 RESTRICTED  
  
G/TBT/M/85  
 
2 February 2022  
(22-0806) Page: 1/116 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 10 -12 NOVEMBER 2021  
CHAIRPERSON: MRS ELISA MARIA OLMEDA DE ALEJANDRO  
Note by the Secretariat1 
1   ADOPTION OF THE AGENDA  ................................ ................................ .......................  1 
2   IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  ................................  1 
2.1   Specific Trade Concerns ................................ ................................ .............................  1 
2.2   Ninth Triennial Review  ................................ ................................ ...........................  114 
2.3   Exchange of experiences  ................................ ................................ .......................  115 
3   OBSERVERS  ................................ ................................ ................................ ............  115  
3.1   Updates  ................................ ................................ ................................ ..............  115 
3.2   Pending Requests  ................................ ................................ ................................ . 116 
4   ANNUAL  REPORT (2021) OF THE COMMITTEE TO THE COUNCIL FOR TRADE IN 
GOODS (CTG)  ................................ ................................ ................................ ..............  116  
5   OTHER BUSINESS  ................................ ................................ ................................ ... 116  
6   DATE OF NEXT MEETING  ................................ ................................ ........................  116  
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/21 . 
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT  
2.1  Specific Trade Concerns  
The Chairperson  noted with respect to the minutes of the  meeting, that it was what Members said 
orally  that was the definitive reference for the preparation of the minutes by the Secretariat. If 
Members wished to summarize their statements orally but nevertheless include detailed technical 
statements on the record (in the minutes), Members were always free  to ask the Secretariat to 
circulate such information separately, for example as a "JOB" or a "W" document; this statement 
would then be referenced (and hyperlinked) in the minutes of the meeting.2 
 
1 This document has been prepared under the Secretariat's own responsibility  and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  
2 For an example of this, see the document referenced in the United States'  statement in para 2.194  
below . G/TBT/M/85  
 
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  2.1.1   Withdrawn concerns  
2.1.  The Chair reported that the following STCs had been withdrawn from the agenda at the request 
of the concerned Member:  
• Dominican Republic – General standard on fiscal control and security mechanisms for 
manufacturers, producers and importers of finished alcohol and tobacco products  
 
• Malaysia - Guideline for Approval of Electrical Equipment (Electricity Regulation 1994) 
Information Booklet 2018 Edition (GP/ST/No.14/2017)  
 
• Republic of Korea - Ballast Water Management Act (ID 606)  
 
• United States - Appliance Efficiency for Sprinkler Bodies (ID 653) 
2.1.2   New Specific Trade Concerns  
2.1.2.1   Chile - Efficiency analysis and/or test protocol for electrical products, 
G/TBT/N/CHL/525  (ID 7043) 
2.2.  The representative of the Republic of Korea  provided the following statement. The Korean 
government appreciates this opportunity to provide our comm ents regarding Chile's "Efficiency 
Analysis and/or Test Protocol for Electrical Products: Washer -Dryers (PE No. 1/06 -1/2:2020)", 
notified to the WTO on 24 July 2020 as G/TBT/N/CHL/525 , and in effect from January 2022 (PE No. 
1/06/3:2020). We sincerely respect the vigorous efforts o f the Chilean government in protecting the 
environment and providing relevant information to consumers. Furthermore, Korean companies are 
fully committed to complying with the regulations. However, we would like to present the following 
comments reflecting  concerns raised by Korean companies regarding the energy efficiency 
regulations for "washer -dryers". If the energy consumption tolerance for "washer -dryers" follows 
the example of tolerance for "washing machines" and is established including minus toleran ce, we 
are concerned that washer -dryers with even better performance in energy efficiency may still fail to 
pass the post -market surveillance test. To prevent this, most countries, including the EU, have set 
the tolerance of energy consumption and water co nsumption for washer -dryers to "less than +10%". 
Therefore, we respectfully request the Chilean government to consider establishing both the energy 
consumption tolerance and water consumption tolerance to "less than +10%" for energy efficiency 
labels on wa sher-dryers. We would like to recall that, on 12 October 2020, the Korean government 
submitted similar comments regarding the efficiency regulation for "washing machines" to the 
Chilean WTO TBT Enquiry Point, but there has been no reply from the competent authorities of Chile 
yet so we hope to receive your response as soon as possible on this matter as well.  
2.3.  In response, the representative of Chile provided the following statement. Chile thanks Korea 
for its interest in Chile's notifications on energy effic iency protocols and their objective of protecting 
the environment and providing consumers with information. The information provided in this specific 
trade concern in relation to the energy efficiency tolerances for household washer -dryers, notified 
by Chi le in July  2020 in document G/TBT/N/CHL/525 , and on which no comments were received 
within the 60 -day period, shall be sent to the Electricity and Fuel Board and we hope to be able to 
respond to Korea through the TBT/WTO Enquiry Point as has been done in the past.  
2.1.2.2   European Union - Draft Commission Delegated Regulation amending, for the 
purposes of its adaptation to technical and scientific progress, Regulation (EC) No 
1272/2008 of the European Parliament and of the Council on classification, labelling and 
packaging of substances and  mixtures, G/TBT/N/EU/826  (ID 7054) 
2.4.  The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen, and 
Matsu (TPKM) would like to express concerns about G/TBT/N/EU/826  regarding Regulation (EC) 
1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP 
Regulat ion) of the European Union. We acknowledge the intention of the EU to protect public health 
and the environment by modifying the classification of toxic substances and mixtures under the CLP 
 
3 For previous statements follow the thread under ID 704 . 
4 For previous statements follow the thread under ID 705 . G/TBT/M/85  
 
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  regulation. The proposed measure reclassifies the trimethylolprop ane triacrylate (TMPTA, CAS No. 
15625 -89-5) as Category 2 of Carcinogen. It causes widespread concerns among our industries. 
Firstly, TMPTA has a wide range of uses in various products, such as coating materials, ink, and 
adhesives. Once the regulation is amended, manufacturers must relabel and reconfigure their 
products, which will have a significant impact on the trade of TMPTA and TMPTA -containing products. 
Even worse, there is no alternative to TMPTA, and the search for the substitute will take a long t ime 
and huge cost, resulting in serious damage to global trade. In our views, this proposed measure is 
inconsistent with Article 2.2 of the TBT Agreement as it creates unnecessary obstacles to 
international trade.  
2.5.  Secondly, we would like to urge the EU to observe the requirements of scientific justification 
stated in Article 2.2 of the TBT Agreement. The decision made by the Risk Assessment Committee 
(RAC) of the European Chemical Agency (ECHA) was based on the studies of the US National 
Toxicology Program (NTP) in 2012. Although animal tumours were observed in those studies, there 
is a widely shared view that those studies lack reliability and have major technical discrepancies. 
Experts further raised challenges against the NTP study, which used acetone as a carrier for dermal 
absorption, and did not reflect "normal" exposure. Therefore, the decision to adopt the proposed 
measure with limited scientific evidence may be too hasty and cause unnecessary trade barriers to 
TMPTA or TMPTA -related products. Further more, there are still ongoing studies aiming to 
demonstrate that acetone used in the NTP studies as the vehicle is not appropriate for comparative 
absorption studies and efforts have been devoted in obtaining better insights into the metabolism of 
TMPTA in  the mammalian body by conducting toxicokinetic studies. We believe that these analyses 
will offer the EU more detailed information to decide whether the proposed measures are 
appropriate. Given the inadequacy of the scientific basis and the possibility of  the decision being 
reversed by the ongoing research, we would like to suggest that the EU consider suspending the 
proposed measure, respond to the question raised, and wait until more research results become 
available. Thirdly, according to this notificat ion, the amendment will be adopted in the fourth quarter 
of 2021. It will enter into force 20 days after its publication in the official journal of the EU, which 
will be about two months after adoption. Given that the proposed measure is not due to urgent 
needs and industries need more time to prepare, we would like to call on the EU to extend the 
transition period to ensure consistency with Article 2.12 of the TBT Agreement. We submitted our 
comments to the EU on 30 September 2021 and would be grateful if the above -mentioned comments 
could be taken into account and look forward to a written response.  
2.6.  In response, the representative of the European Union  provided the following statement. The 
European Union would like to thank the Separate Customs Territory o f Taiwan, Penghu, Kinmen and 
Matsu for raising this issue and for the written comments concerning the 18th adaption to technical 
and scientific progress (ATP) of the Classification Labelling and Packaging (CLP) Regulation.5 In this 
statement, the European  Union will also react to the questions from Brazil with regard to the 
classification of the 2 -ethilhexanoic acid (2 -EHA), which have been uploaded to eAgenda under the 
STC No 516, because it is covered by the same draft measure. The EU would like to info rm that 
written replies to the comments of Chinese Taipei and Brazil are currently under preparation and will 
be delivered in the following weeks. Therefore, the EU would like to make some general points at 
this stage and refer to the written replies for d etails. The EU would like to stress that the proposed 
classification of TMPTA and 2 -ethylhexanoic acid (2 -EHA) is based on the scientific opinion of the 
Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA), which assesses all 
reliable an d adequate scientific evidence that is available. This assessment is done on the basis of 
the classification criteria of the CLP Regulation, which are fully aligned with the criteria of the UN 
GHS. During the RAC assessment, stakeholders were given the opp ortunity to comment on the 
proposal, including on the available scientific evidence.  
2.7.  The EU would also like to note that in case new relevant scientific information, which may lead 
to a change of the harmonized classification, becomes available in the futu re, this could be submitted 
to an EU member State in accordance with Article 37(6) of the CLP Regulation so that a re -
assessment of the classification could potentially be initiated. In addition, the EU notes that a 
 
5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC , and amending Regulation (EC) No 1907/2006 (OJ L 353 31.12.2008, p. 1), 
consolidated version available at:  https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri= CELEX%3A02008R1272 -20211001   
6 European Union - Regulation (EC) No 1272/2008 (CLP Regulation) ( ID 539 ). G/TBT/M/85  
 
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  harmonized classification under the CLP Regulation triggers obligations for labelling and packaging 
but does not entail in itself any automatic limitations on the use of a substance. While it is not 
excluded that potential use restrictions for a classified substance may in the future be assessed  
under other specific pieces of EU legislation, it is currently not indicated that there may be an impact 
on the trade of products using TMPTA and 2 -ethylhexanoic acid. Finally, concerning a grace period, 
the EU would like to point out that the notified dr aft will only become applicable 18 months after its 
entry into force, although it may be applied before the date of applicability on a voluntary basis.  
2.1.2.3   China - National Standard of the P.R.C., Lithium Ion Cells and Batteries Used in 
Portable Electronic Equ ipments - Safety Technical Specification, G/TBT/N/CHN/1576  (ID 
7067) 
2.8.  The representative of the Republic of Korea  provided the following statement. Korea respects 
and supports China's efforts to introduce "National Standard of the P.R.C., Lithium Ion Cells and 
Batteries Used in P ortable Electronic Equipment – Safety Technical Specification" for the safety of 
the people. Furthermore, Korean companies are fully committed to complying with China's 
regulations. In March 2021, China notified its draft amendment, GB 31241 -20XX, of the N ational 
Safety Standard for Lithium -Ion Cells and Batteries, to the WTO as G/TBT/N/CHN/1576 . In May 
2021, Korea submitted comments regarding the notification and requested China to align its draft 
amendment with China's current regulation of GB 31241 -2014 and, in a broader sense,  with the 
international standard of IEC 62133 -2:2017. We suggested that the exception clause (5.3.1) "By 
agreement between the cell manufacturer and the end product manufacturer, component cells used 
in the manufacture of a battery need not be marked," be maintained, and that an identical crush 
test standard (7.6) be applied to cells of all types (cylindrical, prismatic, button, pouch types), as 
provided in the current regulation (GB 31241 -2014). In July 2021, China answered that "Different 
battery standard s, including GB 31241 -2014 and IEC 62133 -2, have all proposed requirements for 
marking and crush test, so that draft amendment GB 31241 -20XX also proposed equivalent 
requirements. This is necessary to effectively trace and identify cells and better evaluat e the safety 
of pouch cells." Despite China's kind reply, Korean companies continue to experience difficulties, so 
we would like to reiterate this issue.  
2.9.  We understand that in the IEC 62133 -2, there is a clause that clearly exempts the marking 
requirement on cells when it is agreed between the manufacturers, while there is no clause that 
requires only the pouch cells to pass a bar -crush test. We request China to present the rationales of 
your previous reply and reexamine them. If China requires cell marking  for product 
tracking/identification, this requirement should be amended to oblige only the indication of minimal 
information, such as model designation and date of manufacture. Since the cell is a component that 
is not directly used by consumers, the expo rt destination is determined when the cell is assembled 
into the battery pack or end product, and therefore, it is difficult to separately mark it for the purpose 
of sale in China alone. This will involve a lot of time and cost due to production line chang es and 
additional certification, which will impose excessive and costly burdens on the related industries. 
Korea would like to request China once again to revise the said standard in accordance with the 
relevant international standards.  
2.10.  In response, the re presentative of China  provided the following statement. Identification is 
very important for the safe use of cells and batteries. Cells are an important component of battery. 
Without necessary marking for purpose of identification, they cannot be traced an d identified 
effectively. It has been reported many times in recent years that cells without proper identification 
marking cause confusion to market regulation. Therefore, after much investigation and public 
consultation in the process of its formulation, the new specification requires cell body identification 
marking. We will not consider withdrawing the decision of deleting the exceptions.  
2.1.2.4   Viet Nam - Draft National Technical Regulation on the fifth level of gaseous 
pollutants emissions for new assembled, manufactured and imported automobiles, 
G/TBT/N/VNM/174  (ID 7078) 
2.11.  The representative of Thailand  provided the following statement. Thailand would like to 
express our gratitude to Viet Nam for providing additional information about the implementation of 
QCVN 109:2021/BGTVT through a  bilateral consultation in January earlier this year and a response 
 
7 For previous statements follow the thread under ID 706 . 
8 For previous statements follow the thread under ID 707 . G/TBT/M/85  
 
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  on 16 July 2021. Despite the fact that Viet Nam has clarified that a transitional provision permits 
vehicles certified before a mandatory date of application of the Euro 5 emission standar d to continue 
production and assembly in accordance with the current emission standard under QCVN 
86:2015/BGTVT corresponding to Euro 4 until an expiration date of the certificates, Thailand 
acknowledged that the regulation has been applied only to its dom estic automobile manufacturers 
and assemblers. Meanwhile, foreign counterparts with valid certificates have to comply with the new 
emission standard starting on 1 January 2022. The above -mentioned practices discriminate between 
domestic and imported automo biles which affect the cost of production unequally compared to Viet 
Nam domestic companies.   
2.12.  In light of concerns raised, Thailand wishes to remind Viet Nam of its obligation under 
Article  2.1 of the TBT Agreement to ensure that, in respect of technical r egulations, products 
imported from the territory of any Member shall be accorded treatment no less favourable than that 
accorded to like products of national origin and to like products originating in any other country. 
Therefore, Thailand strongly request s Viet Nam to treat imported automobiles in a non -
discriminatory manner and to avoid creating unnecessary obstacles to international trade. In 
addition, Thailand also calls on Viet Nam to notify relevant regulations, especially document 
No. 371/TTg -CN date d 26 March 2021 regarding implementing the agenda to apply the emission 
standards under Decision No. 49/2011/QD -TTg which stipulates that the manufactured, assembled, 
imported automobiles shall apply the Euro 5 emission standards (QCVN 109:2021/BGTVT) from  1 
January 2022, to the WTO and provide Members with the opportunity for comments.  
2.13.  In response, the representative of Viet Nam  provided the following statement. The document 
No. 371/TTg -CN dated 26 March 2021 affirms the principle of non -retroactivity of l egal regulations 
applicable to various types of manufactured, assembled automobiles which have been granted the 
certificate of technical safety and environment protection before 1 January 2022. According to 
Decision No. 49/2011/QD -TTg of the Prime Minister  of the Socialist Republic of Viet Nam, all types 
of new manufactured, assembled and imported automobiles shall comply with the fifth level of 
gaseous pollutants emissions standard from 1 January 2022. Therefore, it is not discriminatory in 
application of the fifth level of gaseous pollutants emissions standard to new manufactured, 
assembled and imported automobiles. The principle of non -retroactivity is completely consistent with 
Article 28 of Vienna Convention on the Law of Treaties of 1969 to which Viet Nam and Thailand are 
both parties. In addition, the Document No. 371/TTg -CN is basically an instructive document for the 
Decision No. 49/2011/QĐ -TTg and is not necessary to notify this document under the TBT 
Agreement.  
2.1.2.5   European Union - Draft Commission Reg ulation laying down ecodesign 
requirements for light sources and separate control gears pursuant to Directive 
2009/125/EC of the European Parliament and of the Council and repealing Commission 
Regulation(EC) No. 244/2009, (EC) No. 245/2009 and (EU) No. 119 4/2012, 
G/TBT/N/EU/606  (ID 7 089) 
2.14.  The representative of the Republic of Korea  provided the following statement. Korea 
appreciates this opportunity to provide our comments regarding the "Commission Regulation laying 
down ecodesign requirements for light sources and separate control gears" (hereinafter referred to 
as "the regulations "), notified to WTO TBT Committee on 8 October 2018 as G/TBT/N/EU/606  and 
published on 1 October 2019. First of all, the Korean Government fully respects and supports the 
efforts of the EU to protect the environment. Furthermore, Korean companies are committed to 
complying with the r egulations. However, we would like to present the following comments reflecting 
concerns raised by Korean companies regarding the regulations. According to the regulations, which 
are scheduled to take effect on 1 September 2021, manufacturers should make s pare parts available 
to professional repairers for a minimum specified period after placing the last unit of the model on 
the market. For example, according to the Ecodesign Regulation (2019/2019), Annex II, 3.(1), 
manufacturers must provide spare parts fo r the light sources of refrigerators on the EU market after 
the enforcement of this regulation for a minimum period of seven years. It is impossible to use 
alternative light source components that satisfy the new regulation because some home appliances, 
such as discontinued refrigerator models, are not compatible with the alternative components 
without changing the appliances' internal structure. We understand that the EU's Ecodesign 
regulations for External Power Supply (EPS) and Motors specify exceptions for using existing service 
parts or spare parts for replacement, but there are no such exceptions for using spare parts in the 
 
9 For previous statements follow the thread under ID 708 . G/TBT/M/85  
 
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  Ecodesign regulations for light sources and separate control gears. Therefore, we request the EU to 
make an exception of spare pa rts for the light sources of discontinued home appliances that are 
placed on the market before the date of the enforcement (1 September 2021), in a manner similar 
to the EPS and Motor Ecodesign regulations.  
2.15.  In response, the representative of the European U nion provided the following statement. The 
Commission Regulation (EU) 2019/2020 setting ecodesign requirements for light sources and 
separate control gears does not have a specific exemption for products that are spare parts of 
discontinued electric home a ppliances. We would like to emphasise that the Regulation applies to 
new units of light sources and separate control gears placed for the first time on the EU market as 
from 1 September 2021. That which is placed on the EU market prior to 1 September 2021,  can stay 
on shelves and in stock indefinitely.  
2.1.2.6   United States - Energy Conservation Program: Test Procedures for Residential and 
Commercial Clothes Washers, G/TBT/N/USA/903,  G/TBT/N/USA/903/Rev.1  (ID 70910) 
2.16.  The representative of China  provided the following statement. China requests United Sta tes 
to: 1. Clarify the relationship between appendix J and appendix J2 and the implementation time. 2. 
Clarify the text content in Appendix J which is inconsistent: it is specified in chapter 2.12.1 to use 
large load for test evaluation, while table 3.3 in cludes both large load and small load. 3. Consider 
suggestions on "E. Issues on Which DOE Seeks Comment" as follows: For Article 2, China supports 
the decision to add the test method of single inlet machine, and suggests adding specific evaluation 
procedur es, such as the evaluation on the water temperature heated under different procedures. 
For Article 9, in the new appendix J, the weights of large and small loads both are small, which is in 
the middle and lower section according to the capacity of the wash ing machine. Therefore, in this 
case, the energy consumption of the middle and lower capacity is evaluated, which is not in line with 
the actual use of the washing machine. The performance of the washing machine under large load 
is not tested. It is recomm ended to increase the large load weight to evaluate the upper capacity of 
the washing machine. For Article 15, if extreme dry load is required for each test cycle, in order to 
avoid the load that has not been cooled to room temperature being used for the t est, it is suggested 
that the load put into the washing machine for test should be cooled to room temperature.  
2.17.  For Article 17, when conducting the test of drum barrel volume, it shall be clearly stated that 
the volume at the depression of window pad shall not be included in the barrel volume. For Articles 
20 and 21, the coefficients of cold water, warm water and hot water are based on the survey data 
of users' actual use habits. Actually, semi -automatic products rarely feed hot water during practical 
use. T herefore, it is suggested to collect more user data to adjust TUF ratio. For Article 59, it is not 
proper to delete the definitions of "compact" and "standard". Large capacity models have more 
advantages in energy consumption calculation, and the level it can reach due to mechanical structure 
strength is more advantageous than small capacity models (for example, the upper speed limit of 
large capacity is greater than that of small capacity). It is suggested to establish different energy 
consumption access l evels for large capacity and small capacity models, above 45L and below 45L 
shall be subject to different access levels.  
2.18.  In response, the representative of the United States  provided the following statement. The 
United States thanks China for its comments submitted on 29 October 2021 in response to our 
3 September 2021 WTO notification to amend test procedures for residential and commercial clothes 
washers. The United States will take into consideration all comments received during the open 
comment period a nd respond to each substantive comment in the next published rulemaking 
document on the Test Procedures for Residential and Commercial Clothes Washers.  
2.1.2.7   India - Important Instruction regarding Voluntary Star Labelling Programme for 
UHD (4K, 8K) Televisions (ID 71011) 
2.19.  The representative of the Republic of Korea  provided the following statement. Korea would 
like to raise its concerns on India's Important Instruction regarding Voluntary Star Labelling 
Programme for UHD (4K, 8K) Television (hereinafter referred to as the "UHD TV regulation") which 
was not notified to the WTO TBT Committee and published on 21 January 2021. Previously, Korea 
had submitted letters of comments (from Korean companies) via the Indian TBT Enquiry Point for 
 
10 For previous statements follow the thread under ID 709 . 
11 For previous statements follow the thread under ID 710 . G/TBT/M/85  
 
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  five times, in April, June, July, August, and September 2021, but we have not yet re ceived any reply 
from India. Firstly, we received news recently that the regulation will be enforced starting from 1 
January 2022. Regarding this, we would like to ask India whether or not the UHD TV regulation will 
be enforced as mandatory or not, and the  time schedule for its implementation. If India plans to 
implement the regulation as mandatory, we request India to notify the WTO TBT Committee in 
accordance with Article 2.9 of the WTO TBT Agreement, allowing a period of at least 60 days for 
comments fro m other WTO Members and providing a transition period of at least six months after 
its adoption.  
2.20.  Secondly, most countries, such as the EU and Korea, apply the Standby Power Consumption 
Standard Values by separating them into Standby Active mode and Standby  Passive mode, 
depending on whether or not the device is in a network connection. However, India's UHD TV 
regulation has set the sum of both the Standby Active mode power consumption and the Standby 
Passive mode power consumption as the maximum limit in de termining conformity of Standby Power 
Consumption. If the regulation becomes mandatory, this excessive requirement is highly likely to 
act as an unnecessary trade barrier for exporters to India. Therefore, we request India to revise the 
Regulation's Standb y Power Consumption requirement in line with international practice and apply 
reasonable figures for maximum limits of Standby Active mode and Standby Passive mode 
separately. Lastly, we would like to ask India to provide answers to our past enquiries, whi ch were 
sent to the Indian TBT Enquiry Point earlier, about the scope of regulated products.  
2.21.  In response, the representative of India provided the following statement. A standard and 
labelling programme for colour televisions with screen resolution up to 1 ,920 x 1,080 pixels (called 
Full HD or FHD resolution) was launched in 2009. Subsequently, the programme has been mandated 
since 2016. While a new technology commercially known as Ultra -High Definition (UHD) television 
was available in the market for the l ast few years, and this technology was not covered under the 
existing Bureau of Energy Efficiency's programme for televisions, UHD televisions have a much 
higher pixel count than televisions with screen resolution up to 1,920 x 1,080 pixels, and it was 
found that they consume more energy than HD or FHD televisions. The Star rating program for Ultra -
High Definition (UHD) televisions of 4K and 8K screen resolution is based on Annual Energy 
consumption (AEC) of the appliance in accordance with IEC 62087:2015 e dition 1. Also, Bureau of 
Energy Efficiency has reviewed the International labelling programme of UHD television for other 
countries and regions like the European Union, United States and China before formulating the 
Standards for India. The programme cove rs Ultra -High Definition (UHD) televisions of Liquid Crystal 
Display with LED backlighting, OLED displays, QLED displays, Micro -LED displays, that may be 
utilized to make and sell UHD televisions in the Indian market having a native resolution of 3,840 x 
2,160 pixels (4K) and 7,680 x 4,320 pixels (8K) which can be powered only by an external power 
supply at a voltage not exceeding 250 V ac, 50 Hz being manufactured, imported and commercially 
purchased or sold in India. This programme expects a cumulative en ergy savings of 9.75 TWh (Billion 
Units of Electricity) and a corresponding 8 million tonnes (MT) CO2 emissions mitigation by FY 2030. 
The programme for UHD televisions, 4K and 8 K screen resolution, has been launched in a voluntary 
mode initially for a pe riod of one year from 1 January 2021 till 31 December 2021.  
2.1.2.8   Sri Lanka - National Environmental (Plastic Material Identification Standards) 
Regulations No. 01 of 2021 (ID 71112) 
2.22.  The representative of the United States  provided the following statement. On 21  January 
2021, the Minister of Environment published in the Gazette of the Democratic Socialist Republic of 
Sri Lanka, the National Environmental (Plastic Material Identification Standards) Regulations No. 01 
of 2021 (PMI Regulation). Sri Lanka has not yet  notified this PMI Regulation to the WTO TBT 
Committee. We understand that, as currently drafted, the PMI Regulation introduces labelling 
requirements for any manufactured plastic item. Between June and August 2021, US industry and 
the United States Govern ment submitted comments on the PMI Regulation to Sri Lanka highlighting 
concerns regarding the lack of clear scope, the absence of a timeline for implementation, and the 
lack of clarity and feasibility of the labelling requirements. We request that Sri Lan ka please confirm 
the status of the PMI Regulation. Specifically, is this regulation finalized or will Sri Lanka continue to 
engage in stakeholder consultations prior to finalization and implementation? We would also 
appreciate clarification from Sri Lanka  on whether the scope of the PMI Regulation includes all plastic 
inputs and plastic packaging, or if the labelling requirements apply solely to final product plastic 
items. We reiterate our August 2021 request that Sri Lanka use relevant international stan dards, or 
 
12 For previous statements follow the thread under ID 711 . G/TBT/M/85  
 
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  relevant parts of them, for plastic material identification, including those commonly used to regulate 
plastic packaging, as the basis for any implementing measures for this regulation. For example, 
ASTM D7611/D7611M and DIN 6120 are widely accep ted standards for plastic packaging used by 
industry on a global basis.  
2.23.  US industry has noted that applying the PMI Regulation's labelling requirement to every single 
plastic part in a product or packaging is unfeasible. Countless products contain many dif ferent plastic 
parts and/or plastic parts that may be too small to label. For example, laptops contain as many as 
300 plastic parts and desktop computers contain more than 500 plastic parts. US industry has 
stressed that labelling very small plastic parts – for example, those weighing less than 25 grammes 
or having a surface area less than 50 square centimetres – would not only be illegible, costly, and 
overly burdensome but could also disrupt product functionality. Such small plastic parts are also not 
typically collected for recycling. Does Sri Lanka envision exempting small plastic parts from its 
labelling regime? We note that, as currently drafted, the PMI Regulation does not provide clear 
guidance on how manufacturers should label products or packaging containing plastic. For example, 
while the measure lists recycling marks for various types of plastics, it does not provide guidance on 
sizing, placement, colour, the manner in which such marks should be printed or affixed to products 
and/or packaging, or information on how conformity with the PMI Regulation will be assessed. Does 
Sri Lanka intend to provide such additional guidance? We request that Sri Lanka clarify the effective 
date of the PMI Regulation. We understand that US industry has recommended th at Sri Lanka 
consider a two -year transition period. Given the broad scope of the PMI Regulation, we encourage 
Sri Lanka to provide reasonable transition periods for industry to conform to the new requirements, 
in accordance with Sri Lanka's WTO TBT commitm ents.  
2.24.  In response, the representative of Sri Lanka  provided the following statement. We have duly 
noted concerns expressed by the United States on Sri Lanka's regulation especially with regard to 
its scope, the timeline for implementation, the clarity and  feasibility of the labelling requirements 
and notification to the WTO. We understand that the United States has already been communicating 
with our national authorities, in particular with Sri Lanka's WTO TBT Enquiry Point flagging some of 
these specific concerns. My delegation has already had few information exchanges with the 
delegation of the United States and in order to better understand the concerns under reference. We 
wish to place on record our sincere appreciation to the US delegation in Geneva on  the attentive 
nature and promptness at which it shared all the pertinent documentation. During the scrutiny of 
the correspondence between the two TBT Enquiry Points of the US and Sri Lanka, it revealed that 
there has been a possible communication breakdow n, which may have prompted the US delegation 
to reiterate its concerns.  
2.25.  Due to the very long lockdowns imposed by Sri Lanka to contain the spread of COVID -19 
pandemic, most of the institutions were operating with a very minimal staff mainly to focus only o n 
all COVID -19 related facilitation measures. This may have been the most possible reason as to why 
our authorities have not been able to respond in a timely manner. However, my delegation has 
already made our national authorities aware of the concerns exp ressed by the United States, 
including sharing the copies of correspondence had between the two TBT Enquiry Points of the US 
and Sri Lanka, and we expect a formal request from our capital shortly. Accordingly, my delegation 
will continue to engage with the  United States bilaterally in order to address their concerns, including 
a possible notification of the measures to be made to the WTO TBT Committee.  
2.1.2.9   Brazil - MAPA Ordinance No. 208, 26 February 2021 – revision of the Decree No. 
6.87 of 4 June 2009 on the standardisation, classification, registration, inspection, 
production and supervision of alcoholic beverages, G/TBT/N/BRA/1145  (ID 71213) 
2.26.  The representative of the European Union  provided the following statement. The European 
Union would like to ask Brazil about the state of play  of the notified revision of the Decree No 6.87 
on alcoholic beverages and to note it still has not received a reply to the written comments of 29  April 
2021. The EU producers are particularly concerned with setting of a maximum limit of alcohol content 
for distilled alcoholic beverages, the definition of whisky, requirements on the ageing and sweetening 
for rum, requirements for vodka and liqueurs and components allowed for the production of gin and 
the generic use of the EU geographical indications of "Ca lvados" and "Cognac". All these elements 
 
13 For previous statements follow the thread under ID 712 . G/TBT/M/85  
 
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  would constitute significant barriers to trade. The European Union would appreciate a reply to the 
written comments and is prepared to work bilaterally with Brazil with regard to the ongoing revision.  
2.27.  In response, t he representative of Brazil  provided the following statement. Ordinance No. 208 
of the Ministry of Agriculture, Livestock and Food Supply (MAPA) of Brazil, issued on 26 February, is 
a call for contributions regarding the revision of the Decree No. 6.871 of  2009. This decree applies 
to the standardization, classification, registration, inspection, production and supervision of alcoholic 
beverages. This call for contributions is a step prior to a public consultation. As such, there are still 
no draft texts fo r countries to comment on. Brazil is willing to receive countries' feedback on the 
best ways to improve current regulatory stock applicable to alcoholic beverages. We invite all 
interested parties to present technical elements that will substantiate the dr afting of a new regulation 
to be subsequently submitted for public consultation, in accordance with our obligations under the 
TBT Agreement. A call for contributions is an extra step in terms of transparency and stakeholder 
engagement, following provisions  of Article 2.9.1 of the TBT Agreement. Since there are no text 
proposals so far, we understand that the alleged concerns mentioned by the European Union are 
somewhat unwarranted. All of the comments received during this call for contributions will be duly  
taken into account.  
2.1.2.10   Belgium - Draft law introducing additional security measures for the provision 
of mobile 5G services, G/TBT/N/BEL/44  (ID 71314) 
2.28.  The representative of China  provided the following statement. China thanks Belgium for 
making a notification to this Committee, and als o the EU for the reply to China's comments. China 
recognizes that WTO Members are legitimately entitled to protect the security of their 5G network. 
However, the relevant laws, regulations and technical standards shall be adopted and applied in a 
manner co nsistent with the principles of non -discrimination, fairness and transparency and on the 
basis of objective facts and evidence. The laws, regulations and technical standards with regard to 
cybersecurity shall by no means constitute unjustified discriminati on or a disguised restriction on 
international trade. In addition, any party affected by the Draft Law shall be afforded adequate 
remedies. 1. For EU's reply point 1.A. of Article 105, §4 : "It is recommended to use objective and 
product -based technical sta ndards for risk assessment ", China thinks these criteria do not only 
comprise technical criteria but primarily discretionary (geo -political) issues. Moreover, the law 
stipulates that the fulfillment of only one criterion may justify a prohibition. Hence, t he technical 
criteria are not decisive and thus the concern has not been resolved as the decision is not based on 
objective and product -based technical standards. 2. For EU's reply point 1. B.: "It is recommended 
to clarify certain concepts and specify the scope of subjects to which the risk assessment criteria 
apply ", China could not find a definition of "supplier" under Article 105, paragraph 1, subparagraph 
2 of the notified draft. It might be a wrong reference for there is no definition of "supplier". In  this 
regard, it is recommended that Belgium comply with Article 2.4 of the TBT Agreement by using 
technical standards that are based on internationally recognized standards to objectively evaluate 
the product security, or by using certification methods th at are based on international standards to 
assess the product security, instead of applying a high -risk vendor model primarily based on non -
technical criteria.  
2.29.  3. For EU's reply point 1. C.: "it is recommended to specify the procedures to revoke the 
identif ication of HRV ". This article only prohibits or restricts mobile network operators from using 5G 
equipment or services supplied by HRVs in a broad way. However, the notification does not specify 
whether and how high -risk suppliers can be revoked from the i dentification. EU's answers did not 
address our questions on "how to lift the HRV", more importantly, the answer did not address "to 
what extent and how the HRVs are prohibited". "As such, the EU would like to clarify that it is always 
possible to file a n ew application if the situation has changed." This is not a remedy but as the EU 
states, a new application which only may result in another decision if the situation has changed. By 
contrast, it is not a measure to achieve a revision of the decision under the same circumstances. 
"Ministers concerned can always decide to review the case". This is only at the discretion of the 
ministers and no formal remedy for the supplier/vendor or MNO concerned. Hence, it does not 
comply with the rule of law requiring an e ffective remedy.  
2.30.  For Article 105, §4, al.4, it is recommended to adopt a fact -based, objective, and fair risk 
assessment criteria. The risk assessment criteria set out in this article of the notified law are 
discriminatory and vague, some of which constit ute discrimination against non -EU vendors. For 
 
14 For previous statement s follow the thread under ID 713 . G/TBT/M/85  
 
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  instance, the first provision as regards "the extent of interference to the vendor from non -EU 
country" discriminates against the nationality of 5G equipment and service providers from non -EU 
member States. "W hether reached data protection agreements or security agreements with the EU" 
as a factor in the risk assessment of suppliers constitutes discrimination against suppliers from 
Members that have not reached data security or protection agreements with the EU . China thinks it 
is not consistent with non -discrimination requirements in the TBT Agreement. In this regard, China 
suggests that the subjective risk assessment criteria for suppliers in the draft notification could be 
revised to objective criteria based on facts and industry consensus, carry out supply chain security 
certification (e.g. AEO certification, TAPA Certification and C -TPAT Certification), review vendors' 
history records in security compliance, establish security guidance for vendors and requir e vendors 
to make security guarantees.  
2.31.  For Article 105,  §5, it is recommended to give reasons for being identified as HRVs and provide 
reasonable remedies. This article  allows 5G network equipment operators to defend against the 
preliminary results of  the risk assessment  and also regulates that BIPT may, but is not required to, 
participate in the hearing requested by the applicant on the outcome of the assessment. The ri ght 
to request a hearing does only apply to MNOs and there is no possibility for the vendors to be 
formally heard although they are directly affected. Consequently, this is not an effective remedy. As 
the risk assessment objects are suppliers of 5G equipme nt or services, it is recommended to provide 
the suppliers of 5G equipment or services with remedies, require the competent authorities to 
explain the reasons and evidence for the risk assessment results, and allow the suppliers to defend 
against the risk assessment results.  
2.32.  In response, the representative of the European Union  provided the following statement. 
China submitted written comments to which the EU replied on 8 November 2021. Generally, the EU 
would like to clarify that the notified draft's risk assessment criteria are based on the factors set out 
in point 2.37 of the EU coordinated risk assessment and recommended in the EU 5G Cybersecurity 
Toolbox, which has been agreed by all EU member States. Further details and explanations are given 
in the EU 's written reply to China, which was submitted on 8 November 2021. The notified draft is 
expected to be adopted imminently.  
2.1.2.11   United States - Protecting Against National Security Threats to the 
Communications Supply Chain through the Equipment Authorization Program and the 
Competitive Bidding Program, G/TBT/N/USA/1771  (ID 71415) 
2.33.  The representative of China  provided the following statement. China thanks US for notifying 
this document to the TBT Committee. China sent our comments on 18 September, and hopes to get 
reply from the US as soon as possible. The draft only targets five Chinese enterprises and identi fies 
Chinese products as security threats without referring to any technical standards and measurement, 
which is not consistent with the TBT Agreement. 1. For the new provision 47 CFR 2.903, it is 
recommended to revoke this provision. The added provision 4 7 CFR 2.903 prohibits the authorization 
of certain telecommunications equipment and services under provision 47 CFR 1.50002, which lists 
only five Chinese companies. It violates non -discriminatory principles in the TBT Agreement. There 
China recommends to revoke this provision. 2. For Section III.A of the draft regulations, it is 
recommended to provide technical standards that determine the national security threats, and that 
the FCC shall authorize the products that comply with the safety technical standar ds. The draft 
regulations prohibit the authorization of certain telecommunications equipment and services under 
provision 47 CFR 1.50002, on account of national security threats. Without a public technical 
standard and measurement index, the fact that the United States deems products of Chinese 
enterprises to have security threats is not consistent with TBT transparency principles. It is 
recommended to provide technical standards and measurement index, and notify to WTO, moreover, 
to provide the opportuniti es to other WTO Members to make comments. 3. For section III.A.3 of the 
draft regulations, it seeks comments on whether to revoke any of the authorizations that have been 
previously granted for "covered" equipment on the Covered List (47 CFR 1.50002). It i s proposed 
not to revoke the authorizations. Currently, the equipment authorizations that have been previously 
granted strictly followed the then -effective regulations, TCB -certified by the FCC, or SDOC process 
prescribed by the FCC. There is no violation of the situations mentioned in provision 2.939 of section 
III.A.3.  
 
15 For previous statements follow the thread under ID 714. G/TBT/M/85  
 
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  2.34.  In response, the representative of the United States  provided the following statement. The 
United States notified the proposed rule, "Protecting Against National Security Threats to the 
Communications Supply Chain Through the Equipment Authorization Program and the Competitive 
Bidding Program," to the WTO on 3 September 2021. This action is a Notice of Proposed Rulemaking 
(NPRM) by the United States Federal Communications Commission (FCC) in  which the FCC proposes 
to revise rules related to its equipment authorization processes to prohibit authorization of any 
"covered" equipment on the recently established Covered List, included in PUBLIC LAW 116 –124 
Secure and Trusted Communications Network s Act of 2019, enacted by US Congress 12 March 
2020.16 The FCC accepted formal comments on the notification until 18 October 2021, and China's 
comments were submitted on 18 September 2021. In total, the FCC has received nearly 250 
comments, including from China. All of the comments are available to the public and can be found 
on the FCC's website.17 United States appreciates China for its comments. The final rule will include 
information on all substantive comments received, and how the comments were taken into account. 
Information on any rule changes will be notified to the WTO as an addendum to the original 
notification.  
2.1.2.12   Pakistan - Safety of amusement rides and amusement devices, 
G/TBT/N/PAK/164,  G/TBT/N/PAK/165,  G/TBT/N/PAK/166  (ID 71518) 
2.35.  The representative of the United States  provided the following statement. We appreciate 
Pakistan's notification on 9 February 2021, to the WTO TBT Committee of three measures concerning 
the safety of design, manufacture, operation, use, and inspection of amusement parks and 
amusement devices, contained in G/TBT/N/PAK/164 , G/TBT/N/PAK/165 , and G/TBT/N/PAK/166 . In 
April 2021, the US Government and US industry submitted com ments via the US Enquiry Point in 
response to these measures. Does Pakistan intend to respond to substantive concerns? We 
understand that, through these measures, Pakistan will adopt and apply ISO standards to 
amusement rides and amusement devices. We reit erate our earlier comments, which highlighted US 
industry's concerns that these measures may lead to the exclusive use in Pakistan of the ISO 
standards and exclude use of other widely -used international standards for this particular sector, 
such as ASTM In ternational standards. According to US industry, exclusive use of ISO standards 
would require manufacturers and suppliers to make expensive and unique customizations for the 
Pakistan market, resulting in limited price and design options. As noted in our co mments, many US 
and international manufacturers and suppliers currently design to ASTM F24 standards, which are 
accepted in many foreign markets; are updated frequently; and include specifications for inflatables, 
trampolines, hybrid rides, and water slide s, which ISO standards do not currently cover.  
2.36.  Can Pakistan clarify whether it will also recognize ASTM International standards when 
importing rides, attractions, or equipment in the amusement rides and other devices sector? We 
note that there is nothing that prevents a WTO Member from considering more than one international 
standard to serve as the basis for a technical regulation. We encourage Pakistan to recognize rides, 
attractions, or equipment for which design, manufacture, operation, and use have be en tested and 
inspected in compliance with ASTM International's F24 standards and not subject such products to 
further in -country testing. Finally, we encourage Pakistan to provide a six -month transition period 
between the publication of the adopted measur es and their entry into force in accordance with 
Pakistan's WTO TBT commitments, to allow industry to comply with these measures.  
2.37.  In response, the representative of Pakistan  provided the following statement. Pakistan 
Standards and Quality Control Authority  the PSQCA in its process to adopt National Standards has 
considered more than one international standard such as ISO, IEC, OIML, and ASTM International. 
More specifically, the Technical Committee for "Amusement Rides and Amusement Devices" 
considered both  the ISO and ASTM International Standards. After careful review of these two 
international standards, the Technical Committee concluded that the ISO standards were the most 
appropriate to achieve the objectives as they cover both the "Uses" and "Safety" of  amusement 
rides and amusement devices. At the same time, we wish to thank the United States for their 
encouragement and wish to inform that Pakistan continues to consider ASTM International F24 
Standards and other standards related to amusement rides and amusement devices in the relevant 
 
16 Public Law No: 116 -124 (03/12/2020) Secure and Trusted Communications Networks Act of 2019.  
17 https://www.fcc.gov/ecfs  (ET Docket No, 21 -232).  
18 For previous statements follow the thread under ID 715 . G/TBT/M/85  
 
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  Technical Committee of the PSQCA. These will be incorporated in the technical regulations whenever 
found relevant.  
2.1.2.13   United States - Energy Conservation Program: Test Procedure for Metal Halide 
Lamp Fixtures, G/TBT/N/USA/1748  (ID 71619) 
2.38.  The represe ntative of China  provided the following statement. The standby mode power 
measurement of metal halide lamp should be changed from IEC 62301:2011 to IEC 63103:2020.  
2.39.  In response, the representative of the United States  provided the following statement. The 
United States appreciates the comments submitted by China on 13 September 2021, responding to 
our 15 July 2021 notification to the WTO to amend Department of Energy's Energy Conservation 
Program test procedures for metal halide lamp fixtures. The United Sta tes will take into consideration 
all comments received during the open comment period and respond to each substantive comment 
in the next published rulemaking document on the Test Procedures for Metal Halide Lamp Fixtures.  
2.1.2.14   India - Chemical Fibers and Yarns : PSY, IDY, FDY, POY, PSF, and SMF for use in 
Cement -Based Matrix (Quality Control) Orders, 2020, G/TBT/N/IND/185,  
G/TBT/N/IND/188,  G/TBT/N/IND/189,  G/TBT/N/IND/190,  G/TBT/N/IND/192,  
G/TBT/N/IND/194  (ID 71720) 
2.40.  The repr esentative of the Republic of Korea  provided the following statement. Regarding 
India's six Quality Control Orders (QCOs) for Chemical Fibers and Yarns (PSY, IDY, FDY, POY, PSF, 
and SMF) notified to the WTO on February 2021 as G/TBT/N/IND/185 , G/TBT/N/IND/188 , 
G/TBT/N/IND/189 , G/TBT/N/IND/190 , G/TBT/N/IND/192  and G/TBT/N/IND/194 , Korea submitted 
comments concerning the enforcement dates in August 2021. In res ponse, the Indian Government 
provided an additional grace period until April 2022, partially resolving the difficulties for Korean 
companies, and Korea fully appreciates the Indian government for its kind efforts. We respect the 
efforts of India to introdu ce Chemical Fibers QCOs for the health and safety of the Indian people. 
Furthermore, Korean companies are committed to complying with the regulation of India. However, 
we would like to deliver requests as Korean companies still have unresolved technical di fficulties 
regarding the six QCOs. Firstly, we have difficulty complying with the regulations as detailed test 
procedures and the attachment location for the ISI Mark have not been notified. Therefore, we 
request India to provide clear information on the t echnical regulations.  
2.41.  Secondly, the notified BIS regulations deviate from international standards. Unlike other 
countries such as the United States and Germany, which have unified systems of issuing certificates 
after testing at local laboratories, India's  regulations require products to be tested twice, including 
local audits and designated laboratory tests, increasing the burden of certification to the industry. 
Therefore, we request India unify the product testing procedures to tests conducted by BIS 
certification agencies and exempt local on -site audits. Third, despite a simple classification only in 
the manufacturing process, POY, FDY, and IDY are regulated separately, causing unnecessary 
burdens in certification. Because these three products share the same properties and the 
composition of raw materials, we request India consider integrating them as one unified regulatory 
item of PF, Polyester Filaments. Lastly, after BIS certification, redundant administrative procedures 
occur in the process of attachi ng the ISI mark, resulting in excessive certification cost compared to 
other certifications in general. Therefore, we ask India to mitigate the relevant procedures by 
recognizing BIS certification numbers declared in shipping documents in substitute of ISI  mark 
attachments.  
2.42.  In response, the representative of India provided the following statement. Extension of QCOs 
for PSY, IDY, FDY, POY, PSF, and SMF for use in Cement -Based Matrix (Quality Control) Orders, 
2020 has been issued on 8 October 2021 and will co me into force on completion of six months from 
date of its publication in the Gazette of India.  
 
19 For previous statements follow the thread under ID 716 . 
20 For previous statements follow the thread under ID 717 . G/TBT/M/85  
 
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  2.1.2.15   Egypt – Halal Certification Measure, based on Egyptian Standard ES 4249/2014 
General Requirements for Halal Food According to Islamic Sharia (ID 71821) 
2.43.  The repr esentative of the United States  provided the following statement. The United States 
understands that Egypt is implementing changes to its halal certification requirements but has not 
shared written documentation of these changes nor notified any changes to  the WTO. According to 
the diplomatic note received from the Egypt Ministry of Foreign Affairs on 12 September 2021, 
effective 1 August 2021, Egypt is no longer allowing halal certification bodies other than a single 
Egyptian company to certify halal produ cts for export to Egypt. The United States would like to note 
that we and other Members have successfully used multiple halal certification bodies to meet Egypt's 
halal conformity assessment requirements for many years. Could the Government of Egypt please  
explain why it is no longer willing to accept these certification bodies? We understand that when the 
Ministry of Agriculture delisted all US -based certifiers for beef and poultry in 2019, the sole Egyptian 
certifier raised certification fees by 1000%, re sulting in higher costs for US exporters and higher 
food prices for Egyptian consumers. The United States has also been verbally informed by the 
Government of Egypt that it is planning to expand the scope of products that require halal 
certification as a c ondition of import, despite Egypt's current importation of halal products without 
certification. To date, the United States has not received written notice of any proposed regulation, 
including the product scope, or proposed timeline for the halal technica l regulation that Egypt may 
propose. In the absence of any written, official notices from the Government of Egypt, the confusion 
resulting from these unofficial, opaque proposed changes has already significantly disrupted US 
trade to Egypt. While the Unite d States recognizes Egypt's right to require appropriate halal 
certification, we expect Egypt to fully meet its WTO obligations. The United States strongly urges 
Egypt to immediately pause implementation of any new certification requirements related to hal al 
until all WTO obligations have been met.  
2.44.  The representative of the European Union  provided the following statement. The European 
Union would like to express its concerns with regard to the new requirements on halal certification 
as of 1 October 2021 bas ed on the Egyptian Halal standard 4249/2014. The EU industry is worried 
about negative impact this measure would have on food and beverages imports to Egypt. The EU 
regrets that Egypt did not notify the measure in its draft stage to this Committee and did not give 
the WTO Members an opportunity to submit comments. The EU would like to thank Egypt for useful 
bilateral contacts and welcomes some of the steps envisaged to mitigate the negative impact, such 
as the grace period until 15 December 2021 during whic h certification by IS EG Halal will be voluntary 
and for free. Nevertheless, this facilitation would only be temporary, and the companies will not 
have sufficient time to adapt to the new certification and labelling requirements. This is why the EU 
would u rge Egypt to postpone the implementation of this measure and to provide for a reasonable 
adaptation time of at least six months in accordance with Article 2.12 of the TBT Agreement.  
2.45.  The EU would also like to invite Egypt to reconsider the decision to gran t the right to certify 
the compliance with halal requirements to a single company, IS EG Halal, and to provide for a halal 
certification system that would allow multiple, well -established certification entities, in accordance 
with the international best pr actices. Re -certification by IS EG Halal of products from establishments 
already certified by other companies would lead to longer time to market and higher costs for 
consumers, while Egypt is suffering food security problems, aggravated by the coronavirus  
pandemic. The EU would also like to ask Egypt to consider keeping the Halal certification and labelling 
voluntary, in order to pursue the legitimate objective of ensuring reliable information without unduly 
hindering trade flows. The consumers should be a ble to decide whether to buy halal -certified food 
or not, based on clear labelling. Finally, the EU invites Egypt to provide more information about the 
new measure, including detailed description of the certification procedure, its duration and cost, and 
the product coverage, and comply with the notification obligations under the WTO TBT Agreement.  
2.46.  The representative of Canada  provided the following statement. Canada joins the United 
States, the European Union and other intervening Members to signal its con cerns with Egypt's new 
halal certification requirements for all imported food and beverage products which came into effect 
as of 1 October 2021. While Canada supports Egypt's objective to ensure that Egyptian consumers 
are confident that they are buying an d consuming Halal -certified products, Canada is deeply 
concerned that Egypt failed to notify the WTO TBT Committee of this new measure to provide 
Members and stakeholders the required period of at least 60 days to review the measure and provide 
comments. I n addition, as per Egypt's obligations under the TBT Agreement, a reasonable amount 
 
21 For previous statements follow the thread under ID 718 . G/TBT/M/85  
 
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  of time, understood as a period of not less than six (6) months, should be provided between the 
publication of a regulation and its entry into force to allow time for indus try and Members to review 
and implement the new requirements. This has obviously not been the case with this measure. 
Canada is also concerned that the lack of specifics and/or documentation regarding the 
implementation of the measure has created an unpred ictable trading environment for our exporters. 
Based on the very limited information gathered to date, the halal certification requirements imposed 
by Egypt could be overly burdensome, unjustified, costly and more trade restrictive than necessary 
to achiev e Egypt's objective. We strongly encourage Egypt to have an open and transparent 
discussion with trading partners to share information, further clarify the requirements under this 
new measure and consider the impact it may have on trade prior to its implem entation. Specifically, 
we request that Egypt notify this measure to the WTO, pursuant to Egypt's transparency obligations, 
and provide trading partners and stakeholders with the opportunity to review and comment. Until 
then, we respectfully request that E gypt suspend the implementation of the measure.  
2.47.  The representative of New Zealand  provided the following statement. New Zealand welcomes 
the opportunity to speak in support of the concerns raised by the European Union, Canada, and the 
United States. We thank Egypt for its bilateral engagement to date on this issue. New Zealand 
understa nds that Egypt is implementing changes under Prime Ministerial Decree (No. 35/2020) to 
require that certification of relevant halal standard(s) shall only be undertaken by IS EG Halal. 
Certification from other Halal assurance bodies will not be accepted fo r goods imported into Egypt. 
New Zealand also understands that the measures will apply to a broad category of food and drink 
products imported into Egypt, irrespective of whether Halal labelling is applied to these goods, and 
irrespective of whether these goods have previously been treated as Halal, for example, fresh fruit, 
vegetables, milk and other dairy products that do not include any other ingredients or additives. 
New Zealand has serious concerns with these measures. New Zealand would draw Egypt's at tention 
to its WTO obligations, including its obligations under the TBT Agreement concerning the use of 
conformity assessments, including under Articles 5 and 6, and the requirement that measures not 
be more trade restrictive than necessary. New Zealand wo uld like to better understand what 
consideration Egypt has accorded to less trade -restrictive alternatives. We are also interested in 
what factors led Egypt to introduce a measure that only allows conformity with the relevant Halal 
standard(s) to be determ ined by a single commercial body, and requires Halal certification of 
products, which have commonly been treated as Halal. New Zealand further notes that Egypt is yet 
to notify the certification procedure to the TBT Committee in accordance with Article 5.6 .2 of the 
TBT Agreement. We request that the new measures be suspended until all WTO obligations, including 
those requiring consultation with other WTO Members, have been met.  
2.48.  The representative of Chile provided the following statement. Chile supports the  STC recently 
raised by the countries that took the floor before it. Chile is concerned about Egypt's communication 
in which it is reported that ISEG Halal is the only establishment authorized to issue halal certificates. 
A further matter of concern is the  lack of alternatives for certifying products, such as agreements 
between ISEG Halal and certification entities in third countries, given that Chile is home to 
internationally recognized certification centres that could be recognized by Egypt, thereby avoi ding 
the creation of unnecessary barriers to trade, which ultimately restricts bilateral trade.  
2.49.  The representative of Australia  provided the following statement. Australia recognizes Egypt's 
right to implement religious requirements to ensure that consumer s can identify and purchase 
products which meet their needs. Australia notes Egypt's obligations to implement measures which 
are no more trade restrictive than necessary, and to notify Members of proposed measures that may 
have a significant effect on othe r Members' trade and that are not based on relevant international 
standards. While Australia acknowledges and thanks Egypt for bilateral communication and 
engagement on the implementation of new halal certification requirements, we kindly request that 
details regarding the new requirements are notified to the TBT Committee and Members provided 
an opportunity to comment. In particular, Australia requests clear advice regarding the 
implementation timelines and scope of product coverage. Australia welcomes ong oing discussion on 
the implementation of Egypt's new halal certification measures and the opportunity to provide 
further comment through a formal TBT notification process.  
2.50.  The representative of Argentina  provided the following statement. Argentina wishes t o convey 
its concern regarding the extension of the scope and new requirements of Egyptian Standard 
ES 4249/2014 General Requirements for Halal Foods According to Islamic Sharia, in order to extend, 
as of 1  October  2021, the IS EG Halal certification to al l imported food and beverages and not only 
to those products claiming to be halal. It is important to highlight that the extension of this measure G/TBT/M/85  
 
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  has not been officially published in a timely and appropriate manner, nor duly notified to the WTO, 
given tha t it is a regulation that creates higher burdens and costs for exporters. In this regard, 
exporting countries do not have clear and precise information on the measures and requirements 
that must be met. Nor do they have any information on the respective im plementation costs and 
periods. This situation leads to unpredictability for food and beverage exporting companies, which 
results in practice in the creation of unjustified obstacles to international trade. In addition, taking 
into consideration that the P rime Minister's Decree (No.  35/2020) gave responsibility for halal 
certification of all animal products imported into and exported from Egypt exclusively to IS EG Halal 
and the short deadlines reportedly set, significant delays in trade have already been c aused by the 
extensive goods verification processes at ports. We request Egypt to review the measure, while at 
the same time expecting it comply with the requirement to submit the measure to the WTO, so that 
Members can have rapid and official access to th e adopted regulation, including all the information 
on requirements, products covered, deadlines set, costs and any other additional details.  
2.51.  The representative of Paraguay  provided the following statement. Paraguay shares Egypt's 
concern that consumers be  provided with certainty regarding the purchase and consumption of Halal 
certified products, however, as a food exporter to Egypt, we continue to follow closely the 
implementation of this measure and the information that Egypt can give us about it. In that  regard, 
we thank Egypt for the recent bilateral meeting in Geneva and we hope that Egypt can provide us 
with more information so that we can study it and its implications for Paraguay carefully. In addition 
to meat and other animal products, Paraguay expo rts other products of plant origin to Egypt, such 
as fruits, grains and derived products, for which the addition of or contact with food considered 
unlawful under Islamic law is highly unlikely and for which Halal certification and labelling will also 
mean  a significant burden and additional cost. The apparent requirement for all food and beverages, 
even for those that do not claim to be Halal and the possible process required to obtain certification 
renders this measure more restrictive and costly than nec essary to achieve Egypt's goal. Paraguay 
therefore respectfully requests Egypt to notify the measure under the WTO transparency obligations 
and to continue the transparent process of information exchange and dialogue with the Members 
concerned, in order to  provide the necessary information and to respond to Members' comments so 
that this measure is not more burdensome and restrictive than necessary. With respect to the 
certification and labelling obligation, even for those products that do not claim to be H alal, we request 
Egypt to confirm this requirement and to consider keeping certification on a voluntary basis in order 
to meet the legitimate requirement to provide accurate information to consumers without it 
becoming a trade restriction.  
2.52.  In response, the  representative of Egypt  provided the following statement. We thank the 
Members with which we had some fruitful bilateral discussions. Given the extensive comments made 
yesterday, I really regret the fact that we are still following up with capital on this  matter. We take 
note of all the comments received today and will convey them to capital and come back with concrete 
answers to concerned delegations in due course.  
2.1.2.16   India - Plastic Waste Management (Amendment) Rules, 2021 (ID 71922) 
2.53.  The representative of t he Republic of Korea  provided the following statement. Korea respects 
and strongly supports India's efforts to introduce the Plastic Waste Management Rules for the 
protection of the environment and the safety of its people. Furthermore, Korean companies ar e fully 
committed to complying with India's regulations. However, Korean companies have concerns 
regarding the "Plastic Waste Management (Amendment) Rules, 2021" published in the Gazette of 
India on 12 August 2021, so Korea shall present the following comm ents. Firstly, with regard to this 
amendment, Korea requests India to notify the WTO so as to provide the WTO Members with a 
comment period of more than 60 days, and to grant a sufficient grace period so that the affected 
industry can comply with the relev ant regulation. This amendment should have been notified to WTO 
Members and should have allowed a reasonable time for WTO Members to make comments. But as 
the Amendment came into force without WTO TBT notification and without any grace period, the 
new requ irements are quite burdensome for the affected industries. Secondly, we request an 
exception to labelling requirement on plastic packaging from regulation when using imported plastic 
packaging, regardless of whether it is used for imported products or dome stic products. Imported 
packaging materials do not have registration numbers in India, and therefore, it is impossible to 
comply with labelling requirements such as manufacturer name, producer name, registration 
number, etc. With Electrical and Electronic Equipment (EEE products) in particular, it is difficult to 
 
22 For previous statements follow the thread under ID 719 . G/TBT/M/85  
 
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  comply with the labelling requirements and to manage the packaging material registration number 
itself, due to the use of packaging materials from multiple companies even on the same model, 
frequen t packing company changes, and packing sometimes taking place in India with imported 
plastic packaging. Under the Amendment Rules, "multilayered packaging used for imported goods" 
is excluded from the labelling requirement. Accordingly, we request India to  kindly consider 
exempting "imported plastic packaging" as well.  
2.54.  In response, the representative of India provided the following statement. Since the 
statement was uploaded rather late and we did not have the full gist of the question, the response 
now is well as we are able to dispatch. The Plastic Waste Management Rules, 2016, provides the 
statutory framework for plastic waste management in India. Rule 4 of the Plastic Waste Management 
Rules, 2016, provide for minimum thickness requirement for plastic car ry bags and plastic sheets 
used in packaging and Rule 9 casts Extended Producer Responsibility on Producers, Importers and 
Brand Owners for environmentally sound management of plastic packaging introduced in the market 
along with the products. The marking and labelling requirement on plastic packaging under Plastic 
Waste Management Amendment Rules, 2021, is not discriminatory and is not a barrier to 
international trade. The requirements are applicable in a uniform manner to both domestic and 
international c ompanies. Such marking and labelling requirements have also been put by other 
countries / regional groupings such as the European Union.  
2.1.2.17   Sri Lanka - Imports (Standardization and Quality Control) Regulations 2017, 
G/TBT/N/LKA/36  (ID 72023) 
2.55.  The representative of Indonesia  provided the following statement. The Government of 
Indonesia intends to request further clarification from the Government of Sri Lanka regarding the 
policy of prohibiting the import of palm oil as contained in the Operating Instruction of the Sri Lanka 
Export and Import Supervision Department No. 8/2021 which has been updated with Operating 
Instruction No. 9/2021 dated 12 April 2021. In this policy, crude palm oil products are categorized 
into a list of products that are prohibited from being imported bec ause the Sri Lankan government 
does not know how to deal with the issue of micro -toxin contamination as a result of the actions of 
importers who are deemed to have acted unethically by bringing crude palm oil to the market by 
claiming it as refined palm oi l and mixing it with coconut oil. Sri Lanka is a major producer of coconut 
oil products, and in recent years there has been an increase in imports and consumption of palm oil 
which is seen as detrimental to domestic producers and smallholders. Thus, the Sr i Lankan 
government issued a prohibition policy to make Sri Lanka free from palm oil plantations and free 
from palm oil consumption. The implementation of the prohibition policy has had a direct impact on 
the export of palm oil products to Sri Lanka, espec ially from Indonesia and this affects the livelihoods 
of small palm oil farmers in Indonesia and has a systemic impact on the global palm oil trade. 
Indonesia is of the view that the prohibition policy is a form of discrimination and is not permitted 
under  WTO provisions and has the potential to create unnecessary barriers to international trade.  
2.56.  The Indonesian government appreciates the Sri Lankan government's step in notifying the 
policy to the WTO's Technical Barriers to Trade (TBT) Committee through the  G/TBT/N/LKA/36  
document, an d for that Indonesia asks for clarification which has been sent to Sri Lanka's inquiry 
point and to date have not received a response or answer. In this regard, Indonesia hopes that the 
Sri Lankan government can immediately provide responses and answers re garding the clarification 
referred to, and if there is a renewal of the policy, it can immediately notify the WTO TBT Committee 
and can explain further regarding rationality, administration, objectives, duration of policy 
implementation and the basis for t he scientific justification of the policy. The Indonesian government 
hopes that Sri Lanka will be able to review the implementation of the palm oil import ban policy and 
use other alternative policy instruments that are permitted and in line with the appli cable provisions 
in the WTO, such as through the implementation of technical standards/regulations to ensure the 
quality of imported palm oil products.  
2.57.  In response, the representative of Sri Lanka  provided the following statement. My delegation 
would like to note that the subject matter has also been raised at the Committee on Import Licensing 
held on 8 October, Committee on Market Access held on 11 October and Council on Trade in Goods 
held on 1 November, where Sri Lanka responded to the concerns expressed  by Indonesia 
substantially. Today we understand that Indonesia has specific concerns with regard to Sri Lanka's 
notification to the TBT Committee No. G/TBT/N/LKA/36  dated 28 May 2018. Through this 
 
23 For previous statements follow the thread under ID 720 . G/TBT/M/85  
 
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  notification, Sri Lanka has notified its Imports Standardization and Quality Control R egulations of 
2017, which was introduced through the Extraordinary Gazette of Sri Lanka No. 2064/34 dated 29 
March 2018. This regulation governs the Compulsory Import Inspection Scheme of Sri Lanka 
operated by Sri Lanka Standards Institution. Under the Com pulsory Import Inspection Scheme, 
importers are not permitted to import the specified 122 items listed in the Schedule -I of this 
regulation, including palm oil to Sri Lanka, unless they conform to the relevant Sri Lanka Standards 
and other related SPS Stan dards.  
2.58.  Sri Lanka Standards for main palm oil products are as follows: Palm Oil: SLS 720; Palm Olein: 
SLS 961; Palm Stearin: SLS 960. These related standards were first published in 1985 subject to 
the restrictions imposed under the Sri Lanka Food Act No. 2 6 of 1980 (and revisions framed 
thereunder) and subsequently have been subject to revisions, the latest revisions having been made 
in 2016 and 2017. In these revisions, quality requirements have been updated, including 
requirement for detection of heavy me tals and mycotoxins with the references to the latest methods 
of test. In revising these standards, the Codex Alimentarius Commission, International Organization 
for Standardization (ISO) and Official Methods of Analysis of the Association of Official Anal ytical 
Chemists (AOAC), including the relevant Standard institutions of certain palm oil exporting countries 
have been consulted. In relation to the relevant Food (Mycotoxins) Regulations 2021, which stipulate 
the types of Mycotoxins with their respective maximum residual levels (MRLs) against all edible oils, 
including all forms of palm oils, have been framed based on European Commission Regulation (EC) 
No 1881/2006 of 19 December 2006 and its subsequent revisions, which set the maximum levels 
for certain contaminants in foodstuffs. The EU Regulations have apparently been in conformity with 
the new information and developments in Codex Alimentarius Commission. Palm oil products falling 
under HS codes 1511.90.10, HS 1511.90.30 and HS 1511.90.90 can be import ed to Sri Lanka by 
obtaining an import licence from the Department of Import and Export Control with a fee of 0.4% 
of CIF Value. The principal set of procedures that relate to automatic and non -automatic licences 
are stipulated in the Regulation published in Extraordinary Gazette No. 1739/03 dated 2 January 
2012. Sri Lanka has already notified this Regulation also to the WTO in 2014. Sri Lanka would like 
to further engage with Indonesia to address its concerns.  
2.1.2.18   Guatemala - Technical Standard 84 -2021 for the  Sanitary Registration of 
Repellent Products for External Use in Humans and Spatial Repellent Products (ID 72124) 
2.59.  The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to Technical Standard 84 – Sanitary Registratio n of Repellent Products for External Use in 
Humans and Spatial Repellent Products, the final version of which was published on 28  August this 
year on the website of the Department for the Regulation and Control of Pharmaceutical and Related 
Products of the  Directorate -General of Health Regulation, Surveillance and Control at the Ministry of 
Public  Health and Social Welfare. The concerns regarding this regulation relate primarily to the 
principles of proportionality, use of international standards and transp arency under the Agreement 
on Technical Barriers to Trade. The Technical Standard in question requires toxicity studies for the 
sanitary registration of repellents for external use in humans. However, it does not clarify whether 
it will be possible to use existing or bridging toxicological studies on the formulations or whether 
new studies need to be carried out for each formulation, even where there is precedent. Flexibility 
in terms of allowing the use of existing information helps to reduce the number of  studies to be 
carried out and, therefore, registration costs for importers, by limiting the requirement to conduct 
toxicity studies only to cases where there is a new ingredient in the formula.  
2.60.  Furthermore, in relation to the toxicity studies contained in  Article 5.1 of the Technical 
Standard, we note that the studies required by Guatemala for sanitary registration could include 
animal testing, which tends to be prohibited around the world. Accordingly, we would be grateful if 
the delegation of Guatemala c ould share with us the technical and scientific evidence on which they 
based the final version of the Technical Standard so we can learn more about the justification behind 
it. In addition, contrary to the transparency requirements of this Committee, the T echnical Standard 
was not notified to the members of this Committee or subject to international public consultation, 
which prevented the Government of Mexico from presenting its comments and concerns regarding 
this technical regulation through official cha nnels. Mexico has contacted Guatemala and expressed 
its concerns in detail to those responsible for the technical barriers to trade agenda, via email and 
in an online bilateral meeting, in July and September, respectively, of this year. These concerns 
were not taken into consideration in the final version of the Technical Standard in question. In light 
 
24 For previous statements follow the thread under ID 721 . G/TBT/M/85  
 
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  of this, the delegation of Mexico requests the good offices of the delegation of Guatemala to put the 
regulatory procedures related to Technical Standard 84 on hold in order to allow public consultations 
on this regulation and to facilitate and promote public -private sector dialogue in which the industry 
and the Government of Mexico can take part and express our concerns. The delegation of Mexico is 
grateful f or the opportunity to deliver this statement and for the consideration of the requests made 
therein.  
2.61.  In response, the representative of Guatemala  provided the following statement. Guatemala 
welcomes the statement made by Mexico; we are awaiting a reply fro m the relevant authority. 
However, we will forward the details of Mexico's statement to the relevant authorities in our capital, 
so as to have an early response.  
2.1.2.19   Canada – Regulatory requirements for the import and marketing of cannabis and 
cannabis based p roducts for medicinal use (ID 72225) 
2.62.  The representative of Colombia  provided the following statement. Colombia would like to 
express its concern regarding the difficulties noted in respect of the importation into Canada of 
cannabis and cannabis -based produ cts for medicinal use. We welcome the Canadian authorities' 
willingness to address my delegation's doubts and concerns within the context of bilateral dialogue. 
Canada is a leader in establishing progressive regulations on the use of cannabis for medicinal  
purposes. Canadian firms are key players in this growing and evolving market. Canada in fact has 
one of the most developed medicinal cannabis markets in the world, and is a recognized exporter of 
these products. Canada is also a significant investor in th is sector, and Colombia is one of the 
countries where considerable investment in the development of this industry has been recorded. 
Nevertheless, Colombian firms have encountered difficulties in exporting cannabis and cannabis -
based products for medicinal  – not recreational – use to Canada. In addition to general restrictions 
on the commercial importation of medicinal cannabis and difficulties obtaining marketing licences 
under Canadian legislation, Colombian firms have faced obstacles when seeking to obta in the 
certification required to market their products in this market.  
2.63.  According to Part 5 of the Cannabis Regulations under the Cannabis Act, the Canadian 
authorities require compliance with their own manufacturing standards known as "Good Production 
Practices" (GPP). These standards are only required in Canada, and Colombian exporters have not 
had access to them. In this regard, we would like to ask the Canadian authorities about Health 
Canada's requirements for granting GPP certification, both to Canadia n firms and to foreign firms: 
what exactly are these requirements? We would like some clarification as to whether any foreign 
firm meeting the requirements in the "Good production practices guide for cannabis", published by 
the Canadian authorities in June  2019, can obtain this certification. We would also like to ask the 
Canadian authorities whether they are able to recognize or approve the certificates of good 
manufacturing practices (GMP certificates) issued by the national authorities in Colombia. Lastl y, we 
would like some clarification as to whether a GMP certificate issued by an authority from another 
reference country, such as a member of the European Union, could be recognized or accepted for 
exports to Canada.  
2.64.  In response, the representative of Canada provided the following statement. The international 
control of drugs is regulated through the three UN Drug Conventions. Cannabidiol (CBD) is an 
internationally controlled substance under the Single Convention on Narcotic Drugs, 1961 (Single 
Convention ), as a preparation or extract/tincture of cannabis. Under the Single Convention, only the 
Commission on Narcotic Drugs (CND) can agree to list or delist a controlled substance, upon 
receiving advice from the WHO and/or member states. The UN CND is a funct ional commission of 
ECOSOC and is the central drug policy -making body within the UN system. In late 2020, the CND 
reviewed and voted on WHO recommendations relating to cannabis. However, the majority of the 
recommendations, including those related to CBD, were not adopted. As a result, the status of CBD 
as a controlled substance under the UN drug conventions did not change. Consistent with its 
controlled status internationally, CBD is a controlled substance in Canada and is regulated under the 
Cannabis Act.  The Cannabis Act and its regulations set out the restrictions pertaining to the import 
and export of cannabis. Only holders of licences issued by Health Canada under the Cannabis 
Regulations may import or export cannabis, and only for medical or scientifi c purposes. Under the 
Cannabis Act and its regulations, the import and export of cannabis for any other purpose (such as 
distribution or sale for non -medical purposes) is strictly prohibited. As outlined in Canada's Cannabis 
 
25 For previous statement s follow the thread under ID 722 . G/TBT/M/85  
 
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  Import/Export Bulletin, authori zation of the import or export of cannabis for medical or scientific 
purposes is only granted in very limited circumstances, in a manner that is consistent with the public 
health and public safety objectives of the Cannabis Act and Canada's obligations und er international 
drug control treaties, to which Canada is a party. Before issuing an import permit, Health Canada 
considers whether there are risks to public health and public safety. More information on importation 
of cannabis and cannabis products for m edical use is available on Health Canada's website.  
2.1.2.20   France - LOI n° 2020 -105: Anti -Waste Law for a Circular Economy (AGEC Law) 
(ID 72326) 
2.65.  The representative of the Republic of Korea  provided the following statement. Korea respects 
and strongly supports France's efforts to introduce "Prohibition of Mineral Oils on Packaging" as a 
part of "Law No. 2020 -105: Anti -Waste Law for a Circular Economy" (the "AGEC Law") to protect 
the environm ent and facilitate recycling procedures. Furthermore, Korean companies are fully 
committed to complying with the regulations of France. Korean companies understand that the use 
of mineral oil in printing inks on packaging materials will be banned from Janu ary 2022, but there is 
not enough detailed information about the regulation, which makes it difficult for them to be in 
compliance. Therefore, we would like to present the following enquiries and requests. First, we 
request that France specify the regulate d substance list with the chemical substance name and CAS 
No., and specify the detailed range of packaging materials to be regulated, such as ink, box, plastic 
bag, etc., for clarification of the range of regulated substances. Second, we request a grace pe riod 
of one year after the announcement to enforce the regulation. This is because for finished product 
manufacturers, a regulatory response period of more than one year is required to investigate the 
use of regulated substances by ink manufacturers and pr inting companies, as well as to make 
improvement and ship the necessary substances. For this reason, we request that a grace period of 
12 months or longer be applied after France provides the essential information for regulatory 
compliance.  
2.66.  In response, th e representative of the European Union  provided the following statement. Law 
No. 2020 -105 of 10 February 2020 is a framework law and the basis for several implementing 
Decrees, which were notified to the WTO through separate TBT notifications. The question s and 
requests posed by Korea seem to relate to Article 112 of Law No. 2020 -105, which requires the 
adoption of an implementing decree. The Decree is still at a draft stage. The French TBT Enquiry 
Point intends to notify the Decree to the WTO in accordance  with the TBT Agreement, which will 
provide sufficient time to discuss the matters raised by Korea.  
2.1.2.21   Indonesia - Government Regulation 28 of 2021 – Implementing Regulation (for 
the Manufacturing/Industry Sector) to Law No. 11 of 2020 the "Job Creation Act" (ID 
72427) 
2.67.  The representative of the United States  provided the following statement. The United States 
has concerns with the Government of Indonesia Regulation No. 28 of 2021, which is the 
Implementing Regulation (for the Manufacturing/Industry Sector) to Law No. 11 of 2020 of the "Job 
Creation Act" (GR28/2021). We ask that Indonesia halt implementation of the measure, notify the 
measure to this Committee, provide a 60 -day comment period for stakeholders, and take those 
comments into consideration before re issuing the measure. Specific concerns include that the 
measure appears to mandate conformity assessment bodies use Indonesian citizens domiciled in 
Indonesia for all conformity assessment. Such a requirement would effectively negate use of any 
current ove rseas inspection or testing bodies. We ask Indonesia for the justification for including the 
nationality and domicile of the personnel as a requirement for product conformity testing. Many 
industries obtain Indonesian national standards (SNI) certification  by submitting product sampling 
for each shipment. Does this nationality and domicile requirement apply to product sampling 
collection in a foreign territory as well, such that if a shipment will be tested by an Indonesian 
conformity assessment body, sampl ing is required to be performed by Indonesian nationals 
domiciled in Indonesia travelling to the manufacturing site to collect the sample? If yes, with 
widespread travel restrictions still impacting much of the world, how does Indonesia envision 
companies complying with these requirements? Because Indonesia is not allowing for remote factory 
inspections, companies that rely on factory inspections to obtain SNI certification will also be 
impacted if they have to rely on pre -shipment testing. We are therefore  concerned that requiring 
 
26 For previous statements follow the thread under ID 723. 
27 For previous statements follow the thread under ID 724 . G/TBT/M/85  
 
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  collection of product samples be done by Indonesian nationals domiciled in Indonesia will effectively 
halt imports, and in fact, already appears to be doing so.  
2.68.  We would also appreciate if Indonesia could clarify whether Article 3 8 of GR28/2021, which 
requires that conformity assessment bodies must also operate their own testing laboratories for all 
products required to be certified to SNIs. SNI requirements apply to a wide swath of product 
categories, and not all conformity assess ment bodies are likely to operate testing facilities for all 
categories. Industry stakeholders have reported that, in the absence of implementing regulations 
from the Ministry of Industry clarifying the requirements in GR 28/2021, many conformity 
assessmen t bodies have halted certification for foreign products, resulting in the halt of exports 
requiring SNI testing per shipment. As companies' SNI certifications based on factory inspection 
expire, those exports also will be impacted because there currently i s no means for foreign 
manufacturers to meet either requirement - factory inspections or pre -shipment product sampling. 
We ask that Indonesia urgently communicate to Indonesian conformity assessment bodies that 
certification of foreign product shipments ca n, and should, continue while the Ministry of Industry 
prepares the implementing regulations. We additionally request that Indonesia notify the 
implementing regulations to this Committee in draft form and allow for stakeholder comment and 
consideration of those comments prior to finalization.  
2.69.  The representative of the European Union  provided the following statement. The European 
Union is concerned by Regulation No. 28 of 2021 and new requirements for Indonesian National 
Standard (SNI) certification. In Febr uary 2021, the Government of Indonesia issued a Government 
Regulation No. 28/2021. This Regulation is one of the implementing regulations of the Omnibus Law 
on Job Creation (Law 11/2020) passed last year, both of them not notified. Government Regulation 
28/2021 aims to increase the competitiveness of Indonesia's national industry and mainly outlines 
measures related to raw materials. It also introduces new requirements with regard to product 
certification bodies (Lspros). We understand that the new requirem ents affect in principle all 
products subject to SNI certification. Certain sectors appear to be particularly concerned. This is the 
case, for instance, with the toys sector. With regard to the toys sector, articles 38 and 39 create 
significant challenges.  Article 38 prohibits Lspros from using third -party testing facilities, while article 
39 stipulates that product certification bodies (Lspros) be Indonesian entities, employ Indonesian 
citizens, residents of Indonesia to assess product compliance to Indone sian National Standards. 
Regulatory bodies are now giving this article an overly strict literal interpretation as requiring that 
every step of the SNI certification be conducted by Indonesian nationals residing in Indonesia, and 
all the criteria just menti oned. We understand this is both required for scheme 1 (batch testing and 
pre-shipment inspection) and scheme 5 (factory certification). This new approach appears to be 
implemented despite no ministerial implementing regulation, which is normally required in the 
Indonesian regulatory process to implement a Government Regulation.  
2.70.  In terms of impact, this means that for batch testing and pre -shipment inspection, samples 
need to be taken by an employee of the certification body/Indonesian resident. Due to COVI D-19 
restrictions, it is very difficult for Lspros to send personnel overseas to sample products or to conduct 
factory audits. As a result, all Lspros have either stopped overseas sampling or stopped overseas 
certification altogether. In addition, even whe n international travel would be easier, the new 
requirements will still add significant costs and delays. With regards to another sector, the tyre 
industry, we understand that they are also facing major problems. According to our information 
Indonesia is a pplying a mandatory certification system for certain spare parts (original and non -
original) including tyres, safety glazing, rims, primary -batteries and audio/video -components. This 
implies the audit of the plant where the spare parts are produced (in acc ordance with ISO 9001) as 
well as an analysis of the products conducted by Indonesian test institute. This is followed by 
scheduled conformity of production audits. Currently the Indonesian test institute has suspended 
both the audit of the plants for new certifications, as well as the conformity assessment inspections. 
The result is that products requiring new certifications cannot be imported into Indonesia, and those 
products which already have a certification will be also banned from Indonesia when thei r respective 
certifications expire.  
2.71.  The European Union would like to understand what measures Indonesia is putting in place to 
ensure that EU spare parts can be smoothly imported into Indonesia. In addition, we would like to 
stress that EU products certifi ed in accordance with United Nations (UN) regulations under the 1958 
Agreement have similar or higher levels of road safety and environmental protection performance 
than those certified in accordance with the Indonesian regulations. Therefore, the European  Union 
would like to invite Indonesia to accept the EU spare parts bearing a UN marking or being G/TBT/M/85  
 
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  accompanied by an UN certificate. The European Union would like to propose extending the validity 
of issued Indonesian certificates until Indonesia can resume the conformity of production activities. 
Indonesia could also consider allowing the import of EU original parts, given that original parts have 
already proven their performance on vehicles in use in Indonesia. Finally, we would like to highlight 
that new S NI requirements have negative impact also on EU machinery industry. The European 
Union would like to invite Indonesia to take into account the concerns just mentioned. We remain 
available of course to discuss the issue also bilaterally as we did already.  
2.72.  In response, the representative of Indonesia  provided the following statement. This Omnibus 
Law revised a number of important Articles from 77 existing Laws with job creation as its main 
purpose by improving "ease of doing business (EODB)". The implementing  regulations of this 
Omnibus Law are aimed, among others, to simplify and harmonize investment regulations, to banish 
red tape, and to reform the investment licensing procedures with the improved risk -based Online 
Single Submission (OSS) system. Indonesia would like to inform that Government Regulation 28 of 
2021 is aiming to clarify and complement the previous requirements set in Government Regulation 
(PP) 2/2017 regarding Development of Industrial Facilities and Infrastructure. Regarding provisions 
for co nformity assessment bodies to conduct SNI certification as regulated in Government Regulation 
No 28 of 2021, Indonesia is of the view that such provisions are a general requirement and will 
create no technical barriers to trade. Adoption of standard and co nformity assessment procedures 
into technical regulations are regulated through individual Ministry Regulation. Foreign conformity 
assessment bodies will also be facilitated upon the availability of bilateral mutual recognition 
agreement in accordance with  its SNI mandatory regulation. Conformity assessment procedure is 
conducted based on conformity assessment scheme stated in the related regulation. For foreign 
manufactures, onsite inspection and/or factory visits can still be conducted as long as the dest ination 
countries open their border for representative from Indonesia conformity assessment body to 
perform the onsite inspection. Over the years, Indonesia has fully committed notifying the relevant 
Ministry Regulation regarding adoption of standards into  technical regulation for industrial sectors 
to the TBT Committee.  
2.1.2.22   Republic of Korea - Proposal for revision of the implementation rules and 
operation notification of the electrical appliances and consumer goods safety control act, 
G/TBT/N/KOR/950  (ID 72528) 
2.73.  The representative of China provided the following statement. China hopes  Korea (1) clarif ies 
the differences between safety standard KC 60570 and IEC 60570. (2) delete s the classification of 
"Track system for power supply of lighting" listed in Type 5, Point 11, Schedule 2 of P roposed 
Amendment to the Operation Bulletin of the Electrical Appliances and Consumer Products Safety 
Control Act in order to avoid unnecessary trade barriers.  
2.74.  In response, the representative of the Republic of Korea  provided the following statement. 
This WTO/TBT notice is about the amendment of "Enforcement rules and operation bulletin of 
electrical appliances and consumer goods safety control act" to introduce electrical supply track 
systems for luminaires as electrical goods subject to safety management.  This amendment is in 
order to manage the safety of electrical supply track systems for luminaires, which has recently seen 
a surge in demand. Due to the ease of interior design, the use of the item is increasing in shopping 
malls and homes. Accordingly, i n order to prevent safety accidents and protect consumers, we plan 
to verify the safety of electrical supply track systems for luminaires by designating the product as 
an electrical appliance subject to certification and applying KC 60570 which is harmoniz ed to 
international standard IEC 60570. It is currently undergoing amendment and is scheduled to be 
completed by 2022. However, as a result of collecting opinions from stakeholders such as public 
hearings, it will be officially implemented after a six -month grace period is granted. China's comment 
made today will be conveyed to our competent regulatory authority and will be replied to China 
soon.  
2.1.2.23   United States - Energy efficiency requirements for general service lamps (GSL), 
G/TBT/N/USA/1734  (ID 72629) 
2.75.  The representative of China  provided the following statement. We would like to make the 
following suggestions to Energy efficiency requirements for general service lamps (GSL).  (1) A 
 
28 For previous statements follow the thread under ID 725 . 
29 For previous statements follow the thread under ID 726 . G/TBT/M/85  
 
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  transition period of at least three years should be given to GSIL to fulfill the requirements of 
minimum efficacy as 45 lm/W. (2) For museums, art galleries, art classrooms, etc. which have higher 
requirements for colour rendering index (RA ≥90 and R9≥60~80), the use of halogen tungsten 
lamps should be allowed. (3) The statement "and any other lamps that the Secretary determines 
are used to satisfy lighting applications traditionally served by GSILs" gives the Secretary too much 
discretion. It is recommended that the new product categories within the scope be clearly listed in 
the regulations, and a three -year transition period for the new product categories should be given.  
2.76.  In response, the representative of the United States  provided the following statement. The 
United States appreciates the comments submitted by China on 24 June 2021, concerning our 27 
May 2021 WTO notification of a request for information regarding general service lamps ("GSLs"). 
The United States will take into consideration all comments received during the open comment 
period and respond to each substantive comment in the next publishe d rulemaking document for 
General Service Lamps.  
2.1.2.24   Spain – Amendment of Royal Decree 1521/1984 by the Secretariat for Fisheries 
of Spain (ID 72730) 
2.77.  The representative of Chile provided the following statement. Chile welcomes the opportunity 
to comment in this Committee on the Spanish General Secretariat for Fisheries' draft legislation, 
which seeks to amend Annex IV to Royal Decree No.  1521 of 1  August  1984 of the Secretariat f or 
Fisheries of Spain with regard to the national trade names accepted in this country and the names 
of prepared and preserved foods applicable to fisheries and aquaculture products. Under current 
Spanish legislation, the entire family of the Mytilus  species is known commercially as "Mejillón" 
(mussel). The draft amendment proposes the trade name "Mejillón" for the species Mytilus  edulis  
and Mytilus galloprovincialis , with the species Mytilus chilensis  being exclusively described as 
"Mejillón Chileno" or "C horito" (Chilean mussel). The scientific evidence shows that the European 
species ( Mytilus galloprovincialis  and Mytilus edulis ) are of the same genus as the endemic species 
Mytilus chilensis . The Mytilidae  family is a diverse group of marine bivalves with  a wide anti -tropical 
distribution. In Chile, at least three species of the Mytilus  genus are present in the south of the 
country. The study "Genetic characterization and spatial distribution of the Mytilus  genus in Chile", 
conducted by the Universidad Aus tral de Chile (Southern University of Chile), carried out work on 
different species of the Mytilus  genus using molecular markers. The results of this study indicate 
that the three species Mytilus  edulis , Mytilus  galloprovincialis  and Mytilus  chilensis  are closely related 
both taxonomically (descriptive physical structure) and phylogenetically (molecular evolution). This 
study has therefore demonstrated with a strong bibliographical background, as do the digital 
taxonomic platforms specializing in registers of marine species (World Register of Marine Species 
(WoRMS)), that the three species of the Mytilus  genus share many structural, sexual, physiological 
and molecular characteristics that mean that they are undoubtedly classified under the same 
taxonomic gen us. As a result, any separation of the group beyond the level that groups them (genus) 
can be considered discriminatory as it is not in line with the scientific evidence presented.  
2.78.  In September  2019, Chile contacted Spain's official TBT/WTO enquiry point i n relation to the 
date of notification to the Committee of this proposed regulatory change, with a view to making the 
relevant comments, and did not receive a response. Chile continued to do so through diplomatic 
channels in 2020 and 2021. The response giv en was that the draft amendment to the Royal Decree 
was under discussion internally and so could be subject to changes, which, if applicable, would have 
to be submitted to the European Commission, and this is why the draft regulatory text has not yet 
been sent to the WTO. For this delegation, it is important to note that, within Chile's industrial and 
commercial activities, mussel cultivation is the second aquaculture activity after salmon farming, 
with 377,000 tonnes found in the sea, 11,000 hectares of se a under cultivation, 550 producing SMEs, 
17,000 direct formal jobs, over 5,000 indirect jobs and 20 processing plants that contribute over 
USD 250 million per year to GDP. This is why an amendment to the regulation in question, in view 
of Spain's obligatio ns under the WTO TBT Agreement, should be notified to the Committee, thereby 
allowing for a period of time to make comments and accept the scientific evidence provided in order 
to avoid issuing regulations that have a detrimental impact on the importation of this product from 
Chile, without any justification. Chile hopes that this specific trade concern shall be duly addressed 
by the Spanish Ministry of Agriculture, Fisheries and Food, for which reason this delegation would 
be grateful for a prompt response  through the official TBT/WTO enquiry point.  
 
30 For previous statements follow the thread under ID 727 . G/TBT/M/85  
 
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  2.79.  In response, the representative of the European Union  provided the following statement. The 
modification to the Decree was notified on 18 September 2020 to the European Commission in 
accordance with the procedur es foreseen in Directive (EU) 2015/1535 which lays down a procedure 
for the provision of information in the field of technical regulations and of rules on Information 
Society services. The following dialogue between the European Commission and Spain conclu ded in 
July 2021. The proposed modifications to the Decree are still at a draft stage. The Spanish TBT 
Enquiry Point intends to notify the measure to the WTO in accordance with the TBT Agreement, 
which will provide sufficient time to discuss the matters ra ised by Chile.  
2.1.2.25   Indonesia - Import quota and SNI certification requirements (ID 72831) 
2.80.  The representative of China  provided the following statement. Regarding the SNI certification 
requirements of Indonesia, we would like to suggest that Indonesia recognize  the SNI certification 
and accreditation institutions and test laboratories which locate outside of Indonesia. In addition, 
the CB scheme or other third -party test data shall also be recognized.  
2.81.  In response, the representative of Indonesia  provided the fol lowing statement. Indonesia 
respected its international obligations under the TBT Agreement. Indonesia would like to recall that 
SNI certification requirements for certain mandatory products have been all notified to TBT and 
provide a period of 60 days for  Members to comment on the draft of regulations. Certification process 
for mandatory SNI in the industrial sector is carried out in accordance with common practice stated 
on the related ministerial regulations. Indonesia remains available for further bilat eral engagement 
and invites China to elaborate detailed concerns on SNI certification system.  
2.1.3   Previously raised concerns  
2.1.3.1   China - Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (ID 29432) 
2.82.  The representative of Japan  provided the following statement. Japan continues to have 
concerns regard ing the China's "Regulation on the Administration of Commercial Cipher Codes" and 
"Cyber Security Multi -Level Protection Scheme." Japan would like to refer to the previous statement 
we made at the last TBT Committee in June 2021. At the last TBT committee,  China explained that 
they would release the regulations for public consultation. We recognize that the public consultation 
had done until 19 September 2020. Japan would like to request that China provide relevant 
information regarding the current revision  process and that the regulations would be implemented 
transparently.  
2.83.  The representative of the European Union  provided the following statement. Regarding the 
Multi-Level Protection Scheme, the EU would like to refer to its comments raised at previous TBT 
Committee meetings, namely concerns around (i) the nature of the expert review that the Guidelines 
prescribe, (ii) the lack of clarity in certain definitions, and (iii) the subsequent unwarranted and 
significant market entry restrictions. The EU calls for enhanced proportionality and transparency in 
the implementation of the Cyber -MLPS. The EU also asks China to confirm whether the draft will be 
notified to the WTO for comments, to allow for adequate participation of interested parties.  
2.84.  In response, the rep resentative of China  provided the following statement. With regard to the 
management of commercial encryption products, China has cancelled the approval of varieties and 
models of commercial encryption products, since 1 January 2020, and established a unif ied national 
certification scheme for commercial cryptography. The management of commercial encryption 
products fully reflects the principles of non -discrimination and fair competition. It treats domestic 
and foreign products as well as companies equally. China implements mandatory testing and 
certification on commercial encryption products related to national security, national economy, 
people's livelihood, and public interest, and implements voluntary testing and certification on other 
commercial encrypti on products. Regarding the MLPS （Multi-level Protection of Information Security 
Scheme ), with technological development and the increasingly complicated cybersecurity 
 
31 For previous statements follow the thread under ID 728 . 
32 For previous statements follow the thread under ID 294 . G/TBT/M/85  
 
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  circumstances, information security multi -level protection scheme needs to be improved in China. 
Based on experience in past years and responding to new development, Cybersecurity Law stipulates 
that China will carry out the cybersecurity MLPS, which is based on information security MLPS. To 
fulfil the requirements in Cybersecurity Law, the reg ulation on cybersecurity MLPS is under drafting, 
which was published for comments  and will replace the former administrative measures on 
information security MLPS.  
2.1.3.2   European Union - Hazard -based approach to plant protection products and setting 
of import to lerances (ID 39333) 
2.85.  The representative of Costa Rica  provided the following statement. Once again, as on previous 
occasions, Costa Rica reiterates its support for the trade concern raised by Australia. Costa Rica is 
concerned about the hazard -based approac h adopted by the European Union given that, under the 
obligations of the multilateral system, all technical requirements must be based on the relevant 
international reference standard or a risk assessment providing the scientific evidence to support 
the me asure. Costa Rica reiterates its request to the European Union to ensure that the 
implementation of its regulations is based on the use of risk assessments through the application of 
criteria supported by sufficient scientific evidence, in line with the co mmitments established in the 
TBT Agreement.  
2.86.  The representative of Australia  provided the following statement. Australia would like to thank 
the EU for clarifying in previous sessions that requests for import tolerances for substances not 
authorized within the EU will be conducted in line with risk assessment principles on a case -by-case 
basis. However, Australia notes that the EU is considering to take into account environmental effects 
when assessing requests for import tolerances for active substances no longer approved in the EU. 
Australia does not support this approach as it assumes the EU is better placed to assess the 
environmental impacts of active substances in third countries than the chemical regulators in those 
countries. Australia would like to r eiterate it has a robust regulatory framework for agricultural and 
veterinary chemicals providing Australian farmers with safe access to the pesticides they need to 
maintain productivity and profitability while looking after Australia's unique environment.  Australia 
would again request that the EU respects the conclusions of trading partners' regulators on the 
environmental impact of chemical substances and limits its assessment of requests for import 
tolerances to the consideration of dietary risks. Depart ing from this approach will result in significant 
and unwarranted trade disruption. We look forward to continued constructive engagement on this 
issue with the EU.  
2.87.  The representative of Colombia  provided the following statement. As indicated on previous 
occasions, Colombia shares and supports the trade concern regarding the approach of the European 
Union (EU) to identifying substances with endocrine -disrupting or carcinogenic properties. As we 
have previously stated in this Committee, we reiterate the need to use risk analysis as a 
methodological tool for decision -making within the framework of assessment, management and 
communication. With the EU's action, it appears that risk assessment is losing ground, with the 
decision to accept or allow the use of subs tances following a hazard -based approach, disregarding 
the conditions of use and risk scenarios that enable science -based decisions to be made. Since this 
trade concern has been repeatedly raised in this Committee on several occasions, we request the 
EU to  inform us how they are taking these comments into account and we would appreciate an 
update on how decisions on the use of plant protection substances are being made, as well as the 
methodology for defining maximum residue levels in products.  
2.88.  The represen tative of Brazil  provided the following statement. Brazil would like to refer to its 
previous statements regarding STC 393. We emphasize that regulations on endocrine disruptors 
should be established according to sound scientific principles, taking all ava ilable data into 
consideration. Serious evaluations must be able to separate chemicals that have the potential to 
cause harm due to their endocrine mode of action from those substances that do not pose a threat 
to human health. A solid risk analysis, consi stent with Codex guidelines, is important to ensure 
transparency and predictability in the regulatory processes regarding plant protection products and 
LMRs. Brazil believes that the European approach to limit the use of pesticides is more trade 
restrictiv e than necessary to fulfill its legitimate objectives under the TBT Agreement. It also 
 
33 For previous statements follow the thread under ID 393 . G/TBT/M/85  
 
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  disregards risk analyses in the setting of regulatory measures that may have a serious impact on 
trade.  
2.89.  The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and refers to its previous statements by stressing the importance of adopting a scientific 
approach to the regulation of phytosanitary products based on the risk and not just on the hazard 
arising from the intrinsic propert ies of a chemical. In this regard, Paraguay once again requests the 
European Union to take into consideration information on pesticides provided by the specialized 
agencies recognized by the WTO, such as the Codex Alimentarius; reconsider its approach and  base 
its decisions on conclusive scientific evidence and real risk weightings, in accordance with 
international standards and principles; ensure import tolerances; and, where necessary, provide 
adequate transitional periods.  
2.90.  The representative of Canada  provided the following statement. Canada would like to take 
this opportunity to once again echo the concerns raised by many other Members regarding the EU's 
hazard -based regulation for active substances in plant protection products. Canada does not favour 
or promote the use of any one production method over another. Instead, we support producers 
having access to a wide range of effective plant protection products that can be used safely in 
accordance with registered label directions and following their own as sessment of growing 
conditions, market demand and other factors. Plant protection products are registered for use in 
Canada only after rigorous scientific evaluations confirm that the risks are acceptable and the 
products have a demonstrated benefit to the  prevention of pests. As such, these products have a 
role in supporting a variety of production methods and enable the sector to supply the vast array of 
differing products demanded by Canadian and international consumers. We encourage the EU not 
to limit or discourage the use of these agricultural tools, and base its regulatory decision -making on 
both hazard and risk for all active substances. The EU has mentioned that import tolerances are 
established based on risk assessments as set out in Regulation (EC ) 396/2005 and it has begun to 
provide clarity on the process. While we appreciate these efforts, Canada is not reassured and has 
yet to be convinced with the real -world feasibility, commercial viability and compliance with 
international obligations regard ing the EU's approach for setting import tolerances when a plant 
protection product has met the hazard -based "cut -off" criteria. We remain concerned with the 
predictability of the outcomes. Canada would be interested in receiving any available updates sinc e 
the last seminar held in January 2021 including whether the EU will offer further opportunities to 
learn more about the process.  
2.91.  In the information session DG SANTE hosted on 20 January 2021, it was mentioned that the 
Commission will "take into account e nvironmental aspects when assessing requests for import 
tolerances for pesticide substances no longer approved in the EU, while respecting WTO standards 
and obligations". Who in the Commission will be responsible for assessing environmental impacts? 
To eli minate the need for import tolerance requests for some substances and minimize disruptions 
to trade, Canada once again requests that the EU consider maintaining MRLs for substances that do 
not pose unacceptable dietary risks. We recognize that a dietary ri sk assessment as part of the re -
authorization process would likely be needed, regardless of the results of the hazard screen. We 
welcome further engagement on this issue and invite the EU to share any relevant information on 
upcoming regulatory or policy c hanges to ensure that unnecessary trade barriers are minimized and 
that measures are consistent with international trade obligations.  
2.92.  The representative of Ecuador  provided the following statement. Ecuador shares the concerns 
raised by the Members who have  spoken before me. My country recognizes the importance of 
protecting human health and the environment; however, we consider that regulatory decisions taken 
on the basis of hazard -based criteria are inconsistent with international risk -assessment practices . 
Ecuador urges the EU to take into account scientific information emanating from the international 
specialized bodies recognized by the WTO, such as the Codex Alimentarius, which has relevant 
information on pesticides. Ecuador also urges the EU to take in to account the recommendations of 
the Committee on Technical Barriers to Trade related to good regulatory practices, particularly with 
regard to carrying out a Regulatory Impact Analysis prior to the issuance of regulatory proposals, 
which examines all pos sible social, economic, environmental and health impacts. This is to ensure 
compliance with the obligation not to be more trade restrictive than necessary to fulfil a legitimate 
objective, in accordance with Article 2.2 of the TBT Agreement. Lastly, my cou ntry once again calls 
upon the EU to ensure that, in cases where there is a lack of scientific information, EFSA does not 
make a recommendation on the MRL, since decisions on regulatory measures must be based on G/TBT/M/85  
 
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  conclusive risk analyses that provide real h ealth protection and do not constitute a technical barrier 
to trade.  
2.93.  The representative of Argentina  provided the following statement. Argentina once again 
reiterates its concern regarding this matter and stresses the importance of ensuring that all Member s 
implement SPS measures based on risk assessments, taking account of the risk assessment 
techniques developed by international reference bodies. The latter include the principles for 
establishing pesticide MRLs, as well as the many risk analyses that, ove r the decades, the Codex 
Alimentarius has conducted to ensure safety in terms of MRL recommendations for different 
substances and crops.  
2.94.  The representative of Chile provided the following statement. Chile associates itself with the 
statements by Australia,  Costa Rica, Colombia, Brazil, Paraguay, Canada and Ecuador, as these 
EU regulations will have far -reaching trade effects for Chile's export sector to this destination.  
2.95.  The representative of Uruguay  provided the following statement. We support the comments 
made by the preceding Members and reiterate our trade and systemic concern relating to the 
European Union's use of a hazard -based approach, instead of an approach based on full scientific 
risk asse ssments, when making regulatory decisions concerning the authorization of active 
substances used in plant protection products and when setting import tolerance levels for substances 
that meet the cut -off criteria in Regulation No. 1107/2009. We again empha size the need to base 
such determinations on conclusive scientific evidence, gathered from an assessment of the actual 
risks, to avoid some of these active substances, which remain important components of pest 
management systems, being withdrawn despite th eir safe use. This is due to the fact that an 
approach based on hazard rather than on actual risk could have a negative and disproportionate 
impact on production, while contributing little or nothing to the cited aim of protecting public health. 
Like other  Members, we would like to be given further details on the way in which the European 
Union plans to take environmental effects into account when assessing requests for import 
tolerances for active substances no longer approved in its territory. Uruguay con tinues to support 
any multilateral work undertaken by the Codex Alimentarius to develop a harmonized, risk -based 
approach that ensures the protection of health, while facilitating international trade in food products. 
In the meantime, we once again call on  the European Union to listen to and address the concerns 
expressed by a number of Members, and to reconsider its regulatory approach with a view to 
preventing the unjustified proliferation of barriers to international trade in agricultural products and 
the serious social and economic consequences of such an approach for other Members, in particular 
developing and least developed countries.  
2.96.  The representative of Panama  provided the following statement. Panama echoes the 
statements made by the Members that h ave already taken the floor. My delegation is concerned 
about the hazard -based, not risk -based, approach adopted by the European Union to identify 
sanitary and phytosanitary protection substances. Panama reiterates its request to the European 
Union to adhe re to criteria supported by sufficient scientific evidence as set out in the 
TBT Agreement. We appreciate any information that the European Union can share on how this 
matter is being addressed.  
2.97.  In response, the representative of the European Union  provide d the following statement. The 
EU reiterates that the scientific criteria to identify endocrine disruptors for plant protection products 
based on the WHO definition are applicable since 10 November 2018 and included in Regulation (EU) 
No 2018/605. We are a ware of general concerns on EU policy on plant protection products for the 
definition of scientific criteria to identify endocrine disruptors and on the establishment of import 
tolerances for substances not authorized in the EU, due to the so -called "cut -off" criteria in 
Regulation (EC) No 1107/2009. As previously explained, the European Union decided to follow the 
procedures of Regulation (EC) No 396/2005 for the management of import tolerance requests 
concerning active substances falling under these cut -off criteria, which include a risk assessment by 
an Evaluating EU member State and a scientific opinion by the European Food Safety Authority 
(EFSA). The granting of the import tolerance is then considered in line with risk analysis principles 
on a case -by-case basis and taking into account all relevant factors. The EU reiterates its 
commitment to act in full transparency and keep Members duly informed about further 
developments.  G/TBT/M/85  
 
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  2.1.3.3   China - Cyberspace Administration of China – Draft implementing measures for 
the Cybersecurity Review of Network Products and Services (ID 53334) 
2.98.  The representative of Japan  provided the following statement. Japan has its interest in and 
concern with regard to the Cybersecurity Review and would like to refer to the previous statement  
we made at the last TBT Committee in June 2021. China released the amendment of Cybersecurity 
Review Measures for public consultation in July 2021. In the amended proposal, we understand that 
the scope of the measure has expanded from the "important infor mation infrastructure operator" to 
"development of data processing activity conducted by data process operator". We would like to 
request that China clarify the definitions of "data process operator" and "data process activity". In 
addition, the amended pr oposal mandates those who affect or could affect national security to take 
the Cybersecurity review. Japan asks China to conduct such review based on technical neutrality 
and in a manner that does not discriminate foreign products. Japan would like to requ est China 
carefully consider entire comments submitted by Japanese government to the public consultation.  
2.99.  The representative of the European Union  provided the following statement. The EU has raised 
the Security Review of Network Products and Services, inc luding the Cybersecurity Review Measures, 
in this Committee on several occasions, stressing our concerns related to these measures, which 
entered into force on 1 June 2020. We remain concerned that the measures are quite general and 
very broad discretionar y powers are left to the authorities in charge of the security review, raising 
concerns for foreign ICT operators. The measures are directed towards the purchasing activity of 
Critical Information Infrastructure (CII) operators by encouraging operators to apply for reviews in 
the case that they deem their purchase or procurement may pose a risk to Chinese national security. 
Most European companies established in China would become suppliers or sub -suppliers of these 
operators, and therefore would also be af fected by these reviews. The EU urges China to ensure 
clarity, transparency and objectiveness in the security review so that the measure does not become 
a new market access barrier. The EU also seeks an update of this measure from China.  
2.100.   In response, the r epresentative of China  provided the following statement. In April 2020, 
Cyberspace Administration of China (CAC)and 12 other authorities jointly issued Cybersecurity 
Review Measures, focusing on national security risks associated with the procurement of ne twork 
products and services by critical information infrastructure operators. Through the cybersecurity 
review, the possible risks and hazards brought by the purchase of products and services to the 
operation of critical information infrastructure could be  detected earlier and avoided, ensuring the 
security of the supply chain of critical information infrastructure, and safeguarding national security. 
The Measures came into effect on 1 June 2020, and the former Cybersecurity Review of Network 
Products and S ervices (for Trial Implementation) issued in May 2017 was repealed at the same time. 
In July 2021, CAC issued the revised draft Cybersecurity Review Measures for public comments. The 
measures are currently under revision.  
2.1.3.4   India - Air Conditioner and its re lated Parts (Quality Control) Order, 2019, 
G/TBT/N/IND/110,  G/TBT/N/IND/74  (ID 59835) 
2.101.   The representative of the Republic of Korea  provided the following statement. Korea 
appreciates this opportunity to provide our comments again on "Air Conditioner and its related Parts 
(Quality Control) Order, 2018", notified to WTO TBT on 4 April 2018 as G/TBT/N/IND/74 , and on 
28 October 2019 as G/TBT/N/IND/110 . Korean companies are having difficulti es regarding the 
regulations on air conditioners, so the Korean Government would like to make the following requests. 
First, factory inspections by the BIS (Bureau of Indian Standards) are not being conducted outside 
India at all, so the manufacturing fact ories located in other countries outside India are having 
difficulties with the factory inspection. Therefore, we would like to request an additional grace period, 
or a non -face-to-face factory inspection plan for overseas factories that need BIS certifica tion. 
Additionally, at the WTO TBT Committee in November 2018, the Indian Government responded that 
the High Voltage Test Time requirement in Clause 15.3.4 of IS 1391 (Part 2):2018 would be revised 
in accordance with the international standard IEC 60335 -1. We would like to ask for the current 
status of India's efforts to harmonize its standard in line with international standard.  
2.102.   The representative of China  provided the following statement. Firstly, it is suggested that 
India carry out online remote video i nspection and test samples should be properly sealing in a 
 
34 For previous statements follow the thread under ID 533 . 
35 For previous statements follow the thread under ID 598 . G/TBT/M/85  
 
- 28 - 
 
  secured area during the COVID -19 period. Secondly, it is suggested to accept sample tests and the 
testing results in Indian accredited third -party laboratories in China. Thirdly, it is suggested to  
postpone the effective date of BIS certification of air conditioner QCO to the ninth month after 
inspection could be audited by Indian BIS officials.  
2.103.   In response, the representative of India provided the following statement. Foreign inspection 
visits are on hold due to the prevalent restrictions on international travel imposed by the Government 
of India, but in some instances by the government of other respective countries because of the 
ongoing COVID -19 pandemic. As soon as the situation of COVID -19 impro ves and the restriction is 
lifted, India will plan the inspections (factory visit). There is no provision in BIS (Conformity 
Assessment) Regulations, 2018, for remote assessment or any other means for inspection.  
2.1.3.5   Colombia - Food Prioritized for its Sodium Content, Certification Requirements (ID 
60936) 
2.104.   The representative of Costa Rica  provided the following statement. Costa Rica reiterates its 
concern regarding the proposed Colombian Technical Regulation establishing the maximum sodium 
content for a prioriti zed list of a broad range of foods, such as tuna, chicken sausages, chorizo, 
salted biscuits, ham, peanuts, butter, mayonnaise, breads, pastas, wheat flour products, cream 
cheese, soups, sauces and sausages. Costa Rica firmly believes in implementing strat egies aimed at 
protecting public health by reducing the underlying factors of arterial hypertension and related 
non-communicable diseases. However, it is worrying that the proposed maximum sodium levels for 
the selected products are not substantiated by sc ientific evidence. Costa Rica also does not consider 
them to be based on the international reference standards established under the Codex Alimentarius. 
We call on Colombia to share with Costa Rica the scientific basis and risk assessment supporting the 
sodium levels established for each product, so as to facilitate our analysis of the legislation. We 
would be grateful if the delegation of Colombia could provide us with information on the status of 
this Regulation and the possible date for its entry into fo rce. 
2.105.   In response, the representative of Colombia  provided the following statement. Colombia 
welcomes the comments shared by Costa Rica and would like to present the following considerations 
in this regard. Colombia reiterates that Resolution No.  2013 of 20 20 was issued for public health 
reasons and is part of a comprehensive national strategy that covers not only the sodium content of 
processed foods, but also other sources of sodium, such as the salt added to food preparations in 
restaurants, at home and i n institutions. The strategy seeks to reduce the number of deaths 
attributable to high blood pressure and cardiovascular disease by gradually reducing the 
consumption of salt from food sources until the WHO recommendation for 2021 has been achieved: 
5 gram s of salt or 2 grams of sodium per person per day. With regard to concerns about the technical 
and functional role of sodium in the production of prioritized foods, Colombia wishes to reiterate that 
this aspect was analysed at all the technical meetings fo r the 12 categories of food with industry, 
academic and government representatives, resulting in agreement on, and the dissemination of, the 
draft regulations. The following documents shared by Colombia were produced by the Ministry of 
Health and Social We lfare and provide support for the measures taken through Resolution No.  2013 
of 2020 on the maximum sodium content for processed foods.37 Colombia would also like to point 
out that the relevant authorities have expressed their willingness to hold technical  discussions with 
the Costa Rican authorities in order to address the concerns raised and ensure compliance with the 
technical regulations on the maximum sodium content for processed foods. We therefore very much 
look forward to setting up a meeting.  
 
36 For previous statements follow the thread under ID 609 . 
37 National Strategy for the Reduction of Sodium/Salt Consumption 2012 –2021. Available at:  
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital /RIDE/VS/PP/SNA/Estrategia -reduccion -sal-
2012-2021.pdf   
Regulatory impact analysis of the draft resolution defining the maximum sodium content for prioritized 
foods. Available at:  
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/PP/SNA/analisis -impacto -normati
vo-sodio.pdf   G/TBT/M/85  
 
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  2.1.3.6   Europ ean Union - Non-renewal of the approval of the active substance mancozeb, 
G/TBT/N/EU/712  (ID 62738) 
2.106.   The representative of Costa Rica  provided the following statement. Costa Rica wishes to 
express its support for the concern raised by Paraguay, Brazil, Australia, Colombia and Ecuador in 
relation to the draft Implementing Regulation notified by the European Union, under which approval 
for the use of mancozeb would not be renewed. As previously stated, Costa Rica recognizes that 
Members have the right to determine the appropriate level o f sanitary or phytosanitary protection 
needed to protect human, animal or plant life or health, and to establish measures to that end. In 
turn, may we remind Members that these measures must be science -based and should not create 
unnecessary barriers to tr ade, especially at a time when the pandemic continues to affect the 
economic recovery of international markets. To assess just how crucial the substance mancozeb is 
to agricultural production in Costa Rica, it is sufficient to note that it is currently use d for more than 
20 crops that are grown for export and domestic consumption, and is therefore vital for ensuring 
the supply of food. Mancozeb is also used to combat pests of economic importance, particularly in 
banana production.  
2.107.   Costa Rica is the world's second largest exporter of bananas, and the first country to have 
obtained a geographical indication for this product. The main destination for exports is the European 
Union, to which over 50% of the fruit produced in Costa Rica is sent. In Costa Rica, the re are 
currently no authorized plant protection products that could be used as substitutes for, or are similar 
to, mancozeb. This illustrates the impact that would be generated by the ban on the use of mancozeb 
and the subsequent reduction in MRLs for this  substance in bananas. Despite Costa Rica's many 
reservations about the reasoning behind EU regulations, the Costa Rican banana sector continues to 
seek alternatives to mancozeb. However, time will be needed to complete the relevant tests and 
approval proc edures for any alternatives found. Costa Rica therefore once again requests that the 
EU postpone the non -renewal process and subsequent reduction of MRLs for mancozeb, so as to 
give the national sanitary and phytosanitary authorities a reasonable period of  time to respond to 
the numerous challenges posed by the COVID -19 pandemic and find an alternative substance so 
that Costa Rican farmers can continue to grow bananas and export the volumes required to meet 
the EU market demand.  
2.108.   The representative of Colomb ia provided the following statement. Colombia reiterates its 
concern regarding the measure notified by the European Union (EU) in document G/TBT/N/EU/712  
of April  2020 relating to non -renewal of the approval of the active substance mancozeb. As we have 
already explained, the EU has a dopted measures resulting in the non -approval of the use of plant 
protection products, which is affecting exports from Colombia. Measures to suspend or not approve 
the placing on the market of many active substances, and the subsequent reduction of their M RLs 
to the minimum level of detection, are being taken without strong scientific evidence and without 
demonstrating that they are indeed the least trade -restrictive measures to achieve an appropriate 
level of protection. We have already referred to the imp ortance of this plant protection substance 
for Colombian industry on previous occasions. On this occasion, we would like to ask the EU to 
provide clarification on the relationship between the notification in document G/TBT/N/EU/712  on 
mancozeb and the notification in document G/TBT/N/EU/797  regarding the REACH regulation, with 
respect to substances that are carcinogenic, mutagenic and toxic for reproduction.  
2.109.   We would also like to recall that, even though in this and various other cases we have 
requested the EU to provide information on the deadline for the adopt ion of the standard and on the 
implementation of maximum residue limits, the EU has failed to respond to these requests. We ask 
it to please respond to these concerns. We recall that Article 2.12 of the TBT Agreement provides 
that "Members shall allow a re asonable interval between the publication of technical regulations and 
their entry into force in order to allow time for producers in exporting Members, and particularly in 
developing country Members, to adapt their products or methods of production …". In  line with the 
above, the information available indicates that EFSA has initiated the procedure for revising MRLs 
for mancozeb. In this regard, we ask the EU how, as interested trading partners, we can participate 
in this review process and how our comment s will be taken into account, and we request information 
on the time frames envisaged for a decision by EFSA. Lastly, we once again invite the EU to follow 
the recommendations for good regulatory practices, under which standards must be based on clear 
 
38 For previous statements follow the thread under ID 627 . G/TBT/M/85  
 
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  and objective information, and open dialogue with stakeholders, transparency and the minimizing 
of market distortions must be promoted.  
2.110.   The representative of Brazil  provided the following statement. Brazil would like to convey 
once again its concerns regarding  the non -renewal of the approval of the active substance mancozeb, 
according to European TBT notification G/TBT/N/EU/712 . Mancozeb is a substance whose use is 
approved for many different crops by the Brazilian Health Regulatory Agency, including soy. MRLs 
for soybeans in Brazil are set in 0,3 mg/kg. Around 11% of the soy produced in Brazil is exported to 
the EU. Therefore, restrictions on mancozeb will significantly impact the income of Brazilian farmers. 
The availability of an alternative to mancozeb in the short to medium term is also limited by the fact 
that other substances of similar use have already been banned in the European market, such as 
chlorothalonil. Mancozeb is an important substance for the management of fungicide resistance to 
control soybean rust. It is used as a  crop protection additive, intended to increase the effectiveness 
of other fungicides, minimizing resistance, and prolonging the life cycle of other molecules. In light 
of the insufficient transitional period granted by the EU, such crops cannot have their  treatments 
changed in time for exportation to the EU market before the entry into force of the regulation. Brazil 
would like to urge European authorities to consider establishing transition periods that are adequate 
to the production cycle of the affected  crops. Brazil also respectfully asks the EU to align MRLs with 
limits established under the framework of Codex Alimentarius and to consider less trade -restrictive 
alternatives that would also safeguard its legitimate policy objective.  
2.111.   The representative o f Australia  provided the following statement. Australia recognizes the 
European Union (EU)'s right to regulate the manufacture and use of plant protection products in 
agriculture to address risks unique to its settings. However, Australia reiterates its co ncerns about 
the proposed non -renewal of mancozeb and the potential impact on Maximum Residues Limits 
(MRLs) and effects this may have on trade, including wine exports to the EU. Australia seeks 
clarification on whether stocks which are in -market prior to the required period from entry into force 
of this regulation will continue to be eligible for sale in the EU. Australia also notes that the EU has 
recently made several plant protection product non -renewal decisions and subsequent changes to 
relevant MRLs which are impacting Australia's trade with Europe. Australia seeks further clarification 
on how this decision will impact future decisions around MRLs. Australia notes the EU's previous 
advice that they are undertaking a review of existing MRLs for dithioc arbamates. We would welcome 
a progress report on this. Australia would also note that our competent domestic authority 
(Australian Pesticides and Veterinary Medicines Authority) and Codex have determined MRLs for 
dithiocarbamates that ensure the continued protection of human, animal and environmental health 
while allowing trade to continue.  
2.112.   The representative of Paraguay  provided the following statement. This concern and the 
non-renewal of the approval of the remaining substances were already discussed exte nsively both 
in this Committee and in the SPS Committee because of the subsequent reduction in the MRLs. 
Paraguay therefore refers to its previous statements and reiterates its cross -cutting concern with 
regard to the EU's decision not to renew the approva l of these substances without a proper risk 
analysis and without complying with scientific principles. Paraguay reiterates, like other Members, 
that the climatic conditions and pest -pressure levels of our countries are very different from those 
of the Euro pean Union and substances such as mancozeb are effective and safe tools for their control. 
In the case of this substance, our position is shared by some EU Members, who, unlike Paraguay 
and other WTO Members, may benefit from emergency authorizations. Arti cle 53 of Regulation (EC) 
No. 1107/2009 provides that "in special circumstances a Member State may authorise, for a period 
not exceeding 120 days, the placing on the market of plant protection products, for controlled and 
limited use, where such a measure appears necessary because of a danger which cannot be 
contained by any other reasonable means." According to data from EU countries, such as Austria, 
Belgium, Denmark, Germany, Italy, Portugal, Romania, Slovakia, Spain and Sweden, have benefited 
from emerg ency authorizations for this substance, thus it is well established that it is necessary to 
control dangers "which cannot be contained by any other reasonable means".  
2.113.   As we have already heard in this room, the mancozeb compound was developed in Europe 
almost 60 years ago to protect crops. It is currently registered for more than 70 crops and over 400 
approved uses around the world. It is one of the most robust active assets, in that there have been 
no reports since its registration of a loss of sensitivity,  of resistance or of any harmful effects on 
treated crops. This is owing to the substance's multi -site properties, which enable it to attack 
different parts of the fungus without creating resistance. As a result, when used in accordance with 
the instructio ns on the labels, it is considered to be a key tool in fungus control programmes. The G/TBT/M/85  
 
- 31 - 
 
  most recent emergency authorization in the EU public database (BE -Be-2021-13), for example, cites 
studies on the need to use this substance to combat a fungus that requir es temperatures of between 
25°C and 30°C and a relatively high degree of humidity, conditions that the country concerned sees 
only on a few occasions. Imagine, Chair, how many more times and for how many more fungi those 
thresholds are reached in tropical and sub -tropical countries such as ours. The same authorization 
highlights this product's importance because it does not create resistance.  
2.114.   Paraguay shares the objectives that the EU seeks to address with these policies, but does 
not share its adopted meth od for attaining them because it is not based on conclusive scientific 
evidence and does not consider less trade restrictive options or valid alternatives for hazard control 
that, based on the requirements for emergency authorizations and the number of suc h 
authorizations approved for mancozeb, we can assume the EU agrees do not exist in this case. The 
EU has stated on previous occasions that emergency authorizations are only given for 120 days and 
that 90% of these are for approved substances. However, it should be recalled on this point that 
there is no limit on these authorizations, even for the 10% for unapproved substances, and that 
given the lack of viable alternatives, renewals will continue to be granted. We echo Colombia's 
question on how the Member s concerned by the process can participate in the analysis that the 
European Food Safety Authority (EFSA) is conducting on the MRLs for mancozeb and also on how 
comments submitted by Members will be taken into account.  
2.115.   The representative of Ecuador  provide d the following statement. Mancozeb is a fungicide 
used throughout the world for a wide range of strategic crops, a number of which are produced in 
Ecuador. Examples include, inter alia , bananas, cocoa, broccoli, pineapples, pitahayas, mangoes and 
cape goo seberries. This compound is important for pest management in countries with tropical 
climates – like Ecuador – in which pest behaviour follows patterns that are very different from those 
prevailing in countries with four seasons, meaning that chemical pest icides for agricultural use with 
the active ingredient mancozeb are vital for agricultural production. Prohibiting the use of mancozeb 
– without effective alternatives – could have a very significant economic impact on small -, medium -, 
and large -scale prod ucers in Ecuador, as well as on consumers in the EU, because the supply of our 
products would be affected. I must point out that the way in which this substance is applied in 
banana production means that the use of mancozeb is the most effective and enviro nmentally 
friendly phytosanitary control method for Black Sigatoka. Black Sigatoka is considered to be the 
most destructive foliar disease for banana and plantain crops; it is thought to pose the highest 
economic risk for such crops and can cause yield los ses of up to 50%. It is concerning that there are 
currently no approved and properly registered alternatives to this substance that are as effective as 
mancozeb.  
2.116.   Ecuador urges the EU to take into consideration the relevant scientific information emanating 
from international specialized agencies recognized by the WTO, such as the Codex Alimentarius, 
which has information relating to this substance. We wish to recall that Ecuador was part of a group 
of 39 WTO Members that, in 2020, called upon the EU to tempo rarily suspend processes related to 
the review of authorizations for the marketing and use of plant protection substances, and their 
entry into force, in the context of COVID -19, a disease that continues to claim  thousands of lives 
throughout the world. Fo r these reasons, Ecuador calls upon the EU to consider alternative measures 
that are less trade -restrictive, to identify substitute substances that enable existing trade to 
continue, to base its measures on conclusive studies, not only the precautionary pr inciple, and to 
establish transition periods of at least 36 months for the registration of alternative substances, in 
view of the current shortage of tools available to control pests.  
2.117.   The representative of Chile provided the following statement. The delega tion of Chile 
welcomes the earlier statements concerning the EU's non -renewal of the approval of the active 
substance mancozeb and echoes the trade concern raised at this meeting and previous meetings of 
the Committee.  
2.118.   The representative of Panama  provided  the following statement. Panama supports this STC 
and reiterates its concern regarding the non -renewal of mancozeb. We are concerned that the 
inclusion of this item on the agenda for every meeting will be treated merely as a matter of 
procedure, which wou ld suggest that our concern has not been satisfactorily addressed. The active 
substance mancozeb is vitally important for the country's main crops. Its specific mode of action 
means that it is irreplaceable in the control of black sigatoka, which is the ma in pest in tropical crops. 
There are currently no other active ingredients available to replace mancozeb, leaving the industry 
without any phytosanitary tools, and thereby having a severe impact on Panama's exports to the G/TBT/M/85  
 
- 32 - 
 
  European Union and negatively affe cting the way of life of many farmers in my country who depend 
on agricultural exports. Panama recognizes the right of Members to determine the appropriate level 
of sanitary or phytosanitary protection necessary to protect human, animal or plant life or he alth, 
yet this must be based on conclusive scientific evidence and should not create unnecessary barriers 
to trade. In the light of the foregoing, Panama once again requests that the EU postpone the non -
renewal process for the maximum residue limit for man cozeb.  
2.119.   The representative of Uruguay  provided the following statement. Mancozeb is an active 
substance that is authorized and widely used in a safe manner in Uruguay for the control of diseases 
and pests in various national fruit and vegetable sector produ cts, including apples, pears and citrus 
fruits. It is particularly important for the control of apple and pear scab, which is the main disease 
affecting apple and pear production and is caused by fungus of the genus Venturia spp. In this 
connection, we sup port the concerns and requests raised by other delegations, particularly with 
respect to the possibility that, as a result of the ongoing review process, the EU may significantly 
reduce the corresponding maximum residue levels, even lowering them to the li mit of determination, 
without having any conclusive scientific evidence that substantiates such a decision in line with the 
WTO SPS Agreement. Against this backdrop, like other Members, Uruguay recalls the importance of 
taking due account of international standards, guidelines and recommendations and the scientific 
information produced by international standard -setting bodies recognized at the WTO, such as the 
Codex Alimentarius.  
2.120.   In response, the representative of the European Union  provided the following s tatement. We 
have provided detailed explanations on this issue in previous TBT Committees. On 17 April 2020, 
the European Union notified to the TBT Committee a draft Commission Implementing Regulation 
concerning the non -renewal of the approval of the activ e substance mancozeb, in accordance with 
Regulation (EC) No 1107/2009 on the placing of plant protection products on the market. 
Implementing Regulation (EU) No 2087/2020 entered into force on 4 January 2021. The non -renewal 
was based on a scientific asses sment conducted under Regulation (EC) No 1107/2009 by experts 
from the EU member States and the European Food Safety Authority (EFSA). Since EFSA concluded 
that mancozeb does not meet the approval criteria as outlined in Article 4 of Regulation (EC) No 
1107/2009, the approval of this substance was not renewed. EU member States had to withdraw 
existing authorizations for plant protection products containing mancozeb at the latest by six months 
from the date of entry into force of the Implementing Regulation (by 4 July 2021). The grace period, 
in line with Article 46 of Regulation 1107/2009, shall expire, at the latest, after 12 months from its 
entry into force (by 4 January 2022). The withdrawal period for existing authorizations and the grace 
period have bee n extended, when compared to the original proposal, in order to accommodate 
requests. Following non -approval and the expiry of all grace periods for stocks of products containing 
this substance, separate action on Maximum Residue Levels (MRLs) may be taken  and a separate 
notification will then be made in accordance with SPS procedures.  
2.121.   The EU would like to inform Members that EFSA has recently started a review of the existing 
MRLs for dithiocarbamates (group of which mancozeb is part). Interested parties ar e invited to 
actively contribute with relevant information to this MRL review through the main authorization 
holder, as described in document G/SPS/GEN/1494/Rev.1 .39 For advice on alternatives to mancozeb, 
the EU pesticides database40 is publicly available and contains information on all active substances, 
their approval status and their main purpose (e.g. fungicide, insecticide or herbicide). As regards 
the joint Request for the suspension of the processes and entry into force of redu ction of MRLs of 
plant protection products in light of the COVID -19 pandemic in documents G/SPS/GEN/1778  and 
G/TBT/GEN/296  and subsequent revisions, the EU position is included in the document of 28 May 
2021 with double reference G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315  circulated in both 
Committees.  
 
39 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl -review_en.pdf   
40 https://ec.europa.EU/food/plant/pesticides/eu -pesticides -db_en   G/TBT/M/85  
 
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  2.1.3.7   India - Quality Control Orders for Chemical and Petrochemica l Substances, 
G/TBT/N/IN D/150,  G/TBT/N/IND/151,  G/TBT/N/IND/152,  G/TBT/N/IND/153,  
G/TBT/N/IND/154,  G/TBT/N/IND/116,  G/TBT/N/IND/121,  G/TBT/N/IND/122,  
G/TBT/N/IND/123,  G/TBT/N/IND/124,  G/TBT/N/IND/125,  G/TBT/N/IND/126,  
G/TBT/N/IND/127,  G/TBT/N/IND/128,  G/TBT/N/IND/129,  G/TBT/N/IND/130,  
G/TBT/N/IND/132,  G/TBT/N/IND/133,  G/TBT/N/IND/134,  G/TBT/N/IND/135,  
G/TBT/N/IND/136,  G/TBT/N/IND/137,  G/TBT/N/IND/138,  G/TBT/N/IND/139,  
G/TBT/N/IND/140,  G/TBT/N/IND/141,  G/TBT/N/IND/142,  G/TBT/N/IND/144,  
G/TBT/N/IND/175,  G/TBT/N/IND/176,  G/TBT/N/IND/177,  G/TBT/N/IND/186,  
G/TBT/N/IND/187,  G/TBT/N/IND/191,  G/TBT/N/IND/193,  G/TBT/N/IND/199 , 
G/TBT/N/IND/201 , G/TBT/N/IND/202 , G/TBT/N/IND/203 , G/TBT/N/IND/204 , 
G/TBT/N/IND/205 , G/TBT/N/IND/206 , G/TBT/N/IND/208  (ID 63041) 
2.122.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to express its concerns about the Order issued by India's Ministry of Chemicals and 
Fertilizers on phthalic anhydride, n -butyl acrylate and ter ephthalic acid, which were notified by 
G/TBT/N/IND/116 , G/TBT/N/IND/123  and G/TBT/N/IND/124 . We would like to thank India for 
postponing the enforcement date on the products concerned until 20 December 2021. However, 
since the pandemic will not likely end in the short term, we understand the difficulty of conducting 
regular conformi ty assessment procedures under the current situation, especially "on -site" factory 
inspection. Nevertheless, we still suggest that India implement alternative measures during the 
pandemic regarding all products concerned, such as allowing testing laborator ies and inspection 
bodies from other WTO Members to participate in the conformity activities procedures and accepting 
their reports or remote factory inspection, to address the difficulties of physical inspection resulted 
from international travel restrict ions. 
2.123.   The representative of the United States  provided the following statement. As of November 
2021, India's Ministry of Chemicals and Fertilizers (MoCF) notified 44 Quality Control Orders (QCO) 
to the WTO TBT Committee. Each QCO appears to identify substa nces that correspond to or fall 
under the 72 identified chemicals and petrochemicals for which India intends to mandate compliance 
to standards set by the Bureau of Indian Standards (BIS). We also understand that in April 2021, 
MoCF published final version s of seven of the notified QCOs in the Gazette, with the measures set 
to enter into force on 15 October 2021. Given the impact on trade and the difficulty in accessing the 
referenced standards, we kindly reiterate our request for the notified QCOs and any future QCO 
notifications, India provide the website links to and/or complete copies of the BIS proposed standard. 
With respect to the previously notified QCOs, we recommend that such website links and/or copies 
be notified as addenda. Without access to the  BIS standards, Members and industry are unable to 
understand the QCOs or provide meaningful comments.  
2.124.   We welcome India's 8 October 2021 amendment to the Polyethylene QCO, which postpones 
the implementation date by 180 days, and we understand from industry  that Indian authorities will 
engage in industry consultations during this period. Notwithstanding this development, we note US 
industry's concern that the draft of the Polyethylene QCO (notified as G/TBT/N/IND/191)  which 
mandates the marking of individual unit packages of polyet hylene product with "designation codes" 
containing an array of technical information (e.g. a product's melting point, density, and destination 
use), may pose challenges for exporters. Specifically, as India engages in consultations on the 
Polyethylene QCO,  we would like to relay US industry's concern that, as proposed, the designation 
code for polyethylene products may provide limited utility to end users considering the numerous 
physical properties and applications that a category of polyethylene product m ight have. We 
encourage India to consider the use of alternative methods, such as QR codes, to meet the 
Polyethylene QCO's mandatory labelling requirements. We want to highlight that Polyethylene QCO 
may inadvertently disrupt Indian imports of, and access to, essential materials used by Indian health 
care, pharmaceutical, and other Indian export -critical sectors such as the automotive sector. Would 
India consider exempting polyethylene products used as intermediate inputs from the labelling 
requirements set  forth in the Polyethylene QCO for these purposes?  
2.125.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on this matter. The EU remains concerned over 
the visible trend towards mandatory domestic standards in India that deviate from international 
 
41 For previo us statements follow the thread under ID 630 . G/TBT/M/85  
 
- 34 - 
 
  ones in a growing number of sectors. In this case, they pertain to a whole range of chemical products 
under the HS chapters 28 and 29. The EU took note of recent Indian TBT notif ications pertaining to 
Quality Control Orders for chemical substances. We note that QCO notifications bearing numbers 
G/TBT/N/IND/201 -206, G/TBT/N/IND/208 , and G/TBT/N/IND/215  do not have a determined date of 
entry into force. In fact, the entry into force is dependent on the adoption date, which is not 
indicated. Could Indi a provide information regarding the planned time for the adoption of these 
measures? Furthermore, the EU noticed that there is an increasing number of TBT -notified Indian 
QCOs on chemicals and petrochemicals that are not implemented. The European Union wou ld like 
to ask India to explain the reasons for repeated postponement of implementation of notified 
measures in this sector. Given the confusion this situation creates, could India provide a list of 
chemicals and petrochemicals which have already been impl emented, together with copies of 
relevant Orders?  
2.126.   The European Union would like to recall its request to India for clarification explaining the 
reasons for establishing India -specific Quality Control Orders when these chemical products already 
comply with internationally recognized standards. The EU would like to remind the authorities of 
India that in accordance with the TBT Agreement, standards are considered voluntary, whereas 
mandatory standards are considered as technical regulations. The EU would like  to recall Article 2.2 
of the TBT Agreement, according to which Members shall ensure that technical regulations are not 
prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to 
international trade. The EU would al so like to encourage India to align the BIS standards with 
international approaches.  
2.127.   The representative of Singapore  provided the following statement. Singapore echoes the 
concerns raised by other Members, and we would like to reiterate our concerns expres sed at the 
previous meeting, contained in document G/TBT/M/84 . We remain concerned about the operational 
challenges that we had outlined previously vis -à-vis the labelling requirements for polyethylene (PE) 
materials used for moulding and extrusion. We respectfully request for India to posit ively consider 
alternatives that have been proposed by the industry to meet the information requirements of the 
Quality Control Orders on PE products, to ensure that the mandatory labelling requirements are not 
too onerous and challenging for the industry to comply with. With regards to the QCOs on ethylene 
glycol and styrene monomer, we understand that India is looking to allow virtual inspections as part 
of the certification process. We remain interested in, and look forward to working with India to 
initiate these inspections, whether virtual or in -person, as soon as possible, to facilitate progress in 
the certification process for the industry. For any new additional QCOs, Singapore would like to 
reiterate our request for India to provide specific weblink s and/or copies of the proposed BIS 
standards together with the notification to the WTO in a timely manner, to enable interested parties 
to acquaint themselves with the new requirements, and provide meaningful comments to India. 
Finally, we respectfully ur ge India, as per its obligations under the TBT Agreement, to align the QCO 
standards with international standards which already exist, to reduce industry's compliance costs, 
and to ensure that measures imposed are not more trade -restrictive than necessary.  
2.128.   In response, the representative of India provided the following statement. India issuing 
Quality Control Order for chemicals and petrochemicals of HS chapters 28 and 29 as mandatory is 
in line with the international practices. India has formulated individ ual standards for specific 
chemicals indicating discrete and separate numbers under the BIS Act, giving technical 
characteristics and testing methods. Since each chemical has a different BIS standard number and 
possesses different features and testing meth ods, India has not preferred to file a single 
comprehensive mandatory notification. DCPC (Department of Chemicals and Petrochemicals) has 
notified the draft Quality Control Orders on chemicals and petrochemicals under the provisions of 
BIS Act 2016 and Rul es and Regulations framed thereunder, which envisages conformity assessment 
Scheme -1 of BIS Regulations 2018. As per draft QCOs, the product specified therein shall conform 
to the corresponding Indian Standard and shall bear the standard mark under the lic ence from BIS 
as per Scheme -1 mentioned above. These QCOs are equally applicable to domestic and foreign 
manufacturers. Under the provisions of the BIS Act 2016, no person shall manufacture, import, 
distribute, sell, hire, lease, store, or exhibit for sale  chemicals and petrochemicals notified in the 
QCO without a standard mark, except for a valid licence. Violators often attract the penal provisions 
of the BIS Act 2016. The requirement for using Standard Mark as per Scheme -1 is given in BIS 
(Conformity Ass essment) Regulations 2018. A copy of the same is available on the BIS website 
(www.bis.gov.in ). G/TBT/M/85  
 
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  2.129.   Under the provisions of Scheme -1 of BIS (Conformity Assessment) Regulation 2018, the 
licence can be granted for a minimum of one but up to two years and subsequently can be renewed 
for a period of a minimum of one, but up to five years. Under these provisions, BIS grants a licence 
to the manufacturer based on a successful assessment of the manufacturing infrastructure, 
produc tion process, quality control and testing capabilities of a manufacturer through a visit to its 
manufacturing premises. Conformity of the product to the relevant standard is also established 
through third -party laboratory testing in India or testing in the  manufacturing premises or a 
combination of both. Under Scheme -1 of BIS (Conformity Assessment) Regulation 2018, there is no 
provision to accept quality control assessments conducted by foreign firms and Labs. As per Quality 
Control Orders on chemicals and  petrochemicals, every product shall conform to corresponding 
Indian standards specified therein and shall bear the standard mark under the licence from BIS as 
per Scheme -1 of BIS (Conformity Assessment) Regulation 2018. The standards of chemicals and 
petrochemicals which DCPC notified were reviewed by BIS, and due consideration was given to 
international standards like ISO/ASTM, wherever available. As per Article 2.2 of the TBT Agreement, 
Members can formulate technical regulations to fulfil legitimate obj ectives inter alia national security 
requirements, prevent deceptive practices, protect human health or safety, animal or plant life or 
health or environment. As per the laid down procedure, the draft Quality Control Orders (QCO) were 
notified to the WTO T BT Committee, giving an opportunity to the Members to comment within 60 
days.  
2.130.   These standards are made mandatory to protect human health and the environment. For a 
long time, the Indian standards of chemicals and petrochemicals were voluntary in nature. Th e trade 
of chemicals and petrochemicals usually occurs as per the specifications settled between the 
manufacturer and buyer irrespective of the specifications stipulated in the BIS standard, which 
sometimes results in dumping poor quality chemicals into In dia. Many chemicals are toxic and 
hazardous. The impurities such as heavy metals, cyanides, isocyanates, halides etc., enter the 
human and plant chain, harming human and animal life. Under mandatory standards regime, safe, 
reliable and quality chemicals ar e expected to be available. TRs for chemicals and petrochemicals 
have not been formulated to create unnecessary obstacles to international trade. The standards 
have been made mandatory after reviewing existing standards, stakeholder consultations, includin g 
leading manufacturers, to ensure the requirements reflect new testing methods. This measure does 
not hinder the ability of the foreign manufacturer to penetrate and reach into Indian chemical 
market.  
2.1.3.8   Bangladesh - Hazardous Waste (E -waste) Management Rule s, 2019, 
G/TBT/N/BGD/3,  G/TBT/N/BGD/3/Add.1  (ID 62042) 
2.131.   The representative of the United States  provided the following statement. On 10 June 2021, 
Bangladesh published an updated draft of its Hazardous Waste (E -Waste) Management Regulation, 
2021 (E -waste Rules). Could Bangladesh notify this updated dra ft to the WTO TBT Committee? US 
industry provided its latest comment on the revised draft on 20 September 2021. Previously, US 
industry raised concerns regarding the inclusion of threshold limits and restrictions of certain 
substances, which, if applied, w ould have disrupted or prevented the sale of many important 
electrical and electronic goods in Bangladesh, including certain medical devices, washing machines, 
and cellular phones. Based on an unofficial translation we have obtained of the previous draft E -
waste Rules, our understanding of the revised draft is that it addresses concerns of certain 
substances by removing threshold limits for the following: antimony trioxide, beryllium metal, 
beryllium oxide, copper beryllium alloys, nickel, liquid crystals, and polyvinyl chloride (PVC).  
2.132.   Please confirm that the June 2021 draft E -waste Rules no longer include threshold limits on 
these substances. Please also confirm that Bangladesh does not plan to include threshold limits on 
these substances in future iteratio ns of the E -waste Rules. The United States also asks Bangladesh 
to provide further details on its plans regarding implementation of the E -waste Rules, including 
implementation timelines, registration deadlines, and points of contact. Given the broad scope of 
the E -waste Rules, we encourage Bangladesh to provide a reasonable transition period, ideally of 
one year, for industry to adapt its products or methods of production to the new requirements. 
Finally, we ask that Bangladesh notify the revised draft text  of the E -waste Rules to the WTO TBT 
Committee, provide a public comment period of at least 60 days, and take comments received into 
account before finalizing the regulation.  
 
42 For previous statements follow the thread under ID 620 . G/TBT/M/85  
 
- 36 - 
 
  2.133.   The representative of the Republic of Korea  provided the following statement. Alt hough the 
Rules are in effect from this year, several of its provisions are still ambiguous. We request 
Bangladesh to clarify this information to help Korean manufacturers comply with the E -waste 
management rules.  
2.134.   The representative of Canada  provided the following statement. Canada supports 
Bangladesh's efforts to protect the environment by introducing Waste Management Rules and 
facilitating resource recycling. Canada acknowledges Bangladesh's WTO notification made on the 
draft Hazardous Waste (E -waste) Ma nagement Rules, 2019 and appreciates the opportunity given 
to WTO Members to provide comments. Previously, Canada raised industry's concerns with the lack 
of clarity on this measure and asked Bangladesh to share the full regulatory text of the Management 
Rules with WTO Members. Furthermore, Canada strongly encouraged Bangladesh to ensure that the 
Management Rules are no more trade restrictive than necessary to meet its environmental 
objectives. At the last TBT Committee, Bangladesh indicated that most of th e concerns raised by 
WTO Members have been addressed and hopefully responses will be notified in due course. Canada 
understands that on 10 June 2021, Bangladesh published an updated draft of its Hazardous Waste 
(E-Waste) Management Regulation, 2021 (E -waste Rules). What plans does Bangladesh have for 
notifying this updated draft to the WTO TBT Committee? Will Bangladesh provide Members with a 
60-day comment period, and a reasonable transition period for industry to adapt its products or 
methods of productio n to the new requirements? Also, will interested Members be receiving the full 
text of the measure and its supportive documentation? Canada would appreciate if Bangladesh could 
provide Members with a notional implementation timeline of the updated draft of  its Hazardous 
Waste (E -Waste) Management Regulation, 2021 (E -waste Rules).  
2.135.   The representative of the European Union  provided the following statement. The European 
Union has concerns on the Hazardous Waste Management Rules. We sent written comments to 
Bangladesh in April 2020 and are looking forward to receiving written replies before the adoption of 
the notified drafts. Our main point is that the notified draft restricts use of substances that are not 
restricted by any existing international legislation an d thus creates more restrictions to trade than 
necessary. On 10 June 2021, Bangladesh published an updated draft of the E -Waste rules. This 
revised draft should be notified to the WTO TBT committee with a comment period of at least 60 
days in order to prov ide the possibility for Members to comment.  
2.136.   In response, the representative of Bangladesh  provided the following statement. Bangladesh 
would like to refer to its submission G/TBT/W/759  dated 22 June 2021 where concerns raised by the 
Members have been addressed. On this occasion Bangladesh would also like to mention that 
Bangladesh has revised the schedule according to the European Union Directive 2015/863, so 
Bangladesh believes all the concerns raised by Members have been addressed. The proposed  rule 
will be effective after five years and Bangladesh has informed and notified accordingly. Bangladesh 
believes that the Members, especially those who raised concerns, need not to be concerned that 
Bangladesh did not do anything against the WTO TBT Agreement. If Members have further issues or 
concerns, then Bangladesh would also like to have bilateral meetings with Members for those 
concerns.  
2.1.3.9   India - Indian standards and import restrictions in the automotive sector 
(Quality  Control Orders): wheel rims, safety glass, helmets, G/TBT/N/IND/118,  
G/TBT/N/IND/147,  G/TBT/N/IND/167  (ID 64943) 
2.137.   The representative of the European Union  provided the following statement. India has 
defined and introduced specific standards and certification requirements for a number of products 
across sectors that require on -site, in person audits. This is the case of the so -called Quality Control 
Orders (QCOs), which require a physical audit by an auditor of the Bureau of Indian Standards (BIS) 
in order for products manufactured in third countries to receive the approval for exp orts to India. 
However, for the last two years Indian auditors are not in a position to conduct international audits 
due to the COVID -19 context. Unfortunately, India has refused to consider meaningful alternative 
options, such as virtual audits. Consequen tly, European Union companies, despite doing all that is 
necessary to meet the Indian requirements, are not able to obtain the required Indian certification 
or marking. Thus, while the EU and other foreign companies are not able to access the Indian market  
due to the lack of virtual audits on India's side, Indian auditors are conducting domestic audits that 
allow domestic companies to receive certification/marking and place their products on the market. 
 
43 For previous statements follow the thread under ID 649 . G/TBT/M/85  
 
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  This is a clear case of discrimination against EU and other foreign companies. In this context, the 
EU welcomes the steps taken by the BIS to allow its auditors to audit foreign manufacturing plants. 
In the case of Indian QCOs, allowing the inspections out of India would be an important step towards 
solving t he current difficult situation and eliminating the discrimination between local and foreign 
companies. However, the EU is concerned that BIS auditors may only be conducting these audits in 
a few selected countries, and under certain, strict criteria drawn by India for auditing foreign plants.  
2.138.   BIS has reached out to some EU member States with these questions requesting their input 
that would allow them to plan their on -site international audits. However, while these audits, if re -
initiated, may provide some relief to EU companies, the BIS' response would need to be much wider, 
given that many of the products under QCOs are produced in China or South East Asia which – as 
far as the EU knows – would not be on the travel plan of BIS auditors for the time -being. The EU 
would like to recall that the QCOs in question have protectionist orientation and are sending worrying 
signals to EU industry, EU investors, and EU member States. Once these measures come into force, 
they will cause extra burden and economic cost to  the EU industry that will have to undergo 
cumbersome procedures to obtain necessary permissions and/or licences for products already 
certified under established international standards. In this context, the QCOs would add little value 
for Indian consumers , making the reason of their introduction not evident. Furthermore, the 
implementation of the QCOs for foreign companies with production facilities outside India may 
continue to prove difficult due to the still existing restrictions in view of the ongoing COVID -19 
pandemic. That is why the EU would like to voice once again its concerns regarding the QCOs on 
automotive safety glass and wheel rims.  
2.139.   While the EU appreciates the postponement of these two QCOs – on safety glass to the 
spring of 2022, and on whee l rims until 1 September 2022, concerns persist that the continued 
COVID -19 pandemic and restrictions on international travel may not allow for their actual 
implementation. That poses the risk that on 1 April and 1 September 2022, when the QCOs for 
automot ive safety glass and wheel rims are due to enter into force, production lines may come to a 
standstill due to the lack of supply of safety glass and wheel rims compliant with Indian QCO. Such 
a situation could damage the Indian economy and Indian consumers  and should be avoided. 
Therefore, the EU would like to suggest that India considers further postponement, of at least six 
months, of the entry into force of the QCO for safety glass, with a view to ensuring the continuity of 
imports of safety glass into I ndia. The EU would also like to urge India to consider virtual audits or 
audits performed by recognized third party certification experts in the location of the manufacturing 
plants. The EU would also like to recall that EU safety glass and wheel rims are certified under 
established international standards, which are not much different from the Indian ones, introduced 
by the QCOs in question. In this context, the QCOs on automotive safety glass and wheel rims will, 
as already mentioned, generate important a dditional costs for European automotive manufacturers 
without adding any qualitative value for Indian consumers. The EU therefore asks India to reconsider 
the introduction of the QCOs on automotive safety glass and wheel rims. Furthermore, the EU would 
like to recall its suggestion to keep the BIS marking as optional for components, which are already 
in compliance with the current marking requirements.  
2.140.   The representative of Indonesia  provided the following statement. Indonesia thanks India 
for notifying the  draft of Automobile Wheel Rims (Quality Control), Order 2020 on 25 May 2020 to 
TBT WTO Members through G/TBT/N/IND/147 . Under these measures, wheel rims products shall 
conform to the IS 16192 and shall bear India Standard Marking under the licence form the Bureau 
of Indian Standar d (BIS). Indonesia has extensively communicated its concern through the Enquiry 
Points of TBT WTO on 25 August 2020, bilateral meeting in February 2021 and even the Permanent 
Mission of India in Geneva. Indonesia regrets that India is yet to provide substa ntive response to 
Indonesia's concern. According to the notification, this order shall come into force with effect from 
1 October 2020, yet India has not made any addendum to the notification regarding the stipulation 
of the regulation. Indonesia seeks cla rification regarding the status of the implementation of the 
regulation. Indonesia is of the view that the regulation has impacted and become a trade barrier for 
the exporters as there is no clarity regarding the mechanism of the regulation. Therefore, Ind onesia 
requests India to postpone or provide sufficient transition time to allow industries to comply with 
the regulation. Indonesia remains concerned that the conformity assessment procedure as required 
in the document is more restrictive than necessary. The procedure includes audit and certification 
can only be carried out by BIS and requires factory visit as part of the scheme. Indonesia regrets 
that India has not taken into account the current pandemic situation that made factory visit 
impossible due to  the travel ban and social distancing policy. Therefore, Indonesia urges India to G/TBT/M/85  
 
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  consider the use of remote assessment in conducting factory inspection or any relaxation policy as 
a means to facilitate trade and minimize technical barrier to trade, partic ularly in this difficult time.  
2.141.   Moreover, Indonesia has also regulated wheel rims products distributed in the market to 
conform with a national standard since 2012 that refers to an international standard. The procedure 
of certification is based on internat ional standard on conformity assessment, specifically type 5 of 
ISO IEC 17067, which is similar to India's certification scheme. Thus, Indonesia encourages India to 
recognize and accept conformity assessment results performed by accredited conformity asses sment 
bodies in Indonesia or outside India under the framework of IAF and ILAC signatory. Indonesia is 
also aware that before the mandatory implementation of IS 16192, India requires all manufactures 
of automobile wheel rims to implement ICAT (Internationa l Center for Automotive Technology) 
Standard prior to entering India's market. Therefore, we would like to ask clarification from India 
regarding the implementation of the ICAT standards once this regulation comes into force. Indonesia 
remains concerned ab out the potential duplicative conformity assessment procedure. Hence, 
Indonesia requests India to harmonize both requirements with a single conformity assessment 
procedure and remain using the mechanism of remote assessment as has been done in implementing  
the ICAT Standard.  
2.142.   In response, the representative of India provided the following statement. The COVID -19 
pandemic and the travel restrictions are not under our control. The foreign inspection visits are on 
hold due to the prevalent restrictions on trave l on account of the ongoing pandemic. India has stated 
it formally and we will reiterate: As soon as the situation improves and the restrictions are lifted, 
India will plan the inspections (factory visits). Further, there is no provision in the BIS for rem ote 
assessment or any other means of inspection. Wheel Rims: India would like to refer to its previous 
responses on this issue and reiterate them. The testing and certification system in India is in line 
with the global regime. Component certification is a n essential prerequisite of Whole Vehicle Type 
Approval, and the two are complementary. This practice is well established worldwide and quite 
harmonized under Whole Vehicle Type Approval. Unlike in European Union, where the wheel rim is 
not identified as a  separate safety -critical component in UNECE, in India wheel rim is recognized as 
one of the critical safety components under the CMVR. This has been warranted considering India's 
local road infrastructure, the variety of tyres used, and driving behaviour.  Wheel rim is a critical part 
influencing driving safety. These Indian standards have been prepared to ensure quality, reliability 
and consistency required, keeping in view human safety and consumer protection. These standards 
prescribe wheel rims' general  and performance requirements intended for use on two, three and 
four-wheeled motor vehicles. The Quality Control Order (automotive wheel rims) is non -
discriminatory, both at the original fitment level of automobiles and after sales/repair service, to 
ensure supply of only quality products in the Indian market duly certified approved by the Indian 
implementing agency. The QCO also provides for market surveillance to check the entry of sub -
standard products into the Indian market. This was necessitated to pr otect human life and consumer 
interest. The Quality Control Order was issued after due consultation with stakeholders. Further, as 
desired by the stakeholders, a sufficient lead time of one year from the date of publication of the 
Gazette Notification of t he QCO has been provided for the industry to prepare itself. Safety Glass: 
Implementation of safety glass QCO has been again extended by one year beyond 1 April 2021, i.e. 
new implementation date is 1 April 2022. Like I said, foreign inspection visits are on hold due to the 
prevalent restrictions on international travel given the ongoing COVID -19 Pandemic. As soon as the 
situation of COVID -19 improves and the restrictions are lifted, India will plan the inspections (factory 
visit).  
2.1.3.10   China - Commercial Cryptography Administrative Regulations (ID 64444) 
2.143.   The representative of the United States  provided the following statement. The United States 
has concerns regarding China's draft Commercial Cryptography Administrative Regulations, issued 
by the  State Cryptography Administration on 20 August 2020 and we submitted comments to China 
in September 2020. The United States is concerned that this draft measure would impose potentially 
far-reaching, highly trade -restrictive cryptography -related constrain ts on foreign ICT products. Does 
China intend to notify this measure to the TBT Committee and allow for additional stakeholder 
comments? The provisions in the draft measure may raise serious concerns under the WTO 
Agreements, and appear to conflict with gl obally accepted practices to assess encryption in 
commercial ICT applications. We understand that China has received numerous comments on this 
draft. We hope that China will carefully consider the input from all stakeholders, including the US 
 
44 For previous statements follow the thread under ID 644 . G/TBT/M/85  
 
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  Government an d our industry stakeholders, and make substantial changes and clarifications to the 
draft measure prior to implementation. The draft measure would establish a licensing scheme for all 
imports and exports of commercial cryptography in instances where "socia l and public interests" are 
concerned. Can China explain how it plans to implement this scheme in line with its national 
treatment commitments? What steps is China taking to ensure the scheme will be not operated as 
an unnecessary obstacle to trade?  
2.144.   What s teps is China taking to ensure its cryptography accreditation, testing and certification 
system will operate in accordance with Article 5 of the TBT Agreement? Specifically, how will China 
ensure that the conditions for foreign products are no less favoura ble than those accorded to 
domestic products? Although the draft measure ostensibly encourages participation in "the 
development of international standards for commercial cryptography", Articles 10 to 12 appear to 
mandate compliance with Chinese standards,  which may diverge from international standards. In 
addition, the draft measure includes a standard setting process for commercial cryptography that 
appears to provide a different level of openness to domestic participants as compared to foreign 
participan ts. In the United States' view, China should adopt the use of relevant international 
standards and harmonize its practices with relevant international best practices. We would 
appreciate any update you can provide on the status of the draft measure, and ho w China intends 
to consider the public comments it has received.  
2.145.   The representative of the European Union  provided the following statement. The EU is 
concerned about this partial implementation measure of the Cryptography Law, and sent comments 
to the Stat e Cryptography Administration of the People's Republic of China (SCA) last September. 
Specifically, concerns relate to (i) the scope of the law; (ii) the lack of clarity of concepts and 
precision of procedures; (iii) the protection of intellectual property ; (iv) the imposition of pre -market 
and export controls; (v) the requirements around testing and certification; (vi) the imposition of 
additional "national security reviews"; and (vii) the use of domestic standards, along with a lack of 
meaningful access t o pertinent Chinese standards development organizations. The EU urges the SCA 
to address these concerns in the further development of the draft regulations in order to ensure that 
legal and regulatory requirements are applied on a non -discriminatory basis,  do not favour specific 
technologies, do not limit market access and do not lead to forced transfer of intellectual property. 
Additionally, the EU encourages the SCA to open up, in practice, the "Cryptography Industry 
Standardisation Technical Committee" ( CISTC) to foreign -invested industry based in China. The EU 
would appreciate its comments being taken into consideration and invites China to notify the draft 
regulations to the WTO.  
2.146.   The representative of Canada  provided the following statement. Canada note s China seeks 
to establish a unified national certification scheme for commercial cryptography. In September 2020, 
Canada provided China with written comments on a draft of China's State Cryptography 
Administration's cryptography regulations and continues to look forward to a response. At the last 
TBT Committee meeting in June 2021, as well as the one in February 2021, China indicated that a 
revision of the Regulation was still being studied and that China would solicit public opinions or public 
input when it is appropriate. Could China please indicate when the regulation will be notified to the 
WTO TBT Committee and available for WTO Members and stakeholders review and input? Canada 
requested, in previous meetings of the Committee, that China consider modif ying the regulations, 
and the Cryptography Law they implement, to provide further clarity, transparency and 
predictability. For example, Canada seeks the definition of terms, clarification that international 
standards will be used and further precision of the measures' scope. Canada would appreciate 
China's consideration of its comments and invites China to notify the draft regulations to this 
Committee.  
2.147.   In response, the representative of China  provided the following statement. The Revised 
Regulation on the  Administration of Commercial Cryptography has been listed in the State Council 
Legislation Plan for 2021. The revision of the Regulation will follow law -based, democratic and 
scientific principles. And it will be open, transparent, and on a scientific bas is, to ensure participation 
of interested parties in the process of revision.  G/TBT/M/85  
 
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  2.1.3.11   United Kingdom - Wine labelling and documentation requirements at the end of 
the Brexit transition period (ID 66345) 
2.148.   The representative of Australia  provided the following statem ent. Australia would like to 
reiterate the concerns we have raised in previous meetings. We acknowledge the United Kingdom's 
response in the previous Committee meeting, that wine marketed in Great Britain can show either 
a United Kingdom or a European Unio n importer on the label until 1 October 2022. As was raised in 
the previous meeting, we are seeking flexibility to allow the listing of importers on the label of wine 
bottles imported into the UK and for multiple destinations, particularly after that grace  period ends. 
We believe it is possible, and less trade restrictive, to include details of the relevant UK importer as 
well as the details of importers for third -party markets on the same label, without undermining the 
UK's stated policy objective. Austral ia would appreciate further clarification on whether, following 
the conclusion of the grace period, the UK would consider it acceptable for wine to include a label 
indicating the importer for a third country, provided the label also clearly articulates the  details of 
the UK importer, and that the third country importer is not the importer for the UK. For example: 
'For the UK, imported by x:' and 'For the EU, imported by y:' If the UK does not consider this 
acceptable, can the UK explain the rationale for th is position, and how it is consistent with the UK's 
obligations under Article 2.2 of the TBT Agreement. Australia welcomes the bilateral engagement 
we have had to date on this issue.  
2.149.   The representative of Uruguay  provided the following statement. We wish t o refer to our 
previous statements on this matter and once again express our interest in remaining informed of 
the regulatory requirements and conditions that will apply to the importation of wine into the United 
Kingdom market from 1 October 2022, in part icular with respect to documentation and labelling, 
and in such requirements being the least trade -restrictive possible.  
2.150.   In response, the representative of the United Kingdom  provided the following statement. 
The United Kingdom welcomes Australia's and Uru guay's continued interest in our wine labelling and 
documentation requirements, and the constructive bilateral engagement we have had with Australia 
on this topic to date. As per our previous statements, for wine imported into Great Britain, our 
regulation s allow for an importer situated in either the European Union or Great Britain to be shown 
on the label of wine products marketed in Great Britain until 1 October 2022. After that date, wine 
products marketed in Great Britain must bear the details of an im porter situated in Great Britain on 
the label of products. We reiterate that we designed the transitional arrangements in consultation 
and close cooperation with industry to minimise the impact on trade. The UK will seek to work 
collaboratively with the in dustry as we develop our regulatory regime to facilitate the global trade 
in wine, taking into account our policy objective on consumer protection. We remain available for 
further bilateral discussions with Australia and Uruguay to discuss our regulatory a pproach. Further 
details of the labelling measures that apply are available on the UK Government website.46 
2.1.3.12   European Union - Wine labelling requirements – listing of importers for multiple 
destinations (ID 65947) 
2.151.   The representative of Australia  provided th e following statement. Australia thanks the EU for 
clarifying its wine labelling requirements at the previous TBT Committee meeting in June. At that 
meeting, the EU indicated that "mentioning the entity that brought the wine into another third 
country befo re import into the Union could be only acceptable as an optional particular, provided it 
does not appear in combination with the words 'importer' or 'imported by (…)' and provided it is not 
misleading for consumers as regards the business food operator." W e have stated in previous 
committees and maintain that the EU allowing an "optional particular" on labels to cover importers 
in other third countries would be consistent with the EU's objectives, while still clearly identifying 
the EU importer and person a ssuming responsibility. For example: statements such as "For the EU, 
imported by:" and "For the UK, imported by:" would not mislead consumers as regards the business 
food operator. Australia seeks clarification on why the EU will not allow an optional part icular that 
appears in combination with the words "importer" or "imported by (…)". As we raised in the previous 
Committee meeting, we are also seeking clarity from the EU on whether it is possible to list importers 
for multiple destinations on the same win e bottle label under the current EU Regulation. Further 
guidance and clarity are important to provide certainty to traders and ensure no interruptions to 
 
45 For previous statements follow the thread under ID 663 . 
46 https://www.gov.uk/guidance/importing -and-exporting -wine  
47 For previous statements follow the thread under ID 659 . G/TBT/M/85  
 
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  trade occur. If the EU does not consider this acceptable, can the EU explain the rationale for this 
position, and how it is consistent with its obligations under Article 2.2 of the TBT Agreement. We 
look forward to working closely with the EU on this issue to ensure a mutually satisfactory outcome 
as we continue similar discussions with the UK to resolve t his issue for wine imported into the UK.  
2.152.   In response, the representative of the European Union  provided the following statement. As 
explained in previous TBT Committees, the indication of the "importer" is a compulsory indication 
for wine imported into the  EU and the importer is a natural or legal person or a group of such persons 
established in the EU. Any other indication on the label mentioning the entity that brought the wine 
into another third country before import into the Union could only be acceptab le as an optional 
particular, provided it does not appear in combination with the words "importer" or "imported by 
(…)" and is not misleading for consumers as regards the business food operator (i.e. the person 
assuming responsibility for bringing the wine  into circulation in the EU).  
2.1.3.13   India – Draft Food Safety and Standards (Import) Amendment Regulation, 2020, 
G/TBT/N/IND/180  (ID 66748) 
2.153.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Terr itory of Taiwan, Penghu, Kinmen and 
Matsu respects India's effort to ensure imported food safety through this draft measure. As the 
proposed measure provides limited information on its implementation details, we submitted our 
comments on 30 December 2020 a nd raised the STC twice to seek clarification from India. However, 
we have not received any response from India up to this date. We urge India to observe the principle 
of transparency in relevant implementing measures of this regulation and would like to r equest India 
to provide clarifications on the following: 1. The specific categories of food products subject to 
compulsory registration mentioned in this draft. 2. Information on the inspection items covered by 
Article 18(3)(b) of the draft. 3. Format for the licence/registration specified in the Article 18(1)(c) 
of the draft. 4. Samples of documents listed in Annexure -I. 5. Fees involved in the whole registration 
process. 6. Guidance documents for manufacturers outside India to complete the required 
regist ration procedures. Our manufacturers will be positioned in a disadvantaged situation without 
knowing how to prepare themselves to meet the requirements. We would be grateful if our concerns 
could be taken into account and look forward to a written response . 
2.154.   The representative of the United States  provided the following statement. The United States 
remains concerned with India's draft amendment "Registration and Inspection of Foreign Food 
Manufacturing Facilities" to its Food Safety Standards (Import) Amendm ent Regulation, 2020, 
notified to the WTO TBT Committee as G/TBT/N/IND/180  on 25 November 2020. In response to 
India's notification, we submitted comments on 22 January 2021. This draft regulation leaves many 
unanswered questions for foreign food manufacturing facilities, competent  authorities, and other 
stakeholders. The United States raised this issue at the TBT Committee meetings in February and 
June 2021, and India responded that it was reviewing comments received. The United States wishes 
to reiterate our main concerns, and we ask that India please provide a more detailed response and 
update on the status of the proposed regulation. The draft regulation states that India may identify 
categories of "risk" for food products "from time to time… for which inspection or audit of fore ign 
food manufacturing facilities producing such categories of foods shall be mandatory." We are 
concerned about the lack of detail regarding the scope of this proposed technical regulation and the 
scientific and technical information India will use to det ermine the specific "risk" for food product 
categories. We again ask that India please provide further information on this measure and its plan 
for implementation.  
2.155.   The representative of the European Union  provided the following statement. The European 
Union would like to highlight its strong concerns with this Indian measure. Many questions for foreign 
food manufacturers and competent authorities remain unanswered, which would create an 
unpredictable trading environment. Most importantly, the proposed stand ards appear much more 
trade restrictive than necessary to fulfil the intended food safety objectives. We sent you written 
comments and are still waiting for a written reply. I want to highlight our main elements of concern: 
The transition period is too sho rt and should be extended to 18 months. India should further clarify 
the scope of products/food categories. A list of low -risk products should be defined that should be 
exempted. An example would be wines and spirits due to their inherent stable nature. In spections 
and audit of foreign food manufacturing facilities as well as registration need to be clarified and 
 
48 For previous statements follow the thread u nder ID 667 . G/TBT/M/85  
 
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  simplified. We understand that FSSAI has adopted and published very recently, on 10 November 
2021 a revised, final version which will become appli cable as of June 2022. The revised text mentions 
that the registration obligation would only apply to food (and drink) products presenting a specific 
risk, but there is no list of such products in the rules themselves. Could India please clarify that 
produ cts which are inherently stable and do not present sanitary risks such as spirits or wine, will 
be excluded from the scope of these new obligations?  
2.156.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to the Draft  Food Safety and Standards (Import) Amendment Regulation notified by the 
Government of India on 25  November  2020 to the Members of this Committee in 
document  G/TBT/N/IND/180 . The delegat ion of Mexico has requested further information and 
clarification regarding the scope of this measure at the past two meetings of this Committee, and 
today we find ourselves obliged to repeat this request. The measure is highly relevant to the industry 
and Government of Mexico, which is why, considering that the delegation of India had indicated in 
its statement at the Committee meeting in June that the comments received from stakeholders were 
being examined, the delegation of Mexico requests up -to-date inf ormation regarding the status of 
this examination and it would like to know how the concerns that have been raised in this forum will 
be considered and addressed. The delegation of Mexico thanks the delegation of India for giving its 
consideration to this statement and reiterates the importance of maintaining transparent channels 
of communication to allow concerns to be addressed in an efficient manner.  
2.157.   The representative of Australia  provided the following statement. Australia recognizes the 
right of the I ndian Government to take measures necessary to protect food safety and public health. 
Australia thanks India for its recent engagement on this issue during a bilateral technical discussion 
with Australia. Australia respectfully recommends the regulation be  amended to clarify the categories 
of food included. The proposed measures should be linked to the risks posed by the imported food. 
Australia is happy to work with India to support a more risk -based approach to food safety.  
2.158.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at the February and June 2021 TBT Committee meetings regarding India's 
draft amendment to its Food Safety Standards (Import) Amendment Regulation pertaining to the 
registration,  inspection and/or audit of foreign food manufacturing facilities producing food products 
destined for India. While Canada recognizes India's right to take necessary measures to protect 
public health and safety, a number of elements contained in India's pr oposed amendments remain 
ambiguous. As previously stated, it is unclear what criteria would be used to determine the level of 
risk for food products imported into India, what circumstances would instigate an audit or an 
inspection of a foreign manufacturin g facility or, how such actions will be taken given the ongoing 
travel restrictions resulting from the pandemic. In addition, Canada remains concerned with the 
measure's target commodities, source -countries, implementation plan, audit rates, compliance 
actions and appeals. We are of the view that India's approach in these areas could create 
unnecessary obstacles to trade. Canada is disappointed that India has yet to respond to comments 
submitted to India's Enquiry Point on 21 January 2021. We would apprecia te if India could inform 
when it expects to provide the requested details. In closing, Canada recalls its request to India to 
notify these amendments to the SPS Committee given that India's proposed regulation covers food 
safety measures aimed at protectin g human health and safety.  
2.159.   The representative of Argentina  provided the following statement. Argentina wishes to 
reiterate the concerns raised during the previous meeting of the Committee. As we have already 
stated, my country has a number of doubts about giving effect to and implementing the provisions 
contained in the draft standard notified in document G/TBT/N/IND/180 , particularly with regard to 
the products covered and the provisions on registration, inspection and audit of exporting 
establishments. All our questions have been duly submitted through India's TBT Focal Point and we 
are yet to receive the corresponding clarifications. We hope to receive them as soon as possible and 
also hope that this new standard does not become an unjustified restriction, in order to ensure that 
trade with India, a highly important trading partner for our country's agricultural sector, is not 
affected.  
2.160.   The representative of Japan  provided the following statement. Japan shares the concerns on 
India's proposed draft amendment regulation on food safe ty and standards. While the regulation 
would impose additional burdens on business operators who export to India, there are many unclear 
points yet to be sufficiently explained by India including definitions of "food manufacturing facility", 
scope of "food " subject to the draft regulation, and registration procedure of the facility inspection G/TBT/M/85  
 
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  and audit. Japan would like India to make TBT and SPS notification and provide WTO Members with 
the opportunity to make comments on the detailed regulation regarding t he scope of food, the 
facilities registration procedure and so forth. Moreover, Japan emphasises the importance to have 
sufficient transition period before the implementation of the new rules. Japan's position is that the 
transitional period of 180 days fr om publication in the Official Gazette is still not sufficient. Japan 
recommends that the transition period be extended to more than 18 months. Japan urges India to 
sincerely address Members' concerns and comments to ensure the proposed new rule does not 
create unnecessary trade barriers.  
2.161.   In response, the representative of India provided the following statement. At this time, the 
comments received from various stakeholders are being examined. Once we have a fuller 
examination, we will get back to all the in terested Members.  
2.1.3.14   Mexico - Conformity Assessment Procedure under Mexican Official Standard 
NOM -223-SCFI/SAGARPA - 2018, "Cheese Names, Specifications, Commercial 
Information, and Test Methods," published on 31 January 2019, G/TBT/N/MEX/465  (ID 
67849) 
2.162.   The representative of the United States  provided t he following statement. The United States 
appreciates a bilateral held with Mexico on this issue yesterday. We are submitting our statement 
from the last meeting since the standard and the conformity assessment procedure is under 
consideration in the Mexic an system so as a place -marker we are going to submit our previous 
statement50 and we look forward to the continued discussion within the Committee and Mexico.  
2.163.   The representative of the European Union  provided the following statement. The European 
Union w ould like to join this trade concern, as some aspects of the conformity assessment procedure 
established by the Procedure for the Evaluation of Conformity of the Official Mexican Standard NOM -
223, would cause difficulties for EU exporters. The EU thanks fo r the information provided bilaterally 
by Mexico and would like to ask about the state of play of the ongoing revision of the conformity 
assessment procedure (CAP) for the Mexican Official Standard NOM -223-SCFI/SAGARPA -2018 on 
cheese, in particular the tim eline for the notification to the WTO TBT Committee and the public 
consultation process. We would appreciate a possibility to work bilaterally with Mexico to find a 
satisfactory solution.  
2.164.   The representative of Australia  provided the following statement. Au stralia would like to 
reiterate its concerns that Mexico's measure notified as G/TBT/N/MEX/465  appears discriminatory 
and more trade restrictive than necessary. We note we are yet to receive a response from Mexico 
to the comments we submitted on Mexico's notification detailing our concerns and welcome Mexico's 
consideration of, and response to them in the near future. Australia looks forward to continuing our 
successful trade relationship with Mexico.  
2.165.   In response, the representative of Mexico  provided the following statement. As rei terated by 
the Government of Mexico in this forum and in this Organization's Council for Trade  in Goods, this 
measure was developed to address issues and concerns related to the authenticity of products called 
"cheese" marketed in Mexican territory and the  information consumers receive about them, and to 
prevent misleading practices. As for the status of this measure, the Mexican authorities are still 
conducting a comprehensive analysis of this procedure in light of its international commitments, in 
order t o achieve a balance in the regulation while fulfilling the legitimate objective pursued. In this 
vein, a new version of the procedure will be notified to the Members of this Committee for public 
consultation in the coming months. The delegation of Mexico r eiterates its willingness to keep 
transparent channels of communication open to clarify any doubts that the Members of this 
Committee may have and to provide information on any progress made via the relevant contact 
points.  
 
49 For previous statements follow the thread under ID 678 . 
50 G/TBT/M/84 , paras. 4.135 -4.139.  G/TBT/M/85  
 
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  2.1.3.15   Thailand - Ministerial Regulatio n Prescribing Description, Production, and 
Method of Displaying of Standard Marks on the Industrial Products, G/TBT/N/THA/577 , 
G/TBT/N/THA/577/Add.1  (ID 67251) 
2.166.   The representative of the United States  provided the following statement. The United States 
appreciates Thailand's continued extension o f the date of enforcement of its Ministerial Regulation 
prescribing the description, production, and method of displaying of Standard Marks on its Industrial 
Products. US industry submitted several comments through the US and Thai Enquiry Points 
beginning in October 2020, through January 2021. We appreciate the exchange through that 
mechanism and Thailand's willingness to engage bilaterally on this issue. However, the United States 
continues to have concerns regarding the QR code requirements provided in th e regulations. We 
encourage Thailand to consider other approaches that may meet consumer protection goals in a less 
trade-disruptive manner. In particular, a voluntary e -labelling approach in line with international 
best practices and standards should be c onsidered. A voluntary e -labelling programme can help 
consumers discover important information without unnecessarily raising compliance costs and 
slowing time to market. We understand that TISI indicated that proof of paperwork factory inspection 
can only be used once. We encourage Thailand to reconsider as this duplicative and burdensome 
approach would require a new inspection and fee for each shipment without actually improving the 
safety or quality of the products. We further understand that the price of  a paperwork factory 
inspection is almost three times higher than the usual onsite factory inspection price. Can TISI please 
provide more explanation about this cost structure and explain the difference in scope and objectives 
between these two inspection processes?  
2.167.   We appreciate TISI's flexibility regarding the labelling requirement for small batteries. 
However, we request that TISI simplify the requirements for the TISI logo and QR code for use on 
small AV products. We also request that TISI remove the re quirement for the importer's name to be 
imprinted on the power cord. If this requirement is to be maintained, efforts should be made to 
minimize the logistical and cost impact of this requirement, such as simplifying the requirements for 
the importer's nam e to be listed on a paper tag rather than moulded or labelled on the power cord. 
The United States asks Thailand to continue to examine the regulation and consider less trade -
disruptive conformity assessment and labelling requirements to meet Thailand's ob jective of 
consumer protection.  
2.168.   In response, the representative of Thailand  provided the following statement. Thailand would 
like to thank the United States for comments to the Ministerial Regulation Prescribing Description, 
Production and Method of Displa ying of Standard Marks on the Industrial Products B.E.2563 (2020) 
and related matters. The Ministerial Regulation Prescribing Description, Production and Method of 
Displaying of Standard Marks on the Industrial Products B.E.2563 is necessary to be promulga ted to 
fulfil legitimate objective under the scope of the TBT Agreement, Article 2.2, the purpose of which 
is to prevent deceptive practices and consumer protection. The ministerial regulation stipulates that 
the electronic information shall be displayed c learly visible, prominently and indelibly on industrial 
products. In case where the electronic information cannot be displayed on the industrial products, 
the regulation is allowed to display on a package, a container, wrapper or binder in order to facilit ate 
the manufacturing process. The regulation has been enforced since 20 July 2021 after 180 days 
extension for manufacturers' preparation. After enforcement, Thailand has received many views 
from both manufacturers and consumers which reflect that the dis play of electronic information meet 
its purpose, to prevent deceptive practices and to protect consumers. However, in case the United 
States needs our clarification on the ministerial regulation and related matters, we would like to 
propose a constructive dialogue with the United States for our better understanding.  
2.1.3.16   India - Refrigerating Appliances (Quality Control) Order, 2020, 
G/TBT/N/IND/173  (ID 67152) 
2.169.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to appreciate India for responding  to comments related to the Refrigerating Appliances (Quality 
Control) Order, 2020 of India at the WTO TBT Committees in February and June 2021. However, 
Korea would like to make some additional comments regarding this Refrigerating Appliances QCO 
as follo ws. First, factory inspections by the BIS are not being conducted outside India at all, so the 
manufacturing factories located in other countries outside India are having difficulties with the 
 
51 For previous st atements follow the thread under ID 672 . 
52 For previous statements follow the thread under ID 671 . G/TBT/M/85  
 
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  factory inspection. Accordingly, Korea would like to request an  additional grace period, or a non -
face-to-face factory inspection plan for overseas factories that need BIS certification. Second, we 
have previously requested that the High Voltage Test Time specified in the Indian Standard IS 1476 
(Part1):2000 Clause 14 .8 and IS 15750:2006 Clause 19.8 be revised from two seconds to one 
second. At the June 2021 Committee meeting, we received a response from India that the industry 
would be able to adapt to the Indian standards because there is enough time between the noti fication 
date and the implementation date of the regulations. However, apart from the adaptation period, 
there are still difficulties in responding to the regulation because the High Voltage Test Time specified 
in IS 1476 (Part1):2000 Clause 14.8 and IS 15 750:2006 Clause 19.8 deviates from the relevant 
international standard (IEC 60335 -1). Therefore, we reiterate our request that India revises its 
standards to harmonize with the international standard. In addition, Korea also requests that India's 
Refrigera ting Appliances (Quality Control) Order, 2020 be implemented after the revision of Indian 
standards are completed and an appropriate transition period is provided.  
2.170.   In response, the representative of India provided the following statement. The standards 
are chosen after due stakeholder consultation, including industry associations. As per the note in 
QCO notified in the gazette, "the latest version of Indian Standards including the amendments issued 
thereof, as notified by the Bureau of Indian Standards from  time to time, shall apply from the date 
as notified by the Bureau". The QCO was notified on 10 December 2020 with an implementation 
date of 1 January 2022 thus providing sufficient time for the industry to prepare.  
2.1.3.17   European Union - Draft EU Batteries Regu lation (implementation of the 
European Green Deal), G/TBT/N/EU/775  (ID 68553) 
2.171.   The representative of the Russian Federation  provided the following statement. The Russian 
Federation reiterates its statement made during the previous meeting of the Committee on TBT. The 
Russian Federatio n expresses deep concern on the draft EU Regulation on batteries and waste 
batteries that is developed in order to implement the European Green Deal. It sets out product 
requirements for new batteries as a condition for access to the EU market as well as m aterial 
recovery targets for waste batteries. For new batteries the draft Regulation specifically sets 
requirements on the maximum level of carbon footprint over the life cycle of batteries and minimum 
level of recycled materials such as cobalt, lithium an d nickel. Apparently, the requirements for the 
minimum level of recycled materials in batteries is aimed to reduce use of primary metals in the EU 
for the purpose of battery manufacturing. It is no secret that the EU does not have sufficient 
capacities of primary non -ferrous metals in its territory in order to meet domestic demand. By 
introducing provision that discriminates imported primary materials vis -à-vis domestically 
remanufactured, the draft Regulation is aiming to substitute imported primary metals  for the like 
domestically recycled ones. This is protectionist aim which we reject as a legitimate one. Article 2.2 
of the Agreement on TBT requires Members to ensure that technical regulations are not developed, 
adopted and implemented in a manner more t rade restrictive than necessary to fulfill legitimate 
objectives. The article also requires that technical regulations do not create unnecessary obstacles 
to international trade. In this regard, we are wondering if the European Union considered less trade 
restrictive measures to stimulate recycling of nickel, lithium, cobalt, copper and lead rather than 
such administrative measure as minimum level of recycled materials in the battery. If yes, please 
name the measures that the EU has considered and reasons w hy these measures have not been 
employed or proposed for implementation.  
2.172.   Current draft Regulation provisions on recycling efficiencies and minimum requirement of 
recycled materials targets five metals – cobalt, copper, lead, lithium and nickel. We are wond ering 
what criteria have been used by the European Commission to choose these particular five metals. 
As far as requirement on maximum level of carbon footprint over the life cycle of batteries is 
concerned, there is no comprehensive methodology to calcula te this parameter. Moreover, the draft 
Regulation does not specify the ways for the stakeholders from outside the EU to submit their data 
and calculations made under internationally recognized protocols, which are likely to be different 
from the EU standar ds. As a result, the lack of methodological clarity as well as the unresolved 
recognition issue unfairly penalizes non -EU battery value chain economic operators and constitutes 
a technical barrier to trade. Finally, the Russian Federation is concerned with  many elements of the 
European Green Deal and implementing legal acts. One of the objectives of the Deal is import 
substitution which goes against the spirit of the WTO. Russia urges the EU to stick to the WTO law 
 
53 For previous statements follow the thread under ID 685 . G/TBT/M/85  
 
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  and develop all climate and ecological mea sures in cooperation with its trading partners and other 
Members of the organization.  
2.173.   The representative of China  provided the following statement. 1. In accordance with Article 
7 and Annex II, the carbon footprint of rechargeable industrial batteries and electric vehicle batteries 
with internal storage and capacity above 2 kWh is required. However, there is no unified international 
calculation criteria or basis for the carbon footprint of such products, therefore the equitable and 
scientific assessment is hard to carry out. Besides, as industrial batteries are widely used, and of 
various types, it is difficult to make a unified footprint calculation. Therefore, China thinks it is not 
the right time to carry out those works. 2. Regarding the recycled content  in active materials from 
batteries in Article 8, it is suggested to cancel the "Minimum share of recycled content" at the current 
stage, and to consider it after the methodology of the calculation and verification is set up. For 
industrial batteries, elec tric vehicle batteries and automobile batteries, the regulations set the 
minimum share of cobalt, lead, lithium or nickel recycled from waste present in active materials by 
2030 and 2035, but the methodology for the calculation and verification of the recy cled materials 
will not be set out until the end of 2025. In addition, companies in China also considered that the 
recycled proportion of cobalt is relatively high. 3. It is suggested that the EU cancels the disclosure 
of the technical documents containing  commercial secrets of enterprises on the premise that 
regulatory purpose has already been met. Article 7, article 8 and appendix 2, appendix 13 require 
to provide the technical information, but the technical information about the battery content, the 
material and processing process involves some core secrets, such as the content of cobalt, nickel, 
lithium contained in batteries, and data about carbon emissions of materials in the process of 
production, which increases the risk of disclosure.  
2.174.   4. China sugge sts that the EU re -evaluates these performance indexes before formulating 
scientific and reasonable product performance index requirements. 5. China suggests that when the 
EU conducts the supply chain due diligence investigation, consult with the relevant market regulatory 
authorities of other parties at first, and then carry out investigation only upon the agreement reached 
by both parties through consultation. 6. China thinks that it is not reasonable to set the date of entry 
into force as of 1 January 20 22, because the publication date of this regulation is uncertain and more 
time is also needed to complete the general legislative process in the EU. Besides, the new labelling 
requirements in the regulation involve changes in hardware equipment, and the re lated technical 
documentation also needs some time to be prepared, which imposes a great burden on 
manufactures, it is recommended that the EU provides a transitional period of at least 12 months or 
more for manufacturers with a view to ensuring business c ontinuity of the enterprise.  
2.175.   In response, the representative of the European Union  provided the following statement. 
The EU would like to recall that the Batteries Regulation proposal was presented on 10 December 
2020 and notified to the WTO on 26 January 2021 with a commenting period of 90 days. During the 
commenting period, the EU rec eived written comments from China, Japan and Canada to which the 
EU replied on 18 October 2021. Regarding some of the general issues raised by the delegations of 
China and Russia, the EU would like to remind that batteries are an important source of energy  and 
one of the key enablers for sustainable development, green mobility, clean energy and climate 
neutrality. In order for the EU's product policies to contribute to these objectives, it needs to be 
ensured that batteries marketed and sold in the EU are s ourced and manufactured in a sustainable 
manner. Thus, batteries are essential for the energy transition, helping to achieve climate neutrality. 
However, at the same time the raw material acquisition, pre -processing, manufacturing, distribution 
and recycli ng of batteries causes greenhouse gas emissions and to a certain extent offset those 
benefits of batteries. The EU carefully considered how to address this and the draft Regulation 
introduces progressive requirements to minimise the carbon footprint over t he life cycle of batteries. 
Accordingly, the EU opted for a step -wise approach of first detailing the calculation rules based on 
the Product Environmental Footprint (PEF) method, then requiring reporting, after that comparative 
labelling, and only at the l ast stage applying a maximum life cycle carbon footprint threshold. The 
EU has chosen the PEF method because, among the different existing life cycle assessment 
approaches, it is the one that the EU considers guarantees the highest level of reproducibility , 
comparability and verifiability of the results. Moreover, it has gone through a multi -year road testing 
phase (2013 -2018), involving about 300 companies of different sizes and located in different parts 
of the world.  
2.176.   The introduction of minimum levels of  recycled content of cobalt, lead, lithium and nickel in 
batteries is part of the EU's effort to foster the circular economy and have markets for secondary 
raw materials work efficiently. The EU has estimated the availability of such materials recovered G/TBT/M/85  
 
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  from waste by 2030 and 2035 on the basis of the best available evidence and information. The EU 
has included the possibility to adjust the targets in 2027 should trends in availability differ 
significantly from those estimates. Moreover, the EU would like to  reassure that there will be 
sufficient time to consider the feedback received on the notified draft prior to adoption. Implementing 
and delegated acts that will be developed under the notified draft will involve consultation of 
stakeholders, though the ex act way in which this will be done is to be determined in each case. 
Drafts of those implementing measures and delegated acts will be notified to the WTO in accordance 
with the TBT Agreement. The application dates for some of the provisions in the notified  draft are 
relatively soon. This is because significant developments in the battery sector are taking place in the 
near future. However, the EU would like to clarify that the indicated application dates are provisional, 
because it will depend on the time n eeded for the regulatory process to adopt the notified draft. In 
conclusion, the EU stresses that the notified draft seeks to fulfil multiple, interlinked objectives 
including the protection of the environment and human health and safety, all of which are legitimate 
policy objectives under Article 2.2 of the TBT Agreement. For the reasons specified above, the EU 
considers that the notified draft is not more trade restrictive than necessary to fulfil these legitimate 
policy objectives, taking into account th e risks that non -fulfilment would create. Regarding 
Article  2.1 of TBT Agreement, the EU does not consider that the notified measure gives rise to a risk 
of discrimination within the meaning of that provision. The notified draft therefore fully complies 
with the provisions of the TBT Agreement.  
2.1.3.18   EU - Phosmet, G/TBT/N/EU/790  (ID 70354) 
2.177.   The representative of Chile provided the following statement. Chile appreciates the 
opportunity to comment in this Committee on the EU's notification submitted to the WTO Committee 
on Technical Barriers t o Trade in document G/TBT/N/ EU/790 , which concerns the non -renewal of 
the approval of the pesticide active substance phosmet under Regulation (EU) No.  1107/2009 on 
the reduction or definitive elimination of the maximum residue levels (MRLs) for this substance in 
food, as well as on t he responses that the EU provided through the WTO TBT enquiry point following 
the meeting in June, during which this STC was raised. Gowan Chile, the agrochemical company 
applying for the import tolerance and the representative of phosmet in Chile through the Chilean 
Fruit Exporters Association, has reported that the EU's review process for MRLs will take 
approximately one year and that the MRLs are expected to be reduced to the limit of analytical 
determination (LOD) by the end of 2022. We have been inform ed that the MRLs for phosmet or the 
import tolerances may be maintained in the EU only if the toxicological parameters, the acceptable 
daily intake (ADI) and acute reference dose (ARfD) change. Gowan has toxicological data that were 
not reviewed by the Rap porteur Member State (RMS) and by the European Food Safety Authority 
(EFSA), with this data demonstrating that a higher value can be established for the ADI and the 
ARfD, which will allow for the dietary risk assessments for phosmet to be approved. Gowan h as 
already asked the Commission to order EFSA to evaluate all the available published toxicological 
data, as it did for other active substances in the EU, but the Commission has thus far refused to do 
so. Chile will continue to monitor how this STC may evo lve in the EU and would be grateful if our 
delegation could be kept informed through the TBT enquiry point.  
2.178.   The representative of Brazil  provided the following statement. Brazil would like to support 
the STC raised by Chile against the European Union regar ding the Draft Commission Implementing 
Regulation concerning the non -renewal of approval of the active substance phosmet, notified as 
G/TBT/N/EU/790 . Phosmet is registered in Brazil as an active substance for insecticides and 
acaricides used on citrus, apple and peach. It is recogniz ed as an important crop protection tool used 
by Brazilian citrus growers to treat citrus fruit borer, fruit flies and citrus psyllid pests. The non -
renewal of the approval of this active substance, coupled with the following reduction of its MRL, will 
have a significant impact on trade and will be particularly harmful towards the citrus industry in 
Brazil, where citrus is the main source of income to thousands of farmers living in the countryside. 
The European Union is the top destination of Brazilian citru s products with over US$1.13 billion of 
export value in the 2019 -2020 marketing year. Brazil would also like to kindly ask the EU to adopt 
new MLRs that are in line with the limits defined by Codex Alimentarius.  
2.179.   In response, the representative of the European Union  provided the following statement. On 
29 June 2021, the European Union answered the written comments submitted by Chile following the 
EU notification to the TBT Committee of the non -renewal of the approv al of phosmet. As explained 
in the EU written reply, following a comprehensive and transparent assessment of the information 
 
54 For previous stateme nts follow the thread under ID 703 . G/TBT/M/85  
 
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  submitted by the applicant carried out by the designated rapporteur member State and peer -
reviewed by all other member States and t he European Food Safety Authority (EFSA), serious risks 
and concerns in relation to human health and the environment have been identified. It is therefore 
considered that the applicant has not demonstrated that plant protection products containing 
phosmet can be used safely. We can inform you that the member States' vote on the Commission 
proposal not to renew the approval of phosmet will take place in the meeting of 1 -2 December 2021 
of the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). Th e EU notes that the 
non-renewal of the approval of phosmet does not lead to immediate disruptions in trade, as the 
measure itself does not amend the existing Maximum Residue Levels (MRLs). The non -renewal of 
the approval of phosmet will lead to the withdra wal of authorizations for plant protection products 
(PPPs) containing phosmet in EU member States and to the lowering of the current EU MRLs to the 
limit of quantification. The procedure for lowering MRLs will only start after the expiry of the grace 
periods for use of products containing phosmet (nine months after the date of the entry into force 
of the non -renewal act). Furthermore, as already explained in the TBT notification form, any action 
to reduce MRLs in the future will be subject to a separate not ification under the WTO/SPS procedure.  
2.180.   Whether MRLs currently established based on earlier import tolerance requests or based on 
Codex MRLs will remain unchanged, will depend on the outcome of the forthcoming MRLs review by 
EFSA, which will be launched in the beginning of 2022. In case the Chilean or Brazilian authorities 
consider it necessary to ensure that MRLs for phosmet on relevant crops remain or should be newly 
set at a level that is sufficient to facilitate trade, they may wish to submit an applicat ion for setting 
import tolerances according to Article 6 of Regulation (EC) No 396/200555 on maximum residue 
levels of pesticides in or on food and feed of plant and animal origin accompanied by the required 
data. If submitted early enough, the application  will be thoroughly assessed by EFSA at the same 
time as the MRLs review mentioned above and, if the data provided are complete and there is no 
risk for consumers, such an import tolerance can be established. In case they wish to do so, the 
Chilean and Bra zilian authorities are invited to contact Spain, the Rapporteur member State and to 
ensure that the necessary information will be available in due time for the evaluation by the 
Rapporteur member State and EFSA.  
2.1.3.19   European Union - Withdrawal of the approval  of the active substance alpha -
cypermethrin, G/TBT/N/EU/770  (ID 69456) 
2.181.   The representative of Brazil  provided the following statement. Brazil would like to express 
its concerns related to European notification G/TBT/N/EU/770  regarding the Commission 
Implementing Regulation proposal to withdraw the approval of th e active substance alpha -
cypermethrin. Alpha -cypermethrin is registered in Brazil as an insecticide used against harmful pests 
that damage a variety of crops, including soy, cotton, corn, citrus, watermelon, peanut, coffee, 
among other products exported to  the European Union. If the register of said substance is withdrawn 
and MRLs are automatically reduced, it would significantly affect the income of Brazilian farmers, 
especially citrus producers. The substance is essential to control greening, a disease af fecting citrus 
orchards worldwide. Greening has been recognized by EFSA itself as a priority pest for control, 
according to the Commission Delegated Regulation (EU) 2019/1702. The Brazilian citrus industry 
plays an important role in generating jobs in the countryside. Export of orange juices to the European 
market represented almost US$1 billion of exports in the 2019 -2020 marketing year. Alpha -
cypermethrin is also an important component to conduct integrated pest management, once it may 
be combined with ot her insecticides to contribute to increase their useful life, ensuring efficient pest 
control and maintaining the sustainability of crop production. In light of the above, Brazil would like 
to kindly encourage the EU to adopt MRLs for imported products in accordance with the limits set 
under the Codex Alimentarius.  
2.182.   The representative of Paraguay  provided the following statement. Paraguay thanks Brazil 
and shares the concern it raised related to the withdrawal of the approval of the active substance 
alpha -cypermethrin by the European Union. As explained in the previous statement57, this substance 
is used as a systemic insecticide to control pests that attack crops of great economic importance, 
 
55 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides  in or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC (OJ L 70, 16.03.2005, p. 1).  
56 For previous statements follow the thread under ID 694 . 
57 European Union - Non-renewal of the approval of the active substance mancozeb ( ID 627 ). 
 G/TBT/M/85  
 
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  such as maize, soybean, sunflower and cotton. In this regard, Para guay stresses the importance of 
having duly controlled and authorized substances that have met the scientific and technical 
requirements required for use and have proven both effective in controlling pests and vital for the 
rotation of active ingredients, thereby preventing insect resistance as part of the integrated 
management of pests. The withdrawal of this active substance by the European Union could 
significantly restrict the technological substances available for proper crop management, thus having 
a direct impact on the national economy. In this case, as in others, the lack of risk assessment 
continues to limit the use of plant protection products and reduce MRLs to trade -restrictive levels. 
Paraguay considers that the European Union's approach to lim iting the use of pesticides is more 
trade-restrictive than it needs to be for it to attain its legitimate objectives under the TBT Agreement, 
while at the same time retaining emergency authorizations for European Union members.  
2.183.   In response, the representat ive of the European Union  provided the following statement. As 
explained in the TBT Committee last June, the approval of Alpha -cypermethrin had to be withdrawn, 
as the Commission Implementing Regulation that renewed its approval in 2019 included the 
condit ion that the applicant had to submit confirmatory information as regards the toxicological 
profile of certain metabolites by 30 October 2020. In addition, confirmatory information had been 
required for three other points by other deadlines. However, in Oct ober 2020, the applicant informed 
the Commission that it would not submit any confirmatory data. Therefore, as the information 
required in accordance with Article 6(f) of Regulation (EC) No 1107/2009 on plant protection 
products was not submitted and the a pplicant had clearly stated that he will not fulfil his regulatory 
obligations, the approval for Alpha -cypermethrin had to be withdrawn according to Article 21(3) of 
Regulation (EC) No 1107/2009. Following the withdrawal decision, the EU will prepare a dra ft 
Regulation to lower the existing Maximum Residue Limits (MRLs) for Alpha -cypermethrin to the limit 
of quantification, and will notify it to the WTO/SPS Committee. The procedure for the lowering of the 
current EU MRLs will not commence before expiry of t he grace periods for use of products containing 
Alpha -cypermethrin.  
2.184.   Whether MRLs currently established based on earlier import tolerance requests or based on 
Codex MRLs will remain unchanged, will depend on the outcome of the forthcoming MRL review of 
the group of cypermethrins by the European Food Safety Authority (EFSA), which was launched in 
spring 2021. If Brazil or Paraguay consider it necessary to ensure that MRLs for Alpha -cypermethrin 
on relevant crops remain or should be newly set at higher/differe nt levels, they may wish to submit 
an application for setting import tolerances according to Article 6 of Regulation (EC) No 396/2005 
on maximum residue levels of pesticides in or on food and feed of plant and animal origin. The EU 
would like to invite Bra zil and Paraguay to contact the relevant authorities in Belgium, the Rapporteur 
member State, and to ensure that the necessary information will be available in due time for the 
evaluation by the Rapporteur member State and EFSA.  
2.1.3.20   European Union - Chemical s trategy for sustainability (implementation of the 
European Green Deal) (ID 69058) 
2.185.   The representative of the Russian Federation  provided the following statement. On 14 
October 2020, the European Union published Chemicals Strategy for Sustainability. The Str ategy is 
part of the European Green Deal. Implementation of Strategy can have significant worldwide trade 
distorting effect in a wide range of economic sectors. The Russian Federation would like to raise the 
following concerns in respect of this Strategy a nd its implications for foreign trade. The EU's 
legislation, specifically REACH/CLP, employs precautionary principle which implies strict classification 
decisions without available laboratory or epidemiological data. One recent example of this practice 
is cobalt classification under the 14th ATP to the EU CLP Regulation. The Strategy implies banning 
the use of the "most harmful chemicals", classified under this category in the CLP Regulation. This 
situation will entail restrictions and prohibitions of safe substances classified unjustifiably strictly 
using precautionary principle. The EU sticks to the position that once relevant scientific data is 
available the classification decision can be revised. However, such revision will have little practical 
implicat ions since manufacturers of prohibited products would stop production, revise technological 
processes or even go out of business.  
2.186.   In this context, we request that the EU answer the following questions: - Could the EU 
explain how described situation is supp osed to be mitigated? - Could the EU elaborate how such an 
approach complies with the provisions of the Agreement on TBT bearing in mind the requirements 
 
58 For previous statements follow the thread under ID 690 . G/TBT/M/85  
 
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  of scientific justification in Article 2.2 of this Agreement? - Will the EU ban substances only in cas e 
their use leads to actual risks? We urge the EU to comply with its WTO obligations under the TBT 
Agreement when developing the legal acts implementing this strategy.  
2.187.   In response, the representative of the European Union  provided the following statement. 
The European Union would like to recall that the EU Chemicals Strategy for Sustainability was 
adopted on 14 October 2020 and was not notified to the TBT Committee, as it is not a legislative 
proposal containing technical regulations or conformity assessmen t procedures. It does not either 
contain guidance for existing EU legislation. Nevertheless, the European Union provided extensive 
information to the Russian Federation and other Members during the last meeting of the TBT 
Committee in June 2021. In additio n, there has been ample opportunity for engagement with 
stakeholders and WTO Members during several public consultations. Moreover, the European Union 
would like to reiterate that any legislative proposal put forward in the context of the EU Chemicals 
Strategy for Sustainability, including the proposals for the revision of the CLP and REACH 
Regulations, will be notified in accordance with the TBT Agreement. Therefore, the European Union 
considers that the Specific Trade Concern raised by Russia is not appro priate to discuss in the TBT 
Committee, as it does not concern legislative acts containing technical regulations or conformity 
assessment procedures, or guidance for existing technical regulations and conformity assessment 
procedures, in the EU.  
2.1.3.21   Russian Fe deration - On Safety of Wheeled Vehicles (TR CU 018/2011), 
G/TBT/N/RUS/100  (ID 68759) 
2.188.   The representative of the Republic of Korea  provided the following statement. Korea respects 
the EAEU's efforts to protect consumer safety through the amendment of vehicle regulations. 
Furthermore , Korean companies are fully committed to complying with the regulations of EAEU. 
Regarding the EAEU's regulation of "TR CU 018/2011: On Safety of Wheeled Vehicles" notified to 
the WTO on 20 March 2020 as G/TBT/N/RUS/100 , Korea submitted comments three times; in 
December 2020, Febr uary 2021, and May 2021, via the EAEU TBT Enquiry Point. Also, we held two 
corporate seminars between Korea and EAEU in 2020 and 2021. Through this process, a number of 
difficulties for Korean companies were resolved, such as deleting requirements about Ti me Errors 
and providing information about PSAP (Public Safety Answering Points) requirements, and Korea 
fully appreciates the EAEU Commission for its kind efforts. However, the Korean industry still has 
some difficulties left regarding EAEU's vehicle regul ation so we would like to deliver their requests 
at this meeting.  
2.189.   Firstly, regarding Attachment No.2 Item 57a, on Maximum Speed Measurement, the UN ECE 
R-68 regulation has not been well adopted by countries other than Russia due to the requirement of 
techn ical development and financial burden imposed by the addition of actual test driving with each 
combination of engine and transmission. Considering the little effect compared to its technical and 
financial burdens, we request the EAEU to retract this requir ement. If not, we ask for an exemption 
on existing vehicles. Secondly, regarding Attachment No.2 Item 27, on Fuel Tank and Rear Side 
Collision, EAEU's current regulation of Part 1 Fuel Tank Stability applies the UN R -34.02 regulation, 
but EAEU's amendment will be applying the higher regulation, UN R -34.03. In this case, two more 
certificates will be required in addition to the existing Part 1 certificate, and the scope of application 
will be different from Russia's current regulations. Therefore, when apply ing the UN R -34.03 under 
the amendment, we request EAEU to clarify whether or not the application is limited to Part 1 as the 
current regulation. And if limited to Part 1, please specify that "application limited to Part 1 (or 4)" 
or "it is not compulsory in Part 2" as the EU does. Alternatively, for Part 2 -2 (on Rear Side Collision), 
we request to adopt UN R -153 (Rear Side Collision) and specify that "R -34.03 applies only to Part 
1". 
2.190.   In response, the representative of the Russian Federation  provided the fo llowing statement. 
With regards to the procedural aspect of Korean comments, we note that draft amendments No. 3 
to the technical regulation on safety of wheeled vehicles were notified by the Russian Federation to 
the WTO in March 2020 with commenting peri od of 60 days as per the provisions of the Agreement 
on TBT. All comments submitted within due time period were gathered and taken into account. 
Korean comments were received with long delay well outside commenting period. As far as content 
of the suggesti ons is concerned, we note that these suggestions are highly technical and many of 
 
59 For previous statements follow the thread under ID 687 . G/TBT/M/85  
 
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  them put forward in the Committee for the first time hence we will forward them to Moscow for 
consideration and appropriate action.  
2.1.3.22   Brazil - Draft Ordinance Act Nº. 374, 27 N ovember 2014 (Portaria SDA/MAPA 
374/2014) Establishes quality requirements for wine and derivatives of grape and wine, 
G/TBT/N/BRA/613,  G/TBT/N/BRA/613/Add.1,  G/TBT/N/BRA/61 3/Rev.1,  
G/TBT/N/BRA/675 , G/TBT/N/BRA/ 613/Add.2 , G/TBT/N/BRA/613/Add.3  (ID 47060) 
2.191.   The representative of the European Union  provided the following statement. The European 
Union would like to thank to Brazil for notifying the draft Technical Regulation on the identity and 
quality standards for wines and deriv atives of grape and wine and to appreciate the opportunity to 
submit written comments. In many past TBT Committees, the European Union had been raising 
concerns in relation to the Brazilian regulation on wine, which create unnecessary obstacles to 
internat ional trade. From the preliminary analysis of the notified draft, it seems that the ongoing 
revision would further enlarge the already long list of analytical parameters, many of them diverging 
from recommendations of the International Organisation of Vine  and Wine, and would not resolve 
the longstanding issue of the classification of sparkling wine according to sugar content. In this 
context, the European Union would like to encourage Brazil to seek international consensus within 
the OIV framework on issue s relevant to our bilateral trade, such as categories of sparkling wines 
related to sugar content, import documentary evidence and list of analytical parameters for imports. 
The European Union appreciates the efforts previously demonstrated by Brazil to fa cilitate the 
implementation of its wine regulations for importers. However, Brazil is invited to make use to the 
maximum extent possible of the recommendations of the OIV when revising the relevant technical 
regulations and to remove the current requiremen ts that are not in line with the OIV standards on 
identity and quality of wine and on maximum content limits. The European Union is prepared to 
work bilaterally with Brazil with regard to the ongoing revision and to note that detailed written 
comments on t he notified draft are currently under preparation.  
2.192.   The representative of the United States  provided the following statement. The United States 
thanks Brazil for notifying the revised draft ordinance that establishes the identity and quality 
standards for w ine and derivatives of grape and wine to the WTO. The United States looks forward 
to receiving a substantive reply to our bilateral comments. The United States is concerned about the 
analytical parameters for wine included in the draft ordinance and Techni cal Regulation No. 75. Of 
particular concern are the required analyses for potassium sulfate and methanol, which are 
unnecessary and cost prohibitive for exporters. Additionally, the United States seeks a justification 
from Brazil as to why it set a maximu m sulfite content for certain wines at a level lower than what 
has been adopted by Codex. With regards to Technical Regulation No. 75, the United States remains 
concerned about the duplicative testing requirements. We hope Brazil will consider our comments  
on the draft ordinance and reduce its analytical requirements to facilitate trade in wine.  
2.193.   The representative of Chile provided the following statement. The delegation of Chile is 
pleased to be able to comment on Brazil's notifications. Chile recognizes t he importance of 
safeguarding the legitimate objectives of safety and security in the area of human health in the wine 
trade, as well as of seeking to avoid creating unnecessary obstacles to trade. Our country has thus 
made progress in the recognition of o enological practices with the majority of producing and 
exporting countries, and has also simplified the certification requirements, in particular: With regard 
to reducing the number of laboratory analyses that are not related to health and safety aspects,  
there is an understanding that the wines meet the national standards that require extensive quality 
and safety parameters to be met beforehand in order for authorization to produce and export to be 
obtained. In Chile, we do this with respect to quality pa rameters such as dryness and a number of 
others, for which reason we suggest that Brazil's standards be adapted to international models, 
particularly in relation to sugar, so that the country may take this opportunity to modernize its 
regulations in these respects. Chile appreciates the opportunity to comment on these notifications 
submitted by Brazil to the TBT committee and looks forward to closely following the evolution in 
Brazil of the proposed regulations contained therein.  
2.194.   In response, the representa tive of Brazil  provided the following statement. MAPA Ordinance 
No. 346, published on 1 July 2021, opened public consultations regarding a draft regulation that 
establishes identity and quality standards, as well as complementary rules for labelling and 
production process of wine and grape -derived wines. In response to the requests of many 
 
60 For previous statements follow the thread under ID 470 . G/TBT/M/85  
 
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  stakeholders, Brazil decided to extend time for comments by establishing a new public consultation 
with the same draft regulation, which was later notified as G/TBT/N/BRA/613/Add.3  and is open 
until 7 December. We understand that the definition of quality parameters for wine has been a long -
standing concern raised by our trade partners in the TBT Committee. All of the requirements 
resulting from this regulatory process will be applicabl e to national and foreign producers alike, 
following transparency and non -discrimination obligations established by the TBT Agreement. Brazil 
is open to engage bilaterally with each and every Member so as to understand their specific concerns 
regarding thi s draft regulation and its alignment with relevant international standards.  
2.1.3.23   Indonesia - Halal Product Assurance Law No. 33 of 2014 and its implementing 
regulations, G/TBT/N/IDN/123,  G/TBT/N/IDN/131,  G/TBT/N/IDN/131/Add.1,  
G/TBT/N/IDN/134  (ID 50261) 
2.195.   The representative of the United States  provided the following statement. The United States 
appreciates the significant bilateral with Indonesia last evening and I will submit comments through 
a W document.62 
2.196.   The representative of the European Union  provided the following statement. The Europea n 
Union reiterates its serious concerns on the Indonesian Halal Product Guarantee Law No  33 of 
September 2014 and its implementing provisions, which require mandatory Halal certification and 
labelling for a very wide range of products to be placed on the I ndonesian market, resulting in 
significant obstacles to EU trade with Indonesia. The EU regrets that, contrary to Article  2.9 of the 
WTO TBT Agreement, Indonesia failed to notify to the TBT Committee the Halal Product Guarantee 
Law, and that it only notifi ed Regulation 57/2021 on Halal fees on 3 November 2021, after its 
adoption and entry into force on 3 June 2021. The EU encourages Indonesia to notify any relevant 
technical measures when still in draft form and to provide sufficient time for comments, in 
accordance to the WTO TBT Agreement. The EU kindly invites Indonesia to reply to its comments on 
several implementing provisions. Indonesia has not replied to EU comments of 12 May 2020 on 
Regulation 31/2018 on Processed Food Labelling (G/TBT/N/IDN/124), EU  comments of 20 April 2021 
on the draft Government Regulation (RPP) 39/2021 on Halal Product Assurance implementing the 
Omnibus Bill on Job Creation (G/TBT/N/IDN/131), and the recent EU comments of 31 August 2021 
on the draft Decree regarding types of prod ucts and consumer goods to be Halal -certified 
(G/TBT/N/IDN/134). As regards this last measure, the EU regrets that Indonesia published Decree 
No. 748 of 2021 on Types of Products Mandatory to be Halal Certified on 29 June 2021, before its 
notification to t he TBT Committee on 2 July 2021, and before the period of two months for comments 
had expired. The Decree will take effect as from 1 January 2022.  
2.197.   We EU stress the excessive restrictive impact on trade of the measures in question and we 
invite Indonesia to  consider less restrictive alternatives to mandatory Halal certification and labelling, 
in order to pursue the legitimate objective of ensuring reliable information without unduly hindering 
trade flows. The main issues of concern for the EU in the Halal La w and implementing measures are, 
among others, the "non -Halal" information requested for non -Halal products or the extension of 
Halal requirements to products other than food and beverages. Furthermore, in order to ensure the 
workability of the system for foreign operators, there is a need for more clarity and a pragmatic 
approach as regards the requirements for recognition by Indonesia of foreign Halal certificates. In 
particular, we consider that the pre -condition of a government -to-government mutual reco gnition 
arrangement for recognition by Indonesia of foreign Halal certification bodies represents an 
excessive burden for industry and economic operators and does not allow for smooth trade relations. 
The additional registration requirement for Halal certi fications of certain products by foreign bodies 
also appears to be unjustified, costly and duplicative. In addition, the EU is concerned about the 
possibility of imposing much higher Halal certification fees for goods and services from foreign 
business (15 0% more than the baseline fee for services), provided for in Article 8 of Indonesian 
Regulation 57/2021 on Halal fees. The EU stresses the importance of ensuring the continued 
possibility to place non -Halal products on the Indonesian market and urges Indon esia to review 
these measures with a view at adopting a more trade -friendly approach. Notably, the EU firmly calls 
upon Indonesia to: - limit Halal requirements to food and beverages; - avoid the excessively 
burdensome requirement for mandatory "non -Halal"  information as regards non -Halal products, and 
- provide flexibility for the recognition of foreign Halal certification bodies and the acceptance of 
 
61 For previous statements follow the thread under ID 502 . 
62 G/TBT/W/761 . G/TBT/M/85  
 
- 53 - 
 
  foreign certificates. The EU reiterates its willingness to further discuss and cooperate on Halal issues 
with Indonesia, with the aim of finding a practical way forward and solve trade concerns.  
2.198.   The representative of Australia  provided the following statement. Australia welcomes 
ongoing discussions on the Indonesian Halal Product Assurance Law no. 33 of 2014 (Halal Law) and 
continues to seek for the law to be implemented transparently and in close communication with 
businesses and trading partners. We encourage Indonesia to continue to facilitate an open dialogue 
with trading partners to allow foreign business es and their valued Indonesian importers to remain 
adequately informed of Halal Law implementation regulations. Australia is eager to ensure that our 
existing halal assurance processes will continue to be recognized when the grace period for Law 
33/2014 en ds in 2024 and welcomes Indonesia's clarification of this. Australia appreciated the 
opportunity to provide formal comments on Indonesia's latest Decree on Types of Products and 
Consumer Goods Products Mandatory to be Halal Certified, notified to the TBT C ommittee on 2 July 
2021 (G/TBT/N/IDN/134). Australia looks forward to Indonesia's response to our submission and 
welcomes clarification about the methodology for products and services included on the list. Australia 
thanks Indonesia for its response to Aus tralia's comments on notification G/TBT/N/IDN/131  on 
Government Regulation 39/2021 on The Organization of Halal Product Assurance. However, it is 
concerning that Regulation 39 entered into force before these comments were considered by 
Indonesia. Australia would like to emphasise t he importance of adherence to the rules -based WTO 
process for a productive and fair international trade environment. Australia welcomes advice from 
Indonesia on its approach to developing additional regulations to implement the Halal Law, and 
further dialo gue on the Halal Law to ensure its implementation is no more trade restrictive than 
necessary.  
2.199.   The representative of New Zealand  provided the following statement. New Zealand would 
like to thank Indonesia for its ongoing engagement to date regarding this m atter. We ask for some 
clarity on the status of Overseas Halal Certification Organisations whose certification will soon expire 
or has already expired with MUI, and whether there are any transitory arrangements in place for 
them to continue to certify befo re the conclusion of Mutual Recognition Arrangements or other 
agreements. We appreciate any further information from Indonesia as to whether there are any 
other regulations relating to Halal under development. We understand that the halal certification 
fees will need to be set in a Ministry of Finance regulation, and welcome any further clarification on 
this. With regard to the recently -released Ministry of Religious Affairs regulations 748/2021, can 
Indonesia please clarify the process by which items are a dded to the appendix listing the type of 
product that is obliged to be Halal certified? The regulation reads that the head of BPJPH is obliged 
to include a product on the list if a business actor has applied for Halal certification for a non -listed 
product . Will there be a grace period after products are added to the list that will allow other business 
actors enough time to apply for Halal certification? Can Indonesia clarify the mechanism by which 
the updated list will be notified publicly?  
2.200.   The representat ive of Canada  provided the following statement. While Canada supports 
Indonesia's objective of ensuring high -quality halal -certified goods for its citizens, Canada remains 
concerned that several provisions under the Halal Product Assurance Law regulations are more trade 
restrictive than necessary to achieve that objective. Clarification on many aspects of how the Halal 
Product Assurance will be implemented under the halal regulations has not been provided. For 
example, it will be important for exporters to obtain clarification around how foreign halal 
certification bodies will be recognized or accredited and technical elements such as what is 
considered "processing", which triggers the halal certification requirement. We encourage Indonesia 
to issue detailed  guidance as soon as possible to enable Canadian goods to be halal certified and 
subsequently exported to Indonesia. Canadian producers want to continue supplying high -quality 
halal certified and naturally halal products to the Indonesian market. Canada ur ges Indonesia to 
consider how its stated requirement for a Government -to-Government Memorandum of 
Understanding prior to recognizing foreign halal certification is inappropriate for countries, such as 
Canada, where there is no governmental mandate to overs ee halal certification. This requirement 
creates a clear commercial advantage for countries that do have government oversight. Therefore, 
Canada requests that Indonesia consider allowing reasonable alternatives to the MOU requirement. 
Canada is seeking to engage bilaterally with Indonesia, in particular with the Halal Product Assurance 
Organizing Agency (BPJPH), in order to clarify the MoU requirement and we look forward to a 
constructive discussion.  
2.201.   The representative of Chile provided the following statem ent. Chile supports the STC raised 
by the USA and the EU, since it is concerned about the slow progress in the process to recognize G/TBT/M/85  
 
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  Chilean certification entities at the Halal Products Certification Agency (BPJPH) and the effects that 
this has on trade in certified products from Chile to Indonesia.  
2.202.   In response, the representative of Indonesia  provided the following statement. Indonesia 
would like to refer to its statement on the previous TBT meeting in June. Indonesia is mindful of its 
transparency obligati ons as mandated in the TBT Agreement. Thus, Indonesia has notified the 
Government Regulation Number 39 of 2021 on Implementation of Halal Product Assurances through 
addendum notification G/TBT/N/IDN/131 , Types of Products Mandatory to be Halal Certified 
determined the types of prod ucts and consumer goods that must be halal certified through 
G/TBT/N/IDN/134 , and Tariff for Public Services provided by Halal Product Assurance Organizing 
Agency through G/TBT/N/IDN/138 . We once again would also like to reiterate that there are phases 
or stages to implement mandatory halal certification such as for food and beverage products will be 
effective on 17 Oc tober 2024; while for non -food and beverage products will be effective on 17 
October 2026. Furthermore, Indonesia provides a transitory provision to accommodate stakeholder 
and industry that obtained halal certification based on previous mechanisms, as fol lows: All forms 
of cooperation with foreign halal certification body and accreditation agencies in other countries that 
were carried out before this government regulation is made, remain in effect until the period of 
cooperation ends; Foreign Halal Certifi cate recognized by MUI before this Government Regulation is 
made, remains valid until the expiration of the validity period of the foreign Halal Certificate. 
Indonesia would like to reiterate its openness to international cooperation on Halal Assurance Sys tem 
based on the principle of mutual recognition and mutual acceptance in accordance with international 
regulations and practices.  
2.1.3.24   European Union - Regulation (EC) No 1272/2008 (CLP Regulation), 
G/TBT/N/EU/629,  G/TBT/N/EU/826  (ID 53963) 
2.203.   The representative of the Russian Federation  provided the following state ment. The Russian 
Federation reiterates its statements on cobalt classification as carcinogen 1 b for all routes of 
exposure made during the previous meetings of the Committee on TBT and the Council for Trade in 
Goods. First, the Russian Federation stresse s that the EU has failed to provide any scientific 
justification for classification of cobalt in such a strict manner. We note that there are no laboratory 
or epidemiological data to classify cobalt as a carcinogen for any route of exposure other than the 
inhalation one. Second, the laboratory study on cobalt carcinogenicity for oral route of exposure is 
being carried out in compliance with the REACH Regulation. This study is planned to be finished no 
later than 2026. However, as a result of stigmatization and/or further restrictions on cobalt use, 
cobalt and cobalt -containing products will suffer even in case the carcinogenicity is confirmed during 
further scientific studies as negative. In this regard, we urge the EU to take into account such 
implications and develop action plan to mitigate this situation. Finally, Russia appreciates the 
developments on the approval of gastric fluid bioelution protocol at the EU and the OECD levels. We 
are pleased to learn that discussions at the EU level are close to an en d. At the same time, we will 
be grateful if the EU inform the Committee how gastric bioelution will be incorporated into the EU 
legislation. Moreover, we would like to know whether the EU intends to notify the methodology in 
order to fulfill its transparen cy obligations under the Agreement on TBT.  
2.204.   The representative of Brazil  provided the following statement. In August, the European Union 
notified a draft regulation proposing changes to Part 3 of Annex VI of the Regulation (EC) No 
1272/2008 of the European Parliament and of the Council on Classification, Labelling and Packaging 
of Substances and Mixtures (CLP), which introduce a stricter classification of reproductive toxicity to 
2-ethylhexanoic acid (2 -EHA) from Repr. 2 to Repr. 1B. If adopted, the modifica tion would take 
effect in the first semester of 2022. The re -evaluation process was initiated in 2014, when ECHA 
requested new studies to be carried out, specifically an Extended One -Generation Reproductive 
Toxicity Study (EOGRTS). A Substance evaluation ( SeV) process was then carried on by Spain, which 
recommended maintaining the previous classification of reproductive toxicity (Repr.2, H361d). At 
the time, the only modification suggested was the introduction of an explanatory note, which clarified 
the fun damentals of the classification in question. The competent authorities then opened a public 
consultation for the submission of comments on the dossier resulting from the SeV and additional 
information by authorities of other member States and members of th e private sector. During this 
period, Germany and France submitted a reclassification proposal to Repr. 1B, based on analysis of 
analogy (also called "read -across") with the substance valproic acid. The use of read -across relies 
on the assumption that, due  to the presence of similar chemical aspects, the substances in question 
 
63 For previous statements follow the thread under ID 539 . G/TBT/M/85  
 
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  will have similar effects when exposed to the same tests, and thus, will reveal the same toxicity. 
According to our private sector, this does not seem to be the case. The reproductive  toxicity studies 
specific to 2 -EHA, which contradict the applicability of read -across with valproic acid, make up the 
best technical information to support the classification of reproductive toxicity, as they are a direct 
analysis of the substance, withou t relying on assumptions of similarity. Studies specific to 2 -EHA 
conclude that the most appropriate classification would be the Repr. 2, and the more restrictive 
classification adopted by the EU is not justified.  
2.205.   In addition to the higher costs associated  with the registration process of chemicals classified 
as 1B, it is estimated that the reclassification will have a negative impact on the preferences of 
importers of the substance, who will have the wrong indication of its actual level of risk. We believe  
that, if adopted, these regulatory changes would be more trade -restrictive than necessary to fulfill 
the EU legitimate objectives of health protection. In light of the above, could the EU explain why it 
chose to adopt the read -across methodology when ther e are reproductive toxicity studies specific to 
2-EHA that do not support the conclusion underlying draft regulation G/TBT/N/EU/826 ? Could the 
EU indicate whether it will consider not changing the classification of said substance? Does the EU 
consider postponing the adoption of the  new reproductive toxicity classification for 2 -EHA until the 
competent authorities can analyze the private sector's comments on the read -across studies and the 
GHS standards for 2 -EHA? 
2.206.   In response, the representative of the European Union  provided the fol lowing statement. 
With regard to the comments from Brazil, the EU would like to refer to its statement delivered under 
the STC no 264 concerning the 18th ATP. With regard to the comments from Russia, the EU recalls 
that the Commission Delegated Regulation amending the CLP Regulation was published in the Official 
Journal of the EU in the beginning of 2020 and the classification of cobalt became applicable as of 
1 October 2021. As described in previous statements, the classification of cobalt is based on the 
independent scientific opinion of ECHA's Risk Assessment Committee (RAC), which takes into 
account all scientific information available, including the information from the dossier submitted by 
an EU member State (The Netherlands) and from the public consul tation. In addition, all comments 
sent to the TBT Committee were duly taken into account by the European Commission and the 
member States in the decision -making process. Moreover, the Commission considered that the 
method used to determine the Specific Con centration Limit of 0.01% should be assessed in order to 
discuss if the method is relevant for inorganic compounds like cobalt. For this reason, the entry in 
Annex VI to CLP for cobalt is without such specific limit and the generic limit of 0.1% is therefo re 
applied.  
2.207.   The EU would like to reiterate that, in line with the UN GHS (UN Globally Harmonized System 
of Classification and Labelling of Chemicals), the classification of any substance is based on a hazard 
assessment and not on a risk assessment. Classif ication under the CLP Regulation is based only on 
the scientific assessment of the hazards derived from the intrinsic properties of a substance and not 
on its uses, while potential downstream legal or socio -economic considerations are not part of the 
principles for hazard classification. Nevertheless, the classification under the CLP Regulation does 
not in itself restrict the placing on the market of cobalt or cobalt -containing products. When a 
substance is subject to harmonized classification, only labelli ng and packaging obligations are 
triggered for that substance and any mixture containing it, but not for articles (e.g. cutlery or other 
stainless steel articles). As previously announced, on the use of the bioelution method, the EU has 
made progress in th e development of a harmonized approach at international level. The EU 
Reference Laboratory for alternatives to animal testing (EURL ECVAM) Scientific Advisory Committee 
(ESAC) has given a positive opinion on the scientific validity of a bioelution test met hod. On the 
basis of this positive opinion, the method was proposed by the European Commission in November 
2019 at OECD level for acceptance as a technical guideline. In May 2020 the OECD Working Group 
of the National Coordinators of the Test Guidelines Pr ogramme accepted the European Commission's 
proposal and an OECD subgroup has been set up to work on the technical guideline. This expert 
group met several times and made some good progress, but discussions are still ongoing. The 
European Commission would w elcome any support from third countries to actively participate in the 
development of the OECD test method on bioelution.  
 
64 European Union - Draft Commission Delegated Regulation amending, for the purposes of its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2 008 of the European Parliament and 
of the Council on classification, labelling and packaging of substances and mixtures  ID 705  G/TBT/M/85  
 
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  2.208.   Relevant industries are already using the results of the experimental bioelution test to 
classify their alloys in accordance with arti cle 12(b) of the CLP Regulation. No legal amendment of 
this article is required to use this method. The classification of alloys is not subject to harmonized 
classification but it is under the sole responsibility of the industry. Most probably, the compani es 
producing metal alloys and compounds containing cobalt traces are using such bioelution data for 
classifying their alloys. However, as previously announced, in order to further examine this approach 
and to ensure a proper use of the experimental data ob tained from the bioelution method, a 
European expert group has been created with the participation of experts of member States and 
metal industries. This expert group has met twice already and is expected to finalize its discussions 
in November. With regar d to the classification of cobalt as carcinogen for all routes of exposure, 
including the oral route, the EU would like to reiterate that the approach taken is in line with both 
the UN GHS and the CLP Regulation. In particular, the UN GHS stipulates the fo llowing in Table 
3.6.2: Label elements for carcinogenicity: "state route of exposure if it is conclusively proven that 
no other routes of exposure cause the hazard". In the case of cobalt, such evidence was not 
available, i.e. the scientific data available  were not sufficient to conclusively exclude that the oral 
route of exposure causes the hazard. A potential re -examination of the classification as regards 
routes of exposure can only be considered if new and relevant data from scientific studies, 
conclusi vely demonstrating the absence of carcinogenic effects from oral or dermal routes of 
exposure, become available. As previously stated, in view of the time needed for such test results 
to become available, there was no scientific and legal justification to exclude the oral route. In case 
new scientific information becomes available in the future, an amendment could only be envisaged 
following a revised Risk Assessment Committee (RAC) opinion.  
2.1.3.25   European Union - Transitional periods for MRLs and international c onsultations 
(ID 58065) 
2.209.   The representative of Costa Rica  provided the following statement. As in previous meetings, 
Costa Rica associates itself with the concern raised by the United States, Colombia and Guatemala, 
as well as with the request for extension  of the period for compliance with the new tolerances that 
are being established for various substances, in view of the serious impact that they have on the 
agricultural production of our countries. It is impossible for agricultural production in Costa Ric a to 
adjust to new requirements or tolerances within six months, when the registration of new molecules 
alone must undergo a complex assessment process lasting much longer than that period. This relates 
to the European Union's process to revise the toleran ces for different substances used in agricultural 
production. In the current historical context in which the international community finds itself owing 
to the COVID -19 crisis, the implementation of more restrictive measures or additional burdens on 
interna tional trade in agricultural products constitutes a challenge that is hampering worldwide 
economic recovery efforts, especially in developing countries. In this regard, we would like to remind 
the EU of the request made in documents G/SPS/GEN/1778  and G/TBT/GEN/296  - Request for the 
suspension of the processes an d entry into force of reductions of maximum residue levels (MRLs) 
for plant protection products in light of the COVID -19 pandemic.  
2.210.   The representative of the United States  provided the following statement. We continue to 
raise our concern about the European  Union's (EU) transitional measures for pesticide maximum 
residue levels (MRLs). We repeat our request that the EU extend transition periods to allow adequate 
time for US and third -country producers to modify their integrated pest management programmes 
and to allow trading partners to move their products through the channels of trade, including shelf 
stable products with years -long shelf lives. We recall longstanding concerns that trading partners do 
not know with certainty what the impact of the EU's activ e substance non -renewal decisions will be 
on future MRLs. We would have serious trade concerns if the subsequent deletion of MRLs and import 
tolerances is disproportionate to the level of risk to human health. In addition, we reiterate our 
concern about th e EU's consideration of import tolerance applications. The review of additional data 
is often only considered after the EU notifies its intent to issue a non -renewal notice. Trading partners 
have found themselves racing to move shipments through customs fa st enough to prevent rejections 
or turning back orders because a product that complies with an existing EU MRL standard at the 
time of production will face rejection at EU borders. EU growers do not face these tight timelines 
under the current regulatory p rovisions. Once again, the United States reiterates its request that 
the EU retain existing MRL levels while import tolerances are under consideration, complete full risk 
assessments prior to setting new MRLs, and extend its MRL transitional measures to ac count for 
realistic production and processing times for food and agricultural products. We also again request 
 
65 For previous statements follow the thread under ID 580 . G/TBT/M/85  
 
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  that imported products' MRLs be considered on the EU market at the time of production, the same 
as for European products.  
2.211.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regarding the international consultation processes adopted by the European Union (EU) and 
the transition periods granted prior to the entry into force of provisions under which the EU  no longer 
approves the marketing of certain plant protection substances and amends maximum residue limits 
(MRLs). These concerns are being reiterated because the EU has so far not responded to any of the 
requests concerning the granting of longer transiti on periods and has not taken into consideration 
the comments made during international consultation periods. The EU also failed to address the call 
made by a number of developing countries, including Colombia, for the temporary suspension, 
during the most crucial stages of the pandemic, of review processes for approvals for plant protection 
substances. These processes are ongoing, as is the definition of MRLs. Furthermore, we reiterate 
that there is no alternative that would help resolve the problems and un certainty arising from short 
transition periods. These create challenges for fruit - and vegetable -producing countries. This is 
particularly complex for products with long production and harvesting cycles as, while complying 
with European standards at the t ime of sowing, they may face regulatory changes that prevent 
exports at the time of the harvesting and distribution of the product. The same challenges, and those 
referred to by the United States delegation, arise for processed and frozen foods and those w ith long 
distribution chains.  
2.212.   Furthermore, Colombia maintains that notification to the WTO of non -renewal of regarding 
the MRLs to be applied should not be made by the EU as a simple formality. As provided for in 
Articles 2.9.2 and 2.9.4, the notification must be submitted within a time frame that allows the 
Members concerned to submit observations and comments for genuine consideration by whoever is 
developing the technical regulation. Within the framework of this Committee, it is not acceptable to 
Colombi a for the EU to state that, as soon as the European Food Safety Authority (EFSA) 
recommendation is known, countries should be able to "make the relevant adjustments", given that 
this information must first be notified to the WTO and the public consultation  period held. Nor is it 
acceptable for the EU to publish the final regulation in the days immediately after the end of the 
international consultation period, as this shows that the comments submitted have not been taken 
into account. We invite the EU to fo llow the recommendations for good regulatory practices, under 
which standards must be based on clear and objective information, and which promote open dialogue 
with stakeholders. Colombia once again welcomes the opportunity to express its concerns regardin g 
this issue and looks forward to a response from the EU.  
2.213.   The representative of Guatemala  provided the following statement. We reiterate our interest 
in this issue, and our concern regarding how these decisions are affecting agricultural exporting 
countrie s such as Guatemala, by failing to ensure legal certainty for exports. Decisions that have an 
impact on agricultural exports should be adjusted according to the production process time of each 
product. It is also important to highlight that each product ha s a different cultivation and 
post-harvest period, which is why the six -month period, and the uncertainty that it will create for 
pesticide MRLs, will affect productive processes. A temporary suspension was requested, but the 
response of the European Union  was negative, even though at that time there was the severe crisis 
caused by the outbreak of COVID -19, and yet the European Union continued with its processes. We 
would like to ask the European Union to consider our request.  
2.214.   The representative of Brazil  provided the following statement. Brazil supports the concerns 
raised under STC 580 and would like to refer to our previous statements on this agenda item. We 
respectfully bring to the attention of the EU its obligations under Article 2.12 of the TBT Agreem ent, 
which relate to the establishment of a reasonable interval between the publication of technical 
regulations and their entry into force, except in cases of urgent problems of safety, health, 
environmental protection or national security. It is of utmos t importance that the EU provides 
adequate transitional periods, especially for those cases in which the scientific opinions of the EFSA 
on the toxicity of substances are "inconclusive" or only indicate a "suspected risk". Transitional 
periods should also be compatible with the production processes, so as to allow producers – and 
especially small farmers – to adapt to the new regulations.  
2.215.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
position and support for this c oncern and refers to its previous statements in requesting that the EU 
grant an appropriate adaptation period, reflecting the realities of the production processes and the 
geographical locations, including the distances, of the EU's trading partners, as th e six-month period G/TBT/M/85  
 
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  is insufficient for adapting productive systems. Paraguay also stresses the importance of adopting a 
scientific approach based on the risk and not just on the hazard arising from the intrinsic properties 
of a chemical. The European Union 's approach to limiting the use of substances is more trade -
restrictive than it needs to be for it to attain its legitimate objectives under the TBT Agreement. 
Likewise, the reduction of MRLs, on the basis of the argument that it is impossible to determine  
whether the use of many substances is safe and the lack of conclusive scientific evidence, even in 
cases where Codex Alimentarius has identified certain substances as being safe, is not in line with 
Members' obligations under the SPS Agreement. We stress that the pursuance of such policies will 
cause significant trade damage to the economies of developing countries and jeopardize their ability 
to achieve the Sustainable Development Goals, including those related to food security. Like other 
similar concern s, we urge the EU to reassess its approach; base its decisions on conclusive scientific 
evidence and real risks weightings, in accordance with relevant international principles and 
standards; ensure import tolerances; and, where necessary, provide adequate  transitional periods.  
2.216.   The representative of Canada  provided the following statement. Canada would like to 
reiterate its concerns with the EU's approach to transition periods for maximum residue limits. In 
our view, the sudden deletion of MRLs and import t olerances seems disproportionate to the level of 
risk to human health and is more trade restrictive than necessary. The current transition periods 
make it very difficult for exporters to adapt to the new requirements given the distance travelled 
from the s ource. While Canada appreciates the EU's clarification during the recent WTO SPS 
Committee, it still does not acknowledge the reality of agricultural supply chains such as multi -year 
inventory and extensive shelf life, including in foreign countries. Canad a seeks confirmation that the 
EU will allow more reasonable transition periods for MRLs where the risks of dietary exposure are 
acceptable. Transition periods will allow trade to continue uninterrupted, while providing sufficient 
time for producers and exp orters to adapt to the new EU requirements. At a time when ensuring 
food security is paramount, Canada urges the EU to extend transition periods for MRLs to third 
countries, taking into account the need for exporters to adapt to new requirements, as it has  done 
so for its domestic producers.  
2.217.   The representative of Ecuador  provided the following statement.  Ecuador is extremely 
concerned about the "transition periods" granted by the EU for implementing its measures relating 
to the non -renewal of the use of substances and the reduction of tolerances. In order to establish 
reasonable transition periods, it is necessary to consider harvesting periods and the times when 
agrochemicals are applied. Farmers in all countries, and particularly in developing countries, need 
more time to adapt to MRL  requirements, as it takes 36 months on average to develop or register a 
new phytosanitary pest control product.  Ecuador is aware that the EU allows its farmers to request 
emergency authorizations so that, in certain special situations, they can use active substances that 
have already been banned in the European market. For Ecuador, it is important to know whether, 
where emergency authorizations are issued for the use of such substances, EU member countries 
have notified and justified the application of MRLs that differ from those established in the EU's 
existing MRL regulations. We would also like to know how the EU monitors whether the member 
State that has received an emergency authorization for the use of prohibited substances is complying 
with the existing MRL regulations and how it verifies, in the case of no n-compliance with the MRL 
regulations, that the products containing the prohibited substances have not been marketed in other 
EU member States.   
2.218.   The representative of Uruguay  provided the following statement. In view of harvesting 
periods, the stages at wh ich plant protection products are applied, and the time required to develop 
and register alternative substances, in practice, the transitional periods granted by the European 
Union in the provisions amending MRLs for active substances do not provide enough  time to make 
the necessary adjustments to production and ensure that agricultural products, especially processed 
or frozen products, comply with the new, lower MRLs. Like other Members, Uruguay does not 
consider six months to be a sufficient period in thi s regard. In our view, any changes should be 
gradual, and a reasonable period of time, of at least two years or two harvests, should be granted 
to raise awareness in the production sector and among technical advisers, and to ensure that 
effective substitut es for the active ingredients for whose MRLs a reduction is sought are available on 
the market. It is inappropriate to change the rules drastically in the middle of a harvest season, 
given the impact this may have on international and domestic marketing. M y delegation reiterates 
its call on Members to adopt regulatory decisions based on internationally accepted standards or to 
provide conclusive scientific evidence when it is strictly necessary to depart from these standards in 
order to meet their legitimat e objectives, as provided for in the relevant WTO Agreements. Even in 
cases where the European Union decides, based on a full risk assessment, that it is necessary to G/TBT/M/85  
 
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  reduce the MRLs for active substances used in the agricultural production of other Member s, we 
encourage it to take into consideration the need to grant transitional periods that are sufficiently 
long to make the relevant adjustments.  
2.219.   The representative of Chile provided the following statement. Chile echoes the STC raised 
by Costa Rica, the U nited States, Colombia and Guatemala in relation to the tolerances being set by 
the EU for different plant protection substances, which affect Chile's agricultural production and 
foreign trade in these products.  
2.220.   In response, the representative of the Europ ean Union  provided the following statement. 
The EU has provided detailed information on transitional periods for Maximum Residue Levels (MRLs) 
at previous TBT Committees, in particular at the TBT Committee meeting in May 2020. The EU 
considers concerns on the setting of Maximum Residue Levels (MRLs) for pesticides – and any details 
regarding their implementation – to be an issue for discussion at the SPS Committee, rather than at 
the TBT Committee. On the contrary, all measures concerning non -approval or re striction of active 
substances used in plant protection products in the EU are notified to the TBT Committee. These 
measures do not have direct consequences on SPS -related matters. However, in the interest of 
transparency and, further to requests by some M embers, when notifying these measures under the 
WTO/TBT notification system, the EU additionally informs the SPS Committee of the submission of 
those notifications. In practice, both Committees are informed about draft acts on the non -approval 
or restricti on of approval of an active substance. However, comments should only submitted via the 
TBT notification system. The European Union would like to point out in this context that the 
commenting deadlines are always respected and that the comments received wit hin those deadlines 
are duly taken into account in the EU's decision -making process. In the interest of efficient 
proceedings in both Committees and, in line with the respective Agreements, matters on approvals 
of active substances should be discussed excl usively in the TBT Committee, while matters on the 
setting of MRLs for pesticides should be discussed exclusively in the SPS Committee. As regards the 
joint Request for the suspension of the processes and entry into force of reduction of Maximum 
Residue Le vels (MRLs) of plant protection products in light of the COVID -19 pandemic in documents 
G/SPS/GEN/1778  and G/TBT/GEN/296  and subsequent revisions, the EU position is included in the 
document of 28 May 2021 with double reference G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315 , 
circulated in both Committees.  
2.1.3.26   China - Cosmetics Supervision and Administration Regulation a nd Regulation for 
Notification of Non -special Cosmetics, G/TBT/N/CHN/1310,  G/TBT/N/CHN/1311,  
G/TBT/N/CHN/1331,  G/TBT/N/CHN/1453,  G/TBT/N/CHN/1454,  G/TBT/N/CHN/1459,  
G/TBT/N/CHN/1460,  G/TBT/N/CHN/1515,  G/TBT/N/CHN/1524,  G/TBT/N/CHN/1525,  
G/TBT/N/CHN/1526,  G/TB T/N/CHN/1527,  G/TBT/N/ CHN/1539,  G/TBT/N/CHN/16 15, 
G/TBT/N/CHN/1626  (ID 57666) 
2.221.   The representative of the United States  provided the following statement. The United States 
reiterates our concerns with the Cosmetics Supervision and Administration Regulation (CSAR) 
implementing measures. CSAR's final implementing measures, as pu blished, will pose significant 
risks to companies' intellectual property; are not proportionate to cosmetics' low risk compared to 
medical products; and the United States has serious concerns whether it accords unequal treatment 
to imports. Both the draft measures and those published as final appear to continue to require 
extensive disclosures of trade secrets and confidential business information (CBI) that may not be 
limited to what is necessary to assess conformity and fulfill CSAR's regulatory objective s. The United 
States and other WTO Members asked that China consider how CSAR could be made more similar 
with the approaches taken by regulators in other major cosmetics markets, in which cosmetics 
companies maintain responsibility for their products makin g documentation available to regulators 
as needed, upon request. This allows companies to safeguard their information. We urge NMPA to 
address these concerns. Regarding the current draft measures, we have the following concerns and 
questions. We ask that C hina clarify the approval procedures for new toothpaste ingredients in the 
draft Standards of Information File for Toothpaste (G/TBT/N/CHN/1539). Will companies be allowed 
to use the same procedures provided in CSAR for cosmetics ingredients?  
2.222.   We acknowledg e China notified an updated draft of the Good Manufacturing Practices for 
Cosmetics (GMP) to the WTO (G/TBT/N/CHN/1626) for comment in September, given the 
substantive updates. We ask China to confirm that for the purposes of overseas inspections, foreign 
 
66 For previous statements follow the thread under ID 576 . G/TBT/M/85  
 
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  manufacturers will be considered in conformity with the Chinese GMP standard if, as provided in 
Article 17 of the Provisions for the Management of Cosmetics Registration and Notification Dossiers 
(a draft of which was notified as G/TBT/N/CHN/1524 ), they are in conformity with t heir national or 
international GMP standards. We also acknowledge China's July WTO notification 
(G/TBT/N/CHN/1615) of the draft Provisions for the Supervision and Administration of Children 
Cosmetics; we submitted comments on 20 September 2021 and look for ward to China's response in 
addition to the clarifications in provided to US industry input. In addition to the above concerns on 
the draft measures, despite extensive engagement from the United States, US industry, and other 
stakeholders, significant conc erns remain over CSAR's recently finalized implementing measures. 
We acknowledge China's statement at the June TBT meeting, clarifying that NMPA will only require 
a summary of the efficacy claim in the product abstracts published on NMPA's website. Can Chi na 
confirm that the filer/registrant will write the summary, and if the filer/registrant or NMPA will upload 
the summary to the public website? We are disappointed that the finalized Standards for Cosmetics 
Efficacy Claim Evaluation, which was notified in draft form as G/TBT/N/CH N/1526 , may require 
testing that appear to be more burdensome, if duplicative, than what is available from the use and 
testing of the product in other markets.  
2.223.   We urge China to recognize test reports from foreign labs that do not have Chinese 
Metrological Accreditation, if the labs follow Good Laboratory Practices or Good Clinical Practices, 
per the ICH Guidelines, and are in conformity with China's requirements. Will China consider 
alternative means of validating these claims, not included in the Claims Gu idelines, if the means are 
in conformity with China's requirements? We are hearing renewed concerns from US companies that 
NMPA has not instituted adequate procedures to prevent CBI and trade secret disclosures. For 
example, NMPA has not clarified what inf ormation from ingredient filings will be available publicly or 
to companies submitting product filings. We again ask if China intends to develop an explicit 
mechanism for companies to indicate to NMPA when information submitted to comply with CSAR, its 
regulations, measures, specifications and standards, should be marked as trade secrets or CBI. We 
ask that this mechanism provide a means by which protections from unauthorized disclosures can 
be monitored and legally enforced within China and abroad. We rema in disappointed that China has 
not taken into account the concerns raised by several members of the WTO TBT Committee that the 
Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers (draft 
of which was notified as G/TBT/N/CHN/1525 ) may have the effect of requiring importers to animal 
test their products if they cannot provide a regulator -issued Good Manufacturing Practices (GMP) 
certificate. The United States has explained that the US Food and Drug Administration does not issue 
these GMP cert ificates. We therefore again ask that China consider less burdensome means to 
establish conformity with GMP. For example, in the United States, trade associations and other third 
parties can issue certifications in line with the international GMP standard ISO 22716, which the US 
FDA and regulators in other major cosmetics markets reference.  
2.224.   To date, China's WTO TBT Committee delegation and NMPA have not responded to US 
Government or US industry enquiries for additional clarification on China's rationale for  using animal 
testing to establish conformity with GMP or provided an update as to which WTO Member and US 
state certificates will be accepted across China's provinces. On China's Administrative Measures on 
Cosmetic Labelling (G/TBT/N/CHN/1515), while we a ppreciate China's 3 June communication to US 
industry, the concern remains that China's requirement for "consistency" in foreign and Chinese 
labelling is overly burdensome, as it could require China -unique packaging. We ask China to clarify 
that the foreig n language labelling for product safety and claims is not required to match the Chinese 
label exactly, so long as the Chinese and the foreign labelling do not conflict. We are also concerned 
that China did not notify for comment in China or to the WTO all of the transition periods for 
cosmetics already registered to comply with the new requirements in the CSAR implementing 
measures. China's failure to notify has prevented companies from submitting comments as to the 
feasibility of the timelines. For example , it may not be feasible for companies to update some special 
cosmetics safety assessments in less than a year,  particularly if all required testing must be 
completed in China, with no allowances for cross referencing of testing from other markets. We ask 
that China notify these deadlines for public comment and, given the magnitude of the changes, allow 
manufacturers at least two to three years to update the registrations and sell through existing 
inventory for products already on the market. The United Sta tes appreciates China's most recent 
notifications of CSAR implementing measures and the opportunity to provide comment; however, 
we remain deeply concerned that several serious issues, such as protections for rights holders and 
the potential for disparate treatment between importers and domestic manufacturers, which have 
been raised by several WTO Members, remain unaddressed.  G/TBT/M/85  
 
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  2.225.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea thanks China for providing a resp onse to Korea's comments concerning the specifications 
and regulations under this STC. However, the reply from China did not give direct answers to Korea's 
enquiry but only gave a general explanation on the implementation of the measures. As Korea's 
concer ns were not duly addressed in the finalized specifications and regulations, Korea unfortunately 
would like to raise this STC once again. First, the exporters to China are required to specify the 
sources and quality data of all ingredients in their applicat ions, which is demanding more information 
than what is required in other countries. Such information may contain trade secrets that are critical 
to businesses, and this requirement is more rigorous than necessary to fulfill the objectives of 
ensuring produ ct safety and complying with China's domestic market norms. Korea therefore would 
like to request China to provide an evidence -based explanation for this requirement. Furthermore, 
according to Appendix 12 -14, businesses are required to disclose information  on ingredient safety, 
which leads to a concern that businesses' commercially sensitive information and intellectual 
property may not be protected. Second, the regulations stipulate that test results required for 
cosmetic product registration must be issue d by testing laboratories that have obtained the China 
Metrology Accreditation (CMA). At present, however, only the laboratories in China are known to 
have obtained the CMA. Korea thus requests China to offer flexibility to foreign laboratories in 
granting  the CMA and to recognize test results issued by foreign laboratories or internationally 
recognized laboratories that comply with international standards such as Good Clinical Practice or 
Good Laboratory Practice.  
2.226.   Third, pursuant to Article 13 of the New C osmetic Ingredients Authorization and Registration 
Regulation, in case of using alternative test methods, exporting companies are required to provide 
equivalence evidence which proves that their test results are equivalent to the results of in vivo  
toxicit y testing method, or animal testing. Korea would like to request that OECD -approved and 
internationally recognized alternative test methods also be recognized without having to provide 
equivalence evidence. Fourth, regarding "the Administrative Measures on  Cosmetic Labelling," Korea 
requests China to ensure that labelling requirements comply with internationally recognized 
practices so as not to be more trade restrictive than necessary. Specifically, with respect to the 
requirement of ingredient declaration  in cosmetic labelling, Korea requests China to maintain its 
current regulation. In most countries, cosmetic ingredients are subject to declaration when the 
substances are at a 1% or higher concentration. According to China's proposed regulation, however, 
declaration of ingredients is required for the substances at a 0.1% or higher concentration, and the 
substances at a concentration lower than 0.1% are to be declared as "other ingredients in small 
amounts". This requirement goes against harmonized internat ional standards. Fifth, under the 
regulations for Cosmetic Efficacy Claim Evaluation, China requires disclosing summarized scientific 
evidence that supports cosmetic efficacy claims on NMPA -designated websites. However, the 
information subject to disclosur e may contain a number of trade secrets or undisclosed business 
information that are critical to the Korean industry. Korea therefore requests China to remove the 
provisions requiring the disclosure of such information. Considering the aforementioned conce rns, 
Korea requests China to take into account Article 2.2 of the TBT Agreement, according to which 
Members shall ensure that technical regulations are not prepared, adopted or applied with a view to 
or with the effect of creating unnecessary obstacles to international trade.  
2.227.   The representative of Japan  provided the following statement. With respect to "Cosmetics 
Supervision and Administration Regulation" and its implementing regulations, Japan continues to 
express the following concerns. 1. "Management Rul es for Testing required for Cosmetic Product 
Registration and Notification", which was promulgated on 12 September 2019, stipulates that 
microbiological, physical, chemical, toxicological, and human safety and efficacy evaluation tests 
relevant to cosmetic s registration and filing shall be conducted by the testing laboratories in China 
that obtained China Inspection Body and Laboratory Mandatory Approval (CMA). Japan appreciates 
China taking Japan's repeated request to a certain level of consideration regar ding "Specifications 
for Registration and Filing of New Cosmetic Ingredients", which was promulgated on 4 March 2021, 
and stipulates that physical, chemical and microbiological testing reports relevant to new cosmetic 
ingredients registration and filing ma y be issued by the registrants or filers themselves or by 
entrusting a testing institution with corresponding testing capabilities. Japan would like to request, 
relevant to cosmetics registration and filing, a more flexible framework in which test results obtained 
by foreign laboratories with the equivalent qualifications and abilities as those of Chinese testing 
laboratories are accepted. In addition, regarding test methods, the implementing regulations of the 
"Cosmetics Supervision and Administration Regu lation" stipulate that test methods including test 
items other than those stated above, can be conducted in accordance with China's national standard 
or relevant regulations, and that various restrictions and conditions are imposed in the case of G/TBT/M/85  
 
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  conductin g a test method which is not specified  in the regulations. Japan would like to request that 
China accept internationally accepted methods such as alternative test methods established by the 
OECD, or the ISO.  
2.228.   2. The sales certification that proves the produ cts have been sold on the market in the 
country of production is only imposed on imported cosmetics. Japan requests that China treat 
imported products no less favourably than products produced in China. In addition, regarding 
"Administrative Measures on Co smetic Labelling", which was promulgated on 3 June 2021, Japan 
would like to express its following four concerns. 3. Article 5 stipulates that the content of the added 
Chinese labels, such as information regarding product safety and efficacy, shall be cons istent with 
the original labels. However, the original labels are designed to comply with regulations in the 
country of production and it is natural that their contents do not always comply with China's 
regulations. Therefore, Japan would like to request t hat China assure that such requirement does 
not apply to labelling contents required by regulations in the country of production, and that the 
requirement will not be more trade restrictive than necessary to fulfil legitimate objectives. 
4. Regarding Artic le 6, Japan has concerns that multiple company names and addresses on the label 
may cause misunderstandings on the part of the consumer rather than achieving the aims of this 
article to inform consumers of the persons responsible for product quality and ef ficacy. In order to 
avoid confusion among consumers, Japan would like to ask China that the label indicates a single 
responsible person ("cosmetics registrants or filers" or in the case of imported products, "responsible 
person in China"), and Japan consid ers that the label requirements regarding producers are not 
necessary.  
2.229.   5. With respect to the rules for labelling of all ingredients in cosmetics, there is an 
internationally recognized listing practice that ingredients with a compounding amount of 1% or l ess 
are allowed to be listed in no particular order. However, Article 12 stipulates that only ingredients 
with a compounding amount of 0.1% or less are allowed to be listed in no particular order. It also 
stipulates that ingredients with a compounding amou nt between more than 0.1% and 1% are to be 
listed in descending order. Japan would like to request that China assure that the rules for labelling 
follow the internationally recognized practice so as not to be more trade restrictive than necessary. 
Moreover , the "Provisions for Cosmetics Registration" stipulates that overseas inspections are to be 
conducted in accordance with relevant regulations of overseas inspections. Regarding "Interim 
Measures on the Administration of Overseas Inspections of Cosmetics",  Japan would like to continue 
to express concerns on the following three points. 6. Japan would like to request that China clarify 
which laws and regulations are used to determine conformity and specific purposes for conducting 
overseas inspections. Japan also asks that China ensure that inspections will not be more trade 
restrictive than necessary, ensuring that the legitimate objectives under the TBT Agreement are 
fulfilled. 7. The subject of the inspection including the product research and development s tage is 
broader than necessary, and it causes unnecessary burdens for companies. The main purpose of the 
inspection seems to ensure product safety but information related to research and development is 
not necessarily essential for product safety assurance . It is the most confidential of corporate 
information. Therefore, R&D departments of companies should be excluded from the subject of 
overseas inspections. Furthermore, inspections for domestic Chinese companies are only conducted 
on production sites. Jap an would like to request that China stipulates equal treatment for both 
domestic and overseas companies.  
2.230.   8. Japan requests that China ensures that confidential information will not be disclosed to 
persons other than those who are necessary for the legitima te purpose of the inspection, since 
production sites also contain a large amount of confidential corporate information. Furthermore, 
Japan has the following concerns on other implementing regulations. 9. In "Specifications for 
Registration and Filing of Ne w Cosmetic Ingredients", there are specific requirements for nano 
ingredients and Annex 5 stipulates the definition of such ingredients. Article  29 of "Specifications for 
Cosmetics Registration and Filing" stipulates the rule for naming of nano ingredients  in product 
formulas for registration or filing and also article 27 of "Standards of Information File for Toothpaste 
Notification (Draft for Comments)" stipulates the rule for naming of nano ingredients in the product 
formulation table. Japan considers tha t a more detailed and concrete standard is necessary to judge 
which ingredients fall under the definition of nano ingredients. In addition, Japan would like to 
request that the standard will be formulated in a way that reflects international trends and com ments 
from all stakeholders.  10. Regarding article 33 (II) (Exemption from submitting toxicological testing 
documents) of "Specifications for Cosmetics Registration and Filing", since the legal system and 
enforcement system for cosmetics differ by country or region, some countries may not have the 
relevant authority. Therefore, Japan would like China to accept a certification document on the G/TBT/M/85  
 
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  quality management system or good manufacturing practice qualification which is issued by an 
authorized international  organization or an industry association which is authorized to issue the 
certifications by government agencies  of the country or region where the registering or filing 
company is located, instead of a national institution . 
2.231.   11. Regarding the test of freckle -removing/whitening products, Japan would like to request 
that China adopt the approach of Read -Across that was stipulated in Article 16 (freckle -
removing/whitening effect cross -reference) of "Specifications for Cosmetic Effica cy Claim Evaluation 
(Draft for Comments)" last September. Freckle -removing/whitening is effected by active ingredients 
included in the cosmetics and the Read -Across approach will help shorten the process from 
application to permission. 12. Japan would like  to request clarification so that filers of toothpaste 
products can use new toothpaste ingredients only when registrants/filers of new ingredients have 
confirmed their use in advance during the three -year safety monitoring period after their 
registration/f iling of new ingredients, in the same manner as article 29 of "Specifications for 
Cosmetics Registration and Filing", which stipulates the handling of new cosmetic ingredients. 
13. Article  32 of "Standards of Information File for Toothpaste Notification (D raft for Comments)" 
stipulates that the abstract of an efficacy evaluation report shall be submitted during the filing 
process. The "Cosmetics Supervision and Administration Regulation" stipulates that "cosmetics 
registrants or filers" are the persons resp onsible for efficacy of cosmetic products, however, its 
implementing regulations do not require submission of the abstract of an efficacy evaluation report. 
Japan would like to know the reason for the requirement of submitting the abstract of an efficacy 
evaluation for toothpaste. 14. Article 36 of "Specifications for Cosmetics Registration and Filing" 
newly requires that their registrants or filers retain samples of each batch of cosmetics produced for 
future inspection. It also stipulates that the number of retained samples shall be able to meet the 
requirements for conducting registration and filing tests. Retaining such samples from all lots 
requires prohibitive amounts of space and imposes substantial burdens. Japan would like to request 
that China stip ulate detailed rules allowing for flexible operation, such as setting the storage period 
up to each sample's expiration date since overdue samples from their expiration dat a are not suitable 
for use as samples.  
2.232.   15. "Administrative Measures on Cosmetic Labe lling" stipulates that products that will be 
applied for registration or filing since 1 May 2022 must be adapted to the regulations. It also 
stipulates that products that have been applied for registration or filing before 1 May 2022, must be 
adapted to th e regulations by 1 May 2023. Registrants or filers need detailed rules and guidelines 
to adapt to the new cosmetic labelling system. Japan would like to request that China provide an 
adequate grace period of at least one year after promulgation of all rele vant regulations. 
16. Article  29 of "Specifications for Cosmetics Registration and Filing" requires "Cosmetic Ingredients 
Safety Information" issued by a cosmetic ingredient manufacturer and registrants or filers must 
combine information of the raw materia ls used in cosmetics with "Cosmetic Ingredients Safety 
Information". Therefore, when registrants or filers change a cosmetic ingredient manufacturer, it is 
necessary to submit the document again even if the comparability of quality and safety are confirmed  
by registrants or filers. This causes unnecessary burdens for registrants or filers. Therefore, the 
same as in international practice, Japan considers that the information of ingredients should be 
submitted when requested by the NMPA after launch, but not  at the time of registration or filing. 
"Cosmetics Supervision and Administration Regulation" and "Provisions for Cosmetics Registration" 
require relevant information on registration and notification management of cosmetics and new 
cosmetic ingredients is announced to the public. Japan would like to request that China not announce 
"Cosmetic Ingredients Safety Information" of the raw materials used in cosmetics to the public 
because purchasing information of cosmetic ingredients is confidential corporate inf ormation. 
Implementing schedule of "Cosmetic Ingredients Safety Information" was provided in the related 
notice. It stipulates submitting the cosmetic ingredients safety information for preservatives, 
sunscreens, colorants, hair dyes and the skin whitening  active ingredients contained in products 
applied for registration and filing since 1 January 2022, and cosmetic ingredients safety information 
is submitted through the online system. However, the system is not open and release date is 
undecided to date . In regards to submitting cosmetic ingredients safety information, Japan would 
like to request that China provide an adequate grace period.  
2.233.   The representative of Australia  provided the following statement. Australia respects the right 
of Members to implement  technical measures for legitimate policy purposes and in accordance with 
obligations under the TBT Agreement. As we have said in previous TBT Committee statements, 
Australia is concerned that measures under China's Cosmetics Supervision and Administration  
Regulation (CSAR) and its various implementing regulations, which entered into force on 1 May G/TBT/M/85  
 
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  2021, are more stringent than necessary to ensure the safety and quality of imported cosmetics. 
Australia notes that China has submitted a new notification (G/TB T/N/CHN/1626) on Good 
Manufacturing Practice (GMP) for cosmetics which relates to China's GMP requirement under the 
CSAR. Australia is reviewing this notification and will provide China with written comments in due 
course. Australia firstly would like more  information from China on its reasons for requiring GMP 
certification, particularly as an alternative for animal testing to ensure safety. Our key interests are 
in ensuring that Australian cosmetics exporters have clarity and certainty on the requirements  that 
they need to comply with and that those requirements do not unnecessarily impact on trade. We 
would also request the reason why China has maintained its requirement for mandatory animal 
testing of cosmetics products to be used on children (as notifie d on 23 July 2021 in 
G/TBT/N/CHN/1615 ), regardless of the level of risk presented by individual products? Australia is a 
consistent supplier of high quality and safe cosmetics products domestically, and to the world. As 
we have said before, the Australian Government stands read y to work with China and discuss the 
CSAR, including subordinate regulations such as those for GMP and for children's cosmetics. We 
would welcome the opportunity to exchange information and promote a better understanding of our 
respective regulatory system s for cosmetics.  
2.234.   The representative of New Zealand  provided the following statement. New Zealand welcomes 
China's endeavours to modernize its regulatory system for cosmetics and appreciates the 
opportunity to comment on specific elements of China's Regulat ions. While we welcome the intention 
to improve safety and quality assurance, New Zealand would like to encourage China to ensure that 
facilitation of trade is considered in the implementation of the regulations. New Zealand notes that 
under the measures, non-animal tested cosmetics are able to enter China's market only if a 
regulator -issued GMP certification is provided. Yet non -special use cosmetics are considered to be 
low-risk products in many countries, including New Zealand, and for this reason are no t subject to 
regulator -issued GMP certification. We warmly welcome the introduction of alternatives to 
mandatory animal testing for imported cosmetics. Yet New Zealand, like others, is disappointed that 
the measures do not provide for non -regulator issued GMP certification or other trade facilitative 
mechanisms for providing product assurances, meaning that significant and unnecessary barriers to 
trade for imported cosmetics products still apply for Members who cannot offer regulator -issued GMP 
certificatio n. In this regard, we encourage China to engage directly with affected Members, including 
New Zealand, to identify a trade -facilitative mechanism to demonstrate GMP conformity, without 
imposing animal -testing requirements. Specifically, and following China 's response to New Zealand's 
question submitted during its recent WTO Trade Policy Review, New Zealand seeks clarification 
whether the requirement for a regulator -issued GMP certificate as an alternative to animal testing 
requirements can be exempted on th e basis that: the product fully complies with the relevant 
ISO22716 standard or higher, confirming the safety of the product; or a product safety risk 
assessment result is provided from a laboratory accredited by a National Accreditation Body that 
confirms  the safety of the product.  
2.235.   Additionally, New Zealand requests that China also provide flexibility in respect of product 
testing requirements. In particular, we encourage China to accept test reports from accredited 
laboratories situated outside of China. Otherwise, this is a burdensome and unnecessary trade 
barrier for exporters which send products to China as well as multiple other markets. Building in 
such flexibility would be trade facilitative and in accordance with international best practice. New 
Zealand also holds concerns, that we note are shared by many Members, that China requires more 
detailed disclosure of product formulas than is required in other markets, including specific sources 
of each ingredient. New Zealand encourages China to limit such  disclosure requirements, particularly 
in relation to sensitive information, to that which is required to assure product safety in China's 
domestic market, so as not to compromise intellectual property. New Zealand appreciates our recent 
constructive bilat eral engagement on cosmetics issues and looks forward to engaging further with 
China on its CSAR measures to address these issues. We would welcome China's response to the 
concerns raised by New Zealand and other Members in this and other fora.  
2.236.   The represe ntative of the European Union  provided the following statement. The EU would 
like to refer to its earlier statements on this topic, in particular to the statement delivered in the 
June TBT Committee, as the EU's concerns outlined therein remain unchanged. The main aim of the 
CSAR is to ensure consumer safety. The European Union supports this objective, however there is 
an important concern pertaining to the obligation to transmit confidential information on new 
products and their ingredients to the Chinese authorities. The mandatory disclosure of commercially 
sensitive information required in the notification and registration process, touching on intellectual 
property rights (IPR) of companies involved, remains EU's biggest concern. The EU believes that G/TBT/M/85  
 
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  CSAR 's requirements go beyond what is necessary to ensure consumer safety and traceability of the 
ingredients used in cosmetics. It is also diverging from international practice, as such extensive level 
of information is not required elsewhere in the world for  notification and registration purposes. Other 
important concerns of the EU are the following: - Registration of products: Companies must submit 
a complete list of raw materials used in the finished product. Supplier of raw materials must submit 
detailed i nformation on the raw material, including the production process. - Notification for new 
ingredients: There are concerns over the amount of information required under the new notification 
system and potential issues over the disclosure of such information after a certain period. - Efficacy 
claims: manufacturers are required to make public a detailed summary of efficacy evaluation, which 
can reveal business -sensitive information. Finally, the EU would like to reiterate its comment that a 
differentiated appro ach is needed between new products and products already placed on the market. 
This would avoid a situation when product supply could be interrupted for an extended period of 
time due to insufficient preparation time for both industry and supervision author ities. 
2.237.   The representative of Brazil  provided the following statement. In a bilateral meeting prior to 
the last meeting of the TBT Committee, the Chinese delegation shared with Brazil valuable 
information about the regulatory framework applicable to cosmeti cs. At that time, the Chinese side 
stated that it would be willing to receive suggestions for testing methodologies alternative to animal 
testing in order to further improve its regulatory requirements. In light of this understanding Brazil 
has been trying  to convey a list of OECD tests applicable to cosmetics that can contribute to the 
objective of reducing or eliminating the use of tests on animals. These OECD guidelines for the 
testing of chemicals are methodologies widely used in other countries with th e highest health 
standards. We kindly ask China to consider accepting these OECD -approved testing methodologies 
without having to provide any sort of equivalence evidence or without having to present any 
unnecessary government -issued Good Manufacturing Pra ctice (GMP) certificate.  
2.238.   In response, the representative of China  provided the following statement. 1. Safety -related 
information requirement is a common practice across the world for the safety review of health -
related products. Information such as the br ief description of the production process, production 
process of raw material required is not subject to government information disclosure. According to 
the Regulations on the Disclosure of Government Information, authorities are prohibited from 
disclosing  information involving trade secrets and personal privacy that may harm the legitimate 
rights and interests of third parties. Therefore, trade secrets and intellectual property rights will not 
be damaged in this regard. China attaches great importance to t he protection of trade secrets of 
enterprises. According to articles 47, 56 of the Regulations on the Supervision and Administration 
of Cosmetics, as well as the Measures for the Administration of Registration and Filing of Cosmetics 
issued on 7 January 20 21, trade secrets of the parties shall be kept confidential. 2.  As for the efficacy 
assessment information, it is for the very purpose of protecting intellectual property that only a 
summary, not the full text of its supporting evidence is required. The te chnical materials required of 
new raw materials which are subject to disclosure only include some basic aspects, not the complete 
information. The authorities will also strictly protect business secrets in managing cosmetics 
registration and filing.  
2.239.   3. Str engthening the supervision of cosmetics production is a necessary means of ensuring 
product quality and safety, which is a common practice worldwide. Based on the non -discrimination 
principle of WTO, the Provisions on the Administration of Cosmetics Regist ration and Filing Data put 
forward exactly the same requirements on imported and domestic cosmetics for an alternative 
programme of animal test for safety evaluation. For the required quality management system 
certification issued by the government agency of place of production, while it is non -discriminatory 
to domestic and imported products, it is also for the purpose of ensuring the quality and safety of 
the products. 4. Product safety is closely related to raw material safety. It is an important measure  
to require clarification of the information related to raw material safety when handling registration 
and filing applications, so as to ensure product safety. For cases of changes of raw material suppliers, 
the Regulation provides for different situations . For example, if there are no substantive changes in 
the proportion of the raw material in the formulation, nor changes in the composition of the raw 
material itself, the Regulation only requires updates on changes of suppliers.  If changes occur to 
certai n additives to a raw material, without changes in the proportion and function of the raw 
material in the formulation, only the information related to changes is required. 5. Requirement for 
inspection reports issued by accredited inspection institutions is  in line with the protection of the 
legitimate rights and interests of the consumers. Inspection institutions could be foreign funded 
ones. At present, many laboratories of foreign inspection institutions in China have obtained the 
CMA certification of cos metics. 6. The draft Administrative Measures for Cosmetic Labelling does not G/TBT/M/85  
 
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  require that all contents of the Chinese label and original label should correspond to each other, but 
only requires that the contents of product safety and efficacy claims indica ted in the Chinese sticker 
should correspond to those of original label.  
2.240.   7. Labelling of information of manufacturers is an important measure to protect consumers' 
right to know, and to promote social co -governance and to combat counterfeiting. The Adminis trative 
Measures for Cosmetic Labelling does not require labelling of information on country of origin. Such 
labelling is not expected to contradict labelling of information of manufacturers. For cases where 
manufacturers change production facilities, no i nformation change will be involved as long as 
production quality requirements are met by manufacturers. 8. The efficacy of products is closely 
related to that of their ingredients. In general, there is a positive quantity -effect relationship between 
the ef ficacy of the ingredients and the amount added in the formulation. Therefore, in order to 
prevent the "conceptual addition" of cosmetic ingredients, the proposed draft measures, based on 
the scientific supervision concept, propose that ingredients with for mula content not exceeding 0.1% 
(w/w) should be labelled with "other trace ingredients" as guiding words. 9. On 29 June 2020, China 
has issued a new revision of the regulations on the supervision and administration of cosmetics. It 
came into effect on 1 Ja nuary 2021. For other regulations on cosmetics, reasonable transition periods 
have been or will be set as well.  
2.1.3.27   European Union - Chlorothalonil (pesticide active substance), G/TBT/N/EU/625  
(ID 57967) 
2.241.   The representative of Costa Rica  provided the following statement. Costa Rica once again 
fully supports the comments made by Colombia and reiterates its concern regarding the measure 
notified by the European Union in document G/TBT/N/EU/625 , relating to the non -renewal of the 
approval of the active substance chloro thalonil. Costa Rica's concern has been raised during previous 
meetings of this Committee and is based on the lack of conclusive scientific evidence and the 
application of a precautionary approach in the processes to renew the marketing approvals, which 
then affect the establishment of MRLs. This has happened in the case of chlorothalonil, with the 
Regulation relating to this substance entering into effect in May  2020 despite the many concerns 
raised in various WTO bodies at both the bilateral and regional level, and at an extremely difficult 
time for tropical agricultural exporting countries such as Costa Rica, which continue to feel the 
adverse effects of the pandemic. In this respect, we support the call made by Costa Rica, Colombia 
and 37 other WTO Membe rs in document G/TBT/GEN/296/Rev.3  for the EU to temporarily suspend 
all review processes of market approvals for plant protection substances, as well as the entry into 
force of regulations in this area planned for 2020 and 2021, including the non -renewal of the active 
substance chlorothalonil.  
2.242.   The representative of Colombia  provided the following statement. Colombia reiterates its 
concern regarding the measure notified by the European Union (EU) in document G/TBT/N/EU/625  
relating to non -renewal of the approval of the active substance chlorothalonil. I take this opportunity 
to indicate that my delegation is interested and that it will follow up on the concerns previously 
raised on Phosmet and Alpha -cypermethrin because it involves a very similar approach to the one 
found in relation to this concern. De spite the many technical and scientific comments submitted 
within the consultation periods, the regulation under which the marketing approval of the active 
substance chlorothalonil is not renewed entered into force in May  2020. This decision is already 
beginning to have major implications and consequences for banana producers in Colombia and has 
repercussions for an extensive domestic agricultural production chain. In addition, the Commission 
decided to set the MRL at the minimum level of detection, thereby  creating fresh challenges for 
agricultural producers. In this case, the EU has failed to take into consideration the technical 
comments submitted and the requests for a longer transition period to adapt production processes. 
Nor has the EU given considera tion to the concerns raised by various Members in this Organization, 
and there has been no response to the calls for dialogue made on a number of occasions. A number 
of these calls were already made by my colleague from Costa Rica so I will not refer to th em again.  
2.243.   The EU has taken measures under which approval for the use or marketing of plant 
protection products is not renewed, and MRLs are subsequently reduced. Not only were these 
measures taken in the absence of sound scientific evidence and in a manner  that was inconsistent 
with international standards, they are also being applied in a discriminatory fashion, as, in practice, 
their implementation strongly differentiates between EU domestic producers and foreign producers. 
 
67 For previous  statements follow the thread under ID 579 . G/TBT/M/85  
 
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  While we recognize the health a nd environmental protection objectives involved, these measures 
are being adopted without any proof that they are indeed the least trade -restrictive means of 
ensuring an appropriate level of protection. In Colombia, the use of plant protection substances - 
such as chlorothalonil - is essential in agricultural production. This substance is particularly important 
for banana production in controlling Black Sigatoka, a fungus that can devastate this crop. It is 
important to reiterate that the measures establish ed by the EU should be based on scientific evidence 
and international standards and that they should take into account the diverse agriculture of tropical 
countries such as Colombia.  
2.244.   The representative of Brazil  provided the following statement. Brazil sup ports STC 579 and 
refers to its previous statements on the matter. We respectfully differ from the EU's decision to base 
measures on a hazard -based approach, without an adequate risk analysis and with no compliance 
with long -standing scientific principles.  The non -renewal of approval for chlorothalonil by the EU did 
not duly consider that it is currently authorized in more than 100 countries, and that the MRLs 
allowed by Codex could reach up to 70 mg/kg. We stress our systemic concern with the fact that 
some hazard -based analyses conducted by the European Food Safety Agency (EFSA) led to the non -
renewal of approvals of some substances and subsequently to the reduction of their MRLs. The 
Brazilian National Health Agency has set MRLs for chlorothalonil applied  to more than 30 crops. The 
case of chlorothalonil is particularly harmful towards Brazil's producers of banana, coffee, citrus 
fruits, papaya, watermelon, among others.  
2.245.   The representative of Paraguay  provided the following statement. This concern and the non-
renewal of the approval of chlorothalonil and other substances was already discussed extensively 
both in this Committee and in the SPS Committee because of the subsequent reduction of MRLs. 
Paraguay therefore refers to its previous statements and reite rates its cross -cutting concern with 
regard to the EU's decision not to renew the approval of these substances without a proper risk 
analysis and without complying with scientific principles. In the specific case of chlorothalonil, this 
low-risk substance is sold freely in Paraguay and is used in several export products as part of the 
rotation of substances to avoid pest resistance. It is also the most common alternative for mancozeb, 
another substance whose approval was not renewed by the EU despite the fa ct that neither of these 
substances poses a risk to human health or the environment, if used in accordance with good 
agricultural practice. While we share the objectives that the EU seeks to address with these policies, 
we do not share its adopted approach  for attaining them because it is not based on conclusive 
scientific evidence. We urge the EU to consider less trade restrictive alternatives and base its 
measures on conclusive scientific evidence.  
2.246.   The representative of Ecuador  provided the following stat ement. Ecuador wishes to reiterate 
its concern in relation to notification G/TBT/N/EU/625  on the non -renewal of the approval of the 
active substance chlorothalonil and document SANTE/10186/2018 Rev 1, through which the EU 
confirms the non -renewal of the approval of the substance. Chlorothalonil is one of the main tools 
for controlling Black Sigatoka in bananas due to its effectiveness, low cost and multisite mode of 
action, meaning that the risk of resistance is low. It is available in a wide range of products, through 
many suppliers, and is widely available in the country. Controlling Black Sigatoka ( Mycosphaerella 
fijiensis ) is the main challenge for banana production in Latin America. To control the disease, 
strategies of rotating fungicides with different modes of act ion have been pursued to avoid fungal 
resistance to these compounds. A limited variety of molecules is available for rotation in spraying 
schedules. Restricting the use of chlorothalonil will further complicate efforts to prevent pest 
resistance. Reducing the MRL for chlorothalonil could have a very significant economic impact on 
small -, medium -, and large -scale producers in Ecuador, as well as on consumers in the EU, since 
the supply of our products would be affected. Moreover, no substitute or similar phy tosanitary 
products with the same environmental or toxicological profile are currently available, since the 
alternatives to chlorothalonil (mancozeb, metiram) are already under review, and some prohibited, 
by the EU. The banana sector provides jobs for 2.5  million people. Banana exports generate 
2.1 billion in revenue for the country, accounting for 2% of GDP and 35% of agricultural GDP. 
Furthermore, Ecuador would like to ask the EU if, where emergency authorizations have been issued 
for the use of this sub stance, EU member countries have notified and justified the application of 
MRLs that differ from those established in the EU's existing MRL regulations. If so, which MRL is 
being applied by member countries and how is compliance with that MRL being monitor ed in 
intra-European trade?  
2.247.   The representative of Guatemala  provided the following statement. Guatemala reiterates the 
concern that has been discussed at previous meetings, namely the negative impact of non -renewal G/TBT/M/85  
 
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  on agricultural exports and their minimal  impact in terms of MRLs, in particular when the alternative 
substances have not been renewed and there is no effective like substance on the market for 
agricultural production, particularly the banana sector, in view of tropical climate conditions.  
2.248.   In res ponse, the representative of the European Union  provided the following statement. As 
explained at previous meetings, the EU proposed not to renew the approval of chlorothalonil through 
Implementing Regulation (EU) No 2019/67768, adopted on 29 April 2019 an d previously notified to 
the TBT Committee. Chlorothalonil was evaluated in accordance with Regulation (EC) No 1107/2009 
on the placing of plant protection products on the market.69 The conclusion70 by the European Food 
Safety Authority (EFSA) on this subs tance was published in January 2018. During the peer review 
process, the approval criteria in Article 4 of the Regulation were not satisfied with respect to one or 
more representative uses of at least one plant protection product. Following the non -renewal  of 
approval decision, the EU prepared a draft Regulation lowering the Maximum Residue Limits (MRLs) 
for chlorothalonil, which was notified to the WTO/SPS Committee (G/SPS/N/EU/394). In view of the 
concerns identified by EFSA, the EU lowered all MRLs for c hlorothalonil to the relevant limits of 
quantification through Regulation (EU) 2021/155 of 9  February 2021.71 The new values are 
applicable to all food products since 2 September 2021 (after expiration of a 6 -month deferral of the 
application date that had  been granted). As from that date, also food products produced beforehand 
must comply with the new MRLs. Import tolerance requests, which need to be supported by 
substantial new data addressing the concerns, remain possible and will be assessed on a case -by-
case basis by the "rapporteur" member State and the EFSA. Unless new data would be submitted 
which would address the concerns raised by EFSA, there will be no further developments in the EU 
on that substance. As regards the joint Request for the suspensi on of the processes and entry into 
force of reduction of Maximum Residue Levels (MRLs) of plant protection products in light of the 
COVID -19 pandemic in documents G/SPS/GEN/1778  and G/TBT/GEN/296  and subsequent revisions, 
the EU position is included in the document of 28 May 2021 with double reference 
G/SPS/GEN/1814/Rev.2  and G/TBT/GEN/315  circulated in both  Committees.  
2.1.3.28   Republic of Korea - Amendments to the Act on the Promotion of Saving and 
Recycling of Resources, G/TBT/N/KOR/843,  G/TBT/N/KOR/844,  G/TBT/N/KOR/857,  
G/TBT/N/KOR/918,  G/TBT/N/KOR/919,  G/TBT/N/KOR/937  (ID 58872) 
2.249.   The representative of the European Union  provided the following statement. The EU strongly 
supports actions taken to protect the environment and acknowledges the efforts made by t he 
Republic of Korea to facilitate the recycling procedure by encouraging producers to place recycle -
friendly products on the market. As regards the TBT notifications G/TBT/N/KOR/918 , 
G/TBT/N/KOR/919  and G/TBT/N/KOR/937 , could Korea pleas e provide an update about any new 
revised legislation in relation to QR code applications, etc., and confirm the implementation date of 
these measures? Regarding the TBT notification G/TBT/N/KOR/956 , which relates to the labelling 
and the design of a separate discharge mark, the EU  would like to request an extension to the 
implementation date of 1 January 2022 for new products. As there was a delay in the publication of 
the design of the label, this means that there are only five months to implement these changes, 
which is not suffi cient time to do so. Changes to labelling of new products usually takes 12 -18 
months.  
2.250.   The representative of Australia  provided the following statement. Australia recognizes the 
Republic of Korea's right to implement regulations that promote the reduction o f waste and the 
production of easily recyclable packaging materials. Australia thanks Korea for providing an exclusion 
from displaying recyclability evaluation results on wine bottles ("labelling exemption"). Australia also 
thanks Korea for clarifying why wine bottles are not exempt from the environmental fee. Recognizing 
these changes will impact our wine industry, Australia seeks further information on the timeframe 
for when these measures will come into force and whether any arrangements will be made to assist 
in transitioning to these new requirements.  
 
68 OJ L 114, 30.4.2019, p. 15.  
69 http://eur -lex.europa.eu/legal -content/EN/TXT/?qid=1489747880535&uri=CELEX:32009R1107 . 
70 EFSA 2018 Conclusion on the peer review of the pesticide risk assessment of the active substance 
chlorothalonil. EFSA Journal 2018;16(1):5126. https://www.efsa.europa.eu/en/efsajournal/pub/5126   
71 OJ L 46, 10.2.2021, p. 5.  
72 For previous statements follow the thread under ID 588 . G/TBT/M/85  
 
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  2.251.   The representative of the United States  provided the following statement. The United States 
supports this STC.  
2.252.   The representative of Chile provided the following statement. Chile associates itself with the  
statements by the EU and Australia. As indicated at previous meetings of this Committee, Chile 
recognizes the Republic of Korea's right to implement regulations that promote waste reduction and 
the production of easily recyclable packaging materials, and requests that consideration be given to 
the implementation periods that are required for this type of regulation.  
2.253.   In response, the representative of the Republic of Korea  provided the following statement. 
To the EU : The Guidelines on Separate Discharge Lab elling (Ministry of Environment Notification No. 
2021-140) announced on 7 July 2021 reflects that the period required for replacing copper plate or 
mold of a packaging is usually 6 to 12 months. The revised regulations will be applied on new 
products from 2022, and on the existing products from 2024. The effective date of the amended 
regulations is based on the date of manufacture for both domestic and imported products. However, 
in the case of new products, considering the fact that less than six months is  given from the date of 
final announcement of the amendment to the effective date, it is to be reviewed to grant an 
additional grace period for each product and packaging material after checking the period necessary 
for the application of the new label, su ch as exhaustion of stock. To Australia : The surcharge of 
recycling contribution, which is often indicated as environmental fee, on glass bottles used for 
packaging wine and whisky is applied on the products manufactured or imported on or after 1 
January 2 021, and their producers or importers are to be noticed to pay the surcharge of this year 
around September next year. For specific details regarding the payment of recycling contribution, 
we recommend the individual producers or importers contact Korea Pac kaging Recycling Cooperative 
(KPRC), which is an institution established by producers and importers to jointly fulfill their recycling 
obligations in accordance with the Act on the Promotion of Saving and Recycling of Resources.  
2.1.3.29   China - Draft Administrativ e Measures for Registration of Overseas Producers of 
Imported Foods, G/TBT/N/CHN/1522  (ID 61173) 
2.254.   The representative of the United States  provided the following statement. The United States 
notes that China has published the final version of this measure as Decree 248 on 12 April 2021, 
with an implementation date of 1 January 2022. We remain concerned with such a trade -impacting 
regulation, which does not appear to have clear food safety and public health benefits. The measure 
appears to apply to all food products, regardless of ri sk or whether foods are already subject to other 
import certification requirements. We anticipate that the measure, when implemented, will likely 
create major trade disruptions for the United States and every other country that exports food and 
agricultura l products to China. Any measure of this magnitude requires far more time for industry 
to implement. Therefore, we ask China to immediately suspend or delay implementation of these 
measures until 1 July 2023, when sufficient guidance has been provided and exporting countries' 
questions have been answered and exporting companies will have been given sufficient time to 
register with their competent authorities.  
2.255.   The representative of The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
provided t he following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu has been closely following the development of the measure ever since China notified its draft 
(G/TBT/N/CHN/1522 on 16 November 2020). Given that the measure will aff ect a wide range of our 
food-related industries and that the measure involves a high extent of uncertainties as mentioned 
below, we have expressed our concerns several times before. We have also sent detailed comments 
to seek confirmation and clarification . However, we have yet to receive a sufficient and detailed 
response from China. China published the measure in April. However, even up to the present stage 
when China has started its registration requirements, many uncertainties about the interpretation 
and implementation of the measure still remain, including the scope of products and facilities that 
are subject to this measure, registration requirements and guidelines on how to fill out application 
documents (especially for food producers that need to fi le the application by themselves), procedures 
and timelines for audits, re -evaluation and renewal of registration. An even more essential question 
is how the categories of risks of products are established in this measure, not to mention our 
concerns about  its inconsistency with the TBT Agreement. According to the measure, a food producer 
is required to obtain registration with the GACC and to mark the registration number on both the 
inner and outer package of its product. However, while the GACC has the ri ght to review registration 
 
73 For previous statements follow the thread under ID 611 . G/TBT/M/85  
 
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  application, and the timeline of its review is unspecified, our businesses are worried about whether 
they can obtain the approval in time and if there is sufficient time for them to follow the labelling 
requirement. Besides, Chin a did not provide enough explanation regarding the justification of the 
measures, nor did they offer sufficient transitional period and detailed guidance on implementation. 
These elements will increase risk of trade disruption; we, therefore, urge China to  offer sufficient 
transitional period. And, in order to get the needed clear understanding of the measure and to 
facilitate registration application, we also urge China to give sufficient information and a 
comprehensive briefing in the Committee or provide  us with a more detailed responses to our 
comments.  
2.256.   The representative of the European Union  provided the following statement. The EU must 
express its concern about the implementation of Decree 248 of the Chinese Customs Administration. 
The EU does not in the least question the right of China to ensure that imported food products come 
from legitimate sources. We share and support this objective. However, the EU is gravely concerned 
about the manner in which China is implementing the planned registration of exporting businesses. 
China and the EU trade high volumes of food products and beverages through tens of thousands of 
enterprises, some big, many small. For effective registration of businesses, clear guidance, 
standardized templates and realistic transiti on periods are indispensable in order to minimise 
disruptions to economic relationships between enterprises on both sides. However, instead of 
offering information events, webinars or at least detailed implementing rules and a web site with 
frequently aske d questions, China sent a letter to EU member States and other trade partners with 
the request to identify and register exporting businesses for 14 unclearly defined product categories 
within five weeks. This is clearly impossible given that we are talking  about tens of thousands of 
businesses. As products due to be imported into China early next year have already been produced, 
if existing timeframes are maintained, Decrees 248 and 249 risk disrupting global food supply chains 
and delaying food supply into  China.  
2.257.   The EU must note that China receives very different treatment from the EU in cases where 
our legislation evolves. The EU urges China to: postpone the implementation of the Decree 248 until 
detailed guidelines, templates and functioning web sites ar e available; provide for realistic and 
practicable transition periods of at least 18 months for the self -registration of businesses under 
Article 9 of Decree 248. Trade with businesses not yet registered should continue without disruption; 
once registratio ns are approved and registration numbers are allocated, provisions related to 
labelling under Article 15 must be implemented with adequate transition periods. In particular, 
products with a long shelf life, such as spirits, may be in retail stocks for many  months and must be 
protected by transition periods of at least 36 months; and organize information sessions both for 
trading partners and busines so that we can have a better understanding of the new registration 
requirements.  
2.258.   The representative of Brazil  provided the following statement. Brazil would like to once again 
raise STC 611 regarding new requirements for the registration of overseas producers of imported 
foods. So far, both bilaterally and at the TBT Committee, the Chinese Government has not been  able 
to clarify the risk analysis that grounded such disproportionate requirements for a wide range of 
food products. We understand that these requirements constitute unnecessary obstacles not only to 
our private sector, but also to our regulators, which must operate as the Competent National 
Authority for a much wider range of products. The most recent development of this regulatory 
process was the publication, in April 2021, by the General Administration of Customs of China 
(GACC), of Decrees n. 248 and 249, which deal, respectively, with administration of registration of 
foreign establishments and management of the safety of imported and exported food. Article 7 of 
Decree n. 248 defines the products for which registration will require the recommendation of the 
Competent National Authorities. Could the Chinese side specify the Harmonized System (HS) codes 
for the foods covered in this article? Could China clarify whether some products under Chapter 19 
of the HS, such as the lines for cookies, cakes and oth er wheat -based products (1901.20, 1902.11, 
1902.19, 1902.20, 1902.30, 1905.20, 1905.31, 1905.32, 1905.40 and 1905.90), would need to 
follow the more complex registration procedures?  
2.259.   Article 5 of Decree no. 248 requires that the food safety management syste m of the country 
where the producer is located has passed GACC's equivalence assessment or review. Could China 
explain how and when it intends to carry out these assessments? Could China indicate the criteria 
and procedures used to establish such equivalen ce, especially for regulators that regulate processed 
foods and "health foods"? The Brazilian private sector also expressed concern with the packaging 
requirements contained in Article 15 of Decree no. 248. Could China clarify whether there will be G/TBT/M/85  
 
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  any spe cific adaptation period for labelling requirements? If there are delays in the issuance of the 
registration number by the GACC, will the Chinese government allow for the importation of products 
without marking the registration number? Considering the need for label design and printing, will 
the Chinese government publish in advance additional labelling requirements such as font size and 
colour, format, visibility, placement and use of stickers? In September 2021, the Brazilian 
government received a letter f rom the GACC informing the existence of an accelerated registration 
procedure for food products exported to China since 2017. Attached to the communication, there is 
a specific list of products in this category whose importation from Brazil was accounted f or by the 
Chinese customs. This list, however, does not include categories of processed food products exported 
to China since 2017. Especially in relation to processed foods, the Brazilian government was not able 
to meet the tight deadline for submitting d ocuments for this fast -track registration.  
2.260.   Could China explain why some products exported to China since 2017 are not included in 
the list of accelerated registration products? Since these products are not duly mentioned in said 
list, will China consider e xpanding the time frames for fast -track registration? Finally, as Decrees 
248 and 249 are about to come into force, the GACC has not yet shared the templates of documents 
to be sent by the Brazilian authorities for registration under the terms of Article 8  of Decree no. 248. 
Would the Chinese government be able to provide times frames for the publication of these 
documents? Would it be possible to grant a longer period of adaptation?  
2.261.   The representative of Australia  provided the following statement. Australia respects the right 
of WTO Members to address the safety and quality of imported food products in accordance with the 
TBT Agreement and without unnecessarily restricting trade. Australia thanks China for recently  
providing some guidance on the implementation of measures under its Regulation on Registration 
and Administration of Overseas Manufacturers of Imported Food (Decree 248) for food producers 
already exporting to China. However, Australia remains concerned t hat measures under China's 
Regulation on Registration and Administration of Overseas Manufacturers of Imported Food 
(promulgated as Decree 248) will significantly disrupt trade of food products into China. China has 
provided WTO Members an extremely short timeframe between initial notification of these measures 
in April 2021, implementation guidance only in October 2021 and intended entry into force of Decree 
248 on 1 January 2022. To minimize trade disruptions for both China and exporting countries, China 
will need to provide sufficient time for competent authorities and businesses to comply with the 
Regulation. Australia is concerned that the measures will disrupt trade if an adequate transition 
period is not put in place in advance of entry into force. Au stralia requests that China provide 
Members with an extension of at least 18 months to allow governments and businesses to adjust, 
prepare and register before the measures enter into force. A transition period is particularly 
important for new food labelli ng requirements. Now less than two months out from anticipated 
implementation, Members are still lacking clarity on the labelling requirements for product for export 
in 2022. Many businesses are already producing and labelling product for export in 2022 an d would 
need time to adjust their settings and sell -through existing product. China's delay in clarifying how 
these products will be treated is creating uncertainty for exporters.  
2.262.   Under Article 2.7 of the TBT Agreement Members shall give positive considera tion to 
accepting as equivalent technical regulations of other Members, even if these differ from their own. 
Australia would like to discuss with China how Australia's high quality food safety systems can 
adequately fulfil China's objectives for imported f ood. Australia has also expressed concerns in recent 
SPS Committee meetings regarding the need to ensure that food safety measures under Decree 248 
meet obligations under the SPS Agreement, are based on science, take account of the actual food 
safety risks , and are not more trade restrictive than necessary to manage the food safety risk of 
particular imported foods (including low risk foods). Again, Australia is ready and willing to work 
with China and discuss ways to meet China's food safety needs, while e nsuring trade disruptions are 
minimized.  
2.263.   The representative of Indonesia  provided the following statement. Indonesia thanks China 
for notifying the Draft Regulation on Registration and Administration of Overseas Manufacturers of 
Imported Food through G/TBT/N/CHN/1522  on 16 Novemb er 2020. Indonesia fully respects the 
rights of China's authority to protect the health and safety of its people by ensuring the safety of 
the food products consumed in China's market. Nonetheless, Indonesia is of the view that Decree 
248 stipulated by the  General Administration of Customs of the People's Republic of China (GACC) 
is more trade restrictive than necessary in achieving its legitimate objective. Being one of the largest 
exporting countries for food products to China with a trade value exceeding  US$5.2 million in 2020, 
Indonesia has numerous concerns regarding the implementation of this regulation. Indonesia has G/TBT/M/85  
 
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  sent its enquiry to China TBT WTO Enquiry Point on 29 September 2021. Unfortunately, Indonesia 
has not received any response until now. Indonesia would like to request China to fulfill its 
commitment to TBT Agreement and ensure that such measures will not create unnecessary barriers 
to international trade.  
2.264.   Indonesia, therefore, would like to appeal to China to first, elaborate the justific ation for the 
health and safety objective China wishes to achieve by implementing such measures. Second, 
provide detailed information of products that will fall under this measure by identifying the six to 
eight digits of the HS Code. Third, update the off icial website with the English version and provide a 
complete and thorough implementing guideline covering the mechanism and registration procedures 
either through the competent authority or through independent registration as well as the 
registration time line and labelling requirements. Fourth, consider the necessity of registering low -
risk products, and lastly, grant a reasonable transition period for manufacturers to implement the 
measures for at least twelve months from 1 January 2022. China has been a valued and strategic 
trading partner for Indonesia for a broad range of products, including food and beverages. Indonesia 
wishes to continue becoming a strategic trading partner to China. Indonesia fervently hopes that 
China reconsiders the timing for the implementation of this measure. Indonesia looks forward to 
China's response and welcomes bilateral discussion shortly on this prominent matter.  
2.265.   The representative of Mexico  provided the following statement. The delegation of Mexico 
refers to Decree 248 of the General Administration of Customs of China in relation to the Regulations 
on the Registration and Administration of Overseas Manufactures of Imported Food, notified to the 
Members of this Committee on 16  November  2020 in document G/TBT/N/CHN/1522 . While the 
Government of Mexi co recognizes the sovereign right of every country to determine regulatory 
measures to fulfil their legitimate objectives and shares the Government of China's aim of ensuring 
the legal origin of food imported into the country, we also attach great importan ce to the need to 
consider alternatives that are not more trade -restrictive than necessary and that observe and comply 
with international commitments when deciding on such measures. The delegation of Mexico 
reiterates the concerns raised in this Committee during the previous meetings in February and June 
of this year, regarding Decree 248 and its implementation process, including the registration 
application for exporting companies. It therefore requests the delegation of China to reconsider the 
proposed da te of entry into force in January  2022, owing to the concerns and uncertainty that this 
measure has caused among the Members of this forum, with a view to allowing a dialogue with 
stakeholders in order to strike a balance between the objective pursued and the best way to proceed 
without affecting importers. Furthermore, it reiterates the need to define the scope of application of 
Decree 248 in order to have clarity regarding the type of exporters subject to the registration 
requirement and to extend the rel evant deadline for registration. The delegation of Mexico thanks 
the delegation of China for giving its consideration to this statement and reiterates the importance 
of observing the international commitments to which we are bound as Members of this Organi zation, 
with the objective of implementing measures that facilitate, and do not create unnecessary obstacles 
to, international trade.  
2.266.   The representative of Canada  provided the following statement. Canada and other Members 
continue to raise significant conc erns and challenges with China's administrative measures for the 
registration of overseas manufacturers of imported food. Canada is concerned that Decree 248 will 
negatively impact trade. Over the years, Canada and China have implemented many bilateral 
arrangements that have successfully maintained the safe trade in food between our respective 
nations. Canada remains concerned that the administrative measures being implemented by China 
are overly burdensome and unjustified. These measures are broad and over -arching in scope, and 
will have a significant impact on exports to China. It remains unclear how Decree 248 will contribute 
to achieving China's appropriate level of protection and, if implemented in its current form, the new 
Decree will likely create ser ious barriers to trade including significant financial impacts on both 
industry and foreign competent authorities. Canada is disappointed that Decree 248 was adopted 
and published by the General Administration of Customs of the People's Republic of China ( Customs 
China) immediately following the deadline for comments by WTO Members without sufficiently taking 
into account comments and concerns from Members. The lack of discussions and information from 
China on the new Decree is creating uncertainty and conc ern among trading partners. Greater clarity 
and information is necessary to ensure that industry stakeholders and foreign competent authorities 
understand and are able to comply with the requirements.  
2.267.   Canada remains deeply concerned that these measures wil l create confusion for competent 
authorities and industry due to the lack of details and transparency from China regarding the G/TBT/M/85  
 
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  implementation of these new requirements. Canada urges China to delay the implementation of 
Decree 248 for 18 months to allow bot h foreign governments and industry to fully understand and 
comply with the new requirements contained in the Decree. During the proposed delay, Canada calls 
on China to provide further clarity and hold discussions with Members in a timely manner so there 
is sufficient time for trading partners, including both competent authorities and industry, to comply 
with China's new measures. Although Canada did respond to China's 31 October 2021 deadline for 
information on "medium risk" commodities as part of Decree 2 48 requirements, the purpose of the 
request remains unclear, creating additional uncertainty within Canadian industry. In conclusion, 
Canada urges China to provide Members with additional information and clarification on the 
implementation of Decree 248 an d delay its implementation to provide sufficient time to address 
this uncertainly and allow trading partners to comply with the new requirements.  
2.268.   The representative of the Republic of Korea  provided the following statement. Korea 
understands China's effort s in ensuring food safety to protect the health of its people, but Korea 
would like to reiterate its concern as China has not provided clear response to concerns continually 
expressed by Korea and a number of Member states regarding the Administrative Meas ure since its 
draft was first notified in 2019. It is more trade -restrictive than required to have competent 
authorities obliged with registration of food manufacturers, processors, and storage facilities with 
the Chinese government even for low -risk food products listed in Article 7 of Decree 248. It is even 
inharmonious with the global practices, in which most of the countries require competent authorities 
of exporting countries to be responsible of facility registration only for animal products. Remindin g 
China's obligation as a Party of WTO TBT Agreement, Korea requests China for providing scientific 
evidence for the aforementioned Article 7. As far as we know, Decree 248 enters into force on 
1 January 2022. But, China requested Korea for submitting the list of manufacturers subject to 
government registration by 31 October 2021. However, to date, China has not provided detailed 
guidelines such as HS codes of the additional fourteen items that there are difficulties in identifying 
export items subject to t he Chinese regulation and in submitting the required list.  
2.269.   Therefore, Korea would like to request China for providing detailed guidelines at its earliest 
convenience for export items that require registration through competent authorities of exporting 
countries and the items that are subject to registration by private businesses. We would also like to 
postpone the date of implementation of the Administrative Measure to provide time for exporting 
countries and manufacturers to prepare for it. China is a very  important trading partner for Korea 
as it is the second largest market for Korean agricultural products. And changes in China's regulation 
will significantly impact bilateral trade. Therefore, Korea requests China to take heed of our view 
and will wait fo r China's response to the comment of Korea.  
2.270.   The representative of Switzerland  provided the following statement. Switzerland shares the 
concerns expressed by other Members regarding the two decrees 248 and 249 published by the 
General Administration of Cust oms of the People's Republic of China (GACC). Switzerland 
understands and supports China's objective to ensure that only safe food is imported. We regret 
that the measures still include all food categories irrespective of their risk -profile and seem to be 
more trade restrictive than necessary to ensure the safety of imported food products. We therefore 
reiterate our concerns expressed in previous meetings. Switzerland notes that there are still many 
open questions for which we - as well as our industry - do not have sufficient information. Examples 
of incomplete information include product categories (by their HS codes), the types of operations 
that will need to be registered or questions regarding labelling. Switzerland encourages China to 
brief all interes ted WTO Members on the detailed guidelines, implementing rules and template forms 
at the earliest possible date. It is important that we all have access to the same information, which 
can then be shared with competent authorities and the industry. Furtherm ore, Switzerland invites 
China to foresee realistic and practicable implementation and transition periods and asks for an 
extension by at least 18 months.  
2.271.   The representative of Japan  provided the following statement. Japan shares the concerns 
with other Me mbers on China's regulation on registration and administration of overseas 
manufacturers of imported food (GAC Order No. 248) We understand China published the 
explanatory annotation article by article via website. We also understand China held the explana tory 
meeting in Shanghai on this regulation. We appreciate China's efforts to provide additional 
information and to let relevant people informed, but we received a new letter from GACC at the end 
of September. This letter asked to provide GACC the list of companies until the end of October, the 
last month. This timeline was unrealistic. Moreover, the details continue to be insufficient. We are 
deeply disappointed with the lack of information, especially with the ambiguity of the regulation 's G/TBT/M/85  
 
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  scope of food i tems. Since China specifies the scope of the regulation only by product names and 
not by HS codes, it is unclear whether various food items would be affected by this regulation. The 
explanatory annotation implied to announce HS codes via website, but this information has not been 
uploaded to the website yet. Japan suggests "foodstuffs" stipulated in Article 9 should be specified 
by the HS code, and the concrete number of HS code should be announced as soon as possible. 
Furthermore, GACC opened a website so that private companies can apply for registration by 
themselves. However, this website is still in a test phase, which causes a pretty big confusion among 
private sector in Japan.  
2.272.   In addition to these, we are not informed of the clear timeframe from the a pplication to the 
registration by GACC. We think this measure lacks the necessary transparency in this sense. The 
lack of transparency will cause a significant negative impact on trade with all other WTO Members. 
We have already heard from many companies t hat they are worried about lack of time preparing for 
this regulation and it might interrupt the existing trade after the enforcement of regulation. This 
shows the proposed measure has already created unnecessary trade barriers between China and 
other WTO Members. We suggest that China take account of the comments and concerns from the 
WTO Members and reconsider the timing of the enactment of the regulations. As we have already 
submitted a joint letter with some other Members to the GACC, Japan also request s China to provide 
a sufficient transition period of 18 months after providing WTO Members with a satisfactory 
information to ensure that the regulations do not negatively impact trade between China and other 
WTO Members.  
2.273.   The representative of Turkey  provided the following statement.  Turkey would like to thank 
the other delegations for bringing this issue to the agenda and share the concerns expressed in their 
statements regarding the Draft Administrative Measures for Registration of Overseas Producers of 
Imported Foods of China. Turkey believes that Decree 248 covers a wide range of food items and 
its product coverage and details of the implementation need further clarifications. Additionally, 
anticipated system for registering exporting businesses is burde nsome not only for overseas 
producers of given food items, but also for competent authorities of exporting countries, especially 
considering the complexity of the new system of registration process and short time frames provided. 
Turkey, therefore, would l ike to ask China to provide additional information and clarification 
regarding the implementation of the Decree 248 and postpone the implementation of the new 
registration system at least 18 months in order to allow both governments and businesses to adopt  
to the new system.  
2.274.   The representative of the Philippines  provided the following statement. We see that the two 
overriding suggestions, which we hope China will accommodate, are the provision of sufficient 
information and briefings on the measure and the e xtension of the transition period. We have 
submitted comments and asked clarifications to China, first on 2 February 2021, and then again on 
11 May 2021. We subsequently received replies after the June meeting of the Committee. We 
continue to evaluate thes e replies as they seem to merely restate the textual provisions of Decree 
248. We have also requested an extension of the 31 October 2021 deadline for submission of the 
list of manufacturers that would be subject to government registration. China has not r eplied to this. 
We respect China's right to regulate in order to ensure food safety. The Philippines, nevertheless, 
joins other WTO Members in requesting China to abide by the clear rules of the TBT Agreement and 
ensure that its regulations do not create u nnecessary obstacles to trade and are not more trade 
restrictive than necessary to fulfil its legitimate objectives.  
2.275.   The representative of Peru provided the following statement. Peru echoes the concerns 
expressed by the preceding Members. In this regard, P eru wishes to express its concern about the 
negative impact that Decree 248 would have on international trade. We also support the proposal 
made by other Members, requesting that China postpone the implementation of Decree 248, as 
companies and authorities  need time to adapt to the new provisions. Furthermore, we urge China 
to provide sufficient information about this Decree and its implementation. Lastly, we reiterate the 
importance of complying with the international commitments under the TBT Agreement, w ith a view 
to implementing measures that do not create unnecessary barriers to trade.   
2.276.   In response, the representative of China  provided the following statement. In order to 
effectively implement the "Food Safety Law of the People's Republic of China" and its implementing 
regulations, China revised the original "Administrative Measures for Registration of Overseas 
Manufacturers of  Import Foods". The new version （Decree 248 ）was released on 12 April 2021 and 
will take effect from 1 January 2022. Before China released Decree 248, a notification had been G/TBT/M/85  
 
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  made to the WTO. Comments from Members had been received, reasonable suggestions an d 
recommendations were accepted. China had also set a transitional period before its implementation. 
These provisions optimize the registration procedures, implement classified management for 
different categories of overseas production enterprises, clarify  the responsibilities of enterprises and 
the supervisory responsibilities of the competent authorities of the country (region) in which the 
enterprise is located, and specify the application of the provisions. The above provisions shall not 
affect the impl ementation of the agreements signed between Members with China. In order to ensure 
that the food trade will proceed normally after the implementation of Decree 248, in September the 
General Administration of Customs has notified the relevant Members in wri tten format about the 
application for registration of overseas food production enterprises of different categories and the 
requirements of the materials to be submitted. The interpretation of the Decree 248 and 
implementation of the guidance documents will  be issued shortly. We will inform all parties in a 
timely manner.  
2.1.3.30   Peru - Supreme Decree No. 015 -2019 -SA, which amends the Manual of 
Advertising Warnings approved by Supreme Decree No. 012 -2018 -SA (ID 61874) 
2.277.   The representative of Costa Rica  provided the fo llowing statement. Costa Rica wishes to 
thank Peru for keeping it informed of the progress of the process to implement the draft Regulation 
established under Supreme Decree No.  015-2019-SA, which amends the Manual of Advertising 
Warnings approved by Suprem e Decree No.  012-2018-SA. The delegation of Peru recently informed 
us that the entry into force of this Regulation had been postponed until 30  March  2022. Although 
this postponement offers some respite for our exporters, we wish nonetheless to reiterate ou r 
concern and respectfully request that the Peruvian authorities consider permitting the use of 
adhesive labels on a reciprocal basis, given that these labels may be used on Peruvian food products 
to be marketed in Central America. The food industry has in formed us of the negative repercussions 
on trade that a potential discontinuation of the use of adhesive labels would entail. It should be 
noted that the use of adhesive labels is widely recognized internationally, as such labels achieve the 
same public he alth protection and consumer information purposes achieved by permanent labels. At 
the CODEX level, for example, Articles 8.1.1 and 8.2.1 of CODEX -STAN  1-1985, General Standard 
for the Labelling of Prepackaged Foods, permit the use of supplementary or adhe sive labels, as long 
as it is guaranteed that they will not become separated from the container, or in cases where the 
language on the original label is not acceptable to the consumer for whom it is intended. 
Furthermore, we note that countries with labell ing schemes requiring the use of high fat, sodium or 
sugar content warnings, similar to Peru's, have considered supplementary labelling using stickers, 
which not only provides the required level of protection but also makes it easier for exporters to 
compl y with non -harmonized international requirements. Peruvian food products sent to the Costa 
Rican market are able to comply with domestic labelling requirements through the use of 
supplementary adhesive labels, instead of having to affix permanent labels in  the country of origin, 
exclusively for the Costa Rican market. This undoubtedly fosters trade and is proportionate to the 
level of protection sought. We therefore ask for reciprocity of treatment.  
2.278.   Moreover, we note that other Peruvian instruments, such as  Supreme Decree No.  007-98-SA 
adopting the regulations on sanitary surveillance and control of food and beverages, permit the use 
of stickers to meet labelling requirements, given that this is an appropriate means for the fulfilment 
of the proposed legitim ate objectives. The fact that Peruvian legislation, in other instruments, 
permits the use of an adhesive or additional label no doubt shows that there are less trade -restrictive 
measures through which it is possible to fulfil the proposed legitimate object ives, in accordance with 
the obligations regarding technical barriers to trade established in the relevant World Trade 
Organization Agreement and in the existing Agreement between our countries. Costa Rica would like 
to emphasize once again, as it has alre ady done before this Committee, that in light of the current 
situation faced by the world as a result of COVID -19, international cooperation in all areas is crucial 
for tackling the crisis and laying the groundwork for a swift economic recovery post -pandem ic, 
through the promotion of trade -facilitating measures, as opposed to measures that might create 
technical barriers to trade and hinder economic recovery. In view of the above, we respectfully 
restate Costa Rica's wish that the Peruvian authorities remov e the proposal to prohibit the use of 
stickers and maintain the possibility of permitting their permanent use.  
2.279.   The representative of Colombia  provided the following statement. Colombia thanks Peru for 
its consideration of the concern regarding the use of a dhesive advertising warning labels under 
 
74 For previous stateme nts follow the thread under ID 618 . G/TBT/M/85  
 
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  paragraph 8.3 of section 8 of the Manual of Advertising Warnings approved by Supreme Decree No. 
012-2018-SA. Given the recent publication of DS 018 -2021-SA, extending the deadline for the use 
of adhesive labels to 3 1 March 2022, Colombia thanks Peru for this additional time period but 
considers that this requirement should be maintained on a permanent basis and that the deadline 
should not continue to be extended via specific deadlines or for fairly limited periods. Colombia 
reiterates that this policy, while seeking to promote and protect public health, should be 
implemented in a manner that is not more restrictive than necessary and does not subsequently 
create an unnecessary obstacle to trade. Colombia also conside rs that allowing the use of adhesive 
labels does not distort the purpose of the Peruvian standard, since the warnings, whether included 
on adhesive labels or printed directly on the packaging of products, will continue to be clear, legible, 
prominent and c omprehensible, as required by the regulations. We reiterate that this standard on 
labelling that is so specific to a particular market and is binding in the country of origin constitutes 
a major access barrier, particularly for small and medium -sized enter prises, and does not take into 
consideration complicated distribution and logistics processes, which require certainty as to the 
applicable rules for the marketing of products in the medium and long term. Furthermore, extending 
the use of adhesive labels f or six -month periods causes uncertainty and creates management 
difficulties for companies when exporting to Peru. We would therefore like Peru to take into account 
these considerations and study the possibility of amending the regulations so as to allow th e use of 
adhesive labels on permanent basis. We welcome the bilateral talks that have taken place at different 
levels, and the progress duly reported.  
2.280.   The representative of the European Union  provided the following statement. The European 
Union (EU) apprec iates that Peru further extended the possibility to use stickers for compliance with 
labelling requirements for processed foods, until 31 March 2022. However, the EU would like to 
repeat once again the urgent invitation to Peru to provide for a permanent p ossibility to use stickers. 
The EU recognizes that reliable information to the Peruvian consumer is a legitimate objective. 
Nevertheless, the obligation to print information on the product package is trade restrictive and 
represents a disproportionate burd en for foreign producers, in particular SMEs. In the EU and in 
most countries around the world, stickers are allowed for food products, provided that the 
information is accurate and the stickers are not easily removable. We are committed to working with 
Peru bilaterally on this issue.  
2.281.   The representative of Brazil  provided the following statement. Brazil regrets having to once 
again express its concerns regarding labelling requirements expressed in the Manual of Advertising 
Warnings approved by Supreme Decre e 012 -2018-SA (notified under G/TBT/N/PER/97/Add.1  and 
amended by Supreme Decree 015 -2019-SA (unnotified). The use of stickers is a widespread practice 
internationally, as it does not affect the provision of reliable information to consumers. Codex 
standard CODEX -STAN 1 -1985 for pre -packaged goods, Articles 8.1.1 and 8.2.1, explicitly allows for 
the possibility of using additional labels or stickers, as long as they are attached to the packaging 
and if the language of the original label is not necessarily that of the consu mer for whom it is 
intended. Brazil shares Peru's endeavour to ensure the highest health standards through technical 
regulations that help better inform consumers. Despite Peruvian legitimate concerns with deceptive 
practices, advances in labelling technol ogies allow for their safe affixation. We acknowledge that, 
according to Supreme Decree 018 -2021-SA, the entry into force of the prohibition on stickers was 
delayed until 31 March 2022. However, Brazil would like to respectfully ask Peru to permanently 
align its labelling requirements with current international standards established under the Codex and 
withdraw the prohibition of stickers for the products under the scope of the Manual of Advertising 
Warnings. Brazil considers such postponement a provisional  solution and will continue to raise this 
STC until Peru permanently removes its burdensome requirements for food labelling.  
2.282.   The representative of Chile provided the following statement. Chile appreciates the 
opportunity to comment on the implementation pr ocess for the draft regulation laid down in Supreme 
Decree No.  015-2019-SA, which amends the Manual of Advertising Warnings approved by Peru. As 
was indicated by the delegations that spoke before me, food exporting companies and trade 
associations are conc erned by the fact that adhesive labels/stickers shall only be accepted until the 
end of March  2022, and not on a permanent basis.  
2.283.   In response, the representative of Peru provided the following statement. As we have done 
at previous meetings, Peru wishes to  reiterate that it is committed to its work to protect the health 
of its citizens and vulnerable groups, such as children and adolescents, through public policies aimed 
at achieving this goal, in accordance with the country's international trade commitment s in this 
domain. In this connection, Peru is seeking to ensure that the information contained in the Manual G/TBT/M/85  
 
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  of Advertising Warnings (MAP) reaches consumers clearly and effectively, so that they can make 
informed choices. In response to the concerns expres sed by some Members, Peru, by means of 
Supreme Decree No.  018-2021-SA, extended again until 31 March 2022, the period during which 
the use of adhesive warning labels, provided for in paragraph 8.3 of section 8 of Supreme Decree 
No. 012-2018-SA approving th e MAP under Law No. 30021, Law to promote healthy eating among 
children and adolescents. Lastly, we reiterate that Peru wishes to honour its WTO commitments, 
and, in this connection, Peru reaffirms its commitment to not prepare, adopt or apply technical 
regulations that may create unnecessary barriers to international trade, as established in the 
Agreement on Technical Barriers to Trade.  
2.1.3.31   Kingdom of Saudi Arabia - Technical Regulation for limiting and restricting 
hazardous materials in electrical and electro nic equipment, G/TBT/N/S AU/1166  (ID 
66675) 
2.284.   The representative of Japan  provided the following statement. Japan shares concerns about 
the Technical Regulation for Restriction of Hazardous Substances in Electrical and Electronic 
Equipment (EEE). Japan understands that the regulation was promulgated on 9 July 2021. At the 
past WTO/TBT Committee meetings, the Kingdom of Saudi Arabia stated that it would make the 
conformity assessment procedures reasonable in response to comments from many countries. 
However, the international standard for type approval ISO/IEC 17067, which many c ountries 
consider problematic, was adopted for granting certificates of conformity under the promulgated 
regulation. In addition, if the Kingdom of Saudi Arabia Government will amend the conformity 
assessment procedure, there is the possibility that import s will be suspended because companies do 
not have enough preparation time by the enforcement date that is assumed to be January 2022. 
Also, in this situation where details of the conformity assessment procedures have not yet been 
presented, it is impossibl e to complete the certification procedures by the date of enforcement for 
manufacturers importing many kinds of products. Japan requests that a sufficient transitional period 
be given for obtaining certification before the date of enforcement and requests that this technical 
regulation be harmonized with international standards and practices, that the above -mentioned 
concerns be dispelled, and that the implementation of these regulations be promptly clarified, so 
that they will not create unnecessary obstac le to international trade.  
2.285.   The representative of the European Union  provided the following statement. The European 
Union would like to reiterate its concerns regarding the draft Technical Regulation for Restriction of 
Hazardous Substances, notified by Saud i Arabia on 1 December 2020. The EU would like to refer for 
details to its written comments of March 2021 and to the minutes of the previous TBT Committees. 
In particular, the EU would like to repeat the invitation to Saudi Arabia to reconsider the require ment 
of third -party conformity certification, which deviates from common international practice that relies 
on first party declaration of conformity. The EU also invites Saudi Arabia to provide for a sufficiently 
long transition period that would ensure a smooth implementation and adaptation for economic 
operators. The EU would like to ask Saudi Arabia about the state of implementation of the measure 
and any planned guidance to industry. Finally, the EU would also like to underline again the 
importance of p romoting the GCC harmonized requirements, which should also guarantee their 
uniform application and a mutual recognition of conformity assessment results in the region. The 
European Union remains available to discuss this issue with Saudi Arabia bilaterall y. 
2.286.   The representative of the United Kingdom  provided the following statement. The United 
Kingdom thanks Saudi Arabia for their continued engagement on this technical regulation. We 
continue to encourage Saudi Arabia to accept self -declaration as a means of  demonstrating product 
conformity, which UK industry has previously evidenced as proportionate to product risk. Acceptance 
of self -declaration would provide a less trade -restrictive means of achieving Saudi Arabia's legitimate 
objective. We now understand that Saudi Arabia intends to develop guidelines to support compliance 
with third party certification procedures. We also understand that these guidelines will address 
comments raised on the scope of this measure and product exemptions. The United Kingdom n otes 
this intention with interest and requests confirmation on the development process, the timelines, 
and on plans to consult with international industry. The United Kingdom appreciates the constructive 
engagement to date, Saudi Arabia's willingness to di scuss this issue, and welcome continued 
productive interaction on this matter.  
 
75 For previous statements follow the thread under ID 666 . G/TBT/M/85  
 
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  2.287.   The representative of the United States  provided the following statement. The United States 
reiterates its concerns regarding the Kingdom of Saudi Arabia's notification of its " Technical 
Regulation for the Restrictions of Hazardous Substances (RoHS)", which we understand was 
published in the Official Gazette July and will enter into force on 5 January 2022. While we appreciate 
SASO's willingness to engage with us and other stakeh olders regarding this regulation to date, there 
remains a great deal of confusion on several details associated with the measure. In addition, in the 
absence of clarification and detailed guidance, manufacturers and conformity assessment bodies will 
face m any challenges implementing this measure particularly since the proposed measure deviates 
significantly from international practices regulating RoHS that rely on a Supplier's Declaration of 
Conformity. Saudi Arabia instead proposed a mandatory conformity a ssessment procedure based on 
a technical file of supporting documentation for a supplier's declaration of conformity, a third -party 
conformity assessment by approved bodies and test reports from an accredited laboratory.  
2.288.   Most significantly, the Type Approv al Conformity Assessment testing and certification regime 
and required factory certifications outlined in the draft regulation raise concerns regarding the 
potential of the measure to create unnecessary obstacles to trade. The United States requests that 
Saudi Arabia align its proposed regulation with international practice, clarify the required procedures, 
and avoid creating any duplicative or unnecessarily trade restrictive conformity assessment 
requirements. We also remain interested in receiving further  details from Saudi Arabia in a number 
of areas: First, we continue to urge Saudi Arabia to provide clarification of the precise scope of the 
regulation. For example, some of the HS codes in the annex cover products, such as batteries, that 
are outside of the scope of the categories covered by the final regulation. Further, the definition of 
hazardous substances refers to radioactive substances, yet some of the regulated substances are 
not actually radioactive. Also, there are missing exemptions for certain  necessary uses of the 
regulated substances for products in the monitoring and controlling equipment category. Second, 
we request further guidance on the process for testing whole equipment and/or critical components 
of a product. We understand that typica lly other WTO Members have not asked industry to provide 
test reports on critical components as such testing requires dismantling the product and destroying 
its parts. Saudi Arabia's proposed approach may be more strict than is necessary to give Saudi 
Arabia adequate confidence of product conformity, and result in added costs and delays in getting 
products to market. We request that Saudi Arabia provide a process for manufacturers to meet the 
RoHS requirements without providing test reports for critical com ponents.  
2.289.   Third, we request that the requirement for suppliers to attach the entire technical file of 
supporting documentation proving compliance to their products, be modified to instead require a 
copy of the certificate of conformity from the conformity a ssessment body, as consumers will not be 
able to discern compliance from a technical file, and the technical file likely contains proprietary 
business information. Fourth, we request that Saudi Arabia provide as soon as possible the guidance 
it intends for  notified bodies regarding this measure, and outline plans for engagement with trading 
partners and private sector stakeholders to ensure such guidance is as clear as possible for those 
who must comply with and enforce the rules, possibly in the form of fr equently asked questions 
(FAQ), as has been done with other WTO Members' RoHS regimes. Given the number and 
significance of these concerns, it is difficult to understand how this proposed measure can be 
implemented by the proposed date for entry into force  on 5 January 2022. Therefore, the United 
States requests that Saudi Arabia delay implementation of this proposed measure until the range of 
concerns are adequately addressed. Such a pause will allow continued dialogue between the United 
States and SASO as  we seek to prevent the creation of unnecessary obstacles to trade. The United 
States looks forward to continuing a dialogue with Saudi Arabia, and to providing additional 
information where needed to address those areas that require further guidance to min imize the trade 
restrictive impact on industry.  
2.290.   The representative of China  provided the following statement. We support Saudi Arabia's 
restrictions on hazardous substances in electrical and electronic products, however, the draft 
regulation proposed by Sa udi Arabia is still inconsistent with the international practice, especially 
the provisions on conformity assessment procedures which will create unnecessary obstacles to 
trade. China would like to raise concerns as follows. 1. According to Article 5 and A ppendix 3, 
suppliers need to obtain a conformity certificate (Type 1a) from an approved certification 
organization. However, according to the practice of global implementation of RoHS, it is usually the 
manufacturer to prepare technical documents for produ cts to prove their conformity in the light of 
international standard IEC 63000 and to provide a conformity declaration. In response to the testing 
report requirements described in the notified regulations, a full product testing report means that 
companies  need to test every single component, at the homogenous material level, which is G/TBT/M/85  
 
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  extremely time consuming and resource consuming. On the contrary, the international standard IEC 
63000 allows manufacturers to work with their supply chains to compile technic al documentation as 
evidence of compliance, which is a common procedure or method for restrictions on hazardous 
substances implemented and accepted internationally. Therefore, it is recommended that the 
conformity assessment procedure would comply with cur rent global practices, and the preparation 
of technical documents would comply with IEC 63000.  
2.291.   2. The application scope of the draft regulations of this notification is electrical and electronic 
equipment, but the batteries and accumulators (HS code 8506 a nd 8507) are included in Appendix. 
Based on the differences between batteries and electrical and electronic equipment, and with 
reference to the current management and control method worldwide, it is recommended that this 
regulation excludes batteries and accumulators from the scope of control. 3. Regarding the allowable 
percentage of hazardous substances in electrical and electronic equipment or devices specified in 
Appendix, the percentage of many materials (copper alloys, steel alloys, and high -temperatu re 
solders, etc.) is currently unable to meet the limitation of regulations due to immature technology 
or no alternative materials. It is recommended to refer to Annex III of the EU Directive 2011/65/EU 
(RoHS) or the "Exemption List for Application of Rest ricted Substances in the Compliance 
Management Catalogue" issued by the Ministry of Industry and Information Technology of China to 
clarify the corresponding exemptions. 4. In view of the impact of COVID -19 on the global supply 
chain, we suggest the transi tional period for the implementation of the regulations be extended from 
six months after its publication to 12 months, in order to provide sufficient time for manufacturers 
to replace raw materials and upgrade products in accordance with regulatory requir ements.  
2.292.   The representative of Switzerland  provided the following statement. Switzerland would like 
to support the interventions made by previous speakers on the Kingdom of Saudi Arabia's Technical 
Regulation for limiting and restricting hazardous materials  in electrical and electronic equipment. 
While we share the Kingdom of Saudi Arabia's legitimate objective to protect the environment and 
public health and safety, Switzerland remains concerned that these requirements may have a 
negative impact on trade fo r a wide range of products. The testing and certification requirements 
continue to deviate from common international practices which include supplier's declaration of 
conformity and technical documentations aligned to the appropriate relevant international  standard. 
We encourage the Kingdom of Saudi Arabia to consider less trade -restrictive alternatives and take 
these best practices into account. We would also like to reiterate our call on the Kingdom of Saudi 
Arabia to allow for a sufficient implementation  period so as to allow the industry to adapt to these 
new requirements. As we understand, uncertainties remain related to the scope of these 
requirements. We encourage the Kingdom of Saudi Arabia to implement clear and transparent 
guidelines and to align t he scope of these requirements with internationally accepted RoHS 
requirements, such as those used in Switzerland and elsewhere in Europe. Finally, Switzerland would 
appreciate if the Kingdom of Saudi Arabia could clarify the state of implementation of the se 
measures.  
2.293.   The representative of Canada  provided the following statement. Canada shares the Kingdom 
of Saudi Arabia's legitimate objective pursued by this measure as it relates to the protection of the 
environment, as well as public health and safety. Ho wever, Canada would like to raise the following 
concerns related to the Technical Regulation for Restriction of hazardous Substances in Electrical 
and Electronic Equipment, as published in the Kingdom of Saudi Arabia's Official Gazette, on 9 July 
2021: The  testing and certification requirements seem to deviate from the widely replicated EU RoHS 
Directive, the other aspects of which are very similar to the proposed Saudi measure. The EU 
Directive's best practices include acceptance of a supplier's declaratio n of conformity and technical 
documentation aligned to the appropriate relevant international standard (ISO 63000). Unlike the 
EU's requirement, Saudi Arabia's directive requires exporters to supply a sample of their product for 
testing by a notified Saudi  Conformity Assessment Body, which would inject significant costs into 
the supply chain. We would appreciate it if Saudi Arabia could provide Members with a better 
appreciation of the objectives that this testing would achieve. We would also encourage the Kingdom 
of Saudi Arabia to adopt internationally accepted best practices. In addition, Canada calls on the 
Kingdom of Saudi Arabia to allow for a sufficient implementation period that allows the industry to 
adapt to these new requirements. Canada looks for ward to further engaging with the Kingdom of 
Saudi Arabia on this topic.  
2.294.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. Saudi Arabia is aiming at protecting human health and safety, and the environment, to 
ensure that hazardous substances are not above certain levels in consumer products such as G/TBT/M/85  
 
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  electrical and electronic equipment. Consequently, Saudi Arabia would like to clarify the following: 
Saudi Arabia has notified of the measure in December 2020 and re ceived comments until May 2021. 
The transitional period is set at 180 days after publishing the regulation in the Official Gazette for 
Manufacturers to take corrective actions. Saudi Arabia has aligned the last version of the Saudi 
Technical Regulation wit h international practices like EU RoHS. As for the conformity assessment 
procedures, SASO has chosen to apply the international standard ISO/IEC 17067 for granting 
certificates of conformity (Type Approval) to products issued by Notified Conformity Assessm ent 
Bodies. Moreover, the test report is considered valid unless any change in the materials used to 
manufacture the type. In case it is not possible to perform the test on the entire product, the critical 
components of the device must be tested, which are  determined by the manufacturer based on the 
risk assessment and documents assessing the risk of those components on the final product in 
accordance with the standard IEC 63000.  
2.295.   Within this framework, SASO develops conformity assessment activities (certifi cation, audit 
and inspection, and testing activities) in Saudi Arabia to be one of the tributaries that raise the level 
of quality in the national industry and the safety of imported goods presented in the Saudi market. 
By accepting the conformity assessme nt bodies in the various conformity assessment activities, this 
process aims to ensure the efficiency of the outputs of the accepted conformity assessment bodies 
operating in the conformity verification activities within the systems and requirements of the  
technical regulations approved to provide the necessary activities according to the scopes of 
acceptance of these bodies. Therefore, SASO chose to engage a notified third -party responsible for 
granting conformity certificates in accordance with the intern ational standard ISO/IEC 17067 as part 
of the Kingdom pre -market approach. Saudi Arabia is highly interested in the public's participation, 
including those concerned and interested in expressing their opinion on the regulation. Therefore, 
guidance will be provided to all stakeholders as soon as possible, taking into consideration the 
valuable comments received from trading partners and private sector stakeholders to ensure such 
guidance is clear for those who must comply with and enforce the rules. The requ irements of the 
technical regulation for Restriction of Hazardous Substances in electrical and electronic equipment 
are in line with international practices. Therefore, the transitional period set at 180 days after 
publishing the regulation in the Official  Gazette is sufficient to fulfil all requirements.  
2.1.3.32   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20,  
G/TBT/N/IND/20/Add.1,  G/TBT/N/IND/40,  G/TBT/N/IND/40/Rev.1  (ID 13376) 
2.296.   The representative of Indonesia  provided the following statement. Indonesia would like to 
reiterate its concern on Pneumatic Tyres and Tubes f or Automotive Vehicles as raised previously in 
June 2021. Indonesia has also communicated its concern through Permanent Mission of India in 
Geneva, yet India has not provided substantive response to Indonesia's concern. Indonesia 
understands that India has  imposed loyalty or marking fees for tyre products with IS marking. 
Indonesia remains concerned that the imposition of marking fees is burdensome and has become a 
unnecessary obstacle to trade. The imposition of marking fees is also having no legitimate 
justification with no strong relation to protection of human health, safety or prevention from 
deceptive practice. Indonesia also regrets the measures taken by India in imposing import restriction 
for certain types of tyres. This import restriction provision s were issued shortly after India banned 
the importation of tyre products to India for a period of six months as in notification no. 12/2015 -
2020 dated 12 June 2020 regarding Amendment in Import Policy of Tyres. These policies have 
impacted Indonesia's exp ort and disrupted the flow of goods to India. Indonesia urges India to 
ensure that the implementation of the regulation and technical requirements for tyres are not 
discriminative between imported and domestic products. According to information from our 
exporters, India has currently banned importation for tyres produced domestically. Indonesia is of 
the view that this policy is not in line with non -discriminatory principle as set out in Article 2.1 of the 
TBT Agreement. Indonesia is looking forward to Indi a's response on this issue and requests India to 
review the policy to ensure compliance with the non -discriminatory principle.  
2.297.   In response, the representative of India provided the following statement. We had a bilateral 
meeting in which we tried to clarif y your point, nonetheless we will reiterate the same here again. 
The BIS operates a Product Certification Scheme as per the Scheme -1 of BIS (Conformity 
Assessment) Regulation, 2018 under BIS Act, 2016. Under the scheme, Product Certification licences 
to both domestic and foreign manufacturers are given. Both of them must pay the necessary fees, 
and there is no discrimination between domestic and foreign manufacturers. The fee is inclusive of 
 
76 For previous statements follow the thread under ID 133 . G/TBT/M/85  
 
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  the marking for each of the products; the marking fee for each pro duct is specified as a) Minimum 
Marking fee per annum and b) Unit and Unit rate. The manufacturer is required to pay a minimum 
marking fee in advance for the licence's validity period. The actual marking fee for each year is 
calculated by multiplying the u nit rate. The actual marking fee or the minimum marking fee for the 
year, whichever is higher, is payable by the manufacturer. The marking fee is chargeable on all the 
production of tyres carrying ISI marks.  
2.1.3.33   Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety 
(published on 24 October 2011), G/TBT/N/RUS/2  (ID 33277) 
2.298.   The representative of the European Union  provided the following statement. In 2012, the 
Russian Federation notified a draft technical regulation on the safety of alcoholic products to be 
adopted by the Eurasian Economic Union. An updated version was adopted in December 2018 and 
currently schedul ed to enter into force on 1 January 2022. The revision process seems to be delayed 
following the last meeting of the EEC Consultative Committee and therefore this scheduled date 
seems to be very difficult to comply with (unless the technical regulation ent ers into force in its 2018 
version, without revision). It appears that only in January 2022 it will be known if the new rules will 
be in force, which adds to the already existing unpredictability on the market. Could Russia clarify 
the current revision pro cess: is the revision still ongoing and a new amendment being drafted? Could 
Russia clarify the foreseen timetable? The EU took the opportunity of the ongoing revision process 
of the Eurasian Economic Union Technical Regulation 047/2018 "On the safety of a lcoholic products" 
and submitted on 19 May to the Eurasian Economic Commission a series of drafting proposals. In 
light of transparency and considering the trade implications of this regulation, we understand that 
the revised draft technical regulation wil l be subject to public consultation and that it will be notified 
to the WTO under the TBT Agreement.  
2.299.   We are firmly convinced that the EU proposal, the focus of which is to better align some 
provisions with international standards and practices for alcoholi c products, as well as WTO 
obligations, could ease the implementation and enforcement of the technical regulation by all 
operators, facilitate international trade of alcoholic products both ways, and, thus, contribute to the 
goal pursued by the Eurasian Ec onomic Commission through this text. The European Union would 
like to ask Russia to take these comments into consideration in the new drafting, if envisaged, and 
to renotify the new version of the measure, under the TBT Agreement as well as under the TRIPS  
Agreement.  
2.300.   In response, the representative of the Russian Federation  provided the following statement. 
As rightly mentioned by the EU delegation, amendments to the technical regulation on safety of 
alcohol beverages are now being developed. Unfortunately,  no precise timeline for the finalization 
of the drafting process can be provided now. When amendments are developed, the draft will be 
notified under the Agreement on TBT. Currently, it is scheduled that the technical regulation in its 
present version ent ers into force on 1 January 2022.  
2.1.3.34   European Union - Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) No 
479/2008 as regards protected designations of origin and ge ographical indications, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/44,  G/TBT/N/EEC/264,  G/TBT/N/EEC/264/Add.1,  G/TBT/N/EU/570,  
G/TBT/N/EU/571  (ID 34578) 
2.301.   The representative of the United States  provided the following statement. It is very 
disappointing that the United States must again raise its concerns with the European Unio n's (EU) 
revisions to its draft regulation on geographical indications and traditional terms for wine; and 
specifically, our industry's pending applications for traditional terms which were submitted to the EU 
well over 11 years ago. The EU has failed to p rovide sufficient transparency about this process and 
has hindered market access for our exporters for over a decade. The EU's persistent failure to provide 
any information leaves us no choice but to raise this issue here again at the WTO TBT Committee, 
as well as at the WTO Council for Trade in Goods. Since the June 2018 TBT Committee meeting, the 
EU has been saying that the pending applications for traditional terms are still under consideration, 
but that it could not provide a precise timeline for approv al. Why is the EU still unable to provide 
 
77 For previous statements follow the thread under ID 332 . 
78 For previous statements follow the thread under ID 345 . G/TBT/M/85  
 
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  any estimate or tell us where in the process these applications are after three years? What does the 
EU mean when it said "under consideration?" Are they being actively considered, or have they been 
put on hold? If  the applications have been put on hold, please explain why. At each TBT Committee 
since November 2019, we have asked for transparency about the status of other applications so that 
we can see how our applications compare.  
2.302.   As requested during the last fiv e TBT Committee meetings, please tell us the following: How 
many applications for traditional terms have been lodged over the last 11 years? How many of those 
applications have been approved, rejected, or remain pending? What is the average time between 
application and a final decision? For pending applications, how long have they been waiting? For 
pending application, how many of the applications have come from member States? How has the 
processing of these applications changed, if at all, over the last tw o years following the adoption of 
Implementing Regulation 2019/34? Does the EU intend to answer these questions which have been 
posed repeatedly since November 2019? We also have additional questions that have gone 
unanswered including the following: Could  the EU confirm that US producers can continue to use 
any generic term, such as a grape variety, that is part of a compound term protected as a GI by the 
EU? For example, could US producers still use the grape variety "Dolcetto," even though the EU 
protect s the compound name "Dolcetto d'Alba?" How do third countries find out about amended 
changes with respect to EU Protected Designations of Origin (PDO) and Protected Geographical 
Indications? In its response to our TBT comments, the EU indicated that partie s "… may submit an 
application to the Commission objecting to [an] application … within two months of the date of 
publication in the Official Journal of the European Union." We would like to remind the EU of its 
obligations under Article 2.9 of the TBT Agr eement to notify the WTO of these changes in draft form 
so that parties may comment through the formal WTO process. What is the definition of "generic?" 
Lastly, we continue to seek confirmation that the revised regulation will not alter the ability of US 
producers to use terms such as "barrel aged" as provided for in Appendix II of the Protocol on 
Labelling to the 2006 US/EU Wine Agreement. In its response to our TBT comments, the EU indicated 
that "consumers' expectations have been taken into account by re serving some labelling particulars 
concerning specific production methods." Based on this response, we remain unsure if the term 
"barrel aged" can still be used and ask that the EU please clarify.  
2.303.   The representative of New Zealand  provided the following st atement. We refer the European 
Union to New Zealand's statement on this trade concern made at the June 2021 TBT Committee, 
and those preceding it.  
2.304.   In response, the representative of the European Union  provided the following statement. 
The EU understands t he continued interest of the United States and other Members in this issue. 
The EU has completed the revision of its internal legislation on traditional terms discussed in previous 
TBT Committees leading to the adoption of Commission Delegated Regulation ( EU) 2019/33 and 
Commission Implementing Regulation (EU) 2019/34. The EU believes that its internal legislation 
offers a meaningful and transparent system of protection to traditional terms used on wine products 
from the EU, as well as on products from thir d countries. The EU has demonstrated its ability to 
address specific Members' concerns in this area either via its internal legislation or via bilateral 
agreements.  
2.1.3.35   China - Regulations for the Supervision and Administration of Medical Devices 
(Order No. 65 0 of the State Council), G/TBT/N/CHN/1313  (ID 42879) 
2.305.   The representative of the Republic of Korea  provided the following statement. The Republic 
of Korea recognizes China's efforts to ensure safety and effectiveness of medical devices and to 
strengthen quality control by revising the Regulations for the Supervision and Administration of 
Medical Device s. Korea however notes that the definition of "qualified testing laboratories" still 
remains unclear in the revised regulations published on 1 June 2021. As to our previous enquiry 
asking about the scope of "qualified testing laboratories", China responded  in the latest meeting with 
Korea that operational rules are being drafted for the regulations and that China would notify Korea 
at the completion of the rules. However, as Korea has yet to hear from China, Korea requests China 
to share the current status of development of the operational rules. Also, if internationally accredited 
laboratories are included in the scope of qualified testing laboratories, it will greatly save time and 
costs incurred from unnecessary duplicate testing, which is currently requi red for exporters to be 
 
79 For previous statements follow the thread under ID 428 . G/TBT/M/85  
 
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  authorized or registered in China. Moreover, China will benefit from timely distribution of quality 
medical devices, thereby promoting public health.  
2.306.   In response, the representative of China  provided the following statement. The new  revision 
of the regulation on the supervision and administration of medical devices has been released, and 
took effect on 1 June 2021. The new regulation reasonably sets clinical evaluation requirements, 
simplifies the review procedures, and further encou rages the innovation. Meanwhile, the regulation 
fully implements the system of registrant, strengthens the responsibility of enterprises and 
supervision over the whole process of medical devices.  
2.1.3.36   China - Registration Fees for Drugs and Medical Device Produ cts (ID 46680) 
2.307.   The representative of the Republic of Korea  provided the following statement. As in the 
previous TBT meetings, the Republic of Korea would like to raise this STC regarding China's 
Registration Fees for Drugs and Medical Device Products. Chin a's imposition of registration fees for 
medical devices continues to remain an issue of concern for Korea. Korea expressed, during the last 
meeting, its concern over the discrepancy in fees between domestic producers and importers, 
requesting China to ensu re fair and equitable treatment in charging the registration fees. However, 
China only responded that in the case of medicines, its registration fees are similar to or lower than 
the fees charged by other Member countries, and failed to give any remarks on  medical device 
registration fees. As it is deemed inappropriate to impose twice more registration fees on importers 
compared to domestic manufacturers, Korea would like to once again request imposing the same 
amount of registration fees both on domestic a nd foreign manufacturers.  
2.308.   In response, the representative of China  provided the following statement. Charging 
registration fees for drugs and medical devices are common international practices. For example, in 
2013 the new medicine registration fees of Mem bers were largely around 1 million Yuan, in some 
Members even above 10 million Yuan, while it was only 35,000 Yuan in China. Afterwards, it is 
adjusted to 0.624 million Yuan in China, which is still much lower than the average international 
level. The fees  are mainly determined by the cost of the conformity assessment works. The minor 
difference of the registration fees is due to different workloads and price levels.  
2.1.3.37   Russian Federation - Rules of cement certification, G/TBT/N/RUS/48,  
G/TBT/N/RUS/49  (ID 49781) 
2.309.   The representative of the European Union  provided t he following statement. The EU would 
like to refer to its previous statements in the TBT Committee on this issue. We would also like to 
thank the Russian Federation for a bilateral meeting that took place on the margins of this 
Committee. The EU would like  to recall that its comments on both Russian notifications 
G/TBT/N/RUS/48  and G/TBT/N/RUS/49  sent to the Russian Federation in May and June 2016 were 
never replied to, despite our numerous reminders. The EU deeply regrets that Russia continues to 
adopt restricting measures in the area of cement certification th at are disproportionate, unjustified 
and not notified to the WTO before their entry into force. Further to this, the EU regrets that Russia 
is not willing to provide any information on the state of play of the preparation of the new standard 
for cement. Th e EU would like to ask the Russian Federation to explain the impact of the new Rules 
on Conformity Assessment, adopted on 24 July 2021, on the certification rules for cement and the 
GOST standard 56836 of 2016. The new Rules on Conformity Assessment (Gover nment resolution 
No. 1265 of 24 July 2021) provide certain facilitation of conformity assessment procedures for 
foreign manufacturers. However, the main concern of EU cement exporters to the Russian 
Federation, regarding the inspection controls of certifie d products, remains unresolved.  
2.310.   Chapter XIV, article 60 of the new Rules clearly provides that inspection control of certified 
products must be carried out according the National standards: "60. Inspection controls of certified 
products is carried out in a ccordance with the national standard of the Russian Federation GOST R 
58984 -2020 'Conformity assessment. Procedure for inspection control in certification procedures', 
unless otherwise established by the documents on standardization provided for in the Ann ex to these 
Rules." As regards cement, Annex of the Rules refers to the National standard GOST R 56836 -2016 
"Conformity Assessment. Rules for Certification of Cement", which is the same National standard, 
which effectively restricted EU cement exports to R ussia since 2016. This means that despite the 
 
80 For previous statements follow the thread under ID 466 . 
81 For previous statements follow the thread u nder ID 497 . G/TBT/M/85  
 
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  adoption of new Rules on Conformity Assessment, every shipment of cement going to Russia still 
has to be sampled and tested at the border. According to EU companies, this implies a cost of around 
€1500 for each  shipment, as well as a delay of 28 days (with railway transport costs of such delay 
at €210/tonne), which makes export of cement to Russia practically impossible. In EU's view, 
paragraph 8.2. of previously notified GOST Standard establishes a clear discri mination of imported 
cement by introducing additional inspection control for each cement shipment, arriving from third 
(non-EU) country, despite products being already certified. The EU regrets to note that the new 
Rules on Conformity Assessment did not re ctify the discriminatory treatment regarding cement 
certification and inspections. The EU would like to ask the Russian Federation to provide information 
about the new Rules on Conformity Assessment and about the preparation of previously announced 
new sta ndard for cement, as well as to share the planned timing for its TBT notification.  
2.311.   In response, the representative of the Russian Federation  provided the following statement. 
The Russian Federation reiterates that GOST R on rules of cement certification was developed to 
ensure safety and quality of products marketed in Russia. We note that certain provisions of this 
standard are under review. No timeline for this process can be provided now. As regards to the new 
Rules on Conformity Assessment, mentioned by the EU, we note that these rules lay down general 
standard procedures for conformity assessment in respect of all products subject to these  
procedures.  
2.1.3.38   India - Draft Food Safety and Standards (Alcoholic Beverages Standards) 
Regulations, 2015, G/TBT/N/IND/51,  G/TBT/N/IND/104  (ID 49482) 
2.312.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate some remaining concerns regarding this measure. We took  note of the new 
amendment regarding alcoholic beverages that was published on 18 December 2020 and is applied 
as from 1 July 2021. Several of our concerns for wine have been taken into account and an alignment 
to OIV standards took place for large parts. This is a big step in the right direction. There remain 
however some issues, described in EU comments on notification G/TBT/N/IND/104 , for which we 
would welcome a reply. We request Indian authorities to consider alignment with OIV standards. 
Moreover, we would appreciate if India could take into account the following: The lack of stock -
exhaustion clause (to allow the sale of products already present on the Indian market until stocks 
are exhausted in order to minimize the impact for economic operators) and transition period. The 
presence of some technical specifications (the maximum alcohol content, some spirits definitions) 
that may not be in line with international widely accepted practices and could result in an adverse 
impact for international trade. Concerning the use of coloran ts in combination, we received 
information that an internal FSSAI meeting took place recently in order to review the situation. It 
seems that the use of colorants in combination has been allowed under certain conditions. We would 
like to get clarification as to what exactly has been agreed and when it will be made public. We hope 
that we can continue our discussion and find an acceptable solution to the outstanding issues. In 
this context, we request FSSAI to consider extending the implementation period up to the next 
excise year, i.e. July 2022.  
2.313.   In response, the representative of India provided the following statement. The majority of 
the standards prescribed in the FSSAI Alcoholic Beverages Regulations, 2018, have been aligned 
with OIV in line with WTO com mitments. In addition to this, alignment of the analysis methods of 
alcoholic beverages with the OIV is under process. FSSAI via direction dated 22 June 2020 
operationalized the use of food colours "Tartrazine, Carmoisine, Brilliant Blue, Sunset Yellow and  
Ponceau 4R" in the food category 14.2.6 -Distilled Spirituous Beverages. Further, via direction dated 
7 December 2020, revised provisions for using these colours, and one additional colour, Allura Red, 
was operationalized for use in food category 14.2.6 -Distilled Spirituous Beverages. Further, as per 
appendix A, the colour, namely caramel, beta carotene and grape skin extract, are allowed in 
aromatized alcoholic beverages.  
2.1.3.39   Egypt - Manufacturer Registration System (Decree No. 43/2016 and Decree No. 
992/2015) , G/TBT/N/EGY/114,  G/TBT/N/EGY/115  (ID 50583) 
2.314.   The representative of the European Union  provided the following statement.  The EU would 
like to reiterate its concerns with regard to the registration of companies exporting to Egypt under 
 
82 For previous statements follow the thread under ID 494 . 
83 For previous statements follow the thread under ID 505 . G/TBT/M/85  
 
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  Decrees No. 991/2015, No. 43/2016 and No. 44/2019. This registration pr ocedure constitutes a 
considerable obstacle to trade and imposes unnecessary administrative burden and blocks or 
substantially delays EU exports. We therefore continue to question the measure and Egypt's 
justification for this mandatory registration of EU companies. We note with concern that the pending 
registration cases known to the EU have still not been successfully processed and that some sectors 
(like ceramic tiles) continue being disproportionately affected by the discretionary application of 
Decree 43. Moreover, we would like to highlight the structural problems related to the Decree 
43/2016, like the lack of transparency of the registration process, lack of clear deadlines for 
processing the requests, lack of a clear appeal procedure, and a high lev el of discretion in granting 
registrations. We are ready to work with Egypt in order to terminate the measure.  
2.315.   The representative of Turkey  provided the following statement. We join the European Union 
to emphasize our ongoing concerns on Egypt's Decree on manufacturer registration system. Turkey 
would like to thank Egypt for continuing constructive bilateral discussions on this issue. However, 
Turkey remains concerned on Egypt's Decrees on manufacturer registration system, since the 
structural problems rela ted to the Decree 43/2016 - such as the lack of transparency of the 
registration process and unclear deadlines for processing the requests - have been continuing. In 
addition, Turkey has additional concerns on the implementation of the registration system due to 
the new Decree of the Ministry of Trade and Industry of Egypt numbered 273 for the year 2021 that 
foresees the prohibition of the dismantled parts of the goods prescribed in the Decrees numbered 
43/2016 and 44/2019. Besides, we have been informed at  the latest CTG (Council for Trade in 
Goods) meeting that the Decree 273/2021 has been suspended by the said Ministry for a certain 
period of time and we welcomed the suspension decision of the Ministry. In this regard, Turkey 
would like to ask Egypt if su ch suspension has been announced publicly and in written form and if 
Egypt could share the relevant suspension announcement with us by providing justification behind 
the suspended Decree and information regarding the process to be followed after the suspen sion. 
In addition, we understand that Egypt did not notify the new Decree to the WTO. Therefore, we urge 
Egypt to notify the measure to the WTO, conduct a consultation process for at least 60 days following 
that notification, and take into account the comm ents before finalizing the measure. In conclusion, 
Turkey would like to invite Egypt to repeal the registration process with the objective of removing 
unnecessary barriers to trade and ensure not to implement the new Decree as a final measure 
considering t he principles and obligations under the WTO Agreements.  
2.316.   In response, the representative of Egypt  provided the following statement. Egypt and the 
EU have engaged on this issue on numerous occasions and at various fora and in the context of 
these meetings an d exchanges Egypt has explained its understanding of the issues raised by the EU 
and explained that over 90% of the European companies have indeed been registered. Remaining 
companies are currently subject to consideration and we have exchanged with the EU  the status of 
a number of companies. On the systemic issues raised by the EU and Turkey regarding transparency 
and the unclear deadline, and those related to the implementation of the registration system in 
Egypt, Egypt has indeed taken a number of positi ve steps in the right direction in this respect and 
will continue to work on the improvement of the system. I would like to note that on the website of 
the General Organization of Export and Import Control there is a list of companies that has been 
publish ed, explaining that those companies have been given a time period to renew their quality 
control certificates. Regarding Decree 273 for the year 2021, as has been explained, it has been 
suspended based on a number of studies of the potential impact of this  decree on both the consumer 
and the industry, and it is currently under review. In case of any updates, it will be notified to the 
TBT Committee.  
2.1.3.40   India - Mandatory Certification for Steel Products, G/TBT/N/IND/32,  
G/TBT/N/IND/32/Add.1,  G/TBT/N/IND/32/Add.2  (ID 22484) 
2.317.   The representative of The Separate Customs  Territory of Taiwan, Penghu, Kinmen and Matsu  
provided the following statement. The Separate Customs Territory of Taiwan, Penghu, Kinmen and 
Matsu would like to express its concerns about Steel and Steel Products (Quality Control) Order, 
2020 issued by In dia's Ministry of Steel on stainless steel bars and flats (IS 6603:2001) and 
electrogalvanized hot rolled and cold reduced carbon steel sheets and strips (IS 17404:2020). 
Firstly, we would like to express our appreciation to the Bureau of Indian Standards for granting the 
approval to our enterprise's application for ISI Mark licence on Stainless Steel Bars and Flats in early 
October. It facilitates bilateral trade on Steel and Steel Products. Secondly, we would like to thank 
 
84 For previous statements follow the thread under ID 224 . G/TBT/M/85  
 
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  India for postponing the enforce ment date for electrogalvanized hot rolled and cold reduced carbon 
steel sheets and strips (IS 17404:2020) until 21 September 2021. However, due to the persistent 
impact of COVID -19, most countries still impose international travel restrictions and nationa l 
quarantine policies. This situation continues to make on -site factory inspection difficult to conduct in 
practice. As a result, we would like to urge India to postpone the implementation of IS 17404:2020 
once again. In addition, we strongly suggest that India consider other facilitative measures, such as 
allowing virtual inspections as a part of the certification process, or accepting conformity assessment 
results from testing laboratories and inspection bodies outside India, as alternatives.  
2.318.   The represen tative of Japan  provided the following statement. First of all, Japan appreciates 
that India gave us the opportunity to discuss this issue bilaterally ahead of the Committee meeting. 
However, we believe that we still have some concerns and would like to ra ise those points. Japan 
again appreciates India's remarks at the last TBT Committee meeting regarding consideration for 
the introduction of virtual/remote inspection for BIS conformity assessment in the steel sector. We 
would like to know about the current  status of the consideration and possible timeline for the 
introduction of such alternative inspection methods. In addition, approval procedure of BIS 
conformity assessment is still taking an excessively long period of time. We request that India 
accelerat e its examination procedure and shorten its examination period. Thirdly, we have heard 
that India still requests end -users to switch to local procurement or to submit future plans for 
domestic production in India instead of importing certain products, whic h is not related to the 
conformity assessment procedures. We again strongly request immediate removal of such 
inappropriate demands. Lastly, we welcome India's decision to postpone the enforcement of certain 
steel standards. We would like to request that I ndia take all stakeholder's opinions into consideration 
and flexibly postpone other standards in the steel sector.  
2.319.   The representative of the Republic of Korea  provided the following statement. Korea would 
like to support the statements by Japan and Chinese  Taipei. Regarding the mandatory certification 
for steel products of India, due to the delays in the certification process, a request was submitted 
asking India to postpone the enforcement of the mandatory standards until December 2021. But 
there has been no response to the request, nor any customs clearance. We hereby request India for 
alternative measures to remedy the certification process until the current situation improves, such 
as exemption from factory audit, substitution into paper -based audit, or speedy introduction of 
virtual/off -site inspection currently under review by the Indian Government.  
2.320.   The representative of the European Union  provided the following statement. EU would like 
to support the delegations of Chinese Taipei, Japan and Korea. Indi a has designed and introduced 
specific standards and certification requirements for a number of products across sectors that require 
on-site, in -person audits. The Quality Control Orders have protectionist orientation and are sending 
worrying signals to th e EU industry, EU investors and EU member States.  Once the QCOs come into 
force they cause extra burden and economic cost to the EU industry that has to undergo cumbersome 
procedures to obtain necessary permission and/or licences for products already certi fied under 
established international standards. Additionally, the QCOs require physical audit by an auditor of 
the Bureau of Indian Standards in order for product manufacturers in third countries to receive the 
approval for exports to India. The ongoing CO VID-19 pandemic and the restrictions linked thereto 
have negative impact on the certification process in India especially for foreign companies with 
production facilities outside India. The EU would like to support the introduction of virtual remote 
inspec tions for BIS conformity assessment in the steel sector. Alternative inspection methods are 
crucial to maintain access to Indian markets. The steel and steel products Quality Control Order 
2020 targets 145 products. The QCOs for the majority of these produ cts are already in force, 
however it remains unclear to the European Union which of QCOs for steel products are already in 
force. India defers from time to time the date of implementation of certain steel products. The EU 
would therefore appreciate it if I ndia could provide an updated list of steel and steel products for 
which the QCOs are already in force, together with the list of steel products for which the 
implementation of QCOs has been deferred. The EU would also like to know whether India plans to 
further expand the scope of the steel and steel products Quality Control Order of 2020. Finally, does 
India plan to accept steel and steel products produced in line with internationally accepted standards 
and limit the list of steel and steel products falli ng under these QCOs?  
2.321.   In response, the representative of India provided the following statement. India has started 
granting licences to manufacturers whose audit was completed before the pandemic. If there are 
specific issues of concern, it is requested to share the details. As regards the auditing remotely, 
India is seized of the matter. There is no provision in BIS (Conformity Assessment) Regulations, G/TBT/M/85  
 
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  2018, to undertake virtual inspection or the use of recognised third -party certification of companies 
in the country of manufacturing to meet the QCO's in -person audit requirements for foreign 
manufacturing facilities. However, the Government of India is considering introducing relevant 
enabling provisions to undertake virtual/remote inspection for BIS conform ity assessment activities. 
G/TBT/N/IND/90  on 25 March 2019 is related to the Essential Requirement clause included in the 
QCO regarding "Stampings/laminations/cores of Transformers (with or without winding)" & 
"Stainless Steel Pipes and Tubes." In this regard, it may be noted enforce ment date for 
"Stampings/laminations/cores of Transformers (with or without winding)" was extended from 
30 June 2021 for another three months and is now in force from 1 October 2021 and "Stainless Steel 
Pipes and Tubes" is under enforcement since 16 June 2 020. Regarding the implementation of IS 
17404:2020 (Electrogalvanized hot rolled and cold reduced carbon steel sheets and strips), it may 
be noted that the date of enforcement was 22 June 2021.  
2.1.3.41   China - Cybersecurity Law (ID 52685) 
2.322.   The representative of Japan  provided the following statement. Japan continues to have 
concerns regarding the China's "Cybersecurity Law" and would like to refer to the previous statement 
we made at the last TBT Committee in June 2021. Japan is concerned with related enforcement 
regulation as well. Japan would like to request that China provide notification of the enforcement 
regulations to the TBT Committee and consider comments from stakeholders. In addition, Japan 
would like to request that China provide adequate lead time from com pletion of these regulations 
until their enforcement, and to implement these measures in a transparent manner.  
2.323.   The representative of the United States  provided the following statement. The United States 
remains concerned about this measure and we refer bac k to our previous statements.  
2.324.   The representative of the European Union  provided the following statement. The EU would 
like to refer to its statements at previous TBT Committees with regard to the Cybersecurity Law, 
namely that the scope of the requirements  is unclear as key terms have still not been specified in 
sufficient detail. The EU would like to request more clarity regarding several of the implementing 
measures of China's Cybersecurity Law. For example, the Cyberspace Administration of China's 
Cross -Border Data Transfer Measures continue to raise concerns about the broad scope of these 
regulations as to what is considered as critical information infrastructure and which kinds of cross -
border data transfers are affected. The definition of critical info rmation infrastructure appears to 
cover many commercial activities and whole sectors that have no connection to national security. 
Additionally, the list of what is considered important data is open -ended and this has not been further 
clarified by the rele ased draft for the Data Security Law in July 2020. As a result of the data 
localization and security assessment requirements, foreign companies operating in China could find 
themselves in a less competitive situation compared to domestic operators. The EU calls on China 
to implement the provisions in a non -discriminatory manner, respecting the principles of 
proportionality, necessity and technology neutrality, and ensuring adequate protection of intellectual 
property (IP). Furthermore, the EU would like to repeat its previous requests for clarifications on the 
relationship with existing Multi -Level Protection Schemes and the expected implementation timeline. 
The EU requests that China notify draft measures concerning any sectoral implementation to the 
WTO in  order to give adequate opportunity to Members and their stakeholders to comment on any 
subsequent developments.  
2.325.   The representative of Canada  provided the following statement. Canada continues to have 
significant concerns with China's suite of cybersecurit y and cryptography/encryption laws and 
related implementing regulations. This includes the Cybersecurity Law and the following measures 
that support it namely the Cybersecurity Review Measures, a new version of which was published 
for comment on 10 July 20 21 and, most recently, the Critical Information Infrastructure (CII) 
Security Protection Regulations, a final version of which was released on 17  August 2021. Among 
other things, Canada continues to have concerns regarding the lack of precision regarding t he two 
implementing measures' scope and adherence to the principles of the TBT Agreement. Regarding 
the revised Cybersecurity Review Measures, Canada was pleased to provide written comments to 
China on 23 July, expressing our concerns. Regarding China's ne w CII Security Protection 
Regulations, they raise a number of issues and questions for Canada: While Canada appreciates the 
inclusion of a broad definition of CII, Canada believes it is an open -ended, imprecise list of sectors, 
which does not permit compan ies to assess adequately whether their infrastructure is CII. Will the 
 
85 For previous statements follow the thread under ID 526 . G/TBT/M/85  
 
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  Public Security Department assist CII operators by consolidating and making publicly available the 
various security protection departments' determinations of what constitutes CII?  
2.326.   Canad a is also concerned terms used throughout the regulations could: (i) permit objectives 
other than legitimate national security goals; and (ii) result in uncertain IP protection. Examples of 
such terms can be found in the following provisions of the regulat ions: Article 4: The CII Operator's 
responsibility to "give full play to the role of the government and all aspects of society"; Article 11: 
The CII Operator's obligation to "timely report" any "major change" occurring to its CII; and Articles 
39-40: legal  liability when a CII operator "endangers cybersecurity or causes other consequences". 
China's CII Security Protection Regulations have been in effect since 1  September 2021, however, 
they were only published on 17 August 2021 and were never notified to th e WTO. This approximately 
2-week period is much less than the 6 -month period understood to be a 'reasonable interval' 
between final publication and entry into force. In closing, Canada believes that both the 
Cybersecurity Review Measures and Critical Infor mation Infrastructure (CII) Security Protection 
Regulations raise a number of other ongoing concerns: the absence of defined criteria operators of 
CII is to use in assessing a security threat; and the lack of a clear commitment to national treatment, 
MFN t reatment or the use of international standards.  
2.327.   The representative of Australia  provided the following statement. Australia appreciates 
China's efforts to consult with interested parties on its measures relating to cybersecurity, including 
China's May 2021  public consultation process on its revised draft Data Security Law and revised 
draft Personal Information Protection Law. We were pleased to make submissions to the Chinese 
Government as part of these public consultations. We welcome a number of the revis ions to these 
laws but continue to encourage China to provide as much detail as possible, especially when it comes 
to issues such as the scope of the laws. Australia reiterates that, consistent with the TBT Agreement, 
we expect that measures will be implem ented in a non -discriminatory manner and in a way that is 
no more trade restrictive than necessary. Australia further urges China to consider less trade -
restrictive measures that are reasonably available to achieve its objectives.  
2.328.   In response, the represen tative of China  provided the following statement. The 
Cybersecurity Law has been implemented since 1 June 2017. It is a basic, framework and 
comprehensive law in the field of cybersecurity in China. It clarifies the responsibilities and 
obligations of gove rnment authorities at all levels and related departments, network providers, 
users, etc. Since its implementation, it has played an important role in safeguarding the national 
cybersecurity. The purpose of enacting and implementing the cybersecurity law is  to safeguard the 
national cyberspace sovereignty, national security, social and public interests, and to protect the 
rights and interests of citizens, legal persons and other organizations.  
2.1.3.42   China - Encryption Law of the People's Republic of China by the O ffice of State 
Commercial Cryptography Administration (OSCCA) (ID 53486) 
2.329.   The representative of the United States  provided the following statement. We still remain 
concerned about this measure and we are referring back to our statements.  
2.330.   The representative  of Japan  provided the following statement. Japan continues to have 
concerns regarding the China's "Encryption Law" that entered into force on 1 January 2020 and 
would like to refer to the previous statement we made at the last TBT Committee in June 2021. 
Japan would like to request that China's regulation not hamper foreign companies' activities or 
market access to China.  
2.331.   The representative of the European Union  provided the following statement. The EU would 
like to reiterate its concern relating to the Cr yptography Law that came into force on 1 January 2020. 
The EU remains concerned about the wide scope of the law, in conjunction with the lack of clarity of 
a number of foundational concepts as well as the administrative procedures described in the text. 
These factors will negatively impact business confidence. The EU also notes with concern that the 
new law does not recognize China's previous commitment made in 2000 that the cryptography -
related regulation would only apply to products whose core function is  that of providing encryption 
– the so -called "Year 2000 Clarification" by the State Cryptography Administration (SCA). The EU 
calls on China to ensure that legal and regulatory requirements are based on a non -discriminatory 
basis, do not favour specific t echnologies, do not limit market access and do not lead to a forced 
 
86 For previous stateme nts follow the thread under ID 534 . G/TBT/M/85  
 
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  transfer of intellectual property. The EU urges China to guarantee the possibility for foreign invested 
enterprises (FIEs) to participate on an equal footing with domestic companies in the  production, 
research, development and sale of cryptography products on its market.  
2.332.   In response, the representative of China  provided the following statement. The Law on 
Cryptography of China took effect on 1 January 2020. The Law clearly stipulates that g overnments 
at all levels and relevant departments shall follow the principle of non -discrimination, and treat all 
parties equally including foreign -invested enterprises that engage in commercial cryptography 
research, production, sales, service, import, ex port, etc. China encourages voluntary technical 
cooperation in commercial cryptography based on commercial rules in the process of foreign 
investment. Administrative agencies and their staff are prohibited to force transfer of commercial 
cryptography techn ology by means of administrative measures.  
2.1.3.43   European Union - Organic production and labelling - Maté (erva -mate), 
G/TBT/N/EU/738  (ID 52487) 
2.333.   The representative of Brazil  provided the following statement. Brazil regrets having to raise 
STC 524 after being consistently reassured by the E U that Regulation (EU) 2018/848 would come to 
force on 1 January 2021. Brazil had raised this STC for the last time in the TBT meeting of November 
2019, in which the European Union stressed that erva -mate was not within the scope of the current 
organic Reg ulation (Regulation (EC) 834/2007) and there was no possibility to modify this. However, 
the EU noted that, as proposed by the European Commission, the new Regulation (EU) 2018/848 on 
organic production and labelling adopted on 30 May 2018 by the European Parliament and the 
Council included Maté under its scope. In September 2020, the EU notified a proposal for a regulation 
of the European Parliament and of the Council amending Regulation (EU) 2018/848 on organic 
production as regards its date of applicatio n and certain other dates (G/TBT/N/EU/738). Following 
its adoption, instead of entering into force on 1 January 2021, Regulation (EU) 2018/848 will now 
enter into application on 1 January 2022. The postponement of the entry into force of Regulation 
(EU) 20 18/848 shows the EU's disregard towards the matters presented by Brazil under this long -
standing STC. As we have stated in previous meetings, not including erva -mate in the organic 
product list without any technical or scientific justification was discrimi natory and more trade -
restrictive than necessary, and thus inconsistent with the TBT Agreement. Until January 2022, 
provided that no further postponements will be enacted, Brazilian producers will be denied access 
to EU markets on an equitable basis, and t heir losses are not expected to meet any sort of 
compensation.  
2.334.   In response, the representative of the European Union  provided the following statement. 
The European Union has replied to Brazil on this issue in previous TBT Committee meetings, as well 
as bilaterally. The new Regulation (EU) 2018/848 on organic production and labelling adopted on 30 
May 2018 by the European Parliament and the Council includes Erva Mate under its scope. The 
Regulation was due to enter into application on 1 January 2021. Neverth eless, following the on -
going COVID -19 crisis, the organic sector needed additional time to adapt to the new rules on 
production, controls and trade. The EU notified to the TBT Committee a draft Regulation postponing 
the entry into application of the organ ics Regulation by one year (G/TBT/N/EU/738). Regulation (EU) 
No 2020/1693 of 11 November 2020 amending Regulation (EU) 2018/848 on organic production 
and labelling of organic products as regards its date of application and certain other dates and was 
published in the Official Journal of the European Union on 13 November 2020.88 Therefore, new 
organic rules will enter into application on 1 January 2022. From this date, erva -mate will be included 
in the scope of Regulation (EU) 2018/848, as it is listed in it s Annex I.  
2.1.3.44   Russian Federation - Federal law No 487 -FZ, providing a framework for 
comprehensive use of special labelling and traceability of goods and Decision No. 792 -r 
specifying the goods to which labelling will apply and the dates of introduction of the  
mandatory labelling (ID 56789) 
2.335.   The representative of the European Union  provided the following statement. On 28  April 
2018 the Russian Government adopted decision No. 792 -R, listing goods which will be subject to 
mandatory marking. The EU has very serious  concerns on the proportionality of the measure: 
 
87 For previous statements follow the thread under ID 524 . 
88 OJ L 381, 13.11.2020, p.1.  
89 For previous statements follow the thread under ID 567 . G/TBT/M/85  
 
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  individual labelling and registration creates significant burden and cost, well beyond the cost of the 
individual labels. This may be justified for some products of high value and with a high record of 
count erfeit or tax evasion, such as tobacco products or furs. Therefore the EU requests that Russia 
reviews the scope of products covered by the measure so that this focuses on high -value products 
for which there is evidence of a high level of counterfeit and/o r tax avoidance. Though we commend 
the Russian government in its efforts to tackle counterfeiting, this measure includes technical 
regulations and will have a significant impact on imports from the EU and from other WTO Members 
to Russia. According to the Decision of 1995 of the TBT Committee, "Members are obliged to notify 
all mandatory labelling requirements that are not based substantially on a relevant international 
standard and that may have a significant effect on the trade of other Members". Therefor e, this 
measure should have been notified under the TBT Agreement before its adoption. The Russian 
government adopted Resolution No 515 on 26 April 2019 on the "marking of goods subject to 
mandatory labelling by means of identification". This measure also falls within the scope of the TBT 
Agreement and needs to be notified to the WTO.  
2.336.   Several categories of products have been covered so far. We would be interested to get 
confirmation as to what the next categories of products will be. The scheme will soon ha ve been in 
operation for over a year for certain categories of goods. The EU therefore wishes to enquire whether 
a regulatory evaluation is planned which weighs costs versus benefits of the implementation of the 
scheme so far. In accordance with good regul atory practice, such evaluation is unavoidable before 
consideration of a possible extension of the labelling and tracing requirements to further categories 
of goods. We ask the Russian Federation to take into consideration the European Union's comments 
to ensure that the implementation of this measure is not unnecessarily trade -restrictive, in 
accordance with the WTO TBT Agreement.  
2.337.   In response, the representative of the Russian Federation  provided the following statement. 
Russia previously explained its pos ition on this issue in this Committee and in the Council for Trade 
in Goods. The position holds. The objective of the Track and Trace System is to fight against illicit 
trade and to ensure that taxes due are paid. The system is needed for law enforcement. No law -
abiding company can compete with the one that is not paying taxes due. In this sense, the T&T 
system is levelling the playing field and lawful companies benefit from it. The concept of the system 
in respect of each product category is developed toge ther with the companies involved in 
manufacturing, imports and distribution of the respective products. The business community is 
extensively consulted before the approval of the system for each product. Mandatory implementation 
of the system for each prod uct category is preceded by voluntary experiment with importers, 
manufacturers and representatives of foreign stakeholders in order to ensure system performance 
and adjust it to specificities of production and distribution process of each product. Above -mentioned 
steps enable interested companies to shape new requirements as well as to prepare to them 
beforehand.  
2.1.3.45   European Union - Medical Device Regulation (MDR) and In Vitro Diagnostic 
Medical Devices Regulation (IVDR), G/TBT/N/EU/71/Add.1,  G/TBT/N/EU/72/Add.1  
G/TBT/N/EU/845  (ID 59490) 
2.338.   The representative of the United States  provided the following statement. As we have long 
noted, the United States supports the development and enforcement of a well -defined medical device 
regulatory system that assures the safety and performance of medical devices, especially now given 
the global health crisis we are facing. The one -year delay in implementation of the Medical Devices 
Regulation (MDR) to May 2021, provided some necessary relief. Additionally, we appreciate and 
support the continued utilization of remote audits to alleviate  the assessment backlog and ultimately 
ensure patients' continued access to much needed medical devices and in vitro  diagnostic tools. The 
US has previously expressed concerns regarding implementation of the in vitro diagnostics regulation 
(IVDR), and the continued access of US firms to the EU market. In particular, we are concerned 
about the number of Notified Bodies (NBs) approved to assess conformity to the IVDR, with only six 
such NBs approved as of October 2021. However, we note the recent notification  by the EU to the 
TBT Committee proposing a delay in the implementation of IVDR. We appreciate the recognition of 
the challenges around building adequate certification capacity under the legislation's timeline. We 
are still studying the proposed timeline a nd scope of products covered under the new notification, 
and we understand that the delayed implementation provides for a staggered extension based on 
the class of IVDR. Can you please provide a brief explanation of the new proposed timelines? We 
 
90 For previous statements follow the thread under ID 594 . G/TBT/M/85  
 
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  hope the Commission will continue to work with the United States as well as stakeholders to address 
any future challenges with IVDR implementation to avoid unintended adverse effects on patients.  
2.339.   We understand that the Commission intends to create harmonized European standards to 
demonstrate compliance with EU legislation rather than use existing international standards. We 
urge the Commission to use internationally recognized standards where possible to avoid duplicative 
efforts and additional burd ens on manufacturers to comply with separate harmonized standards - 
one for the EU and others for other international regulatory authorities. We note that in preparation 
for the implementation of the MDR, the Commission announced in January 2020 that a new  
nomenclature system, the European Medical Device Nomenclature (EMDN) system would be created 
to be the basis of the European Database on Medical Devices (EUDAMED). EUDAMED will include a 
Unique Device Identifier (UDI) module. The EMDN is based on the CND (Classificazione nazionale e 
internazionali), which is not harmonized with the well -established Global Medical Device 
Nomenclature (GMDN).91 The United States uses the GMDN as the basis for our Global Unique Device 
Identification Database (GUDID). GMDN was  developed with the support of ISO and the then Global 
Harmonization Task Force (now the International Medical Device Regulators Forum) and is widely 
adopted by the medical device industry and used by over 70 national medical device regulators to 
support t heir activity.  
2.340.   We are concerned that the Commission's selection of EMDN will undermine the 
interoperability of the two UDI systems (EUDAMED and GUDID) for tracking and reporting purposes 
and will pose several significant obstacles to the medical device and  healthcare community. 
Furthermore, the Commission has not addressed interoperability concerns, and has not made any 
progress on mapping EMDN to GMDN so as to harmonize the UDI systems and reduce duplication 
for industry. An additional consequence of the C ommission's adoption of EMDN is that it has 
encouraged other regulators and entities, like the World Health Organization, to adopt EMDN, 
creating duplicative requirements for the medical device industry, and thus possibly harming public 
safety. The EU has repeatedly stated in bilateral discussions and in published documents that it 
intends to map its nomenclature system to GMDN, but we have yet to see any action by the EU that 
demonstrates an attempt to map to GMDN. In fact, the EU recently published its Eu ropean Medical 
Device Nomenclature for public consultation which does not propose any steps toward mapping to 
GMDN. Could the EU explain what actions it is taking to map EMDN to GMDN?  
2.341.   The representative of Japan  provided the following statement. 1. We appr eciate the June 
update of the MDCG guidance publication plan. We request that public consultation be carried out 
prior to the publication of the MDCG guidance, and that the guidance that is published be made 
mandatory with a transition period. The mapping plan for EMDN (European Medical Device 
Nomenclature) and GMDN (Global Medical Device Nomenclature) mentioned in the MDCG guidance 
publication plan is still N/A (Not Applicable). We request that a publication schedule be set and that 
they be published as pl anned. Post -marketing surveillance and vigilance are required by the MDR. 
Though the plan for publication of guidance on post -market surveillance and vigilance has been 
described, we request that it be published promptly. 2. In June, we stated that we had received 
reports from many companies undergoing technical document review that there had been no 
progress since the start of the review, which was in all cases a lengthy period, and that it was not 
foreseeable that the review would be completed and certifi cates issued by the date of application of 
the MDR. Many companies also reported that despite more than one year having passed since the 
start of the technical document review, it remained incomplete and we also requested an 
investigation into the cause of  the delay and an explanation of the measures undertaken to improve 
the situation. However, there has been no improvement. We would like the regulatory authority to 
continue to investigate the cause and take measures for improvement.  
2.342.   3. In June, we stated that the MDR requires strict clinical evaluation of Class I, IIa and IIb 
medical devices. In order to prevent the MDR from becoming more trade -restrictive than necessary, 
we requested that you consider simplifying the clinical evaluation requirements for C lass I, IIa, and 
IIb medical devices in the same way as Japan's premarket certificate or the U.S. 510(k) regulations. 
We request that you continue to consider this matter. 4. We welcome that the European Commission 
has proposed a Regulation amending the tr ansition period for the IVD Regulation on 14 October 
 
91 The European Commission announced its decision to adopt CND via guidance:  
https://ec.europa.eu/health/sites/health/files/md_topics -
interest/docs/md_emdn_eudamed_nomenclature_en.pdf   
 G/TBT/M/85  
 
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  2021. We deeply appreciate that such a proposal to extend the transition period for three to five 
years depending on risk classifications of products needed to be certified by notified bodies. We are 
confident that this proposal would eliminate our grave concern that many of the IVD devices placed 
on the market would not be certified by the end of the transition period due to a lack of capacity to 
address the issue on the part of the notified bodies. Mean while, since only one guidance document 
on IVD has been issued since June 2021, we would again request prompt issuance of the guidance 
documents and provision of a timeline for their issuance as early as possible, as was requested in 
the previous (WTO/TBT)  meeting. 5. As for the harmonized standards of European regulations, 
despite the publication plan not being disclosed in the EU Official Journal, they were suddenly 
promulgated. Therefore, Japanese companies need to hastily develop a conformity plan and t ake 
action after the harmonized standards are promulgated. We request the release of the plan for the 
development and publication of harmonized standards for MDR and IVDR.  
2.343.   The representative of China  provided the following statement. China thanks the EU fo r the 
new notification, but still remain concerned about the IVDR. We are looking forward to the 
consideration of and reply to our following suggestions. 1. It is recommended that the new proposal 
to extend the IVDR transitional period could enter into for ce and the legislative process could issue 
without delay. 2. It is recommended to announce the laboratory authorization and preparation. 
According to the classification requirements of the IVDR regulation, in addition to applying for a CE 
certificate for e xporting high -risk products to the EU, an authorized laboratory is also required for 
inspection. Therefore, manufacturers need to consider the allocation of laboratory resources in 
advance while applying for product certification. However, the EU has not a nnounced the laboratories 
that have been authorized. In addition, the certification of high -risk products takes a relatively long 
time, and manufacturers cannot choose the suitable laboratory configuration and optimize them, 
which will increase the difficu lty of certification. 3. It is recommended to introduce guidelines under 
the IVDR regulations. For example: 1) The In Vitro diagnostic code and classification guidelines for 
enterprises to conduct classification sampling and determine the number accordingl y. 2) Technical 
guidelines under IVDR regulation, such as detailed technical guidelines of clinical performance 
evaluation, performance analysis of special products, certification of systems and supporting 
consumables, etc. 3) Detailed guidelines on how mo difications are determined.  
2.344.   The representative of Canada  provided the following statement.  Canada again wishes to 
echo the points raised by other Members regarding the implementation of this measure. We remain 
concerned that the number of notified bodies still appears to be insufficient to carry out the 
certification and approval activities provided for in the regulations. Canada supports the 
standardization of international medical devices classification and nomenclature. However, we are 
concerned that the European Union's new European Medical Device Nomenclature (EMDN) is not 
harmonized to the established Global Medical Device Nomenclature (GMDN) that is currently used 
by several major regulatory authorities. We are also concerned this new EMDN wou ld not be 
appropriate as a source for the WHO's International Classification, Coding and Nomenclature (INMD). 
Canada has concerns with the limited transparency and involvement of regulators, medical device 
manufacturers and industry stakeholders in the com parative analysis and the impacts of a new 
nomenclature, including any technical barriers to trade. Canada would like to also highlight the 
relatively low usage of EMDN globally, and reiterates Health Canada's continued position that the 
WHO's proposal to select EMDN as a global medical device nomenclature system is premature and, 
at a minimum, would need to be accompanied by a mapping exercise to support member States 
currently using other nomenclature systems. Canada would like to raise awareness of the r isks of 
incidentally causing complexities, costs and confusion in the medical device technology and 
healthcare sectors due to the creation of an additional and duplicative system.  
2.345.   In response, the representative of the European Union  provided the following  statement. 
The MDR officially entered into application on 26 May 2021. This new Regulation significantly 
improves and upgrades the regulatory system for medical devices, replacing the former two 
Directives. It is important to underline that the shift betw een the Directives to the MDR is a gradual 
one, facilitated by a grace mechanism, which is similar but more stringent approach than 
grandfathering. This mechanism allows that products in compliance with the Directives may continue 
to be in circulation unti l May 2025. As regards the IVDR, the Commission has been closely assessing 
the situation on the ground. It has become apparent that, due to the additional resources required 
to address the COVID -19 pandemic, national authorities, health institutions, Notif ied Bodies and 
economic operators will not be in a position to ensure the proper implementation and application of 
the Regulation from the date of application. With only six Notified Bodies designated so far, there is 
a grave shortage of capacity, making i t impossible for manufacturers to conduct the legally required G/TBT/M/85  
 
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  conformity assessment procedures in time. In addition, due to COVID -19 travel restrictions, Notified 
Bodies were not able to carry out the required on -site audits of manufacturers' premises to verify 
the manufacturing and other relevant processes. This risks significant disruption in the supply of a 
multitude of in vitro  diagnostic medical devices (e.g. HIV tests, pregnancy tests or SARS -CoV-2 
tests) on the European Union market.  
2.346.   As such, a dra ft measure proposing a staggered set of transition periods for devices that are 
required to undergo conformity assessment procedures involving a Notified Body has been submitted 
to the Committee on TBT. The length of the transition periods depends on the r isk class of devices, 
with shorter transition periods for higher risk devices and longer periods for lower risk ones. In 
addition, the notified draft proposes a deferred application of the requirements for "in -house 
devices", i.e. those made and used withi n the same health institution. Currently, we have 23 MDR 
designated Notified Bodies and 6 Notified Bodies under the IVDR, with more following in the pipeline. 
In addition, and pursuant to a January 2021 Commission Notice on audits and surveillance 
assessme nts under the MDR and IVDR, there is some more flexibility for member States to allow 
remote audits carried out by Notified Bodies, if the conditions set out within the Notice are met. Of 
the Notified Bodies that also have a Medical Device Single Audit Pro gram (MDSAP) designated 
auditing organization, 11 out of 13 have been designated so far under the MDR. These organizations 
cover some of the EU's trade partners such Australia, Brazil, Canada, Japan and the US. It is 
important to underline that the EU does  not expect to maintain the same number of Notified Bodies 
as currently existing under the Directives. Therefore, under the MDR/IVDR, the numbers will go 
down. Quantity is not and never has been an indication of capacity. As with anything related to 
demand  and supply, the market will adjust and has in fact already done so, as the 29 Notified Bodies 
already designated under the Regulations reportedly hold more than a significant share of the market 
and have, in addition, considerably up -scaled their capacity . 
2.347.   As regards implementation work, the Commission and member States are continuing work 
on implementing acts and guidelines. To date, there have been above 70 published guidance 
documents, including several key guidance on clinical requirements. On standard ization, we are 
happy to report significant progress, with the first publications in the OJEU of references of 
harmonized standards under the new Regulations in July 2021. New publications are currently 
underway and should take place by the end of 2021. Fu rthermore, the expert panels, who have a 
role in the conformity assessment procedures of certain high -risk products, are officially running and 
processing applications. Very recently, the IVD panel was launched and is now operational. In 
addition, the regi stration module of the EUDAMED database was made available on December 2020 
and the Unique Device Identification (UDI) registration module went live in September 2021. The 
remaining three EUDAMED modules will be made available once the system is fully func tional. As 
regards the UDI, allow us to underline the fundamental difference between the Unique Device 
Identification and the Nomenclature, which are two topics that seem to be confused in high -level 
discussions. While the UDI system employed in the EU is based on internationally agreed upon 
principles, the Nomenclature, also known as the language of use, will be different. This was a decision 
taken after careful assessment and consideration. The EU would like to stress, once again, that the 
EU's choice for  creating the European Medical Device Nomenclature was founded on the need for a 
sensibly structured nomenclature that is transparent, open, completely publicly accessible and 
downloadable for free. There are currently no other nomenclature systems offerin g those 
characteristics. It is important to clarify that the choice of this nomenclature does not constitute a 
barrier and to avoid misinformation and confusion in this respect. The EU is fully committed to 
ensuring that the new system provides a higher le vel of patient protection and counts on trade 
partners to encourage their manufacturers to meet these new requirements to ensure trade 
continuity.  
2.1.3.46   Qatar - Ministry of Public Health Circular regarding shelf life for cheese (ID 
60292) 
2.348.   The representative of t he European Union  provided the following statement. European Union 
would like to refer again to the Qatar's Ministry of Public Health Circular of 30 May 2019 establishing 
new import requirements for UHT milk and white cheese that entered into force the fol lowing day, 
on 1 June 2019. More recently, Qatar's Council of Ministers instructions were issued on 22 August 
2021 affecting imports of dairy products. These instructions expanded further the scope of dairy 
products covered under the Circular of 2019 and t he trade -restrictive measures cover now nearly all 
 
92 For previous statements follow the thread under ID 602. G/TBT/M/85  
 
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  dairy products. The EU regrets that Qatar did not notify any of these measures to the WTO, under 
neither the TBT nor the SPS Agreements. The EU would like to recall that the measure of 2019 is 
now in place  for over two years without any clarity provided by Qatar on when this measure will be 
lifted. Furthermore, the new measures issued since August 2021 create additional barriers to a wider 
range of dairy products impacting thus even more negatively on EU ex ported dairy products to Qatar. 
Therefore, the implementation of these rules is considered more trade disruptive than necessary, as 
compliance with these requirements is not feasible for a wide range of cheeses and milk products 
exported from the EU to Qat ar. 
2.349.   The EU is particularly concerned about the stringent restrictions on the shelf life that 
disadvantage imported products in comparison to local products, but also about certain product 
characteristics for milk products and cheeses, in particular the obl igatory addition of vitamins to milk 
and low -fat-only requirements for certain cheeses. These requirements are not in line with Codex 
Alimentarius relevant international standards, are not science -based and are not required to 
guarantee the safety of impor ted products. The measures therefore appear to be more trade 
restrictive than necessary to fulfil the legitimate objective of public health protection. In this context, 
the EU would like to refer to Articles 2.1, 2.2 and 2.4 of the TBT Agreement. The EU ur ges Qatar to 
suspend the application of both measures without further delay, align it to the WTO rules and comply 
with its notification obligations. The EU would like to thank Qatar for bilateral exchanges during the 
past months, which unfortunately have n ot yet resulted in an effective solution. The EU is prepared 
to continue work constructively with Qatar to resolve this important issue.  
2.350.   The representative of Qatar  did not provide a response to the concerns raised. A technical 
statement was circulated fol lowing the meeting.93 
2.1.3.47   Kingdom of Saudi Arabia - Saber Conformity Assessment Online Platform / 
Saleem Product Safety Program (ID 61594) 
2.351.   The representative of the European Union  provided the following statement. The 
implementation of the electronic certifica tion system SALEEM through the web -portal SABER remains 
a concern for the European Union. While we would like to thank the Kingdom of Saudi Arabia for 
engaging constructively in bilateral talks, the difficulties still have a major negative impact on the 
imports of several products from the European Union to Saudi Arabia. The sector of toys is 
particularly affected, but the system is being gradually extended to other products. While the 
conformity assessment requirements differ depending on the sector, sever al EU industries coincide 
in reporting their overly costly, burdensome and time -consuming nature. EU toy manufacturers 
continue to report difficulties related to obtaining a GCC Conformity Tracking Symbol (so -called 
GCTS) from notified bodies authorized by  Saudi Standards, Metrology and Quality Organisation 
(SASO). As mentioned in previous statements, to which we refer for details, the European Union 
would like to recall the main concerns related to the following issues: request for test reports; 
selection of representative item; and product imported without GCTS. In addition, we would be 
interested in having an update on possible revisions of existing guidance on the process of obtaining 
the GCTS. In conclusion, the European Union would like to invite the K ingdom of Saudi Arabia to 
ensure efficient and less costly procedures for all products including the new conformity assessment 
system. The European Union remains available to continue our bilateral discussion.   
2.352.   The representative of Switzerland  provided th e following statement. Switzerland remains 
concerned over the negative impact of the "Saber Conformity Assessment Online Platform" on 
bilateral trade with the Kingdom of Saudi Arabia. We would like to support the intervention made by 
the EU on this matter.  The registration and certification process remains costly, complex and time -
consuming for our exporters. The industry continues to report that recognized bodies require 
disproportionate fees when carrying out conformity assessment procedures. Depending on  the 
sector, strict conformity assessment procedures apply for products considered in their majority to 
be low -risk products. Furthermore, additional third -party certification and registration is required for 
the same low -risk products that already have be en certified and registered in the system. In 
particular for companies exporting quality products in small quantities, the registration and 
certification process leads to disproportionate costs and documentation requirements which is 
prohibitive to enter t he market. Switzerland would appreciate if the Kingdom of Saudi Arabia could 
ensure that the registration and certification process is not more strict than necessary to give 
 
93 G/TBT/W/760 . 
94 For previou s statements follow the thread under ID 615 . G/TBT/M/85  
 
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  adequate confidence that products fulfil the applicable requirements. Furthermore,  we encourage 
the Kingdom of Saudi Arabia to base the documentation and certification requirements on 
international standards, to implement clear and transparent guidelines and to ensure that the 
requirements are applied in an equal and uniform manner.  
2.353.   The representative of the United States  provided the following statement. The United States 
supports the concerns of the EU and Switzerland on this matter and will be submitting a statement 
that we made in the Council on Trade in Goods.95 We appreciate the bi lateral coordination we have 
had with Saudi Arabia this week.  
2.354.   The representative of Canada  provided the following statement. Canada would like to 
express its support for Saudi Arabia's goal of creating integrated systems that efficiently assess the 
safety of imported products. However, Canada is concerned by difficulties related to the 
implementation of the SALEEM electronic certification system through the Saber web -portal, which 
we believe has some overly costly, burdensome, time -consuming and unnecessary  characteristics. 
Our industry stakeholders report that the Notified Conformity Assessment Bodies, certified by the 
Saudi Standards, Metrology and Quality Organization (SASO), have applied requirements for the 
provision of product samples inconsistently. I n some cases, physical samples of all products in a 
group to be tested must be supplied, while in others only a representative sample from a group is 
needed. Furthermore, industry stakeholders report that Notified Bodies are charging companies to 
select th e representative items. We understand that Notified Bodies have also often required 
importers to provide redundant information, such as additional photos of already certified products, 
which is increasing time and bureaucratic burdens unnecessarily. We see k Saudi Arabia's 
consideration of providing more detailed guidance to Notified Bodies on how to implement the Saber 
platform in order to increase the efficiency of the system, reduce compliance costs and ensure 
consistency.  
2.355.   In response, the representative of the Kingdom of Saudi Arabia  provided the following 
statement. SALEEM programme works through the development of an integrated system of 
regulations and standards that conform to internationally recognized professional practices by 
developing a highly ef ficient system for measuring product safety indicators in the market through 
mechanisms and procedures that comply with the technical regulations of each product, especially 
essential requirements for health of human and animals, environment protection, an d to ensure the 
effectiveness of the services provided by legislative and regulatory bodies to achieve safety by 
conformity of those products to SASO Standards. Within this framework, SASO develops conformity 
assessment activities (certification, audit, in spection, and testing activities) in the Kingdom of Saudi 
Arabia to be one of the tributaries that raise the level of quality in the national industry and the 
safety of imported goods presented in the Saudi market. By accepting the conformity assessment 
bodies in the various conformity assessment activities, this process aims to ensure the efficiency of 
the outputs of the accepted conformity assessment bodies operating in the conformity verification 
activities within the systems and requirements of the tech nical regulations approved to provide the 
necessary activities according to the scopes of acceptance of these bodies.  
2.356.   Therefore, SASO chose to engage a notified third party responsible for granting conformity 
certificates in accordance with the internation al standard ISO/IEC 17067 as part of the Kingdom pre -
market approach. The main purpose of SABER is to improve the import experience and obtain the 
certificates of Conformity and shipment by using one platform integrated with other entities. SABER 
has reduc ed the time to 1 -7 working days compared to 7 -15 working days previously. In addition, 
SABER is linked directly to Saudi customs, which allows product clearance within 24 hours. Moreover, 
SABER is implementing UX design project to improve the experience fo r the importer in registering 
their product and applying for their required certifications. SABER has added bulk adding for products 
and bulk applying for the COC and continue its plan to improve the user experience in SABER. In 
terms of GSO toy regulation , GCTS tracking symbol must be issued through GSO platform. Once the 
GCTS is obtained, the shipment certificates can be easily issued through SABER platform. Please 
note that Saudi Customs is the entity responsible for the HS -code, and all HS -codes can be found 
on their website. Therefore, we recommend viewing their website to find the right HS -code that 
matches the product description. In addition, to find the requirement for each HS -code we advise to 
visit the website ( https://SABER.sa/home/hscodes ); worth mentioning that users of this website can 
search by using the first 6 digits since it matches the international HS -code.  
 
95 G/TBT/W/762 . G/TBT/M/85  
 
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  2.1.3.48   Mexico - Draft Amendment to Mexican Official Standard NOM -051-SCFI/SSA1 -
2010: General specifications for the labelling of pre -packed food and non -alcoholic 
beverages (ID 60896) 
2.357.   The representative of Costa Rica  provided the following statement. Costa Rica maintains its 
trade concern regarding Mexico's proposed front -of-pack nutrition labelli ng for food products. In 
recent years, Costa Rica has very much believed in, and defended, the importance of the work 
carried out within the Codex Alimentarius framework, and has given equal importance to scientific 
justification for the measures adopted b y each country, whether they be based on the Codex itself 
or on other technical or scientific evidence, as required by the Agreement on Technical Barriers to 
Trade. Given that the Codex Alimentarius is currently developing working materials on front -of-pack 
nutrition labelling, Costa Rica wishes to request once again that the Mexican delegation clarify its 
position regarding the work carried out in the Codex in this area. Costa Rica would like to reiterate 
the request made to the Mexican delegation at this Committee's previous meetings, to indicate the 
scientific basis or international reference standard used to define the key parameters of the standard 
in question, and to provide relevant justification for the use of the front -of-pack warning sign as 
supple mentary nutrition information, the scientific basis for setting classification parameters, 
according to which a product is considered to contain excessive calories, sugar, saturated fats, trans 
fats or sodium, given that they are not Codex -based.  
2.358.   Turning to the consumption by children of products containing added caffeine or sugar 
substitutes, Costa Rica requests the delegation of Mexico to refer to either the international reference 
standard used or the risk analysis establishing the risk posed to  children by the consumption of 
products containing these ingredients. Costa Rica believes that the measure adopted by Mexico could 
generate inconsistencies with TBT Agreement obligations, in particular those established in Articles 
2.2 and 2.4. Costa Rica  maintains its view in this Committee that, as things currently stand worldwide 
in light of the COVID -19 pandemic, the implementation of certain sanitary and phytosanitary 
measures that create additional restrictions or burdens, constitutes a challenge tha t hampers global 
economic recovery efforts, especially in developing countries that are reliant on international trade, 
such as Costa Rica. This is without prejudice to the power that Members have to adopt them if 
considered necessary. Costa Rica would be grateful if the Mexican delegation could provide 
information about the status of this draft Amendment.  
2.359.   In response, the representative of Mexico  provided the following statement. As has been 
mentioned in previous meetings of this forum, the delegation of M exico is participating actively in 
the front -of-pack labelling standard -setting work through the Codex Alimentarius. However, the lack 
of an international standard on the subject does not prevent a Member from issuing Technical 
Regulations on front -of-pack labelling on pre -packed foods and non -alcoholic beverages in order to 
protect and fulfil its legitimate public interest objectives. The technical and scientific evidence 
requested can be found in the bibliography of Mexican Official Standard NOM -051-SCFI/ SSA1 -2010. 
Regarding the questions on this measure, we invite those concerned to consult the information that 
was provided in previous Committee discussions and reflected in the minutes contained in documents 
G/TBT/M/80 , G/TBT/M/81 , G/TBT/M/82  and G/TBT/M/83 . In addition, it would be particularly 
relevant to recall that the Government of Mexico granted a period from 1  April to 31  May 2021 for 
the marketing of products without penalty if they only complied with the new front -of-pack labelling 
system on their labels, and not with other commercial and health information that came into force 
on 1 April 2021. This was so as to recognize the need for sto ck turnover of products that were 
already at the final point of sale to the end consumer before 1  April 2021. Furthermore, the use of 
adhesive materials to cover the label of origin is permitted, provided that they meet all the 
commercial and health inform ation requirements under NOM -051-SCFI/SSA1 -2010. The delegation 
of Mexico reiterates its willingness to clarify any doubts that the Members of this Committee may 
have on the implementation of this Technical Regulation. Such concerns may be sent in writing via 
the relevant contact point.  
 
96 For previous statemen ts follow the thread under ID 608 . G/TBT/M/85  
 
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  2.1.3.49   India – Toys (Quality Control) Order, 2020 (IND/131); Amendment in Policy 
Condition No. 2(iii) to Chapter 95 of ITC (HS), 2017 - Schedule -I (Import Policy) 
(IND/143), G/TBT/N/IND/131,  G/TBT/N/IND/143,  G/TBT/N/IND/68  (ID 63297) 
2.360.   The representative of the European Union  provided the following statement. The European 
Union remains concerned about India's Toys Quality Control Order and in particular the certification 
requirements introduced by the Bureau of Indian Standards (BIS). As of 1 January 2021, entry into 
force of the regulatory order, all toy imports have come to standstill. The order mandates that only 
toys with BIS marking may enter the country as of 1 January 2021. Factory audits by BIS auditors 
are a precondition to obtain th e necessary BIS marking. While domestic toy producers have had the 
opportunity to comply with regulatory order and BIS auditors have audited domestic facilities, the 
same cannot be said for plants in third countries. European companies have submitted the n ecessary 
applications well in time to furnish Indian authorities with the necessary information to enable factory 
audits by BIS auditors. Although officially factory audits abroad can now be done, this is still 
conditional on travel restrictions and BIS au ditors do not travel to countries depending on testing 
requirements or quarantine requirements. This represents a major challenge for European 
companies, as it means no certification in Europe so far. The European Union previously suggested 
to allow third -party audits or virtual audits of third country factories (such flexibility is allowed for 
domestic manufacturers). However, we understand that no progress has been made in this direction. 
Without any alternative measure, the requirement for factory certif ication/audits will remain highly 
problematic and European companies will continue to face unfair competition with local 
manufacturers. The European Union would be grateful if India could respond directly to the concerns 
raised.  
2.361.   The representative of the United States  provided the following statement. In the last three 
WTO TBT Committee meetings, the United States has urged India to provide a means by which 
foreign firms can comply with the foreign factory audit requirements of the Toys Quality Control 
Order 2020 (QCO). US firms remain unable to ship toys to India because they have no ability to 
comply with this portion of the QCO, given that India has been unwilling to accept virtual audits and 
will not conduct in -person audits due to COVID -19-related trave l restrictions on the part of India's 
Bureau of Indian Standards (BIS) authorities. One US company reports its last shipment of toys 
occurred over a year ago. At the June meeting, the Government of India noted, "There is no provision 
in BIS (Conformity Ass essment) Regulations, 2018, to undertake virtual inspection or the use of 
recognized third -party certification of companies in the country of manufacturing to meet the QCO's 
in-person audit requirements for foreign manufacturing facilities. However, the Go vernment of India 
is considering the introduction of relevant enabling provisions to undertake virtual/remote inspection 
for BIS conformity assessment activities." We request that India provide an update on this effort.  
2.362.   US industry reports that domestic ma nufacturing facilities have secured inspections from 
BIS authorities, thereby achieving compliance with the QCO's audit requirements, even as foreign 
firms have been unable to secure inspections abroad. US industry has shared reports that BIS has 
started, or is prepared, to conduct factory audits in countries that have lifted their quarantine, 
though this policy does not appear to impact any major toy -producing countries. The US requests 
that India ensure that its conformity assessment procedures are applie d so as to grant access for 
suppliers of imported toys under similar conditions to those accorded to toys produced domestically. 
This can be done by either temporarily waiving the Bureau of Indian Standards (BIS) foreign factory 
audit requirement until suc h a time when Indian inspectors can travel to all foreign facilities or 
implementing a system for conducting and accepting virtual audits in place of in -person audits. As 
the Government of India noted in June, the average time to grant a toy licence is "ge nerally four to 
six months after the scheduled factory audit." Therefore, it is unlikely that foreign exporters will be 
able to resume exports of toys to India until sometime in 2022, even if a solution to this problem is 
implemented immediately. We urge I ndia to address the concerns raised by several members and 
allow for virtual inspections as soon as possible.  
2.363.   The representative of China  provided the following statement. 1. According to the Toys 
(Quality Control) Order, 2020, the toys used by children un der 14 years of age shall conform to the 
corresponding Indian standards. All the toy companies exporting to India encounter repeated 
testing, factory inspection and other requirements. The cost of the certification is high, and it adds 
difficulties to smal l and medium -scale manufactures. During the certification process, an additional 
US$10,000 deposit, application fee, annual licence fee, ISI logo fee are required, which increase the 
 
97 For previous statements follow the thread under ID 632 . G/TBT/M/85  
 
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  cost of the enterprise and cause obstacles to international trade, which is against Article 5.1.2 of the 
TBT Agreement. It is recommended that the Indian Government could consider as much as possible 
not to increase too much cost of enterprises, and only select high -risk toy categories for mandatory 
certification. 2. The Toys ( Quality Control) Order 2020 stipulates that the certification process is 
subject to conformity testing from third party laboratories. But at present, the third -party 
laboratories of BIS approved toy standards IS 9873 and IS 15644 are all located in India. It is 
difficult for Chinese companies to send samples for inspection, which affects the testing efficiency. 
It is recommended that the third -party laboratory could include all ILAC -accredited laboratories.  
2.364.   3. The Toys (Quality Control) Order 2020 came into  force on 1 January 2021, and great 
changes are incorporated into compulsory certification. The certification process is complicated with 
many procedures. Enterprises need to prepare a lot of product certification materials. The factory 
inspections are req uired, and the audit cycle is lengthy. Moreover, the impact of COVID -19 epidemic 
makes factory inspections difficult. Therefore, foreign toy certification is suspended in India. The 
transition period is too short, it is inconsistent with Article 5.9 of the  TBT Agreement. It is 
recommended that the India could give a transition period at least two years and allow online audits 
of foreign factories in terms of factory inspections. 4. In October 2020, the BIS issued the document 
of 10 steps to BIS licence for toys on its official website, in which step 4 stipulated that factories 
producing electric toys should be equipped with instruments required by IS 15644:2006 Clause 8, 9 
and 10. But some tests require expensive and technically demanding equipment that is b eyond the 
ability of small and medium -sized enterprises and those tests are often done by third -party 
laboratories. The equipment requirements are therefore unnecessary and unreasonable. According 
to Article 5.1.2 of the TBT Agreement, it is suggested that  India could cancel the equipment 
requirements for electric toys and other projects. 5. According to newly revised Policy Condition No.2 
(iii) to Chapter 95 of ITC (HS), 2017 -Schedule -I (Import Policy), samples are randomly sent to 
NABL -accredited labs for  testing and clearance is made while samples are tested and qualified. It 
seriously affects the efficiency of customs and increased the importer's storage costs, which does 
not comply with Article 5.1.2 ，Article 5.2.1 and Article 6.1 of the TBT Agreement. I t is recommended 
that the Indian Government could release the products based on the certificate of conformity issued 
by a laboratory accredited by NABL or ILAC.  
2.365.   The representative of Canada  provided the following statement. Canada continues to 
question the  objective of India's requirement that toy manufacturing sites be inspected by Bureau 
of Indian Standards personnel to verify, among other things, production processes and plant layout, 
and to collect product samples. Beyond being costly and time consuming , because Indian inspectors 
are unable to travel due to COVID -19, the inspection requirement is preventing any toy shipments 
from entering India. Until such time as inspectors are able to resume international travel, at a 
minimum, Canada seeks India's agre ement to allow virtual plant inspections. In addition, we 
continue to seek responses to the written questions Canada sent to India in April 2020 that raise the 
following concerns: - the need for in -country product testing when testing by ILAC certified lab s is 
available; - the failure to use international standards; - the requirement to nominate and retain an 
in-country Indian representative; - the need to provide a performance bank guarantee; and - the 
value of providing an indemnity bond. Canada looks for ward to working with India to ensure access 
to safe, high quality toys from Canadian firms.  
2.366.   In response, the representative of India provided the following statement. Foreign inspection 
visits are on hold due to international travel restrictions on account  of current pandemic. As soon as 
the situation of COVID -19 improves and the restriction lifted, India will plan the inspections (factory 
visit). BIS has recognized a number of laboratories for carrying out toys testing as per various parts 
of IS 9873 and I S 15644 (Safety of Electrical Toys). All of these laboratories are currently running 
normally. The IS -wise list of recognized laboratories is dynamically updated and is available on the 
BIS website. Department for Promotion of Industry and Internal Trade ( DPIIT), Ministry of 
Commerce and Industry has issued the Toys (Quality Control) Order, 2020 under the provisions of 
BIS Act, 2016 and Rules and Regulations framed thereunder, which envisages conformity 
assessment scheme -I of BIS (Conformity Assessment) reg ulations, 2018. As per Scheme I of 
Schedule II of BIS (Conformity Assessment) Regulations, 2018, the applicant must submit a 
complete test report of the product issued from a third -party laboratory and the application. The 
testing of sample drawn during th e factory inspection is also carried out in a third -party laboratory. 
Under Scheme -I, a third -party laboratory is defined as "a laboratory established, maintained or 
recognized by the Bureau or Government laboratories empanelled by the Bureau or any other 
laboratory decided by the Bureau's Executive Committee".  G/TBT/M/85  
 
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  2.367.   As regard marking and labelling requirements, under the Scheme -I, BIS licence will be 
granted to a manufacturer of toys as per the Indian Standard and all varieties (maybe called 
items/families/model s/SKU etc.) of toys covered in the standard will get covered under the same 
licence. No separate application and standard mark are required to cover families of similar toys. 
Further, to cover all the varieties in a standard under the licence, BIS will be issuing grouping 
guidelines intending to specify a minimum number of varieties of toys to be tested to consider 
covering a larger number of varieties in the scope of the licence. This will be with the aim of optimum 
testing to ensure the safety of all toys  for children. The marking of standard mark concerning 
standard and licence number is a requirement as per the provision of BIS (Conformity Assessment) 
Regulations and applies to all manufacturers in India as well. The standard mark is essential for the 
common consumer to understand and identify that product is certified and safe to use. This is already 
in practice for more than 200 products under mandatory certification and being implemented by 
more than 1,000 manufacturers of various countries under the F MCS scheme of BIS. As per the Toys 
(Quality Control) Order, 2020, every toy shall conform to corresponding Indian Standards specified 
therein and shall bear the standard mark under the licence from BIS as per Scheme -I of BIS 
(Conformity Assessment) Regulat ions, 2018. Under the provisions of Scheme -I, BIS grants a licence 
to use or apply Standard Mark (ISI mark) on goods and articles as per Indian Standard and not as 
per International Standards. IS 9873 (Part 1,2,3,4 & 7), specified in the QCO, are identical  with 
International Standard ISO 8124 (Part 1,2,3,4 & 7). Part (9) of IS 9873 is an indigenous standard 
published to restrict certain phthalates esters in toys and children products. However, the test 
method used is identical to ISO Standard. Further, IS 1 5644 is also identical with International 
Standard IEC 62115.  
2.1.3.50   Australia - Maturation requirements for imported alcohol (ID 63698) 
2.368.   The representative of Brazil  provided the following statement. Brazil continues to follow 
closely Australia's proposal to amen d current regulations dealing with alcoholic beverages. In past 
Committee meetings, we have shared our concerns with Australian technical requirements applicable 
to cachaça, the Australian Customs Notice Nº 2007/19, which requires that some alcoholic bever ages 
must be matured in wood for a minimum of two years before delivery from Customs control. This 
covers all beverages under tariff classifications 2208.20.10, 2208.30.00 and 2208.40.00. Even 
though said Notice only refers directly to brandy, rum, and whi sky, it encompasses tariff line 
2208.40.00 (rum and other spirits obtained by distilling fermented sugarcane products), under which 
cachaça is classified in Australia. By granting the same treatment to cachaça and rum, the Australian 
Government does not al low imports of cachaça that are not matured for at least two years in wood. 
Such a requirement does not relate to any quality standard or sanitary requirement applicable to 
cachaça.  
2.369.   Following a public consultation in late -2019, the Australian Border Force (ABF) further 
explored a potential avenue to amend the Customs Act 1901 (Customs Act) that would enable the 
legitimate importation of certain alcohol products into Australia whilst retaining the maturation 
requirements for brandy, whisky, and rum. Accordin g to a more recent public consultation, the 
Australian Government is developing an approach that is looking to retain Australia's existing 
maturation requirement for imported brandy, whisky, and rum, but would establish a list of products 
exempt from this maturation requirement. The proposed list of exempt products would include 
Cachaça and Pisco and Bourbon. Brazil acknowledges progress in the course of action proposed in 
the last public consultation. We support the creation of a list of exceptions to the rules set out today 
in section 105A, thus allowing certain cultural and geographical indications (i.e. Cachaça) that are 
not traditionally described as brandy, whisky or rum to be imported into the Australian market. In 
order to avoid any confusion in the Australian market or among Australian consumers, we support 
that none of the sugar -cane products imported to Australia (matured or unmatured) that are not 
specifically "rum" should be labelled or marked as "rum". We kindly urge Australia to answer the 
following questions, which have not been addressed in its previous statements. Could Australia 
please confirm if this new regulation will also establish new labelling requirements for products other 
than rum, brandy and whisky? Could Australia provide timefram es for the publication of the final 
text? 
2.370.   In response, the representative of Australia  provided the following statement. We thank 
Brazil for its interest in Australia's review of maturation requirements for imported alcohol and 
provide the following update  to the matter raised by Brazil. Australia applies equivalent requirements 
 
98 For previous statements follow the thread under ID 636 . G/TBT/M/85  
 
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  on domestic manufactured products and imported products that are classified as whisky, brandy or 
rum to be matured in wood for a period of at least two years. These requirements are  applied through 
the Excise Act 1901 and Customs Act 1901 (Customs Act) respectively. Australia is continuing to 
review its legislative framework for the importation of unmatured alcohol products under section 
105A of the Customs Act. In November 2020, the  Australian Government undertook stakeholder 
consultation, through the release of a consultation paper, to seek views on a refined proposed 
approach to amend section 105A of the Customs Act. The consultation paper was provided directly 
to the participants of the previous consultation sessions, including the Brazilian Embassy in 
Canberra, and is available on the Department of Home Affairs website.99 Australia acknowledges 
Brazil's engagement on the review of Australia's maturation requirements for alcohol. 
Representatives from the Brazilian Embassy participated in both the 2019 and 2020 consultation 
processes, led by the Australian Border Force (ABF). The ABF is taking the issues and specific 
questions raised by Brazil into consideration. The Australian Gover nment is currently considering 
potential reform options. Any proposed changes will be notified to the Committee in accordance with 
Australia's obligations under the TBT Agreement after all necessary Australian Government 
processes have been undertaken rega rding any potential legislative changes. Australia appreciates 
the positive engagement with Brazil to date including recent bilateral discussion on this matter.  
2.1.3.51   India – FSSAI's Food Safety and Standards (Food Products Standards and Food 
Additives) Regulati ons, 2011 and the new implementing veterinary certificate for dairy 
products (ID 633100) 
2.371.   The representative of the European Union  provided the following statement. India has 
adopted in December 2019 a new veterinary import certificate for milk and milk prod ucts based on 
Food Safety and Standards Regulation 2011, that is of great concern to the EU. The provisions of 
FSSAI's Regulation defines cheese as a "product produced from non -animal rennet or another 
suitable coagulating agent, which applies equally to b oth domestic and imported foods". It was 
however still possible for cheese containing animal rennet to access the Indian market provided that 
it was correctly labelled. The new veterinary certificate requires that milk products have not been 
manufactured u sing animal rennet. As most European cheese is traditionally made with animal 
rennet, this means that there is a de facto ban for European cheese entering the Indian market. 
Similar difficulties arise for cheese by -products, such as whey and lactose. While  the EU fully 
supports the importance of labelling the presence of animal rennet, the EU considers that this new 
certificate is not proportionate and not in line with the TBT agreement. Veterinary certificates are to 
address sanitary (human or animal) heal th issues. There is no scientific evidence that cheese 
produced with animal rennet is harmful to health, or more harmful than cheese produced with 
artificial/vegetal rennet. We therefore would ask India to change the provisions of that veterinary 
certifica te and allow for a label clearly indicating the presence of animal rennet in the cheese and its 
by-products, as it was previously the case. This label would allow consumers to make an informed 
choice.  
2.372.   In response, the representative of India provided the f ollowing statement. The provision for 
non-animal rennet in cheese manufacture is not newly introduced in our regulations. This provision 
has been existing in our Food Safety and Standards Regulations (FSSR) notified in 2011 and the 
erstwhile Prevention of Food Adulteration Rules as well. During a recent revision of the milk and milk 
product standards in FSSR, these provisions were retained as such and continue to be a specified 
requirement. The requirement of a veterinary certificate has been recently align ed with our FSSR 
regarding the prohibition on the use of animal rennet. Hence, FSSAI has not introduced any new 
requirement.  
2.1.3.52   India - Order related to requirement of Non -GM cum GM free certificate 
accompanied with imported food consignment, G/TBT/N/IND/168  (ID 651101) 
2.373.   The representat ive of the United States  provided the following statement. The United States 
once again reiterate its serious concerns with India's measure mandating "non -GM (genetically 
modified) origin and GM free certificates" for certain agricultural imports into Indi a, notified on 2 
September 2020, as G/TBT/N/IND/168 , and a later notified entry -into-force date of 1  March 2021. 
The United States submitted comments on G/TBT/N/IND/168  to the WTO on 30  October 2020. The 
 
99 www.homeaffairs.gov.au/reports -and-publications/submissions -and-discussion -papers   
100 For previous statements follow the thread under ID 633 . 
101 For previous statements fol low the thread under ID 651 . G/TBT/M/85  
 
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  United States would like to remind India of our previous statements delivered at the October 2020, 
Febru ary 2021, and June 2021 TBT Committee meetings, which detailed our continued concerns 
regarding India's implementation of this measure. We have also proposed technical cooperation with 
the Food Safety and Standards Authority of India (FSSAI) to explore alt ernatives, an offer which has 
not been accepted. The United States again urges India to withdraw this requirement. India has 
neither provided science -based justification nor referenced any international standards for this 
measure despite numerous requests from multiple trading partners.  
2.374.   The representative of the European Union  provided the following statement. On 21  August 
2020 India issued an Order relating to the requirement of non -GM cum GM free certificate 
accompanied with imported food consignment, not ified on 2 September 2020. This order entered 
into force on 1 March 2021. The EU shares India's food safety concerns. However, we would like to 
highlight the following concerns: 1. The criteria for the selection of the 24 food crops listed in 
Annexure 1 is  not clear. The EU invites India to explain the rationale behind such selection. 2. Non -
GM origin cum GM -free certification per consignment should not be required, at least for the listed 
crops for which no GMOs are authorized in the exporting country for food use. For the EU, this applies 
to 19 out of the 24 crops listed in Annexure I. For these 19 crops, by law there is no authorization 
for GMOs in the EU. Therefore, no certificate should be requested to avoid imposing an unnecessary 
administrative burden . 3. For listed crops for which GM varieties are authorized in the exporting 
country (for the EU, this applies to maize, soybean, cotton, Argentina canola, and sugar beet) a 
requirement to produce a certificate for every consignment is not justified. Such a burdensome and 
expensive measure should only be imposed where recurrent non -compliance has been established 
by official controls. To date, we have not received any information from India indicating that there 
were identified instances of non -compliance w ith GM requirements by the EU.  
2.375.   4. India should explain why it considers it necessary to impose such a burden on trading 
partners with a high prevalence of non -GM food on their domestic market and a robust regulatory 
regime governing the use of GMs. The EU  underlines that in addition to the fact that only a limited 
number of the food crops referred to in the Annexure are authorized to contain GMs, there are very 
strict traceability and labelling requirements applicable to food that contains GMOs. This allow s a 
strict and effective separation between non -GM and GM products, with the exception of those 
containing GM ingredients in a proportion of less than 0.9%, provided that the presence is 
adventitious or technically unavoidable. This means that the EU's tol erance limit is even stricter than 
that indicated by FSSAI in its clarification dated 8 February 2021, i.e. 1%. 5. The EU as well as India 
are both parties to the Cartagena Protocol on biosafety to the Convention on Biological Diversity. 
The EU adopted Reg ulation 1946/2006 on transboundary movements of genetically modified 
organisms. According to Article 12(2) of this Regulation, exporters of GMOs intended for direct use 
as food or feed or for processing must accompany their exports with a document stating that the 
export contains or consists of GMOs. This obligation for accompanying documentation of GMOs 
provides the necessary reassurance to the importers and to the authorities. Therefore, we consider 
that the additional certification of non -GM food is not needed and is unjustified. In conclusion, the 
existing EU regulatory provisions already offer satisfactory assurance that EU produce exported to 
India is in compliance with Indian's requirements. The Indian requirement goes beyond what is 
necessary to achi eve the stated objective and puts an additional burden and costs on EU exporters. 
The EU considers that the Order is disproportionate and creates unjustified barriers to trade. The EU 
would be grateful if the above -mentioned comments could be taken into ac count and replied to.  
2.376.   The representative of New Zealand  provided the following statement. New Zealand 
acknowledges and supports measures that focus on legitimate objectives, including the protection 
of human health and safety. New Zealand remains concerned  that India's requirements regarding 
non-GM certification for specific foods is imposing further restrictions and costs on existing trade in 
goods covered by the measure. New Zealand encourages India to accept a country -wide assurance 
as an alternative con signment -based non -GM certification. We would appreciate clarification on what 
consideration India has accorded to less trade -restrictive alternatives for those countries that have 
not approved the release of any genetically modified crops into the environ ment. New Zealand again 
notes the measure is implemented under India's food safety legislation. If the protection of human 
health is the objective, in whole or in part, can India advise whether it intends to also notify the 
measures to the SPS Committee, g iven its relevance to provisions within the SPS Agreement, 
particularly Codex Alimentarius? We refer to New Zealand's more detailed written submission of 
2 September 2020 on India's notification G/TBT/N/IND/168  which outlines its concerns that remain 
relevant today. We refer India to the comments New Zealand made on this measure at the most 
recent meeting of the SPS Committee. New Zealand strongly requests India adopt the least trade -G/TBT/M/85  
 
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  restrictive alternative/s for those countries that have not approved the release of any genetically 
modified crops into the environment.  
2.377.   The representative of Colombia  provided the following statement. Colombia supports this 
trade concern regarding the requirement for a certificate demonstrating that imports of various 
products, including fresh fruit, vegetables and grains, are free from genetically modified organisms 
(GMOs). The certificate must be issued by the relevant national authority of the exporting country. 
We reiterate our concern about this measure and, in particular, about the way in which it will be 
implemented. Account should be taken of the fact that curre ntly not all analytical techniques to 
check for genetically modified foods have been developed or certified, meaning that the measure 
may become an unnecessary obstacle to trade. It should be noted that developing countries in 
particular have neither the t echnical capacity nor the technologies needed to conduct the relevant 
analyses concerning GMOs. Furthermore, there is a lack of clarity as regards the products covered 
and the requirements for market access. We request India to provide information on the e ntry into 
force of this regulation, and we reiterate that a reasonable interval should be allowed between the 
publication of technical regulations and their entry into force, in order to allow time for exporters, 
and particularly those in developing countr ies, to adapt their products or production methods. Lastly, 
we call upon India to consider alternative ways to avoid the creation of unnecessary obstacles to 
international trade and to re -submit the notification of the regulation in order to have access to  the 
relevant information.  
2.378.   The representative of Canada  provided the following statement. Canada would like to 
reiterate concerns raised at previous TBT Committee meetings, SPS Committee meetings, and the 
Council for Trade in Goods regarding the implementa tion of India's August 2020 Order, which 
mandates that a non -genetically modified or GM free certificate accompany imported consignments 
of 24 imported food products. As detailed in Canada's comments submitted through India's TBT 
Enquiry Point in October 2 020, we are concerned that India's Order will disproportionately impact 
the ability of GM -producing countries to export to India and unnecessarily restrict international trade. 
It also remains unclear how this Order will fulfil India's commitment to ensuri ng the health and 
safety of its population given the lack of available scientific information and/or justification to justify 
its implementation. To date, India has not provided a satisfactory response to our questions and 
concerns. Canada encourages India  to consider a less burdensome approach to meet the Order's 
stated food safety goals. As previously stated, the robust, science -based regulatory frameworks 
developed in countries around the world, including in Canada, should be considered as they assess 
the risks of GM food products prior to their approval and commercialization. These products are 
authorized for commercialization only once they have received appropriate safety approvals. Until a 
satisfactory solution is found and to minimize potential trade  disruptions, Canada again requests 
that India suspend the implementation of this measure and that trade be permitted to continue 
without a certificate requirement. This would allow for further engagement with Members to discuss 
and consider an alternate, less trade -restrictive measure to meet India's intended objective. Finally, 
given the Order's stated objective "to ensure the safety and wholesomeness of articles of food 
imported into India", Canada reiterates its request that India notify the non -GM Orde r to the SPS 
Committee.  
2.379.   The representative of Australia  provided the following statement. Australia thanks India for 
its ongoing engagement and cooperation regarding the use of Non -GM with GM free certificates. 
Australia recognizes the right of the Indian Government to take measures necessary to ensure the 
safety and wholesomeness of food imported into India. However, Australia remains concerned with 
this measure and reiterates that measures should be risk -based and no more trade restrictive than 
necessary.  Australia is concerned that aspects of the regulation add unnecessary costs and create 
an additional regulatory burden on both Australian exporters and Indian importers. Australia 
suggests India consider adopting an alternative arrangement to achieve its objective in a less trade -
restrictive way. We would be happy to work with India on developing a mutually beneficial alternative 
solution. Australia welcomes and looks forward to India's continued engagement on this issue.  
2.380.   The representative of Argentina  provided the following statement. Argentina would like to 
express its concern once again regarding the new Order issued by the Food Safety and Standards 
Authority of India (FSSAI), notified in document G/TBT/N/IND/168 , which requires imports of food 
products to have a certificate of Non-GM product origin. We stress the importance of basing any 
measure of this type on scientific principles so that it does not become an unnecessary barrier to 
international trade. Scientific evidence shows that duly authorized GM products are as safe as their 
conventional equivalents and there is no justification for discriminating between one or the other. G/TBT/M/85  
 
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  We hope that India will amend the notified Order as soon as possible. We recall that we have already 
submitted more detailed comments and specific que stions through the TBT Focal Point and hope 
that they will be reviewed by the Indian authorities in order to safeguard the normal flow of trade in 
agri-food products.  
2.381.   The representative of Paraguay  provided the following statement. Paraguay reiterates its 
support for this specific trade concern regarding the Order issued by the Food Safety and Standards 
Authority of India (FSSAI) requiring imports of food products to have a certificate of non -GM origin. 
The rules apply to 24 food products, requiring the sub mission of an official certificate attesting that 
the imported products have not been genetically modified, but we have not identified the criteria 
considered by India for the selection of these products. Furthermore, we endorse the comments 
made by other Members regarding India's failure to submit or identify the implementation of a 
regulatory impact assessment, scientific evidence or risk analysis underpinning the measure. 
Moreover, we are concerned that this measure may generate the unjustified assumptio n that 
GM foods evaluated and approved on the basis of sound regulatory processes are less safe than 
non-GM food products. GM products have been subjected to rigorous science -based safety 
assessments in line with international standards, guidelines and rec ommendations to ensure that 
they are considered as safe as their conventional counterparts. In view of the above, Paraguay 
considers that India's rules could restrict trade by creating additional trade barriers, and we therefore 
request India to reconsider  its measure. Paraguay also recalls that, together with other members, it 
submitted a note in January to the Government of India with the above -mentioned concerns and it 
looks forward to receiving a reply from India further to its consideration of the said  note. 
2.382.   The representative of Uruguay  provided the following statement. Uruguay would like to 
thank the delegation of India for publishing its response in eAgenda ahead of this meeting. Uruguay 
recognizes India's right to take measures to guarantee the safe ty of food and the health of its 
population. However, Uruguay wishes to recall that there is consensus internationally that genetically 
modified products, approved by exporting countries on the basis of Codex recommendations in 
relation to the risk assessm ent methodology, are equivalent to their conventional counterparts. 
Therefore, in Uruguay's view, there would not appear to be any technical justification for the 
implementation of the certification measure proposed by India, taking into account the legiti mate 
objective, cited in the Order in question, of ensuring the safety and wholesomeness of imported 
food. Bearing in mind the above -mentioned objective, we would like to reiterate the invitation to the 
delegation of India to notify this measure to this Or ganization's Committee on Sanitary and 
Phytosanitary Measures. Uruguay wishes to stress the importance of Members establishing measures 
based on scientific principles and particularly of applying such measures with the objective of 
minimizing the negative trade effects, in line with the provisions of the TBT and SPS Agreements. 
Lastly, we wish to reiterate that we continue to await a reply to the joint note submitted by a number 
of countries, including Uruguay, in New Delhi in January this year.  
2.383.   The represe ntative of Japan  provided the following statement. Japan shares the concerns on 
India's measure requiring "non -GM origin and GM free certificates" for 24 agricultural products 
imported to India, because this measure would create unnecessary trade barriers and have negative 
impacts on agricultural trade between India and other WTO Members. It is very regrettable that for 
Japan the order has come to effect this March, despite our request to consider the comments and 
concerns from Member countries to India. If  the food items have already been appropriately 
managed in the exporting Members, the requirement to attach the "non -GM origin and GM free 
certificates" is unnecessary and excessive measure, because India would have no chance to import 
unsafe food under th e safety inspection system by the exporting Members. Japan ensures the safety 
of GM food by controlling import, distribution, and also cultivation under the Japan 's domestic 
regulations. The GM races not approved by this safety inspection system is not imported to Japan 
nor distributed domestically. Therefore, Japan would like India to waive the requirement to attach 
the certificate for food items from members if these Members manage GM food appropriately.  
2.384.   In response, the representative of India provide d the following statement. The requirement 
to regulate the import of GM food is not new. It already exists under the Environment Protection Act 
(1986). This requirement is already notified to WTO and is not trade restrictive as it is uniformly 
applicable t o import from all countries. The FSSAI order 21 August 2020 made it mandatory for the 
24 identified commodities to be accompanied with a Non -GMO origin cum GM -free certificate issued 
by a competent national authority of the exporting country. On similar li nes, India has been issuing 
such certificates for its exports to other countries. The Government of India has authorized Export 
Inspection Council (EIC) as the nodal agency for issuing Non -GMO certificates for export G/TBT/M/85  
 
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  consignments. EIC is issuing more than 9000 Non -GMO certificates for the export of Primary food 
crops as well as processed food products for export to several countries. It may be noted that the 
said Order is not trade restrictive as the consignments of the identified commodities are already 
being accepted for import to India along with the Non -GM origin cum GM Free Certificate in the 
prescribed format. Section 7 of The Environment Protection Act (1986) and its Rules prescribes that 
no person shall import or export genetically engineered organis ms/substances or cells except with 
the Genetic Engineering Approval Committee (GEAC). DGFT Notification No.2 (RE -2006)/2004 -2009 
dated 7 April 2006 on "Import of Genetically Modified Food" states that import of GMOs/LMOs for 
Food will be governed by the pr ovisions of the Environment Protection Act, 1986 and Rules 1989. 
GEAC has so far not approved any of the crop varieties of Genetically Modified/Engineered origin 
listed on the Order mentioned above. The requirement of a Non -GM certificate for import of 24 food 
crops is an assurance required from Competent Authorities of exporting countries that the food crops 
exported to India are of Non -GM origin and GM -free. 
2.1.3.53   Russian Federation - Federal Law n° 468 on wine making and wine growing in 
the Russian Federation (ID 650102) 
2.385.   The representative of the European Union  provided the following statement. Russia has 
adopted the "Federal Law Nº 468 -FZ of 27.12.2019 on wine making and wine growing in the Russian 
Federation". This measure has not been notified to the WTO. On 2 July 2021, a new set of rules 
entered into force after signature by the President of the Russian Federation of Federal Law N°345 -
FZ. It amends three Federal Laws, including the Russian Winemaking Law 468. This new law passed 
through Duma very quickly and  entered into force immediately, without a transitional period. This 
has created trade disruptions in the immediate aftermath and legal uncertainty for the operators, 
both at national and international level. Government Resolution N°1807 of 22 October 2021  was 
published and appears to lead to a suspension of the inspections and control of compliance regarding 
the classification of products. We would like to get clarification on the impact of the resolution on 
imported products which have not yet gone throug h Russian customs. We urge Russia to commit to 
predictable and transparent trade rules, including in the wine and spirits sector.  
2.386.   A process of alignment of EAEU TR47 is currently on -going. The EU sent proposals of 
amendments aiming at improving the alignme nt to international standards. The EU hopes these will 
be considered and retained in order to facilitate international trade both ways. There is today a very 
limited quantity of wine and spirits produced by EAEU members which are exported to the EU. The 
EU wishes to underline that the improvement of the quality of the products, the increased 
involvement in standard setting organizations, and in particular the International Organization of 
Vine and Wine (OIV), the development of a functioning system of Geogr aphical Indications, are all 
factors contributing to a wider opening of the EU market. Far from being fought against, all these 
factors contributing to a facilitated circulation of products in both directions, are very welcome by 
the EU. Lastly, it seems t hat the Federal Law also contains provisions covered by the Agreement on 
trade-related aspects of intellectual property rights. The EU would like to invite Russia to notify the 
measure to the Council for TRIPS. The EU invites Russia to notify the new wine measure, under the 
TBT agreement as well as under the TRIPS agreement. Meanwhile, the European Union would like 
to ask Russia to take these comments into consideration during the ongoing amendments' 
procedure, while keeping in mind possible future developm ents for the benefit of consumers from 
both entities.  
2.387.   The representative of Australia  provided the following statement. Australia thanks the 
Russian Government and industry for its recent engagements on this issue. However, Australia would 
again like to re iterate our concerns with the Russian Federation's "Federal Law Nº 468 of 27.12.2019 
on wine making and wine growing in the Russian Federation". The Federal law poses several barriers 
to the importation of wine into Russia, which coupled with the short tim elines for the law's 
implementation, are of concern to the Australian wine industry. A key concern is the mandatory 
declaration of vintage and variety required under the new law. This does not reflect International 
Organisation of Vine and Wine (OIV) pract ices, of which Russia is a member. Article 18 of Russia's 
Federal wine law stipulates the start date of the wine ageing process as 1 January of the year 
following harvest, which puts Australian and other southern hemisphere producers at a distinct 
disadvan tage given that the grape harvest for these regions relies on a different biological growing 
season and harvest. That is, 1 January in the northern Hemisphere is winter, whereas Australian 
and New World grapes are harvested early in the year, after 1 Janua ry. In relation to the ageing 
 
102 For previous statements follow the thread under ID 650 . G/TBT/M/85  
 
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  process, Article 18 includes a category referred to as "brand" wine, which requires 18 months ageing 
following 1 January in the year following harvest. If this means wine cannot be given a brand unless 
it has been aged for 18 months, only Australian wine from 2018 and earlier would be permitted to 
carry a brand in Russia.  
2.388.   Article 24 prohibits the addition of water in wine, which poses a significant barrier to trade 
for New World growers. Australian food regulations permit the a ddition of water to dilute high sugar 
musts to aid fermentation. Minimal additions of water aids fermentation during periods of difficult 
seasonal conditions, including drought. Additionally, Australia notes several obligations within the 
Federal wine law are inconsistent with the Eurasian Economic Union Technical Regulation 047/2018 
"On safety of alcohol products". Australia understands that the implementation of the technical 
regulation has been postponed until 1 January 2022 to allow harmonization work w ith the Russian 
Federal Law. Could the Russian Federation please provide an update on this harmonization work and 
confirm whether the Technical Regulation is expected to enter into force on 1 January 2022? 
Australia encourages Russia to take into account M embers' concerns with the Federal Law when 
harmonizing with the EAEU Technical Regulations, including ensuring the Technical Regulation aligns 
with international production standards. Finally, we note Russia has not yet notified the WTO of the 
Federal Law despite it being in force for over a year (entered into force on 26 June 2020). We request 
the Federal Law and the revised EAEU Technical Regulation are notified to the WTO accordingly as 
soon as possible.  
2.389.   The representative of the United States  provided t he following statement. We are supporting 
comments by the EU and Australia.  
2.390.   The representative of Argentina  provided the following statement. Argentina once again 
wishes to note its concern about the implementation of the Russian Federation's wine producti on 
law (Federal Law No.  468-FZ). In particular, we are concerned about the unilateral alterations of the 
name of the product that could result in misinformation about the product and confusion for the 
consumer. Under the new Law, "bulk wine" is considered "wine material", and once the product has 
been divided up and packaged, it cannot be called "wine" even if it is only packaged and does not 
undergo any other process or oenological procedure and is not blended with other beverages or 
substances. Our countr y is confident that through constructive dialogue with stakeholders, 
appropriate amendments can be made to the regulations in order to avoid unnecessary barriers to 
trade.  
2.391.   In response, the representative of the Russian Federation  provided the following sta tement.  
The Federal Law on wine making and wine growing is aimed to settle specific issues in the field of 
manufacturing of wine raw materials and wine products in the Russian Federation. Besides, the 
objectives of the Law are to set mandate of the governm ent and self -managing organizations, as 
well as to set legal status of economic operators in the field of viticulture and winemaking in order 
to fight counterfeiting and eliminate unnecessary administrative obstacles for the industry. 
Moreover, the Federal  Law aims to create and develop the "wine of Russia" brand by improving the 
quality of wine products manufactured in Russia. We note that after the Federal Law entered into 
force the value of wine imports remained stable. As previously explained in this Co mmittee, the Law 
in question does not establish regulatory framework for protection of intellectual property rights and 
therefore does not need to be notified under the TRIPS Agreement. With regards to the mentioned 
Government resolution N°1807, the legal act introduces transition period until 31 December 2021 
for provisions of Federal Law on wine making and wine growing applicable to classification of wine. 
It suspends inspections and market surveillance on conformity for products produced in Russia 
and/or  imported to Russia before entry into force of the Federal Law No. 345. For the update on the 
amendments to the technical regulation of the EAEU we refer to our statement under STC 60.103 
Membership concerns will be conveyed to the capital for further consi deration.  
2.1.3.54   Panama - Onions and Potatoes Harvest Life and Sprouting Requirements, 
G/TBT/N/PAN/86,  G/TBT/N/PAN/102,  G/TBT/N/PAN/102/Add.1  (ID 662104) 
2.392.   The representative of the United States  provided the following statement.  The United States 
thanks Panama for continuing bilateral discussions regarding implementation of Pan ama's technical 
 
103 Russian Federation - Draft Technical Regulation on Alcohol Drinks Safety (published on 24 October 
2011) ( ID 332 ) 
104 For previous statements follow the thread under ID 662 . G/TBT/M/85  
 
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  regulations for potato and onion. We also thank Panama for delaying implementation of the potato 
regulation for another six months. While we appreciate Panama's flexibility on the potato regulation, 
it would provide greater economic certain ty for exporters if Panama would suspend the measure 
until technical discussions have concluded. Given these considerations, we reiterate our request that 
Panama suspend implementation of both the potato and onion regulations until technical discussions 
have concluded. During our bilateral discussions, we indicated that Panama's technical regulations 
for potatoes and onions appear to deviate from relevant international standards, and we further 
indicated Panama's requirements appear to be unjustified, impra ctical, and problematic. How is this 
information being factored into Panama's implementation and review of its regulations? Panama's 
onion regulation continues to cause disruption to US exporters. The potato regulation, which is 
significantly more restrict ive, will likely have a more severe impact once implemented. As such, we 
again urge Panama to suspend the measures permanently in the absence of technical justification.  
2.393.   The representative of the European Union  provided the following statement. The Europea n 
Union would like to join trade concerns voiced by the US. Our exporters are also facing similar 
difficulties in agri -food trade with Panama. The European Union would like to stress the importance 
of speedy, consistent and transparent SPS procedures carri ed out by independent authorities, and 
the need to avoid unnecessary TBT barriers. The European Union is prepared to work bilaterally with 
Panama to find a satisfactory solution.  
2.394.   The representative of Canada  provided the following statement. As a long -standing supplier 
of fresh potatoes to Panama with year -round exports, Canada continues to share some of the 
concerns raised by the United States. In our last intervention at the June WTO TBT Committee, 
Canada indicated that implementing these new quality requ irements could have a direct impact on 
our ability to export potatoes to Panama. Canada recognizes that Panama has since delayed the 
implementation of these measures twice - most recently until 2 April 2022 - to allow for further 
consultations with trading  partners. Panama's openness to engage on this issue in an effort to find 
a viable solution has also been appreciated. In fact, since the last WTO TBT Committee meeting, 
Canada and Panama have held a bilateral technical meeting to address elements of conce rn on this 
issue. Canada found these discussions constructive and hopes to find a long -term solution that will 
provide a more predictable environment for both importers and exporters through further technical 
dialogue. Until a long -term solution is found o n the elements of concern, Canada respectfully 
requests that Panama indefinitely suspend the entry into force of this new regulation.  
2.395.   In response, the representative of Panama  provided the following statement. The delegation 
of Panama thanks the delegation  of the United States, Canada and the European Union and takes 
note of their concerns, which I will transmit to Panama City. In this regard, we wish to inform the 
Committee that Panama has been taking into account the comments made by its trading partners,  
as evidenced by the additional six -month delay granted in the entry into force of the amendment 
for potatoes. We reiterate our willingness to work with our trading partners and to keep 
communication between the authorities open.  
2.1.3.55   Republic of Korea - Revisi on of Safety Conformation Criteria for Textile Products 
for Infants, G/TBT/N/KOR/678  (ID 652105) 
2.396.   The representative of the European Union  provided the following statement. The EU would 
like to thank the Republic of Korea for the productive meeting on this issue that took place last July. 
As a follow -up, can Korea confirm that they are willing to accept conformity testing, to the specific 
Korean rules for infant clothing, to be performed outside of Korea by internationally accredited 
laboratories? We are open to further discussing thi s bilaterally. Additionally, regarding the "best 
practice company" status. Our understanding is that, according to the "Direction on the Designation 
of Goods subject to Custom Confirmation of Clearance Requirements and Methods of the 
Confirmation" under Ar ticle 226 of the Customs Act, when a company applies for the best practice 
company status, the Korea Customs Service (KCS) should consult with the "requirement 
confirmation agency" and decide whether or not the company meets the conditions for the status. 
In the case of infant textile products, the Korean Agency for Technology and Standards (KATS) is 
the "requirement confirmation agency". The legislation is only available in Korean so we would 
appreciate confirmation of this and also the procedure to be und ertaken. Certain EU industry had 
applied for recognition as "best practice company" status but the application was rejected last 
 
105 For previous statements follow the thread under ID 652 . G/TBT/M/85  
 
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  December. It would be extremely helpful if Korea could provide an explanation for this rejection in 
order to facilitate a re -application for the status.  
2.397.   In response, the representative of the Republic of Korea  provided the following statement. 
Korea would like to take this opportunity to respond to the issue regarding South Korea's 
requirements for Textile Products for Infants, wh ich was raised by the EU at this TBT committee. 
With regard to textile products for infants above 36 months of age, manufacturers and importers 
can request a domestic or foreign third party -laboratory to conduct product tests on each model of 
the products in order to confirm that the relevant products conform to safety standards. However, 
a risk assessment on textile products for infants under 36 months of age in Korea found that such a 
risk was in fact very high for infants, especially due to injuries caus ed by strings, cords, harmful 
substances and other hazards. In this vein, the safety of infant clothing products must be tested and 
inspected by a designated laboratory prescribed by the Special Act On The Safety Of Children's 
Products to verify that the r elevant product meets the safety standards specific to infant textile 
products. In such cases, we would like to inform the Committee that a designated laboratory may 
enter into a contract for the mutual recognition of test results and inspections on verify ing the safety 
of infant's textile products with any foreign laboratory or institution according to the Special Act. In 
addition, we would like to point out that the Korea Customs Service (KSC) has the sole responsibility 
for determining "the best practice  importer (company)" according to the Customs Act. In this regard, 
the EU's claim regarding the procedure for selecting "the best practice importer (company)" should 
be dealt with in a relevant committee other than this TBT Committee. Korea very much hopes  to 
resolve the EU's concerns at this TBT Committee in a mutually beneficial manner.  
2.1.3.56   India - Testing and Certification of telegraph (The Indian telegraph 
(Amendment) Rules, 2017) and Phase II of the Mandatory Testing and Certification of 
Telecommunications Equipment (MTCTE), implementing the Indian Telegraph 
Amendment, G/TBT/N/IND/66,  G/TBT/N/IND/159,  G/TBT/N/IND/160,  
G/TBT/N/IND/158  (ID 646106) 
2.398.   The representative of the United States  provided the following statement. We understand 
that in May 2021, India's Telecommunication Engineering Center (TEC) proposed new implementing 
procedures for its Mandatory Testing and Certification of Telecom Equipme nt (MTCTE) scheme, which 
aims to expand the MTCTE's scope to include "applicable ICT equipment" and "related ICT 
equipment." We also understand that on 22 September 2021, India's TEC released Phases III and 
IV of the MTCTE scheme, which expands the scope t o include 46 additional product categories. We 
further understand that this notification also extended recognition of test results from foreign 
laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories as 
proof of con formity to the MTCTE procedures until 30 November 2021 for Phases I and II, and until 
30 June 2022 for Phase III. We request that India notify Phases III and IV to the WTO TBT 
Committee; provide a new comment period of at least 60 days upon notification; a nd take into 
account any comments received prior to finalization, pursuant to India's WTO TBT obligations. While 
we appreciate India's partial extension of its recognition of test results from foreign laboratories 
accredited by ILAC signatories as proof of  conformity to India's MTCTE procedures, we urge India to 
make recognition of such test results permanent.  
2.399.   According to US industry, pre -existing regulations under different ministries already govern 
products under the expanded scope, and expanding the MTC TE scheme would therefore introduce 
unnecessarily burdensome, complex, and overlapping regulations. We ask that India consider 
limiting the scope of products under the MTCTE to only core telecom products which connect to 
telecom networks directly. We also understand that the proposed MTCTE implementing procedures 
introduce India -specific labelling requirements mandating the labelling/affixation of markings such 
as "India" and the TEC Essential Requirements (ERs) number with issue date, certificate validity,  
country of origin, and country of product manufacture. US industry notes that requiring such 
information on a label would be costly and logistically burdensome, while providing limited utility to 
end users. According to US industry, as currently drafted, the labelling requirements would also 
require manufacturers to update labels each time a product certificate is renewed. Furthermore, 
industry notes that it is not feasible to place TEC logos on previously manufactured products already 
stocked at various w arehouses and marketplaces abroad and in India. The United States requests 
that India amend the proposed labelling requirements to allow for the use of QR codes for products 
without a display. Will India consider this or other alternative solutions in lieu  of the currently 
 
106 For previous statements follow the thread under ID 646 . G/TBT/M/85  
 
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  proposed labelling requirements? US industry reports that these proposed procedures were drafted 
and released without stakeholder consultation. We request that India notify these procedures to the 
WTO TBT Committee as an addendum to its 2 017 notification of the Telegraph Rules. We also request 
that India provide a new comment period of at least 60 days upon notification.  
2.400.   The representative of Canada  provided the following statement. Canada appreciates the 22 
September 2021 publication of t he extension, from 30 June 2021 to 30 November 2021, of the 
acceptance of test results and reports from ILAC accredited foreign labs for products covered by the 
already implemented Phases 1 and 2 of India's Mandatory Testing and Certification of Telecom 
Equipment programme. However, we hope the acceptance of foreign test results will be made 
permanent and expanded to include safety and EMC/EMI requirements, and that future changes to 
the programme's conditions for implemented phases will be made available w ell in advance of 
implementation. Moreover, Canada was surprised to see that the same 22 September 2021 
publication, which only appeared on India's Telecommunications Engineering Centre website and 
was not notified to this Committee, also indicated the imp lementation of Phases 3 and 4. This 
increases the number of product categories, for which India has implemented the programme, by 
46. We note with particular concern that the acceptance of applications for the approval of products 
covered by Phase 3 began less than one month later on 11 October 2021 and that firms must 
complete their products' certification by 1 July 2022, just eight months later.  
2.401.   We appreciate that, for Phase 3 products, testing in foreign ILAC accredited labs, for 
requirements other than safety and EMC/EMI, will be extended until 30 June 2022, but believe this 
extension should be permanent. Canada wishes to emphasize, however, that completing 
certifications by 1 July 2022 for safety and EMC/EMI will be particularly challenging. We have sim ilar 
concerns regarding Phase 4. As we indicated in June, producing a product for testing, shipping it to 
India and then waiting for it to be tested, before being able to put it on the Indian market, is a very 
time consuming and costly process. We would al so recall that, consistent with the time needed for 
our exporters to meet new requirements, at the last meeting of the Committee, Canada requested 
a one -year notification period before future phases were implemented. Regarding India's statement 
at the June  meeting of the Committee that MRAs can be used by Members to address in -country 
testing requirements, Canada notes it has had no response to its 2020 indication of its openness to 
discussing an MRA. In closing, we wish to reiterate that the permanent acce ptance of foreign test 
results, in appropriately accredited labs, is the least trade -restrictive manner of achieving legitimate 
safety and security objectives. In addition, we wish to highlight that the use of international 
standards, and both publication and WTO notification transparency requirements, are cornerstones 
of mutually beneficial market access.  
2.402.   In response, the representative of India provided the following statement. Testing capability 
for the requirements outlined in the Indian Telegraph (Amen dment) Rules, 2017, is reviewed from 
time to time. Regarding the need for relaxation for products to be covered under future phases of 
MTCTE, they will be looked into at the time of the launch of notification for such products. Moreover, 
the MRA agreement with India shall facilitate OEMs to test in MRA partner country, which may lessen 
the burden in terms of cost and time. To maintain business continuity and to ensure existing business 
supply chains remain undisturbed, the date of enforcement for the produc ts covered under future 
phases of MTCTE is likely to be from six to eight months from the date of notification. Considering a 
relaxation for six months for the labelling requirement for MTCTE -certified products from the date 
on which testing and certificat ion become mandatory, the OEMs will get more than one year to 
comply with the labelling requirement of MTCTE for such products. The request to provide firms with 
at least one year to comply with any future phases of the MTCTE shall be considered at the tim e of 
launch of future phases of MTCTE. Phase -III of MTCTE is under consideration at the moment, and 
timelines for implementation will be intimated when the proposal is finalized.  
2.1.3.57   India - Plain Copier Paper (Quality Order) 2020, G/TBT/N/IND/140  (ID 681107) 
2.403.   The representative of Indon esia provided the following statement. Indonesia would like to 
reiterate its concern on Plain Copier Paper (Quality Control), Order 2020 as raised previously in 
February and June 2021. Indonesia remains concerned regarding the provisions stated in Plain 
Copier Paper (Quality Control), Order 2020. The certification shall be carried out only by Bureau of 
Indian Standards (BIS) based on the Conformity Assessment Regulation 2018 through the Scheme 
1 of Schedule -II which shall require factory inspection, samplin g and testing of the product as well 
 
107 For previous stateme nts follow the thread under ID 681 . G/TBT/M/85  
 
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  as licensing procedures. Indonesia regrets that India has ignored the current pandemic situation 
that made factory inspection is an impossible task to do due to travel ban and social distancing 
policy. Therefore, Indone sia urges India to consider the use of remote assessment in conducting 
factory inspection or any relaxation policy as a mean to facilitate trade and minimize technical barrier 
to trade, particularly in this difficult time. Indonesia has extensively communi cated its concern 
through the enquiry points of TBT WTO in January 2021, bilateral meeting on February 2021 and 
even the Permanent Mission of India in Geneva. Indonesia regrets that India is yet to provide 
substantive response to Indonesia's concern. To en sure the laboratories competency under ILAC 
signatory framework, particularly the testing methods being used under the Plain Copier Paper 
(Quality Control) Order, Indonesia reminds India to adopt available International Standard which 
are ISO references fo r plain copier paper as a basis for testing method.  
2.404.   Indonesia also seeks clarification from India regarding the following matters: Eco marking 
labelling on paper, is it mandatory or voluntary? Also, international standards are being referred as 
sampling me thod in IS 14990:2018. Indonesia, therefore, requests India to accept testing results 
from accredited laboratory under the ILAC when implementing this regulation as a mean to facilitate 
conformity assessment procedures conducted by conformity assessment bo dies in Indonesia. In this 
regards, a Mutual Recognition Arrangement can take place to ensure that testing results from 
accreditated conformity assessment bodies in Indonesia can be accepted by BIS. Concerning there 
are some products that cannot be exporte d during the COVID -19 pandemic due to stringent 
requirements in the regulation, Indonesia requests India to postpone or provide sufficient transition 
time to allow industries to comply with the regulation. Indonesia is also aware that India through 
the Min istry of Commerce and Industry had published mandatory implementation of Plain Copier 
Paper (Quality Control) Order 2020 Regulation on 5 June 2020 and have come into force on 5 
December 2020. In this regard, Indonesia kindly reminds India to notify this te chnical regulation to 
WTO TBT, as the addenda of the previous notification.  
2.405.   In response, the representative of India provided the following statement. There is no 
provision in BIS (Conformity Assessment) Regulations, 2018, for remote assessment or any othe r 
means for inspection. The Government is considering alternatives for in -person inspections. The 
discussion is in the initial stages. The QCO has listed the mandated standard and the conformity 
assessment procedures required.  
2.1.3.58   United Arab Emirates - Requir ement of G -mark for every toy (ID 702108) 
2.406.   The representative of India provided the following statement. India is deeply concerned 
about the UAE's G -mark requirement for all children's toys exported to the UAE, and it can be issued 
only by the agencies autho rized by the GCC Standardisation Organisation. This requirement of G -
mark makes Indian products uncompetitive in the UAE as no agency is authorized to issue G -mark 
in India. To get G -mark certified products, Indian exporters have to send the entire consign ment to 
the place where it can be G -mark certified. As per the extant regulation, the G -mark needs to be 
obtained for each and every toy. This process involves additional procedural requirements; it is also 
cost intensive and makes the Indian product uncom petitive when placed in the UAE market. Further, 
during the conformity assessment, the G -mark Notified Bodies (NBs) frequently request physical 
samples of all products in a group, not only of the representative item. Despite the latest GSO 
guidance specify ing test reports are required only for one representative item from a product group, 
a physical inspection of all items in a product group is burdensome, costly and inconsistent with 
Article 5.1.2 of the TBT Agreement. As per Article 5.1.2 of the TBT Agree ment, Members are obliged 
to ensure that CAPs are not prepared, adopted or applied with a view to or with the effect of creating 
unnecessary obstacles to international trade. CAPs shall not be stricter or applied more strictly than 
is necessary to give the  importing Member adequate confidence that products conform with the 
applicable technical regulations or standards, taking account of the risks non -conformity would 
create. Hence the UAE requested to consider that when the G mark is obtained for each and e very 
toy, then the physical sampling should not be insisted by the Notified Bodies for all the products in 
the group. Such insistence is trade -restrictive and renders high costs and difficulties. Besides, it is 
also inconsistent with Article 5.1.2 of the T BT Agreement.  
2.407.   The representative of the United Arab Emirates  did not provide a response to the concerns 
raised. These concerns were subsequently transmitted to the relevant authorities.  
 
108 For previous statements follow the thread under ID 702 . G/TBT/M/85  
 
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  2.1.3.59   Kingdom of Saudi Arabia - Technical Regulation for Building Materials – Part 4: 
Bricks, Tiles, Ceramics, Sanitary Appliances, and related products (published on the 
official gazette on 22/03/2019), G/TBT/N/SAU/993,  G/TBT/N/SAU/993/Rev.1  (ID 
698109) 
2.408.   The representative of the European Union  provided the following statement. The European 
Union remains concerned by t he difficulties related to the implementation of the Technical Regulation 
for Building Materials and in particular the Saudi Quality Mark (SQM). Since the establishment of the 
Saudi Quality Mark, the European companies are facing important challenges that has resulted in a 
de facto quantitative restriction to imports. The European Union would like to reiterate the following 
points, which still represent a major concern: Audits are disproportionate and exceed the 
requirements set out in ISO standards. To obt ain the SQM, applicants are requested to prove 
compliance with SASO ISO 13006, which is supposedly based on the International Standard ISO 
13006 (for specific characteristics of ceramic tiles). However, the SQM audits requires to conduct all 
the tests for rectified and non -rectified tiles, which seems to be unnecessary and arbitrarily 
requested by SASO. High Costs . While the previous system applied in Saudi Arabia was based on 
different fees commensurate with the shipment value, the current SQM has a (very high) fixed price 
that is prohibitive for SMEs, which are simply not able to invest this amount of money for limited 
volumes exported each year. This has de facto excluded many EU producers from the market.  
2.409.   Limited number of Certification Bodies . The limit ed number of Certification Bodies accredited 
by SASO in Europe creates bottlenecks as applicants are faced with long waiting times before being 
assigned a date for the audit. This delay results in foregone business for EU companies. Unclear 
audit procedure s. SASO has never published a list of documentation required for the audit; hence, 
there is no standardized procedures and there can be discrepancies in the audit requirements set 
out by different Certification Bodies. As a result, the SQM procedures are u npredictable and 
applicants are subject to different conditions based on the Certification Body they utilize. Yearly 
Surveillance Audits . The yearly renewal of the SQM should entail less requirements due to its 
surveillance nature. However, companies have reported that the yearly surveillance includes the 
same level of detail as the first SQM audit – which is completely disproportionate to its purpose. The 
European Union would like to invite the Kingdom of Saudi Arabia to ensure that the Saudi Quality 
Mark will not constitute a barrier to trade. We appreciate the bilateral talks on this issue and remain 
available to continue the dialogue and solve the concern in the near future.  
2.410.   In response, the representative of the Kingdom of Saudi Arabia  provided the foll owing 
statement. Saudi Arabia would like to thank the European Union for raising this matter and the 
constructive bilateral meeting this week. As a result of this bilateral meeting, the competent 
authority in Saudi Arabia is working on a more comprehensive  response that involves various units, 
and we will reply directly to the EU.  
2.1.3.60   Colombia – Good manufacturing practices of overseas production 
establishments, G/TBT/N/COL/242  (ID 697110) 
2.411.   The representative of the European Union  provided the following statement. The European 
Union would  like to thank Colombia for its reply of November 2020 to the EU written comments and 
for the extensive bilateral discussions and hopes that the Decree no 162 published on 16 February 
2021 will not create unnecessary burdensome requirements for EU exporter s of wines and spirits. 
The European Union notes that Article 3 of the adopted decree refers to the possibility to present 
alternatives to the Good Manufacturing Practices certificate upon import to Colombia. EU exporters 
of wines and spirit drinks already  comply with the existing obligation to submit Free Sales Certificates 
for sanitary register. The Free Sales Certificates state that the product is compliant with the EU 
legislative requirements, which encompass Good Manufacturing Practices. The European U nion 
therefore considers that Free Sale Certificates issued by EU member States would comply with the 
Colombian requirement to provide Good Manufacturing Practices certificate upon import. The 
European Union would, therefore, like to ask Colombia to confir m this interpretation. The European 
Union is prepared to continue the bilateral work should there be any need for additional clarifications.  
2.412.   In response, the representative of Colombia  provided the following statement. Colombia 
thanks the European Union (E U) for working with the relevant health authorities to clarify the 
 
109 For previous statements follow the thread under ID 698 . 
110 For previous statements follow the thread under ID 697 . G/TBT/M/85  
 
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  concerns raised regarding compliance with Decree No. 162 of 2021. In this regard, we wish to report 
that the relevant authorities have been working with the EU, through the EU Trade Section  in 
Colombia, on issues related to compliance with Decree No. 162 of 2021, particularly in respect of 
the acceptance of certificates of good manufacturing practices, thus responding to the concerns 
raised regarding the acceptance of certificates of free sa le (CVL). The text issued amended Article 
22 of Decree No. 1686 of 2012, so as to ensure equal conditions regarding the certificate of good 
manufacturing practices (GMP) for domestic producers and producers located outside the national 
territory, and provi ded the following four (4) alternatives for complying with the technical regulation: 
(a) Certificate of good manufacturing practices (GMP), from the manufacturing and/or packaging 
establishment, issued by the relevant authority of the country of origin; (b ) Hazard Analysis and 
Critical Control Point (HACCP) System certificate or document supporting its implementation, issued 
by the relevant authority of the country of origin; (c) Certification issued by the relevant authority, 
by the accredited certificatio n body or by the authorized third party in the country of origin of the 
product, stating that the alcoholic beverage and the producer comply with the technical standards, 
processes or procedures; (d) Certificate of good manufacturing practices of the manuf acturing 
and/or packaging establishment, issued by the National Food and Drug Surveillance Institute 
(INVIMA).  
2.413.   Thus, in order to comply with the requirement in the case of imported beverages, the Decree 
sets out four feasible options that do not disregard the regulations of the country of origin of the 
parties concerned, meaning that such parties can assess each of the above options and apply one 
of them in order to comply with the Colombian regulations. The health authorities have reiterated 
that certifica tes of free sale – referred to by the EU – may be included within the scope of paragraph 
(c), provided that they comply with the provisions of that paragraph, namely: (i) they are issued by 
the relevant authority, by the accredited certification body or by  the authorized third party in the 
country of origin of the product, and; (ii) they state that the alcoholic beverage and the producer 
comply with the technical standards, processes or procedures or are subject to monitoring and 
inspection. In this context , the relevant authorities have reviewed the documents provided by the 
EU and have expressed their willingness to continue working with the EU and the industry to resolve 
the concerns raised so as to favour compliance with the technical regulation. In ligh t of the foregoing, 
we invite the EU to continue its bilateral work with our health authorities.  
2.1.3.61   Argentina - Requirement of affidavit along with the product certification from a 
certified body for export of boards derived from wood (ID 696111) 
2.414.   The representative of India provided the following statement. In response to India's question 
in the previous TBT Committee meeting, Argentina provided a reply, and we thank Argentina for 
their reply. The reply, however, does not answer the questions raise d by India, hence we reiterate 
our concern. Argentina has notified the requirement of an affidavit in addition to a product 
certification from a certified body for the export of boards derived from wood. India thanks Argentina 
for its notification G/TBT/N/ARG/342/Add.6  dated 22 February 2021 on the proposed draft 
Resolution "Technical quality and safety requirements applicable to boards derived from wood". As 
per Article 2 of the Draft Resolution, besides product certification, an affidavit from a certified body 
indicati ng compliance to the requirements is required. India has submitted its queries to Argentina's 
Enquiry Point seeking relevance of an affidavit indicating a product's compliance, mainly when a 
certification requirement is already in place. India believes tha t the additional requirement of an 
affidavit will add both to the cost and procedural burden for exporters, thereby adversely affecting 
the product's competitiveness in Argentina. Further, no risk assessment for the additional 
requirement of an affidavit i s shared by Argentina. Hence, prima facie Argentina's requirement of 
an affidavit in addition to certification requirement appears to be trade restrictive. It is also not 
known what other less trade -restrictive or alternative measures Argentina considered before 
deciding on the present measure. Given the above, Argentina is requested to: not to impose the 
additional affidavit requirements; respond to the queries submitted by India to its Enquiry Point; 
and if it cannot do away with the additional affidavit requirements, share the risk assessment done 
in arriving at the imposing such a trade -restrictive measure.  
2.415.   In response, the representative of Argentina  provided the following statement. We regret 
that Argentina's response has not been sufficient for our co lleague from India, so we will forward 
this new question to our capital.  
 
111 For previous statements follow the thread under ID 696 . G/TBT/M/85  
 
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  2.1.3.62   China - National Standards on Limits of Volatile Organic Compounds for 
Furniture, G/TBT/N/CHN/1094,  G/TBT/N/CHN/1095,  G/TBT/N/CHN/1096  (ID 509112) 
2.416.   The representative of the European Union  provided the following statement. The European 
Union would like to refer to its previous statements on Chinese notification G/TBT/N/CHN/1094 , 
G/TBT/N/CHN/1095  and G/TBT/N/CHN/1096 . The European Union would like to express concerns 
over the draft Chinese Volatile Organic Compounds (VOC) st andard for furniture "Limit of Harmful 
Substances of Furniture", which is currently open for comments in the context of a public 
consultation in China and which would replace standards GB 18584 -2001 Indoor Decorating and 
Refurbishing Materials - Limit of H armful Substances of Wood -based Furniture and GB 28481 -2012 
Limit of Harmful Substances of Plastic Furniture. As far as we know, the publication of the standard 
is expected in the beginning of 2022, and two years after adoption will be given for implementa tion. 
The draft standard is intended to amend those notified to the WTO in 2015 ( G/TBT/N/CHN/1094 , 
G/TBT/N/CHN/1095 , and G/TBT/N/CHN/1096 ). Unfortunately, despite the collaboration between the 
European furniture industries and Chinese standardization bodies on a new, improved version of the 
standard, that would take into acc ount international standards applied in the area of VOC 
measurements, the draft Chinese standard "Limit of Harmful Substances of Furniture" fails to bring 
relevant improvements and presents similar concerns as the original text notified to the WTO in 
2015.  
2.417.   High indoor air quality is essential for the health and wellbeing of European and Chinese 
consumers. The European Union understands and supports the introduction of standards limiting the 
emissions of harmful substances from furniture. However, several im portant concerns remain. The 
approach to wooden furniture adopted in the draft standard is not in line with existing ISO -standards 
(ISO 16000 -9; -3; -6) and with known (eco -) labels such as BIFMA, EU Eco -flower, Blue Angel. The 
EU believes that it is very important to harmonize testing methods. The use of proven standards as 
a basis should be the reference for all countries and the corresponding testing laboratories. Test 
methods should be chosen by accuracy and should be science -based. The EU would like to  ask China 
to consider harmonizing the requested test methods with ISO 16000 -9, -3, -6. This testing method 
has proved to be reliable and it would be beneficial for international trade in furniture as producers 
exporting worldwide would need to comply with  one test method. The new standard will have an 
important economic impact on both European and Chinese producers as it will pose a barrier to 
exports. The requirement proposed in the Chinese draft standard on Individual Volatile Organic 
Compounds shows an arbitrary choice of thresholds and is not focused on hazardous substances. 
The draft standard will therefore overestimate the impact of natural substances normally present in 
wood but underestimate the impact of toxic substances.  
2.418.   The unscientific TVOC limi t after a short testing time overestimates the impact of natural 
substances normally present in wood, leading to a situation where furniture produced from untreated 
natural wood will fail the test. At the same time, the few restricted individual hazardous substances 
underestimate the toxic substance. The EU is of the opinion that only toxicologically relevant 
substances should be considered as the basis for evidence. To make sure that the standard does not 
hinder the use of natural wooden materials and wate r-based coatings, health -based criteria with a 
focus on individual hazardous substances (not on TVOC) should be applied. As regards the testing 
method referring to surface area approach vs. volume approach, the testing method for wooden 
furniture proposed by China is based on the volume of furniture, despite international standards 
(ISO 16000 -9) recommending basing measuring methods on the emitting surface. At the same time, 
upholstered furniture is tested using the surface area approach, although determini ng the surface 
area of upholstered furniture is very difficult and error -prone due to its shape. The draft Chinese 
standard encourages an approach where producers simplify the designs and functionality of the 
furniture produced for the Chinese market in or der to pass the test. The volume -based approach to 
the testing method used in the draft Chinese standard would make the final emission of the product 
depend on the design and functions (for example number of drawers) rather than the choice of raw 
material.  A simpler design will limit the choice for Chinese and European design. In addition, products 
made from natural materials and/or with water -based coatings will no longer be available to Chinese 
consumers. The Chinese draft standard would also pose problem s for Chinese furniture 
manufacturers when exporting to the EU. This would also be the case for manufacturers producing 
in the EU, because they would then have to use organic solvent -based lacquers to pass the tests.  
 
112 For previous statements follow the thread under ID 509 . G/TBT/M/85  
 
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  2.419.   For wood -based furniture the "volume fa ctor loading" defined as: "the ratio of the volume of 
wooden furniture to the volume of the environmental test chamber" is adopted. This approach is 
different from the surface area approach used in existing internationally recognized product emission 
stand ards, such as ISO 16000 -9. To make sure that the standard pushes the furniture industry 
towards the use of low emitting materials for all furniture, surface area approach is recommended. 
The EU welcomes the change applying to formaldehyde emission, as indi cated in the latest version 
of the standard, dating 21 October. It seems that the standard now follows the internationally 
approved method of ISO 16000 -3 – the DNPH method). The EU hopes that China maintains this 
approach and that DNPH method remains the c hosen way to measure formaldehyde emissions. The 
EU would appreciate it if China could share information about the timing for the TBT notification of 
the new standard.  
2.420.   In response, the representative of China  provided the following statement. In May 2019, the 
Standardization Administration of China (SAC) issued a plan to revise the mandatory national 
standard of the Limits of Hazardous Substances in Furniture (Plan No 20190075 -Q-339). The Limits 
of Hazardous Substances in Furniture will integrate three exis ting relevant mandatory national 
standards, as well as relevant parts in Limits of Hazardous Substances in Plastic Furniture. The 
integrated mandatory national standard will cover wood furniture, soft mattress, soft sofa, plastic 
furniture, stone furniture , etc. Hazardous substances include formaldehyde, volatile organic 
compounds, heavy metal elements, decomposable aromatic amine, flame retardant, etc. In the 
standard -drafting process, we adhere to the principle of openness and transparency, taking into 
account of opinions from all walks of life and giving adequate consideration to ISO -related standards. 
We actively engage foreign enterprises and experts in the formulation and revision of the standard 
to ensure it is scientific and reasonable. At present, t he national furniture standardization technical 
Committee is organizing members to vote on this standard. After the voting, it will be submitted for 
approval and it is expected to be approved by the national Standards Committee in 2022.  
2.1.3.63   European Union - Testing methods for prohibited chemicals of regulation on 
cosmetic products, G/TBT/N/EU/752  (ID 680113) 
2.421.   The representative of China  provided the following statement. China recommends the EU to 
clarify the testing methods for volatile nitrosamines contained in nail polish products.  
2.422.   In response, the representative of the European Union  provided the following statement. 
The EU would like to recall that a reply to China's comments of 16 December 2020 was submitted 
via the TBT Enquiry Point on 4 February 2021, which was elaborated in our stat ement for the TBT 
Committee in February 2021. The EU referred China to this statement and the reply of 4  February 
2021 during the last TBT Committee in June 2021. During the last TBT Committee, however, China 
suggested that the EU clarify the testing metho ds for volatile nitrosamines contained in nail polish 
products. The EU believes this matter concerns the draft Commission Regulation amending 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of 
Methyl -N-methylan thranilate in cosmetic products notified to the WTO on 15 March 2021 under 
reference number G/TBT/N/EU/785 . In this regard, the EU is not aware of a wide use of Methyl -N-
methylanthranilate in nail polish products. Methyl -N-methylanthranilate is a fragrance ingredient 
used in various cosmetics, including fine fragrances, shampoos, soaps and other toiletries as well as 
in non -cosmetic products such as household cleaners and detergents. Methyl -N-methylanthranilate 
is a secondary amine, and thus prone to nitrosation. It should not be used  in combination with 
nitrosating substances. The nitrosamine content should be less than 50 ppb.  
2.423.   The concerned measures do not regulate testing methods to detect volatile nitrosamines in 
nail polish or cosmetic products. It is the responsibility of the man ufacturer to ensure that they 
remain below the permitted concentration. As regards testing methods, there is ISO/TR 14735:2013 
Cosmetics — Analytical methods — Nitrosamines: Technical guidance document to minimize the 
likelihood of N -nitrosamine formation in cosmetic products that also provides a description of the 
analytical methodologies available for the reliable determination of N -nitrosamines in cosmetic 
products: ISO - ISO/TR 14735:2013 - Cosmetics — Analytical methods — Nitrosamines: Technical 
guidan ce document for minimizing and determining N -nitrosamines in cosmetics.  Last but not least, 
Cosmetics Europe, a European trade association for the cosmetics and personal care industry, 
 
113 For previous statements follow the thread under ID 680 . G/TBT/M/85  
 
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  developed in 2009 a technical guidance document on minimising and deter mining nitrosamines in 
cosmetics.114 
2.1.3.64   European Union - Uniform procedures and technical specifications for the type -
approval of motor vehicles with regard to their emergency lane keeping system (ELKS), 
G/TBT/N/EU/767  (ID 700115) 
2.424.   The representative of China  provided the following statement. 1. It is suggested for 
Article  1.4 to change "control the lateral movement of the vehicle" because the purpose of ELKS is 
to keep and control the lane and the regulations shall not specify the technology used. 2.  For 
Article 3.1.1.1, China suggests that self -check requirement should be modified as "When turned on, 
the system should be capable of self -check, which means the system can check if the main electric 
components and sensors relevant to the system work normally". T he purpose of self -check is to 
make sure if the system can satisfy the fundamental running conditions and the number of self -
check can be defined by the enterprise itself.  3. For Article 3.1.1.2,  China thinks that the "Non -
electrical failure condition" is contradicted with "e.g. sensor misalignment", since the sensor bias 
might be caused by electrical failure.  4. For Article 3.2.1.2, China suggests that the behaviour 
manner of manually stopping the system should not be limited. As long as the purpose of lan e 
keeping and controlling is achieved, the specific technology should not be restricted.  5. For 
Article  3.6.2, based on the research conclusion of Chinese LKA system standard, the suggested lane 
departure should be 0.4m for M1 and N1 vehicles and 0.75m for  vehicle of other categories.  6. For 
Article 3.6.2 (a) the definition is unreasonable since the system in the activated status should always 
keep the vehicle within the lane and do not need to differentiate other conditions.  7. For Article 3.6.2 
(e), the r equirement "in all illumination conditions without blinding of the sensors" is too strict. 
Quantitative requirement should be raised such as 500lx.  For Article 3.6.2 we suggest relevant ELKS 
requirements for curve lane should be added by referring to the r elevant parts in Chinese LKS 
standards for passenger car and commercial vehicle.  
2.425.   8. For Article 3.6.3.1, we suggest the requirements of steering control effort should be 
deleted. 9. For Article 3.6.4 the requirements of CDCF warning guidance are too detail ed. We think 
the warning conditions alone are enough. 10. For Article 4 and Article 5, China suggests the curve 
lane testing scenario be added by referring to the relevant parts in Chinese LKS standards for 
passenger car and commercial cars.  11. For Articl e 4.2(b) and 5.2(b) the requirement of 
environment illumination condition, 2000lx, is too high and China suggests that the number should 
be 500lx.  12. For Article 4.2(c) and 5.2(c), China suggests that the environment temperature range 
be modified from 5 ℃~45℃ to -20℃~40℃. 
2.426.   In response, the representative of the European Union  provided the following statement. 
The EU would like to recall that a reply to China's written comments of 7 February 2021 was 
submitted via the EU TBT Enquiry Point on 13 April 2021. Th e main elements of this reply were also 
re-stated in the EU's responding statement during the last TBT Committee in June. During the last 
TBT Committee in June, China formulated several drafting suggestions in its statement. The EU 
would like to thank Chin a for these drafting suggestions. However, the measure was actually adopted 
on 19 April 2021 and it is currently not foreseen to be revised. It is intended, nevertheless, to bring 
this discussion to the working group on automated and connected vehicles (GR VA), subsidiary body 
of the World Forum on automotive regulations (WP29) of the United Nations. For example, ELKS 
requirements could be included in UN regulation 79 on steering and UN Regulation 130 on lane 
departure warning systems. The EU will engage con structively in the UN discussion and calls on 
China to contribute to this process at expert level and to apply these regulations when amended.  
2.2  Ninth Triennial Review  
2.427.   The Committee adopted  its Ninth Triennial Review Report, subsequently circulated in 
G/TBT/46 .  
 
114 
https://cosmeticseurope.eu/files/9114/6407/6715/Technical_Guidanc e_Document_on_Minimising_and_Determ
ining_Nitrostamines_in_Cosmetics_ -_2009.pdf   
115 For previous statements follow the thread under ID 700 . G/TBT/M/85  
 
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  2.3  Exchange of experiences  
2.3.1   Transparenc y 
2.428.   The Secretariat  provided an update on the eTools integration project. As had been 
announced during the Transparency Thematic session , held in February 2021, the Secretariat was 
currently working on developing an integrated platform, merging several TBT o nline tools, namely, 
the TBT IMS, TBT NSS and ePing. The objective of this work, the Secretariat noted, was to improve 
services in terms of ease of use, data consistency and resource efficiencies. The new platform was 
still under development and an overvie w of its planned features had been presented to interested 
delegations during a Friends of eTools meeting held in October 2021. The  intention was to launch 
the platform in March 2022. The Secretariat also recalled that earlier in 2021, the Secretariat had 
carried out a comprehensive survey among registered ePing users and received 1,400 responses. 
These responses gave the tool on average a mark of eight out of ten. More than 80% of the 
respondents read their email alert either daily or weekly  – public and p rivate sector alike. Several 
suggestions for improvements had been made and some of these would be addressed in the new 
platform. One suggestion was for the development of an ePing smart phone application. Following 
up on this, the Secretariat was working together with UNDESA and ITC to develop a prototype 
application in the first half of 2022. Further information on ePing and the results of the survey can 
be found in document G/TBT/GEN/317 . 
2.429.   The Secretariat  also provided an update on new COVID -19 related notifications submitted to 
the TBT Committee. Since the beginning of the pandemic (March 2020), WTO Members had 
submitted a total of 179 Covid -related TBT notifications. This represented slightly over 40 % o f all 
Covid -related WTO notifications. Since the last meeting of the Committee, a total of 26 new such 
notifications had been submitted to the Committee. These notifications, it was noted, covered a 
diverse range of products ranging from medical supplies, personal protective equipment to products 
more generally. Many of the notified measures were conformity assessment procedures and some, 
as had been the case previously, notified trade -facilitating measures.  
2.3.2   Conformity Assessment Procedure s 
2.430.   The Chairperson  summarized the work of the Committee to date and recalled that at the 
Committee 's previous meeting, in June, it had been agreed that the Committee would dedicate an 
informal meeting early in 2022 to discuss work on the conformity assessment gui delines, and that 
this meeting be informed by an "elements paper" to be prepared by the Secretariat.116  
3  OBSERVERS  
3.1  Updates  
3.1.  The representative of  UNECE  updated the Committee on the work of the UNECE Working Party 
on Regulatory Cooperation and Standardisation  Policies (WP.6). He also noted the relevance to the 
TBT Committee of work in the World Forum for Harmonization of Vehicle Regulations (WP.29), the 
United Nations Centre for Trade Facilitation and Electronic Business (UN/CEFACT) and Working 
Party 6. 
3.2.  The re presentative of the BIPM provided an update. The full content of this update can be found 
here. The Chair drew the Committee's attention to information provided by other observers 
(Codex117, ISO118 and CROSQ119). 
 
116 G/TBT/M/84 , para 4.486 . In a subsequen t communication , contained in ICN/TB T/10 and issued on 
9 December 2021,  the Chairperson confi rmed the date of th e informal meeting on 10 February  2022 and note d 
that the Secretariat intended to circulate the elements paper in advance of the February meeting.  
117 G/TBT/GEN/319 . 
118 G/TBT/GEN/320 . 
119 G/TBT/GEN/321 . G/TBT/M/85  
 
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  3.2  Pending Requests  
3.3.  With respect to pending requests for observer status, the Chairperson  noted that no further 
requests for observer status had been received. Updated information was available in documents 
G/TBT/GEN/2/Rev.16  and in document RD/TBT/1/Rev.8 .  
3.4.  The representative of Turkey  reiterated his delegation 's support for the application by SMIIC. 
He stressed that this organization should not be considered as solely specialised in metrology - it 
had varying responsibilities and objectives in the area of standardisation, conformity assessment, 
metrology, accreditation and quality infrastructure. Turkey noted , in addition,  that his delegation 
had been in touch with the delegation of the United States on these points and had expressed a 
willingness to contin ue to work with the United States, and other Members, to address any 
outstanding concerns regarding this pending request.  It was important, Turkey stressed, that the 
lack of clear -cut and predictable procedures should not prevent membership from accepting the 
requests of applications  and that every organization be evaluated based on its own merits . 
4  ANNUAL REPORT (2021) OF THE COMMITTEE TO THE COUNCIL FOR TRADE IN GOODS 
(CTG)  
4.1.  The TBT Committee adopted  its report to the CTG. It was circulated in G/L/1420 . 
5  OTHER BUSINESS  
5.1.  The Secretariat  proposed to organize a TBT symposium in 20 22. The half -day event would aim 
to discuss the value of the TBT Committee's work on alleviating regulatory bottlenecks in the global 
economy. It would address questions about the impact and value of the Committee 's work to th e 
broader economy, particularly in the area of specific trade concerns (STCs). The Secretariat would 
seek input from Members, the private sector and academia, as well as other relevant international 
organizations. The event would most likely take place sep arately from the Committee week.  
5.2.  The representatives of Brazil , United States  and the European Union  expressed support for this 
initiative and welcomed the idea of increasing awareness and understanding of the Committee 's 
work.  
6  DATE OF NEXT MEETING  
6.1.  The next regular meeting of the Committee will take place on 9 -11 March 2022. It will be 
preceded by thematic sessions on conformity assessment procedures, specifically on accreditation  
and digital solutions . These two thematic sessions will take p lace on 8 March 2022. It is recalled that 
an informal meeting on the conformity assessment guidelines is scheduled for 10  February 2022. All 
scheduled dates of meetings in 2022 are listed in JOB/TBT/408/Rev.1 . 
__________  