechos para utilizar el espectro radioel éctrico sean v álidos 
durante un per íodo de al menos 15 a ños, prorrogable otros cinco a ños.  
 
Pregunta:  
21. ¿Cómo se ha llevado a cabo la armonización del uso del espectro radioeléctrico por 
las redes y servicios de comunicaciones electrónicas en la UE?  
 
EU reply:  The European Commission has a long -standing competence (since 2002) to adopt 
decisions for the designation (or allocation) of spectrum under EU -harmonised technical conditions. 
The assignment (or authorisati on) of spectrum use is still largely Member State competence.  
 
The EECC provides for enhanced coordination among Member States on spectrum assignments by 
ensuring: (i) common deadlines for the assignment of pioneer 5G bands (end -2020 for the 3,6 GHz 
and 2 6 GHz bands) and of 2,5 years after the adoption of a harmonisation measure for any frequency 
band for wireless broadband; (ii) coherent mobile licence durations of at least 15 years; (iii) a 
voluntary peer review process between the Member States for cons istency of spectrum authorisation 
rules (e.g. on fees, wireless coverage conditions, new entrants) and developing best practice. 
Furthermore, the EECC strengthens the EU regulatory framework for spectrum and infrastructure 
sharing, spectrum trading and lea sing, as well as for granting individual rights of spectrum use.  
 WT/TPR/M/395/Add.1  
 
- 379 - 
 
  Página 274 (Párrafo 4.324)  
4.324. El CECE refuerza el papel de las autoridades nacionales de reglamentación. Exige a los 
Estados miembros que velen por que las autoridades nacionales de reglamentación y otras 
autoridades competentes desempeñen una serie de tareas especificadas, entre las que se incluyen 
implementar la reglamentación ex ante del mercado, garantizar la resolución de litigios entre 
empresas, llevar a cabo la ge stión o tomar decisiones sobre el espectro radioeléctrico, contribuir a 
la protección de los derechos del usuario final y evaluar y supervisar estrechamente las cuestiones 
de configuración del mercado y de competencia en relación con el acceso abierto al m ercado. El 
CECE también contiene disposiciones destinadas a reforzar la independencia de las autoridades 
nacionales de reglamentación y otras autoridades competentes para velar por la imparcialidad de 
sus decisiones.  
 
Preguntas:  
22. ¿Cuáles son las disposi ciones en materia de competencia económica que incluye el 
Código Europeo de Comunicaciones Electrónicas?  
 
EU reply : The regulatory framework generally aims to ensure a competitive telecoms sector, which 
benefits end -users and provides conditions for incent ivising investments in high -performance 
communications networks. One of the explicit objectives listed in Article 3.2 EECC is to promote 
competition. A considerable number of provisions of the Code concern economic competition, in 
particular those included  in Part II dealing with market entry and deployment (Title I) and those 
addressing Access (Title II).  
 
PARTE II: INFORME DE LA UNIÓN EUROPEA (WT/TPR/G/395)  
3 EVOLUCI ÓN DEL MERCADO INTERIOR, 3.14 La retirada del Reino Unido de la Unión 
Europea  
 
Página 17 (Párrafo 3.51)  
3.51. En el Acuerdo de Retirada se establece un per íodo transitorio, durante el cual, la legislaci ón 
de la UE se aplicar ía en el Reino Unido y al Reino Unido como si siguiera siendo un Estado miembro. 
Esto significa que el Reino  Unido seguir ía participando en la uni ón aduanera y el mercado único de 
la UE, as í como en todas las pol íticas de la Uni ón, incluida la pol ítica comercial. El Reino Unido 
seguir ía estando sujeto a las obligaciones derivadas de los acuerdos internac ionales de la UE, 
incluidos los ALC. Los compromisos y las listas de la UE en el marco de la OMC seguir ían abarcando 
al Reino Unido durante el per íodo transitorio.  
 
Pregunta:  
23. Se podría hablar entonces de que, en el escenario en el que el Reino Unido saliera 
de la UE con Acuerdo, la Comisión Europea buscaría iniciar negociaciones de un acuerdo 
comercial con ese país para regular la relación a futuro. De ser así, ¿el Reino Unido tendría 
que ser considerado como un tercer país únicamente para las negociaciones del acuerdo?; 
¿este acuerdo tendría disposiciones para una implementación provisional en la medida de 
que puede haber prorrogas en el período de transición?  
 
EU reply: On 1 February 2020, the United Kingdom withdrew from the European Union according 
to the arrangements set out in the Agreement on the withdrawal of the United Kingdom of Great 
Britain and Northern Ireland ( "the United Kingdom ") from the European Union and the E uropean 
Atomic Energy Community ( 'the Withdrawal Agreement).[1]  
The Political Declaration that accompanied the Withdrawal Agreement sets out the framework for 
the future relationship between the European Union and the United Kingdom. [2] It establishes the 
parameters of 'an ambitious, broad, deep and flexible partnership across trade and economic 
cooperation with a comprehensive and balanced Free Trade Agreement at its core, law enforcement 
and criminal justice, foreign policy, securit y and defence and wider areas of cooperation. ' In the 
Political Declaration, the EU and UK have stated their intent to begin the formal process of 
negotiations of their future relationship as soon as possible after the UK 's withdrawal, such that it 
can com e into force by the end of 2020.  
 
 
[1] OJ C 384 I, 12.11.2019, p. 1.  
[2] OJ C 384 I, 12.11.2019, p. 178.  WT/TPR/M/395/Add.1  
 
- 380 - 
 
  4. EVOLUCIÓN DE LA POLÍTICA COMERCIAL Y DE INVERSIÓN, 4.2 El programa de 
negociaciones bilaterales de la UE  
 
Página 20 (Párrafo 4.18)  
4.18. Se trata en ambos casos de acuerdos de libre comercio de nueva generaci ón. Van m ás allá del 
comercio de bienes y servicios; abarcan tambi én la propiedad intelectual, las inversiones, la 
contrataci ón pública, las cuestiones aduaneras y la facilitaci ón del comercio, la competencia, la 
cooperaci ón en el ámbito d e la reglamentaci ón, y el comercio y el desarrollo sostenible. Adem ás, el 
AAE UE -Japón fue el primer acuerdo en el que se incluy ó un cap ítulo dedicado a las empresas m ás 
peque ñas. Juntos, esos acuerdos ayudar án a las empresas de la UE a ahorrar has ta 
EUR 1.600  millones en derechos de aduana cada a ño. Se prev é un aumento de las exportaciones de 
la UE al Jap ón de EUR 13.000 millones anuales; por su parte, las exportaciones al Canad á en 2018 
(el primer a ño completo de aplicaci ón provisional) crec ieron un 15% en comparaci ón con los tres 
años anteriores.  
 
Pregunta:  
24. En relación con el Acuerdo Económico y Comercial Global (CETA) entre la UE y 
Canadá y el Acuerdo de Asociación Económica entre Japón y la UE, consideramos como 
acuerdos de libre com ercio de nuevo generación, ¿cuáles son las ventajas que ofrece con 
respecto a acuerdos anteriores en materia de Política de Competencia en ambos 
instrumentos?  
 
EU reply: The competition chapter of the CETA was concluded much earlier than the one in the EU -
Japan EPA. In this context, the EU -Japan EPA can indeed be considered as a new generation FTA. 
Regarding anticompetitive conduct and merger control, the EU -Japan EPA requires a legal framework 
and an independent authority to enforce the legislation. In add ition, it also encompasses provisions 
on non -discrimination, procedural fairness and transparency. The subsidy chapter of the EU -Japan 
EPA applies to subsidies related to both goods and services and it includes transparency obligations, 
a consultation clau se and two types of prohibited subsidies. It brings about the importance the EU 
and Japan attach to internationally agreed rules on subsidies, building on the current WTO 
framework.  
 
4. EVOLUCIÓN DE LA POLÍTICA COMERCIAL Y DE INVERSIÓN, 4.2 El programa de 
negociaciones bilaterales de la UE;  
 
Página 21 (Párrafo 4.23)  
4.23. La UE también mantiene relaciones con socios en América Latina. En noviembre de 2017, la 
UE y Chile comenzaron las negociaciones sobre un acuerdo de asociación que profundice y amplíe 
el Acuerdo existente. En 2018, la UE llegó a un acuerdo político c on México para la 
modernización de su Acuerdo de Asociación. En junio de 2019, la UE concluyó las negociaciones 
con el MERCOSUR para concertar un acuerdo comercial ambicioso, equilibrado y amplio.  
 
Pregunta:  
25. ¿A la luz de las ventajas que ofrece a ambas  Partes la modernización del Acuerdo de 
Asociación, cuáles serían los temas que observan un mayor nivel de complejidad para una 
implementación a corto plazo?  
 
EU reply: The Modernisation of the Association Agreement is a balanced, comprehensive and 
ambiti ous agreement that would bring EU and Mexico trade relations up to new and high standards. 
The Commission expects the provisions of the agreement to be implemented from day one of the 
agreement being applied between the parties and will engage with Mexico for this purpose. The 
Commission does not expect at this stage that there would be areas of the Modernised Association 
Agreement whose complexity will impact their short -term implementation.  
 
4. EVOLUCIÓN DE LA POLÍTICA COMERCIAL Y DE INVERSIÓN, 4.4 Políti ca comercial para 
un comercio abierto y equitativo;   
 
Página 25 (Párrafo 4.53)  
4.53. La UE ha adoptado varias medidas importantes para lograr un comercio abierto y al mismo 
tiempo equitativo:  
 WT/TPR/M/395/Add.1  
 
- 381 - 
 
  b. Reglamento sobre el control de las inversiones extranjeras directas: este Reglamento entró en 
vigor el 10 de abril de 2019. Se aplicará plenamente a partir del 11 de octubre de 2020. En algunos 
casos excepcionales (inversiones extranjeras que afectan a tecnologías críticas, a infraestructuras 
críticas,  al suministro de insumos fundamentales o al acceso a datos sensibles), ayudará a la Unión 
Europea a proteger sus intereses en materia de seguridad frente a las inversiones extranjeras cuyo 
objetivo sea adquirir activos europeos críticos. El marco de contr ol de la UE no reemplaza ni duplica 
ningún mecanismo nacional ya existente, por lo que no añade trámites administrativos para los 
inversores. No está dirigido a los inversores de ningún país en concreto; la no discriminación es un 
principio fundamental del  nuevo reglamento, y los mecanismos de control de los Estados miembros 
de la UE deberán respetar ese principio. Además, las prescripciones aplicables a los mecanismos 
nacionales de control incluyen normas sobre la transparencia, la confidencialidad de la i nformación 
intercambiada y la posibilidad de recurrir las decisiones de control, y medidas para determinar y 
evitar la elusión de los mecanismos y las decisiones por parte de los inversores extranjeros.  
 
Preguntas : 
26. Se podría conocer con anticipación ¿c uáles podrían ser los casos excepcionales de 
inversiones extranjeras que afectan a tecnologías críticas, a infraestructuras críticas, al 
suministro de insumos fundamentales o al acceso a datos sensibles?  
 
EU reply:  There is no list of pre -defined cases in which a foreign investment may be screened. The 
Regulation makes clear that screening of such investments needs to be carried out for reasons of 
security or public order. Article 4 contains an illustrative list of factors that may be taken into 
considerati on when determining whether an investment is likely to affect security and public order.  
  WT/TPR/M/395/Add.1  
 
- 382 - 
 
  NEW ZEALAND  
REPORT BY THE WTO SE CRETARIAT (WT/TPR/S/ 395)  
SECTION 3: TRADE POLICIES AND PRACTICES BY MEASURE  
3.1.3 Tariffs  
3.1.3.3 TRQs and administration  
 
WT/TPR/S/395, pages 64 -66 and 77 -78 Table 3.8  
 
Paragraph 3.45 of the Secretariat's report notes that "The EU has 107 categories of TRQs in its WTO 
schedule, of which 79 (74%) concern agricultural products, and 28 (26%) are with respect to n on-
agricultural products (Table A3.1). Agricultural TRQs cover a diverse group of products, including 
meat, fruit, grains, vegetables, cheese, wine, chocolates, etc., while non -agricultural TRQs are 
mainly on fish, certain metal products, certain wood prod ucts, flax yarn, and glass beads." Table  3.8 
(page 77) then notes that "when it comes to the management of agricultural TRQs, the EU manages 
them through a licensing system for the following products: cereals and rice; sugar; milk and milk 
products; beef a nd veal; pigmeat; poultry meat; eggs….etc."  
For the latest representative period, the use of TRQs varied significantly; some have 100% fill rates 
and others have 0% but with an overall average fill rate of 52%. A fairly significant number, 24%, 
were not ut ilised at all (zero fill rate), and about 30% were fully utilised with 100% fill rates 
(Table  A3.1).  
 
1. Question:  
a. What steps will the EU take to ensure full and proper utilisation of its tariff rate 
quotas?  
 
EU reply:   
The EU does not consider that the management system for any of its TRQs causes low fill rates. Fill 
rates are determined by prevailing economic conditions. The EU notes that many TRQs managed on 
a "first -come, first -served" basis have low fill rates. The E U seeks to apply the TRQ management 
method most appropriate to each TRQ to ensure smooth trade flows and the lowest possible 
administrative burden.  
 
b. Has the EU considered removing in -quota tariffs for these quotas to allow full quota 
utilisation?  
 
EU repl y:  
Removing in -quota tariffs is a market access concession and not a matter of TRQ management.  
 
3.3.7.2.4 Geographical indications  
 
WT/TPR/S/395, pages 153 –154 
Section 3.2, paragraphs 3.357 to 3.362 note the importance of geographical indications (GI) f or the 
EU's external trade, the protection of GIs within the EU (including third country GIs) and the 
protection of EU GIs in other countries through FTAs. We note also that each EU member state and 
the EU itself are members of the Codex Alimentarius Commi ssion (see paragraph 3.222) and the 
importance of the integrity of Codex standards setting system that promotes reliability and 
consistency in international trade rules.   
 
2. Question:  
a. Noting the purpose of the Codex Alimentarius to promote fair trade practic es and 
consistency in international trade, does the EU consider that Codex product standards are 
intended to identify, and apply in relation to, generic or common names of products used 
by producers, traders and consumers trading in those products?  
 
EU rep ly:  
The fact of having a Codex Standard for a product does not automatically imply that the name of 
that product is a generic or common name. The essential objective of a Codex is to harmonise at 
international level the production method, so as to ensure fair competition.  
 
b. How does the EU reconcile the registration of the names danbo and 382 avarti  as 
Gis with the existence of specific Codex Alimentarius standards for each of these cheeses?  WT/TPR/M/395/Add.1  
 
- 383 - 
 
  EU reply:   
Having a Codex Standard for a product does not automatically exclude its name from eligibility as 
Geographical Indication. GI registration aims at res erving the use of a name. Therefore, Codex and 
GI protection have a different scope and purpose and coexistence of a Codex standard and a 
geographical indication cannot be excluded. The EU's commitment to Codex standards and their 
basis in the internationa l trading system is not questioned by the registration of Havarti as PGI in 
the EU.  
 
c. Noting the requirement that a name established in a Codex standard shall be used 
in labelling the applicable food (see CXS -1985), how can a current or future non -Danish 
producer satisfy this requirement when selling danbo or havarti cheese within the EU?  
 
EU reply:   
Producers wishing to include the name "Danbo " or "Havarti " on the label of their products and which 
are established outside the EU may continue to use those re gistered names on the label of products 
marketed outside the EU. The names "Danbo " and "Havarti " may be used within the EU only for 
marketing products which are produced in line with the respective product specifications, one 
requirement of which is that t he producers must be established within the geographical area of 
production (which corresponds to the territory of Denmark). Third countries' producers may market 
their cheese in the EU territory under a different name.  
 
SECTION 4: TRADE POLICIES BY SECTOR  
 
4.1 Agriculture and Fisheries  
4.1.1.2 Agricultural Policies  
4.1.1.2.1 Domestic Support  
4.1.1.2.1.1. Direct payments  
 
WT/TPR/S/395, pages 165 -173 
Direct payments amounted to EUR 41.6 billion in 2017, including EUR 36.5 billion for decoupled 
direct aid, and benefitted 6.5 million farms. Roughly 76% of beneficiaries receive less than EUR 
5,000, and 80% of all beneficiaries receive 20% of total direct payments.  
 
3. Question:  
a. New Zealand appreciates and commends the EU's previous Common Agricultural 
Policy (CAP) reforms towards less trade -distortive measures and fewer payments linked 
to production. However, trade -distorting measures in the form of coupled payments still 
remain.  What work has been undertaken to assess the feasibility of less distortive support 
measures? What were the findings of any such assessments?  
 
EU reply:   
The impact assessment for the CAP Post -2020 proposal is available at:  
https://eur -lex.europa.eu/lega l-content/EN/TXT/?uri=SWD%3A2018%3A301%3AFIN . 
 
b. What efforts has the EU made to encourage its member states to reduce or stop 
coupled support payments to agricultural producers?  
 
EU reply:  
In the Post 2020 CAP proposal, the total maximum percentage of coup led support has been reduced 
compared to the 2015 -2020 period.  
 
c. Can the EU provide an update on its proposal to replace its blue box Voluntary 
Coupled Support with amber box Coupled Income Support?  Can the EU outline how this 
policy supports efforts to str engthen disciplines on trade and production distorting 
support?  
 
EU reply:   
In general terms, it is worth recalling that the policy of decoupling has been a vital element of CAP 
reforms over the last few decades. The European Union has gradually worked to ward the present 
very high share (approximately 90%) of decoupled aid within all direct payments, using only a small 
share of the EU's total Amber Box commitment (under 10%). The Post 2020 CAP proposal is still 
under discussion in the inter -institutional p rocess at the moment. It is too early to tell if and how WT/TPR/M/395/Add.1  
 
- 384 - 
 
  Coupled Income Support will be implemented. The CAP reform proposal does not include any other 
Blue Box programme to replace VCS. However, nothing would prevent Member States to implement 
their coupl ed support in a way that respects the Blue Box requirements. The current cotton Blue Box 
programme will continue.  
 
Based upon the legislative proposal, Coupled Income Support (CIS) would be subject to important 
pre-conditions and limits:  
- only a closed list  of (22) sectors may benefit from the support;  
- it may only be granted to a sector that undergoes certain difficulties;  
- the support shall aim to address this difficulty by way of improving competitiveness, quality, 
 or sustainability;  
- the targeted sector m ust be important from economic, social, or environmental point of view;  
- CIS is subject to a strict budgetary limit per Member State;  
- Limits with regard to the variation of the unit rate compared to the planned amount per 
 hectare/head.  
 
It is worth noting that a number of members, including New Zealand have promoted approaches to 
capping agricultural support which would treat Blue Box and Amber Box support in the same way. 
This does not give an incentive to policymakers to choose the Blue Box rather than the Amber Box; 
quite the reverse.  
 
4.1.1.2.1.2 Internal Market Support Measures  
 
WT/TPR/S/397, pages 174 -185 
According to Table 4.7, Intervention and private storage aid were used only for skimmed milk powder 
in 2017.  
 
4. Question:  
a. Given intervention is not being currently used, has the EU given consideration to 
removing this trade distorting measure?  
 
EU reply:   
The fact that the measure has not been used in a given year does not imply that the need for such 
a measures is gone. Interventi on and private storage aid provide an important safety net for farmers 
during the period of extreme price drops. The current proposal for CAP reform, subject to the 
approval of the EU Member States and the European Parliament, maintains these measure in th e 
toolbox of the Common Agricultural Policy.  
 
b. Has the EU given consideration to alternative methods of supporting farmers that 
support agricultural producers to become more market oriented?  
 
EU reply:   
The EU Common Agricultural policy undergoes constant c hange and has been subject to a series of 
reforms over the past years. The EU always aims at designing the policy that addresses the external 
and internal challenges of the stakeholders in the most sustainable and market -oriented way, leading 
to the dramat ic drop of the trade distorting support granted to the European farmers over the years. 
Subject to the views of the EU co -legislators, the EU intends to continue on this course.  
 
SECTION 4.2 Energy  
 
WT/TPR/S/395, page 201, paragraph 4.131  
Section 4.2, para graph 4.131 states that "On 3 March 2010, the Energy 2020 strategy on climate 
change and energy was proposed by the European Commission, with the following interrelated and 
mutually supportive targets (also known as the "20 -20-20" targets): 20% reduction i n greenhouse 
gas (GHG) emissions compared with 1990 levels; 20% share of renewable energy in gross final 
energy consumption; and 20% cut in energy consumption compared to a 2020 business -as-usual 
projection."  
 
5. Question:  
How does the EU intend to rationalise any inefficient fossil -fuel subsidies that encourage 
wasteful consumption in line with the United Nations' Sustainable Development Goal 12© WT/TPR/M/395/Add.1  
 
- 385 - 
 
  and the G20 commitment so as to contribute to the reduction of greenhouse gas emissions 
and avoid disadvantaging renewable energy uptake?   
 
EU reply:  
Important progress has been made in reporting fossil fuel subsidies with the recent publication of 
"Energy prices, costs and subsidies in the EU" .80 
Under the Governance  regulation81, each EU Member State must report on actions that they 
undertake to phase out energy subsidies, in particular for fossil fuels. In the National Energy and 
Climate Plans Member States are to provide an inventory on fossil fuel subsidies and the ir plans to 
phase them out.  
The European Green Deal82 aims to ensure that different carbon pricing instruments (including 
energy taxation and Emission Trading System) complement each other in a coherent framework.  
 
REPORT BY THE EUROPE AN UNION (WT/TPR/G/3 95) 
 
SECTION 3.7 Common Agricultural Policy  
 
WT/TPR/G/395, page 10, paragraph 3.23  
Section 3.7, paragraph 3.23 of the EU report states that "The EU CAP will account for just under 
one-third of the overall EU budget. The proposed CAP budget will be divided between its two 
traditional "pillars": direct support for farmers/market measures a nd rural development. The EU 
aims to use 40% of the overall financial envelope of the CAP in support of climate objectives."  
 
6. Questions  
a. What proportion of the post CAP 2020 budget in support of climate objectives will 
be Green Box?  
 
EU reply:  
A breakdow n of support to European farmers across the WTO boxes will only be possible after 
adoption of the CAP legislative reform package by the Council and the European Parliament, adoption 
of the Multiannual Financial Framework for 2021 -2027 period and the finali sation of the CAP Strategic 
Plans by the EU Member States, which implements the post -2020 CAP at Member State level.  
 
b. Trade distorting support leads to over -production in environmentally fragile land. 
How does the EU factor in the environmental harm caused by trade distorting support?  
 
EU reply:   
EU does not agree to the NZ statement that all Amber Box support leads to overproduction on 
environmentally fragile land. Not all environmentally -friendly policies can be notified as Green Box 
due to the current wording of Annex II of the Agreement on Agriculture and may have to be notified 
in Amber Box. The EU, in the measures proposed in the CAP reform proposal, has developed a 
coherent policy that includes more environmentally friendly an d climate mitigating measures to 
ensure that future agricultural production within the EU will be even more sustainable than today. 
For instance, coupled income support can be a powerful tool in view of a greener agriculture (e.g. it 
may be granted to a se ctor whose importance is justified on environmental grounds; because it 
undergoes a environmental difficulty; which it aims to address by way of improving sustainability). 
On balance, environmentally fragile land may actually benefit from such support.  
 
The CAP mitigates potential environmental impacts of agriculture and improves the environment. 
The EU currently grants direct payments to farmers that are decoupled from production and subject 
to a series of mandatory environmental and climate requirements a nd standards set out in Annex II 
to EU Regulation 2013/1306. Requirements and standards for the environment are focused on 
protecting soil, water and biodiversity and tackling climate change. In addition, 30% of the direct 
payments are conditional on three  mandatory greening practices, namely: "the conservation of 
permanent grassland, the creation of Ecological Focus areas and the crop diversification". In addition 
more than 50% of the total support for Rural Development Policy is directly targeted at prote cting 
and restoring biodiversity, water, reducing air pollution, protecting soil and tackling climate change. 
 
80 Viewed at: https://ec.europa.eu/energy/en/data -analysis/energy -prices -and-costs. 
81 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32018R1999&from=EN . 
82 Viewed at: https://ec.europa.eu/info/sites/info/files/european -green -deal-communication_e n.pdf. WT/TPR/M/395/Add.1  
 
- 386 - 
 
  The remaining support is targeted at training farmers and providing advisor services to them, animal 
welfare, and to stimulate innovation and mode rnising farms in the respect of the environment.  
 
c. What work has been undertaken by the Commission to consider non -direct payment 
policies to help achieve its climate objectives? What were the relative economic and 
environmental costs and benefits of those policies for reducing GHG emissions while 
achieving other sustainable development goals?  
 
EU reply:   
Environmental friendliness and the nature of support are not necessarily causally linked. The design 
of the next generation CAP is driven by environmental and sustainability concerns in the strongest 
possible manner. The post -2020 CAP, being part of the wider European Green Deal which aims at 
making Europe the world's first climate -neutral continent by 2050, includes the most ambitious 
package of measures to  enable European farmers and consumers to benefit from a sustainable green 
transition. The environmental - and climate -specific objectives are fully integrated into the new green 
architecture of the CAP. This includes addressing the mitigation of and adapta tion to climate change, 
management of natural resources and protecting biodiversity and eco -systems by introducing 
improved mandatory environmental requirements for farmers subject to the CAP support, in 
combination with voluntary schemes and measures help ing to ensure higher climate and 
environmental ambition.  
Detailed analysis of the impact of non -direct payment policies can be found at 
https://ec.europa.eu/agriculture/content/evaluation -cap-climate -change -and-greenhouse -gas-
emissions_en . 
  
The impact as sessment of the CAP post -2020 proposal can be found at https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=SWD%3A2018%3A301%3AFIN . 
 
SECTION 4.1.2 WTO negotiations and initiatives  
 
WT/TPR/G/395, page 18, paragraph 4.12  
Section 4.1.2, paragraph 4.12 of the E U's report states that "The EU has taken a leading position in 
advancing this important work and is committed to finalising [the WTO fisheries subsidies] 
negotiations by December 2019, as agreed in Buenos Aires and in line with the UN Sustainable 
Developme nt Goal 14.6."  
 
7. Question:  
a. New Zealand commends the EU for its commitment to ensure harmful fisheries 
subsidies are prohibited and welcomes the EU's support for an immediate conclusion on 
Fisheries Subsidies in the WTO. How does the EU ensure that its fisheries subsidies do not 
contribute to overfishing and overcapacity?  
 
EU reply:   
EU structural support is provided under Regulation (EU) No 508/2014 of the European Parliament 
and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund for the period 
2014-20. Article 5 states that structural support "shall not result in an increase in fishing capacity".  
 
b. How does the EU rationalise the proposed European Maritime, Fisheries and 
Aquaculture Fund (EMFAF) re -introduction of subsidies for pur chase, renovation and new 
build of fishing vessels in the 2021 -27 EMFAF? While New Zealand acknowledges the 
caveats made by DG MARE with regard to limiting capacity enhancements, we note the 
risks of these disciplines being weakened in the final EMFAF budg et negotiations.  
 
EU reply:  
The Regulation on the European Maritime and Fisheries Fund for the 2021 -27 period has not been 
adopted yet, as the European Commission proposal is currently under inter -institutional negotiation 
between the European Parliament and the Council.  
 
  WT/TPR/M/395/Add.1  
 
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  NORWAY  
Paragraph 4.12 (p. 18) in the report from the EU:  
According to the proposed Regulation of the European Parliament and of the Council on the European 
Maritime and Fisheries Fund and repealing Regulation (EU) No . 508/2014 of the Eu ropean Parliament 
and of the Council , the EU is considering allowing subsidies to modernise fishing vessels. Newer and 
more modern vessels have higher fishing capacity than older vessels. Has the EU considered how 
to make sure that such subsidies will not lead to increased overcapacity in the fishing 
fleet?  
 
EU reply:  
The Regulation on the European Maritime and Fisheries Fund for the 2021 -27 period has not been 
adopted yet, as the European Commission proposal is currently under interinstitutional negotiat ion 
by the European Parliament and the Council.  
 
Sections 3.11 and 3.12 in the report from EU:  
Ambitious targets on environmental action, following -up the Paris Agreement etc. are mentioned in 
the EUs report in paragraphs 3.11 and 3.12.  
 
Last year, the Com mission launched the communication on "The European Green Deal" that sets out 
high ambitions on a broad set of climate and environmental related challenges. How does EU view 
the implementation of "the European Green Deal" in particular with regard to trade ? How 
can trade policy be supportive, and does the EU see any particular challenges related to 
trade rules in the implementation of "the European Green Deal"?  
 
EU reply:   
As the European Green Deal provides trade policy can support the EU 's ecological transition. It serves 
as a platform to engage with trading partners on climate and environmental action.  
 
Commitments to sustainability have been continuously strengthened in EU trade agreements, in 
particular with regard to enhancing climate  change action and the effective implementation of 
Multilateral Environmental Agreements (MEAs). The EU has also been stepping up efforts to 
implement and enforce the sustainable development commitments of EU trade agreements, and 
these efforts will be fur ther enhanced with the appointment of a Chief Trade Enforcement Officer.  
 
On climate change more specifically, the EU 's most recent agreements all include a binding 
commitment of the Parties to ratify and effectively implement the Paris Agreement. The Com mission 
will propose to make the respect of the Paris Agreement an essential element for all future 
comprehensive trade agreements.  
 
The EU 's trade policy facilitates trade and investment in green goods and services and promotes 
climate -friendly public pr ocurement, sustainable consumption and production and resource 
efficiency. Trade policy also needs to ensure undistorted, fair trade and investment in raw materials 
that the EU economy needs for the green transition. It can help addressing harmful practice s such 
as illegal logging, impacting the global supply chains through demand -side measures, enhancing 
regulatory cooperation, promoting high sustainability standards and facilitating the deployment of 
renewable energy by removing non -tariff barriers in thi s sector.  
 
The EU encourages partners to design rules that are as ambitious as current and future EU 's rules, 
including on circular economy and products ' environment foot print, thus facilitating trade and 
enhancing environment protection and climate mitigation in these countries.  
 
As the world 's largest single market, applying high EU standards across global value chains offers 
substantial opportunities.  The EU will continue to work on new standards for sustainable growth and 
promote international standards that are in line with EU environmental and climate ambitions. It will 
work to facilitate trade in environmental goods and services, in bilateral and m ultilateral forums, 
and in supporting open and attractive EU and global markets for sustainable products. It will work 
with global partners to ensure the EU 's resource security and reliable and sustainable access to 
strategic raw materials and clean energy . 
  WT/TPR/M/395/Add.1  
 
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  PANAMA  
En el reporte preparado por la Secretaría en la Sección 4.1.2.6 apoyo estructural se hace referencia 
al Fondo Europeo Marítimo y de Pesca post 2020 en el cual se propone un nuevo presupuesto para 
el otorgamiento de subsidios pesqueros.  
A su vez , en el reporte elaborado por la Unión Europea en la sección de reforma de la OMC, numeral 
4.1.2 sobre negociaciones e iniciativas de la OMC. La Unión Europea hace referencia a que lideran 
los esfuerzos en avanzar en las negociaciones con el objeto de proh ibir las subvenciones a la pesca 
que contribuyen a la sobrecapacidad y la sobrepesca y eliminar las subvenciones que contribuyen a 
la pesca ilegal, no declarada y no reglamentada.  
 
En ese sentido, Panamá desea conocer:   
1. ¿Cómo el Fondo Europeo Marítimo y de  pesca post 2020 contribuye a las 
negociaciones de eliminación y disciplinar los subsidios en la OMC?  
 
EU reply:  
The EMFF post -2020 proposes a strict conditionality to subsidies that are applied to vessels. They 
must not increase fishing capacity. Support will be available for the improvement of control measures 
on board, such as vessel tracking and reporting systems, purchase and installation of compulsory 
remote electronic monitoring systems. These supports are conditional on not increasing capaci ty and 
directly contribute to better monitoring of fisheries to reduce IUU.  
 
2. ¿Cómo este fondo post 2020 apoya la sostenibilidad a largo plazo de los recursos 
pesqueros y las poblaciones de peces?  
 
EU reply:  
The Commission proposal for the EMFF post-2020 aims at providing support for the long -term 
sustainability of fish stocks from several dimensions. Investments which improve monitoring, control 
and data collection would help to reduce IUU fishing and ensure adherence to the sustainable 
fisherie s regimes put in place. Support would be available to vessel owners which incentivises 
knowledge development and exchanges on the adoption of more sustainable techniques. 
Investments in innovations such as new equipment, for example to improve selectivity of the fish 
landed, to reduce bycatch or damage to the seabed would also be supported. Costs associated with 
designating, managing and restoring marine protected areas also greatly contribute to protecting 
biodiversity and sustainability of fish stocks.  
 
3. ¿Cómo la Unión Europea se asegurará que sus subsidios dentro de sus programas 
no contribuyan a la sobrepesca y como verificará que efectivamente el apoyo financiero 
otorgado se asignará para planes de manejo y gestión sostenible de los recursos 
pesqueros?  
 
EU reply:  
The EU approach to managing overfishing is to manage fleet capacity, as a complement to control 
and enforcement measures. Limiting fishing capacity ensures that capacity for overfishing is 
reduced. The EU measures capacity in terms of gross tonna ge (volume of the vessel) and kilowatts 
(engine power). Support for vessels which have a negative impact on the available fishing 
opportunities and overall balance of the fleet are not permitted. The EMFF proposal includes a 
number of safeguards, condition alities and a list of operations that are ineligible for EMFF support 
on the basis that they contribute to overfishing.  
 
Igualmente, en el sector de agricultura, a Panamá le gustaría conocer:  
4. ¿Qué medidas está tomando la Unión Europea a través de su agenc ia EFSA para 
poder concluir los debidos estudios científicos sobre los pesticidas, herbicidas y fungicidas 
cuyo uso están prohibiendo, a pesar de los niveles permitidos en el CODEX de la 
FAO/OMS?  
 WT/TPR/M/395/Add.1  
 
- 389 - 
 
  EU reply:  
The EU body of law foresees the possibility to r esort to the precautionary principle and, more 
specifically, it refers to the precautionary principle as part of the risk management process that leads 
to the development of EU and national food law. The precautionary principle, as laid down in the 
General  Food Law Regulation, Regulation (EC) No . 178/2002 on general food law, allows the 
adoption of provisional risk management measures necessary to ensure a high level of health 
protection when, following an assessment of available information, the possibilit y of harmful effects 
on health is identified but scientific uncertainty persists. It therefore requires a scientific evaluation 
as well as an evaluation and balancing of the risks involved, i.e. whether the potential risks identified 
exceed the threshold o f what is acceptable for consumers as well as the consequences of non -action 
by the risk managers. The EU always bases its decision on a thorough risk assessment carried out 
by the EFSA in conjunction with the EU Member States as basis to assess an import tolerance 
request, set or amend MRLs. This is product -specific and fully in line with SPS Agreement provisions.  
 
5. ¿Cómo garantizarán que estos estudios inconclusos cumplirán con los requisitos de 
los Artículos 2 y 5 del Acuerdo de Medidas Sanitarias y Fitosanitarias de la OMC? En 
especial cómo atenderán el artículo 5.6 de garantizar que estas medidas no entrañen un 
grado de restricción encubierta del comercio mayor del requerido para lograr su nivel 
adecuado de protección sanitaria o fitosa nitaria.  
 
EU reply:  
All data submitted by the applicants and relevant international standards are taken into account 
when assessing a request for an import tolerance or a request for approval of a substance to be 
used in a Plant Protection Product (PPP). I t is a key principle of EU policy in the area of pesticides 
residues that it is the obligation of the applicant to demonstrate that a proposed MRL allows to 
maintain a high level of consumer protection. Similarly, it is the obligation of the applicant for 
(renewal of) approval of an active substance to demonstrate that the representative uses of the 
substance under evaluation are safe for human and animal health and the environment. The EU sees 
that measures taken on the basis of EFSA's risk assessments are  not more trade restrictive than 
necessary to achieve its chosen level of protection and are applied in a non -discriminatory manner 
both to intra -EU trade as well as to imports from third countries . 
 
 
  WT/TPR/M/395/Add.1  
 
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  PARAGUAY  
1. Informe del Gobierno (WT/TPR/G/395)  
Apartado 3.7. Política agrícola común (PAC)  
Párrafo 3.23  
 
Pregunta 1:  
a) ¿Podría la UE informar en detalle sobre cómo planea utilizar el 40% de la CAP en 
apoyo a objetivos climáticos?  
 
EU reply:  
The proposals for of the Common Agricultural Policy post -2020 adopted by the Commission on 
1 June 2018 provide for 40% of its budget to address climate action. This is linked to the higher 
level of climate and environment ambition required under the new CAP Strategic Plans to be drawn 
up by Member States, in particular through the conditions attached to support ("conditionality"), as 
well as new "eco -schemes" as part of direct support for farmers and agri -environment -climate 
schemes under the EU 's rural development policy.  
 
Apartado 3.8 M edidas Sanitarias y Fitosanitarias (MSF)  
Párrafos 3.25 y 3.26  
 
Preguntas 2:  
b) ¿Podría la UE explicar cómo su Legislación sobre Medicamentos Veterinarios se 
articula con los esfuerzos multilaterales contra la resistencia antimicrobiana (RAM)?  
La República del Paraguay entiende que el proceso de reglamentación interna de dicha legislación 
se encuentra en curso.  
 
EU reply:  
The provisions on antimicrobial resistance in Regulation 2019/6 are important part of the EU 's efforts 
to fight antimicrobial re sistance (AMR). The EU is committed to continuing to engaging with its 
international partners to promote and support effective strategies to prevent and contain the global 
threat of AMR, notably in the context of multilateral international fora (e.g. G20, WHO, OIE, FAO, 
Codex Alimentarius).  
 
c) ¿podría la UE brindar información sobre el avance de dicho proceso, específicamente 
en lo relativo al art. 118 de esta Legislación?  
 
EU reply:  
The European Commission is currently reflecting on the most suitable approach for the various 
aspects of the implementation measures relating to Article 118. In order to ensure that the draft 
delegated acts are comprehensive as regards the central operatio nal elements, further reflection is 
warranted by the Commission services in upcoming months. The preparation of the draft legal acts 
will follow the usual institutional process. The delegated acts under Article 118 are to be adopted by 
27 January 2022.  
 
Apartado 4.1.1. Reforma de la OMC  
Párrafo 4.10 Monitoreo y trabajo regular  
La propuesta de la UE relativa al mejoramiento del trabajo de los comités, contenida en el documento 
WT/CG/W/777/Rev.4., propone, entre otros elementos la presentación de una descri pción sustantiva 
de preocupaciones comerciales, sin explicar que se considera sustantivo.  
 
Preguntas 3:  
d) ¿No considera la UE que esta calificación podría ser utilizada como una manera de 
evitar el diálogo en lugar de fomentarlo?  
e) ¿Podría la UE explicar cómo  se condice el fomento del diálogo con la invitación a los 
miembros a referirse a intervenciones anteriores?  
 WT/TPR/M/395/Add.1  
 
- 391 - 
 
  EU reply:  
(d) The proposal aims to incentivise productive dialogue among Members in relation to particular 
trade concerns with a view to facilitating their resolution. It was certainly never the intention to 
create obstacles to dialogue. In order to address the issue ra ised, the co -sponsors chose to delete 
the adjective "substantive" in conjunction with the description of the concern in paragraph 6 in the 
latest revision of the proposal, presented to the General Council of 3 March ( WT/CG/W/777/Rev.5).  
 
(e) The EU and its  co-sponsors have taken good note of the concerns some Members expressed in 
relation to paragraph 11. In order to address these, they adjusted the wording for the latest revision 
with the aim to make their intention - to encourage dialogue - clearer. Parag raph 11 aims to 
encourage Members to keep focus their interventions on new developments since the last time the 
trade concern was discussed in the respective WTO body, and to make use of the fact that previous 
statements are on record. The use of the word "encouraged" underlines the soft nature of this 
guideline. Naturally, Members will retain in full their right to raise all points they deem appropriate.  
 
2. Informe de la Secretaría (WT/TPR/S/395)  
 
Apartado 3.1.3.3. Administración de contingentes arancelar ios  
Párrafo 3.42  
El informe de la Secretaría indica que la UE mantiene una base de datos para el monitoreo de 
contingentes y su utilización.  
 
Preguntas 4:  
En el caso de que los contingentes se vean sub -utilizados:  
a)  ¿podría explicar la UE los motivos para esta sub -utilizaci ón con la información 
recogida por esta base de datos?  
b) ¿Qué medidas ha considerado la UE para dar cumplimiento a la Decisión de Bali sobre 
contingentes arancelarios?  
c) ¿Ha considerado la UE apartar se de un régimen de licencias para asegurar que los 
contingentes puedan ser utilizados en su máxima capacidad?  
 
 
EU reply:  
(a) In the EU, any underfill of WTO TRQs is for economic reasons only. After successive reforms 
of its agricultural policy, prices of EU agricultural products are aligned with global market prices, 
making them internationally competitive. As a result, a number of TRQs have become less interesting 
economically speaking. The EU has also concluded many bilateral trade agreements, liberalisi ng 
further its agricultural sector. Economic operators and consumers therefore have more choices, 
influencing the attractiveness of WTO bound TRQs.  
 
(b) As shown in different settings within WTO, the EU is fully committed to the Bali Decision on 
tariff quotas.  Moreover, EU legislation on TRQs management is fully in line with the provisions of 
this Decision. The EU remains interested in the harmonization of the TRQ notification practices.  
 
(c) As long as management methods are not the reason for any underfill, the E U does not intend 
to change them. We note the Bali underfill mechanism has never been invoked by any member for 
any EU TRQs.  
 
Párrafo 3.44  
 
Preguntas 5:  
d) ¿Podría la UE explicar que planean hacer con los contingentes erga omnes y su 
partición, ante la falta de claridad sobre el futuro de la relación entre el Reino Unido y la 
UE? 
e) ¿Consideraría la UE enmendar su propuesta de listado de compromisos para reflejar 
que estos contingentes incluyen a todos los socios comerciales, exceptuando al 
Reino  Unido?  
 
EU reply  to question (d) and question (e):  
The revised Political Declaration on the future relationship between the EU and the UK, issued on 
October 2019, envisages an economic partnership through a free trade agreement that would ensure WT/TPR/M/395/Add.1  
 
- 392 - 
 
  no tariffs, fees, charges or quantitative restrictions across all sectors. Therefore, it is not expected 
that the EU and UK would be using one another 's erga omnes WTO TRQs.  
 
Párrafo 3.1.6.2 Salvaguardias  
El informe de la Secretar ía señala que las salvaguardias son parte del marco de remedios comerciales 
y que la UE mantiene reglas para salvaguardias globales, de conformidad con el Acuerdo de la OMC 
sobre Salvaguardias y Medidas Compensatorias, así como salvaguardias bilaterales en la mayoría 
de sus TLCs . 
 
Pregunta 6 
f) Ha aplicado la UE salvaguardias bilaterales bajo cualquiera de sus TLCs o han sido 
objeto de salvaguardias bilaterales en el marco de estos acuerdos? En ambos casos, 
Paraguay quisiera contar con más detalles sobre las aplicaciones de esas medidas.  
 
EU rep ly:  
So far, the EU has never applied the bilateral safeguard clauses contained in its FTAs. The EU is 
currently subject to safeguard measures on frozen bone -in portions of fowls of the species gallus 
domesticus imposed by SACU (Southern African Customs Un ion). An Economic and Partnership 
Agreement exists between the EU and SACU, and includes bilateral safeguard clauses.  
The measures were imposed in September 2018 and are set to remain in force until March 2022. 
They consist of a degressive ad -valorem duty  which currently is of 30%. The European Union 
strongly disagrees with the imposition of such measures.  
 
Apartado 3.3.2.6. Comité de Obstáculos Técnicos al Comercio (OTC) en la OMC  
Párrafo 3.210  
En el informe de la Secretaría, se señala que varias de las Preocupaciones Comerciales Especificas 
presentadas a la UE en el ámbito de OTC están relacionadas a sustancias activas de protección de 
plantas. Los miembros han solicitado en numerosas ocasiones a la UE que estas medidas OTC sean 
notificadas en simultaneo  como MSF debido a las implicancias que tienen en dicho ámbito. En la 
última reunión del Comité MSF del mes de noviembre, la UE indicó que iniciaría el proceso de 
notificaciones simultaneas OTC -MSF. 
 
Pregunta 7:  
g) ¿Podría la UE brindar mayor claridad respect o a cuanto empezará a notificar estas 
medidas en ambos comités?  
 
EU reply:  
Following the commitments taken by the EU at the SPS Committee of November 2019, the EU started 
notifying such measures both under the SPS and the TBT Agreement.  
Draft Commission I mplementing Regulation concerning the non -renewal of approval of the active 
substance beta -cyfluthrin was notified in notices G/SPS/N/EU/370 and G/TBT/N/EU/699.  
Draft Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance fenamiphos, in accordance with Regulation (EC) No . 1107/2009 of the European Parliament 
and of the Council concerning the placing of plant protection products on the market, and amending 
the Annex to Commission Implementing Regulation (EU) No . 540/2011 was notified in notices 
G/SPS/N/EU/373 and G/TBT/N/EU/701.  
 
Apartado 3.3.3. Medidas Sanitarias y Fitosanitarias (MSF)  
3.3.3.1 Plantas y productos de protección de plantas  
Párrafo 3.226  
 
Preguntas 8:  
h) ¿Podría la UE explicar cómo justifica una prohibición de importación sin un análisis 
de riesgo completo?  
i) ¿Podría la UE aclarar quien considera debe ser responsable por la conducción de 
dicho análisis de riesgo?  
 
EU reply to question h) and question i):  
Apart from very few instances of obvious, imm ediate and serious risks for consumers, the EU has 
not banned the import of food products due to the use of plant protection products and the presence 
of their residues. The EU does however require compliance with the food safety standards applicable 
to all food products placed on the market in the EU, whether they are domestically produced or WT/TPR/M/395/Add.1  
 
- 393 - 
 
  imported. The EU acknowledges that such standards, including maximum residue levels (MRLs) for 
pesticides, may limit the choice of good agricultural practices in the producing countries.  
 
Risk analysis, with the three elements of risk assessment, risk management and risk communication, 
is a cornerstone of all areas of EU food safety legislation, and applies also to the regulation of plant 
protection products and their residues.  
 
Occasionally, the risk assessment could not be concluded in the process of evaluating an application 
to approve and active substance or set an MRL, due to the lack of sufficient information to reach 
such a conclusion. However, it is a key princi ple of EU policy in the area of pesticide residues that it 
is the obligation of the applicant to demonstrate that a proposed MRL allows maintaining a high level 
of consumer protection. Similarly, it is the obligation of the applicant for (renewal of) appro val of an 
active substance to demonstrate that the representative uses of the substance under evaluation are 
safe for human and animal health and the environment.  
 
Párrafo 3.229  
 
Preguntas 9:  
j) ¿Podría la UE explicar el atraso significativo en la aprobación Organismos 
Genéticamente Modificados (OGM)?  
k) ¿Podría la UE brindar claridad sobre el tiempo que se estima para la aprobación de 
las53 solicitudes de OGM pendientes?  
 
 
EU reply:  
(j) A number of pending applications are under risk assessment, and some have been submitted 
recently (7 in 2018, for example). In addition, in November 2019, the Commission adopted 8 
authorisations for GMOs for food and feed uses.  
 
(k) The EU continues t o progress with the authorisations where the European Food Safety Authority 
has finalised its risk assessment and concluded that there are no safety concerns linked to the GMO. 
No further details on the estimated time for approval can be given, as this dep ends on the risk 
assessment phase as well as on the applicant 's reactivity to address scientific questions raised during 
risk assessment.  
 
Párrafo 3.237  
 
Preguntas 10:  
l) ¿Podría la UE brindar información detallada sobre los motivos específicos de 
rechazos en  frontera?  
m) ¿Podría la UE indicar cuántos de ellos estuvieron relacionados con su política de 
Límites Máximos de Residuos (LMR)?  
 
EU reply:  
(l) In general, regarding grounds for rejections at the border, Regulation (EU) 2017/625 establishes 
that competent authorities shall refuse entry into the Union of any consignment of animals or goods, 
which does not comply with the rules listed in Article 1(2) to that Regulation (cf. Article 66(1) of 
Regulation (EU) 2017/625).  
Regarding specific cases, information on the grounds for border rejection of a particular consignment 
are made available to the concerned third country via the TRACES or iRASFF netwo rk, in the case 
where the third country has access to those networks. If the concerned third country does not have 
access to the said networks, the Commission informs the third country of the grounds of, and risks 
related to, rejections via border rejectio n notifications ' referred to in Article 50(3)(c) of Regulation 
(EC) No . 178/2002 and in Articles 2(20) and 20 of Implementing Regulation (EU) 2019/1715.  
In the case where a consignment is rejected due to non -compliance with an EU MRL for pesticide 
residues, but the acute reference dose is not exceeded, Member States do not make border rejection 
notifications, but register those rejections in the TRACES net work in relation to commodities subject 
to official controls at border control posts by virtue of Article 47(1) of Regulation (EU) 2017/625. 
The Commission informs the third country concerned also of these non -compliances.  
(m) In 2019, 184 border rejectio ns notifications (concerning non -EU products) were transmitted via 
the RASFF system due to non -compliances with pesticide residues legislation. Additionally, WT/TPR/M/395/Add.1  
 
- 394 - 
 
  435 non-compliance notifications concerning non -EU products were transmitted due to 
non-compliance s with pesticide residues legislation.  
 
3.3.3.4. Comité MSF en la OMC  
Párrafo 3.240  
En el informe de la Secretaría, se señala un importante número de Preocupaciones Comerciales 
Especificas presentadas a la UE, tanto nuevas como anteriores. La mayor parte d e estas se 
encuentran relacionadas con la Legislación UE 1107/2009 y 395/2005, sobre la cual no existe 
referencia en el informe del Gobierno y solo se hace una breve mención en el de la Secretaría 
(tabla  3.21) por tratarse de medidas adoptadas con anterior idad. Sin embargo, los efectos 
comerciales de estas medidas se han empezado a notarse recientemente. Paraguay, junto con varios 
otros miembros, han venido manifestado estas preocupaciones de manera sistemática a la UE en 
los distintos Comités y Consejos de  esta Organización.  
 
Preguntas 11:  
n) ¿Podría la UE brindar una definición de que considera como una "sustancia activa"?  
o) En aras de la transparencia ¿podría la UE brindar un listado completo de todas las 
sustancias activas que se encuentran o se encontrarán sujetas a revisión, con una línea 
de tiempo para dichos procesos?  
p) ¿Podría la UE brindar en detalle la base científica para considerar que ciertos LMR 
podrían ser dañinos para la salud humana en casos en los que existen estándares 
internacionalmente estable cidos por el Codex Alimentarius que son menos restrictivos a 
los propuestos por la UE?  
q) ¿Podría la UE explicar que medidas planea adoptar para asegurar a sus socios 
comerciales que los LMR y las tolerancias a las importaciones son y serán basadas en 
evidenc ia científica concluyente?  
r) ¿Podría la UE brindar información detallada sobre cómo serán tratadas las 
solicitudes de tolerancia a las importaciones?  
s) Constantemente, la Unión Europea sostiene que se tendrán en cuenta "todos los 
factores relevantes" a la hora  de establecer la tolerancia a las importaciones ¿Podría la 
UE brindar una definición exhaustiva de lo que considera como "factores relevantes" y 
explicar cómo estos se configuran en criterios científicos y objetivos para una evaluación 
de riesgos?  
t) La falt a de acceso a productos de protección de plantas llevará a la proliferación de 
malezas, y en general a la reducción de la eficiencia en la producción agrícola, necesitando 
utilizar más suelo y más agua para producir la misma cantidad de alimentos. ¿Podría la 
UE explicar cómo su política de LMR ayuda a perseguir los objetivos de lucha contra el 
cambio climático?  
u) En un mundo con una población que continúa creciendo y en el cual los agricultores 
tienen el desafío de producir más, con menos recursos, la falta d e acceso a herramientas 
de protección de plantas indudablemente aumentará el costo de los alimentos a nivel 
mundial, reducirá el volumen de producción y aumentará del desperdicio de alimentos. 
¿Ha considerado la UE cómo afectarán estas políticas la segurid ad alimentaria? ¿Cómo se 
condice esta política con los Objetivos de Desarrollo Sostenible y la Agenda 2030? ¿Qué 
planes tiene la UE para contrarrestar estos efectos negativos?  
 
EU reply:  
 
(n) According to EU legislation 'active substances' are substances, including micro -organisms having 
general or specific action against harmful organisms or on plants, parts of plants or plant products  
 
(o) The approval of active substances in the EU is time -limited. The approval of an active substance 
may be renewed if an applicant submits an application for renewal of approval, supported by a 
dossier with the required data. Such an application must be submitted at the latest 3 years before 
expiry of the approval period, followed by the dossier at the latest 2 .5 years before expiry. Please 
consult the EU Pesticides database (https://ec.europa.eu/food/plant/pesticides/eu -pesticides -
database/public/?event=homepage&language=EN) for information on the expiry date of approvals, 
using the functions "Search active sub stances => Advanced search => Expiration date" to identify 
active substances whose approval expires within a given timeframe.  
For the review of existing MRLs, please consult the document available on the EFSA website, which 
is updated regularly, under the following link.  
http://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -report.pdf.  WT/TPR/M/395/Add.1  
 
- 395 - 
 
  (p) The EU bases its decision on the EFSA scientific advice. EFSA carries out a thorough risk 
assessment that takes into account information submitted by the applicants, international standards 
and any other information that has been made available before and during the assessment process. 
EFSA opinions at times diverge from the opinion of other international scientific agencies due to 
various factors, i ncluding but not limited to the availability of more or less information at EFSA 
compared to other agencies, different regulatory principles, different sets of experts coming to 
different conclusions on the interpretation of study results and/or the weighi ng of evidence.  
 
(q) Please see reply to question 11 (p). Please note that i t is a key principle of EU policy in the area 
of pesticides residues that it is the obligation of the applicant to demonstrate that a proposed MRL 
allows to maintain a high level o f consumer protection. Therefore, assessment may be limited to 
availability of data.  
 
(r) "Import tolerance" requests can be submitted for active substances approved in the European 
Union or for active substances that are not approved in the European Union . Interested parties may 
submit an "import tolerance" request according to Article 6(4) of Regulation (EC) No 396/2005. This 
allows setting EU -MRLs based on Good Agricultural Practices (GAPs) authorised in non -EU countries 
at a level sufficiently high to m eet the needs of international trade, provided that a risk assessment 
demonstrates that the protection of EU consumers is ensured. The data requirements and stringency 
of assessment (e.g. regarding the need to demonstrate safety for all European consumer g roups) 
for import tolerance requests are identical to those for MRL applications based on authorisations in 
EUMS. Please be reminded that MRL can be set only when there is sufficient information to support 
a risk assessment demonstrating that the MRL is su fficiently protective for consumers. The burden 
lies with the applicant to show that residues of the active substance from use in accordance with the 
good agricultural practice under evaluation are safe.  
 
(s) Decisions on import tolerance requests take acc ount of the relevant factors provided for in EU 
legislation. They are:  
- the scientific and technical knowledge available;  
- the possible presence of pesticide residues arising from sources other than current plant protection 
uses of active substances, and  their known cumulative and synergistic effects, when the methods to 
assess such effects are available;  
- the results of an assessment of any potential risks to consumers with a high intake and high 
vulnerability and, where appropriate, to animals;  
- the results of any evaluations and decisions to modify the uses of plant protection products;  
- a CXL or a GAP implemented in a third country for the legal use of an active substance in that 
country;  
- other legitimate factors relevant to the matter under consi deration.  
 
(t) and (u) The first and foremost objective of the EU legislation on pesticide residues is the 
protection of consumers.  
 
That said sustainable development has since long been at the heart of the European project and the 
EU Treaties give recogni tion to its economic, social and environmental dimensions that should be 
tackled together. Sustainable development has been mainstreamed into EU policies and legislation, 
via the EU Sustainable  Development  Strategy  (https://ec.europa.eu/environment/sustain able-
development/strategy/index_en.htm ). The SDGs and sustainability have been made into a guiding 
principle in all the EU our work.  
 
The EU was instrumental in shaping the global  2030 Agenda  
(https://ec.europa.eu/environment/sustainable -development/SDGs/index_en.htm ) and will 
continue to be a frontrunner in its implementation and in the implementation of the SDGs, together 
with its Member States. The 2030 Agenda will further catalyse an EU join t approach between the 
internal and external dimensions of our policies and coherence across EU financing instruments.  
 
Apartado 4.1.1 Agricultura  
Párrafo 4.20  
 
Pregunta 12:  
v) ¿Podría la UE brindar información detallada sobre los requisitos con los cuales los 
granjeros deben cumplir para que su producción califique como orgánica a los efectos de 
recibir subsidios bajo el esquema de "greening"?  WT/TPR/M/395/Add.1  
 
- 396 - 
 
  w) ¿Cuáles son los cultivos que han recibido ayuda bajo este concepto?  
x) ¿Cuánto fue desembolsado hasta ahora en este tipo de subsidios?  
 
EU reply:  
(v) The requirement is set in Article 43(11) of Regulation (EC) No . 1307/2013 that governs greening 
payments: "Farmers complying with the requirements laid down in Article 29(1) of Regulation (EC) 
No. 834/2007 as regards  organic farming shall be entitled ipso facto to the payment referred to in 
this Chapter". This Article 29(1) sets that the farmers have to have documentary evidence proving 
that they fulfil all the requirements laid down in the organic Regulation.  
 
(w) Support for organic farming under Article 29 of Regulation (EU) No . 1305/2013 is not linked to 
any specific crop production, but to the organic farming practices and methods.  
 
(x) The Commission does not have precise data as to what share of greening payme nts were 
allocated to organic farmers in a given year.  
 
Párrafo 4.40  
 
Pregunta 13:  
y) ¿Podría la UE brindar información detallada sobre cómo la CAP buscará potenciar el 
cuidado del medio ambiente, y contribuir a los objetivos ambientales y relacionados al 
cambio climático, de la UE?  
 
Párrafo 4.41  
 
Pregunta 14:  
z) ¿Podría la UE brindar información detallada sobre cómo la CAP buscará fomentar el 
desarrollo sostenible y manejo eficiente de los recursos naturales, como el agua, suelo y 
aire?  
 
EU reply to  question 13 and question 14:  
 
The design of the next generation CAP is driven by environmental and sustainability concerns in the 
strongest possible manner. The post -2020 CAP, being part of the wider European Green Deal which 
aims at making Europe the world 's first c limate -neutral continent by 2050, includes the most 
ambitious package of measures to enable European farmers and consumers to benefit from a 
sustainable green transition. The environmental - and climate -specific objectives are fully integrated 
into the new green architecture of the CAP. This includes addressing the mitigation of and adaptation 
to climate change, management of natural resources and protecting biodiversity and eco -systems 
by introducing improved mandatory environmental requirements for farmers  subject to the CAP 
support, in combination with voluntary schemes and measures helping to ensure higher climate and 
environmental ambition.  
The post -2020 CAP proposal is based on analytical work (impact assessment), public consultations 
with farmers and the general public and new EU international commitments (e.g. the Paris 
Agreement and Sustainable Development Goals).  
The impact assessment of the CAP post -2020 proposal can be found at https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=SWD%3A2018%3A301% 3AFIN . 
 
Párrafo 4.77  
 
Pregunta 15:  
aa) ¿Podría la UE brindar información específica y detallada sobre cómo el 45% de los 
fondos para el desarrollo rural serán utilizados para el mejoramiento de los ecosistemas?  
 
EU reply:  
As shown in table 4.10, during the 2014-2020 programming period, the aggregation of all rural 
development programmes (118) across 28 EU Member States shows that 45% of the European 
Agricultural Fund for Rural Development (EAFRD) contributed to the Priority "Restoring, preserving 
and enhanci ng ecosystems related to agriculture and forestry".  
In practice, measures such as Knowledge transfer & information actions; Advisory services; 
Investments in physical assets; Basic services & village renewal; Investments in forest areas; 
Agri-environment c limate; Organic farming; Natura 2000 and Water Framework Directive; support WT/TPR/M/395/Add.1  
 
- 397 - 
 
  for Areas under Natural Constraints; Forest environmental -climate; and Cooperation are the main 
ones contributing to 45% spending under priority 'Restoring, preserving and enhancin g ecosystems 
related to agriculture and forestry '. 
 
Párrafo 4.13  
La UE ha desembolsado 41.6 mil millones de EUR en 2017 en concepto de pagos directos, se 
conformidad al informe presentado por la Secretaría. La nueva PAC parecería no alterar 
significativame nte el nivel de desembolsos de la UE para continuar subsidiando a los productores, 
que representan un sector muy pequeño de su economía. Estos subsidios tienen un efecto 
sumamente negativo para los precios globales de mercado y para el sustento y producció n de 
millones de agricultores en los países en desarrollo, donde la agricultura es el principal sector de la 
economía.  
 
Preguntas 16:  
bb) ¿Cómo considera la UE que su agricultura es sostenible con estos elevados niveles 
de subsidios?  
cc) ¿Qué reformas planea intro ducir la UE para que la agricultura europea avance hacia 
un régimen menos distorsivo y proteccionista del mercado?  
 
EU reply:  
(bb) The vast majority of EU support are notified as Green Box: most direct payments and rural 
development measures have no trade distorting effects or effects on production.  
 
(cc) The EU has been, and remains fully committed to non - or minimally trade -distorting forms of 
support. This is why around 90% of direct payments have already been decoupled. Under the post -
2020 CAP proposal, the vast majority of EU support including most of the direct payments and rural 
development measures will continue to be Gre en Box. The EU will ensure that its WTO commitments 
are respected.  
 
Párrafo 4.81  
El informe de la Secretaría indica que no se han registrado cambios sustanciales respecto al acceso 
a mercado para productos agrícolas importados a la UE, lo que implica el ma ntenimiento de picos 
arancelarios de más de 100% para varias líneas de aranceles.  
 
Preguntas 17:  
dd) ¿Cómo justifica la UE la continuidad de este elevado nivel de proteccionismo, al 
tiempo de alegar competitividad de sus productos?  
ee)  ¿Ha considerado al UE reformar para ir implementando niveles arancelarios 
similares  
 
EU reply:  
(dd) The EU has successfully reformed its agricultural policy, making it one of the world 's biggest 
importers and exporters of agri -food products.  
 
(ee) The EU does not intend to make unilateral market access concessions. Any change to the EU 's 
bound tariffs will result from successful multilateral negotiations.  
 
Párrafo 4.82  
El informe de la Secretaría nota que muchos productos agrícolas son sujetos a aranceles no 
ad-Valorem. Los aranceles ad valorem  son considerados más transparentes y predecibles sobre todo 
frente a los aranceles complejos utilizados por la UE para bienes agrícolas.  
 
Preguntas 18:  
a) ¿Cuál es el raciocinio de la UE para continuar manteniendo aranceles no ad valorem  
para el comercio de bienes agrícolas y tener aranceles ad valorem  para bienes no 
agrícolas?  
b) ¿Tiene planes la UE para iniciar un proceso de simplificación arancelaria?  
c) ¿Plane a la UE brindar equivalentes no ad valorem  en sus notificaciones a futuro?  
 WT/TPR/M/395/Add.1  
 
- 398 - 
 
  EU reply:  
(a) Specific and mixed tariffs are as predictable as ad valorem  tariffs. The duties to be paid are 
known in advance of any customs clearance procedure. The EU's import re gime for agricultural 
products is fully transparent and predictable, and is set out in the EU's WTO schedule.  
 
(b) Because of the reasons mentioned in the answer to question 18a, the EU does not consider that 
its tariff structure needs simplification.  
 
(c) Due to their specificity, the EU provides non -ad valorem  equivalents on an ad -hoc basis.  
 
Párrafo 4.93  
La Unión Europea cuenta con un atraso de varios años en sus notificaciones de ayudas internas en 
materia de agricultura. Este atraso es una constant e para estas notificaciones y presenta un 
problema respecto a la transparencia y para el monitoreo efectivo de estas ayudas. La UE es uno de 
los miembros que más ayudas internas brinda a los productos agrícolas en la actualidad y de manera 
histórica.  
 
Preguntas 19:  
d) ¿Qué medidas planea implementar la UE asegurarse de recopilar la información 
relativa a sus medidas de ayuda interna para una elaboración más rápida y eficiente de 
sus notificaciones?  
e) ¿Ha considerado la UE la posibilidad de presentar notifica ciones parciales dentro del 
plazo de 90 días para la presentación de notificaciones DS:1?  
f) ¿Cuándo planea la UE presentar las notificaciones DS:1 que tiene pendientes?  
 
EU reply:  
(d)The new CAP post -2020 proposal will not change the notification method or t iming of the EU 's 
annual DS:1 notification. As discussions and documents presented in the Committee on Agriculture 
have shown, very few WTO members (and none with an AMS commitment) have been able to respect 
the deadlines for DS:1 set out in G/AG/2, which clearly needs updating. Further statistics on 
submissions can be found in Room Document RD/AG/71 submitted by Norway for the meeting of 
the informal Committee on Agriculture in June 2019.   
 
(e) The EU does not consider making partial notifications, mainly  due to the fact that most of the 
data needed will not be available within this timeframe and because of time needed for processing 
the data. Such a partial notification would not be useful. The EU is working on improving and 
automating data collection.  
 
(f) The EU will submit its DS:1 notification for 2017/18 soon. The EU 2017/18 notification covers the 
2017/18 marketing year and budget year 2018. As stated in several Regular Committee on 
Agriculture meetings (and other WTO forums), the EU aims to submit a  DS:1 notification within 
15 months of the end of budget year (which for the 2017/18 marketing year is 31 December 2018). 
This secretariat 's nomenclature refers to such a notification as a 2017 DS:1 notification.  
 
4.4.3 Comercio electrónico  
4.4.3.2.2 Aspec tos del comercio electrónico relacionados con el IVA  
 
Párrafo 4.283  
Según el informe de la Secretar ía, la UE "por medio de una miniventanilla única del IVA (MOSS), los 
proveedores de servicios de telecomunicaciones y radiodifusión y de servicios electrónic os han 
podido vender a consumidores de otros Estados miembros de la UE y liquidar en un solo Estado 
miembro el IVA adeudado en varios Estados miembros, evitando así la necesidad de registrarse a 
efectos del IVA en cada uno de los Estados miembros en los qu e venden. El IVA pagado a las 
autoridades fiscales de los Estados miembros se distribuye entre estos por medio de un mecanismo 
administrado por la Comisión".  
 
Preguntas 20:  
a) ¿Podría la explicar la UE en más detalle cómo opera la miniventanilla única del IVA en 
la práctica y que instituciones integran el sistema?  
 WT/TPR/M/395/Add.1  
 
- 399 - 
 
  EU reply:  
The VAT MOSS is an online registration system for VAT on telecommunications and broadcasting 
services and electronic (TBE) services. Each tax authority of the EU Member States has established 
one such electronic portal for their businesses and for non -EU businesses wishing to register in a 
respective EU Member State. For those businesses, one registration in the VAT MOSS is sufficient 
for all their supplies to TBE services to customers in the EU. Such businesses then charge the VAT 
rate of the Member State where the customer is located. At the end of the reporting period (each 
quarter), they make a VAT return to the Member State where they have registered pro viding the 
total amount of sales, the VAT rate and the VAT amount collected for each EU Member State where 
they made sales. The total amount of VAT reported in the MOSS return is paid also quarterly to the 
EU Member State where they are registered. That Me mber State then distributes the money to each 
of the EU Member State where businesses have indicated sales. As an example: A Paraguayan 
business sells TBE services to customers in Spain, Portugal and Italy. The Paraguayan business is 
liable to pay VAT due on those sales. The Paraguayan business can cho ose to register in the Spanish 
VAT MOSS and then will charge Spanish VAT to its customers in Spain, Portuguese VAT to its 
customers in Portugal and Italian VAT to its customers in Italy. At the end of each qua rter, it will 
submit an electronic VAT MOSS return to Spain (where it has registered) indicating the total amount 
of sales, the VAT rate and the VAT amount due for each of the 3 Member States: Spain, Portugal 
and Italy. The amount declared will be paid to the Spanish authorities also quarterly. The Spanish 
authorities will distribute the VAT amount respectively to Italy and Portugal.  
More information on the working of the VAT MOSS can be found on the MOSS webportal: 
https://ec.europa.eu/taxation_customs/bu siness/vat/telecommunications -broadcasting -electronic -
services/content/mini -one-stop-shop_en . 
 
b) De igual modo, ¿podría la UE informar si dicha miniventanilla, así como el paquete de reforma 
impositiva en materia de comercio electrónico, han tenido un efe cto positivo con relación a la evasión 
impositiva y si han aumentado los ingresos al fisco a través de su implementación?  
 
EU reply:  
 
The VAT Mini-One-Stop-Shop ( MOSS) is working well and is appreciated by businesses. It has 
reported increasing revenues on a yearly basis since its introduction in 2015. The Commission 
published aggregated statistics for the VAT collected at EU level via the MOSS with regards to 
telecommunications, broadcasting and electronically supplied services (TBE services):  
 
• https://ec.europa.eu/taxation_customs/news/european -commission -presents -statistics -
vat-mini-one-stop-shop-moss_en.  
• https://ec.europa.eu/taxation_customs/sites/taxation/files /moss -statistics -2019.pdf . 
The VAT collection system falls within the competence of EU Member States and the tax control, 
including tax evasion, are prerogatives of each Member State.  
The new e -commerce package addressing online sales of goods and other ty pes of services to 
customers will enter into force on 1 January 2021, i.e. results are not yet available. Estimates made 
in 2016 show that EU Member States may gain additional revenues up to EUR 7 billion.  
 
c) ¿Podría la UE explicar qué medidas planea adop tar para que las políticas fiscales de los 
Estados miembros no tengan repercusiones negativas en terceros países? Asimismo, si la 
UE pudiera informar si existen acuerdos de cooperación de intercambio de información y 
buenas prácticas vigentes con países Mi embros, ¿o en el contexto de algún Acuerdo de 
Libre Comercio con terceras partes en esta materia?  
 
EU reply:  
 
In 2018, the European Union concluded an agreement with Norway on administrative cooperation, 
combating fraud and recovery of claims in the field of value added tax. This agreement reinforces 
the administrative cooperation between Member States and Norway and allows for exchange of 
information between the respective tax authorities.  
 
Párrafo 4.286  
Según el Informe de la Secretar ía, "la Comisión también propuso, en diciembre de 2018, un paquete 
legislativo para pedir a los proveedores de servicios de pago establecidos en Europa que transmitan WT/TPR/M/395/Add.1  
 
- 400 - 
 
  a las autoridades tributarias los datos de pago pertinentes para el IVA. Esa propuesta exi girá a los 
proveedores de servicios de pago, tales como bancos, empresas encargadas de los pagos con tarjeta 
e instituciones de dinero electrónico, presentar a las autoridades tributarias información sobre el 
beneficiario de los pagos transfronterizos. Esa  información se centralizará después en una base de 
datos europea -el sistema electrónico central de información sobre pagos (CESOP) - en la que las 
autoridades tributarias podrán acceder a los datos para determinar la cuantía de los pagos recibidos 
por los  vendedores en línea y cotejar esa información con otras bases de datos con objeto de 
identificar a los defraudadores. Se preservarán los derechos de los ciudadanos, ya que no se 
recopilará ninguna información sobre el pagador/comprador y se ha fijado un u mbral para garantizar 
que solo se transmita la información relativa a empresas que reciban pagos en cuantías 
importantes".  
 
Preguntas 21:  
a) ¿Podría la UE brindar más información sobre cómo se ha fijado el umbral para 
garantizar la protección de los datos de los ciudadanos, así como la transmisión de datos 
sensibles a través del sistema?  
 
EU reply:  
The threshold requires payment service providers to monitor the cross -border payments they 
process so that they only report data on beneficiaries that receive more  than 25 cross -border 
payments per quarter. Below this threshold, no data on the beneficiary of the payments will be 
transmitted.  
 
The threshold of 25 cross -border payments received is considered an appropriate measure to 
differentiate between businesses and citizens. It was designed taking into consideration the average 
value of e -commerce purchases in Europe, and the threshold of EUR 10.000 to register for VAT when 
performing cross -border supplies of goods.  
 
b) Con relación al funcionamiento del sistema el ectrónico central de información 
¿podría la UE brindar información actualizada sobre el funcionamiento de dicho sistema y 
si existe algún mecanismo de cooperación vigentes con autoridades tributarias de 
terceros países?  
 
EU reply:  
The central electronic sy stem ("CESOP") will have four main functions:  
 
• To store and cleanse the data received from Member States;  
• To aggregate the cleaned data (e.g. per payee, country, etc.);  
• To crosscheck the data with other European database, such as the MOSS, VIES, etc.  
• To make all the information available to Eurofisc officials (Member States anti -fraud 
experts).  
Eurofisc officials will have access to the full set of data available in CESOP (i.e. the raw data 
transmitted, the cleaned data, the aggregated data and the crosscheck reports), and will be able to 
use it to identify potential fraudsters.  
 
There are currently no cooperation mechanisms foreseen with third countries tax authorities in order 
to exchange this kind of data.  
 
4.4.3.2.1 Cooperación en relación con la  aplicación de las normas sobre protección de los 
consumidores  
Según el Informe de la Secretar ía "en diciembre de 2017 se adoptó un Reglamento por el que se 
modifican las normas de existentes de la UE sobre la cooperación entre las autoridades nacionales 
responsables de la protección de los consumidores para hacerlas más eficaces en el contexto digital. 
Ese Reglamento entró en vigor en enero de 2018 y será aplicable a partir del 17 de enero de 2020. 
En él se especifica el conjunto mínimo de facultades de in vestigación y ejecución de que deben 
disponer las autoridades nacionales de protección de los consumidores para hacer frente a las 
prácticas en línea ilícitas. También se establece un mecanismo de asistencia mutua y un mecanismo 
de investigación y ejecució n coordinados para las infracciones generalizadas y las infracciones con WT/TPR/M/395/Add.1  
 
- 401 - 
 
  dimensión en la Unión. Por último, prevé un mecanismo por el que las autoridades nacionales 
competentes deben notificar a la Comisión y a las demás autoridades competentes todos los c asos 
en que una infracción abarcada".  
 
Pregunta 22:  
a) ¿Podría la UE brindar más información sobre la implementación de este Reglamento 
en la práctica, sobre todo aclarar el alcance de la protección del consumidor de la UE con 
relación a un proveedor de bienes o servicios digitales fuera de la UE ubicado en un tercer 
país, las infracciones y sanciones que están previstas y los mecanismos de cooperación 
extra regional?  
 
EU reply:  
According to EU law, when a consumer concludes a contract with a trader in an other country who, 
by any means, directs their commercial activities to the consumer's country of residence, the 
contract is generally governed by the law of the country where the consumer has their habitual 
residence. It is possible to choose another law but that choice cannot deprive the consumer of the 
protection afforded by the law of the habitual residence, which cannot be derogated from by 
agreement under that law.83 On that basis, EU courts apply the EU rules on consumer protection 
even though the tra der is located outside EU/EEA.  
The cooperation mechanism under the preceding Consumer protection cooperation (CPC) 
Regulation84 already proved to be an effective tool to fight unfair commercial practices of major 
global traders across the Single Market. No w, with stronger enforcement powers, more intensive 
cooperation and more active coordination role of the Commission, the EU is even better equipped to 
fight scams against consumers in the digital world.  
Under the recently refined CPC model, national author ities in EU and EEA countries are equipped 
with a stronger set of minimum powers that allows them to address infringements covered by the 
CPC Regulation in a more effective and coordinated manner. In cases of widespread infringements, 
the national authorit ies concerned can launch coordinated actions that include coordinated 
investigation of the alleged infringements and decide on a joint approach to address the issues. 
Where necessary, the CPC Regulation requires the competent authorities to take enforcemen t 
measures in a simultaneous and coordinated manner. If the measures taken do not make the trader 
stop the unfair practice, the national authorities might block or remove (or order to block or remove) 
the entire website in each of the jurisdictions at the same time.  
Further, Article 32 of the CPC Regulation foresees the possibility to conclude formal agreements 
between the EU and third countries. Their purpose is to overcome potential challenges that may 
arise in enforcement against non-compliant traders when the investigation or the enforcement 
measures taken by the competent authorities seem to be inefficient. The cooperation will mainly 
cover  mutual investigation and enforcement assistance in cases of complicated international 
networks of traders causing massive consumer detriment on a global scale. The agreements may 
also include other cooperation activities spelled out under the CPC Regulation.  
 
4.4.4 Servicios de telecomunicaciones  
4.4.4.1 Las telecomunicaciones en el contexto de  la Estrategia para el Mercado Único 
Digital  
 
Párrafo  4.305  
Según el informe de la Secretar ía, "en el marco de este segundo pilar, la Comisión adoptó en 
septiembre de 2016 una comunicación y un conjunto de propuestas conexas destinadas a lograr el 
objetivo  de proporcionar una conexión de muy alta velocidad a Internet. En la Comunicación se 
establecen tres objetivos estratégicos no vinculantes de despliegue de la red para 2025":  
 
 
83 Article 6(1) of Regulation (EC) No . 593/2008 of the European Parliament and of the Council of 
17 June 2008 on the law applicable to contractual obligations (Rome I), OJ L 177, 4.7.2008, p. 6. For 
exceptions to this general rule, see Article 6(2)-(4) of Regulation (EC) No . 593/2008.  
84 Regulation (EC) No . 2006/2004 repealed as of 17 January 2020 by Regulation (EU) 2017/2394 of the 
European Parliament and of the Council of 12 December 2017 on cooperation between national authorities 
responsible for the enforcement of consumer protection laws, OJ L 345, 27.1 2.2017, pp. 1–26. 
 WT/TPR/M/395/Add.1  
 
- 402 - 
 
  • conectividad de alta velocidad para todos los principales motores socioeconómic os, tales 
como centros escolares, centros de transporte, principales proveedores de servicios 
públicos y empresas intensivas en digitalización;  
• que todas las zonas urbanas y las principales vías de transporte terrestre tengan cobertura 
5G ininterrumpida; y  
• que todos los hogares europeos, rurales o urbanos, tengan acceso a una conexión a 
Internet que ofrezca velocidades de bajada de al menos 100 Mbps, actualizables a alta 
velocidad.  
• 4.306. La Comisión estimó en 2016 que esos objetivos requerían una inversió n adicional 
de aproximadamente EUR 155.000 millones.  
Preguntas 23:  
a) ¿Podría la UE aclarar que mecanismos o incentivos de inversión privada han sido 
implementados para lograr estos objetivos, y de igual manera, si existen proyectos de 
cooperación en materia de conectividad con proveedores de otras regiones como América 
Latina o en el marco de sus Acuerdos de Libre Comercio?  
b) ¿Podría la UE explicar cómo se ha realizado el financiamiento para asegurar la 
cobertura de alta velocidad en los centros escolar es, centros de transporte, principales 
proveedores de servicios públicos y empresas intensivas de digitalización? ¿En este 
sentido, podría la UE mencionar proyectos en países miembros específicos en los cuales 
se ha logrado una inserción digital mayor de e stas medidas?  
 
EU reply:  
 
(a) Delivering on its Digital Single Market strategy, the Commission proposed in 2016 a set of 
initiatives and legislative proposals to meet Europeans' growing connectivity needs, encourage 
investment in very high -capacity networks and boost Europe's compe titiveness. Since most of the 
investment required to achieve these objectives will be carried out by commercial operators the 
regulatory and policy frameworks play a fundamental role to foster investment in broadband 
infrastructures.  
 
In this respect, the  European Electronic Communications Code, which will become applicable at the 
end of 2020, includes several measures to foster the rollout of very high capacity networks, notably 
rules on incentivising co -investment in very -high capacity networks, incentiv es for operators with 
significant market power to adopt a wholesale -only model, rules on regulation of access to 
non-replicable elements of networks, and, as regards wireless networks, timely assignment of 
harmonised 5G bands, 20 -year regulatory predictabi lity, streamlined permit granting for small cells 
and facilitation of infrastructure sharing.  
For a specific measure which aims to facilitate and incentivise the deployment of high -speed 
electronic communications networks by reducing their cost, please see  also Directive 2014/61/EU of 
the European Parliament and the Council of 15 May 2014 on measures to reduce the cost of deploying 
high-speed electronic communications networks (https://ec.europa.eu/digital -single -
market/en/cost -reduction -measures).  
For a s ummary of the EU's electronic communications regulatory framework including the new 
European Electronic Communications Code, please see https://ec.europa.eu/digital -single -
market/en/telecoms.  
 
In addition, the 2016 Communication "Connectivity for a Compet itive Digital Single Market - Towards 
a European Gigabit Society" , identified new connectivity targets to be achieved by 2025 which were 
confirmed in the February 2020 Communication "Shaping Europe 's Digital Future".  This 2016 
Communication and its accompa nying Staff Working Paper also proposed a series of initiatives 
supporting the roll out of very high capacity networks and 5G. These also included, among others, 
the use of public funding in the most difficult areas that do not attract commercial investmen t. 
 
(b) The EU is supporting financially broadband roll -out in market failure areas. This is done through 
several instruments, such as the European Structural and Investment Funds (ESIF), the European 
Fund for Strategic Investments (EFSI) and the Connectin g Europe Broadband Fund (CEBF). From 
2021, the European Commission has proposed that a new Connecting Europe Facility (CEF) Digital 
Programme supports and complements Member States ' efforts in digital network investments and WT/TPR/M/395/Add.1  
 
- 403 - 
 
  digital take -up, as well as con tributes to making Europe "5G ready". For a non -exhaustive list of 
projects, please visit https://ec.europa.eu/digital -single -market/en/broadband -good-practices  and 
https://ec.europa.eu/digital -single -market/en/projects ). 
Progress on connectivity and digit alisation is monitored annually as part of the Digital Scoreboard 
and its Digital Economy and Society Index (Please see https://ec.europa.eu/digital -single -
market/en/desi ). 
 
4.4.4.3.2 Abolition of retail roaming charges  
4.4.4.3.2 Supresión de las tarifas de itinerancia al por menor  
 
Párrafo 4.328  
Según el informe de la Secretar ía, "con efecto desde el 15 de junio de 2017, se han suprimido las 
tarifas de itinerancia para los clientes que viajan periódicamente dentro de la UE, en virtud de un 
Reglamento adoptado en noviembre de 2015. Para evitar los efectos negativos de la utilización 
abusiva de los servicios regulados de itinerancia al por menor por los clientes itinerantes, el 
Reglamento permite a los proveedores aplicar una política de "util ización razonable". En un 
Reglamento de Ejecución adoptado en diciembre de 2016 se establecen normas y condiciones 
detalladas en relación con esa política de "utilización razonable".  
 
Preguntas 24:  
a) ¿Podría la UE aclarar a que se refiere por una política de  "utilización razonable" y 
como se determinan dichos criterios?  
b) ¿Podría la UE brindar más información sobre si existen disposiciones de supresión 
de las tarifas de itinerancia al por menor en sus Acuerdos de Libre Comercio y en cuáles 
específicamente?  
 
EU reply:  
(a) For Roam -Like-At-Home" (RLAH) to be provided in a sustainable manner throughout the 
European Union, the co -legislators (European Parliament and Council) have agreed to have in place 
the possibility for operators to apply a " fair use" policy to prevent abusive or anomalous use of 
roaming services at domestic prices. In accordance with the mandate given by the co -legislators, 
the Commission adopted, on 15 December 2016, the Commission Implementing Regulation (EU) 
2016/2286 layi ng down detailed rules on the application of fair use policy85. 
Fair use policy aims in particular at ensuring that roaming at domestic price is used only when 
periodically travelling in the EU/EEA. For this purpose, an operator may ask its customers for a proof 
of residence in, or stable link with, the EU/EEA country where it provides services and issues the 
SIM card to be used at domestic price when travelling abroad. An operator may also check that the 
SIM card is used more in its home Member State than a broad. If such a fair use policy is applied 
and, during a time window of at least four months, the customer has roaming consumption prevailing 
over domestic consumption or presence in other Member States of the EU prevailing over domestic 
presence, the ope rator has to alert the customer to verify whether there is any abusive or anomalous 
use of roaming services at domestic prices. After a period of at least 14 days from the date of the 
alert, the operator may apply small roaming surcharges linked to the who lesale price caps if the 
customer continues to consume mobile services abroad.  
In addition, in order to allow for the continuous development of the best data offers on domestic 
markets (e.g. unlimited data), an operator may apply a volume safeguard on roam ing data 
consumed at domestic prices86. Beyond that volume, the operator may apply a small roaming 
surcharge not exceeding the wholesale roaming price cap on data87. 
(b) None of the EU 's trade agreements currently in force contains any provisions providing for the 
abolition of retail charges for international mobile roaming.  
 
 
85 Commission Implementing Regulation (EU) 2016/2286 of 15 December 2016 laying down detailed 
rules on the application of fair use policy and on the methodology for assessing the sustainability of the 
abolition of retail roaming surcharge s and on the application to be submitted by a roaming provider for the 
purposes of that assessment.  
86 Implementing Regulation (EU) 2016/2286  provides that such a volume limit on roaming data must be 
equal to or greater than twice the retail price of the mo bile bundle divided by the wholesale roaming price cap. 
This means that the user can consume the double (or more) of the data volume that their operator can buy 
(with the price paid by the user) at wholesale level to the visited operator, if the latter cha rges at the level of 
the cap.  
87 Exceeding a data volume safeguard  can only lead to the imposing of roaming surcharges on data 
roaming retail services  (see BEREC Retail Roaming Guidelines , BoR (17) 56 , point 70) . WT/TPR/M/395/Add.1  
 
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  4.4.4.3.3 Fomento de la conectividad a Internet de las comunidades locales  
 
Párrafo  4.329   
Conforme al Informe de la Secretaria "para cumplir sus objetivos de conectividad a I nternet, y 
específicamente con el fin de impulsar la "inclusión digital", la UE emprendió en 2017 una iniciativa 
destinada a prestar apoyo, por medio de subvenciones y/u otras formas de ayuda financiera, con 
objeto de ofrecer en las comunidades locales una  conectividad inalámbrica local de alta calidad, con 
carácter gratuito y sin condiciones discriminatorias, en centros de la vida pública de las comunidades 
locales.  
Esa ayuda financiera está disponible para los organismos del sector público que satisfagan 
determinadas condiciones. En el marco de esta iniciativa, los municipios pueden solicitar bonos de 
hasta EUR 15.000. La cuantía total de la financiación disponible en el marco de esta iniciativa es de 
EUR 120 millones a lo largo del período 2018 -2020".  
 
Preguntas 25:  
a) ¿Podría la UE brindar más información sobre cuáles son las condiciones que deben 
satisfacer los organismos del sector público para acceder a estas subvenciones? ¿Cuál es 
el mecanismo de control de rendición de cuentas sobre estos fondos y su im pacto en las 
comunidades?  
b) ¿Los fondos provienen de inversiones privadas o de contribuciones de cada miembro 
de la UE?  
 
EU reply:  
 
(a) The conditions applicable to the award of the financial assistance foreseen under the "WiFi4EU" 
initiative for the promotion of internet connectivity in local communities are described in Regulation 
(EU) 2017/1953 of the European Parliament and of the Council of 25 October 2017 amending 
Regulations (EU) No 1316/2013 and (EU) No 283/2014 as regards the promotion of internet 
connectivity in local communities on the regulation (EU) 2017/1953 (https://eur -
lex.europa.eu/eli/reg/2017/1953/oj ). Further detail s can be found in the call text and the model 
grant agreement, both available under the following page: 
https://ec.europa.eu/inea/en/connecting -europe -facility/cef -telecom/wifi4eu . 
 
(b) The "WiFi4EU" initiative is financed on the EU 's budget, with contributions of the participating 
EFTA countries, under the Connecting Europe Facility established by Regulation (EU) No 1316/2013 
of the European Parliament and of the Council of 11 December 2013 as later amended by the above -
mentioned Regulation (EU) 20 17/1953.  
 
 
  WT/TPR/M/395/Add.1  
 
- 405 - 
 
  PERU  
Informe de la Secretaría OMC  
 
Medidas sanitarias y fitosanitarias  
 
Report by the WTO Secretariat  
Sanitary and phytosanitary  
 
1. Con base en el párrafo 3.216 del documento WT/TPR/S/395, puede la UE explicar  
sobre  qué base  científica  o razón  de inocuidad  alimentaria  se basa  para establecer en el 
ítem 3.1.17 Nota 26 del Anexo del Reglamento N° 488/2014, la excepción  de nivel  máximo  
de residuo  de 1.0 de cadmio  en el "Pecten  Maximus" (conchas francesas), mientras que a 
los otros tipos de pecten, como el "Agropecten Purpuratus" (concha peruana), se le exige 
que el nivel máximo se aplique a todo el producto y no solo al músculo abductor y las  
gónadas.  
 
EU reply:  
In accordance with Council Regulation (EEC) No . 315/93 where necessary to protect public health, 
maximum levels for contaminants in food are set on the basis of the as low as reasonably achievable 
principle, taking into account occurrence data and consumption patterns. For Pecten maximus a 
footnote has  been added that the maximum level only applies to the adductor muscle and gonads 
because it concerns a very big clam, from which only these parts are consumed. In case Peru 
considers that a similar footnote would be appropriate for Agropecten purpus, it s hould submit to 
the EU a dataset with cadmium concentrations for the entire edible part and for the adductor muscle 
and gonads for the different size categories of this clam. In case Peru is able to submit a dataset 
which is sufficiently large, to allow to  draw statistically significant conclusions, the EU is willing to 
discuss with the EU Member States the possible need to extend the concerned footnote to Agropecten 
purpurus.  
 
2. Respecto al párrafo 3.240 del documento WT/TPR/S/395 y en el marco del 
Reglam ento (UE) Nº 488/2014 de la Comisión, de 12 de mayo de 2014, que modifica el 
Reglamento (CE) Nº 1881/2006 por lo que respecta al contenido máximo de cadmio en 
los productos  alimenticios:  
 
a. Si la norma de la UE aplica para productos vendidos al consumidor  final, 
 ¿cuál es la razón científica para aplicar niveles máximos al cacao en polvo  agregado  a 
un  producto  vendido  al consumidor  final?  ¿Cómo  la UE considera el contenido de cadmio 
de  otros ingredientes que se añaden para el producto  final?  
 
EU reply:  
The EU set maximum levels for cocoa powder sold to the final consumer or as an ingredient in 
sweetened cocoa powder sold to the final consumer, in order to facilitate compliance by producer 
countries, as this allows blending of cocoa powder from bea ns from different origins. In case 
consumer products contain mixtures of cocoa powder and other ingredients, in accordance with 
Article 2 of Regulation (EC) No . 1881/2006, the maximum levels should be applied, taking into 
account the relative proportions o f the ingredients in the product. This approach is taken to ensure 
that consumers are not exposed to cadmium concentrations from cocoa powder, which are higher 
than the established maximum levels.  
 
b. ¿Cómo la UE supervisa el cumplimiento de los niveles máximos establecidos para 
chocolate  y derivados del  cacao?  
 
EU reply:  
In accordance with Regulation (EU) 2017/625 the EU Member States perform official controls on 
food in order to ensure compliance wi th the EU food safety legislation, including controls on 
compliance with the maximum levels for cadmium established under Reg. (EU) No . 488/2014. 
Member States carry out these controls under their multi -annual national control plans for products 
produced i n the EU and under their plans for border control post controls for products imported into 
the EU from third countries.  
 WT/TPR/M/395/Add.1  
 
- 406 - 
 
  c. ¿Por qué la UE afirma en la página 2 sección "Maximum levels of Cadmium in cocoa 
 products" de este documento 
 https://ec.europa.eu/ food/sites/food/files/safety/docs/cs_contaminants_c atalogu
e_cadmiu  m_chocolate_en.pdf , que los niveles máximos de cadmio  aplican  para todo el 
cacao  en  polvo,  si la norma  solo es aplicable en ciertas  condiciones?  
 
EU reply:  
The Maximum levels for cadmium in cocoa powder apply to cocoa powder sold to the final consumer 
or as an ingredient in sweetened cocoa powder sold to the final consumer as laid down in Regulation 
(EU) No . 488/2014. The fact sheet that Peru refers to, is intended to explain and summarise the EU 
legislation on cadmium in chocolate in a concise and comprehensive manner. In the schematic figure 
on page 2 only c ocoa powder is mentioned; however the details can be found in Regulation (EU) 
No. 488/2014, which has been clearly referred to. This factsheet does not replace the Regulation 
nor does it amend its scope.  
 
3. Respecto al párrafo 3.224 del documento WT/TPR/S /395, ¿cuáles son los argumentos 
científicos que demuestran el riesgo de establecimiento de la Anastrepha fraterculus y 
Anastrepha obliqua en el territorio de la  UE? 
 
EU reply:  
Anastrepha fraterculus and A. obliqua  are non -European Tethritidae  that have been regulated pests 
for many years for the EU territory. The management decision to keep these two fruit flies regulated 
under the new Plant Health Regulation was taken on the basis of a recent pest risk assessment of 
non-European Tepthritidae  published by the European Food Safety Authority. The risk that the fruit 
flies would be able to establish in the Southern parts of the Union territory, especially taking into 
account climate change effects, cannot be excluded.  
 
4. Respecto al párrafo 3.240  del documento WT/TPR/S/395, considerando que la 
Comisión establece que el mango es una "fruta grande de piel no comestible",  
¿Cuál es la razón científica de protección a la salud del consumidor en el Reglamento (UE) 
2017/1164 de la Comisión, para que las manzanas tengan un LMR de tiabendazol de 
4 mgs/kg, mientras que los mangos tienen un LMR de  
0.01 mgs/kg? ¿Por qué luego de más de un año que se ha presentado la información 
científica revisada que demuestra que el LMR de 5 mgs/kg de tiabendazol en el mango  
(nivel que también establece el Codex), resulta perfectamente adecuado para proteger la 
salud del consumidor, la UE no proceda con el levantamiento o modificación de la medida?  
 
EU reply:  
In the context of the ongoing review of EU MRLs for pesticides, EFSA re -assessed the MRLs of the 
substance thiabendazole in all crops including mangoes in its opinion of 23 June 2016. EFSA 
identified dietary intake concerns and could not propose a safe MRL, neither could the existing MRL 
be maintained tempo rarily. For these reasons the then existing MRL of 5 mg/kg for mangoes could 
not be supported anymore. To address these EFSA concerns, a Regulation was prepared (Regulation 
(EC) No . 2017/1164) lowering the MRL for mangoes to the default level of 0.01 mg/kg  which is 
applicable since 21 January 2018.  
In 2017 stakeholders and the manufacturer of the substance raised concerns about the impact of 
the new MRL on mangoes trade. These concerns were discussed at the Standing Committee meeting 
in June 2017, including  the question whether processing factors (i.e. peeling) could be applied for 
mangoes. It was concluded however that there was no sufficient data or justification for further 
action. In the meantime an import tolerance request has been submitted to EFSA wit h additional 
data which may address the issue. This import tolerance request is currently still under assessment.  
The situation for apples was different: EFSA was able to propose a tentative MRL based on the 
submitted trial data which was safe for consumer s. 
 
5. Respecto al párrafo 3.241 del documento WT/TPR/S/395 y con relación a la 
legislación sobre nuevos alimentos (novel foods), ¿cuál es el argumento científico  que 
sustenta  esta legislación?  ¿Cuál  es el riesgo  identificado  por la UE que sustenta esta 
medida?  
 WT/TPR/M/395/Add.1  
 
- 407 - 
 
  EU reply:  
Your concerns expressed in the question have already been discussed on previous occasions at the 
WTO SPS Committee. We would just like to repeat our position which is known to the Members of 
the Committee:  
 
• The new regulation is consistent with the SPS agreement.  
• The new Novel Foods Regulation, as the current one, covers foods, production processes 
and production methods new to the EU for various reasons.  
• It is clearly not possible to anticipate the potentia l risks associated with such novel foods, 
production processes or production methods and to address them in an all -encompassing risk 
assessment. Therefore, the high level of food safety pursued in the EU can only be achieved 
through a pre-market approval s ystem .  
• The SPS Agreement envisages such pre -market approval schemes in its Article 8 . The 
conditions are set in Annex C. The new Novel Foods Regulation in this respect is in line with 
the SPS Agreement as it is a pre -market approval scheme based on scient ific risk assessment, 
in line with Articles 5, 8, and Annex C.  
• The new Regulation has established a simplified procedure  for placing on the EU market 
traditional foods from third countries . This procedure, which provides a faster and more 
proportionate saf ety assessment, allows traditional foods from Peru and other Members to be 
authorised in the EU by a simple notification procedure once the history of safe use in at least 
one non -EU country has been demonstrated. This is an important improvement to the pr evious 
situation where such traditional foods needed to undergo a full authorisation procedure.  
• Concerning the period of 25 years  of history of consumption, there is no consensus in the 
scientific community or among regulators about what is the precise thr eshold in years of the 
concept 'history of safe use'. However, most experts and regulators consider that it should 
normally cover a period ranging from one to several generations. The 25 years established in 
the EU regulation translates roughly as one gene ration, which is in the lower end of the 
spectrum.  
• Moreover, setting such definite period gives legal certainty as it does not leave room for 
interpretation on a case by case basis on what is considered a sufficiently long period of safe 
use. It thus makes  the process more predictable for applicants.  
 
6. Con relación a la sección 3.3.3.3 del documento WT/TPR/S/395, si los niveles 
máximos  para cadmio  en chocolate  y derivados  del cacao  establecidos  mediante el 
Reglamento (UE) Nº 488/2014 de la Comisión, entraban en vigencia el 01 de enero 
de 2019, ¿cuál es la razón para que se tengan 5 notificaciones en el sistema RASFF 
respecto a contenido de cadmio en nibs de cacao y polvo de cacao? ¿Por qué se han 
considerado niveles máximos para productos qu e no se encuentran regulados en dichas 
notificaciones RASFF? ¿Qué legislación de la UE permite esta situación?  
 
EU reply:  
In cases where no European Union harmonised legislation is in place, the national authorities can 
apply their own legislation or can n otify with the support of a national risk assessment on the basis 
of Article 14 of Regulation (EC) No . 178/2002. The maximum levels for cadmium in cocoa powder 
were only applicable from 1 January 2019, and before that date, as there was no harmonised EU 
maximum level in place for cadmium in cocoa  beans and cocoa powder, the mentioned notifications 
were justified with national risk assessments calling to the mentioned legal basis.  
 
Informe de la UE  
 
7. Con relación  al párrafo  3.25 del documento  WT/TPR/G/395,  ¿cómo  planea  la UE 
mejorar la transparencia del proceso de evaluación de riesgos y mejorar la comunicación 
de riesgos contemplada en el Reglamento  2019 -1381?  
 
EU reply:  
The new Transparency Regulation (Regulation (EU) 2019/1381) intends to improve the transparency 
of the EU risk assessment process carried out by the European Food Safety Authority (EFSA), 
strengthen the long -term sustainability of EFSA and improve risk communication. To this end, it 
mainly amends Regulation (EC) No . 178/2002 [General Food Law Regulation] and – as far as 
transparency is concerned – eight other sectoral acts, i.e. Regulation (EC) 1829/2003 [GM Food and 
Feed], Regulation (EC) No . 1831/2003 [Feed Additives], Regulation (EC) No . 2065/2003 (Smoke 
flavouri ngs), Regulation (EC) No . 1935/2004 [Food Contact materials], Regulation (EC) WT/TPR/M/395/Add.1  
 
- 408 - 
 
  No. 1331/2008 [common authorisation procedure for food additives/enzymes/flavourings], 
Regulation (EC) No . 1107/2009, Regulation (EU) 2015/2283 [Novel Foods] and Directive 
2001/1 8/EC [GMO cultivation].  
 
The changes brought by the new Regulation, that will improve the transparency of the risk 
assessment process and the risk communication, can be summarised as follows:  
 
• Proactive public disclosure/Confidentiality/Public consultation s of submitted 
studies  
 
All scientific data, studies and other information supporting any request for a scientific output from 
EFSA (including in the area of authorisation procedures) shall be made publicly available proactively, 
with the exception of duly  justified confidential information, early on in the EU risk assessment 
process.  
To that effect, closed lists of clearly -defined information items for which confidentiality may be 
claimed under certain conditions, with the exception of safety relevant inf ormation, are set out in 
the General Food Law Regulation and complementarily – to address sectoral specificities - in seven 
other sectoral acts .  
More specifically: When an applicant submits a request for authorisation accompanied by scientific 
data, studi es and other supporting information, it may request certain parts of the submitted data, 
studies and other information to be kept confidential. This request must be duly justified (proof of 
"potential harm to a significant degree" in case of public disclos ure). The applicant should submit a 
non-confidential version and a confidential version of the submitted data, studies and other 
information. Without delay and once an application is found valid or admissible, EFSA would make 
the non -confidential version o f those studies, as submitted by the applicant, public. In parallel, EFSA 
would assess the confidentiality claim within 10 weeks. Once the assessment is completed, any 
additional data and information for which confidentiality requests has been considered a s unjustified 
would also be made public (final non -confidential version as assessed by EFSA). Upon receipt of the 
confidentiality decision by EFSA, applicants would have the right to make a confirmatory application 
asking EFSA to reconsider its decision. F ollowing public disclosure, EFSA will launch public 
consultations on the submitted data, studies and other information to ensure access to the widest 
evidence -base possible before it delivers its scientific output.  
The public disclosure of all information  supporting applications or other requests for scientific output 
by EFSA shall be without prejudice to any existing rules concerning Intellectual Property Rights 
(which may set out limitations on certain uses of the disclosed documents on their content), a nd 
"data exclusivity rules ". The disclosure to the public shall not be considered as an explicit or implicit 
permission or licence for the relevant data and information and their content to be used. EFSA shall 
ensure that clear undertakings or signed state ments are given to that effect by those accessing the 
relevant documents, prior to their disclosure.  
 
• Notification of studies  
EFSA shall establish and manage a database of studies when commissioned or carried out (at pre -
submission phase) by business oper ators to support a future application or notification in relation to 
which Union law makes provisions for EFSA to provide a scientific output. Business operators shall 
without delay notify EFSA on the title and the scope of the study, the laboratory or tes ting facility 
carrying out the study, and the starting and planned completion dates of any study commissioned 
or carried out by them to support an application or a notification. The notification obligation shall 
also apply to laboratories and other testing  facilities located in the Union carrying out those studies, 
and also to laboratories and other testing facilities located in third countries insofar as set out in 
relevant agreements and arrangements. Certain procedural consequences of non -compliance with  
the notification requirement are also foreseen, e.g. an application or notification shall not be 
considered valid or admissible where it is supported by studies that have not been notified, unless 
the applicant or notifier provides a valid justification f or non -notification of such studies.  
 
• Risk Communication  
A number of objectives that risk communication should pursue (while taking into account the 
respective tasks and responsibilities of risk assessors and risk managers), as well as the general 
princip les of risk communication are listed in the new Transparency Regulation. A general plan for 
risk communication will be adopted by means of implementing acts, in order to achieve the 
objectives of risk communication, in accordance with the general principle s of risk communication.  
 WT/TPR/M/395/Add.1  
 
- 409 - 
 
  8. Respecto al párrafo 3.27 del documento WT/TPR/G/395, ¿en el marco de qué 
legislación, la UE puede adoptar medidas sanitarias y/o fitosanitarias basadas en  un 
enfoque  de peligro?  ¿Cómo  esta legislación  se adapta  a la evaluación  del riesgo conforme 
al Acuerdo MSF  OMC?  
 
EU reply:  
Regulation (EC) No . 1107/2009 concerning the placing of plant protection products on the market 
stipulates that active substances cannot be approved or renewed if they are classified as 
carcinogenic, genotoxic, or toxic for reproduction following Regulation (EC) No . 1272/200 8, or if 
they have endocrine disrupting properties, and if they do not benefit from certain specific derogations 
set in the legislation for a potential restricted approval. Regulation (EC) No . 396/2005 on maximum 
pesticide residues in food and feed allows for the setting of MRLs and import tolerances. This 
Regulation follows a step -by-step risk assessment approach as provided for by Codex Alimentarius 
and does not address the particular situati on of substances meeting the above -mentioned criteria.  
 
9. En el marco del párrafo 3.27 del documento WT/TPR/G/395, ¿por qué la UE considera  
al enfoque  precautorio  como  un principio?  ¿En base  a qué legislación o acuerdo 
internacional se da dicha  considera ción?  
 
EU reply:  
The precautionary principle is laid down in Article 191 of the Treaty on the Functioning of the 
European Union (TFEU) and it has been recognised by the European Courts as a general principle of 
EU law. Its implementation is therefore speci fied in the Commission Communication on the 
precautionary principle, adopted in 2000. In addition, Regulation (EC) No . 178/2002 on general food 
law ("General Food Law Regulation ") refers to the use of the precautionary principle as part of the 
risk management process in the context of the risk analysis principle applicable to the development 
of EU and national food law. The precautionary principle, as laid down in the General Food  Law 
Regulation, allows the adoption of provisional risk management measures necessary to ensure a 
high level of health protection when, following an assessment of available information, the possibility 
of harmful effects on health is identified but scient ific uncertainty persists. It therefore requires a 
scientific evaluation as well as an evaluation and balancing of the risks involved, i.e .whether the 
potential risks identified exceed the threshold of what is acceptable for consumers as well as the 
conse quences of non -action by the risk managers.  
 
10. Respecto al párrafo 3.27 del documento WT/TPR/G/395, ¿en base a qué legislación la 
UE ha utilizado el "principio ALARA ( "tan bajo como razonablemente sea posible 
alcanzar ")" para sustentar alguna medida san itaria o fitosanitaria? ¿Por qué la UE 
considera este enfoque como un principio para asuntos sanitarios y/o fitosanitarios? ¿Por 
qué considera repetidamente en sus reglamentos el concepto de límite de detección (LOQ 
en inglés) para el establecimiento de lí mites máximos de residuos de agroquímicos, 
cuando este concepto es uno de los principios más conflictivos en el área de la Química 
Analítica, y equivale en la práctica, a determinar una  prohibición?  
 
EU reply:  
This default limit of 0.01 mg/kg is to facilit ate the control of pesticide residues and to protect 
consumers from exposure to unauthorised or excessive levels of residues. It is also an expression 
of the principle that MRLs should be set as low as reasonably achievable (ALARA). Practical 
experience sh ows that 0.01 mg/kg is an appropriate default value. A lower value may not be 
attainable for certain substance/matrix combinations. The EU considers that applying a default value 
is preferable to a zero tolerance policy. On the one hand, a zero tolerance i s not necessary for 
consumer protection. For the limited number of substances with exceptionally high toxicity where 
the default value of 0.01 mg/kg is not sufficiently protective for consumers, the EU sets MRLs lower 
than 0.01 mg/kg. On the other hand, a zero tolerance is more trade -restrictive than necessary, as 
acceptance in the importing country cannot be reliably predicted in the exporting country, e.g. due 
to different performance levels of the analysing laboratories, or due to differences in the prod uct 
tested where the commodity is concentrated for shipment.  
 
11. Respecto al párrafo 3.27 del documento WT/TPR/G/395, ¿qué esfuerzos adicionales 
hará la UE para armonizar los procesos regulatorios de las normas sanitarias?  
 WT/TPR/M/395/Add.1  
 
- 410 - 
 
  EU reply:  
In accordance with Ar ticle 5(3) of Regulation (EC) 178/2002 of the European Parliament and of the 
Council88, where international standards exist or their completion is imminent, they are to be taken 
into consideration in the development or adaptation of food law, except where such standards or 
relevant parts would be an ineffective or inappropriate means for th e fulfilment of the legitimate 
objectives of food law or where there is a scientific justification, or where they would result in a 
different level of protection from the one determined as appropriate in the Community. Moreover, 
in accordance with Article 13(e) of that Regulation, the Union is to promote consistency between 
international technical standards and food law while ensuring that the high level of protection 
adopted in the Union is not reduced.  
 
As laid down in the Fitness Check of the General Fo od Law – a comprehensive policy evaluation of 
this Regulation to be found at:  
 https://ec.europa.eu/food/safety/general_food_law/fitness_check_en , the EU has made 
considerable efforts to ensure alignment of EU food law with international standards, followi ng its 
introduction in 2002. This is also reflected in other EU secondary food legislation, where specific 
reference to international standards in the development of food law is made; as a consequence, 
adaptation of EU law takes place in line with internat ional standards and with the EU international 
obligation under the WTO/SPS Agreement.  
 
12. Con relación al párrafo 3.28 del documento WT/TPR/G/395, ¿cómo asegura la UE el 
mismo manejo del riesgo sanitario en cada país miembro de la  UE? 
 
EU reply:  
EU Member States have to ensure compliance with the applicable EU provisions. Moreover, many 
guidance documents exist to support the correct application of the legal provisions. The European 
Commission is responsible for overall coordination, inspection and a udits of inspection systems of 
the Member States and the necessary legislative action to ensure uniform application of standards 
and requirements within the EU's Internal Market. The European Commission works to ensure the 
safety of EU's agriculture and fi shery products and that the same safety standards apply to all 
products regardless of origin or destination inside or outside the EU.  
 
Orgánicos  
 
13. ¿Es posible que la UE modifique el Reglamento (UE) 2018/848 sobre la producción  y 
etiquetado  de productos  orgánicos,  para tener  en consideración  en forma  más realista  el 
sistema  de cooperativas  de productos  orgánicos  en países en  desarrollo,  en particular  en 
lo que se refiere  a al número  de participantes  para una misma certificación, acreditación 
de órganos de control y a sustancias aprobadas?  
 
EU reply:  
Regulation (EU) No . 2018/848 will enter into force on 1 January 2021. Article 45(1) of Regulation 
(EU) No . 2018/848 provides that an organic product can be imported into the EU if the product 
complies with Chapter II, III and IV of the Regulation. However, under Article 45(2) of Regulation 
(EU) No . 2018/848 the European Commission may grant specific authorisations for the use of 
products and substances in third countries and in the oute rmost regions of the European Union. The 
specific authorisation takes into account differences in the ecological balance in plant or animal 
production, specific climatic conditions, tradition and local conditions in those areas.  
 
There is no specific reference to cooperatives in the Regulation. However, Article 36 provides the 
requirements for group certification. Each group of operators shall:  
 
• only be composed of members who are farmers and who in addition may be engaged in 
processing, prepa ration of placing on the market of food or feed  
• be composed of members who have each holdings of maximum 5 ha, 0,5 ha of greenhouses 
or 15 ha of permanent grassland (or conditions based on the certification costs or output of 
production)  
• have a legal ent ity 
 
88 Regulation (EC) No . 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety Authority and 
laying down procedures in matters of food safety (OJ L 31, 1.2.2 002, p. 1).   
 WT/TPR/M/395/Add.1  
 
- 411 - 
 
  • establish a system of internal controls  
 
In addition to the requirements provided in the Regulation, the European Commission can adopt 
more detailed rules covering the following issues:  
 
• The responsibilities of the individual members  
• The criteria to d etermine the geographical proximity of the members of the groups  
• The set -up and functioning of the system of internal controls, including the scope, content 
and frequencies of the control, and the criteria to identify deficiencies of the system  
• The composition and dimension of a group of operators  
• The documents and records -keeping system, the system for internal traceability and the list 
of operators  
• The exchange of information between a group of operators and the control bodies.  
 
Currently, th ese additional rules are being discussed. The final texts are expected to be approved 
before the summer of 2020 and adopted before the end of 2020.  
  WT/TPR/M/395/Add.1  
 
- 412 - 
 
  PHILIPPINES  
PART I: QUESTIONS REGARDING THE SECRETARIAT REPORT  
 
1. ECONOMIC ENVIRONMENT  
 
Para 1.22 (Page 2 2) 
Monetary policy continued to ensure favourable financing conditions and support economic 
expansion during the review period. While the ECB ended its net asset purchases programme in 
December 2018, the ECB monetary policy remained highly accommodative si nce the beginning of 
this year, with a new easing package announced in September. The latest measures were considered 
necessary in light of further downward revisions in the ECB Governing Council's inflation outlook. 
Most notably, the latest package includ ed a 10 basis point (bps) cut in the deposit facility rate (DFR) 
to -0.5%. The interest rate on the main refinancing operations and the rate on the marginal lending 
facility remained unchanged, at 0.00% and 0.25%, respectively. In addition, open -ended net asset 
purchases at a pace of EUR 20 billion per month were due to restart from 1 November 2019. The 
duration of the purchases was not set in advance, with the Governing Council expecting them 
"to end shortly before it starts raising the key ECB interest ra tes". 
 
Question/s:  
1. With the deposit facility rate currently at -0.5% while interest rates on both 
refinancing and marginal lending facility at 0 % and 0.25 %, is there still room for the ECB 
for further monetary policy accommodation?  
 
EU reply:  
The ECB has used in recent years several monetary policy instruments (namely, cuts on interest 
rates, asset purchases, forward guidance, targeted longer -term refinancing operations) to provide 
the necessary monetary stimulus in pursuit of its price stabili ty objective. The ECB Governing Council 
has also made clear that it stands ready to adjust all of its instruments, as appropriate, to ensure 
that inflation moves towards its aim in a sustained manner, in line with its commitment to symmetry.  
 
Para 1.24 (P age 23)  
According to the Summer 2019 edition of the European Economic Forecast (to be updated in 
November 2019 and February  2020), in spite of global challenges, the EU is expected to continue 
growing in the next two years, with annual growth forecast to s low from 2.0% (1.9% in the euro 
area) in 2018 to 1.4% in 2019 (1.2% in the euro area), as the German economy slipped into negative 
territory in 2019 Q2 and it continued to show signs of weak exports. However, the EU economy is 
set to firm up at 1.6% in 202 0 (1.4% in the euro area), as adverse domestic factors are expected 
to fade and economic activity outside the EU to rebound.  
 
Question/s:  
2. Downside risks to global outlook could slow growth substantially. Trade tensions, 
trade policy uncertainties, a sharper than expected downturn in major economies and 
geopolitical pressures in the Middle -East pose as some of the risks to the outlook. The 
growth outlook for EU area may therefore trend lower in 2020. With interest rates already 
falling close to zero or below, what other policy measures are available to help boost 
growth in 2020?  
 
EU reply:  
The global and European outlook remains fragile with the prospect of a protracted period of subdued 
growth in a context of structural challenges and numerous downside risks.  
According to the Commission 's autumn forecast, the aggregate euro area fiscal stance is projected 
to be broadly neutral to slightly ex pansionary in 2020 and 2021, which looks appropriate against 
the baseline scenario of subdued economic growth. However, using available fiscal space more 
actively and pre -emptively would allow Member States not only to provide a fiscal stimulus in case 
of a sharper slowdown, but also to refresh and modernise the public capital stock, thereby boosting 
potential growth. Additional public investment is indeed needed to prevent the erosion of the public 
capital stock. Further boosting investment and other produ ctive spending in Member States with a 
favourable budgetary situation would support their potential growth. Besides a proper differentiation 
of the euro area fiscal stance, it is also important to improve the quality and composition of public 
finances in t he European Union.  WT/TPR/M/395/Add.1  
 
- 413 - 
 
  There are needs for skill upgrading to harness the benefits of digitisation, and for supporting the 
transition toward a climate -neural EU. In addition to boosting the growth outlook, improving human 
and physical capital through increased  investment in education and key infrastructure could raise 
productivity growth. A targeted package of fiscal and structural policies could further contribute to 
the transition to an environmentally and socially sustainable economy that is at the centre of  the 
European Green Deal, which the new Commission has put forward. Last but not least, the EU 
continues to put strong emphasis on investment through the Sustainable Investment Plan and the 
InvestEU.  
 
Para 1.27 (Page 23)  
Given the decreasing trend in inves tments and with the view to creating jobs in the spirit of the  
Europe 2020 Strategy, in 2014, the Investment Plan for Europe of which the Capital Markets Union 
is a main pillar (Section 4.4.1.3), was launched. It aims to reverse the downward trend of low l evels 
of investment and put Europe on the path to economic recovery. The Plan consists of three pillars: 
(i) the European Fund for Strategic Investments (EFSI), which provides an EU  guarantee to mobilize 
private investment. The European Commission  works jo intly with the European Investment Bank 
(EIB) on this pillar; (ii) the European Investment Advisory Hub and the European  Investment Project 
Portal, that focus on providing technical assistance and greater visibility of investment opportunities 
for internat ional investors; and (iii) measures to further improve the EU's investment climate by 
increasing regulatory predictability and eliminating obstacles for investments.  
 
Question/s:  
3. Please cite the reasons for the decreasing trend in investments. What concret e 
measures have been undertaken in relation to the Investment Plan for Europe to address 
these concerns (i.e.  specific details on the EU guarantee, technical assistance and 
obstacles which hinder investments)?  
 
EU reply:  
As a result of the impact of the f inancial and economic crisis that began in the US in 2008 and hit 
the EU economies with full force in 2010, European policymakers reacted with fiscal austerity 
measures to restore confidence in the EU government bond markets and contain rising financing 
costs. In addition, increased risk aversion among financial institutions and investors had contributed 
to a decline in the availability of financing through the banking system, which has particularly 
affected the access to finance for small and medium -sized enterprises.  
 
As a result, EU investment activity in 2013 was 15 % (in real terms), or around EUR 430 billion, 
below its pre -crisis peak. In the hardest hit Member States, the investment deficit is likely to have 
ranged between 25 and over 60 %. The weaknes s reflected low demand growth, low capacity 
utilisation, increased economic and political uncertainty and, in some countries, the bursting of 
construction/residential construction bubbles, corporate debt reduction and financing bottlenecks. 
At that time, s ubdued investment activity threatened Europe's long -term growth potential. It eroded 
the existing productive capital stock and worryingly meant that Europe was not making the 
productive investment in human and physical capital needed for future competitive ness, growth and 
employment. This trend undermined the ability of European businesses to compete in the global 
economy and to create rewarding jobs and high living standards.  
 
As early as 2014, annual gross domestic product (GDP) growth in the EU was expec ted to be 
relatively moderate at 1.3%, while growth in the euro area would be 0.8%. The expected GDP 
growth, which had already been relatively slow before the crisis due to low productivity gains, had 
declined further due to low investment and high structu ral unemployment. It was imperative to find 
ways to break this vicious circle and turn it into a virtuous circle in which investment projects could 
contribute to a stronger increase in employment and demand as well as to a sustainable increase in 
potential  growth.  
 
The Investment Plan for Europe was announced in 2014 as a comprehensive investment promotion 
strategy to help restore the EU's competitiveness and boost growth and investment in the European 
Union by removing barriers to investment, ensuring the visibility and technical support of investment 
projects and using financial resources more wisely. As such, the plan consists of three pillars:  
 
1. First, the European Strategic Investment Fund (EFSI), which provides an EU guarantee to 
mobilise private invest ment. The Commission is working with its strategic partner, the 
European Investment Bank (EIB) Group.  WT/TPR/M/395/Add.1  
 
- 414 - 
 
  2. Secondly, the European Investment Advisory Hub (EIAH) and the Project Portal for European 
investment projects, which provide technical assistance and greater visibility of investment 
opportunities, thus helping to make proposed investment projects a reality. The Hub is a 
joint venture with the EIB Group.  
 
3. Third, to improve the business environment by removing regulatory barriers to invest ment 
at both national and EU level.  
 
EFSI is an initiative of the European Commission, jointly implemented by the EIB Group, with the 
aim of supporting investment and improving access to finance for SMEs (up to 250 employees) and 
mid-cap companies (up to 3  000 employees). EFSI comprises an EU guarantee of EUR 26 billion 
(backed by a budget of EUR 9.1 billion) offered to the EIB Group from the EU budget and a capital 
contribution of EUR 7.5 billion provided by the EIB. Overall, EFSI aims to mobilise addition al 
investment of EUR 500 billion by the end of 2020.  
 
The EIAH is a joint initiative by the European Commission and the European Investment Bank and 
the EIB is responsible for the management of the Hub which is established within the EIB. EIAH is a 
single point of entry to a wide range of advisory and technical assistance programmes and initiatives 
for public and private beneficiaries. EIAH provides support for the identification, preparation and 
development of investment projects. The EIAH started operatin g on 1 September 2015 and is now 
fully operational. More than 1500 requests were received from all MS for technical assistance were 
received until the end of 2019 and more than 430 of those requests received or are receiving more 
detailed advisory support.  
 
Building on the success of the Juncker Plan and EFSI and against the background of large investment 
gaps in key areas of the future, the Commission has proposed the InvestEU Programme (2021 -17), 
which is one of the Multiannual Financial Framework (MFF) p roposals tabled by the Commission with 
the aim of boosting private and public investment in the EU and facilitating access to financing. The 
InvestEU Programme consists of the InvestEU Fund, which will provide an EU budget guarantee of 
EUR 38 billion (subj ect to MFF agreement) with the aim to trigger at least EUR 650 billion in additional 
investment in four policy areas: sustainable infrastructure; research, innovation and digitisation; 
small and medium -sized businesses; and social investment and skills. Mo reover, the pillar two 
initiatives put in place under the Juncker Plan will be continue and enhanced through the InvestEU 
Advisory Hub (replacing the EIAH/European Investment Advisory Hub, and 12 other centrally 
managed advisory initiatives), and the Inves tEU Portal (replacing the European Investment Project 
Portal).  
 
The Third Pillar of the Investment Plan aimed at measures to address barriers to investment, both 
at the EU and at the Member State level. Action at EU level aims at stimulating investment, re moving 
barriers across countries and at supporting the implementation of structural reforms. The 
Commission has acted to remove regulatory barriers that hamper cross -border trade and investment 
in the Single Market, including through its initiatives within  the Digital Single Market strategy, the 
completion of the Capital Markets Union and the Energy Union. To support the implementation of 
structural reforms, the European Commission has set up the Structural Reform Support Programme 
(SRSP) providing technica l support. At Member State level, they are encouraged to ensure well -
functioning markets and institutions and a favourable business environment, in particular by 
reducing administrative and regulatory bottlenecks to investment. Countries are also encourage d to 
invest in human capital – to make sure that skill shortages are not impeding growth. Member States 
should also invest in network industries – digital, transport and energy infrastructures – so that they 
can adequately meet the requirements of the cont emporary economy.  
 
Para 1.32 (Page 24)  
Similarly, the European Commission's Annual Growth Survey 2019 calls for decisive and concerted 
policy action by the EU and its member States to deliver on the promise of inclusive and sustainable 
growth, especially i n the context of rising global uncertainty, and to increase the EU's  growth 
potential and economic and social resilience.  
 
Question/s:  
4. Is there a timeline for EU's policy action to address persisting vulnerabilities, short -
term challenges and medium/long -term challenges, as identified in the TPR? How will the 
European Commission aim to prioritize these challenges?  
 WT/TPR/M/395/Add.1  
 
- 415 - 
 
  EU reply:  
On 11 December 2019, the European Commission adopted the European Green Deal, which aims to 
transform the EU into a fair and prosperous society, with a modern, resource -efficient and 
competitive economy, where there are no net emissions of greenhouse gases  in 2050, and where 
economic growth is decoupled from resource use. It also aims to protect, conserve and enhance the 
EU's natural capital, and protect the health and well -being of citizens from environment -related risks 
and impacts. At the same time, it a ddresses the imperative for this transition to be just and inclusive 
by paying attention to the regions, industries and workers who will face the greatest challenges.  
 
The European Pillar of Social Rights89 is the EU 's social strategy to make sure that the  transitions of 
climate neutrality, digitalisation and demographic change are socially fair and just. The Commission 
Communication: A Strong Social Europe for Just Transitions90 outlines key priority areas and 
initiatives for the period 2020 -2021 to deliver  in this area.  
 
The Communication on the European Green Deal provides an initial roadmap of the key policies and 
measures needed to achieve the European Green Deal91,92 - COM(2019) 640. In particular, the 
European Green Deal puts forward a set of transforma tional policies that aim to increase the EU 's 
climate ambition for 2030 and 2050, to preserve and restore ecosystems and biodiversity and to 
create a zero pollution ambition for a toxic -free environment. This is coupled with a set of targeted 
policies for the sectors of the economy that are key for the transition towards sustainability, in 
particular, energy, industries, mobility, buildings and the food system. To accompany this change, 
the European Green Deal also addresses the economic and financial polic y framework to mobilise 
both the public and private sectors at all levels – European, national and local. For example, on 
14 January 2020, the European Commission launched the Investment Plan for a Sustainable Europe, 
which is the investment pillar of the Green Deal. To achieve the goals set by the European Green 
Deal, the Plan will mobilise at least EUR 1 trillion in sustainable investments over the next decade. 
To ensure that the transition to carbon neutral society is just and inclusive, the Commission p roposed 
the Just Transition Mechanism within the European Green Deal Investment Plan, mobilising 
EUR 100 million over the period 2021 -27 to ensure tailored financial and practical support to workers 
and citizens of the regions most impacted by the transiti on93. 
 
The Green Deal is an integral part of this Commission 's strategy to implement the United Nation 's 
2030 Agenda and the sustainable development. As part of the Green Deal, the Commission will 
refocus the European Semester process of macroeconomic coordination to integrate the United 
Nations ' sustainable development goals, to put sustainability and the well -being of citizens at the 
centre of economic policy, and the sustainable development goals at the heart of the EU 's 
policymaking an d action. Delivering an economy that works for the people and ensuring a just 
transition towards climate -neutrality while providing a high level of economic and political stability 
requires a strong and resilient social market economy that allows all to en joy a high and sustainable 
level of prosperity. Delivering prosperity means raising living standards by increasing the efficiency 
of resource use, i.e. productivity growth. The growth strategy outlined in the Annual Sustainable 
Growth Strategy (ASGS)94 puts emphasis on structural reforms that unlock investment in innovation 
by delivering effectively regulated and integrated markets, so that firms compete on a level playing 
field, and entrepreneurship and innovation are rewarded. The growth strategy underscor es the 
importance of policies that deliver effective equality of opportunity, notably through the provision of 
equal access to high quality public goods. Initial education and lifelong learning play a critical role in 
equipping individuals with the right s kills, so they can seize the opportunities of a knowledge -based 
economy.95 Comprehensive regional development strategies tailored to the regional needs can 
deliver upward convergence in economic and social outcomes among regions, within and between 
EU Membe r States.96  
 
 
89 https://ec.europa.eu/commission/priorities/deeper -and-fairer -economic -and-monetary -
union/european -pillar-social -rights_en . 
90 https://ec.europa.eu/social/main.jsp?catId=1223 . 
91 https://ec.europa.eu/info/strategy/priorities -2019-2024/european -green -deal_en . 
92 About 50 legislative and non -legislative initiatives with a delivery date before the end of 2021 . 
93 https://ec.europa.eu/commission/presscorner/detail/en/ip_20_17 . 
94 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:52019DC0650&from=EN . 
95 https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52016DC0381; https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52019XG0605(01) . 
96 
https://ec.europa.eu/r egional_policy/sources/docgener/factsheet/new_cp/simplification_handbook_en.pdf . WT/TPR/M/395/Add.1  
 
- 416 - 
 
  On 5 February 2020, the Commission published a review of the application and the effectiveness of 
the EU economic governance framework97, including the EU fiscal rules. The review revealed 
strengths as well as possible areas for improvement. It  paid special attention to the current economic 
context. Some EU Member States, in particular in the euro area, have not reduced their high public 
debt. Many are challenged by weak potential growth, associated with persistently low inflation and 
interest r ates. Economic growth may remain subdued for a longer period in the absence of policy 
action to boost potential growth. Also, the transition towards a climate -neutral and digital European 
economy will require significant private and public investments. How ever, the review does not make 
concrete reform proposals. Instead, the Commission invited stakeholders to provide their views on 
how strengthen the implementation of the EU economic governance. For instance, it will be important 
to consider whether and how  Member States ' fiscal and structural policies could contribute to the 
policy mix in the euro area and to raising potential growth without losing sight of fiscal sustainability. 
The Commission will consider all those views and on that basis complete its in ternal reflections on 
the scope for any possible future steps by the end of 2020.  
 
2. TRADE AND INVESTMENT REGIMES  
 
Para 2.53 (Page 46)  
In October 2018, the Commission published a report reflecting the main results of a comprehensive 
mid-term evaluation o f the GSP. The report indicated that the share of imports under the GSP in 
total EU imports is relatively modest, and declined from 5.8% in 2011 to 4.1% in 2016. It offered 
the following observations, based on an evaluation of the GSP in light of the three  general objectives 
of the 2012 reform. Firstly, in relation to the objective of contributing to poverty reduction by 
expanding exports from countries most in need, the effectiveness of the GSP was enhanced by 
focusing better on countries most in need. Sec ondly, the GSP had an overall positive impact on social 
development and human rights in the beneficiary countries. Thirdly, the reform improved provisions 
to protect the EU's financial and economic interests, in that products that are too competitive are 
regularly removed from the Scheme. Overall, the report concluded that there was no need to amend 
the GSP Regulation before its expiry on 31 December 2023 but that measures should be taken to 
improve transparency and inclusiveness in GSP+ monitoring, both in  the EU and in the beneficiary 
countries, and to promote greater awareness of GSP in beneficiary countries.  
 
Question/s:  
5. In view of the Commission's report, the Philippines would appreciate if the EU could 
clarify whether the identified beneficiaries in Para 2.49 (Page 45) under the Unilateral 
Preferences will continue to benefit from EU's GSP scheme until its expiration on 
31 December 2023.  
 
EU reply:  
Countries currently benefitting from the EU 's Special Incentive Arrangement for Susta inable 
Development and Good Governance (GSP+) will continue to benefit until the expiry of Regulation 
(EU) 978/2012 on 31 December 2023, as long as they continue to fulfil the criteria laid out under 
Article 4 and Article 9 of the Regulation, including mai ntaining ratification without reservations and 
effective implementation of 27 conventions on human rights, labour rights, environment and good 
governance.  
 
3. TRADE POLICIES AND PRACTICES BY MEASURE  
 
Para 3.14 (Page 56)  
Binding rulings for tariffs (BTI) a nd binding origin information (BOI) continue to be part of the EU's 
customs regime. As noted in the previous Review, there were some changes to the validity period 
and to their application on the trader, i.e. making them binding, as a result of the UCC's e ntry into 
force. Since that time, there were no further legal amendments. In 2018, as part of DG  TAXUD's 
efforts to provide certain legal clarifications, Administrative Guidance for BTI was developed and 
published; similar guidance for BOI was also made av ailable in 2017. The use of BTI gradually 
increased each year, and over 244,000 valid BTIs were in force as at mid -2019. The use of BOI 
remained relatively stable and, at the end of 2018, there were 4,775 valid BOIs. From October 2019, 
 
97 European Commission, Economic governance review. Viewed at: https://ec.europa.eu/info/business -
economy -euro/economic -and-fiscal-policy -coordination/eu -economic -governance -monitoring -prevention -
correction/stability -and-growth -pact/economic -governance -review_en . WT/TPR/M/395/Add.1  
 
- 417 - 
 
  all BTI  applications  will be done electronically; currently, most of them are submitted in paper form 
only. For BOI, there is no electronic system and these are treated in paper form.  
 
Question/s:  
6. What is the difference between binding origin information and self -certification?  
 
EU reply:  
These are entirely different concepts.  
A binding origin information decision ( "BOI"; in the international context known as 'advance ruling 
on origin ') is issued by a competent customs authority of an EU Member State, upon application by 
an importer or exporter.  
The origin assessment laid down in the BOI is binding on the holder of the d ecision and on the 
customs authorities of EU Member States. It is normally valid for 3 years and gives the economic 
operator legal certainty as to the origin assessment, provided the goods that are imported are the 
same type of goods and were produced unde r the same circumstances determining the acquisition 
of origin;  
It is not mandatory to have a BOI to be able to do import or export operations. In addition, a BOI 
decision is not a proof of origin and in itself does not give right to a preferential tariff treatment, 
because the conditions laid down in the preferential arrangement on when the preference can be 
granted still have to be met (e.g. provision of "proof of preferential origin ",…). 
A condition to be granted preferential tariff treatment laid down i n the preferential arrangement can 
be some type of 'certification of the origin', done by means of for example "self-certification ". 
Self-certification is a declaration by the exporter on a commercial document. These self -certifications 
can be statements o n origin, origin declarations or invoice declarations. Depending on the relevant 
preferential arrangement and the value of the originating products in the consignment, the EU 
exporter will usually be required to be authorised or registered (Approved Export er number or 
Registered Exporter (REX) number).  
 
Para 3.15 (Page 56)  
One new development was the EU's initiative to expand advance rulings to customs valuation, in 
addition to tariffs and origin. In March 2018, the Commission launched exploratory consultat ions to 
gauge the need or desire for a legal basis for decisions on Binding Value Information (BVI), pursuant 
to the UCC. About 200 responses were received during the public comment period, and 86.5% of 
the respondents were in favour of establishing BVI de cisions. Based on the results of the public 
consultation, a Customs 2020 Project Group involving ten member States was set up, with the aim 
of drafting a feasibility study addressing the possible implementation of an EU BVI system. It is 
planned to complet e the feasibility study by early 2020.  
 
Question/s:  
7. Prior to the implementation of the Binding Valuation Information, how does EU deal 
with valuation?  
 
EU reply:  
In accordance with the provisions of Article 14 (1) " Provision of information by the customs 
authorities"  of the Union Customs Code, "…any  person may request information concerning the 
application of the customs legislation from the customs authorities. Such a request may be refused 
where it does not relate to an activity pertaining to int ernational trade in goods that is actually 
envisaged."   
The difference between the current information on valuation under the Article 14 (1) UCC and the 
Binding Valuation Information is the binding character for the latter.  
 
Para 3.31 (Page 58)  
Other new FTAs entering into force in last few years, i.e. Japan, Côte d'Ivoire, Ghana, and the SADC, 
have rules of origin included in the respective EPAs or in the Market Access Regulation. An important 
feature of EU rules of origin is cumulation (Table 3.2).  
 
Ques tion/s:  
8. Please provide concrete examples/scenario on how "cumulation" is being 
implemented in EU Rules of Origin.  
 WT/TPR/M/395/Add.1  
 
- 418 - 
 
  EU reply:  
Bilateral cumulation is allowed in every EU FTA to encourage economic integration of the FTA 
partners. It is applied on originatin g materials between the EU and a Free Trade Agreement partner: 
materials from one Party may be used as materials originating in the other Party if they are used in 
the production of another product. Administrative cooperation arrangement between the partie s 
involved in cumulation is a necessary prerequisite.  
 
The example of the Regional Convention on pan -Euro-Mediterranean preferential rules of origin (PEM 
Convention) gives a good overview on how cumulation is implemented. Please consult the User 's 
Handbook dedicated to the details of this agreement under the following link:  
https://ec.europa.eu/taxation_customs/sites/taxation/files/resources/documents/customs/customs
_duties/rules_origin/preferential/handbook_en.pdf . 
 
Para 3.35 (Page 61)  
During the review period, the EU continually updated the tariff nomenclature of the CN, for statistical 
reasons and to implement the WCO's HS 2017 changes. As a result, the number of tariff lines 
gradually increased over the period. In 2017, there were over 1,260  nomenclature changes, mainly 
on meat, chemicals, fish, and machinery, reflecting the WCO HS changes, compared with about 27 
in 2018, mainly on agriculture, chemicals, and transport products, and 14 in 2019, mainly on fish, 
and chemicals.  
 
Question/s:  
9. What  is/are the basis or reason for the amendments of about 27 tariff lines in 2018 
and 14 tariff lines in 2019 considering WCO HS nomenclature was amended in 2017 only?  
 
EU reply:  
The 1,260  nomenclature changes having occurred in 2017 are mainly due to the f ull implementation 
of HS changes as of 01/01/2017. In 2018 and 2019, only minor nomenclature changes were 
introduced in the Combined Nomenclature.  
 
10. Please include a discussion on EU's additional notes in the CN.  
 
EU reply:  
EU's CN additional notes complem ent the existing HS Heading or Subheading Notes whenever it is 
felt necessary to better define, at EU level, the scope of, for example, one or several CN eight 8 digit 
code(s).  
 
Para 3.36 (Page 61)  
"There have not been many developments with the EU's boun d commitments in its WTO tariff 
schedule since the last Review. The last certified schedule, Schedule CLXXIII, was approved in 2016, 
updating the tariff nomenclature to HS2002; thus, the three subsequent HS changes from 2007, 
2012, and 2017 remain pending certification. The EU is covered by the respective WTO HS waivers 
for the introduction of these changes. A few other issues to the schedule remain pending."  
 
Question/s:  
11. Please elaborate more on the issues encountered and how the EU is addressing 
these iss ues.  
 
EU reply:  
The EU submitted a full new EU -28 Schedule CLXXV for certification in October 2017 (WTO document 
G/MA/TAR/RS/506 plus addenda). The EU received some technical questions and requests for 
clarification by a few WTO Members within the three m onths foreseen for raising objections. At the 
time of answering this question, only one Member maintains its objection.  
As explained in the cover note of the EU submission, this EU -28 Schedule CLXXV will replace the EU -
25 Schedule CLXXIII once it is certif ied. The relevant HS changes from HS -2007 into HS -2012 and 
HS-2017 are documented in detail in G/MA/TAR/RS/506/Add.1.  
 
Para 3.78 (Page 79)  
"The first set of changes were introduced in 2017 and added language with respect to "normal 
value". In essence, this allows for the normal value to be determined by another method where 
there are state -induced distortions in the exporting country. In such  circumstances, normal value is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of WT/TPR/M/395/Add.1  
 
- 419 - 
 
  benchmarks such as international prices or costs in another representative country. A different 
methodology for determining the nor mal value is set out for non -WTO Members."  
 
Question/s:  
12. How do you establish the existence of state -induced distortions in the exporting 
country? Please elaborate and cite examples.  
 
EU reply:  
Sub-paragraph (b) of the Article 2(6)(a) of the EU 's Basic Anti -dumping Regulation lists in a 
non-exhaustive manner circumstances which may result in significant distortions, as follows:  
 
— the market in question being served to a significant extent by enterprises which operate under 
the ownership, control o r policy supervision or guidance of the authorities of the exporting country;  
— state presence in firms allowing the state to interfere with respect to prices or costs;  
— public policies or measures discriminating in favour of domestic suppliers or other wise influencing 
free market forces;  
—the lack, discriminatory application or inadequate enforcement of bankruptcy, corporate or 
property laws;  
— wage costs being distorted;  
— access to finance granted by institutions which implement public policy objec tives or otherwise 
not acting independently of the state.  
 
The presence of significant distortions is examined on a case -by-case basis taking into account cross -
cutting distortions, distortions in the factors of production as well as distortions in the re levant 
sector.  
 
13. As basis for normal value, how do you establish the benchmarks? Please elaborate 
and cite examples.  
 
EU reply:  
The benchmarks include:  
 
o readily available data in an appropriate representative country at a similar level of economic 
development, or if more than one country qualifies, preference will be given to the one with 
adequate level social and environmental protection  
o undistorted inte rnational prices, costs and benchmarks  
o domestic costs if positively established  that they are not distorted  
 
Para 3.79 (Page 79)  
"The changes set out in the second amendment in 2018 are more numerous and diverse; x x x, the 
changes involve procedural aspects, such as shortening the time -period for provisional measures, 
and more substantial aspects, such as how the injury margins are calculated. For example, in 
calculating the non -injurious price, a minimum profit of 6% is included. Another n ew development 
is the ability to take into account the presumably higher costs of EU industry compliance with social 
and environmental standards."  
 
Question/s:  
14. Please elaborate further on the calculation of injury margins and how is this 
different from th e calculation of dumping margin?  
 
EU reply:  
The dumping margin is calculated by finding the difference between the normal value and the export 
price. The injury margin is calculated by finding the difference between the import price and the EU 
target or n on-injurious price. Both are expressed as a percentage of the CIF value of the product 
concerned.  
 
15. What is the basis of setting a minimum profit of 6% in calculating the non -injurious 
price?  
 
EU reply:  
The minimum target profit of 6% was selected on the b asis of historical information on profitability 
for the industrial sector from financial databases, such as Bloomberg and BACH.  WT/TPR/M/395/Add.1  
 
- 420 - 
 
  Para 3.85 (Page 81)  
"During the review period there was a general decline in anti -dumping and anti -subsidy activity in 
the EU, a s measured by initiations. The number of new investigations declined from 15 in 2016 to 
10 in 2018 and, over the same period, judicial cases declined more markedly from 34 to 15 cases. 
x x x."  
 
Question/s:  
16. What are the factors that might have led to the decline in the number of trade 
remedy cases initiated from 2016 -18? 
 
EU reply:  
Trade defence activity is normally driven by requests for action from EU industry meeting the 
standards for initiation.  
  
Para 3.88 (Page 82)  
"Pursuant to EU trade remedy rules, anti -dumping and anti -subsidy measures generally expire after 
five years unless an expiry review demonstrates the need for the continuation of the measure. x x 
x."  
 
Question/s:  
17. In the conduct of an expiry review, what p arameters did EU consider in determining 
continuation or recurrence of dumping and injury? Does the review include recalculation 
of dumping margin and modification of existing applied anti -dumping duty?  
 
EU reply:  
In determining the likelihood of continuat ion or recurrence of dumping in expiry reviews, the 
Commission examines first whether or not dumping is continuing using the relevant dumping 
calculation methods. The Commission then typically examines issues including production and 
capacity in the export ing country, the price behaviour of the exporters both in the EU and in third 
country markets and also the attractiveness of the EU market for the exporters to determine whether 
dumping is likely to continue or recur should measures be removed.  
When examining injury, the Commission will examine the usual injury indicators, while evaluating 
the situation of the EU industry, and whether or not injury is likely to continue or recur if measures 
are repealed.  
An expiry review can result only in the repeal or continuation of the duties in force. If measures are 
maintained, they will normally remain in force for another five years. An expiry review cannot lead 
to a change in the level or form of the duties; that can only be changed by an interim review.  
 
Para. 3.193 (Page 113)  
The standardization needs in support of EU policies are outlined in the annually -updated Rolling Plan 
for ICT Standardization, published by the Commission. The 2019 version identifies 170 actions 
organized around four thematic areas: ke y enablers, societal challenges, innovation for the single 
market, and sustainable growth.  
 
Question/s:  
18. What role does the European Central Bank play in view of facilitating interoperability 
of card and mobile payments in the EU region? What measures have been done so far 
to promote the use of online and mobile payments and make cross -border payments 
safer?  
 
EU reply:  
The European Central Bank (ECB) is responsible for conducting monetary policy for the euro area. 
The ECB operates at the core of the Eurosy stem, which comprises of the ECB and the national central 
banks (NCBs) of those countries that have adopted the euro. Tasked under its statutes with the 
responsibility of ensuring the smooth functioning of payment systems, the Eurosystem has unique 
respons ibilities with regard to the financial market infrastructures handling transactions in euro. The 
Eurosystem acts as an operator, and it currently operates the real -time gross settlement (RTGS) 
system called TARGET2, and the European platform for securities  settlement in central bank money 
called TARGET2 -Securities (T2S). More recently, the Eurosystem has also launched the Target 
Instant Payment System (TIPS) which plays a role with regard to the adoption of pan -European 
payment solutions. Instant payments a re also meant to be accessible on mobile devices and in online WT/TPR/M/395/Add.1  
 
- 421 - 
 
  environments. The ECB has developed the Eurosystem oversight framework for payment systems 
and oversight frameworks for retail payments, payment instruments and payment schemes.  
 
Alongside the ECB, the European Commission plays an active role in the payments sector by 
proposing legislation and ensuring that it is adequately implemented. The EU regulatory framework 
in the payments sphere includes the "cross-border payments regulatio n" (Regulation 924/2009), the 
"Single Euro Payments Area Regulation " (Regulation (EU) No 260/2012), the first and second 
Electronic Money Directive (Directive 2009/110/EC) and the Payment Services Directives (Directive 
(EU) 2015/2366) have allowed for subs tantial process in promoting a fair, transparent, innovative 
and competitive payments market in Europe and a Single Euro Payments Area (SEPA). The Electronic 
Money Directives (EMD1 and EMD2) and the first Payment Services Directive (PSD1) allowed for the 
issuance of E -Money and the provision of payment services by non -bank financial institutions. The 
second Payment Services Directive (PSD2) removed obstacles for the safe and efficient development 
of new business models such as payment initiators and account  information service providers (so 
called "open banking") and, at the same time, elevated the level of security of payment transactions 
by implementing strong customer authentication (SCA). PSD2 has become a worldwide reference in 
terms of open banking and  secure transactions. The EU regulatory framework supports the Single 
Euro Payments Area, which objective is to make cross -border payments in euro as cost -efficient and 
safe as domestically.  
 
For more on the improvements of PSD2, please see: 
https://ec.eu ropa.eu/commission/presscorner/detail/en/IP_18_141 . 
For more on the ECB 's role in market infrastructure and payments, please see: 
https://www.ecb.europa.eu/paym/html/index.en.html . 
 
4. TRADE POLICIES BY SECTOR  
 
Para 4.58 (Page 177)  
From 2017 to 2019, the E U continued to adopt measures to address animal disease and quarantine 
pest outbreaks, and, in particular, the wave of highly pathogenic avian influenza (HPAI) and African 
swine fever in wild boar and domestic pig outbreaks confirmed on its territory over the last years 
(Section 3.3.3). This included the co -financing of specific measures and veterinary programmes to 
prevent, control, eradicate and compensate for the losses and damage caused by animal diseases 
and plant pests pursuant to available instrument s in addition to EU member States' national aid.  
 
Question/s:  
19. In view of the above, the Ph ilippines would appreciate if the EU could elaborate on 
the prevention and control measures of African Swine Fever, including the compensation 
scheme, that were emplo yed in containing the disease.  
 
EU reply:   
Since the early stages of African Swine Fever (ASF)98 at EU borders, the EU took a number of 
initiatives99 to prevent the disease from entering into the EU, and at a later stage, to contain it to 
limited areas of the EU. Specific legislation for the control of this disease has been in place100 in the 
EU for many years. All initiatives taken by the European Commi ssion on ASF (including a specific EU 
Strategic approach101 for ASF, relevant legislation and other guidance documents etc.) are developed 
and continuously updated in close cooperation and with a support of Member States, taking into 
account the latest scien tific evidence and experience gained.  
The Commission provides substantial financial support to Member States and certain non -EU 
countries for fighting ASF. EU co -funding is provided in the framework of emergency measures and 
veterinary programmes for whic h the legal framework is defined in Regulation (EU) No . 652/2014 
of the European Parliament and of the Council of 15 May 2014 (Article 6, 8, 9 and 11).  The eligible 
 
98 Viewed at: https://ec.europa.eu/food/animals/animal -diseases/control -measures/asf_en . 
99 Viewed at: https://ec.europa.eu/food/sites/food/files/animals/docs/ad_control -
measures_asf_chronology_en.pdf . 
100 Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African 
swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (OJ L 192, 
20.7.2002, p. 27), Commission Implementing Decision 2014/709/EU of 9 October 2014 concerning animal health 
control measures relating to African swine fever in certain Member States and repealing Implementing Decision 
2014/178/EU (OJ L 295, 11.10.2014, p. 63) and etc.  
101 Viewed at: https://ec.europa.eu/food/sites/food/files/animals/docs/ad_control -measures_asf_wrk -
doc-sante -2015-7113.pdf . WT/TPR/M/395/Add.1  
 
- 422 - 
 
  costs are further elaborated in relevant guidelines. The main measures co -funded are: sampl ing and 
testing (surveillance in domestic pigs and wild boards), compensation for the value of domestic 
animals slaughtered or culled, removal of wild boards carcasses, disinfection, awareness campaign.  
 
Para 4.80 (Page 183)  
While no export financing progr ammes for agricultural products are operated at EU level, EU  member 
States, with the exception of Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, Malta, Portugal 
and Spain, indicated the existence, at national level, of general programmes that may cov er 
agricultural products….  
 
Question/s:  
20. The Philippines would like to seek clarification on the abovementioned general 
programmes relating to export financing that may cover agricultural products, particularly 
on specific export measures that are included in the general programmes.  
 
EU reply:  
Around half of the EU 's Member States operate export financing programmes that may cover 
agricultural products. The various programmes are all duly notified to the WTO within the framework 
of the yearly Export Competition Questionnaire: see document G/AG/W/ 125/Rev.11/Add.2 for 
details of all the programmes.  
 
Para 4.218 (page 221)  
The (European) Banking Union is an essential complement to the Economic and Monetary Union 
(EMU) and the internal market, which aligns responsibility for supervision, resolution and  a single 
resolution fund at EU  level. It obliges banks across the euro area to abide by the same rules.  While  
the Single Rulebook applies to all EU countries, the Banking Union  applies to countries in the euro 
area. 
 
Question/s:  
21. What would happen if a country were to exit EU?  
 
EU reply:  
The Banking Union is open to all EU Member States. If a Member State decides to withdraw from 
the EU, the EU Treaties shall cease to apply. Accordingly, as a third country, the Banking Union will 
not apply to the state in question.  
 
Para 4.241 (Page 226)  
Political agreement was also reached, in March 2019, on amendments to the European Market 
Infrastructure Regulation (EMIR), to provide for more robust supervision of central counterparties, 
establi shed in EU and non -EU countries, offering or planning to offer services to EU  clearing members 
and their clients, as well as to EU trading venues.  
 
Question/s:  
22. What had been the challenges faced following the amendment of the EMIR in terms 
of its implement ation/adoption?  
 
EU reply:  
The European Parliament and the EU Member States endorsed the political agreement on the EMIR 
amendment to strengthen the supervision of central counterparties (CCPs) in October 2019. The 
main challenges were: (1) to ensure a mo re pan -European approach for the supervision of CCPs 
established in the EU; (2) to introduce a proportionate regime for the supervision of third -country 
CCPs operating in the EU, based on the system of equivalence, depending on their systemic 
importance fo r the financial stability of the EU; and (3) to strengthen coordination of expertise in 
CCP supervision at the EU level, by establishing a new CCP supervisory committee within the 
European Securities and Markets Authority (ESMA) with independent members, n ational supervisors 
and central banks responsible for EU currencies.  
 
The new rules entered into force on 1 January 2020. Several steps are required to implement them. 
First, the European Commission is to adopt legal acts to specify how the new rules will apply to 
third-country CCPs. Second, the CCP supervisory committee has to be set up by ESMA, with the 
assistance of the European Commission, and its chair and independent members have to be WT/TPR/M/395/Add.1  
 
- 423 - 
 
  approved by the European Parliament. The European Commission will prepare a report assessing 
the effectiveness of various aspects of the implementation by January 2023.  
 
Para 4.244 (page 227)  
In March 2019, political agreement was reached between the European Parliament and EU  member 
States on the Commission's propo sal for a regulation on disclosures relating to sustainable 
investment and sustainability risks. The aim of this proposal is to introduce mandatory disclosure, 
in order to allow investors to benefit from lower search costs in finding financial products and  services 
corresponding to their sustainability preferences.  
 
Question/s:  
23. Is there a timeline for the introduction of mandatory disclosure?  
 
EU reply:  
Regulation 2019/2088 envisages three separate areas of sustainability -related disclosures, namely:  
 
1. Sustainability risks . Financial market participants and financial advisers, for all financial products 
in the scope of the Regulation, will be required to disclose on their websites and in 
pre-contractual information how they integrate the negativ e impacts of sustainability risks on 
financial returns in their risk policies, as well as the negative financial impact of these risks on 
the returns of the financial product. The obligation applies from 10 March 2021.  
 
2. Adverse sustainability impacts . The disclosure requirements will apply in the following manner:  
a. Financial market participants that employ at solo and group basis more than 500 employees 
must publish and maintain on their websites a statement on their due diligence policies with 
respect to t he principal adverse impacts of investment decisions on sustainability factors 
(see Article 4(3) and (4)). The obligations apply from 30 June 2021.  
b. Other financial market participants must publish and maintain on their websites either a 
statement on due di ligence policies with respect to principal adverse impacts of investment 
decisions on sustainability factors (see Article 4(1)(a)) or clear reasons why they do not 
consider adverse impacts of investment decisions on sustainability factors (see Article 
4(1)(b)). The obligations apply from 10 March 2021.  
c. Article 4(5) foresees disclosure requirements in respect of adverse sustainability impacts by 
financial advisers. The obligations apply from 10 March 2021.  
d. Under Article 7, for each financial product where a financial market participant applies Article 
4(1)(a) or Article 4(3) or (4), pre -contractual disclosures must include, a clear and reasoned 
explanation of whether, and, if so, how a financial product considers principal adverse 
impacts on sustainability fa ctors. The obligation applies from 30 December 2022.  
 
3. Financial products that pursue the objective of sustainable investment or have environmental or 
social characteristics . Under Articles 8 and 9 financial market participants offering financial 
products t hat pursue the objective of sustainable investment or have environmental or social 
characteristics are required to disclose in pre -contractual information on their websites and in 
their periodical reports, how these characteristics or objectives are met. T he obligations apply 
from 10 March 2021.  
 
24. What measures are in place that help promote sustainable investments in the EU 
region?  
 
EU reply:  
The European Commission adopted the 'action plan on financing sustainable growth" in March 2018, 
with ten actions in order to (1) mobilise private capital to finance climate -related and environmental 
investments; (2) make climate and sustainability risks more transparent in financial markets and 
(3) foster longer -term, more responsible decision -making in financial institutions and companies.  
 
Major actions are currently being implemented, including legislative proposals on transparent 
disclosure requirements for the financial sector on sustai nability matters and new EU climate 
benchmarks to help steer private capital to low -carbon investments. In December 2019, a political 
agreement was reached to establish an EU -wide classification system for environmentally 
sustainable economic activities ( "EU taxonomy "). 
 WT/TPR/M/395/Add.1  
 
- 424 - 
 
  As part of the EU Green Deal, the European Commission presented on 14 January 2020 the European 
Green Deal Investment Plan, which will mobilise at least EUR 1 trillion of sustainable investments 
over the next decade. The latest measures of the European Commission are outlined in the link: 
https://ec.europa.eu/info/business -economy -euro/banking -and-finance/green -
finance_en#committments . 
 
PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
1. TRADE AND THE ECONOMIC ENVIR ONMENT  
 
Para 2.1 (Page 3 -4) 
Looking forward, based on the 2019 summer forecast, the European Commission expects growth of 
the European economy to continue despite global challenges. Growth is expected to moderate to 
1.4% in 2019 and to increase to 1.6% in 2020. GDP in all EU Member States is expected to grow 
supported by domestic demand.  
 
Para 2.5 (Page 4)  
Downside risks to the outlook remain prominent. Externally, these include the risk of a further 
escalation of trade tensions as well as a more persistent  than forecast slowdown in global growth 
and foreign trade. Domestically, these include a possible negative spillover from the manufacturing 
recession to other sectors such as services and the uncertainty surrounding the United Kingdom's 
withdrawal from th e EU, inter alia . 
 
Question/s:  
25. Given the downside risks to the growth outlook, what are the measures to help 
support achievement of the growth outlook in 2020?  
 
EU reply:  
Please see answer to question 2.  
 
2. DEVELOPMENTS IN THE INTERNAL MARKET  
 
Para 3.6 (Page 6)  
Since the last review in 2017, the EU adopted the Regulation on the Mutual Recognition of Goods , 
which will be applied as of 19 April 2020. The aim is to achieve a fairer and deeper single market for 
goods through more and better mutual recogn ition. Companies will be able to use a voluntary 
declaration to demonstrate that their products meet all the relevant requirements in their country. 
This will make it easier for the national authorities in the Member States to assess whether the 
mutual rec ognition principle should be applied. Furthermore, the envisaged problem resolution 
mechanism will allow for a faster resolution of disputes between companies and national authorities.  
 
Question/s:  
26. With regard to the envisaged problem resolution mechanism,  what alternative/s or 
next steps have been put in place to resolve disputes between companies and national 
authorities in case of disagreement on the initial decision/verdict by the said mechanism?  
 
EU reply:  
Regulation EU 2019/515 introduces a problem -solving procedure to provide effective remedy and 
re-establish trust in mutual recognition. The SOLVIT mechanism provides a means of reaching 
amicable, practical solutions.  
 
SOLVIT is an informal problem -solving mechanism that provides an alternative to cou rt proceedings. 
It provides practical solutions for individuals and businesses experiencing difficulties in cross -border 
situations associated with the single market and caused by a public authority. SOLVIT is free of 
charge and is provided by the national  administration in each EU country, as well as in Iceland, 
Liechtenstein and Norway.  
 
Article 8 of Regulation 2019/515 sets out a specific SOLVIT problem -solving procedure that applies 
only in cases where the authorities have issued an administrative deci sion in accordance with 
Article  5 of the Regulation on the mutual recognition of goods. If the decision is found to be 
incompatible with Regulation 2019/515, the authority responsible should take corrective action.  
 WT/TPR/M/395/Add.1  
 
- 425 - 
 
  To make economic operators aware of the availability of the specific SO LVIT problem -solving 
procedure defined in Regulation 2019/515, all administrative decisions issued by national authorities 
under Regulation 2019/515 must include a reference to the possibility for economic operators to use 
SOLVIT in the list of available m eans of redress and information about SOLVIT and its problem -
solving procedure.  
 
Where SOLVIT 's informal approach fails and doubts remain regarding the compatibility of the 
administrative decision with the principle of mutual recognition, any of the SOLVI T centres involved 
may ask the Commission to issue an opinion. The purpose of the Commission 's opinion is to allow it 
to assess whether the national administrative decision is compatible with the principle of mutual 
recognition and with the requirements of  Regulation 2019/515. The Commission 's assessment must 
take account of the documents and information provided as part of the SOLVIT procedure. It can 
request additional information or documents through the relevant SOLVIT centre.  
 
Para 3.18 (Page 8)  
The EU 's Digital Single Market strategy adopted in 2015 and almost completed, represents a major 
step forward in improving the functioning of the EU's Single Market to the benefit of enterprises and 
consumers from both EU Member States and third countries. The m easures create a level playing 
field and ensure equal treatment for all companies, and improve doing business through harmonising 
28, previously different, laws in EU Member States into coherent EU wide legal acts, leading to both 
cost and timeline savings . 
 
Para 3.19 (Pages 8 -10) 
Important legislative developments during the period under review include:  
 
a. Regulation on the Free Flow of Non -Personal Data  harmonizing the rules on non -personal 
data in all EU Member States. The  regulation  makes it easier for professional users of data 
storage or other processing services to switch service providers and to port data, while not 
creating an excessive burden on service providers or distorting the market.  
b. Regulation on promoting fairness and transparency for business users of online 
intermediation services ("P2B Regulation") creating a fairer and more predictable 
environment for business users in the EU to grow th eir business on online platforms and to 
reach consumers. It will attract more business users towards using online platforms, which 
is of particular benefit to many EU SMEs;  
c. Directive establishing the European Electronic Communications Code updating the com mon 
EU rules on electronic communications networks and services, regulatory authorities and 
universal service;  
d. Regulation establishing the Body of European Regulators for Electronic Communications 
(BEREC) and the BEREC Office entities ensuring the consiste nt implementation of the 
regulatory framework for electronic communications;  
e. Directive on open data and the re -use of public sector information making real-time public 
sector data as well as data from research performing organisations and public undertaki ngs 
more easily available and usable by machines and humans alike, helping in turn to fuel the 
development of data -intensive technologies such as artificial intelligence;  
f. Directive on copyright and related rights in the Digital Single Market increasing the  
availability of creative works for people across Europe, ensuring a better -functioning 
copyright marketplace for creators and modernising EU rules applicable to key exceptions 
and limitations in the areas of teaching, research and the preservation of cult ural heritage, 
with a focus on digital and cross -border uses;  
g. Directive on the exercise of copyright and related rights applicable to certain online 
transmissions of broadcasting organisations and retransmissions of television and radio 
programmes simplify ing cross -border distribution and retransmission of television and radio 
programmes across the EU;  
h. Regulation on the cross -border portability of online content services in the internal market  
establishing rules for providers of online content services (fil ms, sports broadcasts, music, 
e-books and games) with the aim of broadening access to online content services for 
travellers in the EU;  
i. Audiovisual Media Services Directive consisting of among others, a strengthened Country of 
Origin with more clarity on w hich EU Member State's rules apply, certain audio -visual rules 
to extend to video sharing platforms (such as YouTube), better protection of minors against 
harmful content in the online world, and increased obligations to promote European works 
for on -deman d services;  WT/TPR/M/395/Add.1  
 
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  j. Geo-blocking Regulation addressing unjustified geo -blocking and other forms of 
discrimination based on customers' nationality, place of residence or place of establishment 
within the internal market;  
k. Regulation establishing a single digital ga teway . The purpose of the gateway is to provide 
access to information on rules and rights that apply to citizens and businesses who want to 
get active in another EU Member State as well as to procedures and to assistance and 
problem -solving services ; 
l. New C onsumer Protection Cooperation Regulation,  equipping national authorities with the 
necessary tools to address online infringements, such as the power to remove or block online 
shopping scams, to conduct test purchases and mystery shopping. The European 
Commission will be able to coordinate enforcement investigations in the event of Union -wide 
infringements of EU consumer protection legislation, e.g. in the field of e -commerce, such 
as geo -blocking or the portability of online content;  
m. Two directives on dig ital contract rules  harmonising key consumer contract law rules across 
the EU. The harmonised rules apply to contracts for the supply of digital content and digital 
services and to contracts for the sale of goods and "smart goods". They will reduce the cos ts 
for traders selling in multiple EU countries and ensure transparency, certainty, and a high 
level of protection for consumers when they buy goods and digital content or digital services 
across the EU. The new rules will begin to apply throughout the EU in January 2022;  
n. Further to Directive on Security of Network and Information Systems the Cybersecurity Act 
was adopted, strengthening the role of the European Cybersecurity Agency (ENISA) and 
establishing a common European Cybersecurity certification framework for IT  Services, 
systems and equipment.  
 
Question/s:  
27. What have been the major challenges that the strategy has enco untered given that 
the level of technological development and markets may vary, as well as readiness of the 
28 EU member/jurisdictions? How does EU aim to address such challenges and encourage 
all its members to work on achieving each of the initiatives?  
 
EU reply:  
The most important challenge with regard to the Digital Single Market strategy was to make sure 
that digital legislation is up to date and fit for purpose, given the rapid changes and developments 
in digital technologies. Furthermore, there are d ifferences in the way digital policies are implemented 
in EU Member States. Most EU digital legislation therefore includes a provision setting the date of 
the first and subsequent reviews to assess if changes to the legislation are needed. Furthermore, all  
EU legislation on a regularly basis (normally on an annual basis) undergoes a "REFIT assessment" 
to check if there is a need for revisions and simplification potential.  
 
28. Is there a timetable to implement the above initiatives under the Digital Single 
Market Strategy such as establishing a European Electronic Communication Code, 
regulations on free -flow of non -personal data, etc.?  
 
EU reply:  
The EU 's Digital Single Market (DSM) strategy aimed at implementing all measures by the end of 
the mandate of the last European Commission (i.e. November 2019). For all 30 measures of the 
DSM strategy, the European Commission has - following extensive stakeholder consultations - 
submitt ed proposals. 28 of these 30 measures have already been formally adopted by the European 
Union 's co-legislators, the Council (representing EU Member States) and the elected European 
Parliament, while two measures are still with the co -legislators. All EU l egislation - including on 
digital matters - specifies a date of entry into force, and one or several deadlines for directly applying 
its legal provisions in the case of EU Regulations, or for adopting National Implementing Measures 
in the case of EU Direct ives.  
 
2. TRADE AND INVESTMENT POLICY DEVELOPMENTS  
 
Para 4.20 (Page 19)  
The Court of Justice confirmed in its opinion 2/15 on the EU -Singapore Free Trade Agreement that 
the majority of areas covered by this FTA (ranging from trade in goods, to services, t o public 
procurement or sustainable development) fall under the exclusive competence of the EU. Only as 
regards portfolio investment and the settlement of disputes between foreign investors and states, 
the EU shares competence with Member States. In view o f this, the EU has introduced a new WT/TPR/M/395/Add.1  
 
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  approach to its trade and investment agreements: free trade agreements cover areas where the EU 
has exclusive competence, while investment protection agreements cover areas of both EU exclusive 
and shared competence. Jap an, Singapore and Viet  Nam were the first trade and investment 
partners with whom the EU followed this new approach. In addition, the EU is pursuing negotiations 
for standalone investment agreements, including with China.  
 
Question/s:  
29. Can the EU further ex pound its new approach to its trade and investment 
agreements; i.e. free trade agreements cover areas where the EU has exclusive 
competence, while investment protection agreements cover areas of both EU exclusive 
and shared competence?  
 
EU reply:  
Followi ng the advisory opinion of the CJEU of 16 May 2017 (opinion 2/15), the EU takes the decision 
on whether to conclude two separate agreement on trade and investment on a case -by-case basis. 
In some cases (e.g. EU -Singapore, EU -Viet Nam), two separate agreeme nts were concluded: one 
FTA including investment liberalisation (which is of exclusive EU competence) and a separate 
investment protection agreement (covering inter alia  non-direct investment and investor -to-state 
dispute settlement which are matters of sh ared competence). In other instances, the EU can and 
has concluded free trade agreements covering both investment liberalisation and investment 
protection (e.g. CETA, Mexico).  
 
30. Will this new approach be implemented mandatorily to future FTAs with its tradi ng 
partners?  
 
EU reply:   
The EU takes the decision on the appropriate architecture of its agreements on a case -by-case basis 
and in view of the entire scope of the agreement.  
 
PHILIPPINES  – ADDITIONAL QUESTIONS  
PART I: QUESTIONS REGARDING THE SECRETARIAT REPORT  
1. ECONOMIC ENVIRONMENT  
 
Para 1.24 (Page 22)  
The EU's economic outlook is mainly subject to domestic policy uncertainty and rising protectionism 
in trade and investment. According to the Organization for Economic Cooperation and Developm ent 
(OECD), the United Kingdom's withdrawal from the EU is not a major threat to the EU 's overall 
economic performance. However, countries with the closest trade links to the UK could be severely 
impacted if the UK left the EU without withdrawal agreement.  While the detrimental effect of a "hard" 
Brexit on the UK's economy would reduce its GDP by some 3.3% by 2020, it would reduce the 
EU-27 GDP by around 1%.  
 
Question/s:  
1. What policy measures are available for the EU to boost growth as well as mitigate 
the impact of Brexit among the EU countries?  
 
EU reply:  
Compared to the period under review, there is now more clarity about Brexit. Following the UK 's 
withdrawal from the EU on 31 January 2020 and the entry into force of the Withdrawal Agreement, 
the UK e ntered a transition period lasting until 31 December 2020, during which EU law, with a few 
exceptions, continues to apply to and in the UK. At the same time, the question of future trading 
relations remains open.  
 
It is thus premature to discuss the effec t of the UK leaving the EU on the EU 's economic outlook. 
This impact will depend on the outcome of the negotiations on the future partnership between the 
EU and the UK. It can be said however that even if a free trade agreement is concluded, it will 
establish a very different relationship in terms of market access than participating in the Internal 
Market and the Customs Union. Therefore, the end of the transition period means significant changes 
in the regulatory relationship between the United Kingd om and the European Union. Since the 
autumn of 2017, the Commission has called upon stakeholders, including businesses, to prepare for 
these changes.  WT/TPR/M/395/Add.1  
 
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  Regardless of the modalities of the future agreement, the results from various published studies on 
the ec onomic impact of Brexit point to negative effects to the UK as well as the EU. However, the 
studies suggest that under any scenario the negative economic impact on the UK (as a share of 
GDP) will be significantly larger than the EU as a whole.  
 
2. TRADE AN D INVESTMENT REGIMES  
 
Para 2.13 (Page 36)  
The first objective is to seal new trade partnerships to build progressive rules for global trade. 
EU trade policy aims to create new economic opportunities through a comprehensive negotiating 
agenda at various (bi lateral and multilateral) levels. The EU is committed to strengthening its 
economic ties with future engines of growth in Asia and Latin America. This first objective also 
involves the use of trade policy to promote the universal values the EU adheres to, regarding 
environmental, consumer, social and labour protection and fundamental rights, as well as the 
express preservation of the right to regulate in the public interest. Section 2.3.2 of this Report 
discusses EU trade agreements concluded and/or entered  into force, and the launch of new 
negotiations during the review period.  
 
Question/s:  
2. Does EU 's trade policy in Asia include promotion of its universal values, such as 
environmental, consumer, social and labour protection and fundamental rights? If yes , in 
what form does the EU envision promoting such values (i.e. technical assistance, bilateral 
engagements, international fora, etc.)?  
 
EU reply:  
As highlighted in the European Commission 's Trade for All communication (2015)  
(https://trade.ec.europa.eu/d oclib/docs/2015/october/tradoc_153846.pdf ), the European Union 's 
trade policy and the promotion of universal values go hand -in-hand. Since 2009, all new free trade 
agreements signed by the EU contain a Trade and Sustainable Development (TSD) chapter, which  
include provisions on labour rights and environmental protection. These provisions involve the 
ratification and effective implementation of international conventions in these areas, including the 
eight fundamental conventions of the International Labour O rganization (ILO), and key Multilateral 
Environmental Agreements (MEAs). This approach aims to ensure that both parties respect 
internationally -agreed values and commitments in these areas. In Asia, the bilateral agreements 
concluded with South Korea, Sing apore, Japan and Viet Nam all contain such a TSD chapter. Human 
rights are also included in our FTAs as an overarching principle in the agreement's preamble.  
 
At the unilateral level, the EU 's Generalised Scheme of Preferences (GSP) also supports the 
promotion of universal values. Beneficiary countries of the Special Incentive Arrangement for 
Sustainable Development and Good Governance (GSP+) must ratify and effectively implement 
27 international conventions in the fields of fundamental human rights, c ore labour standards, 
environmental protection, and good governance. Currently six Asian countries (Armenia, 
Kyrgyzstan, Mongolia, Pakistan, Sri Lanka and the Philippines) benefit from the GSP+ arrangement, 
whilst a number of others benefit from the genera l GSP arrangement and from Everything but Arms 
(EBA), which targets least -developed countries (LDCs).  
 
Finally, the EU 's Aid for Trade development cooperation programmes also play a key role in 
supporting universal values. With the EU 's revised Aid for Tra de strategy (2017)  (https://eur -
lex.europa.eu/legal -content/EN/ALL/?uri=COM%3A2017%3A667%3AFIN ), increased focus has 
been paid to supporting the trade and sustainable development agenda, especially through increased 
support to the implementation of TSD cha pters and the GSP. In 2017, the EU and its Member States 
provided a combined EUR 3.2 billion of Aid for Trade assistance to Asia.  
 
Para 2.15 (Pages 36 -37) 
The review period also saw increased interest in ways to improve the practical implementation and 
effectiveness of sustainable development provisions in EU FTAs. A debate, launched by the 
Commission in July 2017, revealed a clear consensus on the need to improve the implementation of 
such provisions. While there were suggestions for the introduction of ec onomic sanctions to enforce 
compliance with sustainable development provisions, this was opposed by most participants in the 
debate. The Commission pointed out that a cooperative approach is more appropriate and effective. 
A non -paper, issued in February 2 018 concluding this debate, set out an Action Plan of 15 concrete 
steps aimed at: (i) improving coordination between EU institutions and between the EU and relevant WT/TPR/M/395/Add.1  
 
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  international organizations; (ii) enabling civil society to play a more effective role in t he 
implementation of sustainable development provisions, including by facilitating the monitoring role 
of civil society, allowing civil society to comment and provide advice not only on provisions of 
sustainable development chapters but, more generally, on  other FTA provisions with implications for 
sustainable development, and reinforcing the implementation of provisions on corporate social 
responsibility; (iii) taking actions aimed at identifying priority implementation actions for each 
partner country, a more assertive approach to enforcement, the encouragement of the early 
ratification of core international agreements, reviewing the effectiveness of implementation on an 
ongoing basis, developing a handbook for implementation, and stepping up resources; an d 
(iv) improving transparency and communication.  
 
Para 2.18 (Page 37)  
Regarding Opinion 2/15 of the Court (Section 2.1), the Commission adopted a new approach to the 
architecture of EU trade agreements. The agreement completed in 2012 between the EU and 
Singapore was restructured to create two separate agreements: an FTA, covering matters within the 
exclusive competence of the EU and which will be concluded only by the EU; and an Investment 
Protection Agreement including both matters in which the EU has exc lusive competence and matters 
in which the EU and the member States share competences and which will be concluded by the EU 
and the member States. The trade agreement with Viet Nam was restructured in the same way. In 
both cases, the FTAs include provision s on the liberalization of FDI, whereas the Investment 
Protection Agreements contain provisions on the protection of foreign (direct and non -direct) 
investment after their establishment and procedures allowing investors to have recourse to 
international di spute settlement.  
 
Para 2.19 (Pages 37 -38) 
The Council of the EU endorsed this new approach in May 2018 when it noted that "in the future the 
Commission intends to recommend draft negotiating directives for FTAs covering exclusive 
EU competence on the one hand and separate mixed investment agreements on the other, with a 
view to strengthening the EU's position as a negotiating partner. It is for the Council to decide 
whether to open negotiations on this basis". The decoupling of investment protection provis ions from 
trade agreements is a significant change, compared with the trend noted in the previous Review, 
towards the integration of trade and investment in comprehensive economic agreements.  
 
Question/s:  
3. What would be the implication of this new appro ach for future trade and investment 
partners?  
 
EU reply:  
For future agreements, the EU will take the decision on whether to conclude two separate 
agreements or one comprehensive agreement on a case -by-case basis and in view of the entire 
scope of the agreement in question. Obviously, the EU will also discuss with its negotiating partner. 
It should be noted, however, that the architecture does not change or influence the content of the 
agreement.  
 
4. Further, how would this new approach affect ongoing n egotiations with bilateral 
and/or regional partners, such as ASEAN?  
 
EU reply:  
Decisions will be taken on a case by case basis and in view of the precise scope of the agreement in 
question. Obviously, the EU will also discuss with its negotiating partner s. It should be noted, 
however, that the architecture does not change or influence the content of the agreement.  
 
Para 2.21 (Page 38)  
The Commission carries out impact assessment analyses to support its decision -making for all 
proposals with significant di rect impact, including in the trade policy area. In terms of trade 
agreements, up to four major types of evaluation may be conducted during the life of a trade 
agreement. When the Commission recommends the opening of negotiations on a trade agreement, 
it also submits the results of an impact assessment, as required by the Commission's Better 
Regulation agenda. This assessment must verify the existence of a problem, identify its underlying 
causes, assess whether EU action is needed, and analyse the advantage s and disadvantages of 
available solutions and their impacts. The assessment includes an online public consultation of 
interested parties. At the stage of negotiations, the Commission carries out trade sustainability WT/TPR/M/395/Add.1  
 
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  impact assessments (SIAs) to analyse th e economic, environmental, human rights and social 
impacts of the proposed trade agreements for both the EU and its trading partners. SIAs are 
independent studies conducted by external consultants, involving comprehensive consultations with 
stakeholders an d taking into account their knowledge and concerns both in the EU and in the trading 
partner. SIAs are published online. Once the negotiations are concluded, and before the agreement 
is signed, an analysis of the economic impact of the proposed deal for th e EU is prepared for the 
Parliament and the Council. After sufficient time has passed (normally five years after entry into 
force), the Commission carries out an ex post evaluation of the trade agreement, to assess whether 
the expected outcome was achieved , and also to look for unintended effects. Ex post evaluations 
are also published online.  
 
Question/s:  
5. Based on the outcomes of previous SIAs, what factors have been found to generally 
(a) hinder the EU from carrying out trade agreements with developing countries such as 
ASEAN Member States, or (b) cause reservations from the EU side on continuing informal 
discussions with ASEAN regarding a potential trade and investment agreements?  
 
EU reply:  
SIAs are made to inform negotiators so as to avoid or mitigate potential negative effects and increase 
positive outcomes where possible. To this effect, SIAs produce  a set of recommendations for the 
Commission to take into account during the negotiation process. However, SIAs are not intended to 
identify potential stumbling blocks that could hamper negotiations – whether bilaterally with 
individual ASEAN Member States  or with ASEAN as a group.  
 
Para 2.22 (Page 39)  
In addition to the SIA process, the Commission engages stakeholders during international trade 
negotiations through regular Civil Society Dialogue meetings.  
 
Para 2.24 (Page 39)  
The task of the Expert Group  on EU Trade Agreements, established in September 2017, is to provide 
expert advice that can assist the Commission in the negotiation and implementation of trade 
agreements. To this end, the Group: (i) provides technical expertise and practical experience 
relevant to negotiations in bilateral, plurilateral and multilateral trade agreements; (ii) sheds light 
on the different perspectives that the stakeholders they represent may take on certain issues; 
(iii) provides input related to the overall implementatio n of trade agreements; and (iv) provides 
feedback on the perception and public debate on trade agreements across EU member States, and 
issues that may require particular attention on the basis of their contacts with their respective 
European networks. The Group is composed of between 20 and 30 members, selected from 
European -level, non -governmental organizations, which may include employers' organizations, 
trade unions, representative associations, socio -economic interest groups like consumer 
associations, and other civil society organizations. It currently has 27 members.  
 
Question/s:  
6. Does EU include engagement with civil society in its trade negotiation process? If 
yes, what are the parameters imposed by EU on such private organizations in ensuring 
that privileged communication arising from diplomatic discourse with the other state is 
respected/protected?  
 
EU reply:  
We engage with stakeholders to receive concrete substantive input to improve our trade policy and 
to make it evidence -based. We proactive ly engage before, during and after the negotiations:  
 
• Before  the launch of negotiations: by including an open public consultation with stakeholders 
 and civil society.  
• During  the negotiations: through public consultations, civil society dialogues and outre ach 
 activities, such as workshops in the partner countries that are part of our Sustainability Impact 
 Assessments (SIAs).  
• After the negotiations: by engaging with interested stakeholders in the implementation phase 
 of the trade agreements through civil  society advisory bodies that monitor and advise on the 
 implementation of the Trade and Sustainable Development Chapters of the agreements.  
 WT/TPR/M/395/Add.1  
 
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  No confidential document or information arising from diplomatic discourse with the other state is 
shared with civ il society organisations, unless there is an agreement by both parties.  
 
Para 2.36 (Page 42)  
The FTA between the EU and Viet Nam and the Investment Protection Agreement concluded between 
the EU and its member States and Viet Nam were signed on 30 June 2019  and were submitted to 
the European Parliament for its consent. Once the Parliament gives its consent, the FTA can be 
officially concluded by the Council, and will enter into force. The Investment Protection Agreement 
will firstly also have to be ratified by member States according to their respective internal 
procedures. The EU -Viet Nam FTA is similar in scope to the EU's FTA with Singapore, but also includes 
some further topics, such as a chapter on state enterprises, monopolies and enterprises with speci al 
rights. It has been described as the most ambitious FTA ever concluded by the EU with a developing 
country.  
 
Question/s:  
7. Does this paragraph outline the ratification process of an FTA entered into by EU, in 
general and for all its partners? Please outline the steps and timeline of the ratification 
process.  
 
EU reply:  
Yes, this is a good description of the EU FTA ratificati on process. Please look at 
https://trade.ec.europa.eu/doclib/docs/2012/june/tradoc_149616.pdf for further details.  
 
Para 2.47 (Page 44)  
The general arrangement (Standard GSP) grants duty suspensions (non -sensitive products) or duty 
reductions (sensitive p roducts) for about 66% of all EU tariff lines to countries of low or lower -middle 
income status, which do not benefit from other preferential trade access to the EU market. As of 
30 September 2019, there were 15 Standard GSP beneficiaries: Congo, Cook Isla nds, India, 
Indonesia, Kenya, Micronesia, Nauru, Nigeria, Niue, Samoa, Syria, Tajikistan, Tonga, Uzbekistan, 
and Viet Nam.  
 
Question/s:  
8. How did EU conduct the negotiation process for the liberalization of trade with Viet 
Nam in view of Viet Nam being am ong the standard GSP beneficiaries of the EU?  
 
EU reply:  
The GSP Regulation (978/2012) Art. 4.1 (b) specifies that an eligible country shall not benefit from 
the tariff preferences under the general arrangement if 'it benefits from a preferential market access 
arrangement which provides the same tariff preferences as the scheme or better, for substantially 
all trade. Furthermore, Art. 5.2 (b) specifies that a decision to remove a beneficiary country from 
the list of GSP beneficiary countries shall apply as from two years after the date of application of a 
preferential market access arrangement.  
 
However, there is a provision in the FTA between the EU and Viet  Nam which allows for a transition 
up to seven years:  
 
Annex 2-A 
Reduction or elimination of Customs Duties  
Section A – General provisions  
3. Without prejudice to Article 2.7 (Reduction or Elimination of Customs Duties), the 
Union  preferential customs duty under this Agreement shall under no circumstances be high er than 
the Union customs duties applied to goods originating in Viet Nam on the day before the date of 
entry into force of this Agreement. This obligation applies from that date until the seventh year after 
entry into force.  
 
9. What are EU's consideratio ns and parameters in negotiating trade agreements with 
GSP beneficiaries, noting that these potential trade partners are already enjoying liberal 
concessions under the said preferential scheme?  
 
EU reply:  
GSP preferences are provided unilaterally to supp ort the beneficiary country 's sustainable 
development. These are granted to the countries that are most in need (based on levels of income) WT/TPR/M/395/Add.1  
 
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  and cover trade in goods only. EU FTAs are reciprocal and go beyond tariff elimination: they extend 
to areas such as  competition, protecting intellectual property rights, customs cooperation, 
commitments on services and establishment and sustainable development; or concentrate on the 
tightening of economic links by bringing regulatory frameworks closer together.  
 
10. Further, is the EU considering expanding the coverage of products under the current 
GSP scheme? If so, what products are likely to be added under the same?  
 
EU reply:  
GSP Regulation 978/2012 will expire on 31 December 2023. Public consultations on a new, 
succeeding regulation will start shortly and will form the basis for considerations on various elements 
of the future EU GSP.  
 
Para 2.58 (Page 47)  
The Commission defines the objectives of EU investment policy as to: secure a level p laying field so 
that EU investors abroad are not discriminated against or mistreated; make it easier to invest by 
creating a predictable and transparent business environment; promote investment that supports 
sustainable development, respect for human right s and high labour and environmental standards; 
attract international investment into the EU, while protecting the EU's essential interests; and 
preserve the right of home and host countries to regulate their economies in the public interest.  
 
Question/s:  
11. What are the "essential interests" that the EU is specifically protective of with 
respect to potential foreign investments?  
 
EU reply:  
The essential interests and their protection are defined by the Union law and international 
commitments to which the  EU has to adhere. For foreign direct investments, the essential interests 
are "security or public order " which are protected by Regulation (EU) 2019/452 establishing a 
framework for the screening of foreign direct investments into the Union.  
 
12. What are  the specific provisions that are critical to the EU when negotiating 
investment agreements?  
 
EU reply:  
As regards investment liberalisation, the EU attaches importance to including in its agreements 
provisions such as the right to regulate, market acces s, national treatment, MFN, performance 
requirements and denial of benefits. If investment protection is included, the EU includes, inter alia , 
well defined standards of protection for investors such as national treatment, fair and equitable 
treatment, com pensation for expropriation, compensation for losses, denial of benefits, but also the 
right to regulate by governments to achieve legitimate public policy objectives and provisions on 
sustainable development.  
 
13. Does the EU's investment policy extend it s objectives to support sustainable 
development, respect for human rights and high labour and environmental standards to 
prospective trade agreements with third countries? If yes, to what extent has it been 
implemented (i.e. trade agreement text, GSP/GSP+,  technical assistance, etc.)?  
 
EU reply:  
The EU 's objectives on sustainable development with third countries are implemented either through 
Trade and Sustainable Development (TSD) chapters in trade agreements or Sustainable 
Development provisions in comp rehensive investment agreements or – if a third country is eligible 
for GSP or GSP+ treatment - under the EU 's GSP scheme.  
 
Para 2.60 (Page 48)  
The European Commission President proposed the creation of an EU framework for FDI screening in 
the 2017 State of the Union address. The proposal was motivated by growing concerns regarding 
the impact on the strategic interests of the EU or its member States of certain types of FDI, especially 
foreign acquisitions in cases involving state -owned enterprises an d strategic sectors. This legislation, 
a regulation based on the common commercial policy competence in Article 207(2) of the TFEU, was 
adopted on 19 March 2019, entered into force on 10 April 2019, and shall apply from 
11 October  2020.  WT/TPR/M/395/Add.1  
 
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  Question/s:  
14. Please provide more information on the aforementioned cooperation for the 
screening of FDI, particularly whether it will cover only grounds of security or public 
order. If yes, what are the parameters?  
 
EU reply:  
As explained in the EU government report, the Regulation on Screening of Foreign Direct Investment 
will help the European Union in some exceptional cases (foreign investment affecting critical 
technologies, infrastructure, supply of critical inputs or access to sensitive data) to safeguard  its 
security interests from foreign investment targeting the acquisition of critical European assets. The 
EU screening framework does not replace or duplicate existing national mechanisms, and hence does 
not add red tape for investors. It is not targeted against investors from any particular country: 
non-discrimination is a key principle of the new Regulation and screening mechanisms of EU Member 
States will need to respect this principle. The Regulation sets out in Article 3 the essential 
requirements app lying to national screening mechanisms. They include rules on transparency, 
confidentiality of information exchanged, possibility of recourse against screening decisions, and 
measures to identify and prevent circumvention by foreign investors.  
 
15. Is the Screening Mechanism empowered to introduce new grounds for EU to deny 
entry of FDI into the EU market?  
EU reply:  
The Regulation establishes a framework for the screening by Member States of foreign direct 
investments into the Union solely on the grounds of security or public order.  
 
Para 2.72 (Page 51)  
EU foreign investment policy includes transition arrangements regarding bilateral investment 
treaties signed by EU member States with third countries before the entry into force of the Lisbon 
Treaty or the  date of their accession to the EU. According to a notice published by the Commission 
in June 2019, more than 1,400 bilateral investment agreements were in force between EU member 
States and third states, which is more than half of the 2,353 bilateral inve stment agreements in 
force globally, according to the UNCTAD data base on international investment agreements. 
Regulation (EU) No. 1219/2012 lays down the conditions under which such treaties may be 
maintained until they are progressively replaced by inves tment agreements concluded by the EU. It 
also provides that the Commission may authorize member States to negotiate with third states to 
amend existing treaties or conclude new ones, subject to certain conditions.  
 
Question/s:  
16. Will a bilateral investme nt agreement with EU automatically terminate all bilateral 
investment agreements, in any form, entered into by the third state with any EU member 
state? If yes, please explain the process of such termination.  
 
EU reply:  
Regulation (EU) No . 1219/2012 stip ulates that bilateral investment agreements by EU Member 
States with a third country can be maintained until the Union concludes an investment agreement 
with the same third country. In addition, all EU agreements containing investment protection 
provisions  that have so far been concluded with third countries explicitly stipulate that existing EU 
Member States ' investment agreement with the country in question cease to have effect and are 
replaced and superseded by the agreement concluded by the Union.  
 
3. TRADE POLICIES AND PRACTICES BY MEASURE  
 
Para 3.30 (Page 58)  
Two recent agreements, with Canada and Japan, continue an earlier practice in a few FTAs for origin 
determination with the establishment of origin quotas. For goods that ordinarily would not quali fy 
through the product -specific rules, another alternative was given for a limited number of products 
and quantities. For example, the CETA provides for some origin quotas for high sugar containing 
products, sugar confectionary and chocolate preparations, processed foods, dog and cat food, fish 
and seafood, textiles, apparel, and vehicles, as listed by HS code and quota amount in Annex 5 -A 
to the Protocol on Rules of Origin of the CETA.  
 WT/TPR/M/395/Add.1  
 
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  Question/s:  
17. Noting that the EU has included origin quotas in its F TAs with Canada and Japan, but 
has not included a similar arrangement in its FTA with MERCOSUR, what are the EU's 
considerations or parameters in including the same in future trade agreements?  
 
EU reply:  
The EU 's starting position in FTA negotiations nev er includes origin quotas. Origin quotas are rare in 
EU FTAs and are the outcome of a negotiating process, reflecting the specificities of each individual 
FTA negotiation.  
 
Origin quotas are indeed included in the agreement with Canada. However, the agree ment with 
Japan does not include origin quotas; it contains an annex with specific provisions related to certain 
vehicles (Appendix 3 -B-1). 
 
18. Aside from the specified products above with origin quotas under the ROO Protocol 
of the CETA, are there any other products in the other FTAs with origin quotas and/or 
similar conditions?  
 
EU reply:  
Origin quotas or specific annexes allowing derogations to the generally agreed product specific rules 
under the FTA are rare in EU FTAs and are the outcome of a negotiating process, reflecting the 
specificities of each individual FTA negotiation. Other than CETA and Japan, the FTA with Singapore 
foresees origi n quotas for a limited range of processed meat and fish products; the FTA with Korea 
foresees origin quotas for certain processed fish, agricultural, tobacco and textile products.  
 
Para 3.193 (Page 113)  
The Commission recognizes the rapid evolution of tec hnology and the role of new products and 
services, such as Internet of Things (IoT) or the Cloud, in market transformation. Therefore, it seeks 
to ensure that innovative state -of-the-art global information and communications technology (ITC) 
specifications  are used as enablers for growth and development. The standardization needs in 
support of EU policies are outlined in the annually -updated Rolling Plan for ICT Standardization, 
published by the Commission. The 2019 version identifies 170 actions organized around four 
thematic areas: key enablers, societal challenges, innovation for the single market, and sustainable 
growth.  
 
Question/s:  
19. What specific standards does the European Union (EU) consider to adopt or has 
adopted for digital technologies that a re used for payments? Is there a standard that 
particularly applies to cryptocurrencies?  
 
EU reply:  
The EU financial services regulatory framework applies to all non -cash payments, regardless of the 
technological instrument through which these are carrie d out.  
The EU continuously assesses the suitability of the existing framework in view of emerging 
technologies. Presently, the EU financial services regulatory framework does not cover pure 
cryptocurrencies (e.g. Bitcoin). However, the broader category of  crypto -assets can exhibit many 
different features, and as such, it can only be determined on a case -by-case basis whether a specific 
crypto -asset would fall under the EU financial services regulatory framework. As of 10 January 2020, 
Directive EU 2018/843  (the 5th Anti-Money Laundering Directive) came into force, covering firms 
offering virtual currency to fiat currency exchange services as well as custody services for virtual 
currencies. Additionally the EU is currently working to present a legislative proposal co vering all 
crypto -assets, including cryptocurrencies, by Q3 2020.  
 
Para 3.281 (Page 135)  
The 2014 Directives set out the rules on the award of contracts. While most rules in public 
procurement have been harmonized at EU level, the public procurement direct ives allow for flexibility 
in implementation at the national level. The CJEU delivers regular judgements in procurement cases, 
which are binding on EU member States. The core principles of the 2014 Directives are transparency, 
equal treatment, non -discrimi nation, and open competition.  
 WT/TPR/M/395/Add.1  
 
- 435 - 
 
  Question/s:  
20. In what areas or what elements of public procurement does the 2014 Directives 
allow flexibility at the national level?  
 
EU reply:  
The flexibility of EU Member States when transposing the EU Public Procureme nt Directives into 
national law is not specifically stipulated in the text of the Directives themselves but rather stems 
from the nature of an EU Directive, as opposed to that of an EU Regulation. While a Regulation sets 
in detail the legal framework that applies directly at national level, a Directive provides for the 
minimum rules to be followed, allowing EU Member States to detail those rules at national level or 
even to go beyond these minimum rules when the text of the Directive allows it. The margins of 
flexibility for Member States are determined by the Court of Justice of the EU, whenever necessary. 
In practical terms, the EU Public Procurement Directives include provisions where the flexibility for 
Member States is very limited or inexistent (such a s the award procedures to be followed or the 
reasons for excluding an economic operator from an award procedure), but also other provisions 
where Member States enjoy considerable margins of flexibility in going beyond what is stipulated in 
the Directives ( for instance, organising the professional registers of economic operators participating 
in public procurement procedures).  
 
Para 3.290 (Page 143)  
To harmonize procedures and processes, the Commission introduced the European Single 
Procurement Document (ESP D), which is a self -declaration form simplifying the participation of 
suppliers in procurement procedures. The next step is ESPD integration with national databases or 
eTendering platforms.  
 
Question/s:  
21. What is the timeline for the full integration of the ESPD with national databases or 
eTendering platforms? What is/are the next step/s after ESPD integration with national 
databases or eTendering platforms that will be undertaken by the Commission to 
harmo nize procedures and processes?  
 
EU reply:  
There is no timeline for the full integration of the ESPD with national databases or eTendering 
platforms. In the current legal framework, the use of the ESPD has been mandatory since April 2016. 
Since April 2018 , only the electronic version is allowed. Integration with national databases and 
eProcurement systems is encouraged but not imposed. Many EU Member States are moving in this 
direction. For those EU Member States that have already advanced in this regard, next goals include 
an extension of the integration process to cross -border procedures, thereby completing the cycle of 
application of the "once only" principle.  
 
Para 3.295 (Page 144)  
The voluntary ex -ante assessment mechanism for large infrastructure proj ects was introduced in 
October 2017. Currently, the mechanism has three elements: a helpdesk, a notification mechanism, 
and the possibility to exchange information (forum). The helpdesk is available for projects with a 
total estimated value of at least EUR  250 million, and the notification mechanism is for projects with 
a total estimated value exceeding EUR 500 million.  
 
Para 3.296 (Page 144)  
The Commission recommendation on the professionalization of public procurement was adopted in 
October 2017 as part o f a package also containing a staff working document including a toolbox of 
best practices. The toolbox was digitalized in the form of an e -library, providing for the 
cross-fertilization of best practices in different aspects of public procurement. Another  support tool 
for public buyers is the e -Competence Centre. It provides information on, inter alia , green, 
innovative procurement, and on specific tools for procurement in the IT, healthcare and construction 
areas.  
 
Question/s:  
22. Why is the voluntary ex -ante assessment mechanism limited to large infrastructure 
projects? Can it be applied to other categories of procurement, i.e. goods and services, 
regardless of size?  
 WT/TPR/M/395/Add.1  
 
- 436 - 
 
  EU reply:  
In October 2017, the European Commission published the Communication "Making  Public 
Procurement work in and for Europe"  (https://ec.europa.eu/docsroom/documents/25612 ), 
identifying six strategic priority areas. As part of the first priority, "Ensuring wider uptake of strategic 
public procurement" , the need for a targeted approach for priority sectors was recognized. 
Constructions, healthcare and the IT sector are just a few examples because of their leverage effect, 
specificities and particular challenges, including the rapid technological and market evolution. The 
Commission initi ative for a voluntary ex -ante assessment mechanism for large infrastructure 
projects can be seen in this context. Currently it can only be used for large infrastructure projects.  
 
Para 3.317 (Page 144)  
On 30 June 2019, the EU and Viet Nam signed a trade ag reement and an investment protection 
agreement. The trade agreement will open up public procurement opportunities for both sides 
through GPA -based rules on public procurement and market access obligations concerning entities 
at central and sub -central leve l and entities operating in utilities sectors.  
 
Question/s:  
23. What were the EU's sensitivities with respect to its trade agreement with Viet Nam; 
i.e. were there specific products or services that comprised the EU's defensive interests?  
 
EU reply:  
The Commission undertakes consultations with all relevant stakeholders before and during FTA 
negotiations, including in the area of procurement, in order to take into account offensive and 
defensive interests during the talks. The Chapter on public procurement  in the EU -Viet Nam FTA is 
the result of negotiations taking into account different interests at stake. For details of the final text 
agreed please consult the following: https://ec.europa.eu/trade/policy/in -focus/eu -vietnam -
agreement/ . 
 
24. It may be noted that the EU -Viet Nam FTA provides for the definition and treatment of 
"remanufactured goods"; i.e. "The Parties shall accord to remanufactured goods the same treatment 
as that accorded to new like goods. A Party may require specific labelli ng of remanufactured goods 
in order to prevent deception of consumers."  
 
a) Is the EU considering the inclusion of such provision or treatment of remanufactured goods in 
 its future trade agreements?  
b) If not, what are its conditions for the inclusion of  such provision in its FTAs?  
c) What is the minimum requirement for a good to be considered as remanufactured; i.e. activity 
 or process, components, and/or share of parts to total?  
 
EU reply:  
The EU considers the inclusion of provisions regarding "remanufactured goods" as integrant part of 
its modernised trade policy with preferential partners. The requirements are defined in the definitions 
article of each FTA, in the meaning of a good that is entirely or partially comprised of parts obt ained 
from goods that have been used beforehand, has similar performance and working conditions 
compared to the equivalent good in new condition and is given the same warranty as the equivalent 
good in new condition.  
 
Table 3.31 (Page 146)  
Status of partic ipation in WIPO conventions and treaties  
Convention/treaty  Signed  Accepted  In force  
Beijing Treaty on Audiovisual 
Performances  19 June 2013    
Marrakesh Treaty  30 April 2014  1 October 2018  1 January 2019  
Trademark Law Treaty  30 June 1995    
WIPO Copyright Treaty  20 December 1996  14 December 2009  14 March 2010  
WIPO Performances and 
Phonograms Treaty  20 December 1996  14 December 2009  14 March 2010  
Hague Agreement   24 September 2007  1 January 2008  
Madrid Protocol   1 July 2004  1 October 2004  
 WT/TPR/M/395/Add.1  
 
- 437 - 
 
  Question/s:  
25. What hinders the EU's acceptance/ratification of the Beijing Treaty on Audiovisual 
Performances and the Trademark Law Treaty?  
 
EU reply:  
While the European Union signed the Beijing Treaty on Audiovisual Performances on 19 June 2013, 
internal discussions regarding the European Union 's accession are still ongoing.  
 
Para 3.342 (Page 150)  
The EU legal framework offers supplementary protection certificates (SPCs) for medicinal products 
(Regulation (EC) No. 469/2009) and plant protection products (Regulation (E C) No. 1610/96) as a 
sui generis IP category that only applies after expiry of the basic patent. In other words, they are 
considered as legally distinct from patent protection, including international obligations in this 
regard, and may therefore be subjec t to wider exceptions than patent rights themselves. Following 
up on a Commission proposal of 28 May 2018, the EU co -legislators adopted Regulation (EU) 
2019/933 amending Regulation (EC) No. 469/2009 concerning the supplementary protection 
certificate for medicinal products, introducing an exception to let firms established in the 
EU manufacture certain pharmaceutical products for export to non -EU markets during the term of 
the SPC. It also permits the making and stockpiling of a pharmaceutical product six months prior to 
the expiry of the certificate, in order to place it on the market of EU member States immediately 
after expiry of the certificate. These provisions have been described as means to level the playing 
field for Europe -based generic and biosimi lar manufacturers in light of a lack of international binding 
rules on SPCs. Comparable exceptions were included in recent FTAs such as the CETA.  
 
Question/s:  
26. What are the conditions that manufacturers of medicinal products and 
plant -protection product s should satisfy before they can be granted with a supplementary 
protection certificate (SPC)?  
 
EU reply:  
The substantive conditions are laid down in Article 3 of Regulation 469/2009 and 1610/96, notably 
that the product is protected by a basic patent in  force, that a valid authorisation to place the product 
on the market has been granted, the product has not already been the subject of a certificate, and 
the authorisation referred to above is the first authorisation to place the product on the market.  
 
27. What is the period of protection if an SPC is issued to a generic and biosimilar 
manufacturer?  
 
EU reply:  
The duration of a SPC is set out in Article 13 of Regulation 469/2009. That article stipulates that the 
certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the 
period which elapsed between the date on which the application for a basic patent was lodged and 
the date of the first authorisation to place the product on the market in the EU, reduced by a  period 
of five years, and with a cap of five years from the date on which it takes effect. For certificates for 
medicinal products, the period can be extended by six months (only once) if a paediatric investigation 
plan has been concluded.  
 
IV. TRADE POLI CIES BY SECTOR  
 
Para 4.138 (Pages 202 -203)  
The transition towards a more secure and sustainable energy system will require major investments 
in generation, networks and energy efficiency, estimated at some EUR 200 billion annually in the 
next decade. The private sector is expected to bear the brunt of the costs. The European Investment 
Bank, the Connecting Europe Facility and the European Structural and Investment Funds already 
participate. Moreover, the European Fund for Strategic Investments will provide additional support, 
facilitating access to finance for projects of European significance, such as in energy networks, 
renewable energy and energy efficiency.  
 
Question/s:  
28. With the private sector bearing the impact of the transition towards  a more secure 
and sustainable energy system, access to finance is an important factor to encourage and WT/TPR/M/395/Add.1  
 
- 438 - 
 
  ensure investors. With an annual influx of major investments estimated at EUR 200 billion 
within the next decade, will there be:  
 
a) Easing of policies  in the area of finance for energy -related investments projects?  
 
EU reply:  
A sustainable Europe requires significant investment effort across all sectors of the economy. 
Reaching the EU 2030 energy and climate targets will require additional investments of 
EUR 260 billion a year by 2030. In the light of these investments needs, a successful implementation 
the European Green Deal Investment Plan as published on 14 January 2020 is vital. In order to 
mobilize at least EUR 1 trillion of public and  private investments for sustainable investments over 
the course of 10 years and achieve goals as set up in the European Green Deal, we will have to carry 
on the most ambitious and cross -sectoral endeavour of a unprecedented scale in the EU. In addition, 
the EU has proposed hard law to incentivise private capital to flow to green projects.  
 
b) Additional incentives or support in any form to encourage investors to explore 
opportunities in the sustainable energy system?  
 
EU reply:  
The EU has proposed three key pieces of legislation will incentivise and channel private sector 
investment into green and sustainable development. This follows from the 10 -point Action Plan for 
sustainable finance from March 2018. A unified EU green classification system – "Taxonom y" to 
determine if an economic activity is environmentally sustainable based on harmonised EU criteria. 
The European Parliament and the Council reached a political agreement in December 2019. The 
Taxonomy Regulation provides for a general framework that wi ll allow for the progressive 
development of an EU -wide classification system for environmentally sustainable economic activities. 
This aims to provide guidance for policy makers, industry and investors on how best to support and 
invest in economic activiti es that contribute to achieving a climate neutral economy. Sustainability -
Related Disclosures - Enhanced disclosures by manufacturers and distributors of financial products 
to end -investors. Financial market participants will have to disclose to their clie nts the impact of 
sustainability on financial returns and the impact of their investment decision on sustainability. These 
obligations will apply from March 2021.  
 
Para 4.155 (Page 206)  
The full implementation of the circular economy approach is also criti cal for decarbonizing the EU's 
economy, notably in energy -intensive sectors such as steel, cement and glass, while keeping or 
increasing its competitiveness. Reuse and recycling of raw materials lead to lower emissions, and 
reduce dependency on raw materia l supplies. In December 2018, the Commission launched the 
Circular Plastics Alliance, consisting of key industry stakeholders, covering the full plastics value 
chain, as part of its continued efforts to reduce plastics littering, increase the share of recy cled 
plastics, and stimulate market innovation.  
 
Question/s:  
29. The circular economy approach has been proven effective in decarbonizing industrial 
activities, especially energy -intensive sectors. This could mean relocation or 
reorganization of facilities  to adopt such approach. Are there policies in place to support 
/ encourage such activities?  
 
EU reply:  
Circularity will deliver energy and material saving along the whole value chain for all economic 
activities and therefore is non -sector specific. Havi ng said that, particular emphasis is put on key 
value chains where impacts and benefits will be particularly relevant: construction, plastics, textiles, 
food, packaging and ICT. For some high -intensive sectors, such as Textiles and Construction, the 
Commis sion will propose comprehensive tailored strategies – expected for 2021. Moreover, EU funds 
supports industrial innovation (e.g. Horizon 2020 and upcoming HorizonEurope). In the new CEAP it 
is also said that Cohesion Policy funds will help EU regions to im plement circular economy strategies 
and reinforce their industrial fabric and value chains.  
 
30. How does the EU implement the circular economy approach?  
 WT/TPR/M/395/Add.1  
 
- 439 - 
 
  EU reply:  
The Commission established a comprehensive strategy, the Circular Economy Action Plan (ad opted 
11 March 2020), looking at closing the loop by introducing measures covering the whole cycle of 
products – from production and consumption to waste and the market for secondary raw materials. 
Moreover, the Commission works to expand circular economy principles across policy areas, for 
example by looking at specific sectors. The EC will implement the approach via a mix of legislative 
and non -legislative initiatives, putting also a strong emphasis on ground -level progress and 
stakeholder engagement, whi le creating the right framework for more and better investments. This 
is done in cooperation with the co -legislators (in case of legislative measures) and Member States.  
 
31. Does the EU offer support such as technical assistance to third countries planni ng 
to adopt or implement the circular economy approach?  
 
EU reply:  
The EU promotes the circular economy through its international cooperation and development policy, 
notably through programmes in areas such as private sector development, cities, waste an d 
environment. This includes initiatives such as:  
 
• The EU External Investment Plan (EIP), adopted in 2017, which supports partner countries 
 by: mobilising finance through the European Fund for Sustainable Development (EFSD), 
 providing technical assistance to help prepare investment projects, and developing a 
 favourable investment climate and business environment. The EIP prioritises its supp ort to 
 sectors such as: sustainable energy, energy efficiency, sustainable cities and agriculture.  
• The SWITCH to Green initiative, which promotes enabling policy frameworks and green 
 business development through activities such as awareness raising, mapp ing of green 
 economy opportunities, economic modelling, capacity development of public institutions, 
 support to private sector initiatives, business to business dialogue etc. More info on actions in 
 Asia: http://www.switch -asia.eu/switch -asia/about -us/. 
• The Circular Economy Missions are not technical assistance, but are conceived with three clear 
 objectives:  
o To increase cooperation between the EU and third countries in the field of environmental 
 policy. This can be achieved by signing political agreeme nts directed at fostering the 
 circular economy, green public procurement and innovative, sustainable and inclusive 
 growth.  
o To achieve a better understanding of the environmental challenges faced by third 
 countries.  
o To promote green solutions through bu siness partnerships abroad. In this regard, the 
 missions will organise matchmaking events between European and local entrepreneurs 
 and will engage in exchange of views with targeted audiences.  
 
The European Commission 's staff working document SWD(2020) 1 00 "Leading the way to a global 
circular economy: state of play and outlook " (published on 11 March 2020, together with the new 
Circular Economy Action Plan referred to above) provides a comprehensive account of the state of 
play as regards on -going and fo rthcoming actions related to the international dimension of circular 
economy, which are placed in the context of key trends in resource use and the challenges and 
opportunities for various actors across the globe.  
 
Para 4.213 (Page 219)  
In May 2019, the EU  adopted a "banking reform package", based on a Commission proposal of 
November 2016, which consists of amendments to the Capital Requirements Regulation and 
Directive and the Bank Recovery Resolution Directive to implement some outstanding issues that 
are essential to make the financial system more resilient and stable, and which had been finalized 
by the Basel Committee on Banking Supervision and the Financial Stability Board. The package also 
included proposed amendments to the regulation establishing th e Single Resolution Mechanism 
(SRM), one the pillars of the Banking Union.  
 
Question/s:  
32. The adjustments required from banks on the reform package, including the 
requirements for capital and liquidity buffers, place further downward pressure on the 
bank s' efforts to improve their profitability amidst the low interest environment. What 
measures have been adopted by the EU (apart from the comprehensive package of WT/TPR/M/395/Add.1  
 
- 440 - 
 
  measures to tackle NPLs) to assist banks in pursuing a growth strategy that will support 
inves tment, growth and jobs in the EU?  
 
EU reply:  
Banks play a crucial role in the EU 's financial system.  
 
The EU has taken two key measures over the past years to help the banking sector to support 
investment, growth and job creation. In 2013, the EU drew up a roadmap for the completion of the 
Banking Union and a better functioning of the Single Market for banking services. Two essential 
pillars of the Banking Union are the Single Supervisory Mechanism and the Single Resolution 
Mechanism and these pill ars provide a solid basis for financial stability, which is a precondition for 
economic growth. Banking Union also offers the potential to EU banks to conduct business 
Union -wide, including through mergers and the pursuit of economies of scope and scale.  
 
In parallel to Banking Union, the EU has also taken measures to support the lending capacity of the 
banking sector in the context of Capital Markets Union. Important reforms have recently been 
adopted including the measures to help banks securitise their loan portfolios and measures to obtain 
efficient wholesale funding for secured loans through the issuance of covered bonds. Moreover, as 
part of its Fintech strategy, the EU is supporting the competitiveness of its banking sector with a 
view to provide the  right incentives for innovation in a digital economy.  
 
Para 4.243 (Pages 226 -227)  
In March 2019, political agreement was reached between the European Parliament and EU member 
States on the Commission's proposal for a regulation on disclosures relating to sustainable 
investment and sustainability risks. The aim of this proposal is to introduce mandatory disclosure, 
in order to allow investors to benefit from lower search costs in finding financial products and services 
corresponding to their sustainability preferences.  
 
Question/s:  
33. On the proposal to issue regulation which will introduce mandatory disclosures, 
would there be a phased implementation period to be provided to allow the smooth 
transition of all the affected economies, including those emerging ones? On the said policy 
proposal, would other globally accepted frameworks for reporting sustainability be 
considered such as Sustainability Reporting Standards, Integrated Reporting Framework 
and Sustainability Accounting Standards apart from the recommendations of the Task 
Force o n Climate -related Financial Disclosure?  
 
EU reply:  
Please see the European Commission 's previous reply to the Philippines regarding the introduction 
of sustainability -related disclosures.  
 
Regulation 2019/2088 on sustainability ‐related disclosures in the  financial services sector is a 
Regulation that applies to EU Member States. The disclosures as regards adverse sustainability 
impacts must be complied with by financial entities that are active in the EU. Regulation 2019/2088 
includes some phasing in obli gations of a limited nature.  
By way of example the "comply or explain" mechanism outlined in Article 4(1)(a) and (b) applies 
from 10 March 2021. In addition, the mandatory consideration of principal adverse sustainability 
impacts as per Article 4(3) and ( 4) applies from 30 June 2021. Moreover, the product disclosures as 
to adverse sustainability impacts applies from 30 December 2022. By way of another example, 
financial products that are marketed in the EU as sustainable within the meaning of Articles 8 an d 9 
will need to explain their sustainability features from 10 March 2021.  
ESMA, EBA and EIOPA are currently jointly working on draft Regulatory Technical Standards that will 
further specify the requirements of Regulation 2019/2088. ESMA, EBA and EIOPA pl an to launch a 
public consultation on draft Standards this April 2020. Several options will be considered, including 
but not limited, to international methodologies.  
In addition, in its 11 December 2019 Communication on the European Green Deal, the Commis sion 
committed to review the Non -financial reporting directive in 2020 as part of the strategy to 
strengthen the foundations for sustainable investment.  
 WT/TPR/M/395/Add.1  
 
- 441 - 
 
  PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
1. INTRODUCTION  
 
Para 1.3 (Page 3)  
EU trade policy  aims at fostering open, fair and sustainable trade. Openness is necessary to maintain 
the connection between the Single Market and global sources of growth that support job creation, 
innovation and upstream integration in global value chains that translat es into high value -added 
exports. Fairness and sustainability are necessary to promote EU principles and values and help 
maintain EU competitiveness against distortions induced by state capitalist practices and lower 
standards, while providing protection t o EU citizens. In addition to multilateral and plurilateral 
approaches, the EU pursues market opening through bilateral and regional trade agreements.  
 
Para 1.4 (Page 3)  
EU trade policy stays firmly grounded in universal fundamental rights and values – like promoting 
ambitious climate change mitigation, protecting the environment and guaranteeing food safety and 
security as well as the protection and promotion of labour rights. It does so by also actively 
promoting the mutual supportiveness between EU trade  policy and the multilateral governance on 
such issues in the United Nations and the International Labour Organisation context. As enshrined 
in the EU Treaty, the EU has an obligation to ensure a coherent approach in terms of foreign policy. 
EU trade polic y therefore is consistent with its wider foreign policy objectives – that are to pursue a 
policy that benefits society as a whole – and promotes European and universal standards and values 
alongside core economic interests, putting a greater emphasis on su stainable development, human 
rights, consumer protection, and responsible and fair trade.  
 
Question/s:  
34. Given that the EU's trade policy aims to foster open, fair and sustainable trade, will 
it require a potential trade partner to promote ambitious clim ate change mitigation, 
protecting the environment and guaranteeing food safety and security as well as the 
protection and promotion of labour rights at the same level as itself and its member states 
or will it depend on the evolving capacity of said prospe ctive trade partner?  
 
EU reply:  
The EU 's key objective is to maximise the important contribution that trade and investment can 
make to sustainable development. Since 2009, all new free trade agreements signed by the 
European Union contain a Trade and Sus tainable Development (TSD) chapter, which includes 
provisions on core international labour standards and environmental protection. These provisions 
involve the ratification and effective implementation of international conventions in these areas, 
including  the eight fundamental conventions of the International Labour Organization (ILO), and key 
Multilateral Environmental Agreements (MEAs). Since 2015, the list of relevant MEAs has also 
included the Paris Agreement. This approach is built on a long -term enga gement with trade partners 
to ensure that both parties respect internationally -agreed values and commitments in these areas. 
Regarding food safety, all products imported into the European market must conform with the EU 's 
rules concerning food safety and S PS standards.  
 
2. TRADE AND THE ECONOMIC ENVIRONMENT  
 
Para 2.5 (Page 4)  
Downside risks to the outlook remain prominent. Externally, these include the risk of a further 
escalation of trade tensions as well as a more persistent than forecast slowdown in global growth 
and foreign trade. Domestically, these include a possible nega tive spillover from the manufacturing 
recession to other sectors such as services and the uncertainty surrounding the United Kingdom's 
withdrawal from the EU, inter alia . 
 
Question/s:  
35. In light of the Brexit and its possible implications, what measures have been 
implemented, if any, in view of the "possible negative spillover" from the manufacturing 
recession to the other sectors?  
 
EU reply:  
Following the UK 's exit from the EU on 31 January 2020 and the entry into force of the Withdrawal 
Agreement, the UK entered a transition period during which Union law, with a few exceptions, WT/TPR/M/395/Add.1  
 
- 442 - 
 
  continues to apply to and in the UK. It is thus premature to discuss the effect of  UK leaving the EU 
on EU 's economic outlook. The impact will depend on the outcome of the negotiations on the future 
partnership between the EU and the UK. The global and European outlook remains fragile with the 
prospect of a protracted period of subdued growth in a context of structural challenges and numerous 
downside risks. With the outbreak of the Coronavirus in early 2020 and its subsequent arrival in 
Europe, the outlook for the EU economy, including for the demand components, is rapidly changing. 
The outlook is currently subject to a through reassessment in the context of the EC Spring 2020 
Economic Forecast that will be published on 7 May 2020.  
 
3. DEVELOPMENTS IN THE INTERNAL MARKET  
 
Para 3.18 (Page 8)  
The EU 's Digital Single Market strategy adopted  in 2015 and almost completed, represents a major 
step forward in improving the functioning of the EU's Single Market to the benefit of enterprise and 
consumers from both EU Member States and third countries. The measures create a level playing 
field and e nsure equal treatment for all companies, and improve doing business through harmonizing 
28, previously different, laws in EU Member States into coherent EU wide legal acts, leading to both 
cost and timeline savings.  
 
Para 3.19 (Pages 8 -10)  
Important legi slative developments during the period under review as stated in the report:  
 
Question/s:  
36. What mechanisms (e.g. key performance indicators) are adopted by the EU to 
evaluate the progress of their Digital Single Market strategy?  
 
EU reply:  
The Digital  Economy and Society Index (DESI) continues to be the key performance indicator the 
EU will use in evaluating the progress also of the new digital strategy "Shaping Europe 's digital 
future" . Over the past year, all EU Member States have improved their digi tal performance. For 
further information, please see https://ec.europa.eu/digital -single -market/en/desi . 
 
Para 3.34 (Page 12)  
The EU recognizes the role of SMEs in the EU economy with the "Small Business Act" for Europe 
(SBA), an overarching framework for guiding SME policy -making for EU Member States. Every year 
the European Commission prepares an annual SME Performance Review, which is used to monitor 
and assess countries' progress in implementing the SBA recommendations. The last annual report 
for 2017/1 8 provides a synopsis of the size, structure and importance of SMEs to the European 
economy and an overview of the past and forecasted performance of SMEs from 2018 to 2019. 
Comparisons with partner countries outside the EU and with the large enterprise se ctor are also 
included.  
 
Question/s:  
37. Does it afford special treatment to SMEs coming from outside the EU member states? 
If yes, what are these and how could a foreign SME benefit from such treatment?  
 
EU reply:  
The EU is not granting special treatment to third countries ' SMEs. All SMEs oper ating in Europe are 
treated equally and can benefit from transparent rules in the world's largest single market. Moreover, 
a Trade helpdesk is offering online a comprehensive guide to EU market 's import rules and taxes 
(https://trade.ec.europa.eu/tradehelp /). This is a direct and practical help to SMEs wishing to export 
to the EU.  
 
4. TRADE AND INVESTMENT POLICY DEVELOPMENTS  
 
Para 4.18 (Page 18)  
The two agreements are new generation free trade agreements. They go beyond trade in goods and 
services; they cov er also intellectual property, investments, government procurement, customs and 
trade facilitation, competition, regulatory cooperation, trade and sustainable development. 
Moreover, the EU -Japan EPA was the first agreement to include a chapter dedicated to  smaller 
businesses. Together, these agreements will help EU businesses to save up to EUR 1.6 billion in 
customs duties per year. EU exports to Japan are expected to rise by EUR 13 billion per year while WT/TPR/M/395/Add.1  
 
- 443 - 
 
  exports to Canada in 2018 (the first full year of pr ovisional application) increased by 15% in 
comparison to the preceding 3 years).  
 
Para 4.19 (Page 19)  
In Southeast Asia, on 30 June 2019, the EU signed the Free Trade Agreement and the Investment 
Protection Agreement with Viet Nam. The agreement will soon  be presented for the ratification 
procedure. In addition, the EU -Singapore Free Trade Agreement and Investment Protection 
Agreement, signed in October 2018, is under the ratification process. The EU also continues bilateral 
free trade agreement negotiatio ns with Indonesia, launched in 2016.  
 
Para 4.20 (Page 19)  
The Court of Justice confirmed in its opinion 2/15 on the EU -Singapore Free Trade Agreement that 
the majority of areas covered by this FTA (ranging from trade in in goods, to services, to public 
procurement or sustainable development) fall under the exclusive competence of the EU. Only as 
regards portfolio investment and the settlement of disputes between foreign investors and states, 
the EU shares competence with Member States. In view of this, the EU has introduced a new 
approach to its trade and investment agreements: free trade agreements cover areas where the EU 
has exclusive competence, while investment protection agreements cover areas of both EU exclusive 
and shared competence. Japan, Singapor e and Viet Nam were the first trade and investment 
partners with whom the EU followed this new approach. In addition, the EU is pursing negotiations 
for standalone investment agreements, including with China.  
 
Question/s:  
38. How will the EU's approach to exclusive competence factor into the negotiation of 
future trade and investment agreements?  
 
EU reply:  
The EU will take the decision on whether to conclude two separate agreements or one comprehensive 
agreement on a case -by-case basis and in view of the entire scope of the agreement in question. 
Obviously, the EU will also discuss with its negotiating partner. It should be noted, however, that 
the issue of approach does not change or influence the content of the agreement.  
 
Para 4.33 (Page 20)  
At bilateral level, the EU promotes labour and environmental considerations in its trade agreements 
through dedicated chapters on trade and sustainable development (TSD). Bilateral agreements 
under implementation that contain such chapte rs include those with Canada, Central America, 
Colombia, Ecuador and Peru, Georgia, Moldova, South Korea and Ukraine. Also, the recently signed 
agreements with Japan, Mexico, Singapore and Viet Nam have a TSD chapter, as does the recently 
concluded agreeme nt with Mercosur. TSD chapters include commitments to ratify and effectively 
implement fundamental International Labour Organization conventions and Multilateral 
Environmental Agreements. The chapters also contain specific provisions on the conservation an d 
sustainable management of natural resources (e.g. timber, fish and wildlife) and the promotion of 
practices favouring sustainable development and responsible business practices. They also aim to 
prevent the risk of a race to the bottom, by prohibiting de rogations from or lack of enforcement of 
domestic environmental or labour laws in order to encourage trade and investment.  
 
Question/s:  
39. Does the commitment to ratify and effectively implement the Multilateral 
Environmental Agreements mentioned in the T SD Chapter of trade agreements with EU 
include mechanisms to bind home states to commonly accepted practices designed to 
protect host states from polluting multinationals; i.e. Polluter Pays Principle?  
 
EU reply:  
The Multilateral Environmental Agreements (MEAs) covered by the Trade and Sustainable 
Development (TSD) chapters in EU Free Trade Agreements (FTAs) require each Party to the FTA to 
comply with the requirements set out in each of the MEAs they have ratified . For instance, under 
the Basel Convention Parties to the Convention have an obligation to ensure that persons involved 
in the management of hazardous wastes take steps to prevent pollution due to such wastes. Another 
example is the Rotterdam Convention, w here Parties to the Convention have a shared responsibility 
to make sure that international trade of certain hazardous chemicals does not harm human health 
and the environment. More generally, TSD chapters in EU trade agreements underline that each WT/TPR/M/395/Add.1  
 
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  Party h as the right to protect its environment, and environmental protection obligations should apply 
equally to domestic or multinational companies operating in a Party 's territory.  
  WT/TPR/M/395/Add.1  
 
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  RUSSIAN FEDERATION  
REPORT BY EUROPEAN UNION  (WT/TPR/G/395)  
 
3 DEVELOPMENTS IN  THE INTERNAL MARKET  
3.14 The withdrawal of the United Kingdom from the European Inion  
 
Page 15, para 3.49  
Given the uncertainty about when and under which conditions the United Kingdom will withdraw 
from the EU, the EU needs to prepare for a withdrawal without a Withdrawal Agreement (no -deal 
scenario). The no -deal scenario means that trade between the EU and the United Kingdom will take 
place on MFN terms and that EU trade agreements with third countries will cease to apply to the 
United Kingd om as of the United Kingdom's withdrawal.  
 
Question 1: In case of a no -deal scenario, will the EU recognize the results of the United 
Kingdoms' conformity assessment procedures? If so, what will be the product coverage?  
 
EU reply:  
On 1 February 2020, the  United Kingdom withdrew from the European Union. The withdrawal took 
place according to the arrangements set out in the Agreement on the withdrawal of the United 
Kingdom of Great Britain and Northern Ireland ('the United Kingdom') from the European Union and 
the European Atomic Energy Community ('the Withdrawal Agreement). The Withdrawal Agreement 
provides for a transition period that will end on 31 December 2020, unless a one -time extension of 
the transition period for up to 1 or 2 years is agreed by the Parties. During transition, the full 
European Union "acquis" would apply to and in the UK.  
 
Question 2:  On 8 October 2019, the United Kingdom published its tariff that will be applied 
in case of a no -deal scenario. Taking into account close trade relations  between the EU 
and the United Kingdom, does the EU plan to introduce certain changes in its tariffs as a 
result of Brexit? If so, what products will be affected?  
 
EU reply :  
The EU's trade policy will not change as a result of the UK's withdrawal. The EU  has no plans to 
autonomously change its tariffs. Any changes to bound tariffs in the EU schedule will only result 
from successful multilateral negotiations.  
 
Page 16, para 3.52  
The EU trade policy will not change as a result of the United Kingdom's withdr awal. The EU will 
honour its obligations and the EU's WTO schedules will remain in place. However, the 
United  Kingdom's withdrawal from the EU will have implications in the WTO context. Quantitative 
commitments under the goods schedule need to be apportion ed. To this end, as early as 
October  2017, the EU and the United Kingdom engaged jointly with other WTO Members on the 
envisaged approach of apportionment of tariff -rate quotas with the key principle of maintaining the 
existing level of market access to th e EU27 and the United Kingdom. The negotiations under the 
Article XXVIII procedure are currently ongoing with the relevant WTO Members.  
 
Question 3:  Please clarify, if negotiations under the Article XXVIII of the GATT are not 
concluded before the United Ki ngdom withdraws from the EU, will the EU continue to apply 
TRQs in accordance with its Schedule of tariff commitments or will it apply TRQs based on 
the proposed apportionment? In case if it is the latter, could the EU please elaborate on 
the consistency o f such approach with the WTO rules?  
 
EU reply:  
The EU has fully followed the applicable rules under Article XXVIII GATT, which allows a Member to 
modify concessions even in the absence of agreements with all the Members with recognized rights. 
In parallel, the EU has also put in place the necessary internal legislation (Regulation (EU) 
No. 2019/216 and Regulation (EU) No . 2019/386) to apply the apportioned quantities even in the 
absence of agreements in the ongoing Article XXVIII GATT negotiations.  
 WT/TPR/M/395/Add.1  
 
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  4 TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.3 Promoting a sustainable approach to trade  
4.3.2 Supporting inclusive growth in developing countries  
 
Page 20, paras 4.34 -4.35 
4.34. At unilateral level, the EU's Generalised Scheme of Preferences (GSP) remov es duties from 
products coming into the EU market from vulnerable developing countries. Under the general GSP 
arrangement, the EU grants partial or full tariff reductions on around 66% of tariff lines. The Special 
Incentive Arrangement for Sustainable Deve lopment and Good Governance (GSP+) grants mostly 
duty-free treatment to essentially the same 66% of tariff lines. The Everything But Arms (EBA) 
arrangement, also a part of the EU's GSP, gives Least Developed Countries (LDCs) tariff -free, quota -
free access to the EU market for all products except arms and ammunition.  
 
4.35. Under the EU's current GSP Regulation, all GSP beneficiary countries (including Everything But 
Arms beneficiaries) have to respect the principles of fifteen core conventions on human and  labour 
rights. The GSP+ arrangement requires countries to fulfil, ratify and effectively implement a total of 
27 international conventions covering core human and labour rights, environmental protection, and 
good governance. An independent mid -term evalua tion concluded in 2018 that the EU's GSP is 
effective, showing that imports from beneficiary countries have increased substantially. In 2018, the 
share of EU imports coming from LDCs stood at 2.26%, more than double the overall LDC share of 
world exports ( 0.98% in 2017).  
 
Question 4:  
The EU by its regulation No. 978/2012 has determined that to benefit from tariff 
preferences provided under the special incentive arrangement for sustainable 
development and good governance the beneficiary countries should meet  obligations 
strict enough under 27 international conventions covering core human and labour rights, 
environmental protection, and good governance. On the one hand, these obligations will 
contribute towards the promotion of sustainable development in the b eneficiary 
countries. On the other hand, these commitments will put an additional burden on the 
budgets of the aforementioned countries. Moreover, as a result, the EU member states' 
producers, exporters and investors will also enjoy a better business envir onment while 
operating on the beneficiaries' markets. In this context, we consider GSP+ as a mutually 
beneficial deal rather than a pure supporting measure on behalf of the EU for inclusive 
growth in developing countries.  
 
In this regard, could you please  provide us with additional information on the subject, 
including your own vision regarding this matter?  
 
EU reply:   
Through the GSP+ initiative, the EU provides developing countries with further tariff preferences 
(compared to the standard GSP arrangement) i n return for the ratification and implementation of 
27 international conventions. These conventions promote the international values of human rights, 
core labour standards, environmental protection, and good governance on which the EU was 
founded. Additionally, as the EU has consistently reiterated, the adoption of sustainable development 
practices and respect for fundamental rights are a boost to economic growth, not a deterrent. EU 
importers and industry present in the GSP beneficiary countr ies also support the sustainable 
development agenda  and can play a positive role, notably in promoting labour reforms and 
occupational health and safety  
The additional tariff preferences under GSP+ help beneficiary countries assume the special burdens 
and responsibilities resulting from the ratification of the 27 conventions. In addition,  the EU supports 
them in the implementation of the conventions through various projects. For example, the EU 
currently funds a number of projects in Bolivia, Kyrgyzstan, Pa kistan, Mongolia, Armenia and Cabo 
Verde, ranging from an observatory on political harassment and violence, support to the economic 
and socioeconomic rights of women in the agricultural sector, to the formalization and regulation of 
domestic work.  
 
Page 20 , paras 4.36 -4.37 
4.36. In December 2017, the EU and its Member States updated their joint Aid for Trade (AfT) 
Strategy to change their collective approach towards supporting developing countries' trade and 
productive capacities. The objective of the updat ed strategy is to better align EU AfT interventions 
with actual market -driven opportunities and constraints, to ensure a better quantitative focus on WT/TPR/M/395/Add.1  
 
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  LDCs and to increase the contribution of AfT to sustainable development goals, while supporting a 
stronger  participation of women in the economy. The most recent EU Aid for Trade Progress Report 
(2019) was presented at the 7th Global Aid for Trade Review in July 2019.  
 
4.37. The EU and its Member States collectively constitute the world's largest AfT donor, ac counting 
for more than one -third of global AfT, with collective commitments amounting to EUR 14.5 billion in 
2017 (increase of 7.8% compared to 2016). The EU's and its Member States' commitments for Trade 
Related Assistance reached EUR 4.5 billion in 2017 (increase of 31% compared to previous year).  
 
Question 5:  
The EU together with its Member States is a leading donor in international development 
assistance and, in particular, in the Aid for Trade Initiative. Recent data shows that EU 
financing of the Aid for Trade Initiative is growing almost twice as fast as the total EU 
official development assistance (ODA).  
 
Does it mean that EU and its Member States collectively stand for increased commitments 
on Aid for Trade within the overall EU ODA? In the cont ext of the SDG 17 achievement, 
what is the projected level of EU total ODA disbursements under the Aid for Trade 
Initiative by 2030?  
 
EU reply:   
The EU and its Member States' aid in support of trade and productive capacities represents a third 
of the glob al Aid for Trade and makes the EU the biggest Aid for Trade donor worldwide. In addition, 
the EU's trade policy instruments, such as the Generalised Scheme of Preferences and Economic 
Partnership Agreements, as well as its Aid for Trade programmes, have si gnificantly contributed to 
support increased exports from developing countries and contributed to their economic 
diversification.  
The updated EU Strategy on Aid for Trade of 2017 (COM(2017)667) reflects the policy priorities of 
the UN 2030 Agenda on Susta inable Development adopted in September 2015 and the new European 
Consensus on Development endorsed by the EU and its Member States in June 2017. In this updated 
Strategy, the EU and its Member States have strengthened their commitments to enhance relevanc e 
of EU Aid for Trade, including through tailored interventions with a greater proportion of EU Aid for 
Trade channelled to Least Developed Countries (LDCs), and to improve synergies with EU trade 
agreements and schemes.  
The EU also intends to scale up th e impact of EU Aid for Trade and to increase its leverage. This 
means also better combining the vast array of development finance tools through a variety of 
delivery modalities for EU Aid for Trade. These include technical assistance, grants, budget suppor t, 
and financial instruments (including blending and de -risking mechanisms such as guarantees).  
 
TRADE POLICY REVIEW  
REPORT BY THE SECRETARIAT  (WT/TPR/S/395)  
 
2 TRADE AND INVESTEMENT REGIMES  
2.3 Trade Agreements and Arrangements  
2.3.1 WTO  
 
Page 39, para 2 .26 
The EU attaches great importance to preserving an open, rules -based multilateral trading system, 
with the WTO at its core but, at the same time, emphasizes the need for a comprehensive reform of 
the WTO in respect of its negotiating, monitoring and dis pute settlement functions. The EU presented 
its initial ideas on WTO reform in September 2018. It co -sponsored proposals to enhance 
transparency by improving compliance with notification requirements and to provide procedural 
guidelines for WTO Committees and Councils dealing with trade concerns. It also participates in 
discussions on WTO reform in various other settings, including the Ottawa Group, a trilateral process 
launched in December 2017 in the margin of the 11th WTO Ministerial Conference with Japa n and 
the United States on non -market -oriented policies and practices, state enterprises, industrial 
subsidies, and forced technology transfers, and a joint EU -China Working Group on WTO reform 
created in 2018. The EU underlined the urgent need to resolve the impasse that has arisen because 
of the absence of consensus on the appointment of Appellate Body members, and co -sponsored 
several proposals in this regard.  
 WT/TPR/M/395/Add.1  
 
- 448 - 
 
  Question 6: In light of the Appellate Body crisis, the European Union has proposed to 
replicat e the WTO appellate mechanism through arbitration procedure under Article 25 of 
the DSU. The European Union proposes to establish this procedure in the form of an 
interim arrangement – an individual agreement with a given WTO member. The European 
Union has  already concluded a number of such arbitration agreements with certain 
WTO  members. Could the EU please specify with which WTO members such negotiations 
on interim arrangements have been launched?  
 
EU reply:  
Pending the resolution of the crisis relating to Appellate Body appointments, the EU is preparing 
contingency measures to apply as long as the appointments remain blocked: the "Interim Appeal 
Arbitration Arrangements". The objective of these arrangements i s to preserve the access of WTO 
Members concerned to a binding and two -tier dispute settlement in the WTO, through arbitration 
proceedings provided under Article 25 of the DSU. The arrangement is a contingency measure and 
it will only apply until the WTO A ppellate Body becomes operational again. The EU believes that an 
independent and impartial appeal stage, giving the necessary guarantees of rulings of the highest 
quality, must continue to be one of the essential features of the WTO dispute settlement syst em. 
The EU has concluded such bilateral arrangements with Canada and with Norway, and is open to 
discussing such arrangements with any Member.  
On 24 January 2020, Ministers of the EU and 16 other WTO Members (Australia, Brazil, Canada, 
China, Chile, Colom bia, Costa Rica, Guatemala, Republic of Korea, Mexico, New Zealand, Norway, 
Panama, Singapore, Switzerland, Uruguay) issued a statement that they will work towards putting 
in place a multi -party interim appeal arrangement based on Article 25 of the DSU. Th is arrangement 
will be open to any WTO Member willing to join it. This work is currently ongoing.  
 
2.3.2 Regional and preferential agreements  
2.3.2.1 Reciprocal preferences  
 
Page 40, para 2.30  
The EU divides its FTAs with third countries into four broad categories:  
 
• "first-generation FTAs" are agreements concluded before 2006 and Stabilisation and 
Association agreements concluded with Western Balkan countries between 2009 and 2016. 
First-generation FTAs are in force with: Mediterranean partners (Alg eria, Egypt, Israel, 
Jordan, Lebanon, Morocco, Palestine, and Tunisia), Western Balkan partners (Albania, Bosnia 
and Herzegovina, North Macedonia, Kosovo102, Montenegro, and Serbia), Chile, Mexico, 
Andorra, the Faroe Islands, Iceland, Norway, San Marino, Swi tzerland, and Turkey.  
• "new-generation FTAs" are comprehensive FTAs, negotiated by the EU after 2006, with 
selected third countries, which typically go beyond provisions on liberalization of trade in 
goods. They cover services and public procurement. In som e cases, they also cover 
investment and regulatory cooperation. Since 2010, all new -generation agreements include 
provisions on sustainable development. New -generation FTAs are currently in force with: 
Japan; Canada; Korea, Rep. of; Colombia/Ecuador/Peru; and Central America.  
• "deep and comprehensive FTAs" are agreements aimed at establishing comprehensive free 
trade areas as part of a process of deepening political association and gradual economic 
integration between the EU and its partners. Deep and compre hensive FTAs are in force 
with: Ukraine, Georgia and Moldova, Rep. of.  
• Economic partnership agreements (EPAs) with African Caribbean and Pacific (ACP) countries 
are in force with: the Southern African Development Community (SADC), Côte d'Ivoire, 
Ghana, Cam eroon, CARIFORUM, the Pacific States, and the Eastern and Southern African 
States  
 
Question 7:  
The paragraphs 2.37 and 2.38 state that the EU envisages to modernize the current 
agreements with Mexico, Chile, MERCOSUR, Tunisia and Morocco. Does the EU hav e any 
plans to reconsider the first -generation FTAs with other countries?  
 
 
102 All references to Kosovo in this report should be understood in the context of UNSC 1244/1999.  WT/TPR/M/395/Add.1  
 
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  EU reply:  
In addition to the agreements mentioned, the EU will consider on a case -by- case basis if other 
agreements need to be modernised. This assessment will be based on the ac tual need for an update 
and on economic and political factors.  
All the information related to concluded agreements, pending agreements and on -going negotiations 
is available at : https://ec.europa.eu/trade/policy/countries -and-regions/negotiations -and-
agreements/#_being -negotiated . 
 
Page 43, para 2.40  
The United States and the EU adopted a Joint Statement in July 2018, in which they agreed to work 
towards elimination of tariffs, non -tariff barriers, and subsidies on non -auto industrial goods, and 
towards th e reduction of barriers to trade in services, chemicals, pharmaceuticals, medical products 
and soybeans. The Statement also provides for a strengthening of strategic cooperation with respect 
to energy, and notes that the EU wants to increase imports of liq uefied natural gas from the United 
States to diversify its energy supply. It envisages a close dialogue on standards, to reduce 
bureaucratic obstacles to trade and slash costs. Additionally, the United States and the EU agreed 
to join forces to better prot ect their companies from unfair trade practices and to work closely with 
likeminded partners to reform the WTO. Finally, the two sides agreed to work together to resolve 
the steel and aluminium tariff issues and retaliatory tariffs. The Statement establish ed an Executive 
Working Group to implement this agenda. In April 2019, the Council of the EU adopted decisions 
authorizing the opening of negotiations with the United States of agreements on the elimination of 
tariffs for industrial goods, and on conformit y assessment. The Council decision on the former notes 
that "the negotiating directives for the Transatlantic Trade and Investment Partnership must be 
considered obsolete and no longer relevant".  
 
Question 8:   
Taking into account that "the negotiating dire ctives for the Transatlantic Trade and 
Investment Partnership must be considered obsolete and no longer relevant", may the EU 
please clarify how the elimination of tariff and non -tariff barriers with the US will be 
carried out? Will it fall under the scope  of the Transatlantic Trade and Investment 
Partnership or any other regional trade agreement?  
 
EU reply:  
The negotiating directives for the Transatlantic Trade and Investment Partnership are indeed now 
obsolete and no longer relevant. In April 2019, the European Council adopted two new mandates 
allowing the EU to enter into negotiations with the US on:  
 
• conformity assessment and;  
• the elimination of tariffs on industrial products.  
 
Page 43, para 2.42  
The EU has customs unions with Andorra and Turkey that cover trade in industrial products 
(HS 25-97) and one with San Marino that covers all goods (except coal and steel). It is currently in 
the process of negotiating an association agreement with Andorra, Monaco and San Marino (AMS) 
the aim of which is t o allow AMS to participate in the EU's internal market. The customs union with 
Andorra will be extended to cover agricultural products, while that with San Marino will be extended 
without a change in scope of product coverage. In June 2018, the Council dec ided that no further 
work regarding the modernization of the EU -Turkey customs union would be foreseen.  
 
Question 9:   
Taking into account that customs union between the EU and Turkey does not cover 
agricultural products, please elaborate on the plans and t imeframe for the expansion of 
product coverage. If there are no plans for such further expansion, may the EU please 
elaborate on the consistency of this customs union with the provisions of Article  XXIV:8 
of the GATT?  
 
EU reply:   
As indicated in the above  text, the Council decided that no further work for an expansion of coverage 
in the EU -Turkey Customs Union is presently foreseen. The EU -Turkey Association Council Decision 
No. 1/95 on implementing the final phase of the Customs Union was duly notified to  the WTO on 
22 December 1995. Article 26 of that Decision foresees further liberalisation of trade in agricultural 
products, which was realised in Decisions No. 1/98 and 2/2006 of the Association Council. WT/TPR/M/395/Add.1  
 
- 450 - 
 
  Consequently, and bearing in mind that trade in agr icultural products in any case only ever 
accounted for a small share of total trade between the Parties (most recently some 5 %), the 
agreement is consistent with GATT Article XXIV:8.  
 
Question 10:  
According to the Article XXIV:8 of the GATT "a customs uni on shall be understood to mean 
the substitution of a single customs territory for two or more customs territories, so that 
… substantially the same duties and other regulation of commerce are applied by each of 
the members of the union to the trade of terr itories not included in the union". 
Nevertheless, the EU concludes a number of regional trade agreements, where Turkey 
does not participate as a party to such respective agreements. Given such circumstances, 
could the EU please clarify, which mechanisms an d instruments allow the EU and Turkey 
to maintain substantially the same trade regime in respect of the third countries.  
 
EU reply:   
As part of the EU -Turkey Customs Union, Turkey undertook to follow EU commercial policy, in 
particular according to Articl es 12 and 13 of Decision No . 1/95 of the EU -Turkey Association Council. 
At the same time, the EU insists that its negotiation partners agree an FTA with Turkey parallel to, 
and consistent with, EU agreements with these partners. Several agreements have bee n concluded 
or are being negotiated according to this principle. Turkey thus gradually concludes free -trade 
agreements with those countries with which the European Union has concluded free -trade 
agreements.  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Me asures Directly Affecting Imports  
3.1.1 Customs procedures, valuation, and requirements  
 
Page 52, para 3.4  
DG TAXUD also continues to work on the EU Single Window (SW) environment for customs initiative, 
which was launched in 2012 with its first pilot proj ect and is currently in operation in nine member 
States. The SW initially incorporated the certificates for the Common Veterinary Entry Document 
and Common Entry Document. Last year, it incorporated new certificates i.e. the Forest Law 
Enforcement, Governa nce and Trade (FLEGT) licence, the Certificate of Organic Inspection (COI), 
the Common Health Entry Document for Plant Protection (CHED -PP). Other certificates are under 
integration (i.e. Ozone -Depleting Substances (ODS), Fluorinated Greenhouse Gases (f -gases) and 
Dual-Use Export Goods); implementation is targeted for early 2021 . 
 
Question 11: At what stage of development is the EU Single Window (SW)?  
 
EU reply:  
The EU Single Window environment for customs, as indicated by the Secretariat, is at a pilot p hase 
for the time being with 9 EU Member States using it. More information is provided at:  
https://ec.europa.eu/taxation_customs/general -information -customs/electronic -customs/eu -
single -window -environment -for-customs_en.  
 
Question 12: Will there be a common SW for all the EU member States or there will be 
individual (separate) SWs for each member State? If latter, how will the cooperation and 
coordination among such SWs be reached?  
 
EU reply:  
At the time of writing, the pilot project on the EU Single Window environment for customs focuses 
on a regulatory SW with a back -end solution at EU level enabling the automated validation by the 
EU national customs systems of supporting documents from partner competent a uthorities hosted 
in EU e -licensing systems. The target architecture of the overall EU Single Window environment for 
customs is still under elaboration in context of the preparation of the legislative package for the 
initiative  
 
Question 13:  As the SW pilo t project is currently in operation in nine EU member States, what are 
the plans and timelines for launching the operation of SW in the other EU member States?  
 WT/TPR/M/395/Add.1  
 
- 451 - 
 
  EU reply:  
The EU targets to propose EU legislation on the EU Single Window environment for cu stoms by early 
2022 with a view to a gradual implementation in the next decade.  
 
Question 14: Please, clarify the meaning of "Common Entry Document"?  
 
EU reply:  
This is a formality in the sanitary and phyto -sanitary area. It is to be noted that the Commo n Entry 
Document (CED) has been replaced by the Common Health Entry Document (CHED) by end of 2019. 
More information can be found about the CHED at:  
https://ec.europa.eu/info/law/better -regulation/initiatives/ares -2018-5253137_en.  
 
Question 15: Could the EU please elaborate on the scope and coverage of documents and 
procedures involved in SW mechanism?  
 
EU reply:  
As indicated in the above replies notably to question 11, there is a webpage which describes the 
formalities in scope of the EU SW environment in the short and medium term: 
https://ec.europa.eu/taxation_customs/general -information -customs/electronic -customs/eu -
single -window -environment -for-customs_en.  
 
3.1.1.1 Legal framework and electronic systems  
 
Page 53, para 3.10  
The Registered Export System  (REX) was implemented on 1 January 2017 to facilitate the origin 
procedures under the GSP and recent EU FTAs. It allows registered exporters to self -certify and 
make out a statement on origin. Another development was the implementation of the New 
Computer ised Transit System (NCTS). This System was designed to increase efficiencies and 
accelerate transactions for goods under transit procedures. It will be updated from Phase 4 to Phase 
5, with deployment foreseen during 2021 –23. There will be new processes f or "Incidents en route", 
i.e. if there is an incident during the transit operation, the economic operator must inform the nearest 
responsible customs office, which will register the incident in the system (in the current phase, this 
task is done by either the customs office of destination or the customs office of transit). A new role 
Customs office of exit for transit" will be introduced. This office will act as the exit frontier customs 
office in case of pure transit (transit not following an export proced ure), and address safety and 
security data and risk management. The declaration acceptance process will be extended, with the 
possibility of submitting the declaration prior to the presentation of the goods. The data structure of 
the information exchange m essages will be aligned with the EU Customs Data Model. Other minor 
adjustments will be made to the existing processes.  
 
Question 16:   
How does the New Computerized Transit System (NCTS) operate for non -EU businesses 
involved in transit procedures in the EU? Who has the responsibility to use the system in 
cases of transit from third countries to the EU? What modes of transportation are covered 
by the system?  
 
EU reply:  
The NCTS is used by EU Member States (MS) and Common Transit Convention (CTC) parties. 
Economic operators in the CTC countries can use all functions of the transit procedure.  
Economic operators of third countries can start an NCTS operation in an EU MS if  they are registered 
for an Economic Operators (EO) Registration and Identification number (EORI), or they can start a 
transit operation in a CTC contracting party if they have a Third Country Unique Identification 
Number (TCUIN) recognized by the contract ing parties.  
In any case the EO must have a customs guarantee valid in the EU and CTC contracting parties 
along the route of the movement. NCTS covers mainly the road and rail transport, and to smaller 
extent the road leg of certain air and maritime trans it movements (and possible to use for fixed 
pipelines and electricity).  
 WT/TPR/M/395/Add.1  
 
- 452 - 
 
  3.1.1.2 Trade facilitation  
 
Page 56, para 3.17  
Another trade -facilitating measure is the Smart and Secure Trade Lanes (SSTL) Pilot Project that 
was initiated in 2006 as a pilot to tes t end-to-end supply chain security instruments between the EU 
and China. The Project operates about 120 trade lanes involving 200 economic operators between 
16 maritime ports in certain EU member States and China. The Project has now entered into a 
third phase, whereby traders will have faster customs clearance with enhanced logistical processes. 
This is expected to result in a higher share of goods traded under the SSTL, thereby improving 
supply chain security and trade facilitation. The Project is expandi ng to other modes of 
transportation, in particular air and rail, and to involve more partner countries.  
 
Question 17:   
How can economic operators from third (partner) countries (apart from China and the EU 
case mentioned in para  3.17) that are also involved in supply chain services (e.g. with use 
of railway transport) participate in the pilot project? What are the EUs' pla ns for the 
expansion of the pilot project based on its results of use?  
 
EU reply:  
SSTL is a restricted pilot project agreed with China (and a limited number of Member States) under 
a specific framework and cannot be extended to other countries. Consequen tly, operators from third 
countries cannot participate in it. The EU is not in a position to reply to any question on expansion 
of this scheme before an evaluation has been done.  
 
3.1.1.3 Customs valuation  
 
Page 57, para 3.23  
No notifications were made to the Committee on Customs Valuation during the review period; the 
modifications made to the EU's valuation rules pursuant to the UCC remain outstanding.  
 
Question 18:   
When will the EU provide a notification on the modifications made to the EU's valuation 
rules pursuant to the UCC?  
 
EU reply:  
The EU is preparing the notification of the UCC's valuation legislation to the Committee on Customs 
Valuation. Moreover, in compliance with the TFA article 1.4 and 1.1.d), all legislation that refers to 
EU customs val uation under the EU Customs Code was notified to the WTO on 20 July 2017 
(notification amended on 6 March 2018). It is publicly available under the following reference: 
G/TFA/N/EU/1rev1 at https://tfadatabase.org/uploads/notification/NEU1R1_1.pdf . 
 
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.1.6.1 Anti -dumping and anti -subsidy measures   
 
Pages 78 -79, para 3.76  
The EU has emphasized the importance of WTO trade remedy rules as a legitimate tool to combat 
trade distortions and unfair t rade practices by others and, through its legislation, applies these 
measures with rigour and consistency. Indeed, the EU is a significant user of trade remedy measures 
as, historically, it ranks third overall among WTO Members in the imposition of anti -dumping 
measures since the WTO's inception and second for countervailing (CVD) measures, or anti -subsidy 
measures as the EU legislation refers to them. At the same time, the EU has generally been a low 
recipient of anti -dumping or CVD measures by other Membe rs, i.e. ranking 12th overall for anti -
dumping and 4th for CVD measures. According to the Commission, about 0.29% of total imports 
were impacted by anti -dumping or anti -subsidy measures in 2018.  
 
Question 19:  
Does the EU have plans to initiate a review of  current trade remedy measures addressing 
the circumstances of the withdrawal of the United Kingdom from the European Union 
("Brexit"), if any, what could be the framework for the mentioned review?  
 WT/TPR/M/395/Add.1  
 
- 453 - 
 
  EU reply:   
Whether existing measures will need to be rev iewed to take account of the withdrawal of the 
United  Kingdom from the European Union will need to be examined on a case -by-case basis. A public 
communication is planned to be issued on this matter in due time.  
 
Page 79, para 3.78  
The first set of changes  were introduced in 2017, and added language with respect to "normal value". 
In essence, this allows for the normal value to be determined by another method where there are 
state-induced distortions in the exporting country. In such circumstances, normal v alue is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of 
benchmarks such as international prices or costs in another representative country. A different 
methodology for determining the normal value is set out for  non-WTO Members.  
 
Question 20:  
The Russian Federation would like to get some clarifications with respect to 
Regulation  (EU) 2016/1036103 (hereinafter – Basic Regulation), as amended by 
Regulation (EU)  2017/2321 .104 
 
EU reply:   
As it is stated in Article 2(6а)(c) of the Basic Regulation, "Where the Commission has well-founded 
indications  of the possible existence of significant distortions as referred to in point (b) in a certain 
country or a certain sector in that country, and w here appropriate for the effective application of this 
Regulation, the Commission shall produce, make public and regularly update a report describing the 
market circumstances referred to in point (b) in that country or sector." (underlining added)  
 
Questio n 21:  
The Russian Federation is interested in the reasons that invite the Commission to 
"produce, make public and regularly update a report describing the market circumstances 
referred to in point (b) in that country or sector". Our understanding is that t he reasons 
are "well -founded indications" referred to in Article 2(6a)(c) of the Basic Regulation.  
 
Please explain, where does the Commission take these "indications" from? How are these 
"indications" determined to be "well founded"?  
 
Question 22:  
Article  2(6а)(c) of the Basic Regulation states: "Where the Commission has well -founded 
indications of the possible existence of significant distortions as referred to in point (b) 
in a certain country or a certain sector in that country, and where appropriate fo r the 
effective application of this Regulation , the Commission shall produce, make public and 
regularly update a report describing the market circumstances referred to in point (b) in 
that country or sector." (underlining added)  
 
Our understanding is that there are actually two preconditions for the Commission to 
"produce, make public and regularly update a report describing the market circumstances 
referred to in point (b) in that country or sector". First, the Commission should have 
"well -founded indications of the possible existence of significant distortions as referred 
to in point (b) in a certain country or a certain sector in that country". Second, it should 
be "appropriate for the effective application of [the Basic] Regulation" . 
 
Please confirm our understanding. Please explain, how does the Commission determine 
that production, publication and update of the report referred to in Article 6a(c) of the 
Basic Regulation is "appropriate for the effective application of [the Basic] R egulation"? 
Please provide examples of situations where production, publication and update of such 
report would not be appropriate for the effective application of the Basic Regulation.  
 
EU reply to Q 21 and 22:  
As regards the existence of distortions, t he Commission may find indications in any number of 
sources including primary sources (legislation of exporting country, policy documents etc.), studies 
by authoritative organisations (WB, IMF, OECD etc.), findings in previous trade defence 
 
103 Referred to in footnote 123 of the  Report by the Secretariat.  
104 Referred to in footnote 124 of the Report by the Secretariat.  WT/TPR/M/395/Add.1  
 
- 454 - 
 
  investigations (not only in the EU), authoritative academic studies, and others such as EU industry, 
expert papers, economic consultants, law -firms etc.  
 
The Commission has selected China and the Russia n Federation  for the first two reports as these 
countries account fo r the most anti -dumping cases in the EU. As regards the use of reports for the 
effective application of the legislation, it should be noted that it is the existence of distortions that 
is relevant to apply the methodology and not the existence of a report.   
 
The existence of a report this does not mean that in subsequent investigations distortions will 
invariably and automatically be investigated. Moreover, if in an anti -dumping investigation it is 
decided to examine distortions, this does not mean that the re will be an automatic conclusion that 
such distortion exists. Finally, a report does not conclude on the existence or non -existence if 
distortions in a given country or sector. A report is only a compilation of facts that can be relevant 
for such a deter mination. The actual determination on whether a distortion exists will only be taken 
at the end of an investigation and remains case specific.  
 
Question 23:  
As it is further stated in Article 2(6а)(c) of the Basic Regulation, "Such reports and the 
evidence  on which they are based shall be placed on the file of any investigation relating 
to that country or sector. Interested parties shall have ample opportunity to rebut, 
supplement, comment or rely on the report and the evidence on which it is based in each 
investigation in which such report or evidence is used. In assessing the existence of 
significant distortions, the Commission shall take into account all the relevant evidence 
that is on the investigation file."  
 
Please explain whether, in case evidence pr ovided within the framework of a specific 
investigation testifies the exact opposite of what is indicated in the report, the 
amendments will be made to the report. Should it be the case, how long would it take to 
introduce those amendments into the report?  Should it not be the case, would such 
evidence be taken into consideration in subsequent investigations, and, if so, how?  
 
EU reply:  
All relevant evidence pertaining to the existence of distortions in an exporting country, and which 
form the basis for a decision in an anti -dumping investigation, will be taken into account in each 
case. Where relevant, country reports will be updated in due course.  
 
Question 24:  
It is stated in Recital (3) of the Regulation (EU) 2016/1036 (Basic anti -dumping 
Regulat ion) that it was adopted inter alia  "in order to ensure a proper and transparent 
application of the rules of the Agreement on Implementation of Article VI of the General 
Agreement on Tariffs and Trade 1994 (1994 Anti -Dumping Agreement), the language of 
that agreement should be reflected in Union legislation to the best extent possible." Could 
the EU please explain the rationale behind crucial legal changes of the mechanism of 
normal value determination, for which reasons the EU was not satisfied with the pr evious 
wording of the Basic anti -dumping Regulation?  
 
EU reply:  
The reasons for the adoption of Regulation (EU) 2017/2321 are detailed in the recitals of that 
regulation. For instance, Recital 3 explains that, in light of experience gained in past procee dings, it 
was appropriate to clarify the circumstances in which significant distortions affecting to a 
considerable extent free market forces may be deemed to exist. In that respect, recital 3 stipulates 
that this is the case when reported prices or costs,  including the costs of raw materials and energy, 
are not the result of free market forces because they are affected by substantial government 
intervention.  
 
Question 25:  
Would the EU specify the reasons why there was no reference in the Regulation (EU) 
2017/2321 of 12 December 2017 amending Basic anti -dumping Regulation to the 
Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 
1994 though such reference was made during previous major overhaul of the EU TDI 
instruments?   
 WT/TPR/M/395/Add.1  
 
- 455 - 
 
  EU reply to Q 25 and 36 together:  
It is common ground that Regulation (EU) 2016/1036 was adopted "in order to ensure a proper and 
transparent application of the rules of the Agreement on Implementation of Article VI of the General 
Agreement on Tariffs and Trade 1994 (1994 Anti -Dumping Agreement) as recalled by  the 
Russia n Federation . There is no obligation or need to repeat that fact each time that regulation is 
amended.  
 
Question 26:  
Would the EU provide corresponding provisions of the 1994 An ti-Dumping Agreement 
under which the normal value could be determined by another method where there are 
state -induced distortions in the exporting country"?  
 
EU reply:  
The purpose of the current Trade Policy Review is not for the EU to offer interpretatio ns or views 
regarding the meaning of the provisions of the 1994 Anti -Dumping Agreement. In any event, the EU 
is of the view that the EU's Anti -dumping legislation is in conformity with the Agreement on 
implementation of Article VI of the General Agreement on Tariffs and Trade 1994.  
 
Question 27:  
According to Article 2 Paragraph 6a of the amended Regulation (EU) 2016/1036 "where 
the Commission has well -founded indications of the possible existence of significant 
distortions as referred to in point (b) in a certain country or a certain sector in that 
country, and where appropriate for the effective application of this Regulation, the 
Commission shall produce, make public and regularly update a report describing the 
market circumstances referred to in point (b ) in that country or sector. Such reports and 
the evidence on which they are based shall be placed on the file of any investigation 
relating to that country or sector. Interested parties shall have ample opportunity to 
rebut, supplement, comment or rely on  the report and the evidence on which it is based 
in each investigation in which such report or evidence is used. In assessing the existence 
of significant distortions, the Commission shall take into account all the relevant evidence 
that is on the investi gation file."  
 
While introducing the first set of changes in 2017 the European Commission issued first 
country report and stated that "the next country report will concern the 
Russia n Federation ".  
 
Please elaborate on the term "well -founded indications of the possible existence of 
significant distortions" and how this criteria is related with another one referred by the 
European Commission - the quantity of EU's anti -dumping investigations concerning  
selected country?  
 
EU reply:  
See reply to Q22  
 
Question 28:  
Which of the above -mentioned criteria the EU considered as prevailing while making 
decision on drafting country report on the Russia n Federation ?  
 
EU reply:  
See reply to Q22  
 
Question 29:  
Does EU have any plans to prepare country reports with respect to other WTO members?  
 
EU reply:  
The Commission will consider the preparation of further reports in due course.  
 
Question 30:  
Does the EU conduct any legal procedure involving EU member -states before 
issuing/preparing a country report or the European Commission has the exclusive 
competence to prepare, issue or approve such documents?  
 WT/TPR/M/395/Add.1  
 
- 456 - 
 
  EU reply:   
The reports are prepared by the C ommission and are Staff Working documents, which can serve as 
factual evidence for the conduct of anti -dumping investigations together with any other factual 
evidence collected and verified in the course of such investigations.  
 
Page 79, para 3.79  
The chan ges set out in the second amendment in 2018 are more numerous and diverse; the main 
elements are outlined in Box 3.2. As illustrated, the changes involve procedural aspects, such as 
shortening the time -period for provisional measures, and more substantial aspects, such as how the 
injury margins are calculated. For example, in calculating the non -injurious price, a minimum profit 
of 6% is included. Another new development is the ability to take into account the presumably higher 
costs of EU industry complian ce with social and environmental standards.  
 
Question 31:  
The Russian Federation would like to get some clarifications with respect to the Basic 
Regulation as amended by Regulation (EU) 2018/825 . 
 
Article 7(2a) of the Basic Regulation states: "When examini ng whether a duty lower than 
the margin of dumping would be sufficient to remove injury , the Commission shall take 
into account whether there are distortions on raw materials with regard to the product 
concerned." (underlining added)  
 
Article 7(2) of the B asic Regulation states: "The amount of the provisional anti -dumping 
duty shall not exceed the margin of dumping as provisionally established, but it should be 
less than the margin if such lesser duty would be adequate to remove the injury  to the 
Union indu stry." (underlining added)  
 
Article 9(4) of the Basic Regulation states: "The amount of the anti -dumping duty shall 
not exceed the margin of dumping established but it should be less than the margin if 
such lesser duty would be adequate to remove the injury  to the Union industry." 
(underlining added)  
 
Please explain, why did the drafters of Regulation (EU) 2018/825 decide to use different 
wordings, i.e. "sufficient to remove injury" in Article 7(2a) of the Basic Regulation and 
"adequate to remove the i njury" in Article 7(2) and Article 9(4) of the Basic Regulation? 
Do those wordings imply different standards of establishment whether the duty less than 
the margin of dumping can be applied? In case of positive answer please explain the 
difference.  
 
EU re ply: 
There is no difference implied in the use of different wording.  
 
Question 32:  
Article 7(2a) of the Basic Regulation states: "For the purposes of this paragraph, 
distortions on raw materials consist of the following measures: dual pricing schemes, 
expo rt taxes, export surtax, export quota, export prohibition, fiscal tax on exports, 
licensing requirements, minimum export price, value added tax (VAT) refund reduction or 
withdrawal, restriction on customs clearance point for exporters, qualified exporters list, 
domestic market obligation, captive mining if the price of a raw material is significantly 
lower as compared to prices in the representative international markets ." (underlining 
added)  
 
a) How would the European Commission determine what "international markets " are 
"representative " for the purpose of comparison of the prices of raw materials with the 
prices in those markets? In case it is planned to determine, whether an "international 
market" is "representative " on a case by case basis, please explain what criteria, if any, 
will the European Commission be guided by for that purpose.  
 
b) The wording "significantly lower " suggests that there must be some extent to which 
the prices actually  paid for the raw material are less than "the prices in the representative 
markets ", so that there could be a "distortion on raw materials". In other words, it is WT/TPR/M/395/Add.1  
 
- 457 - 
 
  enough to establish that the prices actually paid are lower, but it is also needed to 
demonst rate that the difference between the prices is "significant".  
 
Please explain, what difference does the European Commission deem "significant" enough 
to prevent setting the anti -dumping duty less than the margin of dumping? Should a case 
by case assessment  of such difference be intended, please explain what criteria will the 
European Commission be guided by for that purpose.  
 
EU reply :  
As suggested by  the Russia n Federation , these are case -by-case analyses that will be conducted and 
assessed on the basis of the factual evidence collected and verified in the course of the relevant 
investigations looking into these questions.  
 
Question 33:  
Article 7(2a) of the Basic Regulation states: "The investigation shall cover any distortion 
on raw materials ident ified in the second subparagraph of this paragraph, for the 
existence of which the Commission has sufficient evidence pursuant to Article 5."  
 
As we understand the main source of evidence needed for the European Commission to 
cover a "distortion on raw mat erials" in its investigation is the one provided in written 
complaint on behalf of the Union industry. Please confirm our understanding.  
 
In case the complaint does not include such evidence, can the Commission still cover 
"distortions on raw materials" in  its investigation? In such case what sources can the 
Commission use to obtain the evidence?  
 
EU reply:   
As stated in the legislation, the Commission will investigate any raw material distortions for which 
prima facie evidence is provided in the complaint.  It will also investigate any other raw material 
distortions found in the course of an investigation.  
 
Question 34:  
Article 23(1) of the Basic Regulation envisages that the European Commission shall 
present an annual report on the application and implement ation of the Basic Regulation 
to the European Parliament and to the Council. This Article also states: "The report shall 
include information about the application of provisional and definitive measures, the 
termination of investigations without measures, u ndertakings, reinvestigations, reviews, 
significant distortions  and verification visits, and the activities of the various bodies 
responsible for monitoring the implementation of this Regulation and fulfilment of the 
obligations arising therefrom." (underl ining added)  
 
Please explain, what information on "significant distortions" is the European Commission 
going to include in its reports to the European Parliament and to the Council? Will this 
information be different or similar to the ones in the reports o n significant distortions 
envisaged by Article 2(6a)(c) of the Basic Regulation?  
 
EU reply:   
The reporting on significant distortions in the Annual Report to the European Parliament and the 
Council will cover those distortions which are found in the contex t of individual investigations for 
which provisional and/or definitive measures were imposed in the course of the reporting year.  
 
Question 35:  
Could the EU please explain the rationale behind such fundamental review of the EU's 
trade defense instruments since 1995?  
 
EU reply:   
The changes to the EU's anti -dumping and anti -subsidy regulations were proposed in order to better 
equip the EU to deal with the challenges of the global economy and unfair competition from imports. 
Taking into account the interests of EU producers, users and importers alike, the changes were 
proposed to make the EU's trade defence instruments faster, more effective and more transparent.  
 WT/TPR/M/395/Add.1  
 
- 458 - 
 
  Question 36:  
Would the EU please specify the reasons why there is no reference in the Regulation (EU) 
No. 2018/825 amending Basic anti -dumping Regulation to the Agreement on 
Implementation of Article VI of the General Agreement on Tariffs and Trade 1994 though 
such reference was made during previous fundamental overhaul of EU TDI instrument s? 
 
EU reply:  
See reply to Q25  
 
3.1.6.2 Safeguards  
 
Page 84, para 3.91  
In 2019, the EU issued Regulation (EU) 2019/287, the horizontal bilateral safeguard regulation, 
allowing for the implementation of bilateral safeguard clauses and other mechanisms for the 
temporary withdrawal of tariff preferences in certain FTAs.135 The Regulation currently has three 
annexes for the FTAs with Singapore, Viet Nam, and Japan, thus operationalizing and establishing 
procedures for these bilateral safeguard clauses. It cont ains provisions on monitoring, initiation of 
an investigation, prior surveillance measures, imposition of provisional and definitive safeguards, 
confidentiality, etc. In future, it is expected to be expanded to other FTAs. This Regulation brings 
about a ch ange in practice and a rationalization as, previously, the EU established separate 
arrangements for each FTA.  
 
Question 37:  
The Russian Federation would like to get some clarifications with respect to the 
Regulation (EU) 2019/287.105 
According to Article 6(3) of Regulation (EU) 2019/287, "Where possible, the investigation 
shall be concluded within six months from the date on which the notice of initiation is 
published in the Official Journal of the European Union. That time limit may be extended 
by a further period of three months in exceptional circumstances."  
Could the EU please explain why does the EU Regulation (EU) 2019/287 envisage a period 
of six months for bilateral safeguard investigations? Why was this period considered 
sufficient for a bi lateral safeguard investigation?  
 
EU reply:   
While, as a general rule, Regulation (EU) 2019/287 envisages a period of six months to conclude its 
investigation, that time limit can be extended by a further period of three months. The EU considers 
this peri od sufficient to carry out an in -depth investigation considering the nature of the instrument. 
By contrast, Regulation (EU) 2015/478 requires that investigations concerning multilateral 
safeguards, i.e. investigations with a much broader scope, are normall y concluded in 9 months.  
 
Question 38:  
Article 2(4) of the Regulation (EU) 2019/287 states that "'Union industry' means either 
the Union producers as a whole of the like or directly competitive product who operate 
within the territory of the Union or Union  producers whose collective output of the like or 
directly competitive product constitutes a major proportion of the total Union production  
of that product." (underlining added).  
 
Please clarify what quantitative and qualitative criteria does the European  Commission 
apply for determining "a major proportion of the total Union production". Are those 
criteria applicable both for the determination of "a major proportion of the total Union 
production" for the purpose of bilateral safeguard investigations and f or the purposes of 
safeguard investigations conducted pursuant to Regulation (EU) 2015/478 ?106  
 
EU reply:   
The definition of the Union Industry in Article 2(4) of Regulation (EU) 2019/287 corresponds to the 
definition of the domestic industry laid down in Article 4.1(c) of the WTO Agreement on safeguards 
and is indeed identical to the definition laid down in Re gulation (EU) 2015/478. Similarly to the WTO 
Safeguard Agreement, the EU law does not define, neither in quantitative nor in qualitative terms, 
 
105 Referred to in footnote 135 of the Report by the Secretariat.  
106 Referred to in para. 3.90 of the Report by the Secretariat.  WT/TPR/M/395/Add.1  
 
- 459 - 
 
  what constitutes a major proportion. In assessing what is a major proportion, the EU complies with 
relevant WTO jurisprudence and WTO Appellate body reports.  
 
Question 39:  
According to Articles 11(1) -11(2) and 11(6) of Regulation (EU) 2019/287, a bilateral 
safeguard measure can be initially imposed for two years and then extended for two more 
years, with the total d uration of a bilateral safeguard measure not exceeding four years.  
 
According to Articles 19(1) and 19(5) of Regulation (EU) 2015/478, the duration of 
safeguard measures must not exceed 4 years, including the duration of any provisional 
measure. At the sa me time the total period of application of a safeguard measure, 
including the period of application of any provisional measures, the initial period of 
application and any prorogation thereof, may not exceed 8 years.  
 
Could the EU please explain why the dr afters of Regulation (EU) 2019/287 considered it 
sufficient to leave shorter periods of application for bilateral safeguard measures as 
compared to the time periods for safeguard measures applied under Regulation (EU) 
2015/487? How was it determined that s uch shorter periods would suffice for the 
purposes of bilateral safeguard measures?  
 
EU reply:   
While Regulation (EU) 2015/478 implements in EU law the provisions contained in the WTO 
Safeguards Agreement, Regulation (EU) 2019/287 reflects the provisions negotiated by the EU in its 
trade Agreements with third countries. Therefore, the safeguards provisions of these two Regulations 
might differ depending on the prevailing conditions and sensitivities of each bilateral or plurilateral 
trade Agreements.  
 
Page s 84-85, para 3.92  
In March 2018, the EU initiated procedures for a safeguard investigation on certain steel products. 
The final safeguard measures put in place involve 26 categories of steel products whereby TRQs 
have been established based on the level of imports over the last three -year period (2015 -17) plus 
5%. The Commission cited an increasing trend of imports of these products, the situation of the EU 
steel industry, and the risk of trade diversion from US measures besides overcapacity and increased 
use of trade -restrictive practices as the reasons for the initiation of the safeguard measure. 
Provisional safeguard measures were put in place in July 2018, and definitive measures in February 
2019. The implementing regulation was amended in November 2018 to remove several countries 
(Botswana, Cameroon, Eswatini, Fiji, Ghana, Côte d'Ivoire, Lesotho, Mozambique, Namibia, and 
South Africa) from the scope of the measures. In some cases, the TRQs were specifically allocated 
to a country, i.e. based on historical imports; otherwi se, a general TRQ is allocated on a first -come -
first-served basis. An additional duty rate of 25% is applicable for out -of-quota imports. The 
safeguard measure is expected to be in place for slightly less than three years; it is set to expire on 
30 June 20 21. This measure was notified to the WTO.  
 
Question 40:  
According to the paragraph and the Commission Implementing Regulation (EU) 
No. 2019/159 of 31 January 2019 imposing definitive safeguard measures against 
imports of certain steel products due to the restrictive U.S. Section 232 measures there 
was a high risk of further increase of imports resulting from trade diversion. It was also 
repeatedly noted in the European Commission statements that the safeguard 
investigation on steel imports is one of the th ree types of measures the Commission 
announced in response to the US restrictions on steel and aluminium. In this context, 
would the European Commission consider terminating the definitive measures if the U.S. 
Section 232 measures is no longer in place?  
 
EU reply:   
The EU refers to recital 161 of Commission Implementing Regulation (EU) No. 2019/159 of 
31 January 2019, where it noted that "any developments concerning the US Section 232 " could be 
considered as a change in circumstances that could warrant a r eview of the EU steel safeguard 
measures.  
 WT/TPR/M/395/Add.1  
 
- 460 - 
 
  Question 41:  
According to the WTO rules and Regulation (EU) No. 2019/159 the EU's safeguards on 
certain steel products under certain conditions are not applied to products originating in 
developing countries (Ann ex III to the Regulation 2019/159). Could the EU please 
describe the criteria used for compiling the list of developing countries and, in particular, 
those WTO members, which never claimed their developing status before and are not 
considered as developing  countries within the WTO framework?  
 
EU reply:   
In order to determine the list of developing countries for the purpose of the EU steel safeguard 
measures, the EU took into consideration a combination of factors such as: those WTO members 
that had self -declared themselves as developing or developed countries, countries benefitting from 
the EU General Scheme of Preferences as well as the level of development of countries based on the 
classification of international organizations, such as the World Bank and t he International Monetary 
Fund.  
 
Question 42:  
Could the EU please provide economic justification for the definitive safeguards measures 
to lapse in 2021?  
 
EU reply:  
The EU decided to introduce the safeguard measures for a period of slightly less than three years 
since it considered it initially adeq uate in order to remedy or prevent the circumstances established 
in Regulation (EU) 2019/159.  
 
Question 43:  
Following the review the Commission considered it necessary to replace country -specific 
TRQ for Category 25 (Large welded tubes) with a single glob al TRQ. It is mentioned in the 
Implementing Regulation (EU) 2019/159 of 26 September 2019 107 that this change in 
the TRQ system "was deemed in line with the Union interest, since it was more apt to limit 
the risk of potential shortage of supply stemming fro m an inadequate allocation of TRQs, 
while ensuring, at the same time, adequate diversity of supply and equal opportunities 
for all potential suppliers…". Could the EU please explain why this approach was applied 
in respect of Category 25 and not in respect  ofthe other categories with significant 
underuse of country -allocated TRQs?  
 
EU reply:   
The EU decided to introduce the safeguard measures for a period of slightly less than three years 
since it considered it initially adequate in order to remedy or prev ent the circumstances established 
in Regulation (EU) 2019/159.  
 
Question 44:  
Following the results of the review of the definitive measures reflected in the 
Implementing Regulation of 26 September 2019 (EU) 2019/159 the European 
Commission decided inter alia to adjust the TRQ allocation mechanism and reduce the 
liberalization pace for the second and third years of measures. It is mentioned in the 
Regulation that several interested parties asked the European Commission to provide a 
mechanism to deal with t he withdrawal of the United Kingdom from the European Union 
("Brexit"). Could the EU please elaborate on its' plans to address the situation with 
"Brexit" in the context of steel safeguards, the specific grounds for eventual review. Could 
the termination o f steel safeguards measures be possible scenario of such review?  
 
EU reply:   
The Withdrawal Agreement between the EU and the UK foresees a transition period during which 
the EU law – including the EU steel safeguard – continues to apply to and in the UK. Unless it is 
decided to extend it, this transition period ends on the 31 December 2020. It is therefore too early 
to consider at this stage any review of the steel safeguard for this purpose.  
 
 
107 Commission Implementing Regulation (EU) No. (EU) 2019/159, Recital (55) . WT/TPR/M/395/Add.1  
 
- 461 - 
 
  3.3 Measures Affecting Production and Trade  
3.3.1 Incentives  
3.3.1.1 EU -level subsidies  
 
Page 97, para 3.132  
The EMFF helps fishermen in the transition towards sustainable fishing; supports coastal 
communities in diversifying their economies; finances projects that create new jobs and improve 
quality of life along Eu ropean coasts; supports sustainable aquaculture developments; and makes it 
easier for applicants to access financing. It is used to co -finance projects, along with national 
funding. Each member State is allocated a share of the total EMFF budget, based on the size of its 
fishing industry. Once the Commission approves this fund, it is up to the national authorities to select 
the operations eligible for funding. The national authorities and the Commission are jointly 
responsible for the implementation of the fund. 
 
Question 45:   
Could the European Union please provide the list of operations eligible for funding selected 
by each Member State?  
 
EU reply:  
The EU does not keep such a list. Each Member State has selected from the EMFF Regulation the 
measures it intends to implement. All operational programmes can be found at : 
https://ec.europa.eu/fisheries/cfp/emff/country -files. Page 100, table 3.14 . 
 
Question 46 :  
Could the European Union please clarify what kind of state aid is provided for the mar itime 
transport? In what form this state aid is provided?  
 
EU reply:   
Public support in the maritime sector can be provided in a variety of forms. The form would depend 
on the beneficiary (transport service providers and ports) and the type of measure. This may include 
direct subsidies, compensation for the provision of publ ic service obligations, tax benefits and similar. 
Any public sector intervention must comply with EU State aid rules.  
 
Question 47 :  
Within what waters should maritime transport operate in order to receive the relevant 
state aid?  
 
EU reply:   
In general, there is no rule which would include or exclude a beneficiary on the basis of the waters 
in which it operates.  
 
3.3.2 Standards and technical requirements  
3.3.2.1 New Legislative Framework  
 
Pages 109 -110, paras 3.169 -3.172  
3.169. As part of the "Goods Pa ckage" and in order to address the matter of non -compliant products 
that do not meet EU requirements being placed on the EU market, thereby endangering consumers, 
the Commission also proposed a new regulation on compliance and enforcement to create a faire r 
internal market for goods through more cooperation among national market surveillance authorities. 
This new regulation was adopted on 20  June 2019 as Regulation (EU) 2019/1020213 and partially 
repeals Regulation (EC) No. 765/2008. It provides for informa tion-sharing mechanisms between 
national market surveillance authorities regarding illegal products and ongoing investigations. It will 
also help national authorities improve checks on products entering the EU. Since 30% of goods in 
the EU are imported, th e Regulation also provides for the reinforcement of inspections at ports and 
external borders.  
 
3.170. Under the NLF, one of the main tasks of the Commission is to bring harmonization legislation 
in line with the reference provisions of Decision No. 768/2 008/EC. The following directives and 
regulations were aligned with these reference provisions since the last Review: Medical devices – 
Regulation (EU) 2017/745; In vitro diagnostic medical devices – Regulation (EU) 2017/746; 
Unmanned aircraft systems – Delegated Regulation (EU) 2019/945; Accessibility requirements for WT/TPR/M/395/Add.1  
 
- 462 - 
 
  products and services – Directive (EU) 2019/882; and Fertilising products – Regulation (EU) 
2019/1009.  
 
3.171. An NLF directive requires member States to implement the legislation at national  level within 
a set time -frame. This is expected to give more flexibility to the member States, as they can reflect 
the principles of the legislation within their own legal and administrative frameworks.  
 
3.172. The alternative approach to product legisla tion in the EU (known as the "Old Approach"), 
where the authorities drew up detailed regulations containing all the required technical and 
administrative requirements for each type of product is still employed for certain products, such as 
motor vehicles. Other specific approaches to EU harmonization were developed in certain sectors 
(e.g. pharmaceuticals, chemicals, cosmetics, and construction products), and tailored to their 
particular needs.  
 
Question 48 :  
How does the New Legislative Framework (NLF) im pact on the registration, certification 
and conformity assessment procedures for rolling stock, signalling  equipment, wagons, 
containers and the other equipment used in railway transport?  
 
EU reply:  
The EU has a new rail framework (4th Railway package) for authorisation and certification of rail 
rolling stock, including signalling  systems based on Technical specifications for interoperability which 
we define through implementing acts.  
 
3.3.3 Sanitary and phytosanitary requirements  
 
Page 118, para 3.216  
Additional specific import requirements for bivalve molluscs, fishery products and composite 
products were also included. The import requirements laid down in this Regulation consider (as do 
the existing  rules laid down in Regulation (EC) No. 854/2004) the specific characteristics of certain 
products. They also consider the need for greater flexibility when certain products pose a lower level 
of risk to public and animal health.  
 
Question 49 :  
Could the E U please provide a definition for "lower level of risk ", as well as respective 
additional information on the criteria used to determine when a certain product poses a 
"lower level of risk to public and animal health "?  
 
EU reply:  
The issue raised concerns composite products. The way in which composite product s are categorized 
will change. Entry requirements will no longer be based on percentage of ingredients of animal origin 
but rather on the animal health or public health risk linked to the composite product itself.  
Article 12 of Commission Delegated Regula tion (EU) 2019/625 establishes three categories of 
composite products: (1) non shelf stable composite products, (2) shelf stable composite products 
that contain meat products, and (3) shelf stable composite products that do not contain meat 
products. The r equirements for entry into the Union of the three categories of composite products 
will be applicable as from 21 April 2021.  
 
The Commission identified products under category 3 as posing a lower level of risk to public and 
animal health, due to their comp osition and treatment applied (products stable at ambient 
temperature). While an official certificate will be required for composite products of categories 
(1) and (2), a private attestation will accompany composite products of category (3). The model 
certificate will be established in 2020. The elements to present in the attestation are described in 
Commission Delegated Regulation (EU) 2019/625 for public health aspects, and will be 
supplemented in 2020 by animal health requirements.  
 
Question 50 :  
Could the EU please explain how will greater flexibility be achieved in cases when "certain 
products pose a lower level of risk to public and animal health "?  
 WT/TPR/M/395/Add.1  
 
- 463 - 
 
  EU reply:   
The greater flexibility concerns, as explained in the reply to question 49, the fact that t hose products 
will be accompanied by a private attestation and not by an official certificate, but will be, in any 
case, controlled at the Border Control Post. It should also be noted that, according to the Article 
48(h) of Regulation 2017/625 a list of ve ry low risk composite products not controlled at the Borders 
and accompanied by a private attestation will be established by 2021.  
 
3.3.3.2 Live animals and animal products  
 
Page 120, para 3.230  
The Animal Health Law will apply from 21 April 2021. It prov ides for new animal health requirements 
for entry into the EU of animals and their products, but it does not make significant changes to the 
existing system. Under the currently applicable legislation, to export live animals and germinal 
products, products  of animal origin for human consumption, animal by -products and derived 
products to the EU, the competent authority of the exporting country must be recognized as being 
able to "ensure credible inspection and controls throughout the production chain, which  cover all 
relevant aspects of hygiene, animal health and public health" and provide adequate guarantees. In 
addition, the country of origin must: be authorized, i.e. listed for entry into the EU for the specific 
species of animals or animal products; and,  where appropriate, have an approved residue plan for 
the relevant animal species, a Salmonella control programme for poultry and poultry products, and 
meet other requirements depending on the animal and/or product.  
 
Question 51 :  
Could the EU please provide additional information on the "adequate guarantees ". What 
guarantees will be considered as "adequate "?  
 
EU reply:  
The term "adequate guarantees" is not used in the Animal Health Law in relation to lists of third 
countries. The provisions relevant for animal health purposes, including the guarantees regarding 
animal health, are laid down in Article 230(1) of the Animal Health Law. In addition to that, for public 
health or other purposes the relevant provisions are laid down in Article 127 of the Regulation (EU) 
2017/625 of the European Parliament and of the Council on official controls.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and fisheries  
4.1.1 Agriculture  
4.1.1.2 Agricultural policies  
4.1.1.2.1 Domestic suppo rt 
4.1.1.2.1.2 Internal market support measures  
 
Pages 179 -180, para 4.67  
To address the fast evolution in the organic sector, a new regulation on organic production and 
labelling was adopted in May 2018. This will apply from 1 January 2021. According to t he 
Commission, it was designed to modernize the sector, harmonize rules, and ensure fair competition 
for farmers, while preventing fraud and maintaining consumer confidence. Production rules should 
be simplified and the control system strengthened. It shou ld also operate a shift from the principle 
of equivalence to the principle of conformity: producers from third countries should be required to 
comply with the same set of rules as those prevalent in the EU. The new rules also set out 
simplification element s, such as the establishment of a procedure exempting low -risk operators from 
the yearly control, and the introduction of the group certification scheme for small producers, with 
a view to reducing administrative and certification costs. The reform also in cludes a wider range of 
products eligible for organic certification84, as well as new rules to facilitate the conversion to organic 
production.  
 
3.3.4 Competition policy  
3.3.4.2 Mergers and acquisitions  
 
Page 128, para 3.260  
In early 2019, the Commission p rohibited the merger of Siemens and Alstom. Based on an in -depth 
investigation, the Commission found that the merger would have reduced competition in some 
signalling markets and in very high -speed trains, depriving customers of choice of suppliers and 
products. No appropriate remedy had been proposed, so the proposed merger was blocked. As WT/TPR/M/395/Add.1  
 
- 464 - 
 
  explained by Commissioner Vestager: "Siemens and Alstom are both champions in the rail industry. 
Without sufficient remedies, this merger would have resulted in higher p rices for the signalling 
systems that keep passengers safe and for the next generations of very high -speed trains".  
 
Question 52 :  
How does Siemens and Alstrom case impact possible mergers and acquisitions with the 
participation of major foreign companies from non -EU countries in the railway sector? 
Does this case set a certain threshold or a rule of a non -allowable Merger and acquisition 
(M&A) action in railway sector?  
 
EU reply:   
The European Commission's decision of 6 February 2019 in the Siemens/Alstom  case does not alter 
the standard of review for mergers in the railway sector, regardless of whether they involve EU or 
non-EU acquirers. The Commission's decision has been adopted under the EU Merger Regulation, 
which provides that " concentration [s] which  would significantly impede effective competition, in the 
common market or in a substantial part of it, in particular as a result of the creation or strengthening 
of a dominant position, shall be declared incompatible with the common market ". 
 
Prohibition decisions are rare and are only adopted in cases in which, as in Siemens/Alstom, parties 
to a concentration do not offer remedies adequate to solve competition concerns.  
 
3.3.6 Government procurement  
 
Page 135, para 3.279  
In 2015, total general  government public procurement expenditure on works, goods and services in 
the EU (excluding utilities) amounted to EUR 2,015.3 billion (above and below public procurement 
thresholds), or about 14% of GDP, with some EUR 350 billion published on the Tenders  Electronic 
Daily (TED) supplement to the Official Journal of the EU. Including defence and utilities, the total 
value of government procurement in the EU and published on TED is about EUR 450 billion i.e. 3.1% 
of the EU's GDP. Almost half of the EU's Stru ctural and Investment Funds (ESI), worth over 
EUR 450 billion, are spent via public contracts for the period 2014 -20  
 
Question 53:   
Could the EU please clarify, what is the percent of SOE's procurement in the total value of 
the EUs' procurement?  
 
EU reply:   
The estimated value of tenders published in TED for the procurement of utilities in the EU in 2017 
amounts to 108 billion euros, which represents about 20% of the total value of tenders published in 
TED in that year. The most recent available data are presented in the European Commission's "Public 
Procurement Indicators 2017", available for download at : 
https://ec.europa.eu/docsroom /documents/38003 .  
 
Page 136, para 3.287  
The 2014 Directives mandate a gradual transition to e -procurement. The electronic publication of 
procurement notices ("eNotification") and electronic access to tender documents ("eAccess") are 
mandatory since April 2016. The electronic submission of bids ("eSubmission") is mandatory since 
October 2018. Besides fulfilling these obligations, member States are using this opportunity to 
further enhance their eTendering systems, with the final aim of digitalizing the whol e public 
procurement life -cycle.  
 
Question 54:   
Could the EU please clarify what timeframes are envisioned for "digitalizing the whole 
public procurement life -cycle "? 
 
EU reply :  
The timeframe for the digitization of those stages of the public procurement life-cycle that are not 
covered by the European legal framework fall under the discretion of each Member State. 
Nevertheless, most Member States are moving towards digitizing the whole public procurement 
life-cycle, and many of them already have the digita l capabilities in place to cover both pre -award 
and post -award phases.  
 WT/TPR/M/395/Add.1  
 
- 465 - 
 
  Page 139, para 3.300  
Public authorities can choose among different procedures, including: open procedure, when all 
eligible economic operators may submit a tender; restricted procedure , when the contracting 
authority invites tenders from a selected group of those that respond to the call for competition; 
competitive procedure with negotiation, which is similar to a restricted procedure followed by 
negotiations with the selected economic  operators; and competitive dialogue, when the contracting 
authority enters into a dialogue with a selection of the suppliers that responded to the call for 
competition in order to find a suitable product or service to meet its needs. Tenders are then invi ted 
from a selection of bidders, and from innovation partnerships under which a selection is made from 
suppliers that responded to the call for competition followed by negotiations for search and 
innovation projects aimed at meeting the needs identified by  the contracting authority that cannot 
be met by existing solutions.  
 
Question 55:  
Could the EU please provide statistics on the number of contracts awarded and the 
respective value of contracts awarded by each procurement method indicated in 
para. 3.300 ?  
 
EU reply:   
The percentage of calls for procurements in the EU in 2018 by procurement method can be estimated 
as follows: Open procedure: 91%; Competitive procedure with negotiation: 6%; Competitive 
dialogue: 0.15%; Restricted procedure: 2%.  
 
Page 143, para 3.313  
Similarly, the chapter on procurement of the EPA of the EU with Japan incorporates the GPA as part 
of the Agreement, and its norms apply mutatis mutandis . It goes beyond the text of the GPA, in that 
it puts in place further transparency mechanisms, refers more explicitly to environmental 
considerations, and sets additional norms on review mechanisms. The parties also agreed to 
additional coverage. For instance, Japan opened its procurement market of the railway sector, 
hospit als, academic institutions and electricity distributors to EU economic operators. At the local 
and regional level, Japan extended the coverage to 54 "core cities" with more than 300,000 
inhabitants. The EU, in turn, offered Japan partial access to the proc urement market of 
transportation equipment in cities, such as trains for metro systems and facilities for overland 
railways. Coverage was also enhanced through lowering the thresholds (on the part of Japan).  
 
Question 56:  
Could the EU please further elabo rate on the preferences given to Japan as part of the 
government procurement deal in railway sector under GPA? Under which terms will Japan 
get access to the EU railway market?  
 
EU reply:   
Japan is getting access to the railway procurements specified in p oint 4 of Section A of Part 2 of 
Annex 10 of the EPA, i.e. railways facilities and certain rolling stock. There is a table setting out in 
precise detail the items that are covered. Japan obtains access to these procurements according to 
the framework of ru les laid out in the GPA and the EPA.  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.3 Measures Affecting Production and Trade  
3.3.7 Intellectual property rights  
3.3.7.2 Industrial property  
3.3.7.2.3 Trademarks  
 
Page 152, para 3.354  
The new rules also removed  the graphical representation requirement for trademarks.441 Instead, 
signs can be represented in any appropriate form using generally -available technology, as long as 
the representation is clear, precise, self -contained, easily accessible, intelligible, d urable and 
objective. This enables applicants to use electronic file formats, e.g. widely -used image and sound 
file formats such as jpeg and mp3, in the registration process. The new requirements are intended 
to modernize the system, and to reduce the rate  of objections related to formalities.  
 WT/TPR/M/395/Add.1  
 
- 466 - 
 
  Question 57:  
The Review states that common electronic file formats may be used for the purposes of 
registration. Is it is possible to consider applications that employ 3D -models of 
trademarks, and are there any pla ns to increase the use of respective formats?  
 
EU reply:   
According to Article 4 of Regulation (EU) 2017/1001 (EUTMR) an EU trade mark may consist of any 
signs, in particular (…) the shape of goods or of the packaging of goods, provided that they fulfil t he 
function of a trade mark and can be represented on the Register in a manner which enables the 
competent authorities and the public to determine the clear and precise subject matter of the 
protection afforded to its proprietor.  
Article 3(3)(c) of the Com mission Implementing Regulation (EU) 2018/626 (EUTMIR) further 
provides that "in the case of a trade mark consisting of, or extending to, a three -dimensional shape 
(…), the mark shall be represented by submitting either a graphic reproduction of the shape,  
including computer -generated imaging, or a photographic reproduction. The graphic or photographic 
reproduction may contain different views. Where the representation is not provided electronically, it 
may contain up to six different views". Where the repre sentation is provided electronically, the 
Executive Director of the European Union Intellectual Property Office shall determine the formats 
and size of the electronic file as well as any other relevant technical specifications (see Article 3(5) 
EUTMIR). Fo r shape marks these are JPEG, OBJ, STL, X3D. Whether there will be an increase in the 
use of these formats will depend on how much use the applicants will make of them.  
 
3.3.7.2.4 Geographical indications  
 
Pages 153 -15, paras 3.359, 3.361  
3.359. As regards GIs of products of non -EU origin, they may be protected in the EU either through 
direct application or by means of inclusion in FTAs. In the former, the application may be sent either 
directly, or through the authorities of the country wh ere the geographical area is located, to the 
Commission. No fees are required for applications from third countries.  
 
3.361. Given the importance of GIs for the EU's external trade, the Commission sought to include a 
comprehensive section on GI protection  for agricultural products in the more recent generation of 
FTAs. As a consequence, a large number of EU and third -country GIs are now protected through 
bilateral and regional agreements.450 The following agreements with GI coverage were finalized or 
have entered into force since the last Review:  
 
• the EU -Japan EPA recognizes the special status of, and offers protection on the Japanese 
 market to, 210 European agricultural GIs. In turn, the EU offers protection for 56 Japanese 
 foodstuff, wine or spirit nam es;  
• the draft FTA between the EU and Singapore provides that Singapore will strengthen its 
 existing GI regime by setting up a system to register GIs in Singapore. Once registered in 
 Singapore, around 190 GIs for wines, spirits and certain agricultural p roducts will enjoy levels 
 of protection equal to those in the EU;  
• once in force, the FTA between the EU and Viet Nam will protect 169 European and 
 39 Vietnamese GIs451; and  
• the agreement in principle reached by the EU and Mercosur in June 2019 on the trade part of 
 an agreement foresees the protection of some 350 European GIs. The EU will also protect 
 some 220  names of traditional Mercosur products such as Cachaça (a Brazili an distilled spirit) 
 or Mendoza wine from Argentina.  
 
Question 58:  
Could the EU please provide a more detailed information on the protection of geographical 
indications via inclusion in FTAs? Is application filing and inclusion in a trade agreement 
consi dered as equivalent grounds for legal protection? Is there any examination and/or 
registration provided for GIs included in trade agreements? Is there any difference in the 
scope of protection and enforcement tools for GIs depending on the grounds for lega l 
protection?  
 
EU reply:   
The level of protection of GIs provided by EU legislation includes:  
 WT/TPR/M/395/Add.1  
 
- 467 - 
 
  • any direct or indirect commercial use of a name in respect of products not covered by the 
 registration;  
• any misuse, imitation or evocation, even if the true or igin of the products or services is 
 indicated or if the protected name is translated or accompanied by an expression such as 
 "style", "type", "method ", "as produced in ", "imitatio n" or similar, including when those 
 products are used as an ingredient;  
• any other false or misleading indication as to the provenance, origin, nature or essential 
 qualities of the product and any other practice liable to mislead the consumer as to the true 
 origin of the product.  
 
In agreements concluded with third-country partners, the EU aims at ensuring the level of protection 
similar to the one above while the outcome depends on each negotiation and could involve certain 
adaptations, which take into account the specificities of the other contracting party's  system.  
 
In the EU, it is the responsibility of Member States to ensure an adequate protection in the EU's 
territory, of GIs both of EU origin and of third country origin. Member States are obliged to have 
procedures in place to ensure the effectiveness a nd appropriateness of official controls and other 
official activities across their territories. In case of suspicion of non -compliance, the competent 
authorities of the Member State perform investigations in order to confirm or to eliminate that 
suspicion.  Where necessary, actions shall include intensified official controls on goods and operators 
and/or the official detention of goods. Where the non -compliance is established, the Member State 
shall take the necessary action to determine the scope of non -compliance, to establish 
responsibilities, to ensure that the non -compliance is remedied and to prevent further occurrences 
of such non -compliance. Infringements of the established rules are subject to effective, dissuasive 
and proportionate penalties at Memb er States' level throughout the Union. The European 
Commission verifies the Member States' control procedures, which include inter alia  in situ controls 
and audits.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and fisheries  
4.1.1 Agriculture  
4.1.1.2 Agricultural policies  
4.1.1.2.1 Domestic support  
4.1.1.2.1.2 Internal market support measures  
 
Page 177, para 4.57  
The sugar quota regime, introduced in 1968, came to an end on 30 September 2017. White sugar 
remains eligible for private storage. W hile this provision was maintained it has not been used thus 
far. The existing provisions for agreements between EU beet producers and sugar processors, 
including value -sharing clauses, are maintained.  
 
Question 59 :  
Could the EU please clarify whether it plans to resume sugar quota regime and if so, under 
which circumstances?  
 
EU reply:  
The sugar quota regime ended on 30 September 2017. There are no plans to reinstate a sugar quota 
regime.  
 
Page 177, para 4.58 -4.59 
From 2017 to 2019, the EU continued to adopt measures to address animal disease and quarantine 
pest outbreaks, and, in particular, the wave of highly pathogenic avian influenza (HPAI) and African 
swine fever in wild boar and domestic pigs outbreaks confirmed on its territory over the last years . 
This included the co -financing of specific measures and veterinary programmes to prevent, control, 
eradicate and compensate for the losses and damage caused by animal diseases and plant pests 
pursuant to available instruments in addition to EU member Sta tes' national aid.  
From 2017 to 2019, the EU also enacted exceptional measures to compensate farmers for economic 
losses resulting from the sanitary crises in the poultry and pigmeat sectors, in addition to the 
instruments already available to face such s ituations.  
 WT/TPR/M/395/Add.1  
 
- 468 - 
 
  Question 60 :  
Could the EU please provide further information about support measures in response to 
African swine fever in the EU?  
 
EU reply:  
The Commission provides substantial financial support to Member States and certain non -EU 
countries for fighting ASF. EU co -funding is provided in the framework of emergency measures and 
veterinary programmes for which the legal framework is defined in Regulation (EU) No . 652/2014 
of the European Parliament and of the Council of 15 May 2014 (Article s 6, 8, 9 and 11). The main 
measures co -funded are: sampling and testing (surveillance in domestic pigs and wild boards), 
compensation for the value of domestic animals slaughtered or culled, removal of wild boar 
carcasses, disinfection, awareness campaign.  
 
Due to a series of outbreaks of African Swine Fever (ASF) in Poland, the European Commission 
adopted an exceptional support measure for the pigmeat market in Poland (Commission 
Implementing Regulation (EU) 2017/647 https://eur -lex.europa.eu/legal -
content/FR/ TXT/?qid=1580131377820&uri=CELEX:32017R0647 ).  
 
Poland was authorised to grant aid to producers in the pigmeat sector whose holdings were subject 
to animal health measures for control of ASF and located in areas listed in the Annex to the 
Regulation. The aid could only be used for the slaughtering of so ws (CN code 0103 92 11) and other 
pigs (CN code 0103 92 19) between 1 August 2016 and 30 November 2016,).  
The measure was eligible for Union part -financing up to 50% and for a maximum of 50,000 animals. 
The total EU contribution was EUR 58,623. In order t o increase the overall level of biosecurity in the 
geographical area, Poland had laid down new requirements. Considering those measures as 
contributing to the EU's pigmeat market as a whole, the Commission adopted an emergency 
measure. This support measure  was available for holders with not more than 50 animals of the 
porcine species, located in certain areas of Poland, when ending their pigmeat production due to 
new requirements in relation to ASF (Commission Implementing Regulation (EU) 2017/1536 
https:// eur-lex.europa.eu/legal -content/FR/TXT/?qid=1580131428621&uri=CELEX:32017R1536 ). 
The total EU contribution was EUR 963,385.  
 
Poland had to take all necessary measures to ensure the compliance with both Regulations and 
informed the European Commission abou t its implementation.  
 
Pages 178 -179, paras 4.60 -4.63 
4.60. Adverse weather conditions in 2017, 2018 and 2019 triggered exceptional responses at the 
EU level. In 2017, 15 member States were first allowed to increase advance payments to farmers 
affected by heavy rains and drought, before an exceptional aid package for a total amount of 
EUR 15 million, to be matched by national funds, was granted to Lithuania, Latvia, Estonia and 
Finland, following heavy rainfalls in the second half of the year. Higher advanc ed payments to 
farmers were also granted following drought conditions in the summer of 2018.  
 
4.61. On account of drought in 2017, exceptional rainfalls or snowfalls in late 2017 and the beginning 
of 2018, and drought again in the summer of 2018, affecting  several member States, derogations 
were also granted in relation to certain greening rules (crop diversification and EFAs). Similar 
measures were announced on 25 July 2019 as a result of the new wave of drought conditions.  
 
4.62. These exceptional measure s came in addition to the instruments already available to face such 
situations, including rural development risk management tools, and options provided to fund 
investment costs to restore agricultural land and production potential damaged in the case of n atural 
disasters.  
 
4.63. Agricultural state aid rules also provide that aid of up to 80% of the damage caused by drought 
(or up to 90% in Areas of Natural Constraints) can be provided, subject to certain specific conditions, 
and that the purchase of fodder  can qualify for aid as income loss. Several member States announced 
emergency compensations in this regard for farms affected by the drought.  
 
Question 61 :  
Could the EU please provide justification for classifying programs (in response to adverse 
weather  conditions) under Article 6 and Annex 2 of the Agreement on Agriculture?  
 WT/TPR/M/395/Add.1  
 
- 469 - 
 
  EU reply:  
None of these aid schemes have been notified in a DS:1 notification yet, and therefore have not yet 
been classified under any of the Boxes of the Agreement on Agricultur e. 
 
Pages 179 -180, para 4.67  
To address the fast evolution in the organic sector, a new regulation on organic production and 
labelling was adopted in May 2018. This will apply from 1 January 2021. According to the 
Commission, it was designed to modernize t he sector, harmonize rules, and ensure fair competition 
for farmers, while preventing fraud and maintaining consumer confidence. Production rules should 
be simplified and the control system strengthened. It should also operate a shift from the principle 
of equivalence to the principle of conformity: producers from third countries should be required to 
comply with the same set of rules as those prevalent in the EU. The new rules also set out 
simplification elements, such as the establishment of a procedure e xempting low -risk operators from 
the yearly control, and the introduction of the group certification scheme for small producers, with 
a view to reducing administrative and certification costs. The reform also includes a wider range of 
products eligible for  organic certification84, as well as new rules to facilitate the conversion to organic 
production.  
 
Question 62 :  
Could the EU please explain how a shift from the principle of equivalence within the new 
regulation on organic production can be consistent wi th the EU's WTO SPS obligations?  
 
EU reply:  
Organic production is not within the scope of the WTO SPS Agreement.  
 
4.1.1.2.3 Market access  
 
Page 185, para 4.89  
The Council also adopted, on 15 July 2019, a Decision on the signing of an agreement with the 
United States on the allocation of a share of 35  000 tonnes within autonomous TRQ of high -quality 
beef, as resulting from the revised memorandum of understanding signed on 21 October 2013.  
 
Question 63 :  
Could the European Union, please, provide trade statistics justifying such allocation?  
 
Question 64 :  
Could the European Union, please, identify Members having substantial supplying interest 
in the product concern ed under this TRQ?  
 
EU reply to Q 63 and 64:  
Information on the use of this high -quality beef TRQ can be found on the following web page:  
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/beef -
quota_en.pdf . 
 
Question 65 :  
Could the European Union, please, indicate how the Agreement between the EU and the 
United States on high -quality beef TRQ comply with the provisions of the chapeau of 
Article XIII:2 of the GATT 1994?  
 
EU reply:  
The agreement complies with GATT Article  XIII:2, notably (d), as the EU reached agreement with 
respect to the allocation of shares in the quota with all other contracting parties having a substantial 
interest in supplying the product concerned.  
 
4.1.2 Fisheries  
4.1.2.6 Structural support  
 
Page 1 97, para 4.118  
On 2 May 2018, the European Commission proposed a new EMFF budget (EUR 6.14 billion) for 
2021-27. The proposed EMFF budget will focus on four priorities: (i) fostering sustainable fisheries 
and the conservation of marine biological resources ; (ii) contributing to food security in the EU 
through sustainable and competitive aquaculture and markets; (iii) enabling the growth of a WT/TPR/M/395/Add.1  
 
- 470 - 
 
  sustainable blue economy and fostering prosperous coastal communities; and (iv) strengthening 
international ocean gov ernance and enabling safe, secure, clean and sustainably -managed seas and 
oceans.  172 The new proposed EMFF budget aims at simplifying the delivery of the Fund and 
providing greater flexibility to member States regarding their strategic priorities, instead  of 
"pre-defined" measures; aligning with the other EU structural and investment funds; broadening 
support for coastal communities; and support for international commitments for better international 
ocean governance at bilateral, regional and multilateral levels.  
 
Question 66:   
Could the European Union, please, describe policy principles of strengthening 
international ocean governance?  
 
EU reply:   
The International Ocean Governance agenda for the future of our ocean is about ensuring healthy, 
productive, safe, secure and resilient oceans following a cross -cutting and integrated approach built 
on strong partnerships, multilateral dialogue and international cooperation. This is a political priority 
of the EU as part of the European green deal and  an integral part of the EU's response to the 
2030 Agenda.  
 
Question 67 :  
What measures are supposed to be implemented with a view of "strengthening 
international ocean governance"?  
 
EU reply:   
The International Ocean Governance agenda brings 50 cross -cutting actions to 1) Improving the 
International Ocean Governance framework,  2) Reducing pressure on the ocean and seas and 
creating the conditions for a sustainable blue economy and 3) Strengthening the international Ocean 
Knowledge System under one umbrella.  
 
Three years into the delivery of the agenda some of the achievements w ith our partners up to date 
including for example:  
 
- EUR 590 million to bilateral and regional cooperation projects on sustainable fisheries, tackling 
 marine pollution and increasing climate change resilience, among others  
- the signature of the Agreemen t to prevent unregulated fishing in the High Seas of the Central 
 Artic Ocean  
- the All Atlantic Research Alliance.  
 
Page 197, para 4.119  
In addition to the EMFF, the member States may provide state aid to the fisheries and aquaculture 
sector, pursuant to  the guidelines on state aid (Section 3.3.1.2). State aid is, in principle, not 
compatible with the internal market (Article 107(1) of the TFEU), except for some cases such as 
de minimis aid and certain types of subsidies covered by the Fishery and Aquacul ture Block 
Exemption Regulation. De minimis state aid cannot exceed EUR 30,000 per beneficiary over three 
years, and cannot exceed 2.5% of the annual turnover on fisheries output per member State. In 
accordance with Article 2 of the Regulation, certain typ es of subsidies may be provided to SMEs for 
projects reflecting the objectives of the EMFF, with eligible costs that do not exceed EUR 2 million or 
if the amount of aid does not exceed EUR 1 million per beneficiary per year. If none of these two 
specific c ases is applicable, each member State must notify any state trading scheme to the 
Commission, declaring that it complies with the TFEU before it can be implemented. Moreover, tax 
exemptions from indirect taxes (e.g. excise duties) for energy products used for water navigation 
(including fishing) in the territorial waters of EU member States are granted in accordance with 
Article 14(1) (c) of the Council Directive 2003/96/EC. For example, fuel tax exemption for inland 
fisheries and commercial marine fishing in Estonia was notified to the WTO during the review period.  
 
Question 68 : Could the European Union please share the data on the amount of support 
provided under fuel tax exemptions?  
 
EU reply:   
The European Commission does not keep separate data on the a mount of support provided under 
fuel tax exemptions. Further information regarding fuel tax exemptions could be extracted from the 
text of the decisions concerning such measures. https://ec.europa.eu/competition/elojade/isef/ . WT/TPR/M/395/Add.1  
 
- 471 - 
 
  4.2 Energy  
 
Page 200, para 4. 129 
SOEs continue to play an important role in the EU's energy sector (Section 3.3.5).  
 
Question 69 :  
Could the EU please provide detailed information concerning participation of SOEs in the 
EU's energy sector?  
 
EU reply:   
The EU does not keep track of the role of SOEs in the energy sector in each and every Member State 
and across the different sub-sectors in which such SOEs might be active (electricity, oil, gas etc.).  
 
Page 202, paragraph 4.136  
In the Commission's view, progress was also made in the gas market, notably with the revision of 
the Gas Directive, according to which gas pipelines ent ering or leaving the European internal gas 
market must now comply with EU rules. In addition, the Commission can now ensure that member 
States' agreements with countries outside the EU comply with EU law before they are concluded. 
These measures are expect ed to increase the predictability of the single market for investors.  
 
Question 70:   
The amendments made by the Directive 2019/692 to Directive 2009/73/EC (Gas 
Directive) provide for inter alia  extension of the Gas Directive and certain associated rules 
to gas pipelines to and from third countries ("Import Pipelines"). Such Import Pipelines 
were previously outside the scope of the Gas Directive. Could the EU please explain the 
rationale behind this particular amendment to the Directive 2009/73/EC?  
 
EU repl y:  
Directive (EU) 2019/692 seeks to address obstacles to the completion of the internal market in 
natural gas which result from the non -application of Union market rules to gas transmission lines to 
and from third countries. The amendments introduced by t his Directive are intended to ensure that 
the rules applicable to gas transmission lines connecting two or more Member States are also 
applicable, within the Union, to gas transmission lines to and from third countries. This will establish 
consistency of t he legal framework within the Union while avoiding distortion of competition in the 
internal energy market in the Union and negative impacts on the security of supply. It will also 
enhance transparency and provide legal certainty to market participants, in  particular investors in 
gas infrastructure and system users, as regards the applicable legal regime.  
 
Question 71:   
Could the EU please elaborate why the amendments to the Gas Directive came into force 
specifically in 2019, when the only advanced project to be affected by such amendments 
was Nord Stream -2? 
 
EU reply:   
Directive (EU) 2019/692 is based on a legislative proposal by the European Commission of 
8 November 2017. The eventual date of adoption of Directive (EU) 2019/692 of 17 April 2019 reflects 
the duration of the ordinary legislative procedure pursuant to Article 291 of the Treaty on the 
Functioning of the European Union (TFEU). This procedure requires an agreement between the 
Council and the European Parliament as co -legislators and can feature m ultiple readings in both 
institutions. The average duration for acts adopted after the first reading (as in the case of Directive 
(EU) 2019/692) was 17 months .108 The procedure for the adoption of Directive (EU) 2019/692 ran 
for 18 months.  
 
Question 72:   
Could the EU please provide examples or elaborate on the plans regarding practical 
application of the abovementioned amendments to any gas pipelines, other than "Nord 
Stream -2", particularly when such application would significantly affect the project's 
econ omic model?  
 
 
108 For the current parliamentary term from July 2014 to December 2017 , cf. 
https://epthinktank.eu/2014/11/26/european -parliament -facts-and-figures/19 -lenght -of-codecision -2/. WT/TPR/M/395/Add.1  
 
- 472 - 
 
  EU reply:   
Further to Directive (EU) 2019/692, the Gas Directive 2009/73/EC is expressly applicable to all 
transmission lines connecting Member States with third countries. Member States have until 
24 February 2020 to transpose Directive (EU)  2019/692. After this date at the latest109, the operation 
of transmission lines connecting Member States with third countries on the territory of the Member 
States of the EU will have to comply with the requirements of the Gas Directive 2009/73/EC. These 
requirements include ownership unbundling, the granting of third -party access and transmission 
tariff regulation. The responsibility for the application and monitoring of these rules lies with the 
national regulatory authorities of Member States.  
 
4.3 Manuf acturing  
 
Page 209, para 4.170  
Several policies, programmes and initiatives, covering a wide variety of fields, contribute to 
EU industrial policy. Examples of initiatives with a budget envelope include249: the ESIF (six funds 
worth EUR 450 billion in 2014-20) (Section 3.3.1.1); Horizon 2020 (EUR 77 billion in 2014 -20); the 
CEF (EUR 30.4 billion in 2014 -20)250; and the programme for the COSME (over EUR 2 billion until 
2020). In addition, the Investment Plan for Europe and the EFSI aim to mobilize at lea st 
EUR 408.4  billion in private and public investment by 2020. Two recurring priorities across these 
programmes and initiatives are SMEs and innovation.  
 
Question 73 :  
Could the EU please describe the mentioned initiatives in detail and provide clarifications 
concerning the following: goals and priorities, types of support measures, duration of 
these measures, condition for receipt of the support etc.?  
 
EU reply:   
The d ifferent EU programmes and initiatives are publically available, a summary is detailed below.  
 
ESIF 
For the period 2014 -20, cohesion policy is financed by the European Structural and Investment 
Funds (ESIF). The Structural Funds have two components:  
 
• the E uropean Regional Development Fund (ERDF), providing financial support for the 
development and structural adjustment of regions, as well as territorial cooperation 
throughout the EU; and  
• the European Social Fund (ESF), set up in 1958 and seeking to contrib ute to the adaptability 
of workers and enterprises, access to employment and participation in the labour market, 
social inclusion of disadvantaged people, combating all forms of discrimination, and creating 
partnerships to manage reforms in employment.  
 
The other three funds constituting the ESIF are:  
 
• the Cohesion Fund, which supports exclusively less -developed Member States;  
• the European Agricultural Fund for Rural Development; and  
• the European Maritime and Fisheries Fund.  
 
HORIZON 2020  
Horizon 2020 is the financial instrument implementing the Innovation Union, a Europe 2020 flagship 
initiative. Horizon 2020 has the political backing of Europe's leaders and the Members of the 
European Parliament. It has an emphasis on excellent science and tackling socie tal challenges. The 
goal is to ensure Europe produces world -class science.  
Horizon 2020 is open to everyone, with a simple structure that reduces red tape and time so 
participants can focus on what is really important. This approach makes sure new project s get off 
the ground quickly – and achieve results faster. The EU Framework Programme for Research and 
Innovation will be complemented by further measures to complete and further develop the European 
Research Area.  
 
 
109 Member States can envisage an earlier application of the rules enshrined in Further to Directive (EU) 
2019/692.  WT/TPR/M/395/Add.1  
 
- 473 - 
 
  CEF 
The Connecting Europe Facility (CEF) is a key EU funding instrument to promote targeted 
infrastructure investment at European level.  It supports the development of high performing, 
sustainable and efficiently interconnected trans -European networks in the fields of transport, en ergy 
and digital services. CEF investments fill the missing links in Europe's energy, transport and digital 
backbone.  
 
COSME  
COSME aims to promote entrepreneurship and improve the business environment for SMEs.  
 
Page 215, para 4.192  
The EU's horizontal and principal regulation concerning chemicals is the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH). In addition, there is the Classification, Labelling 
and Packaging of Substances and Mixtures (CLP), and vertical r egulations for specific families of 
products, such as fertilizers, pesticides and biocides, detergents, explosives, pyrotechnic articles, 
drug precursors, pharmaceuticals, cosmetics, and food contact materials, or for specific areas, such 
as the workplace (workers' legislation framework and related directives on chemicals), industry 
(Industrial Emissions Directive) and air (Ambient Air Quality Directive).  
 
Question 74:   
How will the EU react to OECD's adoption of the gastric bioelution protocol - namely, ho w 
will the EU adapt the existing classifications/classification proposals to reflect/take into 
account bioelution? This question specifically refers to classification of substances for 
systemic health effects. Specifically, what will be the EU's approach t o classification of 
alloys and metals with CMR impurities (e.g. stainless steel and nickel metallic products 
containing more than 0.1% of cobalt metal as impurity)? Does the EU intend to revise the 
specific concentration limits for all proposed/existing cl assifications?  
 
EU reply:   
The EU sent a proposal to harmonise a bioelution method at OECD level and will continue the 
discussion with Member States and stakeholders on how to use this method when classifying alloys 
and metal compounds. If this method is approved, it could be used in the specific case of stainless 
steel, for example. Currently, the EU does not intend to revise the specific or generic concentration 
limits for all proposed/existing classifications.  
 
Question 75:   
What approaches does the EU apply with respect to the alloys' classification and does it 
intend to amend the non -scientific definition of alloys as simple mixtures?  
 
EU reply :  
The approach applied by the EU with respect to the alloys' classification is the same as the one of 
the UN GHS. We do not see the need to amend the definition.  
 
Question 76:  
Taking into account that a bioelution protocol has been submitted to OECD, what specific 
steps will the EU be undertaking to assure that bioaccessibility/bioavailability 
considerations are implemented into the classification of alloys in EU?  
 
EU reply :  
Please see reply to Question 74.  
 
Question 77:  
Does the EU plan to take bioelution tests into account in the context of refining 
classification of alloys for other routes of exposure (apart from the oral one)?  
 
EU reply :  
Indeed, the EU has started with the oral route as a pilot example, with the aim to cover other routes 
of exposure, subject to discussion with Member States and stakeholders on how to use this method 
when classifying alloys and metal compounds.  
 WT/TPR/M/395/Add.1  
 
- 474 - 
 
  Question 78:  
Regarding CLP regulation, could the EU please provide us the scientific data t aken into 
account when classifying chemicals and mixtures.  
 
EU reply :  
Under CLP, the classification of substances (be it self -classification by manufacturers, importers or 
downstream users or EU -wide harmonised classification through inclusion in annex VI to CLP based 
on an independent scientific opinion of ECHA's Risk Assessment Committee) should be based on all 
relevant available information on the physical, health or environmental hazard(s) the substance 
displays. CLP itself does not require the  generation of data for the purpose of classification, but sets 
the criteria for hazard classification based on data available for a substance. Certain data 
requirements for substances may be laid down in other relevant legislation, e.g. the horizontal 
REACH Regulation or the sectoral regulations on certain products, such as plant protection products 
or biocidal products, which lead to the generation of toxicity data that are also to be taken into 
account for classification under CLP. The classification of mixtures is based on available information 
on the mixture itself or on the substances contained in it, based on the principles established in 
Art. 6 of CLP. The classification of mixtures, including for alloys, follows the self -classification 
procedure und er the responsibility of industry.  
 
Question 79:  
Could the EU please provide legal acts' provisions setting the full range of scientific data 
that should be taken into consideration by the Risk assessment committee of ECHA 
(ECHA's RAC) when preparing its s cientific opinion?  
 
EU reply:   
In cases where a substance is subject to an EU -wide harmonised classification according to Art. 36 
of CLP, the initial proposal is submitted by a competent authority of an EU Member State, or – 
subject to certain conditions - by a manufacturer, importer or downstream user of a substance. 
According to the provisions in part 2 of Annex VI of CLP, the dossier for harmonised classification 
and labelling should follow the methodology and format described in relevant parts of secti ons 1, 2 
and 3 of Annex I to REACH. For pesticides and biocides, the main source of information for the 
classification is data submitted under the framework for approval of active substances and for other 
substances, the main source is the data submitted b y the registrant under REACH. The initial dossier 
is subject to a public consultation, during which additional available information may be submitted 
by interested stakeholders, before RAC issues an opinion on the harmonised classification of the 
substance . 
 
Question 80:  
Could the EU please elaborate to what extent WTO members' comments to draft 
regulations regarding CLP are taken into consideration under the Article 2.9.4 of the 
Agreement on TBT?  
 
EU reply :  
The Commission services look carefully at each single piece of scientific evidence (e.g., a new 
toxicological study) submitted by WTO members in order to assess its relevance and its newness. If 
considered relevant it can be taken into consideration when deciding on harmonised classification of 
a subst ance. We also standardly advise WTO members to submit any comments or information 
under the public consultation launched by ECHA (see reply to Question 79).  
 
Question 81:  
The Russian Federation stresses that hazard identification is a necessary step in 
classifying a substance. However, it has to be followed by risk assessment in order to 
ensure its successful conduction. Hazard identification does not necessarily imply the 
existence of health risks for particular material/application/route of exposure. 
Additionally, UN GHS stipulates that classification of chemicals should exclusively be 
based on full assessments of actual risk. Could the EU please elaborate how it plans to 
ensure consistency of its' system (for the classification of chemicals) with the UN G HS?  
 
EU reply :  
Classification and labelling are exclusively based on hazard assessment, and the CLP Regulation 
aims at ensuring that hazards of substances and mixtures are properly identified and communicated 
to the users of a chemical. Under the CLP Regulation, the intr insic hazard properties of chemicals WT/TPR/M/395/Add.1  
 
- 475 - 
 
  are assessed, regardless of their use and therefore their exposure and risk. Risks associated with 
the use of chemicals are typically regulated in so -called downstream – often product -specific – 
legislation.  
 
The CLP R egulation takes up the harmonised provisions and criteria for the classification and labelling 
of substances and mixtures established in GHS. We respectfully disagree with the statement made 
in this question that UN GHS would be based on a full risk assess ment. As clearly described in the 
Scope description in Section 1.1.2. of GHS, the two elements of GHS are (a) harmonized criteria for 
classifying substances and mixtures according to their health, environmental and physical hazards, 
and (b) harmonized haza rd communication elements, including requirements for labelling and safety 
data sheets. Thus, CLP is fully consistent with the UN GHS system.  
 
Question 82:  
The Russian Federation refers to the effective decision of the General Court of the 
European Union o f 7th March 2019 "The Kingdom Sweden vs the European Commission ". 
This decision obliges the European Commission to verify the completeness, coherence and 
pertinence of information provided by the ECHA Committee when it follows its' scientific 
or technical advice.  
 
We also note communication of the EU on "The implementation of the approach based on 
the precautionary principle should begin with a scientific evaluation, as complete as 
possible, and where possible, identifying at each stage the degree of scientific 
uncertainty". Taking into account these two documents, could the EU please elaborate 
how it applies precautionary principles when proposing chemicals and mixtures 
classification based on ECHA's RAC opinion?  
 
EU reply:   
One of the main aims of CL P is to ensure a high level of protection of human health and the 
environment. In this framework, hazard is the exclusive basis of the proposals for harmonized 
classification and labelling of substances (see also reply to Question 81). For the achievement of the 
aims of CLP, there is a legal obligation for the Commission under Article 37(5) CLP to include, without 
undue delay, [new or revised] classifications (entries) in Annex VI, on the basis of the scientific 
assessment carried out by RAC, which takes in to account all the information available in the dossier 
and in the course of the public consultation (see reply to Question 79). The precautionary principle 
is not applied under harmonized classification procedure but the RAC developed its scientific posit ion 
on the basis of the criteria and by applying the weight of evidence and expert judgment approaches.  
 
Question 83:   
Could the EU please elaborate on the reconsideration procedure of chemicals' 
classification, in case if new scientific information is iss ued that refutes ECHA's RAC 
opinion?  
 
EU reply :  
A re-examination of the classification can be considered only if new and relevant data from scientific 
studies becomes available that provides grounds for reviewing the classification. Only in that case 
would it be possible for a Member State to submit to ECHA a new dossier for revision of a harmonised 
classification and labelling, with a view to obtaining a new opinion by RAC.  
 
Question 84:   
Could the EU please provide additional information regarding the l egislation regulating 
activity of the Competent Authority for Reach and CLP (CARACAL)?  
 
EU reply :  
The appointment and functioning of the CARACAL ("Competent Authorities for the REACH and CLP 
Regulations") expert group is based on the relevant provisions of the REACH and the CLP 
Regulations. These include Article 121 of REACH and Article 43 of CLP, with regard to CARACAL's 
task of providing advice to the Commission and ECHA on the implementation and the functioning of 
these Regulations, and Article 53a(4) of CLP, in relation to the preparation of delegated acts.  
 WT/TPR/M/395/Add.1  
 
- 476 - 
 
  Question 85:  
Could the EU clarify, how and to what extent is the position of third countries taken into 
account when discussing the proposals regarding the chemicals classification during 
CARACAL meetings?  
 
EU reply:   
In accordance with the CARACAL Rules of Procedure,  (a maximum of) one representative of third 
countries may attend the meetings of CARACAL as observer. Moreover, documents that third 
countries may submit for the consideration of CARACAL, are distributed electronically by the 
Commission or ECHA. The Commis sion makes all efforts to take into account the positions expressed 
in the discussions of classification proposals, including comments from Member States, stakeholders 
and third countries, in the final legal text (See also reply to Question 80).  
 
4.4 Servi ces 
4.4.3 E -commerce  
4.4.3.1 E -commerce in the context of the Digital Single Market (DSM) Strategy  
 
Page 234, para 4.271  
Adapting the EU economy to the opportunities and challenges created by the digital transformation 
has been a major policy priority for the EU in recent years. The digital economy is regarded as a 
prominent example of an area in which the potential of the EU's Single Market has not been fully 
exploited. This is particularly important in view of the close complementarities between services 
provided by digital means and different sectors of the economy. According to a recent communication 
of the European Commission, "[d]igital technologies have become an integral part of the Single 
market to a point that the distinction between the traditiona l "brick and mortar" Single market and 
the 'digital' Single market is no longer relevant". Digital services are of critical importance to enable 
the EU to improve its performance in the services sector  
 
Question 86:   
Regarding to development of digital eco nomy and the creation of a digital single market, 
could the EU please elaborate on its' position regarding taxation in digital economy? What 
taxation principles are fundamental in the sphere of e -commerce facilitation and in terms 
of creating a predictable  and trustworthy e -commerce space? Could the EU please clarify 
why, for example, France has introduced digital tax on respective base, and how it 
corresponds with predictability for businesses?  
 
EU reply :  
A fair and effective taxation of the digitalised economy remains a top priority for the EU. The 
modernisation of our tax system is necessary to fully seize the opportunities of the digital economy, 
while also ensuring fair taxation and a level playing field. This is a pre -condition for all businesses 
to be able to innovate, develop and grow to support higher levels of productivity, employment and 
prosperity.  
 
The EU is fully and actively engaging in the international tax negotiations and fully committed to 
reaching a global solution by end of 2020. The C ommission welcomes the commitment at global 
level to work on both the reallocation of taxing rights and effective minimum taxation and looks 
forward to getting an agreement on the statement for a two -pillar approach within the Inclusive 
Framework. Only a c ombination of both can ensure a solution to problems linked to how countries 
share the profits of multinationals.  
 
In case of no agreement, the strong rationale for EU action will remain. In due time, the Commission 
will assess possible scenarios before pr oposing a way forward, taking into account the developments 
of the OECD discussion.  
 
The fundamental taxation principles in the sphere of the VAT e -commerce package are:  
 
- Ensuring taxation takes place where goods and services are consumed; and  
- Bringing the level playing field between EU businesses and non -EU businesses.  
 
As concerns the digital tax, the negotiation of EU proposals are on hold given that the international 
tax negotiations aimed at reaching a global solution are to be finalized in 2020. France and some 
other Member States, believe that the interim solution c ould be put in place at a national level to WT/TPR/M/395/Add.1  
 
- 477 - 
 
  ensure fair taxation of the digital economy in the short term. These measures are to be withdrawn 
once the agreement for the global solution is achieved.  
 
4.4.3.2 Improving access for consumers to online goods an d services across Europe   
4.4.3.2.5 Harmonization of contract and consumer protection laws  
 
Page 240, para 4.296  
A Directive on certain aspects concerning contracts for the supply of digital content and the provision 
of digital services and a Directive on certain aspects concerning contracts for the sale of goods406 
entered into force in June 2019. Member States have until 1 July 2021 to adopt and publish the 
measures provided for in these Directives, and are required to apply them from 1 January 2022.  
 
Question 87:   
Please clarify, for what purposes is the "digital content" defined separately from services 
and goods? Is different treatment provided for trade in goods, trade in services and trade 
in digital content? If so, how does such approach comply with the EU's WTO 
commitments?  
 
EU reply :  
Directive (EU)2019/770 regulates certain aspects of contracts for the supply of digital content and 
digital services. In particular, it lays down the requirements for the digital content or the digital 
service to be i n conformity with the contract, provides for the consumer's remedies in case there is 
a lack of conformity and specifies the modalities for the exercise of these contractual remedies. 
Although for clarification purposes both 'digital content' and 'digital services' are defined in Directive 
(EU)2019/770, the Directive does not make a distinction between digital content and digital services; 
the same rules apply to both. In addition, Directive (EU)2019/770 does not include a legal 
classification of contracts for the supply of digital content or digital services.  
 
Directive (EU)2019/771 regulates certain aspects of contracts for the sale of goods, and will replace 
as of 1 January 2022 the currently applicable Directive 1999/44/EC on Consumer Sales and 
Guarante es.  
 
Both Directives (EU)2019/770 and 2019/771 deal exclusively with the contractual rights and 
obligations of the consumer and the seller/trader who are parties to a business -to-consumer contract 
for the supply of digital content/digital services or for the sale of goods respectively. They do not 
introduce requirements or specifications for placing in the market goods or digital content and digital 
services. The above legislative framework is in line with the EU's WTO commitments.  
 
  WT/TPR/M/395/Add.1  
 
- 478 - 
 
  SINGAPORE  
PART I: QUE STIONS REGARDING THE  SECRETARIAT REPORT  
 
QUESTION:  
 
1.2.2 Fiscal governance and performance  
 
Page 20 (Para 1.16)  
 
1. On the digital services tax, could the EU update on its plans for an EU -wide digital 
services tax, and the timeline for discussion at the Council of the EU and 
implementation?  
 
EU reply:  
The negotiation of EU proposals for digital tax are on hold given t he international tax negotiations 
aimed at reaching a global solution that are to be finalized in 2020. EU is fully engaged in the debate 
with the international partners and is encouraged by the progress being made at the Organisation 
for Economic Co -opera tion and Development in this respect.  
 
2.4.2.1 Establishment of a cooperation mechanism for the screening  of FDI  
 
Page 47 -48 (Paras 2.59 – 2.63)  
 
2. The WTO Secretariat Report notes that 15 EU Member States have national FDI 
screening mechanisms. Do the other EU Member States have plans to develop and 
implement their own FDI screening mechanisms?  
 
EU reply:   
It is possible that other Member States hav e plans to develop and implement their own FDI screening 
mechanisms, however so far the European Commission has indeed received 15 notifications in 
accordance with Article 3(7) of the Regulation.  
 
3. The WTO Secretariat Report also notes the preparation and a doption of a legislation 
providing for the establishment of an EU framework for the screening of FDI (Regulation (EU) 
2019/452). Noting that there is a mechanism for cooperation110, could the EU elaborate on 
how the EU intends to reconcile potential differen ces between Members States, e.g. when 
Member States differ on their assessment on the potential effects of the investment on 
the factors as listed in Para . 2.63? Additionally, under Regulation (EU) 2019/452, 
Member  States are not required to adopt screenin g mechanisms or to harmonize them. 
Nevertheless, does the EU have plans to eventually harmonise the FDI screening 
mechanisms of its Member States?  
 
EU reply:   
Under the cooperation mechanism, EU Member States and the Commission will be able for the first 
time to exchange information and comments about likely effects on security or public order of a 
certain FDI. This will allow the member States in whose territory the FDI takes place to better identify 
and assess any such risks and take appropriate me asures under their domestic law. At this stage, 
there are no plans to harmonise the national FDI screening mechanisms. The Regulation itself shall 
apply only from 11 October 2020 and the first evaluation of the Regulation pursuant to Article 15 of 
the Regu lation is only due by 12 October 2023.  
 
4. Could the EU clarify if the list of critical technologies and dual use items as defined 
in point 1 of Article 2 of Council Regulation (EC) No. 428/2009 is intended to be an 
exhaustive list?  
 
 
110 The Regulation requires member States to  notify the Commission and other member States of any 
FDI that is undergoing screening, provides that other member States may submit comments to the member 
State undertaking the screening, and allows the Commission to issue an opinion to such member State,  on its 
own initiative or at the request of the screening member State. Such opinion is legally non -binding.  WT/TPR/M/395/Add.1  
 
- 479 - 
 
  EU reply:  
Regulation (E C) No . 428/2009, apply to dual use items, as defined in Art. 2(1) : "dual use items " as 
"items, including software and technology, which can be used for both civil and military purposes, 
and shall include all goods which can be used for both non -explosive uses and assisting in any way 
the manufacture of nuclear weapons or other nuclear explosive devices".  
Many dual -use items have been identified technically and listed in Annex I to Regulation (EC) 
No. 428/2009. Where appropriate in consideration of the int ernational security criteria applicable 
under the Regulation, controls under the Regulation may also apply to non -listed dual use items.  
Regulation (EC) No . 428/2009 does not mention "critical technologies".  
 
3.3.2.3 The role of standardisation for digital  technologies  
 
Page 113 (Para 3.193)  
 
5. The WTO Secretariat Report notes the publication of an annually -updated Rolling 
Plan for ICT Standardization. Could the EU share about (i) the process through which 
these priority technologies are determined, and (ii) the benefits to industry that have 
materialised following ICT standardization?  
 
EU reply:   
The Rolling Plan for ICT Standardisation (RP) gives an overview of the ICT domains where 
standardisation initiatives are considered relevant to support EU legislation and policies, and defines 
the most important standardisation actions that should be carried out by European or international 
standard development organisations.  
 
The Rolling Plan is an informal Commission document drafted with the support of a Task Force under 
the EC expert group "Multi -Stakeholder Platform for ICT standardisation" (MSP). The update of the 
Rolling Plan is done on a yearly basis with the involvement of all ICT stakeholders within the Task 
Force (not only the European standardisation organisations). The process is initiated b y 
Commission 's officials, who are outlining the current EU policies in which ICT standardisation may 
contribute. Then over the year, the Task Force members provide contributions. At the end, the 
Commission will validate all contributions and publish (norma lly in February) an update. The benefit 
for industry is that their active participation in this process can contribute to shape future 
standardisation work and priorities.  
 
Page 113 (Para 3.194, 3.196 – 3.198)  
 
6. Could the EU share more details on the European Commission's plans for a (i) 5G 
cybersecurity toolbox; (ii) proposed new legislation to address the ethical implications of 
Artificial Intelligence; and (iii) new Digital Services Act?  
 
EU reply:  
(i) In Mar ch 2019 the European Commission recommended111 measures to ensure a high level of 
cybersecurity of 5G networks across the EU. In October 2019, a high -level report on the coordinated 
risk assessment112 of 5G networks was published. Most recently on 29 January 2 020, the 
Commission endorsed113 the joint toolbox of mitigating measures agreed by EU Member States to 
address security risks related to the rollout of 5G. The Commission has been launching relevant 
actions within its competence and has been calling for key measures to be put in place by 
30 April 2020.  
The toolbox provides strategic and technical measures to put in place and mitigate the risks and 
threats identified to create a robust framework of security measures, which in turn will ensure an 
adequate level  of cybersecurity of 5G networks across the EU through coordinated approaches 
among Member States.  
 
(ii) On 8 April 2019, the High -Level Expert Group on Artificial Intelligence presented Ethics Guidelines 
for Trustworthy Artificial Intelligence. This follo wed the publication of the guidelines' first draft in 
December 2018, on which more than 500 comments were received through an open consultation. 
See the full guidelines here : https://ec.europa.eu/digital -single -market/en/news/ethics -guidelines -
 
111 Viewed at: https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=58154  
112 Viewed at: https://ec.europa.eu/commission/presscorner/detail/en/IP_19_ 6049. 
113 Viewed at: https://ec.europa.eu/digital -single -market/en/news/secure -5g-deployment -eu-
implementing -eu-toolbox -communication -commission . WT/TPR/M/395/Add.1  
 
- 480 - 
 
  trustworthy -ai. So far, legislation has not been proposed; however, the Commission envi sages 
publishing an AI White Paper on 19 February 2020.  
 
(iii) Internal deliberations for the Digital Services Act are not yet concluded. The Commission 
announced in its 2020 Work Programme "[a] new Digital Services Act [to] reinforce the single market 
for digital services and help provide smaller businesses with the legal clarity and level playing field 
they need. Protecting citizens and their rights, not least the freedom of expression, will be at the 
core of our efforts '". Any legal intervention will be preceded by in -depth evidence gathering and an 
impact assessment, as well as a broad open public consultation with all concerned stakeholders. A 
legislative proposal should be made by the end of the year. The ordinary legislative procedure will 
then follow  on the basis of the Commission 's proposal.  
 
3.3.7 Intellectual Property Rights  
 
Page 145 (Para 3.323)  
 
7. The WTO Secretariat Report notes "EU accession to the Geneva Act of the Lisbon 
Agreement on Appellations of Origin and Geographical Indications, proposed by the 
Commission in 2018, is expected to take place in 2019." According to the press release 
from the  European Council dated 7 October 2019, the EU acceded to the Lisbon Agreement 
on 7 October 2019. Could the EU (a) elaborate on the changes to its laws (if any) to enable 
compliance with the Lisbon Agreement (particularly in the area of protection of non -
agricultural products), and (b) how the EU's accession to the Lisbon Agreement could 
affect existing (and/or future) FTA relationships?  
 
EU reply :  
The EU adopted Regulation (EU) 2019/1753 of the European Parliament and of the Council of 
23 October 2019 on  the action of the Union following its accession to the Geneva Act of the Lisbon 
Agreement on Appellations of Origin and Geographical Indications, which was published in the Official 
Journal L 271 of 24.10.2019 (pages 1 -11). As regards the protection of ge ographical indications for 
non-agricultural products by the European Union in the context of the Geneva Act in particular, 
protection at Union level of geographical indications is currently not provided in respect of such 
products. However, a Member State which is already party to the Lisbon Agreement may maintain 
any existing registration in the International Register.  
 
It is premature to anticipate the details of the future relationship between protection of geographical 
indications in the Lisbon system and through bilateral or regional agreements. In any event, the 
Commission considers that the EU 's accession to the Geneva Act of the Lisbon Agreement will not 
be to the detriment of existing (and/or future) FTA relationships but rather would comple ment them.  
 
3.3.7.2.1 Patents  
 
Page 149 (Para 3.340)  
 
8. Regarding the Communication to the Institutions on Setting out the EU approach 
to Standard  Essential Patents published in 2017, which of the proposed measures have 
been implemented? Could EU please provide the implementation details of the measures, 
including the status and the latest plan to progress the implementation?  
 
EU reply:   
The Commun ication on Setting out the EU approach to Standard Essential Patents published in 2017 
proposes actions to increase transparency in order to facilitate the SEPs licensing negotiations. It 
also proposes common principles which should be used when valuing SE Ps technology and makes 
proposals for a balanced and predictable enforcement regime.  
In line with the Communication a Commission Expert Group on licensing and valuation of SEPs was 
established in 2018. A first report from the group is expected in 2020.  
The Commission also commissioned a number of studies, the results of which are already published 
or will be published soon:  
 
- a study to assess the feasibility of checks whether the patents are essential. The final report 
 will be presented at a workshop on  30 March 2020.  WT/TPR/M/395/Add.1  
 
- 481 - 
 
  - a study on the interrelation between open source and patents in standardization activities. 
 The report can be found here https://ec.europa.eu/jrc/en/science -update/relationship -
 between -open-source -software -and-standard -setting.  
- a stud y on the Governance of Standard Development Organizations (SDOs) and their Policies 
 on Intellectual Property Rights. The report can be found here 
 https://ec.europa.eu/jrc/en/publication/making -rules-governance -standard -development -
 organizations -and-their-policies -intellectual -property . 
 
9. For measures  pending implementation, could EU please provide the status and 
plans towards implementation, or any review being taken?  
 
EU reply:   
The Commission is currently monitoring the market developments with regard to licensing and 
valuation of standard essential  patents. On the basis of the studies and the report of the expert 
group, the Commission may conduct additional analysis and make further proposals. Those will be 
the subject of a public consultation/hearing/workshop.  
 
10. Will there be an update to the Commun ication document or an implementation 
update to the Communication?  
 
EU reply:   
No decision on an update has yet been made.  
 
3.3.7.2.4 Geographical indications  
 
Page 154 (Para 3.361, bullet point 2)  
 
11. The WTO Secretariat Report notes that "once registered in Singapore, around 
190 GIs for wines, spirits and certain agricultural products will enjoy levels of protection 
equal to those in the EU". We clarify that the number should more correctly be "around 
130" as to date, only 139 EU GIs have been r egistered.  
 
EU reply:  
As of today, there are 138 registered European GI names in Singapore that will also be protected 
through the Agreement.  
 
PART II: QUESTIONS REGARDING THE GOVERNMENT REPORT  
 
Introduction  
 
Page 3 (Para 1.5)  
 
12. On the enforcement of EU rights under negotiated Free Trade Agreements, could 
the EU clarify the exact roles and responsibility of the EU's proposed Chief Trade 
Enforcement Officer?  
 
EU reply:  
The Chief trade enforcement officer will be a new deputy Direc tor General in the directorate general 
for trade of the European Commission. As a deputy Director General, this person will supervise 
several directorates including the trade defense directorate. The work of this high -level Commission 
official will be also  to monitor and improve the compliance of EU trade partners with the 
commitments made in multi -lateral or bilateral trade agreements. This work will include a close 
monitoring of the implementation of commitments related to climate, environmental and labou r 
protection enshrined in EU bilateral trade agreements. The Chief trade enforcement officer will also 
regularly report on those issues to the European Parliament and the Council.  
 
3.12 The EU 's actions on climate change  
 
Page 13  
13. Regarding the European Commission's proposed European Green Deal, (i) how 
would the EU implement the proposed carbon border adjustment mechanism, (ii) what is 
the timeline for implementation, and (iii) will there be consultations with other WTO WT/TPR/M/395/Add.1  
 
- 482 - 
 
  members or discussions at relevant WTO Committees to ensure its compatibility with WTO 
rules?  
 
EU reply:  
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of a mbition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commi ssion has announced in the European Green Deal that, should differences in levels of 
ambition worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carb on leakage. It would be an 
alternative to the measures that currently address the risk of carbon leakage in the EU 's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and t hat this should include "developing effective measures to tackle carbon 
leakage in a WTO compatible way".  
A Carbon Border Adjustment mechanism is not designed to protect European industry from open 
competitions but rather to ensure the environmental integr ity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the border measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU 's climate policies. The internal market of the EU will stay open to foreign competition under 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, including the rules of the World Tr ade Organisation and our trade agreements.  
There is a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of eco nomic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading Sy stem.  
The EU will continue to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of e ngagement. The EU will continue to 
engage with the economies of the G20 that are responsible for 80% of global greenhouse gas 
emissions".  
 
3.14 The withdrawal of the United Kingdom from the European Union  
 
Page 16 (Para 3.51)  
 
14. In the scenario that the With drawal Agreement is ratified, could the EU provide more 
details of how third countries will be notified on the transition period, and if the modality 
of the notification provides for the consent or assent by third countries?  
 
EU reply:  
The Withdrawal Agreement entered into force on 1 February 2020 and provides for a transition 
period that will end on 31 December 2020, unless an extension of the transition period for up to 1  or 
2 years is agreed by the Parties. During transition, the full Eur opean Union "acquis" would apply to 
and in the UK as if it was still a Member State. This means that the UK would continue to participate 
in the EU Customs Union and the Single Market and all EU policies including trade policy  
The EU international agreemen ts form part of the "acquis" covered by the transition. The UK is bound 
by the obligations stemming from all EU international agreements. This means, for example, that 
third countries will have access to the UK market under the conditions set out in the EU 's trade 
agreements.  
After signature of the Withdrawal Agreement on 24 January, the EU notified the other parties to the 
international agreements of the consequences of the UK's withdrawal from the EU. The notification 
covers all international agreements a nd arrangements and address international partners also in 
their capacity as depositaries of international agreements. The EU also informed its international 
partners of the specific arrangements foreseen in the Withdrawal Agreement under which, during 
the transition period, the UK would be treated as a Member State for the purposes of the 
international agreements, including those agreements that would provisionally apply or enter into 
force during the transition period. It is for the EU's international par tners to determine whether this 
requires anything from their side.  WT/TPR/M/395/Add.1  
 
- 483 - 
 
  Page 16 (Para 3.52)  
 
15. How does the EU plan to approach the consequential amendments to the EU's FTAs 
following the UK's withdrawal from the EU?  
 
EU reply:  
The EU 's trade policy will not cha nge due to the withdrawal of the UK. The EU does not consider it 
necessary to amend the current EU agreements, including the EU 's FTAs. The references to the UK 
in EU international agreements will simply become obsolete after the end of the transition peri od. 
 
4.4 Trade Policy for open and fair trade  
Page 23 (Para 4.53d)  
 
16. On the International Procurement Instrument, could the EU update on the status 
of discussions at the Council of the EU and the European Parliament, and expected 
timeline for implementation ?  
 
EU reply:   
The IPI Commission proposal is currently discussed by the co -legislators, the Council and the 
European Parliament: they review the proposal by the Commission and might propose amendments. 
Eventually, if the two institutions agree on amendmen ts, the proposed legislation can be adopted.  
 
If the Council and the Parliament cannot agree upon amendments, a second reading takes place. In 
the second reading, the Parliament and Council can again propose amendments. Parliament has the 
power to block the proposed legislation if it cannot agree with the Council. If the two institutions 
agree on amendments, the proposed legislation can be adopted. If they cannot agree, a conciliation 
committee tries to find a solution. Both the Council and the Parl iament can block the legislative 
proposal at this final reading.  
 
As the legislative process is ongoing, it is impossible to provide any details on the timeframe for 
adoption or implementation of the envisaged instrument.  
 
SINGAPORE – ADDITIONAL QUESTIONS  
PART I:  QUESTIONS R EGARDING THE SECRETARIAT REPORT  
 
QUESTION:  
 
2.4.2.1 Establishment of a cooperation mechanism for the screening of FDI  
 
Page 49 (Para 2.63)  
 
17. The EU Regulation sets out an indicative list of factors to determine whether an 
inves tment is likely to affect security or public order (e.g. critical infrastructure, critical 
technologies, critical inputs). For Member States which do not have existing national 
screening mechanisms, how would they identify the investments that fulfil these  factors? 
Are there any guidelines that the EU is providing for Member States to quickly and 
effectively identify relevant investments?  
 
EU reply:  
The EU Regulation does not impose an obligation on Member States to screen foreign direct 
investments and t he EU does not provide specific guidelines for Member States to identify relevant 
investments. There are currently 15 Member States that screen foreign direct investments. Pursuant 
to Article 7 of the Regulation, the Commission or a Member State may provid e comments or an 
opinion regarding an investment not undergoing screening in another Member State. It is noted that 
there are already several other EU instruments which require Member States to identify 
infrastructures which they consider important for the  functioning of their societies, such as COUNCIL 
DIRECTIVE 2008/114/EC of 8 December 2008 on the identification and designation of European 
critical infrastructures and the assessment of the need to improve their protection.  
 WT/TPR/M/395/Add.1  
 
- 484 - 
 
  18. How would the relationship bet ween an investor and the government of a third 
country be definitively established (either by the Member State or by the EU)? Are there 
any immediate implications for third -country investors that are government -owned?  
 
EU reply:  
The Regulation applies to all foreign investments, irrespective of whether a foreign investor is a 
state-owned or a private enterprise. The Regulation is therefore fully in line with the principle of 
non-discrimination. The question whether a foreign investor is directly  or indirectly controlled by the 
government is, however, an important element for the assessment of a potential effect of FDI on 
security or public order of the Union or the EU Member States. The link to a foreign state will be 
determined based on a case b y case analysis, taking into account all circumstances.  
  WT/TPR/M/395/Add.1  
 
- 485 - 
 
  SWITZERLAND  
Report by the Secretariat ( WT/TPR/S/395 ) 
 
1 ECONOMIC ENVIRONMENT  
 
Question 1: Para. 1.16: The Secretariat's report mentions that proposals for a "digital 
services tax" have been suspende d until 2020 and that some member States, including 
Austria, France, Italy, and Spain, have taken steps for their own versions of such a tax. In 
view of this development, how does the EU ensure that taxation in the EU develops 
coherently and that no new di stortions are created?  
 
EU reply:  
The EU is fully engaged in the debate with the international partners to achieve a long -term global 
solution for the taxation of digital economy and is encouraged by the progress being made at the 
Organisation for Economic Co -operation and Development in this respect.  
The Commission has strongly suggested that Member States wanting to introd uce national measures 
use the Commission 's proposal for a common digital services tax as a blueprint. The Commission 
DST proposal takes into account the design considerations set out in the OECD's interim report on 
the tax challenges arising from digitalis ation.  
This approach will help to minimise the fragmentation of the Single Market and ensure compatibility 
with EU law.  
 
Question 2: 2.3.2.2 Unilateral preferences  
 
In para. 2.52, the Secretariat's report refers to the Commission's biennial report to the 
Parliament and the Council on the effects of the reformed GSP. It is mentioned that the 
third biennial report, covering the period 2010 -19, is expected to be published in 
December 2019 or January 2020. Has the third biennial report been published and where ? 
What are the main findings of the report?  
 
EU reply:  
Under Article 40 of the EU 's GSP Regulation (Regulation 978/2012), the Commission submits biennial 
reports to the European Parliament and to the Council on the implementation of the scheme and its 
effects. The first such report, covering the years 2014 -15, was published in January 2016; the 
second report, covering the years 2016 -17, was published in January 2018. The third biennial report, 
covering the years 2018 -19, will be published by the beginni ng of February. Once adopted, the 
report will be published on the EU 's GSP website. The report will also be made available on the 
EUR-Lex website, which contains all documents and legal acts published in the EU 's Official Journal.  
 
3 TRADE POLICIES AND PRA CTICES BY MEASURE  
3.1.3.3 TRQs and administration  
 
Question 3: In para. 3.44, the Secretariat's report informs on EU's Regulation 2019/216 
on the apportionment of tariff rate quotas following the withdrawal of the United Kingdom 
from the Union. Is it pos sible that following UK withdrawal from the EU customs union 
without a new trade arrangement, imports from UK will fill EU's WTO tariff rate quotas? 
Can the EU provide information on how it intends to maintain market access for other 
WTO members in such a scenario?  
 
EU reply:  
The negotiations under the GATT Article XXVIII procedure are confidential and are currently ongoing 
with the WTO Members whose rights the EU recognised. Any agreements will be notified in 
accordance with the applicable rules.  
 
3.1.4 Other charges affecting imports  
 
Question 4: Para. 3.59 and 3.60: According to these paragraphs, the Commission has 
elaborated two proposals regarding excise duties, one regarding alcohol and alcoholic 
beverages and one aimed at addressing the shortf alls about the general arrangements for 
goods subject to excise.  WT/TPR/M/395/Add.1  
 
- 486 - 
 
  • Could the EU indicate whether the negotiation with the member States has been 
finalized?  
 
EU reply:  
The Council agreed on 8 November 2019 the proposal on the directive on general arrangements for 
excise duty: https://www.consilium.europa.eu/en/press/press -releases/2019/11/08/excise -duty-
council -agrees -on-a-modernised -framework -for-excise -goods/  
 
Discussi ons regarding the revision of the alcohol Directive are ongoing in the Council.  
 
• What are the main modifications retained in the two proposals?  
 
EU reply:  
The new rules adopted by the Council on the general arrangements for excise duty are available at 
the bottom of the press release (see link above).  
 
The objective of the alcohol proposal is to update the rules governing excise duty on alcohol within 
the EU, pave the way for a better business environment and reduce costs for small alcohol producing 
busin esses.  
More particularly, this legislative proposal aims at:  
 
i) putting in place a uniform certification system in the EU for confirming the status of 
independent small producers throughout the Union, recognisable in all EU countries;  
ii) extending the special regime of small producers to cider producers across the EU in order 
to have access to the reduced rates as currently afforded to small beer and ethyl alcohol 
producers;  
iii)  clarifying the conditions for application of the exemption for denatured alcohol in the 
 EU; increasing the threshold for lower strength beer that can benefit from reduced rates 
 from 2.8% volume to 3.5% volume, to provide an incentive for brewers to be in novative 
 and create new products. This should encourage consumers to choose low -strength 
 alcoholic drinks over standard ones, reducing alcohol intake.  
 
• What is the current state of play regarding the adoption and entry into force of the 
two proposals?  
 
EU reply:  
The new rules adopted by the Council on the general arrangements for excise duty are available at 
the bottom of the press release (see link above).  
 
Please see article 57:  
 
Article 57  
Entry into force and application  
This Directive shall enter into force on the twentieth day following that of its publication in the Official 
Journal of the European Union.  
Articles 1, 4, 5, Articles 7 to 11, Articles 13 to 15, Articles 18, 23, 24, Articles 30 to 32, Articles 47 
to 53, Article 56 and Article 58 shall apply from 13 February 2023.  
 
3.1.6 Anti -dumping, countervailing, and safeguard measures  
 
Question 5: Para. 3.79: The Secretariat's report mentions that a new development with 
regard to trade remedy modernization is the ability to take into accoun t the presumably 
higher costs of EU industry compliance with social and environmental standards. Could 
the EU elaborate on how these new rules are or will be implemented and provide some 
explanations on the practical consequences of these rules?  
 
EU reply :  
The European Union will take account of social and environmental standards in the application of the 
trade defence instruments in the following ways:  
 
• In the context of selecting a representative country, when establishing normal value under 
the alternative dumping calculation methodology, from a group of several potentially suitable WT/TPR/M/395/Add.1  
 
- 487 - 
 
  countries, an assessment of the level of social and environmental prote ction in the countries 
under consideration may be used in the decision.  
• Injury margins will reflect the cost of social and environmental standards within the 
European Union. The cost of production also includes costs that EU producers incur when 
complying  with multilateral environmental agreements and with important International 
Labour Organisation conventions. It means that actual costs incurred by EU manufacturers 
as well as future cost increases during the lifetime of TDI measures resulting from 
compli ance with these standards will be taken into account, in calculating a non -injurious 
price.  
• In examining the acceptability of price undertaking offers from exporters, social and 
environmental standards in the exporting country concerned may also be a cons ideration.  
 
3.3.4 Competition policy  
 
Question 6: Para. 3.244: It is mentored that the tool eTrustEx through which the entities 
can submit complaints, drafts of remedies in merger cases, responses to requests for 
information, etc. was launched. Has its us e so far been satisfactory? Is there any potential 
for improvement?  
 
EU reply:  
eTrustEx (Trusted Document Exchange) has been satisfactory as it supports secure transmission of 
documents between DG Competition and external stakeholders. With message encryption, message 
integrity through the use of checksum algorithms, authentication v ia EU Login and traceability, it 
serves as a secure communication channel to send documents to DG Competition. Since it has been 
recently launched, the Commission will assess and review the feedback received from external users, 
including the limits curren tly envisaged, to improve eTrustEx, should there be a need and possibility 
to do so.  
For further information see: 
https://ec.europa.eu/competition/contacts/exchange_platform_en.html . 
 
3.3.4.4 International cooperation  
 
Question 7: Para. 3.268: As regards international cooperation in the area of competition 
policy, EU signed an agreement with the competition authority of Mexico on the exchange 
of information related to competition legislation and the sharing of non -confidential 
information on cases under in vestigation (first generation agreement). EU and Japan also 
started negotiating a review of their EU -Japan Agreement on cooperation on 
anti-competitive activities, with a view to enhancing the exchange of information between 
their respective anti -competiti ve authorities (second generation agreement). Could the 
EU explain why different approaches were applied with these two countries?  
 
EU reply:  
In the field of  competition, the EU has entered into more than 40 international agreements and 
arrangements, and cooperation provisions therein are characterized by a great variety. They range 
from the close cooperation within the European Economic Area based on the EEA Agreement to the 
dedicated Competition Cooperation Agreements with five third co untries (Canada, Japan, 
South  Korea, Switzerland and US). Currently, negotiations are ongoing with a view to upgrade the 
cooperation agreement between the EU and Japan. Cooperation provisions are also regularly 
included in Stabilization and Association Agr eements and Free Trade Agreements. In addition, 
principles of cooperation can also be laid down in administrative arrangements concluded between 
competition authorities themselves. The administrative arrangement with the Mexican competition 
authority of Ju ne 2018 
(https://ec.europa.eu/competition/international/bilateral/mexico_mou_2018_en.pdf ) is the latest of 
this kind.  
 
3.3.5 State trading, state -owned enterprises, and privatization  
 
Question 8: Para. 3.273: Regarding regulation and state -owned entrepris es (SOE), do they 
have to comply with the same rules as private entities (for example regarding 
competition, tax system, governance)? Also, some of these enterprises are probably 
active in other areas where they are in competition with private firms. Which  instruments 
do you apply to guarantee a competitive neutrality regime.  WT/TPR/M/395/Add.1  
 
- 488 - 
 
  EU reply:  
SOEs are subject to the same laws as privately -owned companies, in terms of taxation, competition 
and governance. This guarantees a level playing field in sectors where SOE s and privately -owned 
companies are in competition with each other.  
Competitive neutrality is guaranteed by the fact that all enterprises are subject to the same laws. 
As a result, there are no specific instruments that would apply to SOEs to guarantee fa ir competition.  
The SOEs have additional transparency obligations that do not apply to privately -owned companies. 
The additional transparency requirements further ensure that the activities of the SOEs do not cause 
competition distortions.  
 
3.3.7 Intellectual property rights  
 
Question 9: In the report by the WTO Secretariat, table A3.5 summarises the main 
legislative measures on IPRs. Regarding the Resale Right Directive (2001/84/EC), 
Switzerland notes that the first report on the implementation an d effect of the 
aforementioned Directive was issued in December 2011. Therein, the European 
Commission indicated that a further report would be undertaken and its results published 
in 2014. The periodical establishment of such reports is also foreseen by A rticle 11 of the 
Directive. To Switzerland's knowledge, no such further report has been issued. 
Switzerland would be interested to know: (1) What new findings on the implementation 
and effect of the Resale Right Directive have been made since the first rep ort? (2) When 
will the second report be available?  
 
EU reply:   
The date for the transposition of this Directive was set for 2006, but some EU Member States were 
given a so -called 'derogation' until 1 January 2010 that could also be extended to 1 January 2012 
(to exclude the application of the resale right to works by deceased artists). A first report was 
published in 2011. Due to this additional derogation period until 2012, the Commission focused 
afterwards on a dialogue with stakeholders to achieve a smooth application of the resale right, which 
took place in 2013. A s a result, representatives of collective management organisations, authors 
and art market professionals (art dealers, galleries, auctioneers) signed up in 2014 to "Key Principles 
and Recommendations on the management of the Author Resale Right ". The objec tive of those 
principles and recommendations was to highlight ways of helping to improve the administration of 
the right by all stakeholders. No particular issues related to the implementation of the Directive were 
brought to the European Commission 's atte ntion hereafter. The timing for a further report has not 
yet been decided. The report "Key Principles and Recommendations on the management of the 
Author Resale Right " is available here: https://ec.europa.eu/digital -single -market/en/news/eu -
copyright -legislation -useful -documents . 
 
4.1 Agriculture and Fisheries  
4.1.1.2.1.1 Direct payments  
 
Question 10: Para 4.21: It is noted that eight member States o pted to allow farmers to 
meet some of their greening obligations through equivalent practices between 2014 and 
2018. Could the EU please specify what such equivalent practices to meet the greening 
obligations could be? Can the EU give specific examples of members that implemented 
such equivalent practices?  
 
EU reply:   
The agricultural practices under greening include the maintenance of existing permanent grassland, 
crop diversification and the establishment of Ecological Focus Areas (EFA). The underlying legislation 
authorises Member States, subject to a notification to  the European Commission and provided it is 
not rejected, to allow farmers to meet one or more greening requirement through equivalent 
(alternative) practices. These equivalent practices must be carried out either under agri -
environment -climate schemes wit hin Member State rural development programmes (RDPs), or in 
accordance with national or regional certification schemes, and must yield an equivalent or higher 
level of benefit for the climate and the environment. A close -ended list of equivalent practices is 
provided in the underlying legislation (Annex IX to Regulation (EU) No 1307/2013: https://eur -
lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:02013R1307 -
20190301&qid=1579259416856&from=EN . 
 WT/TPR/M/395/Add.1  
 
- 489 - 
 
  In 2018, eight Member States used equivalence to the greening  requirements (at national or regional 
level). For example:  
 
- France applies winter soil cover under certification scheme suitable for maize farming – as 
equivalence to crop diversification  
- Poland applies crop diversification (at least 4 crops with set thre sholds) carried under RDP – as 
equivalence to crop diversification  
- Italy (region Marche) applies management of uncultivated buffer strips and field margins carried 
under RDP – as equivalence to EFA . 
 
Question 11: Para 4.34: In this paragraph, the Secretari at's report indicates that three EU 
Members states received the Commission's approval to provide more than the maximum 
percentage of their annual national ceiling for direct payments to finance voluntary 
coupled support. Can the EU explain the reasons for the Commission to approve more than 
the foreseen maximum share for coupled support? Did the decision result in a decrease of 
non- or minimally trade -distorting payments in favor of more coupled support?  
 
EU reply:  
The EU has been, and remains fully committed to non - or minimally trade -distorting forms of 
support. This is why 90% of direct payments already have been decoupled; and the remainder has 
been used for production limiting (coupled) support that meets Blue Box criteria.  
Voluntary coupled supp ort (VCS) is optional for the Member States. Support is only be available to 
a limited list of potentially eligible sectors and type of production and on the condition that they are 
undergoing difficulties in the Member State concerned. In addition, the bu dgetary allocation which 
may be granted by Member States to such type of support is strictly limited.  
With regard to this latter, the budgetary limit is 8% of national ceiling for direct payments (an 
optional top -up of 2% may be used for the support of pr otein crops). A Member State that meets 
certain pre -conditions may increase this up to 13%. The 13% (+ 2% optional) may only be increased 
under strict pre -conditions (Article 53(4) in Regulation (EU) No 1307/2013). Amongst other 
conditions, the Member Stat e concerned should justify the need for increased support relating to 
specific needs defined in EU law. For example, the need to sustain a certain level of specific 
production due to lack of alternatives and so reducing the risk for production abandonment,  or the 
need to provide stable supply to the local processing industry and thereby avoiding the negative 
social and economic consequence of any ensuing restructuring. A Member State 's decision to 
increase the level of support must be approved by the Europe an Commission by way of an 
implementing act. It is worth recalling that only three Member States (Finland, Portugal and Belgium) 
have used this possibility between claim years 2015 and 2020.  
 
4.2 Energy  
 
Question 12: Para. 4.122 states that the EU spends 1 20 billion Euros on energy subsidies. 
Parts of these subsidies are fossil fuel subsidies with the effect of energy market 
distortions and possible obstacle to the energy market transformation. With a view to the 
EU commitment to becoming the world leader i n renewable energy stated in para. 4.150 
and the vision for a carbon -neutral economy by 2050 stated in para 4.159 is the EU 
undertaking any reforms of their fossil fuel subsidies? If yes, what is the scope of these 
reforms and how are they implemented?  
 
EU reply:   
Important progress has been made in reporting fossil fuel subsidies with the recent publication of 
"Energy prices, costs and subsidies in the EU ".114 
Under the Governance regulation115, each EU Member State must report on actions that they 
undertake to phase out energy subsidies, in particular for fossil fuels. In the National Energy and 
Climate Plans Member States are to provide an inventory on fossil fuel subsidies and their plans to 
phase them out.  
The European Green Deal116 aims to ensure that different carbon pricing instruments (including 
energy taxation and Emission Trading System) complement each other in a coherent framework.  
 
 
114 Viewed at: https://ec.europa.eu/energy/en/data -analysis/energy -prices -and-costs. 
115 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32018R1999&from=EN . 
116 Viewed at: https://ec.europa.eu/info/sites/info/files/european -green -deal-communication_en.pdf . WT/TPR/M/395/Add.1  
 
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  4.3 Manufacturing  
 
Question 13: Para 4.162 and 4.175 : The EU -policy "For a European Industrial 
Renaissance" states "the target of 20% of GDP for manufacturing activities by 2020". Will 
this target be maintained beyond 2020? How was the target set and how do you reconcile 
such a target with the aim of enabli ng and supporting structural change of the economy?  
 
EU reply :  
In its Conclusions, the European Council of 20 and 21 February 2014, commenting on the 
Communication "For a European Industrial Renaissance", highlighted  the pre -eminent importance of 
industry for economic growth and hence expressed its general support for pursuing the Commission's 
aspiration of raising the contribution of industry to GDP to as much as 20% by 2020 with the 
objective of revitalising the EU e conomy  
(https://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/ec/141749.pdf ).  
 
In several EU Member States, the manufacturing industry already accounted for more than 20% of 
total value added in 2013, so that the proportion could be expected to rise in all Member States, as 
the EU economy would return to its historical growth rate in the following years, as the European 
Competitiveness Report 2014 stated. The long -term vision for the EU's industrial future beyond 2020 
is under preparation. The  European Commission will adopt an EU industrial strategy setting out this 
long-term vision in March 2020.  
 
Question 14: Para. 4.174: Regarding the renewed Industrial Policy Strategy, how do you 
evaluate the effectiveness of employed measures promoting the  so-called key enabling 
technologies?  
 
EU reply:   
Measures in favour of key enabling technologies can be found in several initiatives implemented as 
part of the Industrial Policy Strategy and are subject to the evaluation guidelines applicable to the 
initiatives. This holds, e.g., for the EU research fram ework programme "Horizon 2020 ", whose 
interim evaluation was published in 2017 at https://op.europa.eu/en/publication -detail/ -
/publication/33dc9472 -d8c9-11e8-afb3-01aa75ed71a1/language -en.  
 
Report by the European Union ( WT/TPR/G/395 ) 
 
3.7 Common agricultural policy  
 
Question 15: Para 3.23: In this paragraph, the EU indicates the aim to use 40% of the 
overall financial envelope of the CAP in support of climate objectives for the 2021 -27 
period. Can the EU provide us with an update on the specific m easures that are planned 
and on how many of them are expected to be notified in the Green Box?  
 
EU reply:  
A break down of support to European farmers across the WTO boxes will only be possible after 
adoption of the CAP legislative reform package by the C ouncil and the European Parliament, adoption 
of the Multiannual Financial Framework for 2021 -2027 period and the finalisation of the CAP Strategic 
Plans by the EU Member States, which implements the post -2020 CAP at Member State level.  
 
4.2 The EU bilatera l negotiating agenda  
 
Question 16: Para 4.21: EU's report refers in this paragraph to a new Africa -Europe 
Alliance for Sustainable Investment and Jobs. Could the EU provide more information on 
this alliance? How the alliance has materialized? Has a plan of  action been adopted and 
operationalized?  
 
EU reply:  
Launched in September 2018117, the Africa – Europe Alliance for Sustainable Investment and Jobs 
is EU's economic strategy for EU -Africa relations. It represents a paradigm shift in the way the EU 
works with Africa, in line with political commitments taken at the 5th African Union – European Union 
 
117 Communication on a new Africa –Europe Alliance for Sustainable Investment and Jobs: Taking our 
partnership for investment and jobs to the next level - 12.09.2018 COM(2018)643 . WT/TPR/M/395/Add.1  
 
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  Summit, held in Abidjan in 2017.  It puts job creation as the  key target and African and European 
sustainable investments as the main vehicle, focusing on areas with the greatest potential for jobs 
and added -value creation. Its implementation is based on four interconnected strands of actions: 
(i) Boosting strategic  sustainable investments by de -risking investments, using development aid as 
a guarantee or blended with loans; (ii) Strengthening business environment and investment climate; 
(iii) Investing in education and skills; (iv) Building markets through economic integration and trade. 
Significant progress has been achieved in all strands of action, and targets set for 2020 are expected 
to be met. More information on its implementation can be found at the following website: 
https://africa -eu-
partnership.org/sites/d efault/files/documents/21.11.2019_alliance_progress_factsheet_en.pdf . 
 
4.3.2 Supporting inclusive growth in developing countries  
 
Question 17: In Para. 4.37, the EU provides information on the amounts of its commitment 
to Aid for Trade (AfT) until 2017. Could the EU also provide some figures for 2018? Is the 
concrete List of activities included under AfT available?  
 
EU reply:  
The EU publishes annual Aid for Trade Progress Reports with detailed qualitative and quantitative 
data of its Aid for Trade activities. Due to natural delays in the collection and processing of this data, 
the report for a year Y covers quantitative data for a yea r y-2. Therefore, the latest annual Progress 
Report, published in July 2019 contains data related to the year 2017. The next report, due for 
publication in December 2020, will contain the data relative to 2018.  
 
A full list of activities carried out by the  EU under Aid for Trade can be found in the EU 's Aid for Trade 
Progress Report from 2019 (page 65), which can be found in the EU 's International Development 
and Cooperation website. Physical copies of this report were also distributed on the occasion of th e 
WTO's Aid for Trade Global Review in July 2019.  
 
  WT/TPR/M/395/Add.1  
 
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  CHINESE TAIPEI  
PART I: REGARDING TH E SECRETARIAT REPORT  (WT/TPR/S/ 395) 
 
SUMMARY  
 
Page 1 4 (Para 34) 
During the review period, the EU adopted legislative measures under the first pillar of the Digital 
Single Market (DSM) Strategy launched in 2015 that address different types of barriers to the growth 
of cross -border e -commerce. These measures deal with: cross -border portability of online content 
subscriptions; cooperation between national consum er protection agencies; VAT aspects of 
e-commerce; unjustified geoblocking; cross -border parcel delivery services; copyright in the DSM; 
copyright and related rights applicable to certain online transmissions of broadcasting organizations 
and retransmissio ns of television and radio programmes; contracts for the supply of digital content 
and services; and contracts for the sale of goods.  
 
Question(s):  
1.  Could the EU please elaborate further on the potential impacts or opportunities for the 
e-commerce trade of non -EU member countries, or e -payment in the EU region under the 
recently amended regulatory framework of the Digital Single Market (DSM) Strategy?  
 
EU Reply :  
Through the DSM Strategy, the EU has made it easier and safer for European consumers to shop 
online no matter where they are in the EU. To realise the full potential of e -commerce, the EU has 
worked, amongst others, on:  
 
• the revised Payment Services Directive118;  
• new rules on cross -border parcel delivery services119; 
• new rules to stop unjustified geo -blocking120; 
• revised consumer protection rules that will enter into force in 2020121; 
• new VAT rules for online sales of goods and services that will enter into force in 2021 .122 
 
These EU wide rules also affect companies fro m non –EU countries, for example, by making it easier 
and less costly to do business thanks to the application of one set of EU rules.  
Regarding payments, a new Directive on payment services (PSD  2) 
(https://ec.europa.eu/info/law/payment -services -psd-2-directive -eu-2015-2366_en), to improve 
the existing rules and take into account new digital payment services, entered into force in January 
2018. It:  
 
• makes it easier and safer to use internet payment services;  
• better protects consumers against fraud, abuse, and payment problems;  
• promotes innovative mobile and internet payment servi ces; 
• strengthens consumer rights;  
• strengthens the role of the European Banking Authority to coordinate supervisory authorities and 
draft technical standards.  
 
This Directive is part of a legislative package that also includes a Regulation on multilateral 
interchange fees  (https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:32015R0751). 
Together, they:  
 
• limit the fees for transactions based on consumer debit and c redit cards;  
• ban retailers from imposing surcharges on customers for the use of these types of cards.  
 
 
118 Viewed at: https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1580296553337&uri=CELEX:32015L2366 . 
119 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/?ur i=CELEX%3A32018R0644 . 
120 Viewed at: https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.LI.2018.060.01.0001.01.ENG&toc=OJ:L:2018:060I:TOC . 
121 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex%3A32017R2394 . 
122 Viewed at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex:32019L1995  and https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=celex:32019R2026 . WT/TPR/M/395/Add.1  
 
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  Further information can be found at https://ec.europa.eu/info/business -economy -euro/banking -
and-finance/consumer -finance -and-payments/payment -services/payment -services_en .  
 
EU Member States have also agreed on new measures to support the digital economy when it comes 
to VAT compliance. After 2021, all goods bought online by EU consumers from sellers outside the 
EU will also be subject to VAT, in line with current EU sales practices.  
 
2 TRADE AND INVESTMENT REGIMES  
2.2 Trade Policy Formulation and Objectives  
 
Page 37 (Para 2.19) 
The Council of the EU endorsed this new approach in May 2018 when it noted that "in the future the 
Commission intends to recommend draft negotiating directives for FTAs covering exclusive EU 
competence on the one hand and separate mixed investment agreements on the other, with a view 
to strengthening the EU's position as a negotiating partner. It is for the Council to decide whether 
to open negotiations on this basis". The decoupling of investment protection provisions from  trade 
agreements is a significant change, compared with the trend noted in the previous Review, towards 
the integration of trade and investment in comprehensive economic agreements.  
 
Question(s):  
2.  It may be pragmatic for the European Commission to de -coup le the investment 
protection provisions (IPAs) from trade agreements so as to expedite the ratification 
process, but while FTAs can be ratified only at the EU level IPAs are most likely to continue 
to face a lengthy process of uncertainty because they stil l need to be ratified by all 
EU member states. It takes just one single member state to try to obstruct the procedures, 
for the agreements not to be enforced and implemented. Considering the great importance 
of IPAs in terms of job creation and boosting ec onomic development, will the European 
Commission try to envisage methods to expedite the ratification procedures? For example, 
does the European Commission really think it is pragmatic to reduce the scope of an IPA 
in order to let the areas covered all fal l within the exclusive competence of the European 
Union?  
 
EU reply:  
The EU takes the decision on whether to decouple investment protection provisions from trade 
agreements on a case -by-case basis. In some cases (e.g. EU -Singapore, EU -Viet Nam), two separate 
agreements were concluded: one FTA including investment liberalisation (which is of exclusive EU 
competence) ratified at EU level and a separate investment protection agreement (covering inter alia 
non-direct investment and investor -to-state dispute settlement which are matters of shared 
competence) to be ratified by all EU member States. In other instances, the EU can and has 
concluded agreements covering both investment liberalisation and investment protection (e.g. CETA, 
EU-Mexico). The  Commission aims - in the joint interest of the EU, the EU member States and its 
partners - to facilitate the national ratification procedures to the extent possible. When negotiating 
trade and investment agreements, it is also important for the Commission  to ensure that they 
contain all the key elements of Union policy in a specific area, and are consistent with WTO and 
Union law.  
 
2.3 TRADE AGREEMENTS AN D ARRANGEMENTS  
 
Page 40 (Para 2. 30) 
The EU divides its FTAs with third countries into four broad categ ories:  
"new-generation FTAs" are comprehensive FTAs, negotiated by the EU after 2006, with selected 
third countries, which typically go beyond provisions on liberalization of trade in goods. They cover 
services and public procurement. In some cases, they a lso cover investment and regulatory 
cooperation. Since 2010, all new -generation agreements include provisions on sustainable 
development. New -generation FTAs are currently in force with: Japan; Canada; Korea, Rep. of; 
Colombia/Ecuador/Peru; and Central Ame rica.  
 
Question(s):  
3.  Have  there been any significant changes on e -commerce issues by the EU in its new - 
generation FTAs?  
 WT/TPR/M/395/Add.1  
 
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  EU Reply:  
The EU has started addressing e -commerce issues in trade agreements in a comprehensive manner 
in all FTAs whose negotiations started after 2016. This is done through the inclusion of a Title on 
Digital Trade, a regulatory Title including provisions that ar e not specific to any sector but are instead 
of horizontal application to online trade in goods, services, etc. The Title on Digital Trade establishes 
basic horizontal disciplines that are indispensable for the good functioning of (cross -border) online 
trade. These disciplines aim at ensuring predictability and legal certainty for businesses; ensuring a 
secure online environment for consumers who engage in digital trade transactions across borders; 
removing unjustified barriers; and preventing discriminatio n between online and offline activities.  
In FTAs negotiated before the introduction of the Title on Digital Trade, the EU typically included 
only a couple of e -commerce related provisions, such as a permanent prohibition from charging 
customs duties on el ectronic transmissions and a clarification of the scope of commitments in 
Computer and Related Services.  
 
2.4 Investment Regime  
2.4.2 Investment relations with third countries  
2.4.2.1 Establishment of a cooperation mechanism for the screening of FDI  
 
Page 48 (Para 2.60) 
The European Commission President proposed the creation of an EU framework for FDI screening in 
the 2017 State of the Union address. The proposal was motivated by growing concerns regarding 
the impact on the strategic interests of the EU or its member States of certain types of FDI, especially 
foreign acquisitions in cases involving state -owned enterprises and strategic sectors. This legislation, 
a regulation based on the common commercial policy competence in Article 207(2) of the TFEU, w as 
adopted on 19 March 2019, entered into force on 10 April 2019, and shall apply from 
11 October  2020.  
 
Question(s):  
4.  Now that the EU framework for FDI screening has entered into force from April 2019, 
what preparation work at the EU and at member States level is likely to be entailed before 
it officially applies from mid -October 2020?  
 
EU reply:  
First of all, the Member States that maintain screening mechanism have notified these mechanisms 
to the Commission (cf. Article 3). Expert meetings pursuant to A rticle 12 with the Member States 
and the Commission are being organised on a regular basis. Second, the Commission is preparing 
further the application of the cooperation mechanism between the Member States and the 
Commission. To this end, it is recalled t hat the Commission needs to provide a secured and encrypted 
system through which the exchange of confidential information under the cooperation mechanism 
can be carried out (cf. Articles 10 and 11.2). In the Commission, the Directorate –General for TRADE 
is responsible for coordinating the implementation and notably the application of the cooperation 
mechanism. This requires close cooperation with several relevant other services and agencies of the 
Commission, notably in view of the programmes and projects of Union interest. Lastly, the 
Commission and the Member States have engaged with the responsible authorities of third countries 
to exchange best practices on screening of foreign direct investments on grounds of security and 
public order.  
 
5.  Currently 15 EU member States have national FDI screening mechanism in place. Does 
the EU foresee that there will be more member States establishing or modifying FDI 
screening mechanisms in the future? If so, will the EU consider setting up a public 
infor mation portal for the sake of transparency?  
 
EU reply:  
The Regulation leaves the decision whether to adopt national screening mechanism with the EU 
member States. It is however not excluded that more Member States will establish a FDI screening 
mechanisms  in the future. In addition, Member States may modify their mechanism. In any event, 
Member States shall notify the Commission of any newly adopted or amended screening mechanism 
and the list of Member States' screening mechanisms (as notified by them) is available through the 
web pages of the European Commission.  
 WT/TPR/M/395/Add.1  
 
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  Page 48 (Para. 2.62)  
Regarding the first pillar – the establishment of a framework – it is important to note that the 
Regulation does not require member States to adopt screening mechanisms or to harmonize them. 
Rather, it provides that member States may maintain, amend or adopt mechanisms to screen FDI 
in their territory on the grounds of security or public order, and lays down certain requirements that 
these screening mechanisms must satisfy with respect to the following factors: transparency and 
non-discrimination between third countries; the application of time -frames; the protection of 
confidential information; the right of foreign investors and the undertakings concerned to se ek 
recourse to screening decisions; the avoidance of circumvention of screening mechanisms and 
screening decisions; and the notification to the Commission of existing screening mechanisms and 
of the adoption of new screening mechanisms or amendments to exi sting ones.  
 
Question(s):  
6.  The Regulations provide that screening mechanisms must satisfy certain requirements 
with respect to certain factors. What is the rationale behind the factors chosen in the 
Regulations?  
 
EU reply:  
Indeed, Article 3 of the Regulation lays down the essential requirements for screening. These 
requirements are in line with requirements from Union law, international commitments and inspired 
by the OECD recommendations .123 
 
7.  Is our understanding correct that the requirements which the screening mechanism 
must satisfy under the regulations constitute binding obligations on member States that 
choose to adopt screening mechanisms? If so, what are the legal consequences of failure 
by a member State to comply with these requirements?  
 
EU reply:  
As mentioned before, Article 3 of the Regulation lays down the essential elements of the framework 
for the screening of FDI by a Member State. These are indeed binding requirements. As for any other 
measure adopted by the Union institutions, purs uant to the Treaties, the Commission will oversee 
the application of the Regulation under the control of the European Court of Justice, in line with its 
role as the guardian of the EU Treaties set out in Article 17 TEU.  
 
2.4.2.2 Agreements with third count ries 
 
Page 50 (Para 2.70)  
The dispute settlement provisions of the Investment Protection Agreement are similar to those of 
the CETA and reflect what is now commonly referred to as the Investment Court System. This new 
System results from a policy adopted by the EU in 2015 as part of the Trade for All Strategy, to work 
towards the reform of the traditional investor -state dispute settlement mechanism of international 
investment agreements. Instead of ad hoc arbitration bodies, the System provides for  a permanent 
Tribunal of First Instance and a permanent Appeal Tribunal to hear appeals from provisional awards 
issued by the Tribunal of First Instance. The members of these Tribunals are appointed in advance 
by the contracting parties, must meet specifie d requirements regarding expertise and qualifications, 
and are subject to strict rules of ethical conduct. The new rules also include detailed provisions on 
the transparency of proceedings, notably through public access to documents, hearings and the 
possibility of third persons making submissions. In addition to the inclusion of provisions regarding 
the System in bilateral agreements, the EU is also pursuing the establishment of a multilateral 
investment court system and the reform of the investment provis ions in the Energy Charter Treaty.  
 
Question(s):  
8.  Please could the EU provide an update on the latest progress on the establishment of 
bilateral investment court systems under the current investment agreements it has 
concluded?  
 
EU reply:  
Bilateral Investment Court Systems are included in the EU -Canada  Comprehensive Economic and 
Trade Agreement (CETA), the EU -Singapore Investment Protection Agreement, the EU -Viet Nam 
 
123 OECD Guidelines for recipient country investment policies relating to national security, 
recommendation adopted by the OECD Council on 25 May 2009, p.4.  WT/TPR/M/395/Add.1  
 
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  Investment Protection Agreement and the trade part of the modernised EU -Mexico Global 
Agreement. Bilateral Investment Court Systems are al so under discussion in all ongoing bilateral EU 
negotiations on investment protection.  
 
As regards CETA, the EU and Canada have been working on designing rules setting out the 
functioning of the Appellate Tribunal of the Investment Court System, a code of  conduct for members 
of the Investment Court System, the mediation  procedure for investment disputes and the procedure 
for adopting binding interpretations. These rules are already included in the Agreements with 
Singapore, Viet Nam and Mexico and in the d raft texts of ongoing negotiations.  
 
9.  Please could it also provide an update on the latest progress on the establishment of a 
multilateral investment court system ?  
EU reply:  
In July 2017, the United Nations Commission on International Trade Law (UNCITRAL) decided to 
task its Working Group III to examine the possible reform of investment dispute resolution, which 
could include the creation of a Multilateral Investment Court.  
 
Working Group III has so far held six rounds of discussions. At the last  session held in Vienna from 
20 to 24 January 2020, the Working Group started  substantive discussions on core issues for the 
creation of a permanent investment dispute settlement body, such as an appellate mechanism and 
a two -tier Multilateral Investment C ourt. The discussions focussed on questions relating to 
(i) appellate review of investment dispute settlement decisions; (ii) enforcement of decisions of an 
appellate mechanism and of a two -tier Multilateral Investment Court; (iii) methods of financing of a 
permanent mechanism; and (iv) selection and appointment of adjudicators to a permanent body. 
The Working Group requested the UNCITRAL Secretariat to prepare further work on those conceptual 
issues to proceed with more detailed discussions in future sessi ons.  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.1 Customs procedures, valuation, AND requirements  
 
Page 56 (Para 3.16) 
Under the EU Authorised Economic Operator (AEO) programme, trusted traders, who voluntarily 
meet a wide range of criteria, work in close cooperation with customs authorities to assure the 
common objective of supply chain security. This entitles AEOs to benefit throughout the EU. As 
described in the previous Review, there are two types  of authorizations: AEOs for customs 
simplification programmes (AEOC) and for security (AEOS). It is possible to combine AEOC and AEOS 
status. From 1 October 2019, an EU harmonized trader interface, the eAEO, will be operational. It 
will allow electronic e xchange of information, i.e. notifications between Customs and AEOs regarding 
the AEO processes relating to the application and management of authorization. The system is 
expected to be fully operational on 15 December 2019.  
 
Question(s):  
10. Could  the EU plea se give more details of the above -mentioned eAEO and explain how 
it works? What are the difficulties you have encountered in promoting the eAEO system? 
What are the main factors contributing to the success of eAEO systems?  
 
EU reply:  
The EU trader portal has been designed by the Commission and the Member States in agreement 
with each other in order to meet the legal requirements set out by the Union Customs Code.  
 
As of 1 October 2019 the new EU Customs Trader Portal started its operations. It is th e single point 
of access for economic operators and other persons to interact with EU customs systems that are 
connected to the portal.  
 
Objective:  
The EU Customs Trader Portal provides a single access point to the AEO and EBTI systems, and in 
2020 it will  connect to the INF system for Special Procedures. As the aim of this portal is to harmonise 
the accesses to the different EU customs systems, it is expected that in a near future all other EU 
customs systems will be connected to this portal. The purpose o f the e -AEO trader portal is to 
facilitate and speed up the exchange of information, communications and notifications related to WT/TPR/M/395/Add.1  
 
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  AEO applications, authorisations and their management processes as set out in in the UCC and 
related UCC DA and UCC IA.  
 
How it works:  
The EU Customs Trader Portal will use the authentication solutions covered under the project Uniform 
User Management & Digital Signature (UUM&DS).  
Economic operators and other persons need to possess an EORI number and the appropriate roles 
assigned to access the system. In order to obtain an EORI number and role, economic operators and 
other persons need to contact the competent authority for EORI registration in the country where 
they are established.  
 
After being authenticated in UUM&DS, the e nd-user will be able to:  
 
• interact with customs via the connected IT systems;  
• manage his tasks and notification;  
• register his email address in order to receive the notifications also by email;  
• have a complete view on submitted applications and requests;  
• save a draft of an application or request for later submission, and manage these drafts;  
• manage attachments, which are used in the applications and requests.  
• Receive AEO authorisation and manage it  
• Receive and send  notifications relating to the AEO authorisa tion (suspension, take measures, 
 revocation, re -assessment, right to be heard, etc.) . 
 
More information can be found on TAXUD website:  
https://ec.europa.eu/taxation_customs/news/aeo -transition -online -system_en . 
 
 
Legal references.  EU Trader Portal comes from a legal obligation set out by the EU legislation. In 
particular:  
• Article 6 (1) and (2) of Regulation (EU) No . 952/20135 of the European Parliament and of 
 the Council of 9 October 2013   
• Article 30 (1) second sub -paragraph of the  Commission Imple menting Regulation (EU) 
 No. 2015/2447 of 24 November 2015   
• Article 5 (1) of the Commission Delegated Regulation (EU) 2016/341 of 17 December 2015  
• Commission Implementing Decision (EU) 2016/578 of 11 April 2016 establishing the Work 
 Programme relating to  the development and deployment of the electronic systems provided 
 for in the Union Customs Code.  
 
Main difficulties  
The implementation of e -AEO module of the EU Customs Trader Portal represented for the past two 
years a big challenge involving differen t parties at Commission and Member State side. The massive 
work done by the Commission together with the Member States required a remarkable commitment 
involving time and resources in both IT and legal areas.  
 
Main factors contributing to the success  
Comm ission and Member States worked in strict cooperation and agreement with each other. All 
necessary IT and business activities were perfectly synchronised with each other in order to meet 
with success the legal requirements  
 
3.1.6 Anti-dumping, countervailing, and safeguards measures  
 
Page 79 (Para 3.78)  
The first set of changes were introduced in 2017, and added language with respect to "normal value". 
In essence, this allows for the normal value to be determined by another method where there ar e 
state-induced distortions in the exporting country. In such circumstances, normal value is 
determined on the basis of costs of production and sale reflecting undistorted prices, or of 
benchmarks such as international prices or costs in another representa tive country. A different 
methodology for determining the normal value is set out for non -WTO Members.  
 WT/TPR/M/395/Add.1  
 
- 498 - 
 
  Question(s):  
11. What level of distortion in the exporting country would make the EU decide to 
construct a normal value? How would the EU select a representative country to construct 
such a value?  
 
EU reply:  
Sub-paragraph (b) of the Article 2(6)(a) of the EU's Basic Anti -dumping Regulation lists in a non -
exhaustive manner circumstances which may result in significant distortions, as follows:  
 
— the market in question being served to a significant extent by enterprises which operate under 
the ownership, control or policy supervision or guidance of the authorities of the exporting country;  
— state presence in firms allowing the state to interfer e with respect to prices or costs;  
— public policies or measures discriminating in favour of domestic suppliers or otherwise influencing 
free market forces;  
—the lack, discriminatory application or inadequate enforcement of bankruptcy, corporate or 
prope rty laws;  
— wage costs being distorted;  
— access to finance granted by institutions which implement public policy objectives or otherwise 
not acting independently of the state.  
 
The presence of significant distortions is examined on a case -by-case basis taking into account cross -
cutting distortions, distortions in the factors of production as well as distortions in the relevant 
sector.  
 
In order to construct a normal value in such cases, the Commission uses readily available data in an 
appropriate repres entative country at a similar level of economic development. Where more than 
one country qualifies, if appropriate, preference will be given to the one with adequate level social 
and environmental protection. Other undistorted international prices, costs a nd benchmarks may 
also be used.  
 
Page 79 (Para 3.79) 
The changes set out in the second amendment in 2018 are more numerous and diverse; the main 
elements are outlined in Box 3.2. As illustrated, the changes involve procedural aspects, such as 
shortening t he time -period for provisional measures, and more substantial aspects, such as how the 
injury margins are calculated. For example, in calculating the non -injurious price, a minimum profit 
of 6% is included. Another new development is the ability to take in to account the presumably higher 
costs of EU industry compliance with social and environmental standards.  
 
Question(s):  
12. Concerning  the cost of EU industry compliance with social and environmental 
standards, please elaborate on how the EU takes this into consideration in recent trade 
remedy investigations.  
13. As the new Commission puts significant emphasis on creating a level playing -field for 
EU industries, is it expected that the above -mentioned practice will be increasingly applied 
in the future?  
 
EU reply to Q12 -13:  
The European Union will take account of social and environmental standards in the application of the 
trade defence instruments in the following ways:  
 
• In the context of selecting a representative country, when establishing normal value under 
 the alternative dumping calculation methodology, from a group of several potentially suitable 
 countries, an assessmen t of the level of social and environmental protection in the countries 
 under consideration may be used in the decision.  
• Injury margins will reflect the cost of social and environmental standards within the 
 European Union. The cost of production also i ncludes costs that EU producers incur when 
 complying with multilateral environmental agreements and with important International 
 Labour Organisation conventions. It means that actual costs incurred by EU manufacturers 
 as well as future cost increases during the lifetime of TDI measures resulting from 
 compliance with these standards will be taken into account, in calculating a non -injurious 
 price.  WT/TPR/M/395/Add.1  
 
- 499 - 
 
  • In examining the acceptability of price undertaking offers from expor ters, social and 
 environmental standards in the exporting country concerned may also be a consideration.  
 The legislation sets out the provisions regarding the application of social and environmental 
 standards in investigations. Therefore, the Commissio n will apply the provisions in all 
 investigations where they are relevant.  
 
3.3 Measures Affecting Production and Trade  
3.3 Measures Affecting Production and Trade  
3.3.3 Sanitary and phytosanitary requirements  
 
Page 116 (Para 3.213 and 3.214 ) 
Since the la st Review, the most significant change in the EU's SPS regime refers to the new 
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 regarding 
official controls on products of animal origin intended for human consumption.  It includes rules for 
the performance of official controls and other control activities by the competent authorities of the 
member States, sets out the requirements to be fulfilled for the entry into the EU of consignments 
of animals and goods from third countries, and empowers the Commission to adopt delegated acts 
concerning those requirements. This Regulation will apply from 14 December 2019. However, the 
requirements will only apply from 21 April 2021.  
The new Regulation will replace Regulation (EC) No . 882/2004 and repeal Regulation (EC) 
No. 854/2004. The key SPS legislation in the EU is summarized in Table 3.21.  
 
3.3.3.2 Live animals and animal products  
 
Page 121 (Para 3.234 ) 
As from 14 December 2019, under the new Official Controls Regulation (OCR), the BIPs will be 
changed to Border Control Posts (BCPs), the CVED to the Common Health Entry Document (CHED), 
and TRACES to the Information Management System for Official Controls (IMSOC).  
 
Question(s):  
14. As indicated in Table 3.21, the new  Regulation (EU) 2017/625 repeals Regulations 
(EC) No. 854/2004 and (EC) No. 882/2004 on official controls for verification of 
compliance with feed and food law, animal health, and animal welfare rules. What are the 
major differences and the implications f or third countries wishing to export food products 
containing ingredients of animal origins?  
 
EU reply:  
The requirements laid down in the OCR and tertiary legislation adopted based on empowerments of 
the OCR in relation to performance of official controls and requirements for entry into the Union of 
food of animal origin ensure a continuation of the requirements laid down in Regulations (EC) 
No. 854/2004 and (EC) No 882/2004 to ensure a high level of protection of health and in order to a 
avoid a d isruption of the entry into the Union of consignments of food of animal origin.  
At the same time, the experience gained in the application of the rules laid down in those two 
Regulations is taken into account using a risk -based approach.  
With regard to public health requirements applicable to the entry into the European Union of 
consignments of certain animals and goods intended for human consumption, the OCR was 
supplemented in particular by three acts on:  
 
- requirements for the entry into the European U nion of consignments of certain animals and 
 goods intended for human consumption124,  
- list of third countries authorised for the entry into the EU of certain animals and goods 
 intended for human consumption125,  
 
124 Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 
2017/625  of the European Parliament and of the Council with regard to requirements for the entry into the 
Union of consignments of certain animals and goods intended for human consumption OJ L 131, 17.5.2019, 
p. 18–30. 
125 Commission Implementing Regulation (EU) 201 9/626 of 5 March 2019 concerning lists of third 
countries or regions thereof authorised for the entry into the European Union of certain animals and goods 
intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists  OJ 
L 131, 17.5.2019, p. 31 –50.  WT/TPR/M/395/Add.1  
 
- 500 - 
 
  - model official certificates for certain animal s and goods126. 
 
The public health requirements remain essentially similar to those presently applicable to the entry 
of foodstuffs into the EU. There are overall no changes in the current lists of countries and 
establishments allowed to export to the EU and  no major changes have been made to existing 
certificates.  The limited changes include the requirement for the listing of countries for all products 
of animal origin (the procedure of which has been simplified). Additional lists have therefore been 
created  for rendered fats and greaves, reptile meat, insects, other products of animal origin (not 
covered by existing lists) and further to this specific model health certificates have been laid down 
and are now mandatory for the export to the EU of these commod ity types. The procedure for listing 
of establishments has also been simplified  
There are also now more detailed rules on the coordinated performance of intensified official controls 
established in Commission Implementing Regulation (EU) 2019/1873. The re sults of the intensified 
official controls are recorded in the Integrated Management System for Official Controls (IMSOC) 
and the competent authority of the third country concerned may be requested to make investigations 
and to adopt an action plan to reme dy the situation. The common procedures and electronic means 
of communication Integrated Management System for Official Controls (IMSOC) will help to ensure 
further efficiency of the system for intensified controls, to the benefit of trading partners and 
competent authorities alike.  
However, the case of foodstuffs containing both products of plant origin and processed products of 
animal origin, also known as "composite products", is specific.  
With regard to animal health, a Commission Delegated Regulation establishing notably the animal 
health requirements for the entry into the Union of composite products, based on Regulation (EU) 
2016/429127, is in preparation. Once adopted, these requirements will also have to be taken into 
consideration in addition to the  public health requirements.  
 
The way in which composite products are categorised will change. Entry requirements will no longer 
be based on percentage  of ingredients of animal origin but rather on the animal health or public 
health risk linked to the comp osite product itself.  
Article 12 of Commission Delegated Regulation (EU) 2019/6252 establishes three categories of 
composite products: (1) non shelf stable composite products, (2) shelf stable composite products 
that contain meat products, and (3) shelf stable composite products that do not contain meat 
products. The public health requi rements for entry into the Union of the three categories of 
composite products will be applicable as from 21 April 2021. A letter explaining the rules were sent 
to the embassies or representations of all non -EU countries in December 2019 
(Ref: Ares(2019)74 43220.)  
 
Composite products are among the products listed in Article 47(1)(b) OCR, as amended by Delegated 
Regulation (EU) 2019/478128. However, until 21 April 2021, the current rules laid down in Decision 
2007/275/EC129 concerning composite products subject t o official controls at border control posts 
continue to apply, as amended by Implementing Regulation (EU) 2019/2007130. 
 
15. As the new OCR combines several information management systems, including 
TRACES into IMSOC, will the EU consider holding regional worksh ops to provide the 
necessary technical assistance for competent authorities of the third countries?  
 
 
126 Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official 
certificates for certain animals and goods and amending Regulation (EC) No . 2074/2005 and Implementing 
Regulation (EU) 2016/759 as  regards these model certificates OJ L 131, 17.5.2019, p. 101 –194.  
127 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on 
transmissible animal diseases and amending and repealing certain acts in the area of animal heal th ("Animal 
Health Law ") OJ L 84, 31.3.2016, p. 1 –208 
128 Commission Delegated Regulation (EU) 2019/478 of 14 January 2019 amending Regulation (EU) 
2017/625 of the European Parliament and of the Council as regards the categories of consignments to be 
subject ed to official controls at border control posts, JO L 82 du 25.3.2019, p. 4.  
129 Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be 
subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC ( OJ L 116, 
4.5.2007, p. 9 ). 
130 Commission Implementing Regulation (EU) 2019/2007 of 18 November 2019 laying down rules for 
the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regard s the lists 
of animals, products of animal origin, germinal products, animal by -products and derived products and hay and 
straw subject to official controls at border control posts and amending Decision 2007/275/EC (OJ L 312, 
3.12.2019, p. 1).  WT/TPR/M/395/Add.1  
 
- 501 - 
 
  EU reply:  
The EU organises regional workshops under the Better Training for Safer Food (BTSF) initiative to 
train non -EU competent authorities in the use of the new TRACES -NT platform where the official 
certificates for importing animals, animal products and plants into the EU are available. Regional 
workshops combine hands -on courses and EU legislation on the policy areas covered by TRACES. 
Links betwe en TRACES -NT and the other IMSOC components (EUROPHYT and RASFF) are presented.   
Upon request of the Tapei Representative Office in the EU a two -day training workshop is already 
envisaged for operators and authorities for February 2020 in Taipei.  
 
3.3.7 In tellectual property rights  
 
Page 152 (Para 3.353)  
Among others, the 2017 Regulation and its delegating and implementing regulations introduced the 
EU certification mark. This is defined as a mark that is "capable of distinguishing goods or services 
which are certified by the proprietor of the mark in respect of material, mode of manufacture of 
goods or performance of services, quality, accuracy or other characteristics, with the exception of 
geographical origin, from goods and services which are not so certified". It thus provides a guarantee 
of the specific characteristics of certain goods and services, irrespective of the identity of the 
undertaking that actually produces or provides the goods and services at issue. The role of the 
certification mar k owner is to control the compliance of the goods and services with a given standard 
set out in the regulations of use of the certification mark.  
 
Question(s):  
16. In contrast to the EU collective marks, which may serve, in trade, to designate the 
geographical  origins of goods or services, the EU certification marks cannot be used to 
certify geographical origins. What, if any, are the grounds for this distinction?  
 
EU reply : 
Regulation 2017/1001 on the European Union trade mark provides for a system of the col lective and 
certification trademarks. Article 74(1) provides that the EU collective mark is an EU trade mark which 
is capable of distinguishing the goods or services of the members of the association which is the 
proprietor of the mark from those of other undertakings. Article 74(2) provides that signs or 
indications which may serve, in trade, to designate the geographical origin of the goods or services 
may constitute EU collective marks. This is a specific derogation from Article 7(1)(c) which provides 
for absolute grounds of refusal (i.e. such trade marks shall not be registered) for "trade marks which 
consist exclusively of signs or indications which may serve, in trade, to designate […] geographical 
origin […]". Article 74(2) further provides that an EU  collective mark does not prevent use of 
geographical names in accordance with honest practices in industrial or commercial matters; in 
particular, such a mark shall not be invoked against a third party who is entitled to use a geographical 
name.  
Article 8 3(1) provides that the EU certification mark is an EU trade mark which is capable of 
distinguishing goods or services which are certified by the proprietor of the mark in respect of 
material, mode of manufacture of goods or performance of services, quality , accuracy or other 
characteristics, with the exception of geographical origin, from goods and services which are not so 
certified. In essence, an EU certification mark indicates that the goods and services bearing the mark 
comply with a given standard set  out in the regulations of use and controlled under the responsibility 
of the certification mark owner, irrespective of the identity of the undertaking that actually produces 
or provides the goods and services at issue and actually uses the certification m ark. 
 
4 TRADE POLICIES BY SECTOR  
4.2 Energy  
 
Page 198 (Para 4.122)  
The EU imported 55.1% of its energy in 2017, making it the world's largest energy importer, with 
an annual energy -import bill averaging EUR 300 billion over the last five years. Some EU member 
States depend on one or two external suppliers for their entire gas imports, and therefore remain 
vulnerable to supply shocks. It has been estimated that every additional 1% increase in energy 
savings cuts gas imports by 2.6%. Some 75% of the EU' s housing stock is energy  inefficient, and 
94% of transport relies on oil products, of which around 90% is imported. Collectively, the EU spends 
some EUR 120 billion per year, directly or indirectly, on energy subsidies, often not justified.  
 WT/TPR/M/395/Add.1  
 
- 502 - 
 
  Question(s):  
17. The international community, and the EU in particular, is dedicated to promoting a fair 
and transparent competition environment. Could the EU please elaborate further on the 
purpose, criteria, relevant measures, current status, and future plan s concerning the 
unjustified energy subsidies? Is there any corresponding withdrawal mechanism in place?  
 
EU reply:   
Important progress has been made in reporting fossil fuel subsidies with the recent publication of 
"Energy prices, costs and subsidies in the EU" .131 
Under the Governance regulation132, each EU Member State must report on actions that they 
undertake to phase out energy subsidies, in particular for fossil fuels. In the National Energy and 
Climate Plans Member States are to provide an inventory on  fossil fuel subsidies and their plans to 
phase them out.  
The European Green Deal133 aims to ensure that different carbon pricing instruments (including 
energy taxation and Emission Trading System) complement each other in a coherent framework.  
 
Page 201 ( Para 4.131)  
There are five targets of European Union's energy policy, including improving security of energy 
supply, completing the internal energy market, boosting energy efficiency, decarbonizing the 
economy and becoming the world leader in renewable ene rgy, and promoting research, innovation 
and competitiveness. With regard to improving security of energy supply, "diversification of energy 
sources, suppliers and routes, and more efficient energy consumption" are considered crucial for 
achieving this goal . 
 
Question(s):  
18. Could  the EU please describe in more detail how it plans to achieve its target of 
improving the security of energy supply by diversifying gas supply sources, while abiding 
by international rules such as those of the WTO?  
 
EU reply:   
The EU is promoting the diversification of gas supplies and routes through the implementation of the 
Southern Gas Corridor, the development of new sources in the East -Mediterranean and the Black 
Sea and taking advantage of the opportunities provided by a growi ng and ever more flexible global 
LNG market. Through diversification, the EU aims at ending energy isolation and single source 
dependency and allow access for all Member States to at least three different sources of gas.  
 
Page 20 2 (Para 4.138)  
The transiti on towards a more secure and sustainable energy system will require major investments 
in generation, networks and energy efficiency, estimated at some EUR 200 billion annually in the 
next decade. The private sector is expected to bear the brunt of the cost s. The European Investment 
Bank, the Connecting Europe Facility and the European Structural and Investment Funds already 
participate. Moreover, the European Fund for Strategic Investments will provide additional support, 
facilitating access to finance for projects of European significance, such as in energy networks, 
renewable energy and energy efficiency.  
 
Question(s):  
19. Could  the EU  elaborate further on the criteria of the so -called "European significance"? 
Is the additional support provided to facilitate access to finance for EU businesses only?  
 
EU reply:   
In terms of energy networks, Projects of common interest (PCIs) are key cro ss-border infrastructure 
projects that link the energy systems of EU countries. Those European -relevant projects are intended 
to help the EU achieve its energy policy and climate objectives: affordable, secure and  sustainable 
energy for all citizens, and t he long -term decarbonisation of the economy in accordance with the 
Paris Agreement  (https://ec.europa.eu/clima/policies/international/negotiations/paris_en) .To 
benefit from access to finance, the projects need to prove commercial soundness, economic and 
technical viability, and maturity enough to be bankable. The access to funding is not restricted to 
EU businesses only.  
 
131 Available at: https://ec.europa.eu/energy/en/data -analysis/energy -prices -and-costs.  
132 Available at: https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32018R1999&from=EN.  
133 Available at: https://ec.europa.eu/info/sites/info/files/european -green -deal-commu nication_en.pdf.  WT/TPR/M/395/Add.1  
 
- 503 - 
 
  Page 20 6 (Para 4.153)  
The EU currently has two targets for biofuels, namely to source 10% of transport fuels from 
renewables by 2020, and to oblige fuel providers to reduce the GHG intensity of their fuels by 6% 
by 2020. The Commission proposed to scrap these two targets after 2020.  
 
Question(s):  
20. After  2020, will the EU be implementing other policy objectives for the use of biofuels, 
or the composition of fuel sources for transportation purposes?  
 
EU reply:  
Neither the renewable energy directive (Directive 2009/28/EC), nor the fuel quality directive 
(Directive 98/70/EC) include binding targets for biofuels. The recast renewable energy dir ective 
(Directive (EU) 2018/2001) includes a sub target for advanced biofuels. Other pieces of legislation 
may provide indirect incentives for the use of biofuels.  
The Fuel Quality Directive provides for the 6% greenhouse gas lifecycle intensity reduction of diesel 
and petrol fuels traded on the EU market compared to a baseline reference value in 2010 
(94.1g  CO2/MJ): biofuels are one of the possible options to achieve that target by 2020 and 
subsequent years.  
 
4.4 Services  
4.4.5 Other measures adopted during the review period under the second pillar of the DSM 
Strategy  
 
Page 251 (Para 4.341 ) 
Fifthly, the Regulation requires that providers of online intermediation services establish an internal 
complaint -handling system to address complaints of b usiness users and to identify in their terms 
and conditions two or more mediators with which they are willing to engage to attempt to resolve, 
out of court, any dispute between the provider of that service and a business user. It lays down 
certain conditio ns that such mediators must fulfil, and provides that the Commission shall encourage 
the creation of organizations providing such mediation services.  
 
Question(s):  
21. Are there any relevant measures designed to assure the enforceability of the 
agreements reac hed through mediation under the framework of the "REGULATION OF THE 
EUROPEAN PARLIAMENT AND OF THE COUNCIL on promoting fairness and transparency 
for business users of online intermediation services" among EU member States or 
elsewhere?  
 
EU Reply:   
The Regulation does not deal with the enforceability of agreements reached through mediation. In 
line with Directive 2008/52/EC of the European Parliament and of the Council (10), the mediation 
provided for in this Regulation should be a voluntary process in t he sense that the parties are 
themselves in charge of the process and can start and terminate it at any time. However, any 
genuine bilaterally agreed outcome could reasonably be expected to cover the question of 
enforceability and applicable law in a manne r that is acceptable to both parties.  
 
Page 251 (Para 4.342)  
The EU Cybersecurity Act entered into force on 27 June 2019. It reinforces the role of the EU Agency 
for Cybersecurity (ENISA) by expanding its mandate and providing it with more resources. The 
revised mandate of ENISA is to: contribute to the development and implementation of EU policy and 
law in the field of cybersecurity; support capacity building and preparedness across the EU; promote 
operational cooperation at the EU level; support and promo te the development and implementation 
of EU policy on cybersecurity certification; provide analysis and advice, and raise awareness and 
identify research needs in the field of cybersecurity; and contribute to the EU's  international 
cooperation in this fiel d. The Act also establishes a European cybersecurity certification framework 
in order to increase the level of cybersecurity and enable a harmonized approach to cybersecurity 
certification within the EU, with a view to creating a single digital market for ICT products, services 
and processes.  
 
Question(s):  
22. Does  ENISA set a specific timetable for developing EU cybersecurity certification? Are 
there any concrete results available currently?  WT/TPR/M/395/Add.1  
 
- 504 - 
 
  23. Does every ICT product sold to the EU market need to pass the cybers ecurity 
certification? How does the EU ensure foreign ICT products can enter the EU market fairly 
without causing trade barriers?  
 
EU reply to Q22, 23:   
The Cybersecurity Act, which entered into force in June 2019, brings two major changes: a 
comprehensive  reform of the European Union Agency for Cybersecurity (ENISA) and the creation of 
the European cybersecurity certification framework.  
The EU cybersecurity certification framework will allow the establishment of individual, tailor -made 
EU certification sch emes for ICT products and services.  
The schemes will be first prepared by ENISA in consultation with stakeholders and then will be 
adopted by the Commission.  
ENISA has received two requests to prepare candidate cybersecurity certification schemes. The fi rst 
request is to prepare a scheme based on the Common Criteria Standards. The second, to prepare a 
scheme for cloud services cybersecurity certification. Preparation is underway. Results are expected 
towards the end of 2020.  
Companies established within the EU or elsewhere that choose to certify their products will be able 
to obtain certificates that are valid across the whole EU.  
The European cybersecurity certification schemes should be non -discriminatory and based on 
European or international standard s, unless those standards are ineffective or inappropriate to fulfil 
the Union's legitimate objectives in that regard.  
As such, the new framework does not constitute a barrier to entry of products outside Europe into 
the EU market.  
Certification may be carried out either by national cybersecurity certification authorities or private 
conformity assessment bodies depending on the requirements of each individual scheme.  
 
PART : REGARDING THE EU's RePORT (WT/TPR/G/395)  
 
3 developments i n the internal market  
3.6 Digital single market  
 
Page 10 (Para 3.19.n ) 
Further to Directive on Security of Network and Information Systems  the Cybersecurity Act was 
adopted, strengthening the role of the European Cybersecurity Agency (ENISA) and establishing a 
common European Cybersecurity certification framework for IT Services, systems and equipment.  
 
Question(s):  
24. EU's Cybersecurity Act in troduces for the first time an EU -wide cybersecurity 
certification framework for ICT products, services and processes. The certification 
framework will provide EU -wide certification schemes as a comprehensive set of rules, 
technical requirements, standards  and procedures. If this framework will have a potential 
impact on trade between EU and its third countries' trading partners, could EU more 
specifically provide information regarding what sorts of products or services would be 
most likely required mandato ry certification and the respective time frame scheduled?  
 
EU reply:   
The use of the new European certification schemes is voluntary.  
Nevertheless, the Cybersecurity Act provides for the Commission to regularly assess whether an 
adopted European scheme i s to be made mandatory through relevant Union law.  
The first assessment will be carried out no later than 31 December 2023, and subsequent 
assessments shall be carried out at least every two years.  
As a priority, the Commission shall focus on the sectors  listed in Annex II to Directive (EU) 
2016/1148 (NIS Directive), which shall be assessed at the latest two years after the adoption of the 
first European cybersecurity certification scheme.  
As the new European schemes will be recognized across the entire E U, there will be a strong incentive 
for companies to certify products, processes and services at EU level.  
 
3.11 The implementation of the EU Environment Action Programme  
 
Page 13 (Para 3.38) 
The Circular Economy Action Plan (CEAP), which was adopted in 2015 and established a 
comprehensive framework introducing measures covering the whole product lifecycle from WT/TPR/M/395/Add.1  
 
- 505 - 
 
  production via consumption to waste management and the market for secondary raw mate rials, is 
now fully implemented. On 4 March 2019, the European Commission adopted a comprehensive 
report on the implementation of the CEAP. The report on the implementation of the Circular Economy 
Action Plan presents the plastics strategy as an example of  where a systemic approach was 
successfully adopted to tackle barriers and challenges in a material specific lifecycle. In January 
2018, the EU adopted the EU Strategy for Plastics in a Circular Economy. The strategy pursues an 
ambitious approach for plast ic packaging recyclability and contains a strong response to the problem 
of microplastics, which are a significant source of marine pollution. By 2030, all plastic packaging 
should be reusable or recyclable. Furthermore, the strategy calls for global actio n to reduce plastics 
pollution.  
 
Question(s):  
25. The EU's strategy calls for global action to reduce plastics pollution. What is the EU's 
plan to cooperate with third countries to halt the pollution of plastics waste? What does 
the EU expect third countries' exporters/manufactures to do to reduce plastics pollution? 
Can the EU share its best practices and scientific knowledge regarding the solutions 
against the plastics waste with third countries? Will the EU develop an international 
standard to improve the qu ality of plastics recycling?  
 
EU reply:   
The key aim of EU international cooperation concerning plastic waste is prevention at source, in line 
with the EU's circular economy approach. This will require the promotion of a circular plastics 
economy in third countries through policy dialogues on environment, industry and trade. The 
Commission has regular policy dialogues on e.g. environment with partner countries (notably those 
members of the G20, including China and India) and is in the process of devel oping such dialogues 
also with key regional organisations, such as the Association of South East Asia Nations (ASEAN). 
Beyond policy dialogues, the cooperation mechanisms established under Free Trade Agreements and 
in particular their Trade and Sustainable  Development Chapters and the Generalised Scheme of 
Preferences can also be used for these purposes.  
Furthermore, the EU supports improved and sound waste management in third countries through 
its bilateral and regional funds. The EU SWITCH to Green progra mmes (Switch Asia, Switch Africa 
Green and SwitchMed) supporting sustainable consumption and production (SCP) practices, 
including concerning plastics, are one of the main EU contributions to the circular economy in partner 
countries. They also contribute to SDG 12 ('Ensure sustainable consumption and production 
patterns') and a number of other relevant SDGs.  
Moreover, the EU has adopted a number of actions that support the circular economy and, indirectly, 
the EU Plastics Strategy under the EU Partnership  Instrument. These include the China EU Water 
Platform (CEWP), the India -EU Water Partnership (IEWP), and the Resource Efficiency Initiative 
(REI) in India which bring together expertise from the EU and its Member States experts, and 
strongly engage with t he private sector.  
Furthermore, a project for contributing to reducing plastic waste and marine litter in East and South 
East Asia was launched in May 2019. The project will contribute to reducing plastic waste, including 
marine litter (e.g. fishing gear),  via a set of activities in hot spot countries in the region (China, 
Indonesia, Philippines, Thailand, Viet Nam), as well as Singapore and Japan, including relevant major 
rivers. These activities will take place in the context of the circular economy conce pt, promote the 
waste hierarchy and extended producer responsibility; address abandoned, lost and otherwise 
discarded fishing gears (ALDFG), and support sustainable plastic production and green public 
procurement.  
 
More information about EU policies relate d to plastics waste management ca be found at:  
 
(a) The EU Strategy for Plastics in a Circular Economy, https://eur -lex.europa.eu/legal -
 content/EN/TXT/?qid=1516265440535&uri=COM:2018:28:FIN  
 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019L0904  
(b) The EU Marine Strategy Framework Directive, 
 https://ec.europa.eu/environment/marine/eu -coast-and-marine -policy/marine -strategy -
 framework -directive/index_en.htm  
(c)  The Directi ve on Port Reception Facilities for the delivery of waste from ships, https://eur -
 lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019L0883  
(d) The Directive on the reduction of the impact of certain plastics products in the environment 
 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019L0904  WT/TPR/M/395/Add.1  
 
- 506 - 
 
  (e) Restriction report on microplastics from ECHA 
 https://www.echa.europa.eu/documents/10162/12414bc7 -6bb2-17e7-c9ec-652a20fa43fc  
 
3.12 The EU's actions on climate change  
 
Page 13 (Para 3.41) 
The EU has put climate action as a central policy objective. The EU is on track to keep its 2020 
greenhouse gas emissions well below the target and finalised the legislative framework to deliver on 
its objectives for 2030. This should allow the EU to adopt an  ambitious long -term strategy, striving 
for climate neutrality in line with the Paris Agreement and confirming Europe's commitment to lead 
in global climate action to the UNFCCC by 2020. Transitioning to a low greenhouse gas emission, 
resource efficient, a nd climate resilient economy will require a transformative effort demanding a 
fundamental shift in technologies, energy systems, business and investment behaviour, and 
ultimately, in society as a whole.  
 
Question(s):  
26. In 11 December 2019, the Commission published its communication on The European 
Green Deal. On page 21, it mentioned "The EU's trade policy facilitates trade and 
investment in green goods and services...".  
Could the EU please further provide details of th e actions it will be taking into 
consideration for green goods and services facilitation in the near future?  
 
EU reply:  
The EU market is open for green goods and services, with ambitious GATT commitments on tariffs 
for environmental goods and comprehensive GATS commitments on environmental services 
(GATS/SC/157). The EU will continue using its multilateral and plurilateral engagement as well as 
its bilateral engagement with partners to facilitate trade and investment in green goods and services. 
Checked with colleagues and updated text proposed.  
 
Page 14 (Para 3.44) 
In 2018, the EU adopted a directive revising the EU Emissio n Trading System for the period 2021 -30 
(so-called "phase 4"), including a reduction of the number of quotas by 2.2% per year from 2021, 
instead of 1.74% at present. It includes strict, predictable and equitable rules to prevent risks of 
carbon leakage.  
 
Question(s):  
27. Aside from the revision/expansion of the Emission Trading System, the European 
Commission will propose a carbon border adjustment mechanism for "selected sectors" 
by 2021 to prevent carbon leakage, according to the Communication on the European  
Green Deal released on December, 2019. Will the "selected sectors" be the same as the 
sectors covered by the Emission Trading System?  
 
EU reply:  
The European Green Deal foresees that the Carbon Border Adjustment mechanism will be proposed 
for a number o f selected sectors that are at risk of carbon leakage.  
The decision in terms of scope and coverage will be informed by the impact assessment. In any 
event, compliance with World Trade Organization (WTO) rules, trade agreements and other 
international obli gations of the EU will be ensured.  
 
28. The carbon border adjustment mechanism is referred to as "Carbon Border Tax" in the 
political guidelines of the new European Commission. Does this indicate that such 
mechanism will be applied on importing goods in a way which is similar to the levy of 
customs tariff?  
 
EU reply:  
There is a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible intera ction with the Emission Trading System.  
 WT/TPR/M/395/Add.1  
 
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  3.14 the withdrawal of the united kingdom from the european union  
 
Page 16 (Para 3.52)  
The EU trade policy will not change as a result of the United Kingdom's withdrawal. The EU will 
honour its obligations and the EU's WTO schedules will remain in place. However, the 
United  Kingdom's withdrawal from the EU will have implications in the WTO context. Quantitative 
commitments under the goods schedule need to be apportioned. To this end, as early as 
October  2017, the EU and the United Kingdom engaged jointly with other WTO Members on the 
envisaged approach of apportionment of tariff -rate quotas with the key principle of maintaining the 
existing level of market access to the EU27 and the United Kingdom . The negotiations under the 
Article XXVIII procedure are currently ongoing with the relevant WTO Members.  
 
Question(s):  
29. The United Kingdom's withdrawal from the EU would have implications on the 
continuing application of existing EU anti -dumping, anti -circumvention and safeguard 
measures, as the scope of the EU domestic industry and the basis of calculating import 
volume wo uld be changed. Would the EU revoke existing anti -dumping, anti -
circumvention and safeguard measures when the UK becomes a third country? Does the 
EU investigating authority envisage conducting ex officio  reviews on existing measures in 
response to the UK' s withdrawal? When and how would the revocation or reviews take 
place? TRADE H1/G1/TRADE F1 (Ursula)  
 
EU reply:   
The EU will ensure that its trade defence measures remain compatible with its WTO rights and 
obligations after the withdrawal of the UK from t he European Union. Whether existing measures will 
need to be reviewed to take account of this event will need to be examined on a case -by-case basis. 
A public communication is planned to be issued on this matter in due time.  
 
Question(s):  
30. Please provide a n update on the latest progress in negotiations under the 
Article  XXVIII procedure. Has any agreement been reached with WTO Members on the 
apportionment of tariff -rate quotas?  
 
EU reply:  
The negotiations under the GATT Article XXVIII procedure are confid ential and are currently ongoing 
with the WTO Members whose rights the EU recognised. Any agreements will be notified in 
accordance with the applicable rules.  
 
4 TRADE AND INVESTMENT Policy developments  
4.2 the eu bilateral negotiating agenda  
Page 19 (Para 4.20)  
The Court of Justice confirmed in its opinion 2/15 on the EU -Singapore Free Trade Agreement that 
the majority of areas covered by this FTA (ranging from trade in goods, to services, to public 
procurement or sustainable development) fall under t he exclusive competence of the EU. Only as 
regards portfolio investment and the settlement of disputes between foreign investors and states, 
the EU shares competence with Member States. In view of this, the EU has introduced a new 
approach to its trade and  investment agreements: free trade agreements cover areas where the EU 
has exclusive competence, while investment protection agreements cover areas of both EU exclusive 
and shared competence. Japan, Singapore and Viet  Nam were the first trade and investmen t 
partners with whom the EU followed this new approach. In addition, the EU is pursuing negotiations 
for standalone investment agreements, including with China.  
 
Question(s):  
31. In 2013, the European Parliament adopted its first resolution to call on the 
Comm ission to start negotiations on BIA with the Separate Customs Territory of Taiwan, 
Penghu, Kinmen and Matsu. In 2015, the European Commission made known its wish to 
explore the possibility of launching negotiations on a BIA with the Separate Customs 
Territ ory of Taiwan, Penghu, Kinmen and Matsu (Trade For All, October 2015), and stated 
in 2017 that the EU was "preparing to launch investment negotiations with Hong Kong 
and the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu" (Report on 
the Imp lementation of the Trade Policy Strategy Trade for All, September 2017). WT/TPR/M/395/Add.1  
 
- 508 - 
 
  Moreover, the European Parliament adopted three more resolutions from 2016 to 2018 to 
strongly support such an agreement.  
With the EU's new leadership taking office on December 1st, 2019, what would be the 
timetable for the EU to start negotiations with the Separate Customs Territory of Taiwan, 
Penghu, Kinmen and Matsu on BIA?  
 
EU reply:  
As the new EU Commission only took office on 1 December 2019, the College of Commissioners will 
first need to discuss and validate any new proposal such as the launch of investment negotiations 
with the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu. In the event of a 
decision to launch such negotiations, there are various procedural steps to be completed on the EU 
side such as a scoping exercise, an impact assessment and receiving the negotiating authorisation 
and directives from EU Member States to launch negotiations. It is not possible to give an exact 
timeframe for those various steps as they vary depending on the complexity of the issues to be 
examined.  
 
Pages 19 and 20 (Paras 4.29 and 4.30 ) 
The EU is putting increasing efforts into implementation and enforcement of commitments made 
under bilateral trade agreements. Following its 2015 commitment, the European Commission 
published its third annual report on implementation of EU free trade agreements in October 2019. 
This report is comp lemented by a comprehensive working document which provides detailed 
information on the implementation of each agreement, including on the work of committees and 
sub-committees established under the agreements.  
The Annual Report on implementation of free t rade agreement now provides information on the 
preferential utilisation of the agreement for EU imports based on EU statistics. The EU works closely 
with its trade partners to obtain reliable statistics on preferential utilisation for EU exports in order 
to be able to assess the effects of the agreement.  
 
Question(s):  
32. The EU is going to establish a Chief Trade Enforcement Officer position soon to monitor 
and improve the compliance of trade agreements signed by the EU and third 
countries/areas. How does the EU evaluate the efficiency of the implementation of current 
free trade agreements between itself and third countries/areas? What are the main areas 
that the Chief Trade Enforcement Officer is likely to focus on in order to improve the 
efficiency of the imp lementation of those free trade agreements?  
 
EU reply:  
The EU carries out regular ex -post evaluations of its trade agreements. The post recent one concerns 
the EU Korea trade agreement and was completed in 2019. Information on ex post evaluations of 
EU trade agreements including the methodology used to carry out these evaluations is available at 
https://ec.europa.eu/trade/policy/policy -making/analysis/policy -evaluation/ex -post-evaluations/.  
 
On top of these evaluations, a report on the implementation of f ree trade agreements is prepared 
every year since 2017. The report which is complemented by a set of information sheet on each 
agreement (called staff working document) provides factual information on the development of trade 
in goods and services and the implementation of the agreements. The 2019 report and its staff 
working document are publicly available at https://ec.europa.eu/trade/policy/countries -and-
regions/negotiations -and-agreements/ . 
 
The Chief trade enforcement officer will be a new deputy Direc tor General in the directorate general 
for trade of the European Commission. The mission of this high -level Commission official will be to 
monitor and improve the compliance of EU trade partners with the commitments made in multi -
lateral or bilateral trade  agreements. This work will include a close monitoring of the implementation 
of commitments related to climate, environmental and labour protection enshrined in EU bilateral 
trade agreements. The Chief trade enforcement officer will also regularly report o n those issues to 
the European Parliament and the Council.  
 WT/TPR/M/395/Add.1  
 
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  4.3 promoting a sustainable approach to trade  
4.3.1 Promoting labour rights and environmental protection  
 
Page 20 (Para 4.33) 
At bilateral level, the EU promotes labour and environmental considerations in its trade agreements 
through dedicated chapters on trade and sustainable development (TSD). Bilateral agreements 
under implementation that contain such chapters include those with Canada, Central America, 
Colombia, Ecuador a nd Peru, Georgia, Moldova, South Korea and Ukraine. Also, the recently signed 
agreements with Japan, Mexico, Singapore and Viet  Nam have a TSD chapter, as does the recently 
concluded agreement with Mercosur. TSD chapters include commitments to ratify and e ffectively 
implement fundamental International Labour Organization conventions and Multilateral 
Environmental Agreements. The chapters also contain specific provisions on the conservation and 
sustainable management of natural resources (e.g. timber, fish a nd wildlife) and the promotion of 
practices favouring sustainable development and responsible business practices. They also aim to 
prevent the risk of a race to the bottom, by prohibiting derogations from or lack of enforcement of 
domestic environmental or  labour laws in order to encourage trade and investment.  
 
Question(s):  
33. How does the EU ensure that its trade partners are fulfilling their commitments on 
those TSD chapters? For example: Is the TSD chapter of the EU -Mercosur free trade 
agreement sufficient  enough to let Mercosur take compatible action to implement a 
Multilateral Environment Agreement along the same lines as the Paris Agreement?  
 
EU reply:  
Commitments to trade and sustainable development have been continuously strengthened in EU 
trade agre ements, in particular with regard to enhancing climate change action. The Commission 
has also been stepping up efforts to implement and enforce the sustainable development 
commitments of EU trade agreements, and these efforts will be further enhanced with the 
appointment of a Chief Trade Enforcement Officer.  
 
4.3.6 Promoting fair and ethical trade schemes  
Page 22 (Para 4.48 and 4.49)  
In addition, a market study on consumer demand for fair and ethical products was finalised and 
presented in May 2018. The study focused on selected EU Member States and concluded that 
sustainable product sourcing has become a top priority for retailers who are increasingly "greening" 
their supply chains, adopting fair and ethical trade criteria and applying sustainability sta ndards in 
overwhelming numbers.  
 
Question(s):  
34. Fair and ethical trade schemes are promoted as part of the EU's concluded bilateral 
trade agreements and through the network of EU delegations. Could the EU please indicate 
what is the impact of fair and ethica l trade schemes on trade between the EU and its 
trading partners?  
 
EU reply:  
The EU does not have data on the impact of fair and ethical trade schemes for trade between the 
EU and its trading partners. The Commission promotes awareness among consumers on 
contributions fair and ethical trade schemes can make to sustainable development through ´the 
cities for fair and ethical trade Award' and raises awareness in partner countries through stakeholder 
events (Brazil). The Commission also looked into use of sus tainability schemes and broader 
sustainability strategies of retailers in the EU. In May 2019, the EU published in cooperation with the 
International Trade Center a study on the 'European Union Market for Sustainable Products' which 
points out to the fact that sustainable product sourcing has become an important priority for retailers 
in France, Germany, Italy, the Netherlands and Spain.  
 
4.4 Trade Policy for open and fair trade  
 
Page 22 (Para 4.53)  
The EU took several significant measures to achieve open but fair trade:  
(b) Regulation on Screening of Foreign Direct Investment: The regulation entered into force on 
10 April 2019. It will become fully applicable as of 11 October 2020. In some exception al cases 
(foreign investment affecting critical technologies, infrastructure, supply of critical inputs or access WT/TPR/M/395/Add.1  
 
- 510 - 
 
  to sensitive data), it will help European Union safeguard its security interests from foreign 
investment targeting the acquisition of critical  European assets. The EU screening framework does 
not replace or duplicate existing national mechanisms, and hence does not add red tape for 
investors. It is not targeted against investors from any particular country: non -discrimination is a 
key principle of the new Regulation and screening mechanisms of EU Member States will need to 
respect this principle. In addition, requirements applying to national screening mechanisms include 
rules on transparency, confidentiality of information exchanged, possibility  of recourse against 
screening decisions, and measures to identify and prevent circumvention by foreign investors.  
 
Question(s):  
35. If the EU's new screening regulations for FDI are not completely the same as the 
existing screening regulations of its member states, foreign investment may be subject 
to lengthy approval timelines due to differing regulations. Could the EU therefore pleas e 
explain how it expects to harmonize and coordinate the various foreign investment 
screening mechanisms among all EU member states?  
 
EU reply:  
The Regulation establishes a cooperation mechanism between the Member States and the Member 
States and the Com mission. The Regulation does not harmonise the screening mechanisms of the 
Member States, but it rather stipulates the essential elements that Member States' screening 
mechanisms must comply with (e.g. all screening Member States shall have rules and proce dures in 
place that are transparent and do not discriminate between third countries). The cooperation 
mechanism is subject to short, business -friendly deadlines, i.e. in principle the cooperation should 
be carried out within 35 calendar days.  
 
  WT/TPR/M/395/Add.1  
 
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  THAILAND  
PART I: QUESTIONS REGARDING THE REPORT BY WTO SECRETARIAT   
 
1. ECONOMIC ENVIRONMENT  
1.2 Recent Economic Developments  
1.2.2 Fiscal governance and performance  
 
Pages 20 -21, Para. 1.16.  
1.16.  There are ongoing efforts to rationalize expenditures by shifting resources from the common 
agricultural and cohesion policies to areas such as research and innovation, young people, the digital 
economy, migration, and climate objectives. There are also o ther tax -related developments at the 
EU level and in some member States. The proposal to apply a rate of 3% to the new Common 
Consolidated Corporate Tax Base (CCCTB) seems to have beneficial features, as it reduces 
opportunities to shift profits within the  EU. According to the International Monetary Fund (IMF), tax 
competition remains an issue. Proposals for a "digital services tax" have been suspended until 2020. 
However, some member States, including Austria, France, Italy, and Spain, have taken steps for  
their own versions of such a tax.  
 
Question 1  
What is the "next step" for the digital services tax in 2020 after the end of its suspension 
period? And how would it be implemented/integrated in existing digital services tax 
already applied by some EU membe r states?  
 
EU reply:  
The EU is fully engaged in the debate with the international partners to achieve a long -term global 
solution for the taxation of digital economy and is encouraged by the progress being made at the 
Organisation for Economic Co -operation and Development in t his respect.  
In case of agreement, the measures applied by some Member States are to be withdrawn.  
In case of no agreement, the strong rational for EU action will remain. In due time, the Commission 
will assess possible scenarios before proposing a way f orward, taking into account the developments 
of the OECD discussion.  
 
2. TRADE AND INVESTMENT REGIMES  
2.4 Investment Regime  
2.4.2 Investment relations with third countries  
2.4.2.1 Establishment of a cooperation mechanism for the screening of FDI  
 
Pages 48 -49, Paras. 2.60 and 2.65.  
2.60.  The European Commission President proposed the creation of an EU framework for FDI 
screening in the 2017 State of the Union address. The proposal was motivated by growing concerns 
regarding the impact on the strategic inter ests of the EU or its member States of certain types of 
FDI, especially foreign acquisitions in cases involving state -owned enterprises and strategic sectors. 
This legislation, a regulation based on the common commercial policy competence in Article 207(2)  
of the TFEU, was adopted on 19 March 2019, entered into force on 10 April 2019, and shall apply 
from 11 October 2020.  
 
2.65.  With regard to the second pillar - the mechanism for cooperation - the Regulation requires 
member States to notify the Commission a nd other member States of any FDI that is undergoing 
screening, provides that other member States may submit comments to the member State 
undertaking the screening, and allows the Commission to issue an opinion to such member State, 
on its own initiative o r at the request of the screening member State. Such opinion is legally 
non-binding. While the member State undertaking the screening must give due consideration to 
such comments and to the opinion of the Commission, the final screening decision shall be taken by 
that member State. Another aspect of the cooperation mechanism is the provision that a member 
State may submit comments to, and request information from, another member State if it considers 
that its security or public order is affected by FDI in another member State that is not undergoing 
screening; the Commission may issue an opinion to, and request information from, a member State 
if it considers that FDI in that member State that is not being screened affects security or public 
order in more th an one member State.  
 WT/TPR/M/395/Add.1  
 
- 512 - 
 
  Question 2  
With regard to the mechanism for cooperation created under the EU framework for FDI 
screening to be applied from October 2020, how long does the consideration time period 
take for the comments and opinions submission proces s among EU member countries? 
Would the Framework help facilitate foreign investors in conducting businesses in the EU?  
 
EU reply:   
The Regulation was designed not to impede investments into the Union. This is why the cooperation 
mechanism is subject to sh ort, business -friendly deadlines. Articles 6 and 7 of Regulation (EU) 
2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a framework 
for the screening of foreign direct investment into the Union stipulate that in principle  (i.e. unless 
additional information is requested) the cooperation should be carried out within 35 calendar days.  
 
3. TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.2 Rules of origin  
3.1.2.2 Preferential  
 
Page 58, Para . 3.30  
3.30.  Two recent agreements, with Canada and Japan, continue an earlier practice in a few FTAs for 
origin determination with the establishment of origin quotas. For goods that ordinarily would not 
qualify through the product -specific rules, another alternative was given for a limited number of 
products and quantities. For example, the CETA provides for some origin quotas for high -sugar -
containing products, sugar confectionary and chocolate preparations, processed foods, dog and cat 
food, fish and sea food, textiles, apparel, and vehicles, as listed by HS code and quota amount in 
Annex 5 -A to the Protocol on Rules of Origin of the CETA.  
 
Questions 3  
(1) Under CETA, does EU have a website that provide update information on usage and 
remailing origin quota of those products listed out on Annex 5 -A? 
(2) Do EU and FTA partners have a mechanism to share/exchange/publish trade statistic 
information especially on origin quota?  
 
EU reply:  
Information related to the tariff quotas managed by the system "First Come First served" can be 
found on the QUOTA website of the Taxation and Customs Union Directorate General (see below):  
http://ec.europa.eu/taxation_custo ms/dds2/taric/quota_consultation.jsp?Lang=en . 
This website displays the balances of each tariff quota applicable in the present year and in the past 
years. It also indicates certain other important information such as the status of the quota 
(ie. critical, blocked) and the date of exhaustion. This information is subject to constant  change as 
a result of the daily operations which take place. This information on the QUOTA website is taken on 
the evening of each working day and is therefore correct a t the time. It remains on the website until 
evening of the following working day.  
 
Page 58 -59, Para 3.31 and Table 3.2  
3.31. Other new FTAs entering into force in the last few years, i.e. Japan, Côte d'Ivoire, Ghana, and 
the SADC, have rules of origin incl uded in the respective EPAs or in the Market Access Regulation. 
An important feature of EU rules of origin is cumulation (Table 3.2).  
 
Questions 4  
(1) Please explain how the EU implements diagonal cumulation and full cumulation under 
the EU's existing PTAs . 
 
EU reply:  
The example of the Regional Convention on pan -Euro-Mediterranean preferential rules of origin 
(PEM Convention) gives a good overview on how cumulation is implemented. Please consult the 
User's Handbook dedicated to the details of this agreemen t under the following link:  
https://ec.europa.eu/taxation_customs/sites/taxation/files/resources/documents/customs/custom
s_duties/rules_origin/preferential/handbook_en.pdf . 
 
(2) Why does the EU allow for diagonal cumulation and full cumulation under certai n PTAs only?  
TRADE F3/TAXUD/ [JB]  WT/TPR/M/395/Add.1  
 
- 513 - 
 
  EU reply:  
Bilateral cumulation is allowed in every EU FTA to encourage economic integration of the FTA 
partners. Other types of cumulation possibilities are the result of, among other things, the 
negotiating context, the i nterests of the negotiating partners and the geographical/economic 
realities.  
 
3.3 Measures Affecting Production and Trade  
3.3.3 Sanitary and phytosanitary requirements  
 
Page 119, Para. 3.220  
3.220.  The Commission's Trade Control and Expert System (TRACES) is an online system which 
manages official controls and route planning for imports of animals, semen and embryos, food, feed 
and plants which must be accompanied by health certificates and/or trade  documents. All 
harmonized certificates for exporting to the EU are available on TRACES which is used to notify the 
relevant authorities in the importing member State of the arrival of a consignment  
 
Question 5  
Are foreign exporters who need to export spec ified agricultural products required to 
contact, register and submit certified products information to the Commission's Trade 
Control and Expert System (TRACES) directly? Or is there any other mechanisms involved 
in the process?  
 
EU reply:  
The use of TRAC ES to certify animals and goods exported to the EU is not mandatory. However, the 
system offers certain advantages to non -EU countries and operators: TRACES users have automatic 
access to the most updated templates of certificates to the EU and they are in formed of the status 
of their consignments in real time.  
The use of TRACES is mandatory for the importing Member States, which have to register their 
checks on imported consignments of animals and goods that are subject to sanitary or phytosanitary 
certifi cation.  
 
3.3 Measures Affecting Production and Trade  
3.3.7 Intellectual property rights  
3.3.7.2 Industrial property  
3.3.7.2.4 Geographical indications  
 
Page 153, Para. 3.358  
3.358.  While the harmonization of the protection of GIs within the EU is advanced with regard to 
agricultural products, that for non -agricultural products is currently only available at the national 
level in a number of member States. Protection for agricultural  products at the EU level can be 
obtained in one of the following ways: as a protected designation of origin (PDO) or a protected GI 
(PGI) for wines and agricultural products and foodstuffs, or as a GI for spirits and aromatized wines  
 
Question 6  
Thailand would like to seek clarification on which member states of The European Union 
secure the protection for non -agricultural products at the national level.  
 
EU reply:  
In the EU, Geographical indication protection for non -agricultural products is available i n all Member 
States through different types of routes, including protected under sui generis systems, as 
collective/certification trademarks and under unfair competition laws.  
 WT/TPR/M/395/Add.1  
 
- 514 - 
 
  4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2 Agricultural policies  
4.1.1.2.1 Domestic support  
4.1.1.2.1.1 Direct payments  
 
Page 166, Para. 4.11  
4.11.  In order to be eligible for direct payments, farmers must comply with "the minimum 
requirements", i.e. be active farmers and have a gricultural land at their disposal that is used for 
agricultural activity.  
 
Question 7  
Please provide more details about "the minimum requirements" and the agency 
responsible for administering the program.  
 
EU reply:  
In order to avoid the excessive admini strative burden caused by managing payments of small 
amounts, Member States should generally refrain from granting direct payments where the amount 
would be lower than EUR 100 or where the eligible area of the holding for which support is claimed 
would be less than one hectare.  
Taking into account that Member States' farming structures vary considerably and may differ 
significantly from the average farming structure in the EU, each Member State sets minimum 
thresholds to reflect its particular situation, a s provided in Article 10 of Regulation (EU) 
No. 1307/2013 adjusting the thresholds within the limits set out in Annex IV.  
For further information on eligibility for direct payments, please consult  
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/key_policies/documents/direct -
payments -eligibility -conditions_en.pdf . 
 
Page 166, Para. 4.12  
4.12.  Until 2017, in all member States, entities operating an activity on the "negative list" were not 
considered "active farmers" unless they could prove that their farming activity was not marginal, 
using one of three possibilities to rebut the negative presu mption. Since 2018, the Omnibus 
Regulation provides greater flexibility to member States to define who is an active farmer, notably 
by allowing them to discontinue the application of the "negative list" or to reduce the number of 
possibilities for rebuttin g the negative presumption and/or by introducing the possibility to consider 
as active farmers only those registered for their agricultural activities in a national fiscal or social 
security register. Member States can exempt farmers from the definition of  active farmer if they 
received direct payments below a certain level of threshold not exceeding EUR 5,000.  
 
Question 8  
Please clarify what activities are included in "The negative list" and the reasons behind 
them.  
 
EU reply:  
The list of negative activit ies in Article 9(2) of Regulation (EU) 1307/2013 precludes the granting of 
direct payments to natural or legal persons, or to groups of natural or legal persons, who operate 
airports, railway services, waterworks, real estate services, and permanent sport and recreational 
grounds. Entities with activities on the negative list usually do not have farming as their principal 
activity or at least such activity is insignificant compared to their other activity. They just happen to 
have some land, which might be considered agricultural and so are presumed to be "non -active".  
Consequently, until claim year 2017 in all Member States, entities operating an activity on the 
"negative list" were not considered "active farmers" unless they could prove that their farming  
activity was not marginal, using one of the three possibilities to rebut the negative presumption in 
line with the third sub -paragraph of Article 9(2) of Regulation (EU) 1307/2013.  
Regulation (EU) 2017/2393 amended this provision to make it optional, considering the 
administrative burden its implementation involved compared to its effect in some Member States.  
When implementing the negative list Member States can also decide to expa nd it to include other 
similar activities.  
For further information on eligibility for direct payments, please consult : 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/key_policies/documents/direct -
payments -eligibility -conditions_en.pdf . WT/TPR/M/395/Add.1  
 
- 515 - 
 
  Page 173, Para 4.41  
4.41.  These three general objectives ought to be achieved through nine specific objectives: 
(i) support viable farm income and resilience across the territory, to enhance food security; 
(ii) enhance market orientation and increase compe titiveness, including greater focus on research, 
technology and digitalization; (iii) improve farmers' position in the value chain; (iv) contribute to 
climate change mitigation and adaptation, and sustainable energy; (v) foster sustainable 
development and efficient management of natural resources, such as water, soil and air; 
(vi) contribute to the protection of biodiversity, enhance ecosystem services, and preserve habitats 
and landscapes; (vii) attract young farmers, and facilitate business development in  rural areas; 
(viii) promote employment, growth, social inclusion and local development in rural areas, including 
bio-economy and sustainable forestry; and (ix)  improve the response of EU agriculture to societal 
demands on food and health, including safe, nutritious and sustainable food, and animal welfare.  
 
Question 9  
According to the EU's Common Agricultural Policy (CAP) beyond 2020, one of its 
objectives (no. vii) is to "attract young farmers and facilitate business development in 
rural areas". Could the  EU share its experiences or give some examples of measure(s) or 
project(s) undertaken to achieve this objective?  
 
EU reply:  
Under the current CAP, the Young Farmer Payment (YFP) is a compulsory scheme for Member States 
to implement in the framework of direct payments. The payment is additional to other direct 
payments and is limited to a maximum period of 5 years following the setting -up. Member States 
had to make a number of policy choices in implementing the YFP. In particular, the method  for 
calculating the payment for young farmers. Article 50(6) to (8) and Article 50(10) of Regulation (EU) 
No 1307/2013 provide for several calculation methods for calculating the payment per farmer. When 
a Member State chose one of the methods provided in  Article 50(6) to (8), a single maximum limit 
has been set for the number of payment entitlements activated by the farmer or to the number of 
eligible hectares declared by the farmer. In addition, Member States may define additional eligibility 
criteria re garding appropriate skills and/or training requirements that have to be met when 
submitting his first application for the YFP.  
In 2017, almost 410 000 young farmers, benefited from the YFP in the EU: an increase of about 5% 
in comparison to 2015. The share  of YFP beneficiaries varies among Member States: between 1% 
and approximately 13% of total decoupled direct payment beneficiaries.  
Further information on the implementation of the Young Farmer Payment is available at 
https://ec.europa.eu/info/sites/info/f iles/food -farming -fisheries/key_policies/documents/summary -
report -implementation -direct -payements -claim -2017.pdf . 
 
4.1.1.2.1.2 Internal market support measures  
 
Page 174, Para. 4.45  
4.45.  The Common Market Organisation (CMO) for agricultural products set o ut in Regulation (EU) 
No. 1308/2013 was also amended by the Omnibus Regulation. Regarding producer organizations, 
some activities, such as planning production, optimizing production costs, placing on the market, 
and negotiating contracts for the supply of agricultural products, were extended beyond sectors like 
olive oil, beef and arable crops, for which they already existed. The possibility for farmers and their 
first purchasers to negotiate collectively voluntary value -sharing clauses was also extended to  
sectors other than sugar.  
 
Question 10  
Please provide more information on the amendments that have been made for the 
Common Market Organization (CMO) for agricultural products set out in Regulation (EU) 
No. 1308/2013.  
 
EU reply:  
Regulation (EU) No . 1308/ 2013 contained a new provision, in Article 152, which deals with 
recognised producer organisations (POs) for all agricultural sectors and allows these POs in particular 
to plan product and conduct negotiations for the sale of agricultural products (joint s ales). Under 
Article 152, recognition may be given if the organisation is formed and controlled by agricultural 
producers in one of the sectors listed in Article 1(2) of Regulation (EU) 1308/2013. Since 2017, 
Regulation (EU) 2017/2393 modified the provisions on recognition (which already existed for all 
sectors since 2013) so that now the PO has not only to follow certain objectives, but also to integrate WT/TPR/M/395/Add.1  
 
- 516 - 
 
  an economic activities for its members, e.g. it carries out transport or it creates a joint label, it buys 
input products on behalf of its membe rs. Other important changes are:  
 
• Deletion of sector exemptions: Specific provisions for olive oil, beef/veal and certain arable 
crops in Article 169 -171 have been deleted.  
• A right to ask the Commission for an opinion on the application of Article 209 which allows 
farmers to work together for the production of an agricultural product and for its sales, 
although competition cannot be excluded and no identical prices can be charged.  
• Article 222 has been extended to other entities such as cooperatives and the last resort character 
of agreements in crisis situations has been removed in the light of experience to enable a more 
rapid reaction to severe market imbalances.  
• Article 148 and 168 allow a farmer to ask for a written contract (even if such contracts h ave 
not been made obligatory), unless his trading partner is a Small or Medium Sized Enterprise. 
Within a cooperative, this applies only if the cooperative does not have statutes that are 
similar. This reflects the current law, in which the requirement for  contracts only applies to 
cooperatives, if they do not have similar statutes.  
• Value sharing mechanism became available for all agricultural sectors, which allows parties to 
agree on sharing losses and market bonuses between them. The price of the products  cannot 
be fixed; the parties merely allocate the risks related to the sale of the product. The 
mechanism must be voluntary.  
 
The changes introduced in Regulation (EU) No . 1308/2013 by Regulation (EU) 2017/2393, may be 
seen at: https://eur -lex.europa.eu/le gal-content/EN/TXT/?uri=celex:32017R2393 . 
 
Page 176, Para 4.53 -4.54 
4.53.  As described by the Commission, the new provisions agreed in 2017 aimed at simplifying 
rules, reducing administrative burden and providing greater financial support in times of crise s, 
notably through: (i) an increase of the withdrawal prices for free distribution and for other purposes 
(compost, animal feed, distillation, etc); (ii) greater attractivity of producer organizations, by 
providing more clarity about the actions eligible t o EU funding and by setting at 25% the maximum 
percentage of products than can be marketed outside the producer organization (subject to 
modification by the member States); and (iii) simplification and clarification of the legislation with 
regards to trans national producer organizations and their associations.  
 
4.54. Support for fruit and vegetable production is focused on producer organizations that can use 
their operational funds to finance operational programmes submitted to and approved by EU member 
States. 
 
Question 11  
(1) It is stated in paragraph 4.53 that "… the new provisions agreed in 2017 aimed at 
…and providing greater financial support in times of crises…". Please clarify whether 
such support has been provided. If yes, when did the crisis happened, and whether 
such crisis has already ended?  
 
EU reply:  
This support is different to emergency and exceptional measures based on Article 219 of Regulation 
(EU) No 1308/2013. This support is granted under operational programmes of producer 
organisations in ac cordance with Articles 33(3) and 34(4) of that Regulation. Operational 
programmes may cover crisis and prevention measures such as withdrawals, green harvesting, 
harvest insurance, coaching, etc. In 2018, the EU support assistance for crisis and prevention  
measures amounted EUR 171 million.  
 
(2) In paragraph 4.54, it is stated that "Support for fruit and vegetable is focused on producer 
organisations …" Please clarify whether individual farmers are eligible for the support. AGRI/TRADE 
D3 [UH]  
 
EU reply:  
EU financial assistance in the fruit and vegetables sector only benefits producer organisations and 
so only indirectly producer organisations ' members.  
 WT/TPR/M/395/Add.1  
 
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  4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2 Agricultural policies  
4.1.1.2.3 Market access  
 
Page 184, Para. 4.86  
4.86.  Previously, the EU notified, in its two latest WTO notifications on imports under tariff and other 
quotas, a total of 124 TRQs, including 60 for marketing year 2017/18 and 6 4 for calendar year 2018. 
As reflected in the latest EU information on the administration of TRQs, of the 124 TRQs, 82 were 
erga omnes and 42 had country -specific allocations. According to the Commission, and as 
enumerated in its notifications, the EU uses  first-come first -served and licenses to allocate 
agricultural TRQs.  
 
Question 12  
EU's notification on imports under tariff and other quotas were based on both marketing 
year and calendar year, which may lead to confusion in time overlap of TRQs. Does it 
correspond to the rules and regulations under WTO? Please clarify the reasons why both 
years are required in the notification.  
 
EU reply:  
The EU has some TRQs opened on a calendar year basis and others on a marketing year basis. There 
is no WTO provision t hat prohibits this. The EU currently makes two notifications: after the end of 
the calendar year for the TRQs concerned and at the end of the marketing year for the others. The 
calendar year notification is made in February (end of year being 31 December) and the marketing 
year in November (end of year being 30 September for the sugar TRQs). Taking into account the 
recent on -line system developed by the WTO Secretariat which only provides for one notification per 
year, the EU is planning to merge its two cu rrent annual notifications; the single notification would 
be made once a year in February.  
 
4.2 Energy  
 
Page 201 Para 4.132  
4.132. In 2018 and 2019, the EU adopted a new comprehensive legislative framework for energy 
and climate policies. The European Parl iament and Council agreed on a revision of the EU's climate 
legislation, including the Emissions Trading System Directive, both for stationary installations and 
for aviation, the Effort Sharing Regulation, and the Regulation on Land Use, Land Use Change an d 
Forestry. They also agreed on the eight legislative proposals in the "Clean Energy for All Europeans" 
package (all of which have entered into force), and on the ten mobility proposals following the 
Low-Emission Mobility Strategy. This framework is expect ed to put the EU on a good trajectory to 
a climate -neutral economy by 2050.  
 
Question 13  
In December 2019, the European Commission presented the "European Green Deal" with 
an aim to achieve climate neutrality by 2050. One of the possible measures that might be 
introduced is "Border Carbon Tax Adjustment" on certain imported products with "high  
carbon footprints". Please clarify the way in which the EU would measure the embodied 
carbon in such imported products, including the criteria abd standards used to determine 
the imposition of such taxes.  
 
EU reply:  
The European Green Deal foresees that a Carbon Border Adjustment mechanism will be proposed 
for a number of selected sectors that are at risk of carbon leakage, should differences in levels of 
ambition worldwide persist, as the EU increases its climate ambition.  
The decision in terms of scope  and coverage will be informed by the impact assessment. In any 
event, compliance with World Trade Organization (WTO) rules, trade agreements and other 
international obligations of the EU will be ensured.  
There is a breadth of considerations that need to b e reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particu lar with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
 WT/TPR/M/395/Add.1  
 
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  4.4 Services  
4.4.1 Financial Services  
4.4.1.1 Recent performance  
 
Pages 218 -253, Paras. 4.205 - 4.351  
4.205. The EU financial services sector accounted for some 4.9% of GDP in 2017, and employed 
around 1.5% of the active population. The EU remained a net exporter of financial services during 
the review period. The sector  plays a central role in the Union's economic performance, including 
business financing. In the Commission's view, financial services should contribute to an environment 
that protects consumers, promotes market integrity, and supports investment, growth an d jobs. An 
ambitious reform package is underway within the EU to operationalize this vision, through the 
establishment of common financial rules for EU countries (Section 4.4.1.2).  
 
4.351. Finally, the revised AVMSD requires member States to establish nati onal regulatory 
authorities or bodies, which must be legally distinct from the Government, and to ensure that such 
authorities or bodies exercise their powers impartially, transparently, and in accordance with the 
objectives of the AVSMD. The national regu latory authorities or bodies must provide to each other 
and the Commission information necessary for the application of the AVMSD. At the EU level, the 
revised AVMSD established the ERGA, a new body composed of representatives of the national 
regulatory bo dies or authorities with primary responsibility for overseeing audiovisual media 
services. ERGA's tasks are to provide technical expertise to the European Commission, to exchange 
experience and best practice on the application of the regulatory framework f or audiovisual media 
services, to cooperate and provide its members with the information necessary for the application 
of the AVMSD, and to give opinions at the request of the Commission on certain matters under the 
AVMSD  
 
Question 14  
Are there any other s ectors, apart from those 5 sectors134 indicated under this section, 
under the review and assessment with a view to simplifying related laws and regulations? 
Please kindly share work plans for such review and assessment.  
 
EU reply:   
In addition to legal acts  in the sectors mentioned, the work programme of the European Commission 
for 2020 (COM (2020)37 final) indicates the following legal acts for simplification under the 
Regulatory fitness and performance (REFIT) initiative:  
 
• The eIDAS Regulation (Regulation (EU) 910/2015), see https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2014.257.01.0073.01.ENG . 
• the Broadband Cost Reduction Directive (Directive 2014/61/EU), see https://eur -
lex.europa.eu/legal -content/EN/TX T/?uri=CELEX%3A32014L0061 . 
 
Page 235, Para. 4.272  
4.272.  The DSM Strategy was launched in 2015 as part of the Europe 2020 Strategy. It aims to 
create a market "in which the free movement of goods, persons, services and capital is ensured and 
where individu als and businesses can seamlessly access and exercise online activities under 
conditions of fair competition, and a high level of consumer and personal data protection, irrespective 
of their nationality or place of residence". The Strategy rests on three m ain pillars: (i) better access 
for consumers and businesses to online goods and services across Europe; (ii) creating the right 
conditions for digital networks and services to flourish; and (iii) maximizing the growth potential of 
the European digital econ omy. 
 
Question 15  
Please clarify how the EU protect individuals and businesses data and deal with issues on 
consumer protection with the non -EU countries.  
 
EU reply:  
EU consumers can rely on the protection of their national consumer law as harmonised by E U rules, 
if and when targeted by traders from outside the EU.  
 
 
134 (1) Financial services (2) Construction service (3) E -commerce (4) Telecommunication services (5) 
Audiovisual service.  WT/TPR/M/395/Add.1  
 
- 519 - 
 
  4.4 Services  
4.4.3 E -commerc e 
4.4.3.2 Improving access for consumers to online goods and services across Europe  
 
Page 236, Para 4.275  
4.275.  The Directive on electronic commerce, adopted in June 2000 and discussed in previous 
reports, constitutes the basic legal framework for the regulation of e -commerce in the EU  
 
Question 16  
Apart from the modification of regulations undertaken by government  side with an aim to 
improve access to goods, services and capital via online platform, how does the EU build 
the awareness of consumers on data protection and their rights?  
 
EU reply:  
The EU, often in cooperation with national consumer authorities or org anisations, are raising 
awareness in form of campaigns (currently ongoing campaign is YourEURight: 
europa.eu/youreuright) and provide information through comprehensible information on citizen -
facing web pages, such as Your Europe (europa.eu/youreurope).  
 
4.4 Services  
4.4.6 Audiovisual services  
 
Page 252 Paras. 4.343 - 4.344  
4.343.  As part of the DSM Strategy, the Commission presented a proposal for the comprehensive 
reform of the existing Audiovisual Media Services Directive (AVMSD) in May 2016. The revised 
AVMSD was adopted in November 2018 and entered into force in December 2018.  It requires 
member States to transpose its provisions into national legislation by 19 September 2020.  
 
4.344.  A key consideration motivating the revision of the AVMSD was the significant evolution of 
the audiovisual services market since the last codific ation of the AVMSD in 2010, as a result of the 
convergence of television and Internet services. Specifically, as summarized in the previous Review, 
the factors which, in the view of the European Commission, required an adaptation of the EU 
regulatory regim e for audiovisual services were: the multiplication of the type of broadcasters 
(traditional TV broadcasters, video -on-demand providers, and video -sharing platforms); the 
decreasing average TV viewing time, especially among young people; the increasing sha re of 
Internet video in Internet traffic; the low share of revenues invested by on -demand service providers 
in original programming as compared to traditional TV broadcasters; the fragmented rules across 
the EU faced by the industry regarding the compulsor y share of European content; the fact that 31% 
of video -on-demand services available in one EU member State were established in another member 
State; and the need for more independence of the regulators from government and industry . 
 
Question 17  
According to the amendment to the Audiovisual Media Services Directive (AVMSD) which 
each EU member state obliges to modify and simplify the rules under its own jurisdiction, 
are there flexibilities or transition periods for those countries with different level of 
development in order to comply with the AVMSD?  
 
EU reply:  
The Audiovisual Media Services Directive (AVMSD) was amended by "DIRECTIVE (EU) 2018/1808 
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 November 2018 amending Directive 
2010/13/EU (AVMSD) on t he coordination of certain provisions laid down by law, regulation or 
administrative action in Member States concerning the provision of audiovisual media services 
(Audiovisual Media Services Directive) in view of changing market realities". Article 2, par agraph 1, 
first sentence of the amending directive, indicates that  "Member States shall bring into force the 
laws, regulations and administrative provisions necessary to comply with this Directive by 
19 September 2020. They shall immediately communicate th e text of those provisions to the 
Commission." The deadline of 19 September 2020 applies to all Member States.  
  WT/TPR/M/395/Add.1  
 
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  TRINIDAD AND TOBAGO  
Government Report - WT/TPR/G/395  
 
Page 3, The EU economic environment and its macroeconomic policy  
 
2.1 – "The European economy continued expanding during the period under review. In 2017, 
economic growth reached 2.6% compared to 2.0% in 2016. However, economic growth slowed to 
2.0% during 2018, in particular, due to a less favorable external environment . Growth in the global 
economy and trade weakened amid tightened global financing conditions, trade tensions, high 
uncertainty, and an exceptional weakness in the manufacturing sector."  
 
Question 1  
It was noted that the slowdown in economic growth in 2018  was attributable to a number 
of factors, including an exceptional weakness in the manufacturing sector. Has the 
European Union identified the causes for the weakness in the sector and what plans are 
envisioned to address these?  
 
EU reply:   
There were sev eral factors behind the exceptional weakness in the manufacturing sector in 2018. 
Among the key ones were (i) rising business uncertainty due to escalating trade tensions; (ii) a 
slowdown in activity in China which weakened Chinese demand for imports, incl uding from the EU; 
and (iii) a prolonged and broad -based downturn in the automotive industry. Within the EU, the 
slowdown in the automotive industry affected many other sectors of the economy across many 
Member States reflecting a complex network of value chains. From the EU perspective, this downturn 
had a supply -side and a demand -side component. The former was related to the new emission test 
procedure (Worldwide Harmonised Light Vehicles Test Procedure) introduced on 1 September 2018 
which triggered deli very delays and supply disruptions. On the demand side, the EU automotive 
industry was heavily affected by the severe weakness in demand for cars coming from both inside 
and outside the EU.  
 
The EU Member States have likely taken macroeconomic as well as sector -specific policy measures 
to address the weakness in manufacturing, albeit stress needs to be put on the fact that many of 
the factors behind the weakness have been of an external nature, as elaborated above. It is to be 
noted that macroeconomic and sectoral policies remain to an important extent at the discretion of 
the EU Member States and the European Commission is not in a position to comment on the future 
policy measures by the Member States.  
 
Developments in the Internal Market  
Page 7 section: 3 .4 Single Market for Services  
 
3.12 - Following the amendments to the Professional Qualifications Directive, which initiated a 
process of evaluation of all national professional regulations in the EU Member States, the European 
Commission adopted a Communi cation with recommendations on national reforms aiming at 
improving the regulatory environment for a number of professional services with high growth and 
jobs potential (i.e. architects, engineers, lawyers).  
 
Question 2  
With the amendment of the Profession al Qualifications Directive in 2013 by the 
European  Union, and the adoption of national reforms for a number of professional 
services such as architects, engineers, lawyers, are there any future policy implications 
for the completion of mutual recognition agreements (MRAs) with third party countries?  
 
EU reply:  
The amendment of the Professional Qualifications Directive and national reforms on professional 
services have no direct implications for future Mutual Recognition Agreements. However, the 
achieved streamlining of domestic regulation might facilitate the preparation of joint 
recommendations as a first step towards such agreements.  
 
Page 19, Section 4.2 – The EU bilateral negotiating agenda  
4.28 – "Finally, during a meeting of Presidents Juncker and Trump in Washington D.C. on 
25 July 2018, the two Presidents announced the launch of a new phase in the bilateral EU -US trade WT/TPR/M/395/Add.1  
 
- 521 - 
 
  relationship. In April 2019, EU Member States adopted the European Commission proposal allowing 
the EU to enter into formal negotiations for a tariff elimination agre ement on industrial goods and 
an agreement on conformity assessment with the U.S."  
 
Question 3  
What is the status of negotiations between the EU and the United States and when is it 
anticipated that this Agreement would be finalized?  
 
EU reply:  
In July 2018, President Juncker and President Trump agreed on the EU -US Joint Statement. On 
15 April 2019, the Council adopted a mandate to open talks for a horizontal agreement on conformity 
assessment and to open talks on the elimination of tariffs on indus trial goods.  
 
Page 20, Sub section: 4.3.2 supporting inclusive growth in Developing Countries  
 
4.36 - In December 2017, the EU and its Member States updated their joint Aid for Trade (AfT) 
Strategy to change their collective approach towards supporting dev eloping countries' trade and 
productive capacities88. The objective of the updated strategy is to better align EU AfT interventions 
with actual market -driven opportunities and constraints, to ensure a better quantitative focus on 
LDCs and to increase the c ontribution of AfT to sustainable development goals, while supporting a 
stronger participation of women in the economy. The most recent EU Aid for Trade Progress Report 
(2019) was presented at the 7th Global Aid for Trade Review in July 2019.   
 
Question 4  
Given the fact that the EU joint Aid for Trade (AfT) Strategy was changed in 
December  2017, was any consideration given to incorporating the content of Trinidad and 
Tobago's National Aid for Trade Strategy which was launched in April 2017?  
 
EU reply:  
The EU joint Aid for Trade Strategy was updated in 2017 in order to better respond to new trends in 
international development, particularly in line with the 2030 Agenda for Sustainable Development 
and at the EU level with the EU 's Foreign and Security Policy, the new European Consensus for 
Development (2016) and Trade for All Strategy (2017). The updated Aid for Trade strategy is a 
global EU policy instrument, guiding the EU aid for trade provision in all partner developing countries 
while differentiati ng approaches in line with their development level (LDC, MIC, MADC), hence, the 
Strategy 's design originates from policy analysis of all of the EU partner developing countries, 
collected through a policy dialogue and stakeholder consultations at a country and regional level, 
where the ACP group countries were consulted. All EU partner countries ' national aid for trade related 
documents were analysed in the process of writing of the Strategy and policy feedback was collected 
through the EU Delegations worldw ide.  
 
Page 21, Sub section: 4.3.3 Promoting Human Rights  
 
4.38.  - The Union's trade policy helps to promote and protect core human rights around the world. 
EU policy involves various trade policy instruments including the EU's unilateral trade preferences  
(GSP), bilateral and regional free trade agreements and trade impact assessments and evaluations.  
 
Comment: Trinidad and Tobago commends the EU for this initiative to promote human rights 
worldwide.  
 
Page 21, Sub section: 4.3.3 Promoting Human Rights  
 
4.40 - In the context of the Alliance for Torture -Free Trade, the EU continues efforts within the 
United Nations to ban or control worldwide trade in products used for torture and capital punishment. 
In September 2018, during the Alliance's first Ministerial , members agreed to work towards an 
UN instrument (such as a binding convention) and in June 2019 the UN passed a resolution launching 
the process to this effect.  
 
Question 5  
What does "Alliance for Torture -Free Trade" mean? Who or what does this Alliance cover? 
Which countries are covered under this Alliance? How effective is this Alliance in 
combating torture and capital punishment in continents such as Africa?  WT/TPR/M/395/Add.1  
 
- 522 - 
 
  EU reply:  
The Global Alliance for Torture -Free Trade, promoted by the European Union and co -sponsored by 
Argentina and Mongolia, was established on 18 September 2017 further to a Political Declaration 
signed by the EU and 58 countries135 during the United Nations Genera l Assembly (UNGA) in 
New York. More info can be found on the dedicated website http://www.torturefreetrade.org/ ). 
Inspired by the so -called EU 'Anti -Torture' Regulation 1236/2005136, concerning trade in certain 
goods which could be used for capital punishment, torture or other cruel, inhuman or degrading 
treatment or punishment, the ultimate aim of the Global Alliance is to end trade in goods used for 
capital punishment and torture g lobally.  
 
By joining the Alliance, countries commit themselves, inter alia , to take effective measures for 
restriction of trade in goods used for torture and death penalty (such as spiked batons, electric shock 
grabbers and shock belts) through domestic l egislation and efficient enforcement.  
The first Ministerial meeting held in the margins of the UNGA in September 2018 showed the strong 
political will to ensure the effective implementation of the political commitments reached by the 
Alliance. All members  subscribed to a Joint Communique that envisaged work towards a new 
international instrument at UN level.  
 
On 28 June 2019, the UNGA resolution "Towards torture -free trade: examining the possibility, scope 
and parameters for common international standards " was adopted with 81 votes in favour, 20 no 
votes and 44 abstentions. It paves the way for future work at UN level towards establishing common 
international standards in this field. In particular, the UN General Assembly resolution calls for 
examining the  feasibility, scope and parameters for possible common international standards  
 
Page 21, Sub section: 4.3.4 Gender Equality and Economic empowerment of Women  
 
4.41 - The EU is committed to gender equality, to which various policy areas, including trade, ca n 
contribute. The EU supported the adoption of the Joint Declaration on Trade and Women's Economic 
Empowerment at the 11th WTO Ministerial Conference in Buenos Aires in December 2017. In this 
context, the EU co -hosted a workshop on Women and Digital Trade in Geneva on 1st July 2019 to 
discuss the opportunities and challenges for women in digital trade. The EU's updated Aid for Trade 
strategy also explicitly recognises gender equality as a fundamental human right, putting women's 
economic empowerment at its forefront.  
 
Question 6  
With regard to the EU's significant commitment to gender equality, are there any best 
practices that the EU can share with Trinidad and Tobago as it refers to women's economic 
empowerment and trade?  
 
EU reply:  
The EU assesses the g ender impacts of its trade agreements. For example, Sustainability Impact 
Assessments in support of the negotiations of trade agreements with Chile, Australia and 
New Zealand includes a gender impact analysis. This contains an assessment, based on the late st 
methodology available — the UNCTAD Trade and Gender Toolbox – of the impact on women in their 
roles as workers, entrepreneurs, traders, and consumers. For further information, please refer to 
the following website: https://ec.europa.eu/trade/policy/poli cy-making/analysis/policy -
evaluation/sustainability -impact -assessments/ . 
 
A recent study "From Europe to the World: Understanding Challenges for European Businesswomen" 
is based on the first -of-its survey on women and trade. The survey looked at the linkages between 
gender, company characteristics and international trade, across  firms in manufacturing and 
 
135 Full list of countries in the Global Alliance for Torture -Free Trade: Albania, Argentina, Armenia, 
Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cape Verde, Chile, Colombia, 
Costa Rica, Croatia, Cyprus, Czech Republic, Den mark, Ecuador, El Salvador, Estonia, Finland, 
North  Macedonia, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, 
Lithuania, Luxembourg, Madagascar, Malta, Mexico, Moldova, Mongolia, Montenegro, The Netherlands, 
New Zealand, Nicaragua, Norway, Palau, Panama, Paraguay, Poland, Portugal, Romania, Serbia, Seychelles, 
Slovenia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, Uruguay, Vanuatu, European Union.  
136 REGULATION (EU) 2019/125 of the European Parlia ment and of the Council of 16 January 2019 
concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman 
or degrading treatment or punishment (codification). It repeals Council Regulation (EC) 1236/2005 and i ts 
successive amendments.  WT/TPR/M/395/Add.1  
 
- 523 - 
 
  agriculture exporting outside the EU. For further information, please see: 
http://www.intracen.org/publication/Europe -to-world/ . 
 
Furthermore, another recent study by the European Commission "Female Participation in EU 
exporting activities: jobs and wages" sheds new insights on the gender -balance of the employment 
opportunities supported by extra -EU exports. For further information, please see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf . 
 
Question 7  
Specifically, can the EU share particular obstacles or challenges that exist as it relates to 
gender -related effects of trade, including, labour and gender iss ues?  
 
EU reply:  
A recent study "From Europe to the World: Understanding Challenges for European Businesswomen" 
found that both women and men -led companies report scarcity in legal, marketing/communication, 
IT/digital, and language skills, but women -led companies are more likely to be negatively affected. 
Women -led companies are also less likely to identify commercial banks as the most important source 
of funding, with significant disparity compared to men -led companies. Both skills and finance -related 
challenges impact women more, irrespective of size.  
For further information, please see: http://www.intracen.org/publication/Europe -to-world/ . 
 
Question 8  
What are the measures taken by the EU government to ensure that women, small and 
medium -sized enterpris e (SME) owners, and indigenous groups adequately benefit from 
gender equality initiatives through trade and other policy areas?  
 
EU reply:  
The recent EU trade agreements contain chapters on small and medium -size enterprises. These 
chapters are beneficial  for women entrepreneurs, as women -led companies tend to be smaller. 
Initiatives like Enterprise Europe Network (EEN) also provides targeted support to women 
entrepreneurs (see for example: https://een.ec.europa.eu/news/women -entrepreneurs -5-tips-
internati onal-success ). 
For women in third countries, the Gender Action Plan (GAP 2016 -2020) is the EU policy commitment 
on women and development. Examples of activities include analysing impacts of international trade 
on gender equality in connection with trade ne gotiations.  
 
Question 9  
Given the fact that the EU co -hosted a workshop on Women and Digital Trade in Geneva 
on 1st July 2019 to discuss the opportunities and challenges for women in digital trade, 
can the EU identify the number of women who are currently practicing and deriving 
benefits from digital trade both domestically and internationally?  
 
EU reply:  
There is currently no comprehensive data available regarding the number of women benefitting from 
digital trade. The EU has an active policy to encourag e and empower women to play a more active 
role in the digital age. This includes initiatives like the European Network for Women in Digital and 
Awards for tech start -ups led by women. For more information, please see: 
https://ec.europa.eu/digital -single -market/en/women -ict. 
 
Page 21, Sub section: 4.3.4 Gender Equality and Economic empowerment of Women  
 
4.42 - EU trade agreements contain commitments related to the implementation of fundamental ILO 
conventions targeting non -discrimination in employment (ratification and implementation of ILO 
Conventions 100 and 111 on equal remuneration and non -discrimination), in a specific chapter on 
Trade and Sustainable Development. In addition, the EU is negotiating specific provisions on trade 
and gender  equality in the context of the modernisation exercise of EU Chile Association Agreement. 
Such provisions will help acquiring a better understanding of the constraints and opportunities faced 
by women in the trade arena, as well as sharing best practices. The EU and Canada are cooperating 
along the same lines in the context of the EU -Canada Comprehensive Economic and Trade 
Agreement (CETA).  
 WT/TPR/M/395/Add.1  
 
- 524 - 
 
  Question 10  
Are the commitments related to trade and gender equality for women and men in EU trade 
agreements measured and monitored, and if so how?  
 
EU reply:  
The EU has various tools for monitoring the implementation of its trade agreements, including 
commitments related to trade and gender equality. This includes an annual FTA implementation 
report (for more information see: 
https://trade.ec.europa.eu/doclib/docs/2019/october/tradoc_158387.pdf ). In addition, for trade an 
sustainable development chapters, which include commitments on non -discrimination in 
employment, the EU implements 15 point action plan on Trade and Sustainable Development (for 
more information see: https://ec.europa.eu/trade/policy/policy -making/sustainable -development/ ). 
Furthermore, after a trade agreement has been implemented and enough time has passed to gather 
an adequate amoun t of evidence the EU is carrying out an ex post evaluation (for more information 
see: https://ec.europa.eu/trade/policy/policy -making/analysis/policy -evaluation/ ).  
 
Question 11  
What has been the experience of the EU in negotiating specific trade and gende r-related 
provisions in the EU -Chile Association Agreement, as well as in the context of EU –Canada 
Comprehensive Economic and Trade Agreement (CETA)?  
 
EU reply:  
The Recommendation on trade and gender, adopted in September 2018 by the Joint Committee of 
the Comprehensive Economic and Trade Agreement (CETA) between EU and Canada, launches a 
cooperation between the EU and Canada on improving the capacity and conditions for women 
(including workers, businesswomen and entrepreneurs) to access and fully benefi t from CETA. This 
includes exchanges of experiences and best practices on collection of gender -disaggregated data, 
on gender -based analysis of trade policies and on developing gender responsive trade agreements 
(please see: https://trade.ec.europa.eu/docli b/press/index.cfm?id=1811 ). 
 
Negotiations with Chile are ongoing, for more information please see: 
https://trade.ec.europa.eu/doclib/docs/2019/december/tradoc_158512.pdf . 
 
Page 22, Sub section: 4.3.6 Promoting Fair and Ethical Trade Schemes  
 
4.47 - The EU continues to promote fair and ethical trade schemes with a view to raising awareness 
on both the supply - and the demand -side and on developing more sustainable trade opportunities 
for small producers in third countries. The EU has introduced initiat ives which aim to recognize cities' 
positive impact in social, economic and environmental sustainability in international trade. In 2017, 
the "EU Cities for Fair and Ethical Trade Award" was set up as a project.  
 
Question 12  
In Trinidad and Tobago, many M SME and SMEs are primarily agro -processor exporters 
who would benefit from the fair and ethical trade schemes. In this regard has the 
European Union made any considerations of incorporating this new scheme/priority into 
the existing CARIFORUM -EU EPA?  
 
EU reply:  
The EU takes the view that all private sustainability schemes can be beneficial for sustainable 
development; their key benefit is the very fact that they are a market mechanism providing 
information to consumers who can then alter their buying habi ts according to their principles and 
what they think is important. Therefore, all recently concluded EU Free Trade Agreements include 
references to promoting voluntary sustainability schemes.  
 
Question on Report by the World Trade Organization (WTO) Secret ariat WT/TPR/S/395  
 
Section: 1.3 Developments in Trade and Investment  
Page 29, Sub section: 1.3.2 Trends and patterns in foreign direct investment (FDI)  
 
1.42 - Figures on extra -EU inbound and outbound FDI flows displayed an important decrease in 
2015-17, in line with the global trend and amid raising global uncertainty over trade and investment. 
According to the OECD, the trend was set to continue in 2018,  and the recent tax policy in the WT/TPR/M/395/Add.1  
 
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  United  States was expected to play a role as US multinationals repatriated large amounts of earnings 
held by foreign affiliates.  
 
Question 13  
What strategies is the EU considering or has the EU implemented to improve the 
investment climate to attract FDI amid the uncertain global trends?  
 
EU reply:   
Please see the reply to question 14.  
 
Page 30, Sub section: 1.3.2 Trends and patterns in foreign direct investment (FDI)  
 
1.46. Pg. 30 - In 2019, according to a report released  by the Commission on FDI, the EU hosts 
investors from about 170 countries, with the United States, EFTA countries, and Canada (the 
historical main investors) (Table 1.5) accounting by far for the largest share in terms of the number 
of companies controlle d and, even more so, in terms of assets controlled. The document also shows 
the emergence of new investors, such as China and other emerging countries, with increasing 
number of deals over the last years, such as, by China in aircraft manufacturing and spe cialized 
machinery, and by India in pharmaceuticals.  
 
Question 14  
What specific measures have been undertaken to attract new investors such as China?  
 
EU reply to Q13 -14: 
The EU is the world 's main provider and the top global destination of foreign investment and is one 
of the most open places to invest in the world.  
Since 2009 the EU investment policy aims to several objectives: -secure a level playing field so that 
EU investors abroad are n ot discriminated or mistreated; - make it easier to invest by creating a 
predictable and transparent business environment; -promote investment that supports sustainable 
development, respect for human rights and high labour and environmental standards. This  includes 
encouraging corporate social responsibility and responsible business practices; - attract international 
investment into the EU, while protecting the EU 's legitimate and essential interests, and; -preserve 
the right of home and host countries to re gulate their economies in the public interest.  
In order to attract new investors The EU is negotiating or implementing investment rules inside its 
bilateral trade agreements or in self -standing investment agreements.  
 
Page 30, Sub section: 1.3.2 Trends and patterns in foreign direct investment (FDI)  
1.44. Pg. 30 – Table 1.3 Extra -EU FDI flows 2015 -17. 
 
Question 15  
According to Table 1.3 Extra -EU FDI flows 2015 -17 on page 30, in which sectors are the 
highest FDI flows concentrated?  
 
EU reply:  
Data on FDI flows by sector is only available up to 2016137. 82% of total EU FDI inward flows in 2016 
came from  financial and insurance activities ( EUR 237.9 billion) and professional, scientific and 
technical activities ( EUR 3.5 billion). In terms of outwar d flows, the largest sources include financial 
and insurance activities ( EUR 171.4 billion) followed by manufacturing ( EUR 78.3 billion) and mining 
and quarrying ( EUR 65.2 billion).  
 
Section: 2.3.2. Regional and Preferential Agreements  
Sub section: 2.3.2. 1 Reciprocal Preferences  
 
Page 44, 2.44  
The majority of the ACP countries are either implementing an EPA or have concluded negotiations 
on an EPA with the EU. EPAs are implemented by 31 countries in the Caribbean, the Pacific, Eastern 
and Southern Africa, Central Africa, West Africa and member States of the SADC.   
 
 
137 Source: Eurostat, Balance of Payments (bop_gdp6_q). Accessed 04/02/2020 . Viewed at: 
https://ec.europa.eu/eurostat/web/balance -of-payments/data/database . WT/TPR/M/395/Add.1  
 
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  Question 16  
In light of the new approach to the architecture of bilateral agreements by the European 
Union and the modernization of their existing trade agreements, are proposals being 
considere d for the addition of features such as climate change and sustainable 
development to the current Economic Partnership Agreement with CARIFORUM states?  
 
EU reply:  
The EPA already contains substantial chapters on sustainable development (chapters 4 and 5 of 
title IV), including environment and social aspects. These issues are also covered in the ACP -EU 
Cotonou Partnership Agreement, the successor of which is currently under negotiations.  
 
Section 4.3 Manufacturing  
Page 212, subsection 4.181 - On the basis of ISIC (Revision 2), MFN customs tariffs on 
manufactured imports average 6.2%, with rates ranging up to 162.9% on certain food 
products.  
 
Question 17  
Can you confirm if these applied MFN rates are higher than the bound rates?  
 
EU Reply:  
The EU confirms that it has no MFN applied rates that are higher than the bound rates for any 
imported product.  
 
General Questions  
 
Question 18  
Will the European Union be willing to reconsider its five (5) years tariff recently imposed 
on Trinidad and Tobago's Urea Ammonia Nitrate (UAN) producers which now have them 
paying EUR 22.24 (TT$174.14) per tonne tariff on fertilizer shipped to the Europea n 
Union?  
 
EU Reply:   
Anti-dumping measures are usually imposed for 5 years.  
 
However, measures may be reviewed, where warranted, on the basis of a request by any exporter, 
importer or EU producer provided one year has passed since the measures were impose d. In such 
cases, the Commission will examine any request for a review and make a decision to open a review 
investigation, or not, based on the merits of the request.  
 
Reviews can also be conducted, at any time, if requested by an EU Member State or on th e initiative 
of the Commission, once sufficient evidence is available justifying the need for such a review.  
 
An interim review can be "full" – covering dumping, injury and Union interest – or "partial " – limited 
to dumping, for example.  
 
The legal basis for such reviews is Article 11(3) of the EU Basic anti -dumping regulation.  
 
Question 19  
What is the FDI policy pertaining to E -Commerce in the EU?  
 
EU reply:  
The EU is among the world 's most open and attractive markets for foreign direct investment  (FDI) 
as acknowledged by the OECD. The EU welcomes FDI because of the substantial benefits it brings 
to the EU economy and society at large. EU FDI is also of key economic importance for the third 
countries that receive EU investment. In its FDI policy, t he EU seeks to ensure improved market 
access, transparency, predictability, national treatment and MFN, while at the same time protecting 
essential interests with regard to security and public order. These principles apply also in the sectors 
relevant for e-commerce.  
 
  WT/TPR/M/395/Add.1  
 
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  TURKEY  
REPORTS BY THE EUROPEAN UNION AND SECRETARIAT  
 
Both reports prepared by the EU and the WTO Secretariat do not refer to "The European Green Deal" 
officially announced by the new President of the European Commission, Ursula Von der Leyen, on 
11 December 2019 as the EU's new growth strategy for 2050. The European Green Deal, which aims 
to render Europe the ever first climate -neutral continent of the World by 2050, comprises some 
policy objectives that might have important repercussions for the EU's trade relations with its 
partners including Turkey. In tha t regard could you please provide some information 
regarding the possible design and scope of the "carbon border adjustment mechanism" 
that is planned to be put in place against the risk of carbon leakage and its compatibility 
with the WTO rules?  
 
EU reply : 
 
The EU has fully translated into legislation the steps to meet its Paris Agreement target and expects 
its international partners to share a comparable level of ambition. As long as climate action by others 
in the world is not on par, there is a risk of carbon leakage. This would lead to an increase in total 
carbon emissions in the world undermining global efforts to reach the well below 2°/1.5°c pathway.  
The Commission has announced in the European Green Deal that, should differences in levels of 
ambitio n worldwide persist as the EU increases its climate ambition, it will propose a carbon border 
adjustment mechanism, for selected sectors, to reduce the risk of carbon leakage. It would be an 
alternative to the measures that currently address the risk of ca rbon leakage in the EU 's Emissions 
Trading System.  
The European Council of 12 December 2019 has endorsed the objective of achieving climate 
neutrality by 2050 and that this should include "developing effective measures to tackle carbon 
leakage in a WTO com patible way".  
A Carbon Border Adjustment mechanism is not designed to protect European industry from open 
competitions but rather to ensure the environmental integrity and effectiveness of EU climate policies 
as they apply to its trade -exposed industries. The design of the border measure will complement the 
EU's carbon pricing policies (in particular a cap -and-trade system) which will remain the cornerstone 
of the EU 's climate policies. The internal market of the EU will stay open to foreign competition und er 
applicable rules.  
The EU is a staunch defender of rules -based trade order and will comply with its international 
obligations, includingthe rules of the World Trade Organisation and our trade agreements in 
particular.  
There is a breadth of consideration s that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibi lity, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
The EU will continue to promote and encourage ambitious climate policies across the world. In the 
European Green Deal, the Commission pledged to step up bilateral engagement with partner 
countries and, where necessary, establish innovative forms of engagement. The EU will continue to 
engage with the economies of the G20 that ar e responsible for 80% of global greenhouse gas 
emissions".  
 
TURKEY – ADDITIONAL QUESTIONS  
THE SECRETARIAT REPORT  
 
1. Economic Environment, 1.2. Recent Economic Developments, 1.2.2. Fiscal governance 
and performance, pg. 20 -21, 1.16  
 
It is stated in the Secretariat Report that "There are ongoing efforts to rationalize  expenditures by 
shifting resources from the common agricultural and cohesion policies to areas such as research  and 
innovation,  young  people,  the digital  economy,  migrati on, and climate  objectives. There  are also 
other  tax-related  developments  at the EU level and in some  member  States.  The proposal  to apply  a 
rate of 3% to the new Common  Consolidated  Corporate  Tax Base (CCCTB) seems to have beneficial 
features, as it reduces opportunities to shift profits within the EU. According to the International 
Monetary Fund (IMF), tax competition remains an issue. Proposals  for a "digital  services  tax" have WT/TPR/M/395/Add.1  
 
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  been suspended  until 2020.  However,  some  member States, including Austria, France, Italy, and 
Spain, have taken steps for their own versions of such a  tax." 
 
Question  1: 
Could the EU provide detailed information about suspended "digital services tax" and  
country  specific  applications  (Austria,  France,  Italy , etc.)  of the digital  services  tax in 
terms of scope and conformity with EU's GATS  commitments?  
 
Answer  
The Report refers to the Member States that believe that the interim solution could be put in place 
at a national level to ensure fair taxation of  the digital economy in a short term pending an 
agreement at the OECD. These measures are to be withdrawn once the agreement for the global 
solution is achieved. These national measures seem to take into account the design considerations 
set out in the OEC D's interim report on the tax challenges arising from digitalisation, as the European 
Commission legislative proposal on a Digital Services Tax does.  
 
According to the EU proposal for a Digital service tax COM(2018) 148 final, the following services 
can re sult in taxable revenues: (a) the placing on a digital interface of advertising targeted at users 
of that interface; (b) the making available to users of a multi -sided digital interface which allows 
users to find other users and to interact with them, and which may also facilitate the provision of 
underlying supplies of goods or services directly between users; (c) the transmission of data 
collected about users and generated from users' activities on digital interfaces.  
 
The EU proposal model of taxation targets the revenues stemming from the supply of digital services 
where users contribute significantly to the process of value creation. The expected effects of the 
application of the tax are published in the Impact assessment accompanying the pro posal 
SWD(2018).81final/2.  
https://ec.europa.eu/taxation_customs/sites/taxation/files/fair_taxation_digital_economy_ia_2103
2018.pdf . 
 
1. Economic Environment, 1.2. Recent Economic Developments, 1.2.4. Outlook, pg. 22, 
1.24 
 
It is stated  in the Secretariat  Report  that "While  the detrimental  effect  of a "hard"  Brexit  on the 
United  Kingdom's economy would reduce its GDP by some 3.3% by 2020, it would reduce the 
EU-27 GDP by around  1%." 
 
Question  2: 
The Withdrawal Agreement between the UK and the EU is expected to enter into force by 
the end of January 2020. In that case, there will be one -year transition period for the 
settlement of a future trade agreement between the parties. Does the Commission foresee 
any risk of hard Brexit after transition period in case the EU and the UK fail to sign a future 
trade agreement? If so, could the EU provide information about its plan to recover from 
the detrimental effects of Brexit?  
 
Answer  
Compared to the period under review, there is now more clarity about Brexit. Following the UK 's 
withdrawal from the EU on 31 January 2020 and the entry into force of the Withdrawal Agreement, 
the UK entered a transition period lasting until 31 December 2020, during which Union law, with a 
few exceptions, continues to apply to and in the UK. At the same time, the question of future trading 
relations remains open.  
It is thus premature to discuss the effect of the UK leaving the EU on the EU 's economic outlook. 
This impact will depend on the outcome of the negotiations on the futu re partnership between the 
EU and the UK. It can be said however that even if a free trade agreement is concluded, it will 
establish a very different relationship in terms of market access than participating in the Internal 
Market and the Customs Union. Th erefore, the end of the transition period means significant changes 
in the regulatory relationship between the United Kingdom and the European Union.  Since the 
autumn of 2017, the Commission has called upon stakeholders, including businesses, to prepare fo r 
these changes.  
 WT/TPR/M/395/Add.1  
 
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  2. Trade and Investment Regimes, 2.1. General Framework, pg. 33,  2.2 
 
It is stated in the Secretariat Report that "The TFEU provides that "[t]he common commercial policy 
shall be based on uniform principles, particularly regarding changes  in tariff rates, the conclusion of 
tariff and trade agreements relating to trade in goods and services, and the commercial aspects of 
intellectual property, foreign direct investment, the achievement of uniformity in measures of 
liberalisation, export pol icy and measures to protect trade such as those to be taken in the event of 
dumping or subsidies" and "shall be conducted in the context of  the principles  and objectives  of the 
EU's external  action".  The negotiation  and conclusion  of international agreements in the field of 
transport are excluded from the scope of the common commercial  policy."  
 
Question  3: 
Could the EU explain how it concludes agreements in international maritime transport? 
Additionally, as transport services is also a part of the GATS, could the EU explain with 
which mandate this agreement was negotiated?  
 
Answer  
Article 207 TFEU on the common commercial policy is only one potential legal basis for the conclusion 
of international agreements. Article 216 TFEU prov ides that the European Union (the "Union") may 
conclude an international agreement where: the Treaties so provide; where the conclusion of an 
agreement is necessary to achieve, within the framework of the Union's policies, one of the 
objectives referred to  in the Treaties; it is provided for in a legally binding Union act; or it is likely 
to affect common rules or alter their scope. Article 207(5) itself states that the negotiation and 
conclusion of international agreements in the field of transport shall b e subject to Title VI (Transport) 
of Part Three and to Article 218 TFEU.  
 
The conclusion by the Union of the Agreement establishing the World Trade Organization and the 
Agreements in Annexes 1, 2 and 3 to that Agreement (including the GATS) was based, with respect 
to the matters that fall within the competence of the Union, on a number of legal provisions, 
including, Article 75 EC (now Article 95 TFEU, which forms part of Title VI (Transport) of Part Three 
TFEU).  
 
2. Trade and Investment Regimes,  2.1. General Framework, pg. 35, 2.9  
 
It is stated  in the Secretariat  Report  that "In light of Opinion  2/15 of the Court,  the Commission 
considers that the EU's exclusive competence to conclude international trade agreements covers the 
following matters: trade in goods, including regulatory matters; trade in services, including mutual 
recognition agreements and all transport services other than air  transport."  
 
Question  4: 
Could the EU provide information on the FTAs that include separate chapters /annexes  on 
transport?  Did the Commission  negotiate  those  chapters/annexes  based  on the Opinion 
2/15 of  ECJ?  
 
Answer  
All existing FTAs concluded by the EU that cover services include specific regulatory provisions for 
international maritime transport services. To date, no FTA concluded by the EU includes specific 
disciplines concerning air, road or rail transport services.  
 
As explained in the answer to question 3, the European Union (the "Union ") has competence to 
conclude international agre ements in the field of transport based on Title VI (Transport) of Part 
Three TFEU). In Opinion 2/15138, the Court of Justice of the European Union clarified the scope of 
the Union 's exclusive competence to conclude international trade agreements, including w ith respect 
to the field of transport.  
 
2. Trade and Investment Regimes, 2.1. General Framework, pg. 36, 2.14  
 
It is stated in the Secretariat Report that "A noteworthy development relating to this first objective 
concerns gender aspects of international t rade, which have begun to feature more prominently in 
EU trade policy. This includes analysis to improve the understanding of the impact of international 
 
138 Opinion 2/15, 16 May 2017.  WT/TPR/M/395/Add.1  
 
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  trade agreements on gender equality. The potential effects of trade agreements on women were 
analysed in sustainability impact assessments and in several ex post assessments of EU trade 
agreements. In 2017, the Commission published a study on the gender  balance  of the employment  
opportunities  supported  by extra-EU exports.  More recently, it  launched  a study,  which  is 
implemented  by the International  Trade  Centre  (ITC),  on "Women in Extra -EU Trade: Opportunities 
and Obstacles". The results of this study were presented at the "Trade for Her" conference, organized 
by the Commission on 30 Septemb er 2019 in Brussels. Furthermore, the Commission is 
implementing a recommendation on Trade and Gender of the Joint Committee, established under 
the EU's FTA with Canada, the Comprehensive Economic and Trade Agreement (CETA). This provides 
for cooperation b etween the Parties to improve the capacity and conditions for women to access, 
and fully benefit from, the opportunities created by the CETA, starting with analytical work to better 
understand the impact of trade on gender equality and women's participatio n in the economy. For  
example,  together  with the Canadian  Mission  to the EU, the Commission  organized  a CETA trade and 
gender workshop in Brussels on 1 April 2019. Also, in negotiations on the modernization of the 
EU-Chile Association Agreement, the Commission tabled a proposal for dedicated provisions on trade 
and gender  equality."  
 
Question  5: 
Could the EU share the results of impact assessments made regarding potential effects of 
trade agreements on women and the ex post assessments of EU trade agr eements?  
 
Answer  
The EU assesses gender impacts of its trade agreements. For example, the Sustainability Impact 
Assessments in support of the negotiations of trade agreements with Chile, Australia and New 
Zealand include a gender impact analysis. This contains an assessment, based on the latest 
methodology available — the UNCTAD Trade and Gender Toolbox — of the impact on women in their 
roles as workers, entrepreneurs, traders, and consumers. The ex post evaluation of the EU 's trade 
agreement with Korea  focuses to a significant extent (§8.3.1) on gender -related discrimination in 
the labour market. Upcoming ex post studies plan to explore gender -related impacts in greater 
breadth and depth. For further information on the above -mentioned studies, please re fer to the 
following website: https://ec.europa.eu/trade/policy/policy -making/analysis/policy -
evaluation/sustainability -impact -assessments/ . 
 
Furthermore, another recent study by the European Commission "Female Participation in EU 
exporting activities: job s and wages " sheds new insights on the gender -balance of the employment 
opportunities supported by extra -EU exports. For further information, please see: 
https://trade.ec.europa.eu/doclib/docs/2019/september/tradoc_158372.pdf . 
 
2. Trade and Investment Regi mes, 2.2. Trade Policy Formulation and Objectives, pg. 36, 
2.14 
 
It is stated in the Secretariat Report that "… Furthermore, the Commission is implementing a 
recommendation  on Trade  and Gender  of the Joint Committee,  established  under  the EU's FTA with 
Canada, the Comprehensive Economic and Trade Agreement (CETA). This provides for cooperation 
between the Parties to improve the capacity and conditions for women to access, and fully benefit 
from, the opportunities created by the CETA, starting with analyt ical work to better understand the 
impact of trade on gender equality and women's participation in the economy. For example, together 
with the Canadian Mission to the EU, the Commission organized  a CETA trade  and gender  workshop  
in Brussels  on 1 April 2019. Also, in negotiations on the modernization of the EU -Chile Association 
Agreement, the Commission tabled a proposal for dedicated provisions on trade and gender  
equality."  
 
Questions  6: 
a) Could the EU provide detailed information about the structure and the functioning 
of the Trade and Gender of the Joint Committee established under CETA?  
 
Answer  
The recommendation on trade and gender, agreed by the Joint Committee of the Comprehensive 
Economic and Trade Agreement (CETA) between EU and Canad a, launches a cooperation between 
the EU and Canada on improving the capacity and conditions for women (including workers, 
businesswomen and entrepreneurs) to access and fully benefit from CETA. This includes exchange 
of experiences and best practices on c ollection of gender -disaggregated data, on gender -based WT/TPR/M/395/Add.1  
 
- 531 - 
 
  analysis of trade policies, or on developing gender -responsive trade agreements. The trade and 
gender Recommendation sets up contact points to facilitate cooperation and information exchanges. 
For mor e information, please see: https://trade.ec.europa.eu/doclib/press/index.cfm?id=1811 . 
 
b) Could the EU further explain the dedicated provisions on trade and gender equality 
proposed in negotiations on the modernization of the EU -Chile Association Agreement?  
TRADE D1/TRADE C3 [AD]  
 
Answer  
The EU is negotiating specific provisions on trade and gender equality in the context of the 
modernisation exercise on EU Chile Association Agreement. Such provisions will help in acquiring a 
better understanding of the constr ains and opportunities faced by women in trade, as well as sharing 
best practices aimed at facilitating women 's participation in international trade and benefitting from 
it. The EU proposal also contains specific commitments to effectively implement international 
agreements on gender equality such as the Convention on the Elimination of all Forms of 
Discrimination Against Women ( CEDAW ) and the relevant ILO conventions as well as prohibits 
lowering the level of protection granted to equality of opportunities between men and women to 
attract trade and investment. For further detail, please see the EU proposal: 
https://trade.ec.europa.eu/doclib/docs/2018/june/tradoc_156962.pdf . 
Negotiations with Chile are ongoing, for more information please see : 
https://trade.ec.europa.eu/doclib/docs/2019/december/tradoc_158512.pdf . 
 
2. Trade and Investment Regimes, 2.2. Trade Policy Formulation and Objectives, pg. 35, 
2.21 
 
It is stated in the Secretariat Report that " The Commission carries out impact assessment analyses 
to support its decision -making for all proposals with significant direct impact, including in the trade 
policy area. In terms of trade agreements, up to four major types of evaluation may be conducted 
during the life of a trade agreemen t." 
 
Question  7: 
Could the EU provide further information about the four major types of evaluation carried 
out during the trade agreement process?  
 
Answer  
The European Commission evaluates the impact of major trade initiatives before, during and after 
negotiations:  
1. At the initial stage , the Commission conducts Impact Assessments , which are prepared for 
all Commission initiatives that are likely to have significant and identifiable economic, environmental 
or social impacts. T hey will usually be prepared for major trade negotiations for which the 
Commission will adopt a recommendation for a negotiating directive and for major draft regulations 
proposed by the Commission which will later be discussed and adopted by the Council and European 
Parliament. Civil  society is consulted via Open Public Consultations. The independent Regulatory 
Scrutiny Board reviews all impact assessments and check their quality. The final Impact Assessments 
are published at the same time as the Commission adopts its proposal. It can  then be used by the 
Council, the European Parliament and national institutions as background information when they 
start their discussions.  
 
2. During the negotiations , Sustainability Impact Assessments (SIAs)  are conducted. These 
are trade -specific and inde pendent ex ante assessments outsourced by the Commission to external 
consultants, academics or think tanks. SIAs contribute to the integration of sustainable development 
issues into trade negotiations; they ensure that trade agreements promote sustainable development 
and that stakeholder input into the negotiations is collected in a transparent manner. They 
complement the earlier Impact Assessments by allowing a more in -depth analysis of the potential 
economic, social, human rights and environmental impacts  and facilitate wider outreach with 
stakeholders, through Open Public Consultations, Civil Society Dialogues and workshops in the EU 
and partner countries during the negotiations. A key feature is that the consultants provide a set of 
recommendations that can feed into the negotiating process or can suggest other flanking policy 
measures. Recommendations can be addressed to the EU institutions but also to the partner 
governments or to certain civil society organizations. Once the SIAs are concluded, the Com mission 
publishes "position papers " setting out which of the recommendations it can support and how they 
have been (or will be) implemented.  WT/TPR/M/395/Add.1  
 
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  3. After the negotiations , the Commission conducts  an Economic Assessment of the 
Negotiated Outcome (EANO),  which presents the economic evaluation of the negotiated outcome 
of the negotiations carried out once they are finalised.  
 
4. During the implementation , the Commission also runs ex post evaluations  (normally five 
years after the start of provisional application of the agreement). These studies assess whether a 
specific trade agreement or regulation is working as expected in achieving its objectives and why. 
Ex post evaluations also look for unintend ed effects and scope for simplification. Research for the 
evaluations is usually outsourced to external consultants, academics or think tanks. Stakeholders 
are also consulted in the process through Civil Society Dialogues and Open Public Consultations. The  
independent Regulatory Scrutiny Board reviews major evaluations and check their quality. At the 
end of the process, the Commission drafts and publishes a Commission Staff Working Document in 
which it in which it briefly summarizes the research findings an d can react to the findings and 
recommendations by the consultants.  
 
2. Trade and Investment Regimes, 2.3. Trade Agreements and Arrangements, 
2.3.2.  Regional and preferential agreements, pg. 44, 2.43  
 
It is stated in the Secretariat Report that "Trade betw een the EU and Switzerland is governed by the 
FTA concluded in 1972, which only covers trade in goods, and approximately 120 bilateral sectoral 
agreements, some of them of trade relevance, notably on agricultural products  and processed  
agricultural  product s, public  procurement,  technical  barriers  to trade, and free movement of persons. 
Negotiations to further liberalize trade in agricultural  products with Switzerland are on hold. The 
conclusion of an Institutional Framework Agreement has been under discussi on since  2014."  
 
Questions  8: 
a) Could the EU provide information on the state of play of Institutional Framework 
Agreement negotiations with Switzerland (i.e. expected benefits, outstanding issues and 
anticipated timeframe for the conclusion of negotiations)?  
 
Answer  
On 23 November 2018, the negotiations on the EU -Swiss Institutional Framework Agreement (IFA) 
came to a close. The agreement aims at restructuring EU -Swiss relations, notably by providing 
crucial rules and procedures for dynamic take -over and homogeneous application of EU internal 
market law, for enforcement of state aid rules and for dispute settlement. After consultations with 
Swiss stakeholders between January and April 2019, the Swiss Federal Council informed the EU si de 
that it could not agree on the text and requested further clarifications on three parts of the 
agreement (the provisions on state aid, the provisions relating to Directive 2004/38/EC on the free 
movement of persons and the provisions dealing with Switze rland's so -called flanking measures 
relating to the posting of workers). Since that time, there was however no technical engagement 
from Switzerland. Internal consultations on the perimeters of these clarifications are still ongoing. 
The EU expects Switzer land to submit the agreement to their Federal Assembly swiftly and sign it 
as soon as possible, once the possible clarifications have been agreed. In the context of the 
Institutional Framework Agreement, the EU and Switzerland have also agreed on a draft p olitical 
declaration, annexed to the agreement, where both parties commit to modernise trade related 
agreements. This commitment would however only apply when the Institutional Framework 
Agreement is signed.  
 
b) As for the negotiations to further liberalizati on of trade in agricultural goods, is there 
any perspective to revitalize the talks in the near future?  
 
Answer  
There are no such plans at this point in time.  
 
2. Trade  and Investment  Regime,  2.4. Investment  Regime,  2.4.2.  Investment  relations  
with third countries, 2.4.2.1. Establishment of a cooperation mechanism for the 
screening of FDI, pg.48,  2.60 
 
It is stated in the Secretariat Report that "The European Commission President proposed the creation 
of an EU framework for FDI screening in the 2017 State of the Union address. The proposal was 
motivated by growing concerns regarding the impact on the strategic interests of the EU or its 
member States of certain types of FDI, especially foreign acquisitions in cases involving state -owned WT/TPR/M/395/Add.1  
 
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  enterprises an d strategic sectors. This legislation, a regulation based on the common commercial 
policy competence in Article 207(2) of the TFEU, was adopted on 19 March 2019, entered into force 
on 10 April 2019, and shall apply from 11 October 2020."  
 
Question  9: 
Could  the EU provide detailed information whether this investment screening mechanism 
is compliant with the GATS commitments of EU?  
 
Answer  
The Regulation is compliant with the commitments undertaken in the WTO, in the OECD and in the 
trade and investment agreements concluded with third countries. It is notably recalled that GATS 
provides for the possibility for members to adopt measures to safeguard security and public order. 
As reaffirmed by Recital (35), the Regulation will be implemented cons istent with the 
WTO agreements and other commitments made in other trade and investment agreements to which 
the EU or the Member States are adherents.  
 
3. Trade  Policies  and Practices  by Measure,  3.1. Measure  Directly  Affecting  Imports,  
3.1.6. Anti -dumping , countervailing, and safeguard measures, 3.1.6.1. Anti -dumping and 
anti-subsidy measures, pg. 78, 3.76  
 
It is stated  in the Secretariat  Report  that "… Indeed,  the EU is a significant  user of trade remedy 
measures  as, historically,  it ranks  third overall  among  WTO Members  in the imposition  of 
anti-dumping measures since the WTO's inception and second for countervailing (CVD) measures, 
or anti -subsidy measures as the EU legislation refers to them  …" 
 
Question  10: 
Could the EU clarify whether there is any agenda to revise injury and import analysis of 
the ongoing investigations and measures in force by excluding UK indicators?  
 
Answer  
The EU will ensure that its trade defence measures remain compatible with its WTO rights and 
obligations after the withdrawal of the UK from the European Union. Whether existing measures will 
need to be reviewed to take account of this event will need to be examined on a case -by-case basis. 
A public communication is planned to be issued on this matter in due time.  
 
3. Trade Policies and Practices by Measure, 3.1. Measure Directly Affecting Imports,  
3.1.6. Anti -dumping, countervailing, and safeguard measures, 3.1.6.1. Anti -dumping and 
anti-subsidy measures, pg. 79, 3.79  
 
It is stated  in the Secretariat  Report  that "… Another  new development  is the ability  to take into 
account  the presumably  higher  costs of EU industry  compliance  with social  and environmental 
standards. " 
 
Question  11: 
Could  the EU provide  detailed  information  about  the implementation  process  of this 
methodology?  
 
Answer  
The European Union will take account of the cost of implementing social and environmental 
standards by producers in the EU in the following way:  
 
• Injury margins will reflect the cost of social and environ mental standards within the 
European Union. The cost of production also includes costs that EU producers incur 
when complying with multilateral environmental agreements and with important 
International Labour Organisation conventions. It means that actual costs incurred by 
EU manufacturers as well as future cost increases during the lifetime of TDI measures 
resulting from compliance with these standards will be taken into account, in calculating 
a non -injurious price.  
 WT/TPR/M/395/Add.1  
 
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  3. Trade Policies and Practices by Measure, 3.2. Measure Directly Affecting Exports,  
3.2.3. Export prohibitions, restrictions, and licensing, 3.2.3.2. Export controls, pg. 889, 
3.111  
It is stated in the Secretariat Report that "… The EU common list of dual -use goods are categor ized 
in ten sectors, and their numbers have varied over the period, from 1,892 items in 2016 to 1,846 in 
2018 …" 
 
Question  12: 
Although Turkey acknowledges the difficulty to assign HS codes corresponding to dual 
use items, could the EU inform if there is any ongoing work as such under 
Regulation  428/2009?  
 
Answer  
Annex I to the Council Regulation (EC) No . 428/2009 contains the EU list of the dual -use items. To 
each dual -use item is assigned a specific entry code (DU codes).  
The EU has developed a tool usef ul to correlate the DU codes to the Combined Nomenclature Codes 
(CN codes). This correlation table is updated yearly, accordingly to the yearly update of the Annex  I, 
and is available for download on the Dual -Use Trade Controls webpage 
(https://ec.europa.e u/trade/import -and-export -rules/export -from-eu/dual -use-controls/ ). 
 
4. Trade Policies by Sector, 4.3. Manufacturing, pg. 211,  4.177  
 
It is stated  in the Secretariat  Report  that "… a proposal  for a regulation  on the free flow of non- 
personal data that will enable data to circulate freely across borders, helping to modernize industry 
and create a truly common European data space (Section 4.4.3.1)  …" 
 
Question  13: 
Could the EU elaborate on this new strategy whether the free flow of non-personal data 
is envisaged also with third countries?  
 
Answer  
The Regulation on the Free Flow of Non -personal Data covers only intra -EU data flows. The extension 
of this scope is not envisaged. In some recent EU 's trade negotiations, we proposed rules on cross -
border data flows and personal data protection.  The EU will continue to address unjustified obstacles 
to data flows in bilateral discussions and international fora – including the World Trade Organisation 
– while promoting and protecting European data processing rules and standards, in full compliance 
with EU legislation.  
 
4. Trade Policies by Sector, 4.4. Services, 4.4.1. Financial Services, 4.4.1.2. Regulatory 
developments, 4.4.1.2.3. Capital Markets Union (CMU), 4.4.1.2.3.2. Measures on 
sustainable finance, pg. 227, 4.244  
 
It is stated in the Secretariat Report that "Political agreement was also reached, in February 2019,  
on a proposal  for a regulation  on low-carbon  and positive -carbon  impact.  It creates  new market 
standards which will reflect companies' carbon footprint, and give investors clearer information on 
how their investments contribute to fighting climate  change."  
 
Question  14: 
Could the EU give detailed information about the political agreement between the 
European Parlia ment and EU member States on the Commission's proposal for a 
regulation on disclosures regarding the sustainable investment and sustainability risks? 
Could the EU elaborate on the market standards related to carbon footprint? How will this 
aforementioned p olitical agreement affect third countries?  
 
Answer  
Regulation 2019/2088 on sustainability ‐related disclosures in the financial services sector was 
published in the Official Journal of the European Union on 9/12/2019.The Regulation applies to EU 
member States and concerns financial entities active in, and financial products sold in, the EU. 
Regulation 2019/2088 includes some phasing in obligations. First, the "comply or explain " 
mechanism outlined in Article  4(1)(a) and (b) applies from 10 March 2021. Second, the mandatory 
consideration of principal adverse sustainability impacts as per Article 4 (3) and (4) applies from 
30 June 2021. Third, the product disclosures as to adverse sustainability impacts applies from WT/TPR/M/395/Add.1  
 
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  30 December 2022. Fourth, financial products that are marketed in the EU as sustainable within the 
meaning of Articles 8 and 9 will need  to explain their sustainability features from 10 March 2021. 
The European Securities and Markets Authority (ESMA), the European Banking Authority (EBA) and 
the European Insurance and Occupational Pensions Authority (EIOPA) are currently jointly working 
on draft Regulatory Technical Standards that will further specify the requirements of Regulation 
2019/2088. ESMA, EBA and EIOPA plan to launch a public consultation on draft Standards in April 
2020.  
 
In more detail, Regulation 2019/2088 envisages three separ ate areas of sustainability -related 
disclosures, namely:  
 
4. Sustainability risks . Financial market participants and financial advisers, for all financial 
products in the scope of the Regulation, will be required to disclose on their websites and in 
pre-contractual information how they integrate the negative impacts of sustainability risks 
on financial returns in their risk policies, as well as the negative financial impact of these 
risks on the returns of the financial product. The obligation applies from 10 March 2021.  
 
5. Adverse sustainability impacts . The disclosure requirements will apply in the following 
manner:  
 
e. Financial market participants that employ at solo and group basis more than 
500 employees must publish and maintain on their websites a statement on their due 
diligence policies with respect to the principal adverse impacts of investment decisions 
on sustainability factors (please see Article 4(3) and (4)). The obligations apply from 
30 June 2021.  
f. Other financial market participants must publish and  maintain on their websites either a 
statement on due diligence policies with respect to principal adverse impacts of 
investment decisions on sustainability factors (please see Article 4(1)(a)) or clear 
reasons why they do not consider adverse impacts of i nvestment decisions on 
sustainability factors (please see Article 4(1)(b)). The obligations apply from 
10 March  2021.  
g. Article 4(5) foresees disclosure requirements in respect of adverse sustainability impacts 
by financial advisers. The obligations apply fr om 10 March 2021.  
h. Under Article 7, for each financial product where a financial market participant applies 
Article 4(1)(a) or Article 4(3) or (4), pre -contractual disclosures must include, a clear 
and reasoned explanation of whether, and, if so, how a fina ncial product considers 
principal adverse impacts on sustainability factors. The obligation applies from 
30 December 2022.  
 
6. Financial products that pursue the objective of sustainable investment or have 
environmental or social characteristics . Under Articles 8 and 9 financial market participants 
offering financial products that pursue the objective of sustainable investment or have 
environmental or social characteristics are required to disclose in pre -contractual information 
on their websites and in their periodical reports, how these characteristics or objectives are 
met. The obligations apply from 10 March 2021.  
 
4. Trade Policies by Sector, 4.4. Services, 4.4.3. E -commerce, 4.4.3.1. E -commerce in the 
context of the Digital Si ngle Market (DSM) Strategy, pg. 234 -5, 4.271 & 4.272  
 
It is stated in the Secretariat Report that "Adapting the EU economy to the opportunities and 
challenges  created  by the digital  transformation  has been a major  policy  priority  for the EU in recent 
years. The digital economy is regarded as a prominent example of an area in which the potential of 
the EU's Single Market has not been fully exploited. This is particularly important in  view of the close 
complementarities  between  services  provided  by digital  means  and different sectors  of the 
economy…Digital  services  are of critical  importance  to enable  the EU to improve its performance in 
the services  sector.  
 
The DSM Strategy  was launched  in 2015 as part of the Europe  2020 Strategy.  It aims to create a 
market "in which the free movement of goods, persons, services and capital is ensured and where 
individuals and businesses can seamlessly access and exercise online activities under conditions of 
fair competition, and a high level of consumer and personal data protection, irrespective of their 
nationality or place of residence".371 The Strategy rests on three main pillars: (i) better access for WT/TPR/M/395/Add.1  
 
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  consumers and businesses to online goods and services across Europe;  (ii) creating  the right 
conditions  for digital  networks  and services  to flourish;  and (iii) maximizing the growth potential of 
the European digital  economy."  
 
Question  15: 
Does the DSM Strategy launched in 2015 as a part of the Europe 2020 Strategy include 
any provisions regarding bilateral e -commerce agreements negotiations? If so, could the  
EU kindly  elaborate  on the main  issues  addressed  in a possible  e-commerce  agreement  
with third  parties?  
 
Answer  
The DSM Strategy focussed on the EU 's internal market. However, it had a section in international 
issues, which i.a. confirmed the openness of the European market and underlined the need to 
counter barriers to global digital trade. It does not speak specifically about bilateral trade 
agreements, as the EU 's trade and investment  strategy was set out in a separate "Trade for All " 
communication, which is accessible here: https://ec.europa.eu/trade/policy/in -focus/new -trade -
strategy/ . 
 
4. Trade  Policies  by Sector,  4.4. Services,  4.4.3.  E-commerce,  4.4.3.2.  Improving  access  for 
consumers to online goods and services across Europe, p. 236,  4.2 
 
It is stated in the Secretariat Report that "When it made its proposals for new rules on digital 
contracts, the Commission illustrated the untapped potential of cross -border e -commerce with in the 
EU by pointing out that only 15% of EU consumers bought online from other EU countries,  while  
44% bought  online  in their own country.  It also observed  that only 12% of EU retailers sold online 
to consumers in other EU countries, while 37% sold online in their own country. More recent data 
indicate that, in 2017, 33% of European consumers bought online from other EU countries, and that 
18% of European retailers sold online to other EU countries."  
 
Questions  16: 
 
a) Could the EU further explain wheth er it has data on e -commerce purchases of 
EU consumers from non -EU countries as well as any specific policy approaches of 
the European Union about cross -border e -commerce in terms of trade facilitation, 
covering both e -imports and e -exports from/to non -EU countries?  
 
Answer  
Global e -commerce revenue is growing at an exponential pace. In 2023, it is forecasted to grow to 
USD 2,7 trillion (from USD 1,8 trillion in 2018). The three most popular groups of goods bought 
online are: (i) fashion; (ii) electronics and media; (iii) toys, hobby and DYI, which account for almost 
¾ of all goods sold online. E -commerce revenues in Europe should grow from USD 347 billion in 
2018 to USD 484 billion in 2023, which means a compound annual growth rate of 6,9%. As a point 
of comparison, China has the highest revenue growth at 11,3% between 2018 to 2023. Among the 
main sources of information we rely on are http://ec.eur opa.eu/eurostat/statistics -
explained/index.php/E -commerce_statistics, as well as figures from Eurostat surveys and other 
sources, including subscriptions to datasets, OECD data etc.  
 
As far as e -commerce trade is concerned, a new customs legislation will be introduced as from the 
date of entry into force of the new VAT e -commerce package (1 January 2021) covering both 
importation and exportation of low value consignments (with a value below EUR 150). For the 
purpose of the importation of such goods a new customs declaration with a "super reduced dataset 
(SRDS) " was created, containing three times fewer data elements than the standard customs 
declaration. This customs declaration will be  available for any declarant and for any goods that 
benefit from a customs duty relief in accordance with Article 23(1) or 25(1) of Council Regulation 
1186/2009 and which are not subject to prohibitions and restrictions. For the purpose of export, the 
postal consignments of a value not exceeding EUR 1,000 which are not liable for export duty, shall 
be deemed to be declared for export by their exit from the customs territory of the EU. In the same 
vein, an ongoing amendment to the Union Customs Code Delegate d Act (UCC -DA) will provide that 
goods in an express consignment, with a value not exceeding EUR 1,000 and which are not liable 
for export duty, shall be deemed to be declared for export by their presentation to the customs office 
of exit, provided that th e data in the transport document and/or invoice are available to and accepted 
by the customs authorities.  WT/TPR/M/395/Add.1  
 
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  b) Could the EU give further information, apart from Digital Single Market Strategy, 
regarding any capacity building/training programs or action plans in itiated by the 
Commission or by the Member States to promote e -exports of EU firms to non -EU 
countries?  
 
Answer  
The European Trade Promotion Organisations, which include those of the EU plus Norway, Iceland, 
Switzerland and Ukraine (please see: https://www .europe -tpo.com/ ) may have national schemes to 
promote e -exports to non -EU countries.  
 
c) Could  the EU further  comment  if there  is a specific  policy  approach  which  may affect  
e-imports from  non-EU countries  within  the framework  of consumer  protection  and 
other  internal  market issues?  
 
Answer  
As far as safety of products is concerned, products entering into the EU must comply with the safety 
requirements existing in the EU. These requirements can be specific to certain products: In this case, 
they are provided in specific legislation (harmonized products). When a product does not have 
specific legislation providing for safety and conformity requirements, then Directive 2001/95/EC on 
general product safety is applicable which contains gene ral provisions to ensure the safety of 
non-food consumer products (non -harmonized products). The Commission has recently adopted a 
Notice on market surveillance of products sold online https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:52017XC08 01(01)&from=EN.  
 
4. Trade  Policies  by Sector,  4.4. Services,  4.4.5.  Other  measures  adopted  during  the review 
period under the second pillar of the DSM Strategy, 4.4.5.1. Online platforms, pg. 250, 
4.334  
 
It is stated in the Secretariat Report that "In November 2018, the EU adopted a revision of the 
Audiovisual Media Services Directive which, for the first time, imposed certain obligations on online 
platforms whose principal purpose, or the principal purpos e of a dissociable section thereof, or 
essential functionality is the provision of audiovisual content to the general public. The  aim of these  
new rules is to reinforce  the protection  of users  and especially  minors  against certain types of illegal 
and harmful audiovisual content online (Section  4.4.6)."  
 
Question  17: 
Could the EU provide detailed information about the requirements for online audiovisual 
service suppliers to be established and licensed in the EU in order to provide services to 
EU nationa ls? 
 
Answer  
Article 28a(1) of the Audiovisual Media Services Directive (AVMSD), refers to the notion of 
establishment within the meaning of Article 3(1) of Directive 2000/31/EC (eCommerce Directive). 
Pursuant to Recital 19 of the eCommerce Directive, the p lace at which a service provider is 
established should be determined in conformity with the case -law of the Court of Justice according 
to which the concept of establishment involves the actual pursuit of an economic activity through a 
fixed establishment f or an indefinite period. Establishment implies the effective and real exercise of 
activity through stable arrangements. With regard to licensing, the AVMSD does not lay down any 
requirements in this respect. However, Article 4 of the eCommerce Directive  provides that "Member 
States shall ensure that the taking up and pursuit of the activity of an information society service 
provider may not be made subject to prior authorisation or any other requirement having equivalent 
effect. " 
The full text of the revise d AVMSD is available at https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:02010L0013 -20181218 . 
 
THE GOVERNMENT REPORT  
 
2. Trade and The Economic Environment, 2.1. The EU economic environment and its 
macroeconomic policy, pg. 3,  2.2 
 
It is stated in the EU Report that " Looking forward, based on the 2019 summer forecast1, the 
European Commission expects growth of the European economy to continue despite global WT/TPR/M/395/Add.1  
 
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  challenges. Growth is expected to moderate to 1.4% in 2019 and to increase to 1.6% in 2020. GDP 
in all EU Member States is expected to grow supported by domestic demand."  
 
Questions  18: 
 
a) Could  the EU provide  detailed  information  about  its 2020  GDP forecasts?  What  are 
the assumptions about ongoing trade  tension?  
 
Answer  
As a general rule, a no -policy -change assumption has been applied to assumptions about trade 
tensions in recent European Commission forecasts. According to this rule, all trade restrictive 
measures credibly announced or legislated by the forecast cut -off date e nter the baseline. Therefore, 
the baseline does not envisage any further escalation/de -escalation of trade tensions, which usually 
become negative/positive risks to the forecasts.  
 
b) Could the EU give further information about the contribution of domestic de mand 
to the 2020 GDP forecast rate? Which component of domestic demand do you think 
will contribute more to the growth rate in 2020? (consumption expenditure, 
investment expenditure or public expenditure?) Does the EU think to use 
expansionary fiscal polic y measures in 2020 in order to stimulate the economy?  
 
Answer  
With the outbreak of the Coronavirus in early 2020 and its subsequent arrival in Europe, the outlook 
for the EU economy, including for the demand components, is rapidly changing. The outlook is 
currently subject to a through reassessment in the context of the EC Spring 2020 Economic Forecast 
that will be published on 7 May 2020.  
 
3. Developments in the Internal Market, 3.6. Digital single market, pg. 10,  3.19.m  
 
It is stated in the EU Report that " Two directives on digital contract rules harmonising key consumer 
contract law rules across the EU. The harmonised rules apply to contracts for the supply of digital 
content and digital services and to contracts for the sale of goods and "smar t goods". They will 
reduce the costs for traders selling in multiple EU countries and ensure transparency,  certainty,  and 
a high level of protection  for consumers  when  they buy goods  and digital content or digital services 
across the EU. The new rules will  begin to apply throughout the EU in January  2022."  
 
Question  19: 
Could  the EU further  explain  the scope  of the two directives  on digital  contract  rules 
especially for digital content and services supply  contracts?  
 
Answer  
Directive 2019/770 on certain aspects concerning contracts for the supply of digital content and 
digital services (DCD) and Directive 2019/771 on certain aspects concerning contracts for the sale 
of goods (SGD) lay down rules on certain requirements concerning sales contracts c oncluded 
between the seller and the consumer. The DCD covers contracts for the supply of digital content 
(e.g. digital games, software) as well as digital services (e.g. cloud services). In addition, the sale 
of durable medium used exclusively as a carrier  of digital content (e.g. CD with music) is also covered 
by the Directive. The DCD applies to contracts where a consumer pays or undertakes to pay a price 
as well as to contracts where a consumer provides personal data in exchange for digital content or 
a digital service (except when personal data are used exclusively to perform the contract).  
 
The SGD covers all sales of goods carried out online or in physical shops. The Directive applies to all 
traditional tangible movable items (with the exception of goo ds that are a durable medium used 
exclusively as a carrier of digital content covered by DCD) as well as to "smart goods " which are 
referred in the Directive as "goods with digital elements ". Goods with digital elements are goods that 
incorporate or are inter -connected with a digital element (content or service) in a way that the 
absence of this digital element would prevent the goods from performing their functions. For 
example, a smart watch or a smart TV could be considered as goods with digital elements and fall 
in the scope of SGD.  
 WT/TPR/M/395/Add.1  
 
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  3. Developments  in the Internal  Market,  3.12.  The EU's actions  on climate  change,  pg. 14, 
3.12 
 
It is stated  in the EU Report  that "In 2018,  the EU adopted  a directive  revising  the EU Emission Trading 
System for the period 2021 -2030 (so -called "phase 4"), including a reduction of the number of 
quotas by 2.2% per year from 2021, instead of 1.74% at present. It includes strict, predictable and 
equitable rules to prevent risks of carbon leakage."  
 
Questions  20: 
a) How does the EU plan to combat carbon leakage? Could the EU further explain the 
details of the available and possible rules, instruments and measures to prevent 
risks of carbon leakage?  
 
Answer  
From the start of the EU Emission Trading System, the EU has recognised and effectively addressed 
the risk of carbon leakage for its emission intensive and trade intensive industries. At present, the 
ETS Directive contains two main ways of protecting against the risk of carbon leakage resulting fr om 
the EU ETS: the free allocation of allowances covering direct emissions and the compensation of 
indirect carbon costs.  
 
In terms of free allocation, over the current trading period (2013 –2020), 57% of the total amount 
of allowances will be auctioned, wh ile the remaining allowances are available for free allocation. 
Power generators since 2013 in principle do not receive any free allowances, but have to buy them. 
Manufacturing industries who have been determined to be at significant risk of carbon leakage  thus 
receive most of the available free allowances and will continue to receive a share of their allowances 
beyond 2020. A benchmarking approach (based on the average of the 10% most efficient 
installations) is used to calculate the amount of free allocat ion of allowances each of these 
installations receives. These benchmarks are developed for each product, where possible (please 
find further information https://ec.europa.eu/clima/policies/ets/allowances_en ). 
 
With regard to indirect carbon costs, Article 10a(6) of the ETS Directive determines that Member 
States may grant state aid to compensate sectors deemed to be exposed to a significant risk of 
carbon leakage due to carbon costs being passed on in electricity prices ( 'indirect costs '). Hence, it 
is for Member States to determine whether they want to give this type of compensation and if they 
do, they have to comply with the EU 's State aid rules, in particular the ETS State aid Guidelines. 
These Guidelines, which are currently under revision for the perio d 2021 -2030, determine inter alia  
which sectors are eligible for this type of support and how much compensation may be granted 
(please find further information: 
https://ec.europa.eu/competition/state_aid/legislation/ets_en.html ). 
 
Finally, it is worth noti ng that in its European Green Deal Communication the Commission has 
announced that as the EU increases its climate ambition, it will propose a Carbon Border Adjustment 
("CBA") for selected sectors, to reduce the risk of carbon leakage should differences in  levels of 
climate ambition persist between the EU and third countries. The Communication clarifies that the 
CBA "would be an alternative to the measures that address the risk of carbon leakage in the EU 's 
Emissions Trading System. ", e.g. the allocation of  free allowances based on ambitious performance 
benchmarks or compensation for the increase in electricity costs.  
 
b) As indicated in the rules under United Nations Framework Convention on Climate 
Change (UNFCCC), parties to UNFCCC shall take into account the specific needs and 
concerns of particularly developing countries susceptible to impacts of response 
measures. Does the EU assess and analyse the cross -border impacts of any 
measure for preventing risks of carbon leakage to other countries? Coul d the EU 
share the possible impacts of the carbon leakage measures to other countries?  
 
Answer  
The abovementioned existing carbon leakage protection mechanisms (i.e. free allocation and indirect 
cost compensation) by their very nature do not take into acco unt the cross -border impacts of the 
EU carbon cost, because third country operators do not incur any costs from the EU ETS. The ETS 's 
leakage protection provisions are domestic measures that offset some of the carbon cost that 
EU-based installations incur as a result of the EU ETS.  
 WT/TPR/M/395/Add.1  
 
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  Should the EU propose and introduce a Carbon Border Adjustment then an assessment of impacts 
on third countries, including developing countries, will be carried out. The objective of such a 
measure would be to prevent carbon lea kage and hence the carbon constraints applicable in third 
countries will be relevant to the design of the CBA. The CBA would not be designed to protect the 
EU industry from competitors in third countries, but rather to ensure the environmental effectivenes s 
of the EU ETS by avoiding that global emissions increase as a result of the relocation of installations 
to countries with laxer climate policies. What is more, the Green Deal Communication is clear that 
the compliance of a CBA with World Trade Organizati on (WTO) rules and other international 
obligations of the EU will be ensured.  
 
c) Could  the EU give detailed  information  on whether  possible  carbon  leakage  
measures  will have impact on international trade, exports and competitiveness of 
other  countries?  
 
Answer  
As set out in our answer to question 21b, work on the development and design of a Carbon Border 
Adjustment is at its early stages and not detailed information on impacts on international trade, 
exports and competitiveness of other countr ies has yet to be carried out. However, the Commission 's 
Inception Impact Assessment on the CBA clearly states that the effects of the measure on the EU 
and third country markets will be analysed as part of the impact assessment of the CBA (please see: 
https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/12228 -Carbon -Border -
Adjustment -Mechanism ). 
 
3. Developments in the Internal Market, 3.14. The withdrawal of the United Kingdom from 
the European Union, pg. 15, 3.49  
 
It is stated  in the EU Report  that "Given  the uncertainty  about  when  and under  which  conditions the 
United  Kingdom will withdraw from the EU, the EU needs to prepare for a withdrawal without a 
Withdrawal Agreement (no -deal scenario). The no -deal scenario means that trade between the EU 
and the United Kingdom will take place on MFN terms and that EU trade agreements with third 
countries will cease to apply to the United Kingdom as of the United Kingdom's  withdrawal."  
 
Question 2 1: 
Is there  any study  about  impacts  of trade  issues  based  on possible  scenarios  regarding the  
withdrawal  of the UK? If yes, could  the EU provide  information  about  the study  and further 
steps about the most probable  scenario?  
 
Answer  
The long -term economic impact of the UK's exit from the EU will largely depend on future EU27 -UK 
trading arrangements. However, the results from various published studies on the economic impact 
of Brexit point to negative effects to the UK as well as the EU.  
 
The Political Declaration, the EU and UK have stated their intent to begin the formal process of 
negotiations of their future relationship as soon as possible after the UK's withdrawal, such that it 
can come into force by the end of 2020. The first round of negotiations between the EU and UK took 
place from 2 –5 March.  
 
3. Developments in the Internal Market, 3.14. The Withdrawal of The United Kingdom from 
the European Union, pg.16, 3.51  
 
It is stated the EU Report that " The Withdrawal Agreement includes a transition period  during which  
the EU law would  apply  in and to the United  Kingdom  as if it were still a Member  State."  
 
Question  22: 
Could the EU give specific information about the application of EU's legislation regarding 
Emission Trading System (ETS) during the transition period and after Brexit?  
 
Answer  
The Withdrawal Agreement requires the UK to comply with the EU ETS obligations during the 
transition period. The first round of negotiations on the future relationship took place from 
2-5 March  2020. The EU's negotiating directives, which are based on the Political Declaration, 
propose that the Parties should consider linking a United Kingdom national greenhouse gas emissions WT/TPR/M/395/Add.1  
 
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  trading system with the Union's Emissions Trading System (ETS). Please find further information: 
https://www.consilium.europa.eu/media/42736/st05870 -ad01re03 -en20.pdf . 
 
3.Developments in the Internal Market, 3.14. The Withdrawal of The United Kingdom 
from the European Union, pg.16,  3.53 
 
It is stated in the EU Report that "The Withdrawal Agreement is accompanied by a Political 
Declaration, which was agreed by negotiators and endorsed by the European Council. It sets out  the 
framework  for the future  relationship  between  the EU and the United  Kingdom,  allowing for  a range  of 
outcomes.  The EU aims to have as close as possible  a partnership  with the United Kingdom in the 
future in line with the Political  Declaration."  
 
Question  23: 
Brexit will have immediate effects on Turkey -EU Customs Union and any future 
partnership  between  the EU and the UK will affect  this Customs  Union.  How does  the EU 
plan to include Turkey in its partnership with the UK in the  future?  
 
Answer  
The EU notified all its international partners, including WTO Members and the WTO itself, about the 
UK's withdrawal and the transitional arrangements foreseen in the Withdrawal Agreement. This 
notification sets out the specific arrangements foreseen in the Withdrawal Agreement under which, 
during the transition period, the UK would be t reated as an EU Member State for the purposes of 
the international agreements, such as the EU -Turkey Customs Union. The EU is committed to keep 
Turkey closely informed of the development pursuant to the specific relationship under the 
EU-Turkey Customs Uni on. 
 
4. Trade and Investment Policy Developments, 4.3. Promoting a sustainable approach to 
trade, 4.3.6. Promoting fair and ethical trade schemes, pg. 22,  4.48 
 
It is stated in the EU Report that "… The study focused on selected EU Member States and concluded 
that sustainable product sourcing has become a top priority for retailers who are increasingly 
"greening" their supply chains, adopting fair and ethical trade criteria and applying sustainability  
standards in overwhelming numbers."  
 
Question  24: 
Could the EU clarify whether there is an EU wide plan to "green" supply chains? What are 
the sustainability standards and how these standards will be implemented in international 
trade?  
 
Answer  
In the Euro pean Green Deal communication of December 2019, the European Commission proposed 
to take measures to increase sustainability. For example, building on the Communication on 
Stepping up EU Action to Protect and Restore the World 's Forests, the Commission has  said that it 
takes measures, both regulatory and otherwise, to promote imported products and value chains that 
do not involve deforestation and forest degradation. Any such measure will be designed to comply 
with World Trade Organization rules and other i nternational obligations of the EU.  
 
4. Trade and Investment Policy Developments, 4.3. Promoting a sustainable approach to 
trade, 4.3.4. Gender equality and economic empowerment of women, pg.  16, 4.41  
 
It is stated in the EU Report that " The EU is committed to gender equality, to which various policy 
areas, including trade, can contribute. The EU supported the adoption of the Joint Declaration on 
Trade and Women's Economic Empowerment at the 11th WTO Ministerial Conference in Buenos Aires 
in December  2017. In this context, the EU co -hosted a workshop on Women and Digital Trade in 
Geneva on 1  July 2019 to discuss the opportunities and challenges for women in digital trade. The 
EU's updated Aid for Trade strategy also explicitly recognises ge nder equality as a fundamental 
human right, putting women's economic empowerment at its forefront."  
 
Question  25: 
Could the EU provide detailed information about the results of workshop on "Women and 
Digital Trade " regarding the discussions on the opportun ities and challenges for women 
in digital trade?  WT/TPR/M/395/Add.1  
 
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  Answer  
The workshop highlighted that digitalisation offers many opportunities for women. Data from some 
online platforms suggest that women are more active in digital trade than in traditional commerce. 
Whilst the driving factors are not entirely clear, ecommerce increases flexibility and thus might be 
advantageous for women given that they spend more time on unpaid care work. Likewise, the 
increase in demand for technology -driven services might benefit women . 
 
Yet, women continue to face barriers such as access to finance which prevent them from fully reaping 
the benefits of trade. Many of these barriers are similar to those faced by SMEs and are therefore 
not necessarily gender -specific. In order to design b etter policies that address barriers for women, 
workshop participants emphasised that equal representation in political decision -making bodies is 
essential. Lastly, all panels highlighted the lack of gender -disaggregated data. Such data are 
required to bet ter identify potential trade -specific barriers. For more information, please see: 
https://www.wto.org/english/tratop_e/devel_e/a4t_e/womenindigitaltrade1719_e.htm . 
 
4. Trade and Investment Policy Developments, 4.3. Promoting a sustainable approach to 
trade, 4.3.4. Gender equality and economic empowerment of women, pg.16, 4.42  
 
It is stated in the EU Report that  "EU trade agreements contain commitments related to the 
implementation of fundamental ILO conventions targeting non -discrimination in employmen t 
(ratification and implementation of ILO Conventions 100 and 111 on equal remuneration and 
non-discrimination), in a specific chapter on Trade and Sustainable Development. In  addition, the 
EU is negotiating specific provisions on trade and gender equality  in the context of the modernisation 
exercise of EU Chile Association Agreement. Such provisions will help acquiring a better 
understanding of the constraints and opportunities faced by women in the trade arena, as well as 
sharing best practices. The EU an d Canada are cooperating along the same lines in the context of 
the EU -Canada Comprehensive Economic and Trade Agreement (CETA)."  
 
Question  26: 
Could the EU provide detailed information about the policies that support women's 
economic empowerment with regard to the updated Aid for Trade Strategy?  
 
Answer  
The EU legal and policy framework for WEE starts from the EU founding Treaties, which set gender 
equality as a fundamental EU value and objective. Women's economic empowerment is recogn ised 
as a priority in EU external action and the EU Global Strategy indicates gender equality and women's 
empowerment as cross -cutting priorities for all polices. The European Consensus on Development, 
based on the 2030 Agenda for Sustainable Development, reaffirms gender equality and women's 
empowerment as vital for achieving sustainable development, cutting across the entire 2030 
Agenda, while underlining the need to mainstream gender perspectives in all actions. Finally, as 
operational guidance for all e xternal action, the EU Gender Action Plan II (2016 -2020) identifies 
women's economic empowerment as one of the three key thematic pillars to close the gender gap.  
The Gender Action Plan  II (2016 -2020)14 contributing to SDG 5 (gender equality), confirms the 
EU commitment to strengthen the efforts to place gender equality and empowerment of women at 
the heart of the EU's external action. It sets out specific objectives to promote access to decent work 
for women of all ages and to ensure equal acce ss to trade among other services and resources.  The 
EU updated 2017 Aid for Trade Strategy, operationalises the EU's renewed and expanded 
commitment towards Gender Equality and Women's Empowerment, stemming from the above 
policies.  
 
4. Trade and Investment  Policy Developments, 4.3. Promoting a sustainable approach to 
trade, 4.3.4. Gender equality and economic empowerment of women, pg.16, 4.43  
 
It is stated in the EU Report that " The GSP+ scheme includes the UN "Convention on the Elimination 
of All Forms of Discrimination against Women ." 
 
Question  27: 
Could the EU provide detailed information about the implementation of UN "Convention  
on the Elimination  of All Forms  of Discrimination  against  Women " that is included in the 
GSP+  scheme?  
 WT/TPR/M/395/Add.1  
 
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  Answer  
All countries benefitting from the EU 's Special Incentive Arrangement for Sustainable Development 
and Good Governance (GSP+) are required to ratify and effectively implement 27 international 
conventions, including seven fundamental United Nations conventions on human rights. One of these 
conventions is the Convention on the Elimination of All Forms of Discrimination against Women 
(CEDAW). For the latest assessment of beneficiary countries ' implem entation of all 27 conventions, 
please see the EU's biennial GSP report covering the period 2018 -19 
(https://trade.ec.europa.eu/doclib/press/index.cfm?id=2112 ). 
 
OTHERS  
 
Question  28: 
The EU member states are applying transit quotas on the road vehicles registered  in 
Turkey. How does the EU reconcile these qu otas with Article V of GATT and Article 11 of 
Trade Facilitation  Agreement?  
 
Answer  
The EU notes that Turkey has also raised this question bilaterally with the EU in connection with 
both the Turkey -EU preferential bilateral rela tionship and the WTO Agreement.  The latter happened 
notably in the final phase of the negotiations on the Trade Facilitation Agreement and led, as a 
compromise between Turkey and the EU, to the formulation of Article 11.3 of the Trade Facilitation 
Agreement currently in force.  The EU would remind Turkey that Turkey continues to agree bilateral 
arrangements on road quotas with EU Member States. These bilateral arrangements are precisely 
what the drafters of Article 11.3 had in mind when referring to "bilateral or multilateral 
arrangements ". 
 
  WT/TPR/M/395/Add.1  
 
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  UKRAINE  
PART I: QUESTIONS REGARDING THE SECRETARIAT REPORT ( WT/TPR/S/395)  
 
1 ECONOMIC ENVIRONMENT  
1.2 Recent Economic Developments  
1.2.2 Fiscal governance and performance  
 
Pages 20 - 21 (Para 1.16)  
The Report refers to some tax -related de velopments at the EU level and in some member States. In 
particular, it mentions discussions on an EU digital services tax regime and states, that proposals 
for introduction of digital services tax have been suspended until 2020. However, some member 
State s, including Austria, France, Italy, and Spain, have taken steps for their own versions of such 
a tax.  
 
Questions  
1. Could the EU, please, inform on the state of play of formulation proposals for a digital 
services tax at the EU level?  
 
EU reply:  
The negotiation of EU proposals for digital tax are on hold given the international tax negotiations 
aimed at reaching a global solution that are to be finalized in 2020. EU is fully engaged in the debate 
with the international partners and is encouraged by th e progress being made at the Organisation 
for Economic Co -operation and Development in this respect.  
 
2. What kind of digital services may be subject to a digital services tax?  
 
EU reply:  
According to the EU proposal for a Digital service tax COM(2018) 148  final, the following services 
can result in taxable revenues: (a) the placing on a digital interface of advertising targeted at users 
of that interface; (b) the making available to users of a multi -sided digital interface which allows 
users to find other users and to interact with them, and which may also facilitate the provision of 
underlying supplies of goods or services directly between users; (c) the transmission of data 
collected about users and generated from users' activities on digital interfaces.  
 
3. What are possible models for the introduction of the digital services tax and its 
expected effects on imports of IT services into the EU?  
 
EU reply:  
The EU proposal model of taxation targets the revenues stemming from the supply of digital services 
where users contribute significantly to the process of value creation. The expected effects of the 
application of the tax are published in the Impact assess ment accompanying the proposal 
SWD(2018).81final/2. 
https://ec.europa.eu/taxation_customs/sites/taxation/files/fair_taxation_digital_economy_ia_2103
2018.pdf . 
 
2 TRADE AND INVESTMENT REGIMES  
2.3 Trade Agreements and Arrangements  
2.3.2 Regional and preferent ial agreements  
2.3.2.1 Reciprocal preferences  
 
Page 43 (Para 2.40)  
The Report states, "The United States and the EU adopted a Joint Statement in July 2018, in which 
they agreed to work towards elimination of tariffs, non -tariff barriers, and subsidies on non-auto 
industrial goods, and towards the reduction of barriers to trade in services, chemicals, 
pharmaceuticals, medical products and soybeans."  
 
Question  
4. Could the EU, please, clarify whether there are any developments or outcomes in the 
joint work w ith the United States towards the elimination of trade barriers?  
 WT/TPR/M/395/Add.1  
 
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  EU reply:  
In July 2018, President Juncker and President Trump agreed on the EU -US Joint Statement. On 
15 April 2019, the Council adopted a mandate to open talks for a horizontal agreement on conformity 
assessment and to open talks on the elimination of tariffs on industrial goods.  
 
2.4 Investment Regime  
2.4.2 Investment relations with third countries  
2.4.2. 1 Establishment of a cooperation mechanism for the screening of FDI  
 
Page 50 (Para 2.67)  
According to the Report Regulation (EU) 2019/452 of the European Parliament and of the Council of 
19 March  2019 establishing a framework for the screening of foreign d irect investment into the Union 
requires member States and the Commission to establish a contact point for the implementation of 
the Regulation, provides that the group of experts on the screening of FDI into the EU shall continue 
its work, and allows the member States and the Commission to cooperate with responsible 
authorities of third countries on issues relating to the screening of FDI on the grounds of security 
and public order.  
 
Questions  
5. Could the EU, please, specify issues relating to the impleme ntation of Regulation (EU) 
2019/452, which may be considered by contact points, established in accordance with 
requirements of Article 11 of this Regulation?  
 
EU reply:   
In each Member State and the Commission, a contact point will be established to enhance the 
communication and cooperation at Member State and Union level concerning all issues relating to 
the implementation of the Regulation. The established contact points should be appropriately placed 
within the respective administrat ion and should have the qualified staff and the powers necessary 
to perform their functions under the cooperation mechanism and to ensure a proper handling of 
confidential information.  
 
6. How will activity of such new contact point be related to continuin g work of the group 
of experts on the screening of FDI into the EU, when the Regulation will become fully 
applicable?  
 
EU reply:   
The contact point for a Member State and the Member State representative in the Expert Group are 
not necessarily the same pers ons. As a matter of fact, the contact point does not even need to be a 
physical person. If the Commission or a Member State reach out to (another) Member State, they 
will reach out to the contact point. The contact point needs to be involved on all issues related to 
the implementation of the Regulation. The Expert Group, composed of Member States ' 
representatives, provides advice and expertise to the Commission, shares best practices and lessons 
learned and exchanges views on trends and issues of common con cern related to foreign direct 
investment.  
 
3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.1 Customs procedures, valuation, and requirements  
 
Page 53 (Para 3.6)  
The Report mentions 20% administrative collection fee, owing to which EUR 5 billion of 
EUR 25.4 billion, collected by the EU in customs duties on imports in 2018, was retained by EU 
member States due to the sharing arrangement in place.  
 
Question  
7. Would the EU kindly inform more on the admini strative collection fee (including its 
structure and rates, procedures for imposition etc.) and describe mentioned 
arrangement?  
 
EU reply:  
This arrangement is provided for in Article 2 of Council Decision 2014/335 of 26 May 2014 on the 
system of own resour ces of the European Union. Please see link below:  WT/TPR/M/395/Add.1  
 
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  https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32014D0335&qid=1579703576395& from=EN  
 
More precisely it is 20% of "traditional own resources consisting of levies, premiums, additional or 
comp ensatory amounts, additional amounts or factors, Common Customs Tariff duties and other 
duties established or to be established by the institutions of the Union in respect of trade with third 
countries, customs duties on products under the expired Treaty e stablishing the European Coal and 
Steel Community, as well as contributions and other duties provided for within the framework of the 
common organisation of the markets in sugar " (see Art. 2 paragraph 1(a) and paragraph 3 of Council 
Decision 2014/335 ).  
 
Member States collect the entirety of the Common Customs Tariff duties established and 
subsequently 80% of the collected duties are transferred to the European Union budget.  
 
3.1.1.2 Trade facilitation  
 
Page 56 (Para 3.14)  
The Report states, "Binding rulings for tariffs (BTI) and binding origin information (BOI) continue to 
be part of the EU`s customs regime. As noted in the previous Review, there were some changes to 
the validity period and to their application on the trader, i.e. making them  binding, as a result of the 
UCC`s entry into force. Since that time, there were no further legal amendments. In 2018, as part 
of DG TAXUD`s efforts to provide certain legal clarifications, Administrative Guidance for BTI was 
developed and published; simil ar guidance for BOI was also made available in 2017. The use of BTI 
gradually increased each year, and over 244,000 valid BTIs were in force as at mid -2019. The use 
of BOI remained relatively stable and, at the end of 2018, there were 4,775 valid BOIs. Fro m 
October  2019, all BTI applications will be done electronically; currently, most of them are submitted 
in paper form only. For BOI, there is no electronic system and these are treated in paper form."  
 
Questions  
8. Would the EU, please, inform how the private sector responded to mentioned changes 
and whether there were any public consultations/discussions in this regard?  
 
EU reply:  
The private sector was involved in the discussions on the changes brought to the customs legislation 
by means of the 'Trade  contact group', this body is composed of industry representatives.  
 
9. Does the EU have any plans to introduce electronic system for BOI applications and, if 
yes, could the EU give some details?  
 
EU reply:  
Due to the fact that the number of BOI applicatio ns remains rather low, there are no plans to 
introduce an electronic system for BOI applications in the near future.  
 
Page 56 (Para 3.15)  
The Report mentions the EU's initiative to expand advance rulings to customs valuation, in addition 
to tariffs and ori gin. 
 
Question  
10. Does the EU have any plans to amend the EU's customs legislation for expanding 
advance rulings to customs valuation and, if yes, would the EU give some details?  
 
EU reply:  
In accordance with the "better regulation " process ( https://ec.eu ropa.eu/info/law/law -making -
process/planning -and-proposing -law/better -regulation -why-and-how_en ) and depending on the 
conclusions of a feasibility study currently under preparation, the Commission will assess further the 
expected and actual impact of the i ntroduction of an EU system of Binding Valuation Information, 
before proposing any new rules in this respect.  
 
Pages 56 – 57  
The Report describes other EU's developments in the field of trade facilitation.  
Article 12 of the Agreement on Trade Facilitatio n envisages provisions on customs cooperation 
between parties and, from our point of view, should enhance bilateral cooperation in this sphere.  WT/TPR/M/395/Add.1  
 
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  Questions  
11. Ukraine would appreciate if the EU could share information on the most successful 
examples of bilateral customs cooperation, which has been established by the EU to 
exchange an information on customs valuation.  
 
EU reply:  
Currently, EU exchanges information on customs valuation with a partner country (or group of 
countries) in the form of mutual administrative assistance and strictly on a case -by-case basis, under 
the framework of the existing Customs Cooperation and Mutual Administrative Assistance 
agreements. ( https://ec.europa.eu/taxation_customs/business/international -affairs/in ternational -
customs -cooperation -mutual -administrative -assistance -agreements_en#heading_0 ). 
 
12. Could the EU, please, briefly describe established mechanism for such customs 
cooperation?  
 
EU reply:  
See the answer to Q11.  
 
3.1.3 Tariffs  
3.1.3.2 Applied rate s 
 
Page 62 (Para 3.39)  
According to the Report the EU's import tariff policy on agricultural products remains almost 
unchanged since the previous Review. The agricultural sector continues to stand out in the tariff 
analysis due to significantly higher rate s (14.2% on average), the wide tariff range, and the 
significant use of non -ad valorem  rates and tariff quotas. There were minor changes to the simple 
average tariffs in the agriculture sector and the tariff range, due mainly to statistical anomalies in 
calculating ad valorem  equivalents. While the highest tariff in the agriculture sector a ppears to have 
declined since the last Review, this was due to one outlying tariff with a high ad valorem  equivalent. 
Nevertheless, there is a much greater incidence of high tariffs in the agriculture sector compared to 
non-agricultural products. Nearly al l tariffs above 20% are in the agriculture sector.  
 
Question  
13. Notwithstanding the ongoing negotiations under Article XXVIII of the GATT 1994, 
does the EU envisage changing in its approach towards liberalization of the customs tariff 
on agricultural pro ducts in the context of withdrawal of the United Kingdom from the EU?  
 
EU reply:  
The EU 's trade policy will not change as a result of the UK's withdrawal. The EU has no plans to 
autonomously change its tariffs for agricultural products. Any changes to boun d tariffs in the EU 
schedule will only result from successful multilateral negotiations. Ukraine naturally benefits from 
preferential access to the EU market under the EU -Ukraine Deep and Comprehensive Free Trade 
Agreement (DCFTA), which has been provision ally applied since 1 January 2016.  
 
3.1.6 Anti -dumping, countervailing, and safeguard measures  
3.1.6.1 Anti -dumping and anti -subsidy measures  
 
Page 79 (Para 3.77)  
As noted in the Report, "The last Review enumerated the main EU rules on anti -dumping and 
anti-subsidies which had been replaced by new codified versions in 2016 (Regulations (EU) 
2016/1036 and (EU) 2016/1037); these remain in place and continue to form the basic rules on 
anti-dumping and anti -subsidy measures for the EU. However, there have bee n significant 
developments, with two new regulations entering into force, resulting in the amendment of these 
Regulations."  
 
Question  
14. Could the EU, please, provide detailed explanations of the basis and formula for the 
calculation of the amount of the anti-dumping and safeguard duty on imports into the EU 
of processed product resulting from outward processing of the European raw materials in 
view of Article 75 "Specific import duty on processed products resulting from outward 
processing or replacement p roducts (Article 86(5) of the Union Customs Code)" of the 
Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing WT/TPR/M/395/Add.1  
 
- 548 - 
 
  Regulation (EU) No . 952/2013 of the European Parliament and of the Council? Please, 
provide the example of formula.  
 
EU reply:   
An anti -dumping duty (ADD) or a safeguard duty is usually imposed in the form of an ad valorem  
duty. 
In cases where ADD or safeguard duty is imposed in the form of a specific duty (e.g. a fixed amount 
in EUR per tonne), Article 75 of Commission Delegated Regulation (EU) 2015/2446 applies.  
Two examples on how the amount of import duty (or amount of ADD or safeguard duty) has to be 
calculated are given on page 54 of the Guidance on Special Procedures, which is available at:  
https://ec.eu ropa.eu/taxation_customs/business/union -customs -code/ucc -guidance -
documents_en#special_procedures . 
 
Page 81 (Para 3.82)  
The Report states, "Most recently, in July 2019, the Commission implemented new rules to extend 
the reach of trade remedy laws to the c ontinental shelf and exclusive economic zones of member 
States. This allows for the operationalization of the rules that were included in the 2018 
modernization."  
 
Question  
15. Could the EU kindly provide some more details about the functioning of the rule s in 
practice?  
 
EU reply:  
Trade defence measures can apply to dumped or subsidised products imported and used on the 
Continental Shelf where the consumption of the product concerned is significant. This covers, for 
example, oil rigs or off -shore wind par ks. The Regulations imposing anti -dumping / anti -subsidy 
measures will specify if these zones are covered.  
 
A Commission Regulation published in July 2019 established a customs tool to implement the 
provisions of the basic anti -dumping and anti -subsidy re gulations which relate to the continental 
shelf. That Regulation sets out the rules on how the collection of TDI duties in the continental shelf 
/ exclusive economic zone of Member States works. The Customs Tool entered into force on 
4 November 2019.  
The text of the regulation can be found here:  
https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1131&from= EN. 
 
TDI measures will continue to apply automatically to the territorial waters, consisting of twelve 
nautical miles off shore of a Me mber State, comprising part of the EU 's customs territory.  
 
3.3 Measures Affecting Production and Trade  
3.3.3 Sanitary and phytosanitary requirements  
 
Page 116 (Para 3.213)  
Under the Report, "Since the last Review, the most significant change in the EU's SPS regime refers 
to the new Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 
2017 regarding official controls on products of animal origin intended for human consumption. It 
includes rules for the performance of official controls and other control activities by the competent 
authorities of the member States, sets out the requirements to be fulfilled for the entry into the EU 
of consignments of animals and goods from third countries, and empowers the Commission to adopt 
delegated acts concerning those requirements. This Regulation will apply from 14 December 2019. 
However, the requirements will only apply from 21 April 2021."  
 
Question  
16. Would the EU kindly provide information on the list of certificates (as well as 
references to the valid legislative acts) for import of animals and products thereof, animal 
by-products that have been amended in view of entering of new legal acts into f orce?  
 
EU reply:  
The requirements laid down in the Official Control Regulation (EU) 2017/625 of the European 
Parliament and of the Council of 15 March 2017 regarding official controls on products of animal 
origin intended for human consumption (OCR) and tertiary legislation, adopted based on WT/TPR/M/395/Add.1  
 
- 549 - 
 
  empowerments of the OCR in relation to performance of official controls and requirements for entry 
into the Union of food of animal origin, ensure a continuation of the requirements laid down in 
Regulations (EC) No 85 4/2004 and (EC) No 882/2004 to ensure a high level of protection of health 
and in order to a avoid a disruption of the entry into the Union of consignments of food of animal 
origin.  
At the same time, the experience gained in the application of the rules l aid down in those two 
Regulations is taken into account using a risk -based approach.  
 
With regard to public health requirements applicable to the entry into the European Union of 
consignments of certain animals and goods intended for human consumption, the  OCR was 
supplemented in particular by three acts on:  
 
- requirements for the entry into the European Union of consignments of certain animals and 
goods intended for human consumption ,  
- list of third countries authorised for the entry into the EU of cer tain animals and goods 
intended for human consumption  
- model official certificates for certain animals and goods.  
 
The public health requirements remain essentially similar to those which were applicable earlier to 
the entry of foodstuffs into the EU. Th ere are overall no changes in the current lists of countries and 
establishments allowed to export to the EU and no major changes have been made to existing 
certificates. The limited changes include the requirement for the listing of countries for all produ cts 
of animal origin. Additional lists have therefore been created for rendered fats and greaves, reptile 
meat, insects, other products of animal origin (not covered by existing lists) and further to this 
specific model health certificates have been laid d own and are now mandatory for the export to the 
EU of these commodity types. The procedure for listing of establishments has been simplified.  
An overview on delegated and implementing acts adopted under Regulation (EU) 2017/625 can be 
found here: 
https://e c.europa.eu/food/sites/food/files/oc_qa_ocregulation_20191212_delegated_implemented
_acts_en.pdf . 
 
3.3.7 Intellectual property rights  
3.3.7.2 Industrial property  
3.3.7.2.1 Patents  
 
Supplementary protection certificates  
 
Page 150 (Para 3.342)  
Under the Rep ort, "… the EU co -legislators adopted Regulation (EU) 2019/933 amending Regulation 
(EC) No.  469/2009 concerning the supplementary protection certificate for medicinal products, 
introducing an exception to let firms established in the EU manufacture certain  pharmaceutical 
products for export to non -EU markets during the term of the SPC. It also permits the making and 
stockpiling of a pharmaceutical product six months prior to the expiry of the certificate, in order to 
place it on the market of EU member Stat es immediately after expiry of the certificate. These 
provisions have been described as means to level the playing field for Europe -based generic and 
biosimilar manufacturers in light of a lack of international binding rules on SPCs. Comparable 
exceptions were included in recent FTAs such as the CETA."  
 
Questions  
17. Would the EU kindly elaborate on the policy rationale for adoption of Regulation (EU) 
2019/933 amending Regulation (EC) No. 469/2009 concerning the supplementary 
protection certificate (SPC) for medicinal products?  
 
EU reply:  
The policy rationale is described in detail in recitals 4 to 9 of the regulation. The text of Regulation 
2019/933, in all the official languages of the EU, can be found at: https://eur -lex.europa.eu/leg al-
content/EN/TXT/?uri=uriserv%3AOJ.L_.2019.153.01.0001.01.ENG&toc=OJ%3AL%3A2019%3A15
3%3ATOC . 
 
18. Could introduction of mentioned exception for the purpose of export be considered as 
indirect support and protective measure in relation to EU manufacturers of generics and 
biosimilars?  WT/TPR/M/395/Add.1  
 
- 550 - 
 
  EU reply:   
This EU measure aims to level the playing field for EU -based manufacturers, whether they have their 
global headquarters in a EU or non -EU country, vis -à-vis manufacturers located in non -EU countries 
without comparabl e EU SPC protection.  
 
19. Would the EU, please, share its opinion how use of such manufacturing exception for 
export purposes could effect on competition between EU -based and 
non-EU generics/biosimilar manufactures, considering the EU's strong pharmaceutic al 
industry and 'pioneering' competitive advantage in the biosimilar sector?  
 
EU reply:   
Biosimilar research and manufacturing can be found in many countries outside the EU. Some of 
those non -EU countries have no SPC protection, or provide for shorter SPC protection than the EU, 
giving an advantage to manufacturers located in their territories, which could start manufacturing 
earlier in time and start commercial activity in global markets before EU -based manufacturers. The 
expected effect of the waiver is t o put manufacturers located in the EU on equal footing so that they 
do not lose the lead -time to global markets.  
 
20. How does this measure correspond to existent free -trade agreements that the EU has 
concluded with non -EU countries and that include SPC p rovisions, but don 't mention 
possibilities of exceptions for manufacturing of pharmaceutical products for export to 
third countries during the term of the SPC?  
 
EU reply:   
This measure is compatible with the trade policy, international commitments and legi slation of the 
EU. 
 
21. What were the views of stakeholders, represented the interests of SPC holders and 
non-EU generics manufactures, in the process of public consultations before adoption of 
Regulation (EU) 2019/933 and how did the EU consider them while making appropriate 
decision?  
 
EU reply:   
Their views can be found on page 4 of the report with the summary of the public consultation 
(point  3.5), which can be found at: https://ec.europa.eu/docsroom/documents/29464.  
 
22. Could the EU kindly describe  any control mechanisms established to prevent 
infringement of SPC holders' rights related to medicinal products manufactured for export 
purposes during the term of the SPC, including labelling requirements, safeguard 
measures etc.?  
 
EU reply:   
Further to the existing EU legislation on enforcement of IPR and EU legislation on health regulatory 
matters, Regulation 2019/933 lays down a number of safeguards, namely a double notification 
system (to the SPC holder and patent office), specific labellin g (logo) and due diligence. It also lays 
down that medicines manufactured for export purpose should not bear a unique identifier (required 
for placing medicines in the EU market).  
 
23. Have such SPC manufacturing exceptions been applied in practice and, if  so, for export 
to which markets?  
 
EU reply:   
They have not yet been applied.  
 
4 TRADE POLICIES BY SECTOR  
4.4 Services  
4.4.3 E -commerce  
4.4.3.1 E -commerce in the context of the Digital Single Market (DSM) Strategy  
 
Pages 234 - 235 (Para 4.271)  
The Report states, "Adapting the EU economy to the opportunities and challenges created by the 
digital transformation has been a major policy priority for the EU in recent years. The digital economy WT/TPR/M/395/Add.1  
 
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  is regarded as a prominent example of an area in which the potential of the EU's Single Market has 
not been fully exploited. This is particularly important in view of the close complementarities between 
services provided by digital means and different sectors of the economy. Accordi ng to a recent 
communication of the European Commission, "[d]igital technologies have become an integral part 
of the Single market to a point that the distinction between the traditional "brick and mortar" Single 
market and the "digital" Single market is n o longer relevant". Digital services are of critical 
importance to enable the EU to improve its performance in the services sector."  
 
Questions  
24. With the upcoming Brexit, could the EU elaborate on the possible implications of this 
process for the e -comm erce, as well as on regulations in this field to be adjusted to match 
new realities?  
 
25. In particular, what will Brexit bring for the international e -sellers?  
 
EU reply to Q24 and Q25:  
The Political Declaration that accompanied the Withdrawal Agreement sets out the framework for 
the future relationship between the European Union and the United Kingdom. It establishes the 
parameters of 'an ambitious, broad, deep and flexible partnership across trade and economic 
cooperation with a comprehensive and balanc ed Free Trade Agreement at its core, law enforcement 
and criminal justice, foreign policy, security and defence and wider areas of cooperation.  
 
The Commission 's proposal for the negotiating directives for the future relation with the UK were 
published on  3 February 2020139, paragraphs 44 and 45 of the draft negotiating directives relate to 
Digital trade.  
 
In the Political Declaration, the EU and UK have stated their intent to begin the formal process of 
negotiations of their future relationship as soon as p ossible after the UK 's withdrawal, such that it 
can be applied from 1 January 2021.  
 
PART II: QUESTIONS REGARDING THE REPORT  BY EUROPEAN UNION (WT/TPR/G/395)  
 
3 DEVELOPMENTS IN THE INTERNAL MARKET  
3.11 The implementation of the EU Environment Action Programme  
 
Page 13 (Para 3.37)  
The Report mentions the EU Environment Action Programme which provides strategic guidance and 
ensures predictable and coordinated action for Europe's environment and climate policy.  
 
Questions  
26. In the context of the EU E nvironment Action Programme, could the EU, please, 
elaborate on the sources of funding, which are used to implement this Programme?  
 
EU reply:   
The European Commission presented its new growth strategy – the European Green Deal. The Deal 
aims to chart a n ew development path where economic growth is decoupled from environmental 
degradation and where the transition towards a sustainable future is not only green but also just. 
The overarching EU environmental and climate objectives until 2024 are therefore se t out in the 
Green Deal. The 8th EAP, which we expect to enter into force in 2021, will have a complementary 
function to support the implementation of the Deal 's objectives and to monitor progress.  
To finance the European Green Deal and bring different in itiatives under one framework, the 
Commission presented the European Green Deal's Investment Plan - the Sustainable Europe 
Investment Plan in January. The Plan will mobilise public investment and help to unlock private funds 
through EU financial instrument s, which would lead to at least EUR 1 trillion of investments. The 
Sustainable Europe Investment Plan includes a Just Transition Mechanism to provide tailored 
financial and practical support to help workers and generate the necessary investments in those 
areas. While all regions will require funding and the European Green Deal Investment Plan caters 
 
139 Recommendation for a Council Decision author ising the opening of negotiations for a new partnership 
with the United Kingdom of Great Britain and Northern Ireland (COM(2020) 35 final, of 3.2.2020) . Viewe d at: 
https://ec.europa.eu/info/sites/info/files/communication -annex -negotiating -directives.pdf  WT/TPR/M/395/Add.1  
 
- 552 - 
 
  for that, the Mechanism provides targeted support to help mobilise at least EUR 100 billion over the 
next decade in the most affected regions, to alleviate the socio-economic impact of the transition.  
 
27. Would the EU also specify whether there was a need to make changes in the fiscal 
policy (in particular to increase taxes) in order to implement such environmental 
programs?  
 
EU reply:   
The European Green Deal C ommunication highlights the importance of ensuring that taxation is 
aligned with climate objectives. The Commission will propose to revise the Energy Taxation Directive 
(ETD) by June 2021, focusing on environmental issues, and proposing to use the provisio ns in the 
Treaties that allow the European Parliament and the Council to adopt proposals in this area through 
the ordinary legislative procedure by qualified majority voting rather than by unanimity. In this 
context, the Commission will look closely at the  current tax exemptions including for aviation and 
maritime fuels and at how best to close any loopholes. Commission services already have started 
working on an impact assessment with a view to proposing a revision of the Energy Taxation 
Directive in 2021 simultaneously with the revision of the Emission Trading System.  
While the ETD is an example of taxation at EU level, competences in the taxation field generally 
remain with Member States. To support achievement of objectives trying to mitigate the emergin g 
challenges brought by climate change, environmental degradation, globalisation, digitalisation and 
aging of population, the Commission will engage with and encourage Member States to carry out 
broader base, future -proof tax reforms. Such reforms would ne ed to take into consideration the 
need to ensure sustainability of tax revenues, support transfer to green economy, ensure social 
justice for (vulnerable) citizens and competitiveness for business. Shifting taxation from labour and 
business to environmenta l taxation has a potential to address all these aspects. The Commission will 
encourage Member States ' effort in reforming their fiscal frameworks through the European 
Semester. It will also provide technical support to facilitate the effort to reform throu gh the 
Structural Reform Support Service and the Structural Reform Support Programme.  
 
UKRAINE - ADDITIONAL QUESTIONS  
QUESTIONS REGARDING THE REPLY, PROVIDED BY THE EU TO THE ADV ANCE WRITTEN 
QUESTION 14, SUBMITT ED BY UKRAINE (RD/TP R/1140)  
 
Pages 398 -399  
Ukraine expresses its gratitude for the provided explanation regarding specific duty calculation on 
imports into the EU of processed product resulting from outward processing and would like to pose 
the follow -up questions.  
 
Questions:  
1. Could the EU confirm that antidumping or safeguard duty imposed in the form of an 
ad valorem  duty for processed product resulting from outward processing is calculated in 
accordance with Article 86(5) of the Union Customs Code?  
 
EU reply:  
Yes, that is cor rect. 
 
2. Would the EU also provide detailed explanations of the basis and formula for the 
calculation of the amount of such duty?  
EU reply:  
Where ad-valorem  import duty rate has to be applied, the calculation of the amount of import duty 
is based on the cos t of the processing operations, undertaken outside the customs territory of the 
Union. Cost of the processing operations undertaken outside the customs territory of the Union 
referred to in Art. 86 (5) UCC should mean the customs value of the processed pro ducts at the time 
of acceptance of the customs declaration for release for free circulation minus the statistical value 
of the corresponding temporary export goods at the time when they were placed under outward 
processing.   
 
Example regarding application  of Art 86 (5) UCC:  
 
- Customs value of the process product (cars)      EUR 50.000  
- Statistical value of the temporary export goods (tyres) + commercial   WT/TPR/M/395/Add.1  
 
- 553 - 
 
    value of software                        EUR 5.000  
- Cost of processing operation undertaking outside   
  customs territories of the EU         EUR 45.000  
- Amount of import duty (import duty rate 10%)       EUR 4.500  
 
Note: 
The amount of ADD is calculated based on EUR 45.000  
 
 
  WT/TPR/M/395/Add.1  
 
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  UNITED STATES  
Part I: Ques tions based on the Secretariat's report (WT/TPR/S/395)  
 
1 ECONOMIC ENVIRONMENT  
1.2 Recent Economic Developments  
1.2.5 Main challenges and policy response  
 
Page 23, paragraph 1.26  
We have been concerned about Chinese financing of infrastructure investments in Europe, and 
whether Chinese companies domiciled in the EU have access to EU investment bank vehicles.  
 
1. Please explain how the EU is monitoring these developments, specifically with respect 
to strategic infrastructure in Europe ? 
 
EU reply:  
As regards your question on access to finance, it is important to note that the European Commission 
can issue an opinion about projects to be financed by the European Investment Bank in accordance 
with Article 19 of the EIB statute. Once the projects are financed, the EIB Group selects promoters 
according to its procurement rules. The project promoters, who choose the procurement of supplies, 
work and services, must act according to EU law.  
As regards foreign investments into "critical " EU in frastructures, the new framework for the 
screening of foreign direct investments (FDI) into the Union (i.e. Regulation (EU) 2019/452) 
established a cooperation mechanism between Member States and the Commission on FDI to better 
identify and mitigate risks related security or public order. Regulation (EU) 2019/452 entered into 
force in April 2019 and will become fully applicable from 11 October 2020 onwards.   
 
2 TRADE AND INVESTMENT REGIMES  
2. Trade and Investment Regimes  
2.2 Trade Policy Formulation and Obj ectives  
 
Page 38, paragraph 2.21: The Secretariat's report notes that the Commission carries out impact 
assessment analyses to support decision -making for all proposals with significant direct impact.  
 
2. Were changes to the General Food Law and the Delegated Regulation on the high -risk 
Indirect Land Use Change for Biofuels informed by an impact assessment? If not, what  
analyses were used to support the proposed changes, and how is this consistent with 
the "Better Regulation" agenda?  
 
EU reply:  
In the case of the delegated act in question, the Commission 's internal rules for better regulation 
did not require an impact assessment given that all major policy decisions regarding ILUC have been 
taken already as part of the Renewable Energy Directive which sets all the main requirements for 
the approaches regarding both high  and low ILUC risk fuels. It should also be noted  that the report 
on the status of production expansion of relevant food and feed crops worldwide includes a thorough 
literature review and analysis of the available scientific ev idence on ILUC and production expansion 
of relevant food and feed crops worldwide. This information has allowed for an in -depth assessment 
and comparison of the existing options.  
Regulation (EU) No . 2019/1381 of the European Parliament and of the Council o n the transparency 
and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) 
No. 178/2002, (EC) No . 1829/2003, (EC) No . 1831/2003, (EC) No . 1935/2004, (EC) No . 1331/2008, 
(EC) No . 1107/2009, (EU) No . 2015/2283 and Directive 2001/18/EC (hereinafter, "the Transparency 
Regulation ")140 was the reply of the EU institutions to a European Citizens' Initiative calling for a ban 
on glyphosate.  
In preparation of the Commission proposal that led to the adoption o f the Transparency Regulation, 
the Commission decided not to carry out an impact assessment, given the following 
considerations:141 
 
140 OJ L 231, 6.9.2019, p.1.  
141 See also Roadmap on this legislative initiative and relevant feedback received, to be found at: 
https://ec.europa.eu/info/law/better -regulation/initiatives/ares -2017-6265773 ; See also Explanatory 
Memorandum of the Commission pr oposal, to be found at: https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX:52018PC0179 .  WT/TPR/M/395/Add.1  
 
- 555 - 
 
  • The revision of Regulation (EC) No 178/2008 (General Food Law Regulation) and eight other 
acts was a targeted revision.  
• Duly justified confidential information would continue to be protected in addition to any 
existing intellectual property rights and dat a exclusivity rules - therefore, incentives for 
innovation would remain largely unchanged;  
• The new provisions would mainly concern the transparency and the way that the Commission 
and EFSA gather and manage the evidence needed to perform their tasks, on th e basis of 
unchanged criteria.  
 
The Commission proposal was largely based on evidence collected through extensive consultations 
and data collection activities (including external studies, extensive surveys, case studies and 
workshops as well as in -depth in terviews with relevant stakeholders) in the context of the Fitness 
Check of the General Food law.  
Despite shorter deadlines, all procedural requirements of better regulation were respected: 
publication of the roadmap, feedback to the roadmap, followed by a public consultation in all 
languages to ensure the maximum participation possible.142 It is indicative that the public 
consultation received replies from 471 participants: 318 citizens and 153 stakeholders representing 
a variety of sectors (business associ ations, companies, NGOs, professional associations, 
national/regional authorities, government agencies, research institutes, public bodies professional 
consultancies, law firms etc.).  
Moreover to ensure the largest possible outreach, targeted consultation activities were also carried 
out in parallel, namely with EU -level stakeholder organisations representing farmers, cooperatives, 
the food industry, retailers, consumers, professionals and civil society as well as with the EFSA 
Advisory Forum, the Scientifi c Committee of EFSA and Commission Expert Group on General Food 
law. 
All these consultation activities and the feedback collected are summarised in the Commission's 
synopsis report that accompanied the proposal.143 This feedback has been taken into account i n the 
preparation of the proposal as indicated in the explanatory memorandum.  
 
2.3.2.1 Reciprocal preferences  
Page 40, paragraph 2.29  
 
3. Do regional and preferential agreements restrict  signatories' ability to draft and 
implement TBT and SPS measures?   
 
EU reply:  
Under regional and preferential agreements, signatories keep their ability to draft and implement 
SPS measures and technical regulations in accordance with the SPS and TBT Agreement and any 
other conditions agreed between the parties . 
 
4. Regarding GIs, how do the EU's FTAs assure that there is a meaningful opportunity for 
opposition to GI designations?  
 
EU reply:   
Opposition procedures are not required under TRIPS. As such, opposition procedures are an internal 
policy matter for a coun try and territory. The EU considers that opposition procedures are desirable 
and conducts such a procedure in the course of examining GIs of trade partners whether under 
direct applications or within negotiations of FTA agreements.  
The GI names to be prot ected in the EU are published in the EU Official Journal and any natural or 
legal person having a legitimate interest may lodge an opposition.  
 
5. Is the protection for GIs sought by the EU in third countries the same as that provided 
in the EU?  
 
EU reply:   
The level of protection of GIs provided by EU legislation includes:  
• any direct or indirect commercial use of a name in respect of products not covered by the 
registration;  
 
142 For further information on the consultation activities carried out for the preparation of the 
Commission proposal, see at: https://ec.europa.eu/food/safety/ge neral_food_law/transparency -and-
sustainability -eu-risk-assessment -food-chain_en .  
143 See at: https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:52018SC0097 .  WT/TPR/M/395/Add.1  
 
- 556 - 
 
  • any misuse, imitation or evocation, even if the true origin of the products  or services is 
indicated or if the protected name is translated or accompanied by an expression such as 
"style", "type", "method ", "as produced in ", "imitation " or similar, including when those 
products are used as an ingredient;  
• any other false or misleading indication as to the provenance, origin, nature or essential 
qualities of the product and any other practice liable to mislead the consumer as to the true 
origin of the product.  
 
In the agreements concluded with third country partners, the EU aims at ensuring a level of 
protection similar to the one above while the outcome depends on each negotiation and could involve 
certain adaptations, which take into acco unt the specificities of the other party 's system.  
 
Page 44, paragraph 2.43:  The Secretariat's reports that "Trade between the EU and Switzerland 
is governed by the FTA concluded in 1972, which only covers trade in goods, and approximately 120 
bilateral se ctoral agreements, some of them of trade relevance, notably on agricultural products and 
processed agricultural products."  
 
6. Can the EU explain and share a website link to which bilateral agreements between 
the EU and Switzerland  cover SPS trade requiremen ts?  
 
EU reply:  
SPS issues are partially covered by the bilateral EU -Switzerland agreement on trade in agricultural 
products. Please find below the link to the relevant website and also the references.  
• L114/132   30/04/2002 Agreement  (https://eur -lex.europ a.eu/legal -
content/EN/ALL/?uri=CELEX:22002A0430(04) ) between the European 
Community and the Swiss Confederation on trade in agricultural products  
Amended by:  
L87/31  25.03.2004  (2004/278/EC) Decision No . 1/2004 of the Joint Committee for 
Agriculture  
L301/55  28.09.2004  (2004/660/EC) Decision No . 4/2004 of the Joint Committee for 
Agriculture  
L78/50  24.03.2005  (2005/260/EC) Decision No . 2/2005 of the Joint Committee on 
Agriculture  
L27/21  31.01.2008  (2008/86/EC) Decision No . 1/2008 of the Joint Committee on 
Agriculture  
L136/2  30.05.2009  Agreement between the European Community and the Swiss 
Confederation amending the Agreement between t he European 
Community and the Swiss Confederation on trade in agricultural 
products  
L312/31  27.11.2010  (2010/724/EU) Decision No . 2/2010 of the Joint Committee on 
Agriculture  
L32/9  08.02.2011  (2011/83/EU) Decision No . 1/2010 of the Joint Committee on 
Agriculture  
L27/155  01.02.2017  Decision No . 1/2015 of the Joint Committee on Agriculture of 
19 November 2015 [2017/169]  
Corrected by:  
L142/92  31.05.2002  Corrigendum  
 
7. What is the status of WTO notifications regarding the harmonization of EU -Swiss SPS 
requirements?  
 
EU reply:  
Measures falling under the SPS Agreement are notified by the EU for EU requirements and by 
Switzerland for Swiss requirements. It is the responsi bility of each Member to notify their own 
measures.  
 WT/TPR/M/395/Add.1  
 
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  3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.1 Customs procedures, valuation, and requirements  
 
Page 55, paragraph 3.11:  According to the Secretariat's report, the EU will allow for a new form 
of import declaration for certain low -value consignments using a "reduced data set" starting in 2021.  
 
8. How did the Commission determine which data elements would be included in the 
reduced data set? Sp ecifically:  
a. Did the Commission conduct any consultations with stakeholders specifically to 
identify appropriate data elements?  
 
EU reply:  
The data requirements of the "super reduced dataset " were introduced in July 2019 as an 
amendment to the Annex B of the UCC -DA, in its column H7. The initial text was drafted by the 
Project Group on Low Value Consignments, where Member States ' customs authorities, postal 
operators, express couriers and othe r trader associations acting in the field of e -commerce were 
represented. The Commission carried out consultations on the draft text with Member States through 
meetings of the group of experts (Customs Expert Group), as well as consultations of the busines s 
community through the consultative stakeholder body (Trade Contact Group – TCG) in joint meetings 
with Member States experts.  
Content wise, the super reduced dataset was built on the structure of the ITMATT message, in order 
to allow postal operators to  meet the new requirements. As of 2021, the customs declaration of the 
low value consignments is needed for VAT purposes as such consignments are exempted from 
customs duties. The customs declaration with the super -reduced dataset cannot be used if the goo ds 
in that consignment are subject to prohibitions or restrictions. Pursuant to the new rules for 
e-commerce, where the VAT has been levied under the so -called Import One Stop Shop (IOSS), the 
import customs declaration must indicate the value of the total  goods imported and the individual 
VAT identification number of the supplier. Where the VAT has not been levied under the IOSS, the 
customs declaration must contain enough information to allow the collection of VAT at import.  
 
b. Is any consideration being gi ven to raising the threshold for consignments of 
negligible value above EUR 150?  
 
EU reply:  
The scope of the new VAT e -commerce rules was adapted to the customs de minimis threshold. 
Adjustment to this threshold was not considered at that time. Since any amendment to the customs 
duty exemption threshold would create discrepancy in the VAT and customs rules, the customs 
threshold is not likely to be changed in the short run. Any change to the customs de minimis 
threshold would need to be synchronised wi th a parallel amendment of the VAT Directive as regards 
its provisions concerning the distance sale of goods from third countries.  
In its current data content, the super reduced dataset does not contain sufficient information 
allowing the levy of customs d uties. As the Commission, Member States and traders are investing 
important resources to implement this dataset by 2021, it would require great efforts if it were to 
be updated in the medium term.  
 
Page 56, paragraph 3.15:  The Secretariat's report describe s the EU's recent initiative to expand 
advance rulings to customs valuation.  
 
9. Given that valuation rulings are encouraged under the WTO Trade Facilitation 
Agreement, this is a welcome initiative. What are the next steps in the exploratory 
process once the Customs 2020 Project Group completes its feasibility study this year?  
 
EU reply:  
In accordance with the "better regulation " process and depending on the conclusions of the feasibility 
study, the Commission would assess further the expected and actual impa ct of the introduction of 
an EU system of Binding Valuation Information, before proposing any new rules in this respect.  
 
Page 57, paragraph 3.21 & 3.23:  U.S. companies with operations in the EU are concerned about 
the implications of the 2017 CJEU decisio n referenced in paragraph 3.21 of the Secretariat's report, 
which questions whether transfer prices can be used under the transaction value method of 
valuation.  WT/TPR/M/395/Add.1  
 
- 558 - 
 
  10. Please explain how the EU, and specifically the Commission, plans to address the 2017 
CJEU dec ision? Please also explain how the EU plans to ensure uniformity and clarity 
in the valuation of goods subject to transfer price adjustments across all 28 Member 
States?  
 
EU reply:  
In its judgement in the case C -529/16 the Court of Justice of the European Union confirmed that the 
provisions of the EU customs legislation pertaining to the value of goods for customs purposes do 
not permit an agreed transaction value, composed of an amount initially invoiced and declared and 
a flat-rate adjustment mad e after the end of the accounting period, to form the basis for the customs 
value, without it being possible to know at the end of the accounting period whether that adjustment 
would be made up or down.  
By excluding a flat -rate adjustment of a transaction value, that judgement provides the customs 
authorities and the stakeholders in the EU with a clear interpretation of the provisions in force, thus 
supporting their direct application. Therefore, the Commission does not see the need to take specific 
action in respect of that case, other than disseminating information on it.  
Besides, where the Commission identifies a need for ensuring a correct and uniform application of 
the customs legislation, including the one regarding the customs value of goods, it norm ally works 
with the customs experts of the Member States, and consults representatives of the business 
community, on possible guidance o, where necessary, proposals to improve the applicable rules.  
 
11. Separately, with respect to valuation generally, when wil l the EU notify the UCC's 
revised valuation legislation to the WTO Committee on Customs Valuation?  
 
EU reply:  
The EU is preparing the notification of the UCC's valuation legislation to the Committee on Customs 
Valuation. Moreover, in compliance with the TFA article 1.4 and 1.1.d), all legislation that refers to 
EU customs valuation under the EU Customs Code was no tified to the WTO on 20 July 2017 
(notification amended on 6 March 2018). It is publicly available under the following reference: 
G/TFA/N/EU/1rev1 at https://tfadatabase.org/uploads/notification/NEU1R1_1.pdf . 
 
3.1.6 Anti -dumping, countervailing, and safegu ard measures  
3.1.6.1 Anti -dumping and anti -subsidy measures  
Page 80, paragraph 3.80  
The Secretariat's report seems to indicate that a trade remedy investigation affecting competition in 
air transport can be initiated by "…a member State, an EU airline, an association of EU airlines, or 
by the Commission itself." Regulation (EU) No. 2019/712 of the European Parliament and of the 
Council of 17 April 2019 on safeguarding competition in air transport, and repealing Regulation (EC) 
No. 868/2004 (Regulation Safeg uarding Competition in Air Transport), however, explains that these 
entities may submit a written complaint that would form the basis of a decision by the Commission 
to initiate, or not, an investigation.  
 
12. Could the EU please clarify whether a private ent ity or association can initiate a trade 
remedy investigation that may result in the imposition of redress measures or whether 
initiation of such a proceeding must be an action of the Commission?  
 
EU reply:   
According to Regulation 2019/712, the Commission  will carry an investigation only based on written 
complaint by an EU Member State, one or more Union air carriers or an association of Union air 
carriers as well as on its own initiative.  
 
3.3.1.4 State Aid  
Table 3.14 Non -crisis related state aid, 2013 -17 (pg. 100)  
In table 3.14 the Secretariat noted that in 2017, the EU spent EUR 5,111.8 million on sectorial 
development.  
 
13. Can the EU provide a list of the programs and sectors that received this state aid along 
with detailed information about why the EU pro vided this aid to these programs and 
sectors?  
 WT/TPR/M/395/Add.1  
 
- 559 - 
 
  EU reply:   
Detailed information on all existing State aid measures, for which the Commission has either adopted 
a formal decision or received a summary information sheet from the Member States for measures 
qualifying for exemption under the General Block Exemption Regulation (GBER), is available on DG 
Competition 's website. This information includes the legal basis and a description of co -financed 
schemes under the objective "Sectorial development ". The data is searchable at the level of the 
State aid measure through the Case Search Tool: 
https://ec.europa.eu/competition/elojade/isef/index.cfm . 
 
3.3.2 Standards and technical requirements  
3.3.2.1 New Legislative Framework  
Page 109, Paragraph 3.165 - Harmonized standards:  
 
14. Please describe how harmonized standards designed to meet EU essential 
requirements are developed through transparent procedures, consistent with the Code 
of Good Practice. What opportunities are available for the public, especially 
stakeholders without a domicile in the EU, to fully participate in the development of 
such standards?  
 
EU reply:  
The development of harmonised standards follows the same exact path of any other European 
standards. CEN, CENELEC and ETSI, as well as any European national standar disation body member 
of CEN and CENELEC are listed in the ISO list of standardisation bodies fulfilling the Code of Good 
Practice criteria.  
The standards produced, even if supporting legislation, remain voluntary and are regional, not 
international like I SO or IEC standards.  
The rules of participation to the European standardisation system remain the responsibility of the 
relevant European Standardisation Organisation: in the case of ETSI, for example, membership is 
open and not based on the national dele gation principle as in CEN CENELEC.  
However, even in CEN CENELEC, participation is not limited to European -based stakeholders, as this 
publicly available Q&A document published by CEN CENELEC details: 
ftp://ftp.cencenelec.eu/EN/IntCooperation/AgreementsAn dMoUs/CooperationAgreements/ANSI -
CEN-CENELEC -ETSI_Q%26As_ESS_Updated_July2019.pdf  Question 15, pages 15 -17. 
 
Page, 109, paragraph 3.167 - Goods Package:  
 
15. How will the Goods Package make it easier for companies, especially small and 
medium -sized companies f rom third countries, to sell into the EU market, particularly 
in light of the requirement to have a responsible economic operator on the ground?  
 
EU reply:  
The EU Goods Package has brought forward the adoption of Regulation (EU) 2019/515 on the mutual 
recognition of goods lawfully marketed in another Members State, and (EU) 2019/1020 on market 
surveillance and compliance of products. Both Regulations improve the rules under which products 
can be marketed in the EU by economic operators, including also SME s.  
Regulation (EU) 2019/515 will start to apply on 19 April 2020 and it is a step forward when it comes 
to transparency of decisions taken by the competent authorities of the EU Member States in the area 
of mutual recognition. Decisions by an EU Member St ate restricting or denying market access to 
goods which have been lawfully marketed in other Member States will be notified to the European 
Commission and to other EU Member States through the "information and communication system 
for the pan -European mark et surveillance " (ICSMS). ICSMS will also be used for exchange of 
information among the competent authorities and domestic product contact points, which will 
facilitate their communication in the area of mutual recognition of goods lawfully marketed in oth er 
EU Member States.  
ICSMS is not a new system. It was established by Regulation (EC) No . 765/2008 on accreditation 
and market surveillance, as a general archiving and exchange of information system, on issues 
relating to market surveillance activities, programmes and related information on non -compliance 
with EU harmonization legislation. ICS MS will be adapted to its new role, which is extended by 
Regulation (EU) 2019/515, and will also be used in regard of non -harmonized goods.  
 
Regulation (EU) 2019/1020 provides flexibility to manufacturers (including SMEs) on who can be the 
responsible person to act as contact point for national market surveillance authorities for certain WT/TPR/M/395/Add.1  
 
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  types of products. Manufacturers not established in the E U can appoint an importer or an authorized 
representative, but the responsible person can also be a fulfilment centre in the EU as laid down in 
Article 4 of the Regulation  
Information on compliance with EU product rules will also be made easily accessible to economic 
operators through the new tool laid down in Article 8 of Regulation (EU) 2019/1020. In particular, 
economic operators will have easy online access through the Your Europe portal that provides 
information about EU product requirements. This will  be operational at the end of this year. In 
addition, there will be contact points at Member State level to which further questions on the 
implementation of product requirements can be addressed.  
Further, the Commission will provide guidelines explaining t he practical implementation of Article 4. 
The aim is to publish them in 2020.  
 
Page 109, paragraph 3.168:  Pursuant to the new Regulation 2019/515212, Member States that 
use existing technical regulations to restrict market access for products lawfully mark eted in another 
Member State must justify their position with technical and scientific evidence and must grant the 
economic operators affected an opportunity to provide comments.  
 
16. At what stage of the regulatory process do Member States grant opportunities  to 
provide comments? Is the opportunity to provide comments restricted to those 
economic operators with a presence in the EU or the Member State? If so, why does 
this restriction exist?  
 
EU reply:  
If a competent authority of the Member State of destinatio n intends to assess goods that are subject 
to Regulation (EU) 2019/515, the economic operator concerned must be informed without delay that 
such an assessment has been initiated. In particular, the authority must inform the economic 
operator of: (i) the go ods subject to that assessment; (ii) the applicable national technical rule or 
prior authorization procedure; and (iii) the possibility to supply the authority with a mutual 
recognition declaration, that is a voluntary declaration of lawful marketing of go ods in (an)other 
Member State(s) for the purposes of mutual recognition.  
Regulation (EU) 2019/515 does not contain any criterion or limitation concerning the establishment 
of the economic operator in the EU.  
 
17. How does the EU ensure Member States are following the WTO TBT obligations in 
situations where a Member State attempts to restrict market access for products 
lawfully marketed in another Member State?  
 
EU reply:   
EU Member States are responsible for notifying national technical regulations – adopted in the 
absence of EU harmonization legislation - in accordance with the TBT Agreement through their 
respective TBT Enquiry Points. Moreover, under the Single Market Transparency Directive (Directive 
(EU) 2015/1535), EU Member States are to notify techn ical regulations at a draft stage to the 
European Commission. When notifying under the Directive, EU Member States are to indicate, 
among others, if the draft has a significant impact on international trade. If EU Member States do 
not indicate such aspect,  but the European Commission is of the opinion that the draft is notifiable 
under the TBT Agreement, the European Commission will accordingly inform the concerned EU 
Member State. Committees consisting of EU Member States and the European Commission under 
the Single Market Transparency Directive and for the TBT Agreement also meet at least yearly, 
where this type of issues, among others, are discussed.  
 
Page 110, paragraph 3.170 - Medical Devices Regulation: On page 110, the Secretariat takes 
note of new E U directives and regulations that have become EU law since the last review including 
the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation 
(EU) 2017/746. We are aware that the Medical Devices Regulation is to be  fully implemented by May 
2020 and the In Vitro Diagnostic Medical Device Regulation in May 2022, but there are still several 
implementing regulations that are pending  and that only a handful of notified bodies have been 
approved under the new regulations.   
 
18. Please  update the implementation status of these two regulations?  
 WT/TPR/M/395/Add.1  
 
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  EU reply:   
In the interest of patient safety, there is a political objective to render the strengthened requirements 
of the two Regulations applicable as early as possible. This has led to an extremely short transition 
period for the preparations for this.  
The Commission and Member States are however working closely together to ensure that patient 
access to medical technologies is at the forefront of the implementation and that contin ued access 
to the EU market by WTO members is sustained.  
Following an agreed roadmap, the Commission and Member States give priority to developing 
Implementing acts and guidance that is crucial for rendering the legislation operational. Although 
the new legislation contains about 80 empowerments for different types of implementing acts, only 
a few acts are in fact necessary for rendering the legislation operational.  
 
The most crucial implementing acts have already been adopted and published. In additi on, a notable 
amount of guidance (approximately 30) for industry, notified bodies, and competent authorities has 
been endorsed and published on the Commission 's website. Work on other prioritized documents is 
continuing. Such a step -by-step approach was al so followed for the existing Directives for which 
work on guidance documents was ongoing until very recently.  
As regards notified bodies, important progress has been achieved. Twelve notified body designations 
have been completed with two more expected ear ly February and additional designations are in the 
impending pipeline. In addition, the notified bodies that are currently already designated under the 
Medical Devices Regulations are estimated to hold a significant share of the market (approximately 
more than half of the existing certificates under the Directives). Additionally, most notified bodies 
have increased their resources, some with up to 50 %.).  
 
19. Please provide a detailed explanation of the steps currently being undertaken by the 
EU to ensure that  patients continue to receive the medical devices  they need?  
 
EU reply:  
Specific grace mechanisms to smooth the transition are already foreseen in the legislation; in 
particular, the extension of the validity of certificates issued under the existing leg islation (up to 
May 2024) under certain conditions and the initial exemption of certain devices from the new more 
strict clinical investigation requirements. In addition, the C orrigendum adopted in December 2019 
extends the grace period to certain up -classified Class I devices and will thus significantly alleviate 
pressure on notified bodies.  
Moreover, on duly justified cases, and in the interest of public health or patient health or safety, 
national competent authorities may authorize within its territory the placing on the market of specific 
devices that have not fulfilled the relevant conformity assessment requirements. Under exceptional 
cases, the Commission may decide to extend those national measures to the territory of the Union 
for a limited duration . 
 
Page 110, paragraph 3.174  
This paragraph indicates that "conformity assessment bodies that have been notified by the national 
authorities in their member State of their establishment to provide conformity assessment 
prescribed by EU harmonized legislation are listed in the New Appr oach Notification and Designated 
Organizations (NANDO) information system." However, the report provides no information on how 
bodies not established in the EU can be approved to provide conformity assessment to EU 
requirements.  
 
20. The United States underst ands that bodies not established in the EU cannot be 
approved to provide conformity assessment to EU requirements (except as part of a 
mutual recognition agreement).  If this is the case, please explain why.  
 
EU reply:   
The EU system of notified bodies (i. e. conformity assessment bodies designated as competent to 
assess conformity of products in accordance with EU harmonization legislation) rests on its political 
accountability, with EU Member States taking responsibility towards the other EU Member States 
and the European Commission for the operation and activities of the notified bodies they have 
designated. This is essential to enable the mutual acceptance of certificates within the EU single 
market. It makes the territorial link necessary, as Member Stat es must have full jurisdiction over 
the notified bodies they designate in order to properly fulfil their monitoring and supervision 
obligations.  WT/TPR/M/395/Add.1  
 
- 562 - 
 
  Member States undertake specific obligations towards the European Commission and the other 
Member States regar ding the continued fulfilment of the conditions attached to their designation by 
the notified bodies. This implies, among others, the ability for the Member State concerned to 
perform the necessary checks on their activities, the ability to investigate and  follow -up any 
complaints regarding such activities, or the ability to take measures for the processing of pending 
files where the notified body ceases its activities. Notified bodies must therefore be answerable to 
the competent notifying authorities and come within the jurisdiction of an EU Member State.  
 
Page 111, paragraph 3.177: This paragraph addresses the role of accreditation as the last level 
of public control in the EU's conformity assessment system. The European Commission appointed 
the European Cooperation for Accreditation (EA), an association of Member State accreditation 
bodies, as the official accreditation infrastructure for the EU.  
 
21. Please provide additional information about this system, including:  
a. How does  the Commission exercise oversight over EA?  
 
EU reply:   
EA is the sole body recognised under Regulation (EC) 765/2008 on accreditation and market 
surveillance. In this respect, EA has been appointed by the European Commission to manage the 
official European accreditation infrastructure. This became effective on 1 April 2009 when the 
guidelines for cooperation between the European Commission, EFTA, EA and the competent national 
authorities were signed. These Guidelines set out the principles and objec tives for such a cooperation 
to take place. The European Commission monitors the fulfillment of the provisions of these 
Guidelines by EA.  
Every four years the European Commission and EA sign a Framework Partnership Agreement that 
sets the main objectives E A has to achieve and allows the European Commission to provide yearly 
grants to EA. For very grant, EA submits to the European Commission a work programme. The 
European Commission assesses it and decides on the grant and its amount. Upon positive 
assessmen t of the EA work plan by the European Commission, EA receives a pre -financing. In order 
for EA to be eligible to receive the final financing, it submits to the European Commission a report 
on its activities. The European Commission assesses the report and,  upon positive assessment, EA 
receives the final financing.  
The European Commission is also present in the EA General Assemblies and the sessions of the 
relevant committees and are in continuous contact with the EA secretariat.  
 
b. How can one accreditation b ody per Member State have the resources to capably 
assess all mandatory and voluntary conformity assessment requirements within its 
jurisdiction?  
 
EU reply:   
According to Regulation (EC) No . 765/2008, each Member State shall ensure that its national 
accre ditation body (NAB) has the appropriate financial and personnel resources for the proper 
performance of its tasks.  
NABs, covering the accreditation of conformity assessment bodies for all or most of the conformity 
assessment activities and the supplement r equirements, have all the resources needed. That is 
checked during the EA peer evaluation.  
In this regard, it should be noted that the big NABs in the EU, which cover all/most activities, have 
up to 300 employees plus more than 1000 external assessors.  
 
c. What is the process for the EU to accept accreditations from non -EU accreditation 
bodies that are members of an internationally recognized mutual recognition 
arrangement, such as the International Laboratory Accreditation Cooperation and the 
International Ac creditation Forum?  
 
EU reply:   
The acceptance by public authorities in the EU of accreditation certificates from non -EU accreditation 
bodies that are signatories to mutual recognition arrangements of private organizations, such as 
International Laboratory Accreditation Cooperation or th e International Accreditation Forum, 
requires an EU legal basis. This legal basis may be established through a government -to-government 
agreement, under the conditions agreed therein, or through a legal provision in EU legislation that 
contemplates that ac ceptance.  
 WT/TPR/M/395/Add.1  
 
- 563 - 
 
  3.3.2.2 Institutional framework  
Page 111, paragraph 3.183: We appreciate that some CEN and CENELEC standards are aligned 
with ISO and IEC standards. However, ISO and IEC are not the only standards bodies that develop 
international standards.  
 
22. How does the EU ensure that it is relying on any international standard that is 
consistent with the TBT Committee Decision on international standards?  
 
EU reply:  
For the EU, the TBT Committee Decision is necessary but not sufficient to identify an international 
standard. The principle of national delegation being applied (such in ISO, IEC or ITU) or being a 
treaty organisation (such as UNECE and Codex Alimentarius) are other non -disputable criteria to 
identify an international standard.  
 
3.3.2.4 Sta ndardization and climate change  
Page 112, paragraph 3.189  
 
23. What are the goals of the EU's Strategic Agenda 2019 -2024? Does this agenda replace 
the JIS, which was terminated in June 2019?  
 
EU reply:   
At its meeting in Brussels on 20 June 2019, the European  Council agreed on an agenda for the EU 
for the next five years. "A new strategic agenda 2019 -2024" sets out the priority areas that will 
steer the work of the European Council and provide guidance for the work programmes of other EU 
institutions.  
The stra tegic agenda focuses on four main priorities: -protecting citizens and freedoms -developing 
a strong and vibrant economic base -building a climate -neutral, green, fair and social Europe -
promoting European interests and values on the global stage. It also s ets out how to achieve those 
objectives.  
The Joint Initiative on Standardisation (JIS) consists of a shared vision that supported the 10 Juncker 
Commission priorities, as well as specific actions ending by 2019.  
 
Page 114, paragraph 3.199: The Secretariat' s report describes the EU Strategy on Adaptation to 
Climate Change. The EU also has published overarching plans for the European Green Deal, stating 
that "imported food products from third countries must comply with the EU's environmental 
standards" under the "From Farm to Fork" proposal.  
 
24. Please explain how the EU Strategy on Adaptation to Climate Change is related to the 
European Green Deal?  
 
EU reply:  
The European Green Deal (COM(2019)640), adopted on 11 December 2019, announces in section 
2.1.1. that "the Commission will adopt a new, more ambitious EU strategy on adaptation to climate 
change ", by the end of 2020/beginning of 2021, as indicated in its A nnex.  
 
25. Please explain how these efforts may affect international trade? For example:  
a. What environmental standards  does the EU plan to use as a basis to determine 
compliance for domestic and imported products?  
b. Has the EU consulted domestic and foreign produ cers to determine ability to comply 
with these standards, and, if so, what  were the results?  
c. Does the EU intend to notify proposed standards to the WTO?  
d. Has the EU conducted risk assessments on the effectiveness of various approaches, 
including voluntary approaches that would reward producers for environmental 
stewardship?  
 
EU reply:  
The EU 's agriculture and forestry sectors, and its rural areas, face a significant threat from climate 
change and must continue to adapt to it. Work underpinning th e planned EU Strategy on Adaptation 
to Climate Change will consider a range of possible tools and approaches relevant to those areas 
and sectors. Those tools and approaches may include changes to regulation and to support for 
voluntary action (such as envi ronmental stewardship going beyond mandatory requirements). Both 
the Strategy on Adaptation to Climate Change and the Farm to Fork Strategy will be founded on WT/TPR/M/395/Add.1  
 
- 564 - 
 
  sound analysis and appropriate consultation. Concerning the environmental standards under the 
Farm to Fork Strategy, the European Commission is currently preparing a proposal and it is 
premature to make any statements on the scope of the these standards.  
 
26. The "From Farm to Fork" proposal states "40% of the Common Agricultural Policy  
Should contribute  to climate action."Does the EU intend to increase CAP funding to 
meet these goals or will the EU shift funding from existing programs?  
 
EU reply:  
The proposals for reform of the Common Agricultural Policy adopted by the College of Commissioners 
on 1 June 2018 provide that 40% of its budget addresses climate action. This is linked to the higher 
level of climate and environment ambition required under  the new CAP Strategic Plans to be prepared 
by Member States, in particular through the conditions attached to support (so -called conditionality), 
as well as new 'eco-schemes ' as part of direct support for farmers and agri -environment -climate 
schemes under  the EU 's rural development policy.  
 
3.3.3 Sanitary and Phytosanitary Requirements  
 
Page 116, paragraph 3.214:  Regarding sanitary and phytosanitary measures, the Secretariat's 
report describes new regulations and refers to Table 3.21 Principal SPS legislat ion in the EU in 2019.  
 
27. Please explain how the EU fulfils its directive under Regulation (EC) No. 396/2005 to 
evaluate MRLs and import tolerances on the basis of risk when hazard -based criteria 
established under Regulation (EC) No. 1107/2009 are triggered .  
 
EU reply:  
Regulation (EC) No . 1107/2009 concerning the placing of plant protection products on the market 
stipulates that active substances cannot be approved or renewed if they are classified as 
carcinogenic, genotoxic, or toxic for reproduction foll owing Regulation (EC) No . 1272/2008, or if 
they have endocrine disrupting properties, and if they do not benefit from certain specific derogations 
set in the legislation for a potential restricted approval.  
Regulation (EC) No . 396/2005 on maximum pesticid e residues in food and feed allows for the setting 
of MRLs and import tolerances. This Regulation follows a step -by-step risk assessment approach as 
provided for by Codex Alimentarius and does not address the particular situation of substances 
meeting the above mentioned criteria. Until today, due to the transitional measures of Regulation 
(EC) No . 1107/2009 and the overall delays in the renewal programme for existing active substances, 
the EU does not have yet any experience on MRL and import tolerance set ting for substances falling 
under these criteria.  
 
28. Specifically, please explain how the EU will establish MRLs and import tolerances 
based on risk assessments as stipulated under Regulation (EC) No. 396/2005 in a 
manner that is consistent with Member obli gations under the WTO SPS Agreement?  
 
EU reply:   
Regulation (EC) No 396/2005 requires that maximum residue levels (MRLs) must be safe for 
consumers. Applicants in the EU or applicants for an import tolerance must therefore provide the 
necessary documentation to enable EFSA to assess whether a safe MRL can be set. Following 
submission of this information to a Member State of the EU a thorough two -step risk assessment 
procedure is carried out jointly by the Member States of the EU and the European Food Safety 
Authority (EFSA).  
Import tolerances can be requested and set even for substances that are not approved in the EU 
provided that there is no health risk for consumers. The EU will carefully evaluate each request on 
a case -by-case basis and in lin e with the WTO SPS agreement.  
 
Page 118, para 3.218: The Secretariat Report describes the role of the Standing Committee on 
Plants, Animals, Food and Feed (SCOPAFF) in delivering opinions on draft implementing measures. 
In 2019, the SCOPAFF intended to mov e forward in establishing import tolerances for clothianidin. 
Despite clear evidence that there would be no risk to consumers associated with residues of this 
substance, the European Parliament blocked the standards from being adopted.  
 WT/TPR/M/395/Add.1  
 
- 565 - 
 
  29. Please explain the  processes in place to ensure compliance with the EU's WTO 
obligations in situations where the European Parliament rejects SCOPAFF opinions on 
draft implementing measures.  
 
EU reply:  
EU measures on maximum residue levels follow the so -called regulatory procedure with scrutiny in 
which the European Parliament and the Council have the right to object within a certain time span. 
In March 2019 the European Parliament objected to a draft me asure that proposed to establish an 
import tolerance for clothianidin in potatoes. The measure was therefore not adopted. In the light 
of the EP objection, the Commission is currently reflecting about the further steps to be taken in this 
matter.  
 
Page 11 9, paragraph 3.219:  The Secretariat's report states that the European Food Safety 
Authority (EFSA) is "responsible for risk assessment for food and feed safety, nutrition, animal health 
and welfare, plant protection, and plant health, as well as, through e nvironmental risk assessments, 
the possible impact of the food chain on biodiversity."  
 
30. Please explain the process or criteria used by the Commission when it sets standards 
that are more trade restrictive than existing international standards or more trad e 
restrictive than a finding by the EFSA that is consistent with that of the relevant 
international standard setting body.  
 
EU reply:  
Regulation (EC) No . 178/2002 on General Food Law (hereinafter, the "General Food Law ") 
establishes certain general princ iples underpinning the development of EU food law. The most 
important of these is the risk analysis principle consisting of three separate but interrelated 
components: risk assessment, risk management and risk communication. Risk assessment at EU 
level is carried out by an autonomous agency (EFSA), separately from the EU risk management 
function, exercised mainly by the European Commission (but also by the European Parliament and 
the EU Member States). Risk management decisions are to take into account the results of the risk 
assessment (EFSA 's scientific output) but also other legitimate factors.  
 
As laid down in the Fitness Check of the General Food Law (a comprehensive policy evaluation of 
this Regulation can be found at: 
https://ec.europa.eu/food/safety/ general_food_law/fitness_check_en ), the EU has made 
considerable efforts to ensure alignment of EU food law with international standards, following its 
introduction in 2002. This is also reflected in other EU secondary food legislation, where specific 
reference to international standards in the development of food law is made; as a consequence, 
adaptation of EU law takes place in line with international standards. There are few cases, however, 
where EU measures are stricter than the international standards established.  
 
Where EU measures are more trade -restricting than the EU risk assessment delivered by EFSA that 
is consistent with international standards, this is because EU risk managers considered appropriate 
that other legitimate factors had also to be c onsidered in addition to the EU risk assessment findings. 
This is part of the risk management process as outlined in Regulation (EC) No . 178/2002 on General 
Food Law.144 In the absence of an exhaustive list of legitimate factors in the General Food Law 
Regul ation, the EU risk managers have in the past considered as legitimate factors nutritional 
advantages and disadvantages, societal factors, ethical considerations, impact on non -
communicable diseases (e.g. obesity), lack of mitigation measures, animal welfar e as well as 
economic factors. The use of legitimate factors in the EU decision -making process is not static; the 
exact range of factors and the weight attributed to them varies on a case -by-case basis depending 
on the subject matter and the measure concer ned. 
 
 
144 Article 6(3) of Regulation (EC) No. 178/2002 of the European Parliament and of the Council  of 
28 January 2002 laying down the general principles and requirements of food law, establishing the European 
Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). See also 
recital (19) of the same Regulatio n which states the following: "[i]t is recognised that scientific risk assessment 
alone cannot, in some cases, provide all the information on which a risk management decision should be 
based, and that other factors relevant tot eh matter under consideratio n should legitimately be taken into 
account including, societal, economic, traditional , ethical and environmental factors and the feasibility of 
controls.  WT/TPR/M/395/Add.1  
 
- 566 - 
 
  Where the EU risk management decisions departed from the EU risk assessment delivered by EFSA, 
an explicit justification to that effect was systematically included in the preamble to those decisions. 
As far as the application of legitimate factors in the a rea of food law is concerned, the Court of 
Justice of the European Union also recognised that "[i]n some cases, scientific risk assessment alone 
cannot provide all the information on which a risk management decision should be based, and other 
legitimate fa ctors relevant to the matter under consideration should therefore be taken into account. 
In the light of the foregoing, the Commission must be recognised as enjoying a broad discretion in 
an area which entails political, economic and social choices on its part, and in which it is called upon 
to undertake complex assessments. "145 
 
Page 119, paragraph 3.221 : The Secretariat's report states, "… to a large extent, SPS measures 
in the EU have been harmonized, and most measures are taken at the EU level. Nonetheless, 
member States may, and sometimes do, take specific measures in the absence of harmonized EU 
requirements."  
 
31. How does the EU address Member State legislation that runs counter to its own 
established , harmonized rules (for example, France's measure banning cherries from 
countries that allow for the use of dimethoate, despite dimethoate having been 
allowed for use on cherries in the EU at the  
time) ?  
 
EU reply:  
According to EU rules, Member States are allowed to adopt national MRLs in very limited 
circumstances, e.g. if they have a serious health concern. Member States are obliged to notify any 
such m easure to the European Commission and the other Member States. The Commission, together 
with the EU Member States, assesses whether the conditions for taking such measures are fulfilled 
and whether harmonised action at EU level is needed. In the case of di methoate/omethoate the 
Commission acknowledged the serious health concerns raised by a Member State and proposed to 
follow -up in the already ongoing renewal of approval procedure of dimethoate. Due to serious health 
risks dimethoate was not renewed in 2019  and the EU is currently in the process to also lower the 
existing maximum residue levels for cherries to the limit of quantification.  
 
32. Please explain the criteria Member States use when setting or amending standards 
that are a higher level of sanitary an d phytosanitary protection than both EU and 
international standards. What is the EU policy regarding ensuring that Member States  
notify such measures to the WTO?  
 
EU reply:  
According to EU rules, Member States are allowed to adopt national MRLs in very l imited 
circumstances, e.g. if they have a serious health concern, on the basis of the information available 
to them. Member States are obliged to notify any such measure to the European Commission and 
the other Member States. The Commission, together with the EU Member States, assesses whether 
the conditions for taking such measures are fulfilled and whether harmonised action at EU level is 
needed. The measures are notified to the WTO via the EU SPS contact point.  
 
33. Please explain the formal process by which  a trading partner can raise concerns about 
Member States that implement SPS measures differently. Specifically, please explain 
the process by which a trading partner can raise concerns about Member States that 
implement different procedures for the accept ance of SPS certificates for food 
products imported into the EU.  
 
EU reply:  
Trading partners should address their concerns to the relevant European Commission service (DG 
Health and Food Safety) in case EU Member States ' measures are deemed not to be in compliance 
with the SPS Agreement.  
 
3.3.3.1 Plants and Plant Products  
Page 119, paragraph 3.224: According to the Secretariat's report, "[Regulation (EU) 2016/2031] 
also introduces a new concept of "high risk plants, plant products and other objects ", whose import 
 
145 Judgment of 16 March 2016 in Dextro Energy GmbH & Co. KG v European Commission, T -100/15, 
EU:T:20 16:150, at paragraph 30 and the case -law cited  WT/TPR/M/395/Add.1  
 
- 567 - 
 
  would be prohibited until a thorough risk assessment is carried out. Temporary import re strictions 
could be introduced if there is insufficient experience in terms of trade, or if the risks are still 
unknown."  
 
34. Many exporters of products newly considered "high risk" have expressed concern  that 
long-term, acceptable  prior trade may not be cons idered and trade may be stopped 
because of this classification. Risk assessments can take over a year to complete, and 
the number of affected plants could mean a backlog of required assessments. What 
does the EU consider sufficient experience in terms of t rade to allow trade to continue 
while the risk assessments are carried out?   
 
EU reply:  
The criteria for classifying a plant as high -risk as set out in Annex III of Regulation (EU) 2016/2031 
and those criteria do not include experience in terms of safe trade. According to the legal basis 
(Article 42 of Regulation (EU) 2016/2031) once a plant is listed as high -risk its import is temporarily 
banned until a thorough risk assessment has been carried out. There is a possibility for any third 
country to s ubmit a dossier of a specific commodity for a risk assessment, based on which the EU 
will decide if and under which conditions the specific commodity from the specific country can be 
imported. There is no possibility for imports to resume before this proce ss is finalised. Nevertheless, 
a one -year transitional period has been established for allowing the evaluation process to start up 
before the entry into application of the new provisions.  
 
Page 119, paragraph 3.225:  Per the Secretariat's report, as of Dece mber 14, all plants will need 
to be accompanied by a phytosanitary certificate unless listed in Commission Implementing 
Regulation 2018/2019. Currently the list of exempted plants are the following: pineapples, coconuts,  
durians, bananas and dates.  However , the United States has received reports that tree nuts and 
some categories of grain are also exempt.  
 
35. Can you confirm the list in Regulation 2018/2019 is a complete list of exempted 
plants? If not, please provide an up -to-date exemption list or a comprehensive list of 
what plants will need to be accompanied by a phytosanitary certificate to enter the 
EU.  
 
EU rep ly:  
Since 14 December 2019, with the entry into force of Regulation (EU) 2016/2031, all live plant 
material needs to be accompanied by a Phytosanitary Certificate except from the five plants 
mentioned above.  
The reports that the United States is referring  to regarding tree nuts and grains do not relate to 
exemptions but to plants or plant products that do not fall under the scope of the Regulation 
according to the definitions given in Article 2 of that Regulation.  
 
36. What is the process for expansion of the current list of products that do not need a 
certificate?  
 
EU reply:  
The process for expansion of the current list is laid down in Article 73 of regulation (EU) 2016/2031. 
According to that article, where an assessment, based on evidence about pest risks and experience 
with trade, demonstrates that such a certificate is not necessary, the Commission can adopt an 
implementing act. That assessment takes into account the criteria set out in Annex VI of that 
Regulation.  
 
Page 119, paragraph 3.226:  The Secretar iat's report states that (EC) No. 2016/2031 includes 
measures to tackle pests from outside the EU under which the Commission will be able to implement 
precautionary measures for emerging risks from plants coming from certain non -EU countries. To 
accomplish  this, the Commission Implementing Regulation 2018/2019 has created a category for 
"high risk" plants that would pose risks at "unacceptable levels for the EU."  
 
37. Does the EU intend to notify its designation of particular plants or plant products as 
"high risk" to the WTO?  
 WT/TPR/M/395/Add.1  
 
- 568 - 
 
  EU reply:  
The draft Commission Implementing Regulation "establishing a provisional list of high -risk plants, 
plant products or other objects, within the meaning of Article 42 of Regulation (EU) 2016/2031 " was 
notified to the WTO on 26 September 2018 (G/SPS/N/EU/272). This implementing regulation 
includes the list of plants, plant products or other objects that have been concluded to qualify as 
"high risk " according to the preliminary assessment set out in Annex III of Regulation (EU) 
2016/2031. The final Commission Implementing Regulation was notified to the WTO on 
8 January  2019.  
 
Three addenda to this notification have since been notified to the WTO, concerning:  
1) Information required for dossiers to support demands for import of high -risk plants, plant 
products and other objects as foreseen in Article 42 of Regulation (EU) 2016/ 2031;  
2) High risk plants and plants exempted from phytosanitary certificate;  
3) Procedures to Carry Out the Risk Assessment of Plants Listed as High -Risk Plants  
 
38. Will exporters be alerted if a product has been listed as "unacceptable"?  
 
EU reply:  
The country submitting the dossier will be notified if their product has been considered unacceptable 
and the relevant decision will be published in the European Union 's Official Journal.  
 
39. Is there a provision to allow for regionalization and continue flow of goods?  
 
EU reply:  
According to Article 42 of Regulation (EU) 2016/2031, the ban can also refer to a third country, a 
group of third countries, or specific areas within a third country. For example, the ban on the plants 
for planting that are in the curre nt list of high -risk plants concerns all third countries. On the other 
hand, for Momordica charantia  and wood of Ulmus, countries or areas of countries that  are free from 
the pests Thirps palmi  and Saperda tridentata, respectively, can export to the EU.  
 
Page 120, paragraph 3.227 : The report notes that the list of products and exporting countries 
subject to additional controls is reviewed quarterly.  
 
40. What criteria will the EU develop to list or de -list products and exporting countries 
subject to additional  control?  
 
EU reply:  
The relevant regulation is set out in the Commission Implementing Regulation (EU) 2019/1793 of 
22 October 2019 on the temporary increase of official controls and emergency measures governing 
the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 
2017/625 (OCR) and (EC) No . 178/2002 of the European Parliament and of the Council. This new 
regulation replaced Commission Regulation (EC) No . 669/2009, which was repealed.  
 
The Commission, assisted by the Member States and acting in accordance with Article 47(2)(b) of 
the Official Controls Regulation (OCR) and Article 53(1)(b) of Regulation (EC) No . 178/2002, may 
decide to subject a product to an increased level of official contr ols or to an emergency measure. 
The list of such goods is laid down in Annexes I and II to Regulation (EU) 2019/1793. The EU 
regularly reviews these lists following an evidence -based process that uses new information related 
to risks and non -compliance, su ch as the data resulting from notifications received through the Rapid 
Alert System for Food and Feed (RASFF), data and information concerning consignments and the 
results of the documentary, identity and physical checks communicated by the Member States t o 
the Commission, reports and information received from third countries, information resulting from 
the controls carried out by the Commission in third countries and information exchanged between 
the Commission and Member States and between the Commission and the European Food Safety 
Authority. Part of this information is collected through IMSOC (Commission Implementing Regulation 
(EU) 2019/1715 lays down rules for the functioning of the information management system for 
official controls and its system com ponents ( "the IMSOC Regulation ")). 
 
3.3.3.2 Live animals and animal products  
Page 121, paragraph 3.232: The Secretariat states that an establishment in a third country that 
would like to export to the EU must be added to the list of eligible exporters.  
 WT/TPR/M/395/Add.1  
 
- 569 - 
 
  41. Please explain what animal products, if any, are not required to be on an eligible 
establishment list.  
 
EU reply:  
Article 5(1) of COMMISSION DELEGATED REGULATION (EU) 2019/625 lays down the Requirements 
for entry into the Union of certain goods from a thir d country in relation to establishments. Article 6 
of the same regulation deals with establishments not subject to the requirements of Article 5(1). 
The regulation is available at: https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32019R0625&qi d=1579854734888&from=EN . 
 
Page 121, paragraph 3.233:  The Secretariat Report describes the certification requirements for 
imports of live animals and animal products into the EU, and the official controls carried out by 
Border Inspection Post. The Report further notes that, depending on the risks associated with the 
animal product concerned, physical checks may be reduced.  
 
42. Please provide illustrative examples and the relevant criteria whereby physical checks 
might be reduced.  
 
EU reply:  
The system of determining the frequency of identity and physical check s on consignments of live 
animals and animal products entering the Union has been established in Commission Implementing 
Regulation (EU) 2019/2129. That Regulation establishes baseline frequency rates for the identity 
checks and physical checks performed o n animals and products of animal origin, germinal products, 
animal by -products, derived products, hay and straw and composite products. The baseline 
frequency rates are established taking into account information regarding the risks associated with 
the cat egories of animals or goods (where e.g. fresh meat is considered more risky than canned 
tuna) and available scientific assessments.  
 
The Implementing Regulation (EU) 2019/2129 also establishes a system for the increase of the 
frequency rates for physical c hecks for specific goods from a specific third country based on 
information collected by the Commission from third countries in accordance with Article 125(1) of 
the OCR, on the outcome of controls performed by Commission experts in third countries in 
accordance with Article 120(1) of that Regulation and on information collected on non -compliances 
in the IMSOC system.  
 
The frequency of documentary, identity and physical checks on specific goods from a specific third 
country may be reduced via Implementing R egulations adopted by the Commission in accordance 
with Article 129 of the OCR, concerning the recognition of equivalency for a certain third country.  
Finally, for certain third countries with which the Union has concluded veterinary agreements on 
equival ency, the frequency of physical checks on certain products is reduced, taking into account, 
inter alia , the application of the regionalization principle in the case of animal disease, and of other 
veterinary principles. Therefore, the frequency rates for p hysical checks specified in these veterinary 
agreements apply for the purpose of Implementing Regulation (EU) 2019/2129.  
 
Page 121, paragraph 3.235:  The Secretariat's Report states that when a recurrent problem has 
been identified with a specific animal pr oduct from a third country, special import conditions may be 
applied, such as reinforced testing or pre -export testing in the country of origin.  
 
43. If special import conditions are applied, how does the EU notify those conditions?  
 
EU reply:  
Emergency measures governing the entry into the Union for placing on the market of food and feed 
of animal origin from certain third countries are adopted by the Commission in accordance with 
Article 53(1)(b) of Regulation (EC) 178/2002. Depending on the g ravity of the situation, such 
measures can range from a suspension of imports from all or part of the third country concerned to 
special conditions for the import of the food or feed in question, such as pre -export testing and 
certification in the country of origin and increased testing at Union borders. In cases other than 
those referred to in Article 53 of Regulation (EC) 178/2002, special measures governing the entry 
into the Union of certain animals and goods can be adopted by the Commission in accordan ce with 
Article 128 of the OCR.  
 WT/TPR/M/395/Add.1  
 
- 570 - 
 
  The aforementioned emergency measures are notified to the third country concerned in accordance 
with the WTO SPS Agreement rules, mostly in the form of emergency notifications. Moreover, these 
measures are notified to the c ompetent authorities of the third country via the normal bilateral 
channel of communication between the European Commission and the concerned third country. Via 
EU Delegations located in the third country concerned. In addition, if needed an urgent meeting  is 
organised between the EU and the diplomatic services of the third country concerned in view mto 
pre-notify this emergency measure.  
 
44. Is there a process to request those conditions be repealed or rescinded?  
 
EU reply:  
The competent authorities of the concerned third country can always provide information to the 
European Commission concerning the relevance of the concerned EU special SPS measures and 
possibly request their repeal via the very well established channel of communication with the 
European Commission on SPS issues. It can be done via the EU delegations located in the third 
country concerned and/or via a meeting organized in Brussels between the EU and the third country 
concerned.  
 
In addition, the European Commission normal ly carries out a control in the concerned third country 
in accordance with Article 120 of the OCR in order to evaluate if the competent authorities adopt 
and implement appropriate measures to remedy the situation. The control reports may make 
recommendatio ns to assist the competent authorities of the third country in taking corrective 
measures (Article 122 of the OCR) and these authorities are also invited to comment on the said 
report. The actions taken are followed up either administratively, in general f ollow-up audits in the 
third country, or by on -the-spot audits.  
 
45. Are there specific criteria that must be met before the special import conditions are 
applied? Does the EU publicize such criteria and if so, where?  
 
EU reply:  
Pursuant to Article 53(1)(b) of Regulation (EC) No . 178/2002 and Article 128 of the OCR, the decision 
to subject a product from a third country to an emergency measure or to a special measure is taken 
by the Commission assisted by the Member States. The approach followed is evidence -based and is 
using information related to risks and non -compliance, such as the data resulting from notifications 
received through the Rapid Alert System for Food and Feed (RASFF), data and information 
concerning consignments and the results of the document ary, identity and physical checks 
communicated by the Member States to the Commission, information received from third countries, 
information resulting from the controls carried out by the Commission in third countries.  
 
3.3.3.3 Rapid Alert System for Food  and Feed (RASFF)  
Page 121, paragraph 3.236:  The Secretariat states that the Rapid Alert System for Food and Feed 
(RASFF) allows food and feed authorities of the Member States and the Commission to exchange 
information about measures taken in response to d irect and indirect risks to human health from 
food, and human and animal health and the environment from feed. Member States notify risks 
detected in products already on the market (market notifications) and when products are refused 
entry into the EU (bor der rejections).  
 
46. Which entities are notified when a product is refused entry (for example, the exporter; 
the competent authority of the exporting country; another entity)? Is there an appeal 
mechanism if the exporter believes the product was in complianc e with EU 
requirements or regulations?  
 
EU reply:  
When a RAFF notification is triggered the EU notifies the RASFF contact point of the concerned third 
country. The RASFF contact point is designated by the third country and it is a competent authority.  
The RASFF contact point in the US (the FDA Office of Crisis Management) and the US Embassy in 
Brussels are notified systematically on each RASFF notification related to the US, with all the data 
and documents available, and also requested to give feedback.  There were more than 50 feedback 
messages received from the US RASFF contact point during last year, although they were mainly 
related to the same product category (nut product), therefore, on other types of product, feedback 
from the US authorities is of ten lacking.  
 WT/TPR/M/395/Add.1  
 
- 571 - 
 
  On the right of appeal, Article 7 of REGULATION (EU) 2017/625 of the European Parliament and of 
the Council of 15 March 2017 on official controls and other official activities performed to ensure the 
application of food and feed law, rules on  animal health and welfare, plant health and plant protection 
products, which entered into force last 14/Dec/2019, provides for such right of appeal.  
 
Page 121, paragraph 3.237: The report notes that there was a significant rise in the notifications 
transm itted through the RASFF, notably in alert notifications.  
 
47. Does the EU require Member States to submit notifications to RASFF where products 
are still under the company's control (and which therefore would not require rapid 
action by a competent authority)?  
 
EU reply:  
Article 50 of the General Food Law: "Where a  member of the network has any information relating 
to the existence of a serious direct or indirect risk to human health deriving from food or feed, this 
information shall be immediately notified to the Commission under the rapid alert system. " When a 
product is still under the control of the producer, routinely such information is not required through 
RASFF, unless it could have consequences elsewhere.  
 
48. How does the EU ensure the accuracy of information in RASFF regarding the source of 
contamination versu s country of origin of products (for example, for transshipped 
products, or for product contamination that occurs after entry into the EU)?  
 
EU reply:  
The source of the contamination and the origin of the product are different and should not be 
confused.  The RASFF notification does not systematically identify the source of the contamination. 
The source of the contamination often cannot be identified with certainty. However the RASFF 
notification should provide information on traceability of the product(s)  concerned including their 
origin. The source of the contamination however is not always identical to the origin of the product 
and it is never implied that it is. Nevertheless investigations and appropriate measures are usually 
necessary at the (country o f) origin of the product.  
 
3.3.3.4 SPS Committee in the WTO  
 
Page 122, paragraph 3.238:  The Secretariat states that the EU and each Member State have 
notified enquiry points under the SPS Agreement. The Directorate -General for Health and Food 
Safety (DG SA NTE) of the European Commission is the EU notification authority.  
 
49. Please clarify who has the obligation to notify a measure to the WTO under the 
following different scenarios:  
a. Where a  Member State adopts a measure that is a higher level of sanitary and 
phytosanitary protection than that set by the Commission;  
b. Where an EU harmonized standard has not been set, but a  Member State has 
determined the need for such a standard.  
 
50. For either of these scenarios, does the EU require the Member State to justify why it 
is deviating from the EU harmonized standard or EU practices?  
 
EU reply (49, 50):  
Measures taken by EU Member States are notified by the EU notification authority both in case of 
non harmonized standards and when seeking a higher level of protection. Regarding the latter, these 
measures are being discussed between the Commission and the EU Member States within the 
relevant regulatory committees and the Mem ber State in question needs to justify its decision to 
apply stricter standards than the EU.  
 
Page 122, paragraph 3.240 -241: The Secretariat's report notes several interventions in the SPS 
Committee (as well as in the TBT Committee (page 115, paragraph 3.2 10)) regarding the EU's 
pesticide policies, among other specific trade concerns. Given the high level of concern expressed 
by WTO Members, has the EU considered revising its pesticide policies? Specifically:   
 
51. Will the EU notify draft decisions regarding p esticide registration to the TBT Committee 
and MRL draft decisions to the SPS Committee at a time when comments can be taken WT/TPR/M/395/Add.1  
 
- 572 - 
 
  into consideration and decisions adjusted based on feedback or additional data from 
trading partners?  
 
EU reply:  
Yes, as announce d at the SPS Committee, the EU will notify draft decisions on pesticide 
authorisations both to the TBT and SPS Committee.  
 
52. Will the EU maintain existing MRLs while applications for import tolerances (ITs) 
are being evaluated and until ITs can be establishe d?  
Many products continue to circulate in channels of trade for years after planting and 
harvest, such as products with long shelf life (for example, dried fruits and nuts), 
processed products such as chocolate, or products with lengthy processing times s uch as 
wine. Further, some ingredients, such as hops and grains, may be stored for lengthy 
periods prior to processing.  
 
53. Will the EU maintain MRLs to allow for such products to clear the channels of trade?  
 
EU reply (52, 53):  
Following Article 49 of Regulation (EC) No . 396/2005, transitional measures may be laid down for 
the implementation of certain MRLs, but those measures shall be without prejudice to the obligation 
to ensure a high level of consumer protection. As a general rule transition measure s are provided. 
Such measures allow products present on the EU market before a certain date to remain on the 
market until the end of their shelf life, even after the date of application of the new MRLs, which is 
six months after the date of entry into forc e of the Regulation. However, when a health concern is 
identified, such transition measures are not provided and the new MRLs apply six months after the 
entry into force of the Regulation.  
 
It should be reminded that early warnings are available and can in form interested parties on coming 
Regulations. As an example, TBT notifications on the non -renewal of approval for an active substance 
are accompanied by a statement indicating the possible impact on MRLs. Recent examples have 
shown that 2 years could elap se between such notifications and the application of the lowered MRLs. 
We are however reflecting on how further improve our notification procedures to make sure that 
WTO members are informed well in advance of any changes in the EU legislation on plant pro tection 
products.  
 
3.3.6 Government procurement  
 
Page 135, Paragraph 3.283: The Secretariat's report notes that one Member State has yet to 
finish transposing the Concessions Directive and Utilities Directive into its national legislation.  
 
54. Please identify which Member State this is referring to and identify the estimated date 
by which the transposition of the Concessions and Utilities Directives will be completed 
for this Member State.  
 
EU reply:  
Spain is the only remaining Member State that has yet to finish transposing the Concessions 
Directive and Utilities Directive into it s national legislation. The European Commission has taken the 
necessary steps foreseen in the EU legal system in order to address the late transposition.  
 
Page 136, Paragraph 3.285: The Secretariat's report notes that "cross -border procurement (direct 
and indirect) has increased in recent years, to around 23% of the total value of procurement in the 
EU." Footnote 339 references an EU report that repeats these figures for direct and indirect cross -
border procurement.   
 
55. The report in footnote 339 mentions a Commission study . Please identify whether or 
not this report is public and, if so, where the study can be found. If the study has not 
been made public, please identify the methodology used to determine the figures for 
direct and indirect cross -border procu rement.  
 
EU reply:  
The final report of the study "Measurement of impact of cross -border penetration in public 
procurement" is available on the website of the EU Publications Office at WT/TPR/M/395/Add.1  
 
- 573 - 
 
  https://op.europa.eu/en/publication -detail/ -/publication/5c148423 -39e2-11e7-a08e-
01aa75ed71a1 . 
 
Page 137, Paragraph 3.293: Box 3.3 of the Secretariat's report highlights strategic priorities for 
the EU in government procurement. Box 3.3 indicates that the EU has set a priority for increasing 
SME participation in government procurement.  
 
56. With respect to the information reported in Box 3.3, please explain what is meant by 
"business intermediaries" and "innovation brokers" when it comes to increasing SME 
participation in government procurement.  
 
EU reply :  
"Business intermediaries " encompass entities working with SMEs and providing support for their 
participation in public procurement, for instance: chambers of commerce, business federations, 
clusters.  
"Innovation brokers " in public procurement are entities addressing gaps in the re lationship between 
public buyers interested in purchasing innovative solutions, and innovative small and medium -sized 
enterprises, especially start -ups. Brokers proactively create and facilitate such links.  
 
Page 141, Paragraph 3.303: The Secretariat's rep ort notes that the contracting authorities may 
divide procurements into lots and further explains that if the total value of the lots is above the EU 
thresholds, then the procurement must be subject to EU rules. The Secretariat's report further notes 
that this does not apply to small lots below a certain level.  
 
57. Please provide the guidance that is provided to contracting authorities on how to 
determine when contracts should be divided into lots and how to divide the contract.  
 
EU reply :  
The division into lots is regulated by Article 46 of Directive 2014/24/EU on public procurement, with 
additional clarifications provided by recitals 78 and 79 of the same act. Similar provisions can be 
found in Directive 2014/25/EU on utilities.  
 
58. For lots that  are below the provided de minimis level in the Secretariat's report, please 
confirm whether a contracting authority needs to follow the procurement directives 
where the total value of the de minimis lots is no more than 20% of the total value of 
the procu rement.  
 
EU reply :  
According to Article 5, paragraphs 8 and 9 of Directive 2014/24/EU, where a proposed work, a 
proposed provision of services or a proposed acquisition of supplies may result in contracts being 
awarded in the form of separate lots, accou nt shall be taken of the total estimated value of all such 
lots. Where the aggregate value of the lots is equal to or exceeds the applicable thresholds laid down 
in Article 4 of the same act, the provisions of the directive shall apply to the awarding of e ach lot.  
According to Article 5, paragraph 10 of Directive 2014/24/EU, "contracting authorities may award 
contracts for individual lots without applying the procedures provided for under this Directive, 
provided that the estimated value net of VAT of the l ot concerned is less than EUR 80 000 for supplies 
or services or EUR 1 million for works. However, the aggregate value of the lots thus awarded without 
applying this Directive shall not exceed 20% of the aggregate value of all the lots into which the 
propo sed work, the proposed acquisition of similar supplies or the proposed provision of services 
has been divided. " 
Equivalent provisions can be found in Article 16 of Directive 2014/25/EU on utilities.  
 
3.3.7 Intellectual property rights  
3.3.7.1 Copyright and  related rights  
 
Page 146, paragraph 3.328:  The Secretariat's report notes that the Directive on Copyright in the 
Digital Single Market includes a number of exceptions and limitations to copyright and related rights 
for certain uses.  
 
59. Please describe all of the exceptions and limitations to copyright and related rights for 
certain uses and what exclusive rights are subject to these exceptions.  
 WT/TPR/M/395/Add.1  
 
- 574 - 
 
  EU reply:  
The new Directive requires Member States to introduce four mandatory exceptions in order to adapt 
existing EU law to digital developments and cross -border uses in certain areas: text and data mining 
(TDM) for research purposes; a general TDM exception for other purposes; teaching and educational 
purposes; preservation of cultural heritage.  
Article 3 introduces an exception for TDM, for the purposes of scientific research, to the rights 
provided for in Article 5(a) and Article 7(1) of Directive 96/9/EC, Article 2 of Directive 2001/29/EC, 
and Article 15(1) of the Directive on Copyright in the Digita l Single Market (Directive (EU) 2019/790). 
An additional exception for TDM (Article 4) for other users covers TDM going beyond the area of 
research; it applies to the rights provided for in Article 5(a) and Article 7(1) of Directive 96/9/EC, 
Article 2 of D irective 2001/29/EC, Article 4(1)(a) and (b) of Directive 2009/24/EC and Article 15(1) 
of Directive (EU) 2019/790. The new teaching exception for educational establishments and teachers 
(Article 5) covers digital cross -border uses of content protected by c opyright for the purposes of 
illustration for teaching, including online. Article 5 provides an exception to the rights provided for 
in Article 5(a), (b), (d) and (e) and Article 7(1) of Directive 96/9/EC, Articles 2 and 3 of Directive 
2001/29/EC, Article 4(1) of Directive 2009/24/EC and Article 15(1) of Directive (EU) 2019/790. 
Article 6 provides for an exception to the rights provided for in Article 5(a) and Article 7(1) of 
Directive 96/9/EC, Article 2 of Directive 2001/29/EC, Article 4(1)(a) of Directive  2009/24/EC and 
Article 15(1) of Directive (EU) 2019/790, for the purpose of preservation of works in the permanent 
collections of cultural heritage institutions.  
 
Page 147, paragraph 3.329:  The Secretariat's report notes that the Directive on Copyright in  the 
Digital Single Market contains measures to improve licensing practices.  
 
60. Please provide a brief summary of any measures related to improving licensing 
practices that are not described in the Secretariat's report.  
 
EU reply:   
All the measures aiming at improving licensing practices and ensuring wider access to content 
included in Directive (EU) 2019/790 are referred to in the Secretariat 's Report. Title III of Directive 
(EU) 2019/790 includes provisions related to out -of-commerce works and other subje ct matters 
(Articles 8 -11); collective licensing with an extended effect (Article 12); access to, and availability 
of, audiovisual works on video -on-demand platforms (negotiation mechanism) (Article 13); and 
works of visual art (Article 14).  
 
Page 147, par agraph 3.330:  The Secretariat's report notes that the Directive on Copyright in the 
Digital Single Market introduces new measures to achieve a well -functioning marketplace.  
 
61. Please describe what measures have been introduced and what exclusive rights they  
affect, if any.  
 
EU reply:   
Article 15 requires MS to introduce a new right for press publishers established in a MS in relation 
to the online use of their press publications by information society service providers. Press publishers 
will benefit from th e rights provided for in Article 2 and Article 3(2) of Directive 2001/29/EC for such 
uses.  
 
According to Article 17, MS are required to provide that online content -sharing services covered by 
the new rules perform an act of communication or making availab le to the public, for which they 
need to obtain an authorisation from the right holders concerned. Article 17 provides that where an 
authorisation is obtained, for instance by concluding a licence agreement, it shall also cover the acts 
carried out by user s of the services, under certain conditions. In situations where no authorisation 
is granted the online content sharing service provider will need to take certain actions in order to 
avoid liability for unauthorised uses of content. In particular, where th ey meet the conditions in 
Article 17(4), they will not be liable. The conditions are: (i) demonstrating best efforts to obtain an 
authorisation, (ii) demonstrating best efforts to ensure the unavailability of unauthorised content, 
regarding which right hol ders have provided necessary and relevant information and (iii) acting 
expeditiously to remove any notified works following a notice received, and making also their best 
efforts to prevent future uploads. Article 17 also provides for a number of safeguards  for users, 
through mandatory exceptions and a complaint and redress mechanism in case of disputes on the 
removal of content uploaded by users.  
 WT/TPR/M/395/Add.1  
 
- 575 - 
 
  Articles 18 to 23 contain five measures related to the remuneration of authors and performers: A 
principle of appropriate and proportionate remuneration for authors and performers (Article 18); a 
transparency obligation to facilitate access for authors and  performers to more information about 
the exploitation of their works and performances (Article 19); a contract adjustment mechanism to 
allow authors and performers to claim additional, appropriate and fair remuneration when the 
remuneration originally agr eed becomes disproportionately low compared to the success of their 
work or performance (Article 20); an alternative dispute resolution procedure for authors and 
performers (Article 21); and a mechanism for the revocation of rights allowing creators to tak e back 
their rights where there is a lack of exploitation of their works (Article 22).  
 
62. Regarding the rights of publishers of press publications, please describe how this 
protection affects existing rights held by publishers (for example, via compilation a s 
this covers a "collection of literary works"; as an employer; or as a transfer of rights).  
 
EU reply:   
Article 15(2) of Directive (EU) 2019/790 provides that "The rights provided for in paragraph 1 [the 
press publishers ' rights] shall leave intact and shall in no way affect any rights provided for in Union 
law to authors and other rightholders, in respect of the works and other subject matter incorporated 
in a press publication. "  
 
63. Please describe the rights granted to pu blishers that are established in a  Member 
State. To  the extent that a right extends protection explicitly to publishers established 
in a Member State, please address how such a right affects the rights held by 
publishers that are not established in a  Membe r State. Please clarify whether Member 
States may implement the right in a manner that could require equitable remuneration 
(i.e., via an exception to the exclusive right).  
 
EU reply:   
Article 15(1) of Directive (EU) 2019/790 provides a new right to publi shers of press publications 
established in a Member State. Therefore, the establishment of the press publisher in an EU Member 
State is a prerequisite to benefit from the rights provided for in Article 15(1). Article 15 does not 
govern the protection of pr ess publications published by publishers established in third countries. 
Article 15(2) of Directive (EU) 2019/790 provides that "The rights provided for in paragraph 1 [the 
press publishers ' rights] shall leave intact and shall in no way affect any rights provided for in Union 
law to authors and other rightholders, in respect of the works and other subject matter incorporated 
in a press publication. " The margin of manoeuvre of Member States to provide for exceptions and 
limitations to the press publishers ' right is governed by Article 15(3): "Articles 5 to 8 of Directive 
2001/29/EC, Directive 2012/28/EU and Directive (EU) 2017/1564 of the European Par liament of the 
Council shall apply mutatis mutandis in respect of the rights provided for in paragraph 1 of this 
Article. " Therefore, the rules on exceptions provided for in Articles 5 of Directive 2001/29/EC as well 
as in Directives 2012/28/EU and (EU) 20 17/1564 apply also to the press publishers ' rights.  
 
Page 147, paragraph 3.331:  The Secretariat's report notes that Article 17 of the Directive on 
Copyright in the Digital Single Market holds online content -sharing service providers responsible for 
the sha ring by users of copyright -protected materials with the public. Please provide the following 
information regarding Article 17:  
 
64. Does the imposed responsibility extend to all kinds of service providers or are any 
exempt? If certain service providers are exe mpt, please list the types of service 
providers that are exempt and explain why they are exempted.  
 
EU reply:   
The new provision applies to specific services, the online content -sharing services, defined in 
Article  2(6) of the Directive: "'online content -sharing service provider ' means a provider of an 
information society service of which the main or one of the main purposes is to store and give the 
public access to a large amount of copyright -protected works or other protected subject matter 
uploaded by i ts users, which it organises and promotes for profit -making purposes ". As explained in 
Recital 62, this definition targets "only online services that play an important role on the online 
content market by competing with other online content services, such as online audio and video 
streaming services, for the same audiences ". 
All providers of services which do not fulfil the criteria of the definition of an online content sharing 
service provider are excluded. An indicative list of services excluded is provi ded in Article 2 (6): WT/TPR/M/395/Add.1  
 
- 576 - 
 
  not-for-profit online encyclopedias, not -for-profit educational and scientific repositories, open source 
software -developing and -sharing platforms, providers of electronic communications services, online 
marketplaces, business -to-business cloud services and cloud services that allow users to upload 
content for their own use.  
 
65. It is our understanding that Poland has brought an action before the CJEU seeking to 
annul a portion of Article 17. What is the status of this case? What is the timeline for 
a decision by the CJEU?  
 
EU reply:   
This case is still pending. It will follow th e normal procedure of the Court. The European Commission 
cannot provide a timeline at this stage.  
 
Page 147, paragraph 3.332:  The Secretariat's report further mentions that the Directive on 
Copyright in the Digital Single Market include requirements that r eaffirm and protect the rights of 
authors and performers.  
 
66. Please provide a brief summary of these requirements and what exclusive rights they 
protect.  
 
EU reply:   
Chapter 3 of the Directive on Copyright in the Digital Single Market includes measures related to the 
remuneration of authors and performers: Article 18 introduces a principle of appropriate and 
proportionate remuneration for authors and performers that shall apply when an author or performer 
has transferred or licensed his rights f or exploitation by another party. Authors and performers will 
also benefit from a transparency provision that requires their contractual partners (publishers, 
producers) to give them up -to-date, relevant and comprehensive information on the exploitation of  
their works and performances (Article 19). Article 20 introduces a contract adjustment mechanism 
to allow authors and performers to claim additional, appropriate and fair remuneration when the 
remuneration originally agreed becomes disproportionately low compared to the success of their 
work or performance. Article 21 introduces an alternative dispute resolution procedure for authors 
and performers. Finally, Article 22 introduces the possibility for authors and performers to revoke 
the transfer or licensin g of their rights from publishers and producers in case of lack of exploitation 
of their works.  
 
Page 147, paragraph. 3.333  The Secretariat's report mentioned that the Directive on Television 
and Radio Programmes provides for the facilitated clearance of c opyright for radio and TV content; 
the establishment of the country of origin principle; and the extension of mandatory collective 
management to all types of retransmissions.  
 
67. Please provide a brief summary of the rules associated with the facilitated cle arance 
of copyright for radio and certain TV content; the establishment of the country of origin 
principle requirement; and the extension of mandatory collective management to all 
types of retransmission.  
 
EU reply:   
Article 3 of Directive (EU) 2019/789 i ntroduces the country of origin principle in order to facilitate 
the clearance of rights for the inclusion of certain television and radio programmes in the ancillary 
online services of broadcasting organisations (such as simulcasting and catch -up services ). The 
application of this principle means that, when providing ancillary online services for certain 
programmes, broadcasters will only have to clear the necessary rights for the country of their 
principal establishment, and not for all the territories in  which they want to provide the service. On 
the basis of contractual freedom, the parties will still be able to limit the exploitation of the rights to 
which the country of origin principle applies, provided that this is in compliance with Union law.  This 
principle applies to radio programmes and only to certain television programmes, which are (i) news 
and current affairs programmes and (ii) fully financed own productions of broadcasting 
organisations.  In addition, television broadcasts of sport events are  excluded from the application of 
the country of origin principle in all cases, irrespective of whether they fall under (i) or (ii).  
 
Article 4 of the same Directive introduces mandatory collective management for the retransmission 
of radio and television programmes by means other than cable (covered by Directive 93/83/EEC). 
Right holders can exercise their rights in retransmissions only through a collective management WT/TPR/M/395/Add.1  
 
- 577 - 
 
  organisation. For retransmissions that are carried out over an internet access service, t he directive 
provides that mandatory collective management only applies when the retransmission service is 
provided in a "managed environment " (an environment in which the retransmission operator 
provides a secure retransmission to authorised users). The p rovisions on mandatory collective 
management do not apply to the rights held by broadcasters whose programmes are being 
retransmitted.  
 
68. Are there other rules/measures introduced by this Directive? If so, please provide a 
brief description of them and what exclusive rights they affect, if any.  
 
EU reply:   
New rules have been introduced to regulate direct injection. Article 8 provides that when 
broadcasters transmit their programme -carrying signals by direct injection exclusively to signal 
distributors only, and the latter transmit these to the public, there is an act of communication to the 
public, in which both the broadcaster and the sign al distributors participate, and for which they need 
to obtain authorisation from rightholders. Member States have the possibility to apply mandatory 
collective management to the clearance of rights by signal distributors. When broadcasters, in 
addition to  transmitting their programme -carrying signals to distributors via direct injection, also 
transmit them directly to the public, the rules applicable to retransmissions continue to apply.  
 
Page 147, paragraph 3.334:  The Secretariat's report states that the EU has introduced new rules 
on cross -border portability.  
 
69.  Please provide additional information regarding this regulation, including:  
a. Have any cases been brought under this regulation, and if so, what was the outcome?  
 
EU reply:   
The Commission is not aware of any legal action taken in relation to Regulation (EU) 2017/1128 on 
cross-border portability of online content services in the internal market.  
 
b. Are there additional rules imposed on service providers with respect to the use of 
services by a user t hat is temporarily outside of the Member State of his/her 
residence? If so, please describe any additional rules imposed on service providers by 
this regulation.  
 
EU reply:   
Providers of paid online content services are obliged to provide cross -border por tability to their 
subscribers when these are temporarily present in another Member States. They have to provide 
access to the same content on the same range and number of devices, for the same number of users 
and with the same range of functionalities as t hose offered in their Member State of residence 
(Article  3 of Regulation (EU) 2017/1128). Free -of-charge online content services can opt in under 
the condition that the provider verifies the subscriber 's Member State of residence (Article 6).  
The obligation to provide cross -border portability is linked to the verification of the subscribers ' 
Member State of residence. Service providers have to verify the subscriber's Member State of 
residence at the conclusion and renewal of the contract and in cas e of reasonable doubts about the 
subscriber's Member State of residence (Article 5).  
 
Page 148, paragraph 3.336:  The Secretariat's report notes that a Directive and Regulation were 
adopted implementing the Marrakesh Treaty and ratified in October 2018, whi ch included exceptions 
from copyright holders' rights in favor of the blind, visually impaired or otherwise print disabled 
people.  
 
70. Please provide additional information about these exceptions, including:  
a. What is the category of beneficiary persons as spec ified in the Directive and the 
Regulation?  
 
EU reply:   
Article 2(2) of Directive (EU) 2017/1564 and of Regulation (EU) 2017/1563 defines a "beneficiary 
person " as "a person who  
(a) is blind;  
(b) has a visual impairment which cannot be improved so as to gi ve the person visual function 
substantially equivalent to that of a person who has no such impairment, and who is, as a result, WT/TPR/M/395/Add.1  
 
- 578 - 
 
  unable to read printed works to substantially the same degree as a person without such an 
impairment;  
(c) has a perceptual or r eading disability and is, as a result, unable to read printed works to 
substantially the same degree as a person without such disability; or  
(d) is otherwise unable, due to a physical disability, to hold or manipulate a book or to focus or move 
their eyes to the extent that would be normally acceptable for reading ". 
 
b. What categories of works are subject to these exceptions?  
 
EU reply:   
Works or other subject matters as defined in Articles 2(1) of both the Directive and the Regulation: 
"a work in the fo rm of a book, journal, newspaper, magazine or other kind of writing, notation, 
including sheet music, and related illustrations, in any media, including in audio form such as 
audiobooks and in digital format, which is protected by copyright or related righ ts and which is 
published or otherwise lawfully made publicly available ".  
 
c. What exclusive rights are subject to these exceptions?  
 
EU reply:   
Article 3 of Directive (EU) 2017/1564 establishes that no authorisation of the rightholder of any 
copyright or related right in a work or other subject matter is required pursuant to Articles 5 and 7 
of Directive 96/9/EC, Articles 2, 3 and 4 of Directive 2001/29/EC, Article 1(1), Article 8(2) and (3) 
and Article 9 of Directive 2006/115/EC and Article 4  of Directive 2009/24/EC for certain acts carried 
out by beneficiary persons and authorised entities.  
The Regulation permits cross -border exchange between the EU and third countries that are parties 
to the Treaty of accessible format copies of certain work s and subject matter made under the 
exception provided for in the Directive without the authorisation of the rightholders.  
 
d. What requirements are placed on beneficiary persons or authorized entities to 
exercise these exceptions?  
 
EU reply:   
The obligations  of authorized entities regarding the making and distribution of accessible format 
copies within the EU and regarding the export and import of those copies to and from third countries 
are set in Article 5 of the Directive and of the Regulation. They should  establish and follow its own 
practices to ensure that it:  
 
1. 
"(a) distributes, communicates and makes available accessible format copies only to beneficiary 
persons or other authorised entities;  
(b) takes appropriate steps to discourage the unauthorised  reproduction, distribution, 
communication to the public or making available to the public of accessible format copies;  
(c) demonstrates due care in, and maintains records of, its handling of works or other subject matter 
and of accessible format copies t hereof; and  
(d) publishes and updates, on its website if appropriate, or through other online or offline channels, 
information on how it complies with the obligations laid down in points (a) to (c) ".  
Member States shall ensure that the practices referred  to in the first subparagraph are established 
and followed in full respect of the rules applicable to the processing of personal data of beneficiary 
persons referred.  
Authorised entities established in the EU should also provide the following information in an 
accessible way, on request, to beneficiary persons, other authorised entities or rightholders:  
 
2.  
"(a) the list of works or other subject matter for which it has accessible format copies and the 
available formats; and  
(b) the name and contact details of the authorised entities with which it has engaged in the exchange 
of accessible format copies pursua nt to Article 4 " 
 
3.3.7.2 Industrial property  
3.3.7.2.1 Patents  
Page 149, paragraph 3.339:  According to the Secretariat's report, the UPC Agreement was signed 
by 25 Member States in early 2013. Ratification by 13 member States, including the three with the WT/TPR/M/395/Add.1  
 
- 579 - 
 
  highest number of European patents in force (Germany, France, and the United Kingdom), is  
required for its entry into force. As of September 30, 2019, 16 EU Member States, including France 
and the United Kingdom but not Germany, had ratified the Agreement.  
 
71. Is Germany  expected to sign the Agreement? If so, when?  
 
EU reply:   
Germany and other EU MS are committed to the entry into operation of the unitary patent system 
(including the UPC). However, Germany will not ratify the UPC Agreement before the German 
Constitutional Court makes a decision regarding the pending legal challenge.  
 
72. Is there a timeline for implementation of the UPC?  
 
EU reply:   
There is no official timeline for the implementation of the UPC. Note that the full entry into operation 
will be preceded by a provisional application period, as defined in a specific Protocol providing for 
this. 
(https://www.unified -patent -
court.org/sites/default/files/Protocol_to_the_Agreement_on_Unified_Patent_Court_on_provisional_
application.pdf ). 
 
Page 149, paragraph 3.341:  According to the Secretariat's report, the President of the EPO 
subsequently referred a decision of the Technical Board related to this amendment to the 
Implementing Regulations of the European Patent Convention (EPC) to the EPO's Enlarged Board of 
Appeal, aiming to reverse it.  
 
73. Has the decision referenced in this paragraph been re versed by the EPO Technical 
Board?  
 
EU reply:   
The Enlarged Board of Appeal is still reviewing the questions referred by the EPO 's President (referral 
G 3/19).  
 
74. Are plants or animals exclusively obtained by an essentially biological process still 
excluded from patentability?    
 
EU reply:   
Rule 28(2) of the Implementing Regulations to the EPC – excluding the patentability of plants and 
animals obtained by essentially biological processes – is still in force. However, a Technical Board of 
Appeal has put its validity into question when assessing an individual case (T 1063/18, "pepper " 
case). It is expected that the Enlarged Board of Appeal will clarify this issue in the pending referral 
G 3/19.  
 
Page 150, paragraph 3.342:  According to the Secretariat's  report, the EU recently adopted 
Regulation (EU) 2019/933 amending Regulation (EC) No. 469/2009 concerning the supplementary 
protection certificate (SPC) for medicinal products, which introduced certain exceptions to the SPC 
rights, such as a waiver for ma nufacturing for export to non -EU markets and stockpiling for 
six months prior to the expiration of the certificate in order for the product to be placed on the 
market in Member States upon expiration.  
 
75. Please provide an explanation of the EU's plan for mo nitoring compliance with the 
provisions of the Regulation in order to prevent possible abuses, specifically with 
respect to the limited scope of the waiver (i.e. manufacturing for export only and the 
six-month stockpiling period)?  
 
EU reply:   
Regulation 20 19/933 will be implemented by EU Member States and enforceable at EU Member 
States ' courts. Moreover, the application of the Regulation will be regularly evaluated.  
 
76. Please provide an explanation of the EU's plan for ensuring compliance with the 
notificati on and marking requirements.  
 WT/TPR/M/395/Add.1  
 
- 580 - 
 
  EU reply:   
Regulation 2019/933 will be implemented by EU Member States and enforceable at EU Member 
States ' courts. Recitals (23) to (25) of the regulation reads: "….This Regulation does not affect the 
application of Union acts that aim to prevent infringements, and facilitate enforcement, of intellectual 
property rights, including Directive 2004/48/EC and Regulation (EU) No . 608/2013 …. ", "This 
Regulation does not affect the rules on the unique identifier, provided fo r in Directive 2001/83/EC " 
and "This Regulation does not affect the application of Directives 2001/82/EC and 2001/83/EC " [the 
EU pharmaceutical regulatory codes on human and veterinary medicines].  
Should users (manufacturers of generics/biosimilars) fail t o comply with the safeguards like 
notification and labelling requirements, a court might consider that the exception introduced by the 
Regulation does not apply and, possibly, that the generics/biosimilars infringe the SPC concerned.  
 
3.3.7.2.4 Geographic al indications  
Page 154, paragraph 3.361:  The Secretariat's report notes the GI protection acquired via FTAs.  
 
77. Could the EU clarify how it indicates which terms are generic terms in compound GIs, 
when included in the lists of GIs exchanged via an FTA?  
 
EU reply:  
The identification of a 'generic term ' depends on the de facto use in any particular territory. Within 
the EU, the Court of Justice of the EU has ruled that all relevant factors shall be taken into account 
when determining if a term is generic. In particular, the existing situation in areas of consumption 
and relevant national or Union legal acts should be considered. Generic status is not a form of 
intellectual property right: there is no explicit right to use a generic term meaning there is a g eneral 
freedom to use a generic term, as no other operator is able to protect it either as a trademark or as 
a GI. As generic determination, in a territory concerned, is a question of de facto use, in case of a 
changing reality and in particular shifting c onsumer appreciation, the generic status of a name can 
weaken.  
GIs are protected under EU legislation and under bilateral agreements that include related 
provisions. GIs containing compound terms are protected as one name. In general, operators are 
aware i f terms are generic, including terms within a compound GI. Nevertheless, in case of a dispute 
a final legal determination can only be made by the courts. Protection of GIs (including the compound 
term GIs) that are part of an agreement follows the legal pr ovisions of the relevant agreement and 
the parties ' legal system for implementation and enforcement of the agreement.  
The EU is aware that in some jurisdictions 'disclaimer texts ' are used, for instance "protection is not 
sought for [x] ". Concerning trademarks, the Court of Justice has recently ruled that in the EU such 
'disclaimer texts ' have no legal value in the validity assessment of trademarks on ground of likelihood 
of confusion (Case C -705/17 Hansson, 12 June 2019). The legal crite ria cannot be circumvented by 
using a disclaimer text. Although there is no explicit ruling on the validity of "disclaimer texts " for 
GIs, the precedent from trademark law would seem pertinent. The EU discontinued the use of 
disclaimer texts regarding GI r egistration in the 1990s.  
 
3.3.7.2.5 Undisclosed information  
3.3.7.2.5.1 Trade secrets  
 
Page 154, paragraph 3.363:  The Secretariat's report notes that all but one Member State have 
adopted legislation to implement the Trade Secret Directive.   
 
78. Please iden tify the Member State that has not yet implemented the Trade Secret 
Directive and provide an estimate as to when the implementation will be completed 
and what, if any, particular barriers are at issue.  
 
EU reply:  
The European Commission started an infrin gement procedure against Cyprus for non -notification. 
Cyprus is expected to notify the transposition measures expeditiously.  
 
Page 155, paragraph 3.365:  The Secretariat's report notes a study on Member States' trade 
secret law and litigation prior to the i mplementation of the Trade Secret Directive.  
 
79. Does the EU plan to do a follow -on study to assess the effectiveness of the Trade Secret 
Directive in harmonizing the law and practices?  
 WT/TPR/M/395/Add.1  
 
- 581 - 
 
  EU reply:  
Yes, the European Commission will issue a report on the impa ct of the Directive, which is foreseen 
for 2022.  
 
3.3.7.3 Enforcement  
3.3.7.3.1 Economic impact  
 
Page 157, Table 3.32:  The Secretariat's report provides trending data for seizures of counterfeit 
goods.  
 
80. Could the EU provide insight into the cause of the overall decline in the seizure data?  
 
EU reply:   
The figures publicly available in the report on the EU customs enforcement of intellectual property 
rights  (results at the EU border, 2018 - 
https://ec.europa.eu/taxation_customs/sites/taxation/files/2019 -ipr-report.pdf) show fluct uations 
during the years 2015 -2018. If we compare the 2018 data with the 2017 one (see page 9 of the 
report), we can see an increase of the number of cases and a decrease of the number of articles 
detained. This is a confirmation of the infringers ' trend t o avail themselves more and more of on -
line market places and to deliver/sell the IPR infringing goods via small shipments containing few 
articles.  
 
3.3.7.3.3 Enforcement at the EU's external borders  
 
Page 159, Table 3.33:  The Secretariat's report provides  data comparing detentions at EU borders 
for 2016 and 2017.   
 
81. Can the EU provide insight into the decline, year over year, in detentions?  
 
EU reply:   
See reply to question 80.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
 
Page 161 -162, paragraph 4.4:  In the overview of agriculture, paragraph 4.4 describes the size 
and output of farms in the EU.  This paragraph indicates that 6.9% of farms are of 50 ha or more in 
size and work two -thirds of the agricultural area.  
 
82. What propor tion of the value of EU agricultural production is accounted for by this 
group of larger farms? What is the average output of these farms?  
 
EU reply:   
Farms of 50 hectares or more account for 52% of total EU standard output in agriculture; the average 
standard output of these larger farms is EUR 260,461.  
 
4.1.1.2.1.2 Internal market support measures  
 
Page 174, paragraphs 4.49, 4.50 & 4.51:  According to t he Secretariat report, public intervention 
stocks of skimmed milk powder (SMP) reached 380,000 metric tons at the end of 2017. The report 
says that these stocks were sold back into the market through tenders in 2018 and 2019, and that 
by July 2019, interve ntion stocks of SMP had declined to zero.  
 
83. Please respond to the following questions about the SMP intervention program:  
a. During the 2017 -19 period, what were the sales prices for SMP sold out of EU 
intervention stocks? How did those sales prices compare to  prevailing EU domestic 
market prices for SMP and international market prices for SMP?  
 
EU reply:  
Details about sales of skimmed milk powder from EU intervention stocks was provided to WTO 
members in the framework of the Regular Committee on Agriculture ( AGIMS ID 92006). During the WT/TPR/M/395/Add.1  
 
- 582 - 
 
  tender period between December 2016 and June 2019, the minimum selling prices accepted in the 
tenders for SMP ranged between EUR 1,050 and EUR 2,051 per tonne. See page 4 of the Milk Market 
Observatory:  
https://ec.europa.eu/info /sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf .  
The sale of intervention stocks by the Commission is governed by Regulation (EU) No . 1308/2013, 
which sets the framework for the cautious approach adopted by the Commission when disposing of 
SMP intervention stocks. Sales did not take place until the market had recovered. The prices at which 
the SMP in public intervention was sold in 2018 and 2019 were in line with market reality, taking 
into account the age ing of the product and therefore its relative loss of commercial value (not the 
intrinsic quality of the product). In the period during which the bulk of the SMP intervention stocks 
were disposed of (April 2018 – January 2019) EU SMP milk prices increased by more than 30% and 
Oceania SMP prices increased by more than 20%.  
 
b. What quantity of the SMP intervention inventory was sold at a price below the EU's 
original intervention purchase price of 1,698 euros per metric ton?  
 
EU reply:  
The intervention skimme d milk powder was sold at prices in line with market prices of the time, 
which were below purchasing price level all through the year 2018.  
The minimum selling price was used as a reference for the sales granted on a given date. Exceptions 
were:  
• The start  of the period (40 tonnes at 2151.00 EUR/t in December 2016 and 138 tonnes 
at 1850.00 EUR/t in June 2017)  
• The end of the period when the market had recovered (162 tonnes at 175.90 EUR/100  kg 
in June 2019 and part of the 925 tonnes sold in May 2019 was also above purchasing 
price).  
 
c. During 2018 and 2019, to what extent did the EU sales of SMP from intervention stocks 
depress prices for SMP on the EU domestic market and on the international market?  
 
EU reply:  
The minimum selling prices accepted in the tender followed the recovery in prices in 2018 -19. There 
was no downward pressure on market prices. On the contrary, during the period between 
January  2018 and June 2019, when most of these stocks were released to the market, the EU price 
for skimmed milk powder increased by 43%. See page 4 of the Milk Market Observatory: 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf  and page 1 of the Milk Market Observatory on dairy commodity 
prices: https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -
dairy-commodity -prices_en.pdf . 
 
d. What quantities of SMP intervention sales were exported to third countries?  
 
EU reply:  
Intervention stocks were sold without any co ndition of further use. The stocks could have found their 
destination on the internal market or they could have been further processed and/or exported in 
powder form. The Commission does not have information about the further use of stocks released 
from in tervention. If exported, these quantities were not differentiated and were counted together 
with other exports from the EU.  
 
e. What were net EU financial outlays for the SMP intervention program over the 
2015 -2019 period, taking into account intervention pur chase costs, storage costs, and 
sales receipts?  
 
EU reply:  
Up to and including September 2019, the EU 's total expenditure was EUR 137 million. This takes 
into account storage costs, some logistical costs at entry into storage and at exit, and price 
deprec iation between buying -in and selling. Not the EU, but the Member States own the intervention 
stocks: Member States financed the buying -in price and received the selling price. The EU only 
covers the storage costs, price difference and financial costs (for the stocks in questions interest 
rate was fixed at 0%).  
 WT/TPR/M/395/Add.1  
 
- 583 - 
 
  4.4.3 E -commerce  
4.4.3.2 Improving access for consumers to online goods and services across Europe  
4.4.3.2.3 Prohibition of unjustified geoblocking and other forms of discrimination based 
on customer s' nationality, place of residence or place of establishment  
 
Page 238, Paragraph 4.287:  The Secretariat's report states that the EU has introduced new rules 
on unjustified geoblocking and other forms of discrimination based on customers' nationality, place 
of residence or place of establishment.  
 
84. Please provide additional information regarding these new rules, including:  
a. Whether these new rules will also address electronically supplied services; and  
b. Any information regarding the exclusion of audiovisual services from the scope of the 
new rules.  
 
EU reply:   
The Geo -blocking Regulation (EU) 302/2018 provides for an obligation to treat EU customers 
(including consumers and other end -users) in the same manner when they are in the same situation, 
regardless of their nationality, place of residence or p lace of establishment (s.c. shop -like-a-local).  
The Regulation applies from 3 December 2018. It applies to all traders, including marketplaces, 
operating within the EU (thus, it covers traders established in EU Member State or in a third country).  
Article 3 of the Regulation bans the blocking of access to websites and re -routing without the 
customer 's prior consent. This increases price transparency by allowing customers to access different 
national websites. This provision also applies to non -audio -visua l services supplied electronically, 
such as e -books, music, games and software.  
 
Article 4 of the Regulation defines certain situations where there can be no justified reason for 
geo-blocking or other forms of discrimination based on nationality, residence  or establishment. In 
these situations, customers from another Member State have the same access and possibility to 
acquire goods and services as local customers. These situations are as follows:  
 
-  Sale of goods without delivery outside the area served b y the trader.  
-  Sale of electronically supplied services.  
-  Sale of services provided in a specific physical location.  
 
Regarding the sale of "Electronically supplied services " those include services which are delivered 
over the Internet or an electronic  network and the nature of which renders their supply essentially 
automated and involving minimal human intervention, and impossible to ensure in the absence of 
information technology. In this case, no physical delivery is required, as the services are bei ng 
supplied electronically. Examples of electronically supplies services are cloud services, data 
warehousing or website hosting.  
 
Article 5 of the Regulation provides non -discrimination of customers within the range of the means 
of payment accepted by the  trader.  
The Geo -blocking Regulation excludes from its scope audiovisual services. These services are also 
excluded from the scope of Directive 2006/123/EC on services in the internal market. Regulation 
(EU) 2017/1128 on cross -border portability of online content services in the internal market allows 
consumers across the European Economic Area (EEA) to access their online content services (for 
example, video -on-demand streaming services) as if they are at home when they travel within the 
EEA. 
The provision  of (non -audiovisual) copyright protected content services (such as e -books, online 
music, software and videogames) is covered by the Geo -blocking Regulation partially: these services 
are not subject to the Regulation's prohibition of applying different ge neral conditions of access on 
the basis of a customer's nationality, residence or establishment, but they are subject to other rules 
of Regulation, including the prohibition to block or limit access to online interfaces on the basis of 
the customer's natio nality, residence or establishment of the customer.  
Article 9 of the Regulation provides for a review clause that stipulates that the Commission should 
regularly report to European Parliament, Council and the European Economic and Social Committee 
on its e valuation of the Regulation. The Regulation envisages a first review already by 
23 March  2020. The Report on the review of the Regulation is being prepared by the Commission 
and inter alia will assess the possibility to include within the scope of the Regulation audiovisual 
services.  
 WT/TPR/M/395/Add.1  
 
- 584 - 
 
  For further information on the Regulation, please see Q&A document available at 
https://ec.europa.eu/digital -single -market/en/news/geo -blocking -regulation -questions -and-
answers . 
 
Page 251 4.4.5.1.1 EU Cybersecurity Act  
Page 251: The Secretariat's report states that the EU Cybersecurity Act establishes a European 
cybersecurity certification framework. The EU Agency for Cybersecurity (ENISA) will support and 
promote the development and implementation of EU policy on cybersecurity certification.  
 
85. As ENISA takes on this new role in developing an  EU cybersecurity certification 
framework, how will ENISA avoid creating barriers to trade for non -EU providers in 
the EU market? What role will non -EU stakeholders, some of whom are market leaders 
in cybersecurity, play in the development of cybersecurity  standards?  
 
EU reply:  
The schemes are prepared by ENISA in consultation with stakeholders, European as well as 
non-European, and then will be adopted by the Commission. The European cybersecurity certification 
schemes are non -discriminatory and based on  European or international standards. The use of the 
new European certification schemes is voluntary.  
 
Companies established within the EU or elsewhere that choose to certify their products will be able 
to obtain certificates that are valid across the who le EU. As such, the new European cybersecurity 
certification framework does not constitute a barrier to entry of products outside Europe into the EU 
market.  
 
As regards cybersecurity standards, non -EU stakeholders will continue to contribute to the 
develop ment of both European and international standards as they do now. The development of 
cybersecurity standards does not take place within the framework but remains with the relevant 
standards development organisations.  
 
Furthermore, the EU has confirmed tha t globally relevant standards, including where applicable 
standards and technical specifications developed by US -domiciled standards development 
organisations, may be taken into consideration in the future development of standards and voluntary 
certificati on schemes in the EU.  
 
Moreover, each scheme, once established will provide further opportunities for international 
cooperation.  
 
WTO TPR: European Union  
Part II: Questions based on the Government's report (WT/TPR/G/395 ) 
 
3 DEVELOPMENTS IN THE INTERNAL MARKET  
 
Page 5, paragraph 3.2: The Government's report notes that the EU single market benefits third 
countries, giving them access to a single market in which goods can circulate freely.  
 
86. How does the EU plan to address Member States implementing  national laws that 
disrupt the free movement of goods and prevent access to a single market? 
Specifically, please explain how the EU plans to address mandatory origin labe lling 
requirements piloted by Member States. Please also explain how the EU plans to  
address bans implemented by France of particular food additives, food packaging 
materials, and agricultural chemicals.  
 
EU reply:   
The European Union has different tools to monitor national laws adopted by Member States that 
might have an impact on the free movement of goods:  
Firstly, under the Single Market Transparency Directive (Directive (EU) 2015/1535), EU Member 
States are to notify draft technical regulations to the European Commission before their adoption. 
Starting from the date of notificat ion, a 3 -month standstill period comes into play, during which EU 
Member States must refrain from adopting the technical regulation in question. This procedure 
enables the European Commission and other EU Member States to examine the proposed text and 
respond. WT/TPR/M/395/Add.1  
 
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  In particular, the European Commission and other EU Member States may submit a detailed opinion 
or comments to the draft if they deem that the notified text may create barriers to the free 
movement of goods, the free provision of information society s ervices or go contrary to EU secondary 
legislation. The submission of a detailed opinion prolongs the standstill period by another 3 months 
and the notifying Member State must explain what it intends to do in response. The European 
Commission can also bloc k a draft for a period of 12 to 18 months if EU harmonisation work is 
planned or is already underway in the same field. At the end of the procedure, the notifying Member 
State must submit the final text of the regulation to the Commission and other Member States. This 
allows them to check whether their opinions were taken into account.  
 
New Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another 
Member State, that will apply as of 19 April 2020, is also a step forward when i t comes to 
transparency in the field of free movement of goods not subject to EU harmonization legislation. 
Decisions by an EU Member State restricting or denying market access to goods which have been 
lawfully marketed in other Member States will be notif ied to the European Commission and to other 
EU Member States through the "information and communication system for the pan -European 
market surveillance " (ICSMS). ICSMS will also be used for exchange of information among the 
competent authorities and domest ic product contact points, which will facilitate their communication 
in the area of mutual recognition of goods lawfully marketed in other EU Member States.  
 
The Commission follows closely the pilots on mandatory origin labelling. The Member States that 
adopted national measures on origin indication committed to submit to the Commission a report on 
their functioning and on the possible impact on the single market. The reports will be submitted by 
the end of the notified temporary national schemes. The outco me and findings of these reports will 
be the starting point for any future Commission 's reflection on a long -term solution on the origin 
indication under the EU legislation.  
 
Pending adoption of specific actions, more transparency on food origin will be en sured as of 
1 April 2020 by the application of the new rules on the indication of the primary ingredient. As 
regards food additives and food contact materials, in some very specific cases, the Commission may 
wait until a thorough scientific assessment by E FSA is completed, before it takes a position, together 
with Member States, on a restriction proposed by one of them. In the meantime, in these very 
specific cases, the Member State may implement the proposed national legislation.  
 
3.1 The EU's better regul ation policy  
Page 5, paragraph 3.4 – 3.5: The Government's report cites the Better Regulation Agenda and 
discusses the results of stocktaking of the key measures introduced.  
 
87. Please provide examples of tangible results from these policies, specifically in  terms 
of how stakeholder input at an early stage changed outcomes in the regulatory policy 
development?  
 
EU reply:  
The Commission 's policy development draws on many sources of evidence. Data analysis, expert 
advice as well as different interactions with stakeholders in conferences, workshops, targeted 
consultations, public consultations as well as feedback on roadmaps, proposals and impact 
assessments. Analytical work is also carried out, including in evaluations and impact assessments. 
This is all important input to the policy making process.  
 WT/TPR/M/395/Add.1  
 
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  The Commission is obliged to consult widely before making legislative proposals. Public consultations 
are important but – as explained – far from being the only source of input. Public consultation s are 
open for 12 weeks and provide input to support all impact assessments, evaluations and policy 
initiatives of broad public interest. The Commission carried out 417 public consultations between 
2015 and 2018, of which 303 to support new policy initiati ves and 114 to support evaluations. The 
number of responses varies markedly depending on the nature of the topic addressed. The average 
number of responses to a public consultation is around 1100.  
 
The above question is, however, based on a wrong premise, since it assumes that there is a proposal 
at the time of consultation, which can be "changed ". This is not the case. The consultation is taking 
place early in the conceptualization stage of a policy initiative. It concerns issues such as whether 
there is a  policy problem, and if so, what the nature of that problem is. It is about whether EU action 
is necessary or not. It is about what public policy objectives should be served, which policy options 
should be considered and the impacts of these. Hence, the co nsultation provides evidence to 
substantiate and define the policy problem, the objectives and policy options. Only after these steps 
have been taken, and the input has been analyzed, is a concrete legislative proposal produced.  
 
Obviously, consultation i nput helps shape initiatives. Take some examples from environmental 
policies: evaluation  of the EU Birds and Habitats Directives (EU Nature Directives)  in 2015 received 
more than half a million responses, followed by the Fitness Check of the Water Framewor k Directive 
from 2019 with more than 370 000 responses. For both, stakeholder responses were influential in 
challenging misconceptions that the legislation was not working and reaffirmed that the objectives 
were worthwhile and showed that there is a consid erable commitment to them. Furthermore, some 
proposals were substantially generated by stakeholder concerns reflected in our consultations (the 
marine litter proposal, single use plastics and discarded fishing gear).  
 
In the area of digital policy the so called "Platform -to-Business " Regulation introduced basic 
transparency and fairness rules on how online platforms need to deal with businesses operating on 
them. This initiative has been greatly influenced by stakeholde rs' feedback, in particular the SMEs 
operating on online platforms. The stakeholders ' engagement on this issue continues, notably thanks 
to the work of the Observatory on the Online Platform Economy.  
In assessing the Better Regulation Agenda in terms of ho w stakeholder input is collected and used, 
it is noteworthy that the OECD Regulatory Policy Outlook 2018 ranked the Commission consultation 
system the best in the OECD.  
 
Finally, besides this early input, the legal proposal from the Commission is published  and subject to 
consultations of national parliaments and feedback from stakeholders for 8 weeks. Afterwards, the 
proposal is negotiated, and likely amended, by the European Parliament and Council. These 
institutions may have their own consultations, analy sis and interactions with stakeholders before EU 
legislation is finally adopted.  
 
3.3 The EU public procurement market  
Pages 7, 8, 17 and, 22, Paragraph 3.10:  The Government's report notes that on 24 July 2019, 
the European Commission adopted the Communication "Guidance on the participation of third 
country bidders and goods in the EU procurement market" and provides a link to that guidance.  
Starting on Page 8,  the Guidance notes that public buyers should check the Annexes to Appendix I 
of the GPA to determine if a bidder has secured access to those buyers' government procurements.  
 
88. Do the Annexes to Appendix I reflect the current entity coverage for the EU? If not, 
how will buyers from covered entities no t listed know to allow third country bidders 
to participate? Please identify how the EU will ensure that public buyers have access 
to accurate information on coverage under the GPA.  
 
EU reply:   
The coverage schedules of Parties are an integral part of the  GPA and are contained in Appendix I 
to the Agreement. The schedule of each Party, including the EU, contains several annexes, which 
define the concerned party's commitment with respect to four dimensions of coverage:  
 
• the procuring entities covered by the  Agreement;  
• the goods, services and construction services covered by the Agreement;  
• the threshold values above which procurement activities are covered by the Agreement;  
• exceptions to the coverage.  WT/TPR/M/395/Add.1  
 
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  In respect of the EU, Annex 1 of the Appendix I to the Ag reement broadly reflects the current 
coverage for the central government entities. Any possible change of name or transfer of function 
from one entity to another does not affect the actual coverage.  
Annex 2 and 3 of the Appendix I to the Agreement provide  for a definitional approach, thus the 
respective lists of sub -central government entities and other entities are only indicative.  
Starting on Page 17, the Guidance also contains guidance on using "quality standards" in evaluating 
tenders. This guidance m entions on Page 18, "The Commission will publish a comprehensive guide 
on introducing social considerations in public procurement in 2020 and will disseminate a collection 
of good practices on Socially Responsible Public Procurement."  
 
89. Please identify when in 2020 the Commission expects to publish this guide and if this 
guide will be publicly available as of the date of publication or soon thereafter.  
 
EU reply:   
The second edition of the European Commission 's "Buying Social " Guide to T aking Account of Social 
Considerations in Public Procurement is scheduled for publication in the third quarter of 2020. It will 
be available for download on the European Commission 's website as of the time of publication.  
Starting on Page 22, the Guidance on the participation of third country bidders and goods in the EU 
procurement market affirms that technical specifications for quality criteria must be linked to the 
subject matter of the contract. On Page 23, the  Guidance further states, "Public buyers ma y require, 
for instance, that the goods purchased are made from a specific material or contain a certain 
percentage of recycled or reused materials."  
 
90. Please explain how "public buyers" in the EU will be instructed to ensure that choosing 
specific material s is consistent with the GPA, particularly Article X.2 and X.3 on the 
use of design and descriptive criteria.  
 
EU reply :  
As reiterated on page 23 of the Guidance on the participation of third country bidders and goods in 
the EU procurement market, technical specifications, requirements and criteria in the selection and 
award phase, as well as contract performance clauses must indeed always be linked to the subject 
matter of the contract. Consistency with GPA Article X.2 (prescription of technical sp ecifications in 
terms of performance and functional requirements) and GPA Article X.3 (tenders of equivalent goods 
or services) is ensured by the applicable EU law, notably Article 42 of Directive 2014/24/EU.  
 
3.6 Digital Single Market  
Page 10, paragraph 3 .20: Artificial Intelligence:  
 
91. Please explain how the EU will ensure that upcoming legislation in artificial 
intelligence does not create barriers to trade, particularly in the standardization 
process?  
 
EU reply:   
The characteristics of the legislation on  artificial intelligence are not defined yet. As all Commission 
proposals, it will be assessed and compliance with EU international trade commitments will be 
ensured.  
 
92. Please explain the mechanism by which the EU will allow non -EU stakeholders to play 
an important role in the development of standards for artificial intelligence applicable 
to the EU market?  
 
EU reply:   
The legislation is not defined yet and there is therefore no decision on the use of standards to 
complement any possible future legislation. Should this become an option, collaboration between 
European standardisation organisations with international counterparts will be encouraged in order 
to promote a global conversation around trustworthy AI standards.  
More generally, the consul tation process underpinning the preparation of possible legislation is not 
limited to the EU but is open to non -EU stakeholders. The High Level Expert Group for Ethics in AI 
includes several non -EU experts. The consultation process to be launched on 19 February  will 
welcome input from non -EU organisations and views from third countries will be sought.  
 WT/TPR/M/395/Add.1  
 
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  3.8 Sanitary and Phytosanitary Requirements  
 
Page 11, Paragraph 3.26:  The Government's report notes that the Regulation on Official Controls 
will provide a single framework for all official controls along the agri -food chain and provides the 
citation for that guidance. This Guidance notes, "the responsibility to enforce Uni on agri -food chain 
legislation lies with Member States, whose competent authorities monitor and verify, through the 
organization of official controls, that relevant Union requirements are effectively complied with and 
enforced."  
 
93. Please explain how the EU  ensures consistency across Member States in terms of 
implementation and enforcement of SPS measures?  
 
EU reply:  
Regulation (EC) No . 882/2004 established a single legislative framework for the organisation of 
official controls, which significantly improv ed the efficiency of such controls and hence the 
enforcement of Union agri -food chain legislation. Its successor, Regulation (EU) 2017/625 (OCR) 
has further strengthened this harmonised Union framework.  
 
Across the Union, competent authorities must perform  official controls regularly, on a risk basis and 
with appropriate frequency, on all the sectors and in relation to all operators, activities, animals and 
goods governed by Union agri -food chain legislation. The controls must be performed, with a 
considera ble level of transparency, by staff who are independent and free from any conflict of 
interest. Common requirements apply as regards the training of staff and the facilities and 
organisation of the competent authorities, in order to ensure consistency. Thi s is further underpinned 
by a European network of reference laboratories and reference centres (Article 92 -101 of the OCR), 
and the mechanisms for cross -border administrative assistance and cooperation between Member 
States (Article 102 -108 of the OCR). In  addition, a considerable number of delegated and 
implementing acts have been adopted under the OCR, most of which provide for common rules 
relevant for consignments entering the Union (see list here: 
https://ec.europa.eu/food/safety/official_controls/legi slation_en ). Those acts will also contribute to 
consistency in the implementation and enforcement of SPS measures.  
 
To ensure the quality and coherence of the official controls performed, the European Commission 
services perform regular checks of the Membe r States ' systems of official controls (see Article 116 
of the OCR). Member States must take appropriate proper follow -up measures to remedy 
shortcomings identified by the Commission experts during those checks (Article 119 of the OCR) In 
case of a serious  disruption of a Member State 's control system, the European Commission may 
adopt measures to apply until the disruption is eliminated (Article 141 of the OCR). Such action may 
include marketing bans and the suspension of border control posts in the country concerned.  
 
Page 11, paragraph 3.26:  According to the Government's report, the EU's new Regulation on 
Veterinary Medicines will strengthen EU action in fighting antimicrobial resistance (AMR) with a wide 
range of measures following the approach of the European One Health Action Plan against AMR. The 
SPS Agreement recognizes that regulatory approaches need to be appropriate to the circumstances, 
and different approaches can achieve equivalent human and animal health outcomes. However, the 
EU Regulati on EC 2019/6 governing veterinary medicinal products appears to require trading 
partners to conform to specific EU veterinary drug requirements.  
 
94. Please explain how the EU will ensure that the implementation of EC 2019/6 is 
consistent with the EU's WTO ob ligations?  
 
EU reply:  
Regulation 2019/6 on veterinary medicines does not discriminate against operators in third 
countries. Therefore, the provisions on imports in Article 118 of the Regulation should not be seen 
as trade barriers, but as part of the ove rall fight against AMR, recognizing that AMR does not respect 
borders. Detailed rules on how to apply the provisions on imports in Article 118 will be laid down in 
delegated acts.  
 
Page 11, paragraph 3.26 : According to the Government's report, with the new  Regulation on 
Official Controls, businesses and authorities will benefit from reduced administrative burdens and a 
more efficient process.   
 WT/TPR/M/395/Add.1  
 
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  95. Given the lack of guidance, and the increased number of products that need 
certificates, please explain how the EU 's new Regulation on Official Controls will 
decrease administrative burdens for third countries and result in more efficient 
processes?  
 
EU reply:  
The new integrated computerized system for information management (IMSOC) will support a more 
efficient management of official controls by allowing for the use of advanced communication, 
including certification tools and electronic signatures. It has been designed to ensure the 
compatibility and inter -operability with other information systems oper ated by public authorities, 
through which relevant data is automatically exchanged or made available. Hence, unnecessary 
duplications of information requirements is been avoided in order to further minimize the 
administrative burdens, IMSOC builds on inter nationally standardized language, message structure 
and exchange protocols.  
 
4 TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.3 Promoting a sustainable approach to trade  
 
Page 20, paragraph 4.31:  The Government's report notes that the EU Treaties require EU external 
action to promote the principles and international values upon which the EU was founded, including 
sustainable development.  
 
96. Please explain exactly how the EU plans to promote such pri nciples and international 
values, including sustainable development? Specifically, does the EU plan to use 
financial, trade -related, or other incentives to promote its efforts? How will the EU's 
efforts affect trade and the rights of third countries?  
 
EU reply:   
As per the Commission 's "Trade for All " communication (October 2015), the EU 's trade policy uses 
a number of instruments to ensure coherence with its external action, particularly as regards 
promotion of the international values on which the EU tre aties are based. All recent free trade 
agreements negotiated by the EU include a Trade and Sustainable Development (TSD) chapter with 
a number of provisions on core labour standards and environmental preservation, including 
commitments by the parties to ra tify and implement key international conventions. The EU 's 
Generalised Scheme of Preferences (GSP) also requires all beneficiary countries to respect the 
principles of 15 key international conventions on human rights and core labour standards, while 
adding  extra incentives (through the GSP+ initiative) for countries to ratify and effectively implement 
these 15 conventions, as well as a further 12, also covering environmental protection and good 
governance. The EU, together with its Member States, is also th e world 's largest donor of Aid for 
Trade funding; an updated Aid for Trade strategy, published in 2017, ensures coherence between 
development assistance and promotion of international values, particularly as regards the 2030 
Agenda 's Sustainable Developmen t Goals.  
 
4.3.1 Promoting labour rights and environmental protection  
Page 20, paragraphs 4.32 – 4.33: The Government's report briefly discusses labor rights and 
environmental protection.  
 
97. Please explain the EU plans under its Green Deal, particularly with  respect to 
strengthened trade -related measures on environment and labor?  
 
EU reply:  
Trade policy can support the EU 's ecological transition. It serves as a platform to engage with trading 
partners on climate and environmental action. Commitments to sust ainability have been 
continuously strengthened in EU trade agreements, in particular with regard to enhancing climate 
change action. The Commission has also been stepping up efforts to implement and enforce the 
sustainable development commitments of EU tra de agreements, and these efforts will be further 
enhanced with the appointment of a Chief Trade Enforcement Officer.  
On climate change more specifically, the EU 's most recent agreements all include a binding 
commitment of the Parties to ratify and effecti vely implement the Paris Agreement. The Commission 
will propose to make the respect of the Paris Agreement an essential element for all future 
comprehensive trade agreements.  WT/TPR/M/395/Add.1  
 
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  The EU 's trade policy facilitates trade and investment in green goods and services and promotes 
climate -friendly public procurement. Trade policy also needs to ensure undistorted, fair trade and 
investment in raw materials that the EU economy needs for the green transition. It can help address 
harmful practices such as illegal logging, enhance regulatory cooperation promote EU standards and 
remove non -tariff barriers in the renewable energy sector.  
 
98. How can WTO members ensure that these policies do not become fut ure trade 
barriers?  
 
EU reply:   
The EU is determined to defend and strengthen the rules -based trade order. This is why we insist 
from the outset on designing and implementing our policies and measures in full compliances with 
EU's international obligations and the rules of the World Trade Organization in particular.  
It is key for the EU to build on the positive agenda and work together with partner countries, be 
sufficiently transparent, and of course take their climate and environm ental efforts seriously.  
Any EU important initiative will be subject to an impact assessment, involving a prior consultation 
open to all stakeholders. That consultation will in particular offer exporters in partner countries the 
opportunity to make their v iews heard. Furthermore, third countries will have the opportunity to 
comment on measures, which are notified by the EU under the WTO agreement on Technical Barriers 
to Trade.  
 
Part III: Questions not based on the Secretariat's or the Government's Report  
 
Carbon border adjustment mechanism  
In her letter to the Executive Vice President for the European Green Deal and to the Commissioner 
for Economy, President Von der Leyen proposes a carbon border adjustment mechanism, for selected 
sectors, to reduce the r isk of carbon leakage.  
 
99. Please  provide more information on which sectors will be covered by the carbon border 
adjustment mechanism and how this mechanism will be implemented?  
 
EU reply:  
The European Green Deal foresees that the Carbon Border Adjustment mechanism will be proposed 
for a number of selected sectors that are at risk of carbon leakage.  
The decision in terms of scope and coverage will be informed by the impact assessment. In any 
event, compliance with World Trade Organization (WTO) rules, trad e agreements and other 
international obligations of the EU will be ensured.  
There is a breadth of considerations that need to be reviewed in the design and implementation of 
such a measure. Before any proposal is made, all measures will first have to be ca refully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, trade agreements and other international commitments, and 
of complementarity and possible interact ion with the Emission Trading System  
 
Digital Services Tax  
Several Member States passed DST legislation in 2019, noting that their taxes would be removed 
once consensus on digital taxation is reached in the OECD. At the same time, President von der 
Leyen s tated in her letter to the Executive Vice President for Europe Fit for the Digital Age that she 
should "coordinate the work on digital taxation to find a consensus at international level by the end 
of 2020 or to propose a fair European tax".  
 
100.   Please define the criteria that the EU intends to use to evaluate progress within the 
OECD?  At what point, if consensus is not reached immediately, does the EU plan to 
introduce the DST legislation?  
 
EU reply:  
The EU is fully and actively engaging in the international tax negotiations and fully committed to 
reach a global solution by the end of 2020. The Commission welcomes the commitment at global 
level to work on both the reallocation of taxing rights and effe ctive minimum taxation and looks 
forward to getting an agreement on the statement for a two -pillar approach within the Inclusive 
Framework.  
 WT/TPR/M/395/Add.1  
 
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  UNITED STATES  - FOLLOW -UP QUESTIO NS 
Follow -up Questions based on the Secretariat Report (WT/TPR/S/395)  
 
2 TRADE AND INVESTMENT REGIMES  
2. Trade and Investment Regimes  
2.2 Trade Policy Formulation and Objectives  
 
Page 44, paragraph 2.43:  The Secretariat's reports that "Trade between the EU and Switzerland 
is governed by the FTA concluded in 1972, which only cov ers trade in goods, and approximately 
120 bilateral sectoral agreements, some of them of trade relevance, notably on agricultural products 
and processed agricultural products."  
 
6. Can the EU explain and share a website link to which bilateral agreements b etween the EU 
and Switzerland  cover SPS trade requirements?   
 
EU reply:  
SPS issues are partially covered by the bilateral EU -Switzerland agreement on trade in agricultural 
products. Please find below the link to the relevant website and also the reference s. 
 
• L114/132  30/04/2002 Agreement  between the European Community and the 
Swiss  Confederation on trade in agricultural products . 
 
Amended by:  
 
L87/31  25.03.2004  (2004/278/EC) Decision No . 1/2004 of the Joint Committee for Agriculture  
L301/55  28.09.2004  (2004/660/EC) Decision No . 4/2004 of the Joint Committee for Agriculture  
L78/50  24.03.2005  (2005/260/EC) Decision No . 2/2005 of the Joint Committee on Agriculture  
L27/21  31.01.2008  (2008/ 86/EC) Decision No . 1/2008 of the Joint Committee on Agriculture  
L136/2  30.05.2009  Agreement between the European Community and the Swiss Confederation 
amending the Agreement between the European Community and the Swiss 
Confederation on trade in agricultu ral products  
L312/31  27.11.2010  (2010/724/EU) Decision No . 2/2010 of the Joint Committee on Agriculture  
L32/9  08.02.2011  (2011/83/EU) Decision No . 1/2010 of the Joint Committee on Agriculture  
L27/155  01.02.2017  Decision No . 1/2015 of the Joint Committee on Agriculture of 
19 November  2015 [2017/169]  
 
Corrected by:  
L142/92  31.05.2002  Corrigendum  
 
U.S. Follow -Up: 
1. Will the EU please share the English or French Internet link for EU -Swiss FTA? In 
addition, will the EU confirm whether the EU -Switzerland FTA covers SPS and agriculture? 
It is our understanding that some areas of SPS and agriculture are exempt from the FT A, 
in which more regulatory autotomy is given to each party covering these areas of trade.  
 
EU reply:  
There is an Agreement between the European Economic Community and the Swiss Confederation 
signed in 1972.  
(https://www.consilium.europa.eu/en/documents -publications/treaties -
agreements/agreement/?id=1972003 ).  
This agreement does not cover agriculture.  
 WT/TPR/M/395/Add.1  
 
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  3 TRADE POLICIES AND PRACTICES BY MEASURE  
3.1 Measures Directly Affecting Imports  
3.1.1 Customs procedures, valuation, and requirements  
 
Page 57, paragraph  3.21 & 3.23: U.S. companies with operations in the EU are concerned about 
the implications of the 2017 CJEU decision referenced in paragraph 3.21 of the Secretariat's report, 
which questions whether transfer prices can be used under the transaction value method of 
valuation.  
 
10. Please explain how the EU, and specifically the Commission, plans to address the 2017 CJEU 
decision? Please also explain how the EU plans to ensure uniformity and clarity in the valuation of 
goods subject to transfer price adjustm ents across all 28  Member  States?  
 
EU reply:  
In its judgement in the case C -529/16 the Court of Justice of the European Union confirmed that the 
provisions of the EU customs legislation pertaining to the value of goods for customs purposes do 
not permit an agreed transaction value, composed of an amount initially invoiced and declared and 
a flat-rate adjustment made after the end of the accounting period, to form the basis for the customs 
value, without it being possible to know at the end of the a ccounting period whether that adjustment 
would be made up or down.  
 
By excluding a flat -rate adjustment of a transaction value, that judgement provides the customs 
authorities and the stakeholders in the EU with a clear interpretation of the provisions in force, thus 
supporting their direct application. Therefore, the Commission does not see the need to take specific 
action in respect of that case, other than disseminating information on it.  
 
Besides, where the Commission identifies a need for  ensuring a correct and uniform application of 
the customs legislation, including the one regarding the customs value of goods, it normally works 
with the customs experts of the Member States, and consults representatives of the business 
community, on poss ible guidance or, where necessary, proposals to improve the applicable rules.  
 
U.S. Follow -Up:  
2. In response to the U.S. question on paragraph 3.21, page 57, the EU indicates, "the 
Commission does not see the need to take specific action in respect of th at case, other 
than disseminating information on it."  
 
a. Please provide copies of any information the Commission has disseminated on the 
case.  
 
EU reply:   
The case C -529/16 is publicly available on the Court of Justice of the European Union's website:  
http://curia.europa.eu/juris/documents.jsf?num=C -529/16.  
The exchanges of views on case C -529/16 between the Commission and the Member States can be 
found here:  
https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId
=10036 . 
The exchanges of views on case C -529/16 between the Commission and the Trade Contact Group 
can be found here:  
https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId
=8350.  
 
b. What action would the Commission take if a Member State reported that another 
Member State's customs administration assessed additional duties on an importer based 
on a post -clearance audit that uncovered flat -rate upward adjustments to the declared 
value of its imports at the end of its accounti ng period?  
 WT/TPR/M/395/Add.1  
 
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  EU reply:   
It is part of the Commission's institutional role, under the Treaties, Treaty on the Functioning of 
European Union and its Functioning, to ensure a correct and uniform application of Union legislation, 
including on customs valuation matters. In the case the Commission was informed of possible 
divergent application, the Commission would use all means at its disposal (bilateral contacts with 
the Member States involved, discussions in Customs Expert Group -Valuation, etc.): to confirm th e 
existence of the divergence; to establish with the assistance of Member States the right way to apply 
the rules in force; and to ensure that it is actually followed by all Member States, for future but also 
where needed for past operations. In certain ca ses, but not necessarily in all cases, this could result 
in the initiation of infringement procedures against Member States.  
 
c. Is it expected that the same "clear interpretation" will apply under the UCC in the 
same way it applies to the terms of the CCC ? 
 
EU reply:  
Insofar as the provisions at stake, as interpreted by the EUCJ, are the same in substance, the answer 
is yes.  
 
d. If the Commission determines with respect to this ECJ determination that there is a 
need for "ensuring a correct and uniform application of the customs legislation" , would 
exporters from foreign countries be given the opportunity to participate in consultations?  
 
EU reply:   
There are established mechanisms for consultations with the stakeholders – see for example the 
exchanges with the Trade Contact Group mentioned in the reply to the question (a.) above.  
 
3.3.2 Standards and technical requirements  
3.3.2.1 New Legislative Framework  
 
Page 110, paragraph 3.170 - Medical Devices Regulation: On page 110, the Secretariat takes  
note of new EU directives and regulations that have become EU law since the last review including 
the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation 
(EU) 2017/746. We are aware that the Medical Devices Regul ation is to be fully implemented by 
May 2020, and the In Vitro Diagnostic Medical Device Regulation in May 2022, but there are still 
several implementing regulations that are pending , and that only a handful of notified bodies have 
been approved under the new regulations.  
 
18. Please update the implemen tation status of these two regulations.  
 
EU reply:  
In the interest of patient safety, there is a political objective to render the strengthened requirements 
of the two Regulations applicable as early as possible. This has led to an extremely short transi tion 
period for the preparations for this.  
The Commission and Member States are however working closely together to ensure that patient 
access to medical technologies is at the forefront of the implementation and that continued access 
to the EU  market by W TO members is sustained.  
Following an agreed roadmap, the Commission and Member States give priority to developing 
Implementing acts and guidance that is crucial for rendering the legislation operational. Although 
the new legislation contains about 80 emp owerments for different types of implementing acts, only 
a few acts are in fact necessary for rendering the legislation operational.  
The most crucial implementing acts have already been adopted and published. In addition, a notable 
amount of guidance (appr oximately 30) for industry, notified bodies, and competent authorities has 
been endorsed and published on the Commission's website. Work on other prioritized documents is 
continuing. Such a step -by-step approach was also followed for the existing Directive s for which 
work on guidance documents was ongoing until very recently.  
As regards notified bodies, important progress has been achieved. Twelve notified body designations 
have been completed with two more expected early February and additional designation s are in the 
impending pipeline. In addition, the notified bodies that are currently already designated under the 
Medical Devices Regulations are estimated to hold a significant share of the market (approximately 
more than half of the existing certificates  under the Directives). Additionally, most notified bodies 
have increased their resources, some with up to 50%.).  
 WT/TPR/M/395/Add.1  
 
- 594 - 
 
  U.S. Follow -Up:  
3. As the transition time is extremely short by the EU's own admission, does the EU 
assert that it is providing a reasonable  interval between the publication and entry into 
force of MDR as required under WTO TBT Article 5.9?  
 
4. Increasing the number of notified body designations to fourteen by February is a 
positive development and we appreciate the EU's efforts to address this serious situation. 
However, the USG understands that fourteen notified bodies is still an inadequate amount 
to fulfil the EU's Directive and prevent major disruptions to trade of medical devices. Is 
the EU preparing further steps to address th is shortage of notified bodies or delay 
implementation of the Directive?  
 
EU reply to question 3 and question 4:  
In order to help economic operators, the EU legislators have provided for a  grace mechanism  to 
smoothen the transition. The new Medical Devices Regulation thus continue to recognize under 
certain conditions the certificates issued in accordance with the current EU's Medical Device Directive 
through the MDR's transition period (i.e. until May 2024) provided the certificate has not reached i ts 
expiry date. Most Notified Bodies designated for the existing legislation are therefore currently 
focusing their resources on re -issuing certificates with an expiry date in the nearer future. Some 
manufacturers have however requested a re -certification after the deadline given by the Notified 
Body or are not able to fulfil more specific requirements that have been introduced since the previous 
certification Overall, the grace period should however provide for ample time to receive a certification 
under t he new Regulations.  
 
It should be noted that the scope of the transitional period was clarified by the corrigendum exercise 
finalised in December 2019, allowing also up -classified lower risk devices that would require the 
involvement of a Notified Body for  the first time under the MDR, to benefit from the transitional 
period. The corrigendum is estimated to have significantly alleviated pressure on notified bodies and 
to have ensured availability of certain essential devices (e.g. certain surgical instrumen t). 
 
As a final resort (in duly justified cases and in the interest of public health or patient health or 
safety), national competent authorities may authorise within their territory the placing on the market 
of specific devices which have not fulfilled th e conformity assessment requirements. In exceptional 
cases, the Commission may decide to extend those national measures to the territory of the Union 
for a limited duration.  
 
Stakeholder organisations have reported that careful planning and preparations ha ve enabled a vast 
majority of their members to take the measures needed for compliance with MDR as from the 
application date. Notified body associations have informed that they are dealing with the 
re certifications requested within the deadlines given.  
 
The option of postponing the date of application has been discussed on several occasions and each 
time the benefits of keeping the current deadlines have been found to outweigh the possible 
problems relating to bottlenecks of certification capacity, for whi ch mechanisms to mitigate have 
been foreseen in the legislation.  
 
In light of all these elements and taking into account that the implementation activities are overall 
progressing according to plan, there are no grounds to explore any amendment to the tran sitional 
periods of the two Regulations. The EU is fully committed at this stage to ensure that the new system 
is introduced with no delay, to ensure a higher level of patient protection.  
 
Page 111, paragraph 3.177: This paragraph addresses the role of acc reditation as the last level 
of public control in the EU's conformity assessment system. The European Commission appointed 
the European Cooperation for Accreditation (EA), an association of Member State accreditation 
bodies, as the official accreditation i nfrastructure for the EU.  
 
21. Please provide additional information about this system, including:  
 
b. How can one accreditation body per Member State have the resources to capably 
assess all mandatory and voluntary conformity assessment requirements withi n its 
jurisdiction?  
 WT/TPR/M/395/Add.1  
 
- 595 - 
 
  EU reply:   
According to Regulation (EC) No . 765/2008, each Member State shall ensure that its national 
accreditation body (NAB) has the appropriate financial and personnel resources for the proper 
performance of its tasks.  
 
NABs, covering the accreditation of conformity assessment bodies for all or  most of the conformity 
assessment activities and the supplement requirements, have all the resources needed. That is 
checked during the EA peer evaluation.  
 
In this regard, it should be noted that the big NABs in the EU, which cover all/most activities, h ave 
up to 300 employees plus more than 1000 external assessors.  
 
U.S. Follow -Up:  
5. The Commission reply indicates that the EA must submit to the Commission a report 
on its activities. Is this an annual report? What happens if the Commission finds EA's work 
to be inadequate in relation to a specific activity?  
 
EU reply:  
The relations between the European Commission and EA are governed by the "General Guidelines 
for the Cooperation between EA and the European Commission, the European Free Trade Assoc iation 
and the competent national authorities" ( OJ C116, 21.5.2009, p. 6) (the "Cooperation Guidelines"), 
and the Framework Partnership Agreement concluded between the European Commission and EA 
every four years.  
 
On this basis, EA submits for approval to the European Commission an annual report to the 
Commission regarding the implementation of its activities. EA is also expected to take due account 
of advice and guidance offered by the European Commission on policy matters related to 
accreditat ion. 
 
6. The Commission notes there are a few large National Accreditation Bodies in a few 
Member States that are able to assess the bulk of conformity assessment requirements 
for the EU market. Does the EU have any oversight authority over peer reviews of  
accreditation bodies? Is there any reporting relating to this that EA must provide to the 
Commission?  
 
EU reply:  
In accordance with the Cooperation Guidelines, EA is expected to inform the European Commission 
about policies and activities under developmen t that are of mutual interest and regularly report on 
EA's strategic and policy development. This includes information on the operation of the European 
peer evaluation system managed by EA.  
 
3.3.3 Sanitary and Phytosanitary Requirements  
 
Page 116, paragraph 3.214:  Regarding sanitary and phytosanitary measures, the Secretariat's 
report describes new regulations and refers to Table 3.21 Principal SPS legislation in the EU in 2019.  
 
27. Please explain how the EU fulfils its directive under Regulation (EC) No. 396/2005 
to evaluate MRLs and import tolerances on the basis of risk when hazard -based criteria 
established under Regulation (EC) No. 1107/2009 are triggered.  
 
EU reply:  
Regulation (EC) No . 1107/2009 concerning the placing of plant protection pr oducts on the market 
stipulates that active substances cannot be approved or renewed if they are classified as 
carcinogenic, genotoxic, or toxic for reproduction following Regulation (EC) No . 1272/2008, or if 
they have endocrine disrupting properties, and if they do not benefit from certain specific derogations 
set in the legislation for a potential restricted approval.  
 
Regulation (EC) No . 396/2005 on maximum pesticide residues in food and feed allows for the setting 
of MRLs and import tolerances. This Reg ulation follows a step -by-step risk assessment approach as 
provided for by Codex Alimentarius and does not address the particular situation of substances 
meeting the above mentioned criteria. Until today, due to the transitional measures of Regulation 
(EC) No. 1107/2009 and the overall delays in the renewal programme for existing active substances, WT/TPR/M/395/Add.1  
 
- 596 - 
 
  the EU does not have yet any experience on MRL and import tolerance setting for substances falling 
under these criteria.  
 
U.S. Follow -Up:  
7. When does the EU e xpect to begin applying its directive under Regulation (EC) 
No. 396/2005 to evaluate MRLs and import tolerances on the basis of risk when 
hazard -based criteria established under Regulation 9EC) No. 1107/2009 are triggered?  
 
EU reply:  
This question cannot be answered with a fixed date. It depends when an MRL application (including 
import tolerance request) in accordance with Regulation (EC) No . 396/2005 is submitted for a 
substance that meets the human health -related cut -off criteria of Regulation (E C) No . 1107/2009.  
 
Page 118, para 3.218: The Secretariat Report describes the role of the Standing Committee on 
Plants, Animals, Food and Feed (SCOPAFF) in delivering opinions on draft implementing measures. 
In 2019, the SCOPAFF intended to move forward in  establishing import tolerances for clothianidin. 
Despite clear evidence that there would be no risk to consumers associated with residues of this 
substance. The European Parliament blocked the standards from being adopted.  
 
29. Please explain the process es in place to ensure compliance with the EU's WTO 
obligations in situations where the European Parliament rejects SCOPAFF opinions on 
draft implementing measures.  
 
EU reply:  
EU measures on maximum residue levels follow the so -called regulatory procedure  with scrutiny in 
which the European Parliament and the Council have the right to object within a certain time span. 
In March 2019 the European Parliament objected to a draft measure that proposed to establish an 
import tolerance for clothianidin in potato es. The measure was therefore not adopted. In the light 
of the EP objection, the Commission is currently reflecting about the further steps to be taken in this 
matter.  
 
U.S. Follow -Up:  
8. Please provide an update on the European Commission's reflection o n further steps 
to be taken in this matter.  
 
EU reply:  
There have been no new developments since our first reply. The Commission is still reflecting about 
the further steps to be taken in this matter.  
 
9. Please provide an update in terms of the processes in place to ensure compliance 
with the EU's WTO obligations in situations where the EP rejects SCOPAFF opinions on 
draft implementing measures.  
 
EU reply:  
In the event that the European Parliament opposes draft measures that received a favourable  opinion 
by the Standing Committee on Plants, Animals, Food and Feed, the Commission shall not adopt 
them. In that event, the Commission may submit to the Committee an amended draft of the 
measures or present a legislative proposal on the basis of the Trea ty of the European Union.  
 
Page 119, paragraph 3.219: The Secretariat's report states that the European Food Safety 
Authority (EFSA) is "responsible for risk assessment for food and feed safety, nutrition, animal health 
and welfare, plant protection, and p lant health, as well as, through environmental risk assessments, 
the possible impact of the food chain on biodiversity."  
 
30. Please explain the process or criteria used by the Commission when it sets standards 
that are more trade restrictive than existing international standards or more trade 
restrictive than a finding by the EFSA that is consistent with that of the relevant 
international standard setting body.  
 
EU reply:  
Regulation (EC) No . 178/2002 on General Food Law (hereinafter, the "General Food Law ") 
establishes certain general principles underpinning the development of EU food law. The most WT/TPR/M/395/Add.1  
 
- 597 - 
 
  important of these is the risk analysis principle consisting of three separate but interrelated 
components: risk assessment, risk management and risk co mmunication. Risk assessment at EU 
level is carried out by an autonomous agency (EFSA), separately from the EU risk management 
function, exercised mainly by the European  Commission (but also by the European Parliament and 
the EU Member States). Risk manage ment decisions are to take into account the results of the risk 
assessment (EFSA's scientific output) but also other legitimate factors.  
 
As laid down in the Fitness Check of the General Food Law (a comprehensive policy evaluation of 
this Regulation can be found at: https://ec.europa.eu/food/safety/general_food_  
law/fitness_check_en), the EU has made considerable efforts to ensure alignment of EU food law 
with international standards, following its introduction in 2002. This is also reflected in other EU 
secondary food legislation, where specific reference to international standards in the development 
of food law is made; as a consequence, ad aptation of EU law takes place in line with international 
standards. There are few cases, however, where EU measures are stricter than the international 
standards established.  
 
Where EU measures are more trade -restricting than the EU risk assessment delive red by EFSA that 
is consistent with international standards, this is because EU risk managers considered appropriate 
that other legitimate factors had also to be considered in addition to the EU risk assessment findings. 
This is part of the risk management  process as outlined in Regulation (EC) No . 178/2002 on General 
Food Law. In the absence of an exhaustive list of legitimate factors in the General Food Law 
Regulation, the EU risk managers have in the past considered as legitimate factors nutritional 
advantages and disadvantages, societal factors, ethical considerations, impact on non -
communicable diseases (e.g.  obesity), lack of mitigation measures, animal welfare as well as 
economic factors. The use of legitimate factors in the EU decision -making process  is not static; the 
exact range of factors and the weight attributed to them varies on a case -by-case basis depending 
on the subject matter and the measure concerned.  
 
Where the EU risk management decisions departed from the EU risk assessment delivered by  EFSA, 
an explicit justification to that effect was systematically included in the preamble to those decisions. 
As far as the application of legitimate factors in the area of food law is concerned, the Court of 
Justice of the European Union also recognized  that "[i]n some cases, scientific risk assessment alone 
cannot provide all the information on which a risk management decision should be based, and other 
legitimate factors relevant to the matter under consideration should therefore be taken into account.  
In the light of the foregoing, the Commission must be recognised as enjoying a broad discretion in 
an area which entails political, economic and social choices on its part, and in which it is called upon 
to undertake complex assessments."  
 
U.S. Follow -Up:  
10. Please clarify how societal factors and ethical considerations will be measured in a 
socio -economic impact analysis in a science -based SPS regulatory decision -making 
process.  
 
11. How have these factors been used in the past to challenge a science based SPS 
regulatory decision?  
 
12. Please clarify which regulatory body will determine and/or measure the societal 
factors and ethical considerations conditions in these socio -economic impact analyses as 
part of a science -based SPS regulatory deci sion-making process.  
 
13. Please explain the scientific basis of these societal factors and ethical 
considerations.  
 
EU reply to questions 10 - 13: 
 
- Risk assessment at EU level is carried out by an autonomous agency (EFSA) and provides the 
scientific basi s of EU decision making. It is performed separately from the EU risk management 
function, exercised mainly by the European Commission (but also by the European Parliament and 
the EU Member States).  
 
- Risk management decisions are to take into account the re sults of the risk assessment (EFSA's 
scientific output ) but also other legitimate factors . WT/TPR/M/395/Add.1  
 
- 598 - 
 
  - This is part of the risk management process as outlined in Regulation (EC) No . 178/2002 on 
General Food Law.  In the absence of an exhaustive list of legitimate facto rs in the General Food Law 
Regulation, the EU risk managers have in the past considered as legitimate factors nutritional 
advantages and disadvantages, societal factors, ethical considerations, impact on non -
communicable diseases (e.g. obesity), lack of mi tigation measures, animal welfare as well as 
economic factors. The use of legitimate factors in the EU decision -making process is not static; the 
exact range of factors and the weight attributed to them varies on a case -by-case basis depending 
on the subje ct matter and the measure concerned.  
 
- Where the EU risk management decisions departed from the EU risk assessment delivered by 
EFSA, an explicit justification to that effect was systematically included in the preamble to those 
decisions. For example, desp ite EFSA's favourable opinion, health claims on the effect of fats on the 
normal absorption of fat soluble vitamins, on the effect of sodium on the maintenance of normal 
muscle function and on the effect of glucose to energy -yielding metabolism were not in cluded in the 
list of EU authorised claims, as they were found inconsistent with generally accepted nutrition and 
health principles.  
 
- The societal factors and ethical considerations are not subject to a systematic socio -economic 
impact analysis as the use of any legitimate factors is not static and the exact range and weight 
attributed to them varies on a case -by-case basis.  
 
- As far as the application of legitimate factors in the area of food law is concerned, the Court 
of Justice of the European Union also recognised that "[i]n some cases, scientific risk assessment 
alone cannot provide all the information on which a risk management dec ision should be based, and 
other legitimate factors relevant to the matter under consideration should therefore be taken into 
account. In the light of the foregoing, the Commission must be recognised as enjoying a broad 
discretion in an area which entails political, economic and social choices on its part, and in which it 
is called upon to undertake complex assessments."  
 
Page 119, paragraph 3.221 : The Secretariat's report states, "… to a large extent, SPS measures 
in the EU have been harmonized, and most measures are taken at the EU level. Nonetheless, 
member States may, and sometimes do, take specific measures in the absence of harmonized EU 
requirements."  
 
31. How does the EU address Member State legislation that runs counter to its own 
established, harmonized rules (for example, France's measure banning cherries from 
countries that allow for the use of dimethoate, despite dimethoate having been allowed 
for use on cherries in the EU at the time)?  
 
EU reply:  
According to EU rules, Mem ber States are allowed to adopt national MRLs in very limited 
circumstances, e.g. if they have a serious health concern. Member States are obliged to notify any 
such measure to the European Commission and the other Member States. The Commission, together 
with the EU Member States, assesses whether the conditions for taking such measures are fulfilled 
and whether harmonised action at EU level is needed. In the case of dimethoate/omethoate the 
Commission acknowledged the serious health concerns raised by a Me mber State and proposed to 
follow -up in the already ongoing renewal of approval procedure of dimethoate. Due to serious health 
risks dimethoate was not renewed in 2019 and the EU is currently in the process to also lower the 
existing maximum residue levels  for cherries to the limit of quantification.  
 
U.S. Follow -Up questions  
 
14. France banned fresh cherry imports where dimethoate was authorized. Whether or 
not growers applied the pesticide to crops wasn't considered; the cherries were banned 
nonetheless, organics being the exception. On 18 April 2019, France continued its 
"emergency" ban on fresh cherry imports.  
 
a. Please explain why this measure is considered an "emergency?" Please also explain 
how the designation of this measure as an "emergency" justi fies that it remains in place 
for four years?  
 WT/TPR/M/395/Add.1  
 
- 599 - 
 
  EU reply:  
According to Regulation (EU) 2019/1090146,147, the approval of dimethoate was not renewed due to 
serious health concerns. Consequently, all maximum residue levels will be lowered to the limit of 
quantification. France made use of its right under Article 54 of Regulation (EU) 178/2002 to adopt 
interim protective measures before the final non -renewal decision was taken, as their assessment 
showed that health concerns could not be ruled out. This is possible under EU legislation and such a 
measure can also be repeated.  
 
b. Will the EU explain how the Commission (DG Health and Food Safety) is working 
with France on finding less trade restrictive measures, and how?  
 
EU reply:  
As explained above the EU legislation gives Member States the right to take national interim 
protect ive measures under the General Food Law (Regulation (EC) No. 178/2002, if it has informed 
the Commission and the Member States of the need for such measures, and if the Commission has 
not acted according to Art. 53 of the Regulation.  
 
3.3.6 Government proc urement  
 
Page 141, Paragraph 3.303: The Secretariat's report notes that the contracting authorities may 
divide procurements into lots and further explains that if the total value of the lots is above the 
EU thresholds, then the procurement must be subject to EU rules. The Secretariat's report further 
notes that this does not apply to small lots below a certain level.  
 
57. Please provide the guidance that is provided to contracting authorities on how to 
determine when contracts should be divided into  lots and how to divide the contract .  
 
EU reply:  
The division into lots is regulated by Article 46 of Directive 2014/24/EU on public procurement, with 
additional clarifications provided by recitals 78 and 79 of the same act. Similar provisions can be 
found in Directive 2014/25/EU on utilities.  
 
U.S. Follow -Up: 
 
15. We note that Article 46 of Directive 2014/24/EU does not reference the EU's 
procurement obligations under Article II (6) of the WTO Government Procurement 
Agreement (GPA), which prohibits a pro curing entity from dividing a procurement into 
separate procurements in order to exclude procurement from the application of the GPA. 
Please clarify how the EU ensures that contracting authorities comply with the GPA when 
determining whether to divide proc urement into separate lots.  
 
EU reply:   
Article 5, paragraphs 8 and 9 of Directive 2014/24/EU provides that, where a procurement may 
result in contracts being awarded in the form of separate lots, account shall be taken of the total 
estimated value of all  such lots, and that where the aggregate value of such lots is equal to or 
exceeds the relevant threshold, the Directive shall apply to the awarding of each lot. For covered 
procurements, these provisions ensure compliance with the GPA.  
 
3.3.7.2.4 Geographical indications  
Page 154, paragraph 3.361:  The Secretariat's report notes the GI protection acquired via FTAs.  
 
77. Could the EU clarify how it indicates which terms are generic terms in compound 
GIs, when included in the lists of GIs exchanged via an FTA?  
 
EU reply:  
The identification of a "generic term " depends on the de facto use in any particular territory. Within 
the EU, the Court of Justice of the EU has ruled that all relevant factors shall be taken into account 
when determining  if a term is generic. In particular, the existing situation in areas of consumption 
and relevant national or Union legal acts should be considered. Generic status is not a form of 
 
146 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1090&from=EN . 
147 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32019R1090R(01)&from=EN . WT/TPR/M/395/Add.1  
 
- 600 - 
 
  intellectual property right: there is no explicit right to use a generic te rm meaning there is a general 
freedom to use a generic term, as no other operator is able to protect it either as a trademark or as 
a GI. As generic determination, in a territory concerned, is a question of de facto use, in case of a 
changing reality and i n particular shifting consumer appreciation, the generic status of a name can 
weaken.  
 
GIs are protected under EU legislation and under bilateral agreements that include related 
provisions. GIs containing compound terms are protected as one name. In genera l, operators are 
aware if terms are generic, including terms within a compound GI. Nevertheless, in case of a dispute 
a final legal determination can only be made by the courts. Protection of GIs (including the compound 
term GIs) that are part of an agreem ent follows the legal provisions of the relevant agreement and 
the parties' legal system for implementation and enforcement of the agreement.  
 
The EU is aware that in some jurisdictions 'disclaimer texts' are used, for instance "protection is not 
sought fo r [x]". Concerning trademarks, the Court of Justice has recently ruled that in the EU such 
"disclaimer texts " have no legal value in the validity assessment of trademarks on ground of 
likelihood of confusion (Case C -705/17 Hansson, 12 June 2019). The legal  criteria cannot be 
circumvented by using a disclaimer text. Although there is no explicit ruling on the validity of 
"disclaimer texts " for GIs, the precedent from trademark law would seem pertinent. The EU 
discontinued the use of disclaimer texts regardin g GI registration in the 1990s.  
 
U.S. Follow -Up: 
The EU relies on Case C -705/17 Hansson, 12 June 2019, to highlight the lack of validity 
of disclaimer for trademarks in a likelihood of confusion analysis. This case points to 
Directive 2008/95 which indicates that signs consisting exclusively of signs or indications 
that are descriptive of categories of goods or services for which registration is sought are, 
pursuant to Article 3(1)(c), not registered or are declared invalid, and may thus be freely 
used by other economic operators. However, the analogy with trademarks is imperfect. 
Whereas the generic nature of a trademark can often be readily determined by consulting 
a dictionary or other reference document, a term in a GI may be generic due to prior non-
exclusive use by numerous parties. For example, provolone is a type of cheese that is now 
produced in many countries. A dictionary may indicate that provolone originated in 
France, but may not go on to explain it can be made elsewhere.  
 
16. Does the EU  plan to indicate which terms are generic in its compound GIs, in order 
to provide certainty for WTO members and their producers?  
 
EU reply:   
WTO rules do not require a WTO Member to draw up a list of terms considered common or generic 
in its territory. Th e only provision related to common terms in Article 24.6 TRIPS provides that a 
member is not obliged to protect a geographical indication of another member in its national legal 
system, if it is identical with a term customary in common language as the com mon name for a 
product in its territory. An application for registration of a geographical registration in the EU is 
subject to an opposition procedure, during which the generic nature of the name can be alleged as 
an argument against protection. Thus, the  genericity of a name or part of name is assessed on case -
by-case basis. Generic status does not create a 'right' in intellectual property law. Further, the 
generic nature of a name may change over time, whether to render generic in a territory a name 
that was specific, or that a name originally generic becomes specific in a territory and thus capable 
of protection as a form of IPR. Attempts to lay down fixed lists of generics, irrespective of territory 
or relevant factors such as consumer perception, are c ontrary to basic principles of intellectual 
property law, rights that in the EU are guaranteed under the EU Charter of Fundamental Rights.  
 
17. How will the EU comply with the Geneva Act of the Lisbon Agreement, which requires 
contracting parties to protec t non -agricultural GIs?  
 
EU reply:   
The EU will only protect GIs of other members of the Geneva Act for products in respect of which 
protection at EU level of GIs is provided. There is no operating means at EU level to grant specific WT/TPR/M/395/Add.1  
 
- 601 - 
 
  GI-protection to non -agricultural products .148 However, many products benefit from such a specific 
protection at national level and EU collective and national trade  marks also provide a certain level 
of protection. The Commission is finalizing a study on the economic aspects of geographical 
indication (GI) protection for non -agricultural products at EU level, to collect further economic 
evidence on the need and possible added value of the protection of GIs for non -agricultural products.  
 
18. The European Court of Justice has hel d that the essential function of an EU collective 
mark is not to distinguish goods according to their geographical origin but according to 
their commercial origin. Could the EU clarify how its collective mark protection for 
non-agricultural GIs is equivalent to its sui generis system for GIs?  
 
EU reply:   
EU collective trade -mark protection provide a certain level of protection to geographical indications 
for non -agricultural products.  
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.1 Agriculture  
4.1.1.2.1.2 Internal market support measures  
 
Page 174, paragraphs 4.49, 4.50 & 4.51:  According to the Secretariat report, public intervention 
stocks of skimmed milk powder (SMP) reached 380,000 metric tons at the end of 2017. T he report 
says that these stocks were sold back into the market through tenders in 2018 and 2019, and that 
by July 2019, intervention stocks of SMP had declined to zero.  
 
83. Please respond to the following questions about the SMP intervention program:  
c. During 2018 and 2019, to what extent did the EU sales of SMP from intervention 
stocks depress prices for SMP on the EU domestic market and on the international market?  
 
EU reply:  
The minimum selling prices accepted in the tender followed the r ecovery in prices in 2018 -19. There 
was no downward pressure on market prices. On the contrary, during the period between 
January  2018 and June 2019, when most of these stocks were released to the market, the EU price 
for skimmed milk powder increased by 4 3%. See page 4 of the Milk Market Observatory: 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -milk-
internal -measures -stocks_en.pdf and page 1 of the Milk Market Observatory on dairy commodity 
prices: https://ec.europ a.eu/info/sites/info/files/food -farming -fisheries/farming/documents/eu -
dairy-commodity -prices_en.pdf . 
 
U.S. Follow -Up:  
19. The reply asserts that the SMP sales of intervention stocks had no downward 
pressure on market prices during the 2018 -2019 period. W hile the EU price for SMP may 
have recovered  during this period, the volume of intervention stocks sold back into the 
market (380,000 metric tons) was equivalent to about 16 percent of the annual global 
trade in SMP. Please explain how such a large volume of SMP sales at discounted prices 
would not have a significant negative impact on the international price for SMP.  
 
EU reply:   
The EU disagrees with the US' assumption that large volumes of SMP were sold at a discounted 
price. The EU underlines that during the period of sales, market prices increas ed - just as prices 
decreased by less during the buying -in period than they would have done without intervention. The 
US seems to focus only on the first period and not on the period during which the world market 
benefitted substantially.  
 
Data shows that not only the EU internal price, but also the US and Oceania prices for Skimmed Milk 
Powder increased in 2018 -2019.  
 
148 The Commission holds a delegated p ower to extend coverage of GIs to products closely linked to 
agricultural products or to the rural economy, in order to take into account international commitments or new 
production methods or material.  WT/TPR/M/395/Add.1  
 
- 602 - 
 
  (See document https://ec.europa.eu/info/sites/info/files/food -farming -
fisheries/farming/documents/world -dairy-commodity -prices_en.pdf of the Milk Market Observatory, 
page 2).  
 
Selling public stocks to private operators does not mean that the corresponding volume finds itself 
as such on the market. Private company stocks were particularly low when significant sales of public 
stocks took place an d demand was dynamic, including on the EU market. (See document 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/documents/mmo -report -
2018-09-25_en.pdf of the Milk Market Observatory, page 42).]  
 
e. What were net EU financial outlays for the SMP intervention program over the 
2015 -19 period, taking into account intervention purchase costs, storage costs, and sales 
receipts?  
 
EU reply:  
Up to and including September 2019, the EU's total expenditure was EUR 137 million. This takes 
into account storage costs, some logistical costs at entry into storage and at exit, and price 
depreciation between buying -in and selling. Not the EU, but the Member States own the intervention 
stocks: Member States financed the buying -in price and received the selling price. The EU only 
covers the storage costs, price difference and financial costs (for the stocks in questions interest 
rate was fixed at 0%).  
 
U.S. Follow -Up:  
20. The reply notes that Member States, not the EU, financed the purch ase and collected 
the sales  revenues from intervention transactions. Please provide details on individual 
Member State purchase costs and sales revenues from the SMP intervention program 
during the period in question.  
 
EU reply:   
Member States purchased Skimmed Milk Powder at the reference price of EUR 1,698 per tonne. They 
sold this product at the prices granted in the EU -level tender. (See document 
https://ec.europa.eu/info/sites/info/files/food -farming -fisheries/farming/document s/eu-milk-
internal -measures -stocks_en.pdf of the Milk Market Observatory, page 4). The EU reimburses 
Member States for their costs for taking -in, storing and taking out of stocks. The financial costs 
reimbursement was been fixed at zero, due to a situation  with negative interest rates. Therefore, 
Member States did not incur any additional costs other than those reimbursed by the EU.  
 
Questions based on the Government Report (WT/TPR/G/395 ) 
 
4 TRADE AND INVESTMENT POLICY DEVELOPMENTS  
4.3 Promoting a sustainable approach to trade  
4.3.1 Promoting labour rights and environmental protection  
 
Page 20, paragraphs 4.32 – 4.33:  The Government's report briefly discusses labor rights and 
environmental protection.  
 
97. Please explain the EU plans under its Gree n Deal, particularly with respect to 
strengthened trade -related measures on environment and labor?  
 
EU reply:  
Trade policy can support the EU's ecological transition. It serves as a platform to engage with trading 
partners on climate and environmental action. Commitments to sustainability have been 
continuously strengthened in EU trade agreements, in particular with regard to enhancing climate 
change action. The Commission has also been stepping up efforts to implement and enforce the 
sustainable development commitments of EU trade agreements, and these efforts will be further 
enhanced with the appointment of a Chief Trade Enforcement Officer.  
 
On climate change more specifically, the EU's most recent agreements all include a binding 
commit ment of the Parties to ratify and effectively implement the Paris Agreement. The Commission 
will propose to make the respect of the Paris Agreement an essential element for all future 
comprehensive trade agreements.  WT/TPR/M/395/Add.1  
 
- 603 - 
 
  The EU's trade policy facilitates trade  and investment in green goods and services and promotes 
climate -friendly public procurement. Trade policy also needs to ensure undistorted, fair trade and 
investment in raw materials that the EU economy needs for the green transition. It can help address 
harmful practices such as illegal logging, enhance regulatory cooperation promote EU standards and 
remove non -tariff barriers in the renewable energy sector.  
 
U.S. Follow -Up:  
21. In May 2019, the Council adopted conclusions on "An EU Industrial Policy St rategy: 
Vision 2030". How will the EU's new Industrial Strategy, to be released in March 2020 per 
the Green Deal Communication, differ from the 2019 conclusions?  
 
EU reply:  
The Council Conclusions from May 2019 reiterates the calls by the European Council for a 
comprehensive and long -term EU industrial policy strategy with a clear vision for 2030, highlighting 
the opportunities and addressing the challenges for European industry, touching upon all relevant 
policy areas. The Conclusions highlight the  key areas for such a long -term industrial vision. The new 
Industrial Strategy presented by the European Commission on 10 March 2020 sets out the vision for 
2030 and beyond for EU industrial future, in line with the calls by these Council conclusions, as w ell 
as March 2019 European Council and other Council conclusions.  
 
Both the May 2019 Council conclusions and the 10 March 2020 Industrial Strategy take an integrated 
approach to industrial competitiveness and cover all relevant policy and instruments for i ndustry. 
Furthermore, the new Industrial Strategy builds on the European Green Deal which the European 
Commission adopted in December 2019 and which is Europe's new growth strategy. At the heart of 
it is the goal of becoming the world's first climate -neutr al continent by 2050.This is a new political 
context and new ambition for Europe, which were not yet there at the time of the May 2019 Council 
Conclusions.  
 
It is also worth noting that the industrial strategy was presented together with concrete steps to 
address barriers to a well -functioning EU single market, as well as with a dedicated Strategy for 
SMEs. This SME strategy aims to reduce red tape and help Europe's numerous SMEs to do business 
across the single market and beyond, access financing and help lead the way on the digital and 
green transitions.  
 
22. Please explain how the 2020 Strategy will be deployed and how it will be consistent 
with the EU's approach to facilitating trade and investment in "green goods and services" 
as described above?  
 
EU reply:  
The new Industrial Strategy is setting a direction for a globally competitive, climate -neutral and 
digitalized industry. A shared commitment from the EU, its Member States and regions and industrial 
stakeholders as well as coordinated decisions and a ctions at all levels (European, national and local) 
will be needed to deliver on the objectives of the strategy.  
 
99. Please provide more information on which sectors will be covered by the carbon 
border adjustment mechanism and how this mechanism will be implemented?  
 
EU reply:  
The European Green Deal foresees that the Carbon Border Adjustment mechanism will be proposed 
for a number of selected sectors that are at risk of carbon leakage.  
The decision in terms of scope and coverage will be informed by the impact assessment. In any 
event, compliance with World Trade Organization (WTO) rules, trade agreements and other 
international obligations of the EU will be ensured.  
There is a breadth of considerations that need to be reviewed in the design and imple mentation of 
such a measure. Before any proposal is made, all measures will first have to be carefully assessed 
in terms of economic efficiency, environmental, social and financial impacts and legal feasibility, in 
particular with respect to WTO rules, tra de agreements and other international commitments, and 
of complementarity and possible interaction with the Emission Trading System.  
 
U.S. Follow -Up:  
23. How will the EU determine which sectors will be covered by an impact assessment, 
and how will the EU determine the parameters of the impact assessment.  WT/TPR/M/395/Add.1  
 
- 604 - 
 
  24. How will the EU determine which sectors will be at risk of carbon leakage?  
 
EU reply to question 23  and question 24:   
For details on how the impact assessment will be carried out, the EU would like to refer to the 
Inception Impact Assessment fiche available on:  
https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/12228 -Carbon -Border -
Adjustment -Mechanism . 
 
Additional Questions based on the Secretariat Report (WT/TPR/S/395 ) 
 
4 TRADE POLICIES BY SECTOR  
4.1 Agriculture and Fisheries  
4.1.2 Fisheries  
4.1.2.1 Fisheries  
4.1.2.2 Trade performance  
 
Page 189, paragraph 4.100: The EU places relatively high tariffs on their imports of fish and 
fishery products.  
 
25. Can the EU provide insight  into how it determines which exporting State is eligible 
for unilateral preference to fishery imports?  
 
EU reply:   
Those products can enter the EU market at zero or reduced duties from countries with which the EU 
has free trade agreements in force or from developing countries that benefit from the EU Generalized 
System of Preferences (GSP).  
 
Page 192 -193 table 4.12:  
 
26. What factors are taken into account for, and what is the methodology for 
determining "an imbalance" between the fishing capacity of Member State and fishing 
opportunities? How is the fishing capacity and fishing  opportunities of a Member State 
determined?  
 
EU reply:   
Total allowable catches (TACs) or fishing opportunities, are catch limits (expressed in tonnes or 
numbers) that are set for most commercial fish stocks. The Commission prepares the proposals, 
based on scientific advice on the stock status from scientific advisory bodies such as the International 
Council for the Exploration of the Sea and the Scientific, Technical and Economic Committee for 
Fisheries. Some multi -annual plans contain rules for the setting of the TACs. TACs are set annually 
for mos t stocks (every two years for deep -sea stocks) by the Council of fisheries ministers. For 
stocks that are shared and jointly managed with non -EU countries, the TACs are agreed with those 
(groups of) non -EU countries.  
The EU measures capacity in terms of gr oss tonnage (volume of the vessel) and kilowatts (engine 
power). The important aspect to remember is that what is important is the size or capacity of the 
fleet in relation to the available fishing opportunities (what can be fished). An imbalance between 
the fishing capacity and the fishing opportunity occurs when the capacity has a negative impact on 
the available fishing opportunities and overall balance of the fleet. In this respect, fishing 
opportunities includes all fishing opportunities available to a  specific fleet (coastal waters, distant 
waters, etc.).  
 
Page 192 -193, t able 4.12 : The  Common Fisheries Policy  (CFP) set a deadline to end overfishing 
by 2020. According to various non -governmental organizations, the limits recently set by ministers 
sugges t that progress to end overfishing has stalled or may have even been reversed.  
 
27. Please comment on why the goal to end overfishing will not be met.  
 
EU reply:   
There has been significant progress towards sustainable fishing in the Atlantic. The rate of 
overexploitation, which was 70% in the North -East Atlantic ten years ago, has drastically declined 
thanks to the more responsible catch limits the EU has set. The numbers are now reverse: in 2020, 
an estimated 99,4% of the volume of stocks managed by the EU alone and subject to full scientific WT/TPR/M/395/Add.1  
 
- 605 - 
 
  assessment will be fished sustainably. Where stocks are shared with non -EU countries, achieving 
Maximum Sustainable Yield (M SY) raises specific challenges since it requires that the non -EU 
countries share the goal and agree on the modalities to achieve it.  
Furthermore, scientists are not yet in a position to provide MSY advice for all stocks due to the lack 
of sufficient data,  notably for deep -sea species or in the Mediterranean. The situation has improved 
significantly in the last years but further improvement of the data collection systems managed by 
the Member States is required. We will however continue working closely with  ICES, STECF and the 
GFCM (for the Mediterranean and Black Sea) on enhancing the scientific advice and data collection 
where improvement is necessary.  
 
4.1.2.4 Market access and import requirements  
 
Page 193 -194, paragraph 4.110: The EU places relatively h igh tariffs on their imports of fish and 
fishery products. Can the EU provide insight into how it determines which exporting State 
is eligible for unilateral preference to fishery imports?  
 
Page 196, paragraph 4.116 - Do EU fishers pay for access to non -EU fisheries, in addition 
to the government -to-government payments?  If so, how is the amount of such payments 
determined?  
 
28. How much money does the EU provide to SFPA partners under each of the access 
agreements?  
 
EU reply:   
The annual EU budget dedicated to SFPAs amount to around 135 Million euros by year ranging from 
550 000 euros to around 57 000 000 euros. A significant pa rt of the total EU budget for SFPAs has 
been devoted to the development of the fisheries sector in the partner countries and to better 
governance of their fisheries sector, in particular through the sectoral support component of the 
Agreements. Concrete pr ojects funded under sectoral support related mostly to control and 
surveillance capacities, small port infrastructures, landing facilities and laboratories, equipment for 
small scale fishermen. At the same time, they contribute to eliminating illegal fishi ng and providing 
good framework conditions for local fishermen.  
 
29. How does the EU manage vessels fishing under these agreements? Do EU Member 
States contribute to these payments  or does the EU solely fund the access agreements?  
 
EU reply:   
The activities of EU fishing vessels active under SFPAs are regularly monitored b y the EU and its 
member States, in particular regarding related effort and catch data. EU vessels also contribute 
financially to the cost of access, both through a fixed part linked to the acquisition of a fishing 
authorization and through a variable part depending on their level of catches.  
 
30. How does the EU ensure that EU vessels do not carry out IUU fishing?  
 
EU reply:   
The EU Regulation to prevent, deter and eliminate illegal, unreported and unregulated fishing (IUU 
Regulation) entered into force on 1 January 2010. It applies to all landings and transhipments of EU 
and third -country fishing vessels in European ports, and all trade of marine fishery products to and 
from the EU. It aims to make sure that no illegally caught fisheries products end up on the EU 
market. To achieve this, the Regulation requires flag States to certify the origin and legality of the 
fish, thereby ensuring the full traceability of all marine fishery products traded from and into the EU. 
The system thus ensures countries comply with their own conservation and management rules as 
well as with internationally agreed rules.  
 
31. Do the harvests caught  under access agreements count against EU quotas under the 
relevant tuna and multi -species agreements?  
 
EU reply:   
Catches occurring under SFPAs are counted against the quota, when relevant, belonging to the EU 
or its member States, as appropriate.  
 WT/TPR/M/395/Add.1  
 
- 606 - 
 
  Page 197, paragraph 4.117  The Secretariat notes that 89% of the EMFF goes to member States 
based on criteria related to the size of its fishing industry.  
 
32. What amount of EMFF goes  to fishing vessels and activities taking place outside of 
EU waters? That is, of the support allocated to each State, what is the total amount being 
spent on distant water fishing?  
 
EU reply:   
Accordin g to the latest data available, three Member States provided EMFF support to vessels fishing 
long-distance in fisheries outside EU waters. Less than 0.1% of the total support provided to those 
Member States was invested in the long -distance fleet.  
 
33. Are vessels not flying the flag of the EU Member State, but owned by a citizen of the 
Member State, eligible  for support?  
 
EU reply:   
No. Recital 2 of the EMFF states that vessels supported by the EMFF should be Union fishing vessels, 
flying the flag of a Mem ber State. Furthermore, Member States must publish details on each EMFF 
operation supported (Article 119 of EMFF). In cases where the operation is linked with a vessel, the 
CFR number (Community Fleet Register) must be provided. A vessel must fly the flag of a Member 
State to have a registered CFR number.  
 
Page 197 -198, paragraph 4.119:  
34. To what extent is assistance under Article 2 of the Fishery and Aquaculture Block 
Exemption Regulation  currently provided for fishing and fishing related activities (other 
than aquaculture)?  
 
EU reply:  
Information provided by Member States on State aid tha t meets the conditions of Commission 
Regulation (EU) No . 1388/2014  (the Fisheries Block exemption regulation or FIBER) is published on 
the Competition website:  
http://ec.europa.eu/competition/elojade/isef/index.cfm?clear=1&policy_area_id=3 . 
 
  WT/TPR/M/395/Add.1  
 
- 607 - 
 
  URUGUAY  
En los párrafos 2.12 a 2.24 del informe de la Secretaría se exponen los avances del bienio en materia 
de formulación de la política comercial. En el informe se señala que se está siguiendo una estrategia 
de "Comercio para todos ". El gobierno de Uruguay está muy interesado en aumentar la transparencia 
y participación ciudadana en el proceso de toma de decisiones en materia de política comercial. Ante 
esto surgen las siguientes preguntas:  
 
Pregunta 1  
Párrafo 2.17 - Se afirma que bu scando un proceso negociador transparente e inclusivo "se 
animó a los Estados miembros a garantizar la participación de los parlamentos nacionales 
en las negociaciones comerciales de la UE en la fase más temprana posible" . ¿Podría 
ampliar qué procedimiento s se utilizaron a los efectos de garantizar esta participación?  
 
EU reply:  
The Commission publishes on its homepage its recommendations for negotiating directives for trade 
agreements and also the EU 's initial negotiating proposals. This increases transparency and 
facilitates public discussions, including in national parliaments, from the outset of negotiations, and 
even before the decision to open negotiations is taken by the Council. The Commission welcomes 
such discussions in the Parliaments of t he Member States, the feedback of which will then reach the 
EU institutions through the Council. The actual procedure for involvement of Member States ' 
parliaments will depend on each Member State 's institutional setting.  
  
Pregunta 2  
Párrafo 2.19 - Con to do el debate en curso en UNCTAD y OCDE sobre las redacciones de 
los acuerdos de inversiones de primera generación, ¿está en los planes de la Comisión la 
renegociación de los acuerdos de primera generación?  
 
EU reply:  
Following the entry into force of the L isbon Treaty in 2009, the EU acquired exclusive competence 
for investment protection as regards foreign direct investment. The EU is closely engaged in the 
international debate in UNCTAD and OECD on reforming old -generation investment agreements. 
Following  up on the international and European debate, the EU has substantially reformed its 
approach to investment protection and has introduced modernised standards on investment 
protection and investment dispute settlement in its recent agreements. The Commissio n also 
encourages EU member States to modernise their older agreements to ensure consistency with the 
EU's approach. In accordance with Regulation 1219/2012 on the transitional arrangements for 
bilateral investment agreements concluded between EU member St ates and third countries, the 
Commission insists on the inclusion of reformed investment protection and dispute settlement 
provision whenever such agreements are amended or renegotiated.  
 
Pregunta 3  
Párrafo 2.21 - ¿Podría ampliar sobre las diferencias y si militudes entre los enfoques de 
los cuatro estudios de evaluación de impacto que se realizan, así como la forma y 
momento en que dichos estudios son presentados a la sociedad civil y a los Estados 
miembros?  
 
EU reply:  
The European Commission evaluates the impact of major trade initiatives before, during and after 
negotiations:  
 
1. At the initial stage , the Commission conducts Impact Assessments, which are prepared for all 
Commission initiatives that are likely to have significant and identifiable economic, environmental or 
social impacts. T hey will usually be prepared for major trade negotiations for which the Commission 
will adopt a recommendation for a negotiating directive and for major draft regulations proposed by 
the Commission w hich will later be discussed and adopted by the Council and European Parliament. 
Civil society is consulted via Open Public Consultations. The final Impact Assessments are published 
at the same time as the Commission adopts its proposal. It can then be use d by the Council, the 
European Parliament and national institutions as background information when they start their 
discussions.  
 WT/TPR/M/395/Add.1  
 
- 608 - 
 
  2. During the negotiations , Sustainability Impact Assessments (SIAs) are conducted. These are 
trade -specific and independent e x ante assessments outsourced by the Commission to external 
consultants, academics or think tanks. SIAs contribute to the integration of sustainable development 
issues into trade negotiations; they ensure that trade agreements promote sustainable developme nt 
and that stakeholder input into the negotiations is collected in a transparent manner. They 
complement the earlier Impact Assessments by allowing a more in -depth analysis of the potential 
economic, social, human rights and environmental impacts and faci litate wider outreach with 
stakeholders, through Open Public Consultations, Civil Society Dialogues and workshops in the EU 
and partner countries during the negotiations. A key feature is that the consultants provide a set of 
recommendations that can feed into the negotiating process or can suggest other flanking policy 
measures. Recommendations can be addressed to the EU institutions but also to the partner 
governments or to certain civil society organizations. Once the SIAs are concluded, the Commission 
publishes "position papers " setting out which of the recommendations it can support and how they 
have been (or will be) implemented.  
 
3. After the negotiations, the Commission conducts  an Economic Assessment of the Negotiated 
Outcome (EANO), which presents  the economic evaluation of the negotiated outcome of the 
negotiations carried out once they are finalised.  
 
4. During the implementation , the Commission also runs ex post evaluations (normally five years 
after the start of provisional application of the a greement). These studies assess whether a specific 
trade agreement or regulation is working as expected in achieving its objectives and why. Ex post 
evaluations also look for unintended effects and scope for simplification. Research for the evaluations 
is usually outsourced to external consultants, academics or think tanks. Stakeholders are also 
consulted in the process through Civil Society Dialogues and Open Public Consultations. At the end 
of the process, the Commission drafts and publishes a Commission Staff Working Document in which 
it reacts to the findings and recommendations by the consultants.  
 
SGP 
 
Pregunta 4  
En el párrafo 2.46 se afirma que las preferencias entraron en vigor por un período de 
10 años y que por el momento no se sugieren modificaci ones al régimen vigente. ¿Se 
realizaron estudios de impacto sobre el efecto en los países que han dejado de calificar 
para dichas preferencias, básicamente sobre cómo impactó esta discriminación negativa 
en ciertos sectores agro -exportadores?  
 
EU reply:   
In October 2018, the European Commission published a Midterm Evaluation of the reformed GSP. 
The evaluation, which was carried out by an external consultant, concluded that the current 
regulation has succeeded in its primary objective of better foc using preferences on the countries 
most in need. In particular, the study found that imports into the EU from countries benefitting from 
the Everything but Arms (EBA) arrangement for least developed countries increased by 62.1% in 
the average of the three years immediately following the entering into force of the new regulation 
(compared to the average of the three preceding years). Additionally, imports from countries 
benefitting from the Special Incentive Arrangement for Sustainable Development and Good 
Governance (GSP+) increased by 53.8%.  
Concerning the effects on those countries that reverted to trade under MFN rules after they ceased 
to qualify for the reformed GSP, the Midterm Evaluation found inconclusive results.  
 
IED 
 
Pregunta 5  
El párrafo 2.59 al 2.67 intenta explicitar el mecanismo de cooperación para el control de 
la IED. Los párrafos intentan transmitir tranquilidad sobre que no hay un mayor "control" 
salvo por cuestiones específicas como "seguridad", "inversión por parte de naciones", etc. 
¿Pod rían ampliarse cómo se definen términos tan amplios como "seguridad" y otros? 
¿Cada Estado miembro tiene discrecionalidad para definir el alcance de estos términos?  
 
EU reply:  
Although the Regulation does not define security or public order, it lays down i n Article 4 a 
non-exhaustive list of factors Member States may take into consideration. By way of example, in WT/TPR/M/395/Add.1  
 
- 609 - 
 
  determining whether a foreign direct investment is likely to affect security or public order, Member 
States and the Commission may consider its potential effects on critical infrastructure, including 
energy, transport, water, health, communications, data processing or storage, aerospace, defence, 
electoral or financial infrastructure.  
 
Pregunta 6   
En el párrafo 2.70 se argumenta a favor de la creación de un Tribunal de Apelación 
permanente, tal como se estableció en el CETA. Esta solución podría ser muy costosa para 
países pequeños. ¿Es la única alternativa que maneja la Comisión en estos sistemas 
mixtos? ¿Qué piensa la Comisión de las propuestas realizadas recientemente por OCDE y 
UNCTAD en la materia?  
 
EU reply:   
The EU is proposing a reformed approach to investment dispute settlement in form of Investment 
Court Systems (consisting of a Tribunal of First Instance and an  Appeal Tribunal) in all its bilateral 
investment protection negotiations. For the EU, it is crucial that the main structural elements of the 
EU's approach which guarantee the independence, impartiality, correctness and transparency of the 
decision -making process are included in all agreements, but the particularities of each individual 
negotiation partner can of course also be taken into account. In the medium term, the EU intends 
to replace all investment dispute settlement provisions of existing and futu re treaties by a permanent 
Multilateral Investment Court. Such a court would also be designed in a way that takes into account 
the special situation of smaller and developing economies. Discussions about this project are 
currently taking place within the U nited Nations Commission on International Trade Law (UNCITRAL).  
 
Contingentes Arancelarios  
 
Pregunta 7  
En el párrafo 3.44 el informe establece el Reglamento adoptado entre la UE y el Reino 
Unido sobre reparto de contingentes arancelarios. ¿Podría especificar cómo se aplicará a 
partir del 31/01/2020 lo allí especificado?  
 
EU reply:  
The EU regulations implementing the apportioned quantities of WTO TRQs will only apply once EU 
law no longer applies to and in the UK, which is after the end of the tran sition period that has started 
on 1/2/2020. During the transition, European Union law applies to and in the UK as if it was still a 
Member State. Therefore, for the time being, the UK continues to be part of the EU customs union. 
EU WTO commitments, such a s TRQs, are implemented as before for the entirety of this customs 
union.  
 
Comercio Electrónico  
 
Pregunta 8  
En el párrafo 3.55 se comenta que a partir del 01/01/2021 se empezará a aplicar el IVA 
a todas las importaciones realizadas a través de comercio ele ctrónico. ¿Podría argumentar 
en base a qué fundamentos se tomó la determinación del cambio de criterio?  
 
EU reply:  
The main drivers for the change in the VAT rules for e -commerce were to ensure taxation at the 
place of destination and that EU businesses a re on an equal VAT footing with non -EU competitors. 
Currently, the EU VAT exemption for importation of low value consignments does not exceed 22  EUR, 
however, this exemption was heavily abused by foreign sellers by constant undervaluation and mis -
descripti on of the goods. This creates an unfair disadvantage to EU businesses that need to apply 
VAT on their sales irrespective of the value of the goods. The standard VAT rates in the EU varies 
from 17% up to 27%, so the exemption for importation of low value go ods discriminated against EU 
sellers. Further details are provided in Section  4.4.3.2.2 of the WTO Secretariat Report EU TPR S395 
or can be found in the impact assessment accompanying the European Commission 's proposal to 
amend the rules: https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:52016SC0379&from=EN . WT/TPR/M/395/Add.1  
 
- 610 - 
 
  Sistema de Alerta Rápida para los Productos Alimenticios  
 
Pregunta 9  
En el párrafo 3.236 se describe el RASFF y en el párrafo 3.237 se muestra un claro aumento 
de las alert as realizadas por el sistema. ¿A qué se debe este aumento? ¿Tienen previsto 
realizar nuevas modificaciones al sistema? ¿Cómo esperan que el uso del sistema 
evolucione?  
 
EU reply:  
In 2019, there was a 10% increase in the number of notifications, confirming the trend. One reason 
for this is the rising importance of e -commerce and their control by the EU authorities, which cause 
an intense exchange of information among the RASFF members, hence the increase of the RASFF 
notifications.  
On the development of RASFF, the new Official Controls Regulation (OCR) (EU) 2017/625, applicable 
from 14 December 2019, offered a more harmonised and coherent approach to official controls and 
relevant enforcement actions along the agri -food chain. The us e of a single standard document, the 
Common Health Entry Document (CHED), will be used by operators for the prior notification of 
consignments. It will be transmitted to the border control post through a new integrated 
computerised system for official cont rols (Integrated Management System for Official Controls, 
IMSOC). In particular, IMSOC will allow the integration of all existing computerised systems 
(TRACES, RASFF, Europhyt, AAC), to optimise the handling and exchange of information, data and 
documents necessary for the enforcement of agri -food chain rules.  
 
PAC y ayudas internas  
 
Pregunta 10  
En el párrafo 4.13 se muestra que los pagos directos fueron superiores a todo el PIB de 
Uruguay. Dados los efectos sumamente distorsivos de esta política para el mundo en su 
conjunto, ¿hay propuestas que piensen en su reforma yendo hacia mecanismos más 
basados en el mercado en materia de asignación de recursos? ¿Podría explicar un poco 
más de qué se tratan los planes estratégicos que se están elaborando?  
 
EU reply:   
Under the post -2020 CAP proposal, the vast majority of EU support including most of the direct 
payments and rural development measures will continue to be Green Box. This includes the strategic 
plans. The EU will ensure that its WTO commitments are respe cted. 
 
Indicaciones Geográficas  
 
Pregunta 11  
En el párrafo 3.362 se establece que la UE encargó un estudio sobre la extensión de las 
IG a productos no agrícolas. ¿Podría adelantar resultados preliminares sobre los hallazgos 
de ese estudio? ¿En qué dimensio nes se está estudiando el impacto de las IG en los 
productos manufactureros?  
 
EU reply:   
In 2019, the Commission has commissioned a "study on the economic aspects of geographical 
indication protection for non -agricultural products at EU level " to assess the added value of a special 
(sui generis) protection regime for geographically rooted non -agricultural products as compared to 
other kinds of protection, in particular trade marks. Preliminary results show that the introduction 
of an EU -wide GI  system for non -agricultural products could bring certain benefits to producers, 
consumers and the regions. Results of the study are about to be published.  
 WT/TPR/M/395/Add.1  
 
- 611 - 
 
  URUGUAY – ADDITIONAL QUESTIONS  
I. INFORME DE LA SECRETARÍA (WT/TPR/S/395)  
 
3 POLÍTICAS Y PRÁCTICAS COMERCIALES, POR MEDIDA  
3.1 Medidas que afectan directamente a las importaciones  
3.1.3 Aranceles  
3.1.3.2 Tipos aplicados  
 
Según el párrafo 3.39, el sector agrícola continúa destacándose en la Unión Europea por observarse 
en el mismo tipos considerablemente más elevados (con respecto a los aplicados en los productos 
no agrícolas), un amplio intervalo arancelario y la utilizaci ón de tipos no ad valorem  y de 
contingentes arancelarios.  
 
P.1) Dada la creciente convergencia entre los precios internos de la Unión Europea y los 
precios internacionales de varios productos agrícolas, señalada por la propia delegación 
de la Unión Europea  en el Comité de Agricultura, ¿considera la UE que existe margen para 
continuar reduciendo, vía reforma unilateral o negociaciones multilaterales, sus aranceles 
para los productos agrícolas? ¿Bajo qué condiciones?  
 
EU reply:  
The EU does not intend to make unilateral market access concessions. Any change to the EU ' 
scheduled bound tariffs will result from successful multilateral negotiations. The EU has successfully 
reformed its agricultural policy, making it a one of the world 's biggest importers and e xporters of 
agri-food products.  
 
P.2) ¿Por qué motivo mantiene la Unión Europea aranceles no ad valorem  -incluyendo 
derechos compuestos, mixtos o matriciales, cuyo efecto final resulta difícil de determinar - 
para las importaciones de productos agrícolas, mientras que no hace lo mismo para los 
productos no agrícolas? ¿Bajo qué condiciones estaría la Unión Europea dispuesta a llevar 
a cabo un proceso de simplificación arancelaria en agricultura?  
 
EU reply:  
Specific and mixed tariffs are as predictable as ad valorem  tariffs. The duties to be paid are well 
known in advance of any customs clearance procedure. The EU's import regime for agricultural 
products, including the composition grid (Meursing table), is fully transparent and predictable, and 
is set out in the EU' s WTO schedule. Therefore, the EU does not consider that its tariff structure 
needs simplification.  
 
3.1.3.3 Contingentes arancelarios y su administración  
En el párrafo 3.45 se hace referencia a los contingentes arancelarios consolidados en la Lista de 
Concesiones de la Unión Europea, aplicados en su mayoría a productos agrícolas, como fruto 
principalmente de las negociaciones de la Ronda Uruguay, así como de las sucesivas ampliaciones 
del bloque comunitario.  
 
P.3) En dicho párrafo se señala que la tasa pro medio global de utilización de los 
contingentes arancelarios de la Unión Europea fue de un 52%, mientras que un número 
bastante importante de contingentes (24%) no se utilizó en absoluto. ¿A qué atribuye la 
Unión Europea esta situación?  
 
EU reply:  
Fill rat es are determined by prevailing economic conditions. After successive reforms of its 
agricultural policy, prices of EU agricultural products are aligned with global market prices, making 
them internationally competitive. As a result, a number of TRQs have become less economically 
interesting.  
 
P.4) ¿Qué niveles del consumo interno de la Unión Europea representan los contingentes 
arancelarios correspondientes a los diferentes productos agrícolas en la actualidad, y 
cómo se comparan con los niveles de 1995?  
 
EU reply:  WT/TPR/M/395/Add.1  
 
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  The EU does not collect information on domestic consumption at EU level. TRQs volumes reflect the 
outcome of negotiations, including the Uruguay Round in particular, based on an agreed 
methodology as part of the tariffication process at th at time. There is no requirement to update 
these volumes and the EU has no intention of doing so unilaterally.  
 
P.5) ¿Se encontraría dispuesta la Unión Europea a participar en negociaciones 
multilaterales de acceso a los mercados que incluyeran, entre otros objetivos, los de 
aumentar los volúmenes de los contingentes arancelarios existentes y reducir sus 
aranceles intra cuota?  
 
EU reply:  
 
The question is hypothetical as multilateral trade negotiations in general, not only on market access, 
have been at an impasse for several years now. The EU is working towards reinvigorating the 
negotiating function of the WTO, together with its monitoring and dispute settlement functions, as 
part of efforts to reform the organisation.  
 
3.3 Medidas que afectan a la producción y al comercio  
3.3.3 Prescripciones sanitarias y fitosanitarias  
 
En los últimos años hemos sido testigos de una creciente tendencia de la Unión Europea a adoptar 
límites máximos de residuos (LMRs) de plaguicidas más estrictos que los aprobados, a  nivel 
multilateral y sobre la base de evidencia científica, en el Codex Alimentarius, lo cual ha tenido 
impacto en el comercio internacional de productos agrícolas.  
 
P.6) ¿Ve valor la Unión Europea en los esfuerzos de armonización de la normativa a nivel 
internacional llevados a cabo en el ámbito del Codex Alimentarius? ¿Qué evaluación 
realiza la Unión Europea de la labor del mismo en la elaboración, a nivel multilateral y 
sobre una base científica, de normas y recomendaciones relativas a los LMRs de 
plagu icidas? ¿De qué manera considera la Unión Europea que podría optimizarse el 
trabajo del Codex en la materia, manteniendo el apego a sus Declaraciones de Principios?  
 
EU reply:  
The EU fully supports the activities of CODEX and works assiduously to contribute to the development 
of its international guidelines, standards and recommendations. EU maximum residue levels (MRLs) 
are regularly and systematically aligned with Codex MRLs (CXLs), provided that these CXLs are 
higher than existing EU MRLs, are r elated to commodities for which the EU sets MRLs, and are 
acceptable in terms of consumer protection, supporting data and extrapolation rules. The EU can 
deviate from international standards when justified for the protection of public health and on the 
basis of an EFSA's scientific advice. Aware of the need to provide sound scientific advice, the EU has 
been supporting the activities of JMPR and other FAO/WHO scientific committees and is one of the 
largest donors to the CTF2.  
 
P.7) En ciertos casos, la Unió n Europea ha tomado decisiones de reducción de LMRs en 
base a dictámenes de la EFSA donde se indica que no existe evidencia suficiente para 
descartar la toxicidad o genotoxicidad de determinados metabolitos en condiciones 
particulares. No obstante, en los mismos casos, otras agencias reguladoras reconocidas a 
nivel internacional no parecen haber hallado, en su análisis, las mismas lagunas en la 
información. ¿A qué atribuye la Unión Europea este fenómeno?  
 
EU reply:  
The EU bases its decision on the EFSA scie ntific advice. EFSA carries out a thorough risk assessment 
that takes into account information submitted by the applicants, international standards and any 
other information that has been made available before and during the assessment process. EFSA 
opinio ns at times diverge from the opinion of other international scientific agencies due to various 
factors, including but not limited to the availability of more or less information at EFSA compared to 
other agencies; different regulatory principle - It is a k ey principle of EU policy in the area of 
pesticides residues that it is the obligation of the applicant to demonstrate that a proposed MRL 
allows to maintain a high level of consumer protection; different sets of experts coming to different 
conclusions on the interpretation of study results and/or the weighing of evidence.  
 WT/TPR/M/395/Add.1  
 
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  P.8) ¿Cómo compatibiliza la Unión Europea la adopción de determinaciones regulatorias 
en materia de autorización de sustancias activas y fijación de LMRs basadas en la 
aplicación del principio precautorio con sus obligaciones internacionales derivadas del 
Acuerdo sobre la Aplicación de Medidas Sanitarias y Fitosanitarias, incluyendo sus 
artículos 2.2, 3.3 y 5?  
 
EU reply:  
The EU law refers to the precautionary principle a s part of the risk management process that leads 
to the development of EU and national food law. Regulation (EC) No . 178/2002 on general food law 
allows the adoption of provisional risk management measures necessary to ensure a high level of 
health protect ion when, following an assessment of available information, the possibility of harmful 
effects on health is identified but scientific uncertainty persists. It therefore requires a scientific 
evaluation as well as an evaluation and balancing of the risks in volved. MRLs related measures 
adopted on the basis of EFSA's thorough risk assessments are necessary to ensure a high level of 
health protection and are not based on a precautionary principle. When taking those measures, the 
EU ensures that all relevant provisions of the SPS Agreement are respected.  
 
P.9) ¿Podría la Unión Europea presentar un listado completo de las sustancias activas 
cuya autorización o cuyos LMRs para diferentes productos serán sujetos a revisión en los 
próximos cinco años?  
 
EU reply:  
The approval of active substances in the EU is time -limited. The approval of an active substance 
may be renewed if an applicant submits an application for renewal of approval, supported by a 
dossier with the required data. Such an application mus t be submitted at the latest 3 years before 
expiry of the approval period, followed by the dossier at the latest 2.5 years before expiry. Please 
consult the EU Pesticides database (https://ec.europa.eu/food/plant/pesticides/eu -pesticides -
database/public/?e vent=homepage&language=EN) for information on the expiry date of approvals, 
using the functions "Search active substances => Advanced search => Expiration date " to identify 
active substances whose approval expires within a given timeframe.  
 
For the review of existing MRLs, please consult the document available on the EFSA website under 
the following link. It is updated regularly.  
http://www.efsa.europa.eu/sites/d efault/files/pesticides -MRL-review -progress -report.pdf . 
 
3.3.7 Derechos de propiedad intelectual  
3.3.7.2 Propiedad industrial  
3.3.7.2.4 Indicaciones geográficas  
 
P.9) ¿Toma la Unión Europea en consideración a las normas internacionales relevantes 
acordadas  a nivel multilateral, como las del Codex Alimentarius, al momento de 
determinar qué términos o denominaciones pueden ser registrados como indicaciones 
geográficas protegidas en su territorio?  
 
EU reply:  
The essential objective of a Codex is to harmonise the production method at international level to 
ensure fair competition. Having a Codex Standard for a product does not preclude eligibility for a 
Geographical Indication (GI). GI registration aims at reserving the use of a name. Therefore, Codex  
and GI protection have different scope and purpose. Coexistence of a Codex standard and a 
geographical indication cannot be excluded.  
 
P.10)  ¿De qué manera considera la Unión Europea los comentarios presentados por los 
Miembros en su proceso de decisión i nterno sobre el eventual registro como indicación 
geográfica protegida de un determinado término? ¿Se ha denegado el registro de términos 
como indicaciones geográficas protegidas o se han introducido ciertas flexibilidades en 
atención a los comentarios pre sentados por Estados Miembros de la Unión Europea? ¿Y 
en atención a los comentarios de otros Miembros de la OMC? ¿En qué casos?  
 
EU reply:  
When, following the scrutiny of the application for registration of a geographical indication, the 
European Commissio n considers that the conditions laid down in EU Regulations are fulfilled, it 
publishes the application in the Official Journal of the European Union. The authorities of a Member WT/TPR/M/395/Add.1  
 
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  State, the authorities of a third country, or any natural or legal person hav ing a legitimate interest 
and established in a third country may oppose the registration of a product name under a quality 
scheme. The notice of opposition should be submitted within three months from the date of the 
publication. The reasons for opposition  are defined in EU Regulations and concern in particular a 
non-compliance with the requirements for a quality scheme, conflict with the name of a plant variety 
or an animal breed, homonymy with a name already protected in the Union, existence of a conflict ing 
trade mark, or name genericity.  
These criteria are evaluated in relation to the territory of the Union. If the opposition is valid, the 
two parties involved (the party opposing the registration and the group of producers registering the 
product) shoul d consult each other to find a solution. If no agreement is reached, the Commission 
takes the final decision on registration. The reasons for which the Commission has decided to register 
a name in case the oppositions were submitted, are set out in the Rec itals of the related Commission 
Implementing Regulations entering a name in the register of protected designations of origin and 
protected geographical indications. Please find the Regulations that are publically available: 
https://ec.europa.eu/info/food -farming -fisheries/food -safety -and-quality/certification/quality -
labels/geographical -indications -register/ . 
 
P.11)  ¿Cuáles son, según la concepción de la Unión Europea, los atributos que definen la 
genericidad de un término?  
 
EU reply:  
The identification of a generic term depends on the de facto  use in any particular territory. Within 
the EU, the Court of Justice of the EU has ruled that all relevant factors shall be taken into account 
when determining if a term is generic. In particular , the existing situation in areas of consumption 
and relevant national or EU legal acts should be considered.  
In general, operators are aware if terms are generic, including terms within a compound GI. 
Nevertheless, in case of a dispute a final legal dete rmination can only be made by the courts.  
 
II. INFORME DEL GOBIERNO (WT/TPR/G/395)  
 
3 EVOLUCIÓN DEL MERCADO INTERIOR  
3.7 Política Agraria Común (PAC)  
 
P.12)  El párrafo 3.23 hace referencia a las propuestas de la Comisión Europea para la PAC, 
particularmente en materia presupuestaria. ¿Cómo ha sido considerada la inminente 
salida del Reino Unido del bloque comunitario en la elaboración y discusiones del 
presupuesto de la PAC?  
 
EU reply:  
The proposed Multi -annual Financial Framework for the peri od 2021 -2027 allocates EUR 365 billion 
for the Common Agricultural Policy for an EU of 27 Member States. The UK will not participate in the 
CAP post 2020. Compared to the amounts for the EU -27 in 2020, this proposal would represent a 
reduction of 5%.  
 
3.8 Prescripciones Sanitarias y Fitosanitarias  
 
P.13)  El párrafo 3.26 hace referencia al nuevo Reglamento 2019/6 del Parlamento 
Europeo y del Consejo sobre Medicamentos Veterinarios, que apunta a la lucha contra la 
resistencia a los antimicrobianos. ¿Podrí a la Unión Europea brindar información 
actualizada sobre el proceso de reglamentación interno que se está llevando a cabo para 
la implementación práctica de dicho Reglamento, incluyendo los cronogramas previstos 
para la aprobación de los actos delegados y de implementación correspondientes?  
 
EU reply:  
The state -of-play as regards the preparation of the various draft legal acts related to antimicrobial 
resistance is as follows:  
 
o Delegated Acts under Article 37(4): the Commission received end of 2019 the sci entific advice 
 it had requested from the European Medicines Agency (EMA) as a basis for its preparatory 
 work in November 2019. It has consulted EU Member States as well as targeted stakeholders 
 on the advice received before starting to prepare a draft a ct. WT/TPR/M/395/Add.1  
 
- 615 - 
 
  o Implementing Acts under Article 37(5): upon request from the European Commission, the 
 EMA set up an expert group at the end of 2019 to start preparing its scientific advice. The 
 indicative date anticipated for the publication of the related scientifi c advice report is 
 November 2020.  
o Delegated Acts under Article 118: the European Commission is currently reflecting on the 
 most suitable approach for the various aspects of the implementation measures relating to 
 Article 118. In order to ensure that the draft delegated acts are comprehensive, further 
 reflection is warranted by Commission services in upcoming months.  
 
• The pr eparation of the draft legal acts will continue to follow its course, according to the 
institutional process. The delegated acts under Article 37(4) are to be adopted at the latest by 
27 September 2021, while the implementing acts under Article 37(5) as we ll as the delegated acts 
under Article 118 are to be adopted by 27 January 2022.  
 
• The Commission remains committed to engage with its trading partners and other countries, 
 both in the context of multilateral international fora and bilaterally, to promote and support 
 effective strategies to prevent and contain the global threat of AMR.  
 
3.14 La Retirada del Reino Unido de la UE  
 
P.14)  En el párrafo 3.52, la Unión Europea afirma que "Deberá hacerse un prorrateo de 
los compromisos cuantitativos con respecto a la lista de mercancías". ¿Por qué considera 
la Unión  Europea que esto "deberá" h acerse? ¿Cuál es la base jurídica relevante en la 
normativa de la OMC?  
 
EU reply:  
The reason is the intention to maintain an equivalent level of market access, as the EU together with 
the UK informed the Membership in October 2017. The EU has followed the applicable rules under 
Article XXVIII GATT, which allows a Member to modify concessions. The negotiations under the 
GATT  Article XXVIII procedure are confidential and are currently ongoing with the WTO Members 
whose rights the EU recognised.  
 
P.15) En el mismo párrafo, la Unión Europea indica que el enfoque para el prorrateo de 
los contingentes arancelarios seguirá "el principio fundamental de mantener el nivel 
existente de acceso a los mercados de la UE -27 y el Reino Unido". Uruguay considera que 
el único nivel pertinente de acceso a los mercados es el de la UE -28, y mantiene sus 
reservas sobre desagregaciones artificiales que pudieran realizarse del mismo. En este 
sentido, ¿cómo espera la Unión Europea mantener el nivel existente de acceso a l os 
mercados de la UE -28, evitando dejar a los Miembros worse off , en los términos del 
Artículo XXVIII del GATT 1994? ¿Tiene previsto la Unión Europea ofrecer a los Miembros 
principalmente interesados los ajustes compensatorios necesarios para restablecer e l 
equilibrio de concesiones en los casos en que se proponga modificar las concesiones 
existentes en materia de contingentes arancelarios?  
 
EU reply:  
EU WTO TRQs were set based on the total volume of imports into all the countries that made up the 
EU, which  so far included the UK. The EU and the UK through the "joint approach " dating back to 
October 2017 are committed to maintain, overall, the existing level of market access of other WTO 
Members. Tariff -rate quotas would be apportioned based on trade flows, so that the existing level 
of market access available to other WTO Members would be maintained – no more no less. Therefore, 
EU maintains that there is no obligation to compensate other Members for the withdrawal of the UK 
if the total volume of market acc ess for WTO Members remains unchanged.  
 
P.16) Como ha sido señalado en reuniones del Consejo de Mercancías, el Comité de Acceso 
a los Mercados y el Comité de Agricultura de la OMC, dada la indefinición de la forma que 
tomará la relación comercial entre la Unión Europea y el Reino Unido luego del  Brexit, 
existe la posibilidad de que, próximamente, la futura UE -27 y el Reino Unido accedan 
recíprocamente a sus respectivos contingentes erga omnes , lo cual generaría una 
alteración sustantiva de las condiciones de competencia al interior de los mismos.  
¿Considera la Unión Europea que dicha situación resultaría perjudicial para los Miembros 
de la OMC que actualmente hacen uso de dichos contingentes? ¿Estaría dispuesta la Unión 
Europea a enmendar su propuesta para indicar que dichos contingentes arancelar ios WT/TPR/M/395/Add.1  
 
- 616 - 
 
  erga omnes  no se aplicarán al Reino Unido, o bien a incrementar los volúmenes 
disponibles bajo los mismos para contemplar el comercio UE -27 – Reino Unido? 
Alternativamente, ¿considera la Unión Europea que correspondería ofrecer otra clase de 
ajustes co mpensatorios en respuesta a esta situación?  
 
EU reply:  
The revised Political Declaration on the future relationship between the EU and the UK, issued on 
October 2019, envisages an economic partnership through a free trade agreement that would ensure 
no tar iffs, fees, charges or quantitative restrictions across all sectors. Therefore, it is not expected 
that the EU and UK would be using one another 's WTO TRQs.  
 
4 EVOLUCIÓN DE LA POLÍTICA COMERCIAL Y DE INVERSIÓN  
4.1 Política de comercio multilateral  
4.1.1 Reforma de la OMC  
 
Uruguay comparte con la Unión Europea la importancia de "revitalizar las negociaciones" para 
mantener la vigencia de la OMC en el mundo actual, así como su apreciación sobre las dificultades 
existentes para "concluir l as negociaciones en curso" o "empezar a examinar nuevas cuestiones" a 
nivel multilateral.  
 
P.17) ¿Qué rol asigna la Unión Europea a las distintas cuestiones pendientes del proceso 
de reforma del comercio agrícola, conforme al artículo 20 del Acuerdo sobre la Agricultura, 
dentro del marco general de la reforma de la OMC?  
 
EU reply:  
The EU invites Uruguay to consider the EU 's statements in the meetings of the Special Session of 
the Committee on Agriculture. The EU remains engaged in working towards outcomes, in the wider 
context of WTO reform at the upcoming 12th Ministerial Conference. The EU appreciates Uruguay 's 
supportive stance at the two previous Ministerial Conferences for which the EU and Uruguay 
co sponsored proposals. We hope such c onstructive cooperation will continue.  
 
5 PERSPECTIVAS DE FUTURO  
 
P.18)  ¿Qué características principales debería tener, a juicio de la Unión Europea, el 
"equilibrio actualizado de derechos y obligaciones", mencionado en el párrafo 5.2, a ser 
alcanzado como fruto de las propuestas de reforma de la OMC? ¿En qué cambiaría con 
relación a la situación actual?  
 
EU reply:  
In part, an update in the balance of WTO Members ' rights and obligations is naturally linked to the 
concept of special and differe ntial treatment (SDT). As the EU argued in recent discussions at the 
General Council, the current distinction between developed and developing countries no longer 
reflects the reality of the rapid economic growth in some developing countries. We should the refore 
continue to work on SDT with a view to ensuring that flexibilities are made available to those 
members who actually need them to enable them to fully benefit from WTO membership.  
 
The EU firmly believes that if the WTO is to prosper, SDT must becom e much more granular, in 
function of an individual Member's demonstrated needs and capacities. Future differentiation should 
be designed in terms of specific individual country needs at the sectoral or activity level rather than 
calling for a block exempti on of a large category of Members. Furthermore, the EU considers that 
each developing country's need for SDT should be assessed on a case -by-case and evidence -based 
basis. The notable exception should be the LDCs who deserve particular treatment and who in  any 
case have a graduation mechanism.  
This said, updating rights and obligations should be seen as part of the wider WTO reform efforts. 
The EU aims to strengthen the WTO in all core three functions, namely dispute settlement, 
negotiations and deliberativ e discussions.  
 
  WT/TPR/M/395/Add.1  
 
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  VIET NAM  
PART I: QUESTIONS RE GARDING THE SECRETARIAT REPORT ( S/395)  
 
4.3 Measures Affecting Production and Trade  
4.3.3 Sanitary and phytosanitary requirements  
 
Page 116 ( Paragraph 4.213): The Secretariat report states that  "Since the last Review, the most 
significant change in the EU's SPS regime refers to the new Regulation (EU) 2017/625 of the 
European Parliament and of the Council of 15  March  2017 regarding  official controls on products of 
animal origin intended for human consumption. It includes rules for the performance of official 
controls and other control activities by the competent authorities of the member States, sets out the 
requirements to be fulfilled for the entry into the EU of consignments of animals and goods  from 
third countries, and empowers the Commission to adopt delegated acts concerning those 
requirements.149 This Regulation will apply from 14 December 2019. However, the requirements will 
only apply from 21 April 2021.150" 
 
Question 1  
In this context, we would like to better understand the concrete requirements the EU would consider 
taking in order to control the entry into the EU of consignments of animals and goods from third 
countries. Viet Nam is interested in learning how the EU wo uld take into consideration the comments 
submitted.  
 
Could the European Union provide further information and explain the rational for change 
in the EU's SPS regime?  
 
EU reply : 
Regulation (EU) 2017/625 establishes a more integrated approach, as common rul es now apply to 
controls carried out at borders on animals, products of animal origin, plants and other products and 
goods that must be checked before they enter the EU.  
 
The new import control system is even more risk -based, targeted and harmonised than b efore. 
Common requirements for facilities, equipment and staff qualifications will apply throughout all 
border control posts. All consignments to be presented at the border control posts must undergo 
documentary checks, while identity and physical checks w ill be carried out at a frequency depending 
on the risk linked to the specific animals or goods. The common criteria to determine and modify 
the frequency has been established i n Commission Implementing Regulation (EU) 2019/2129.  
https://eur -lex.europa.eu /legal -content/EN/TXT/?qid=1579873070417&uri=CELEX:32019R2129 . 
 
In addition, a single standard document, the Common Health Entry Document (CHED), will be used 
by operators for the prior notification of consignments. It will be transmitted to the border con trol 
post through a new integrated computerised system for official controls (Integrated Management 
System for Official Controls, IMSOC) which will optimise the handling and exchange of information, 
data and documents necessary for the enforcement of agri -food chain rules.  
All the comments received are systematically discussed with the EU Member States within the 
framework of the regulatory process. The EU always provides a reply to all the comments submitted 
by another WTO Member on an EU notification and explains in details the planned measures . 
 
__________  
 
 
149 A legislative act may delegate to the Commission the power to adopt non -legislative acts of general 
application to supplement or amend certain non -essential elements of a legislative act (Article 290 of the 
TFEU). Legal acts adopted by the Commission in t his way are referred to as "delegated acts" (Section 2.1).  
150 Requirements laid down in Articles 11, (13)(1) and 13(2) of delegated R egulation (EU) 
No. 2017/625 . 