   
  
G/SPS/GEN/1970  
 
4 November  2021 
(21-8373) Page: 1/7 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
RESPONSE OF THE EUROPEAN UNION TO G/SPS/GEN/1926  
ON EU MRLS FOR CERTAIN PLANT PROTECTION PRODUCTS (CONCERN N° 448)  
SUBMISSION BY THE EUROPEAN UNION  
The following document , received on 3 November  2021, is being circulated at the request of the 
Delegation of the European Union . 
 
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This document provides t he European Union response to the questions raised in G/SPS/GEN/1926  
regarding STC 448.  
1. The European Union indicated, in document G/SPS/GEN/1896 , that MRLs are set at 
the lowest level possible to achieve the desired effect, in line with the As Low As 
Reasonably Achievable (ALARA) principle. The ALARA principle is applied primarily in 
the field of radiation and not to phytosanitary measures. Would the European Uni on 
provide:  
a) The basis for the translocation of this principle to non -radioactive substances;  
b) The scientific justification for this translocation;  
c) The provision of the SPS Agreement covering the ALARA principle; and  
d) An explanation of the meaning of "the desired effect" that is sought when 
determining MRLs at the lowest level possible.  
The ALARA (As Low As Reasonably Achievable) principle is widely recogni zed and applied in the field 
of food safety worldwide. In the European Union , in accordance with Regulation 315/93 on food 
contaminants, contaminant levels must be kept as low as can reasonably be achieved following good 
practices at all stages. The same principle is laid down in Recital 5 of Regulation 396/2005 on 
maximum residue levels for pesticides residues. The European Union has the right to take sanitary 
and phytosanitary measures necessary to ensure the high level of the protection of human, animal 
or plant life or health.  
According to the ALARA principle, maxi mum residue levels should be set at the lowest achievable 
level consistent with good agricultural practice for each pesticide with a view to protecting vulnerable 
groups such as children and the unborn. They should never be higher than toxicologically acce ptable. 
Comprehensive field studies, therefore, determine what amount and what application frequency are 
needed to achieve the intended effect. A maximum residue which occurs under these circumstances 
is only accepted as a maximum residue level for an agri cultural product if it is guaranteed that the 
concentration does not have any harmful effects on human health according to the latest scientific 
findings available.  
2. The European Union indicated that it accepts good agricultural practices (GAP) 
authorized i n third countries even though they are different from those established in 
the European Union, and that third countries may submit a request to review import 
tolerances in cases where there is evidence supporting the request. According to 
which principles is the review of the GAP used by third countries incorporated in the 
process to define import tolerances? What elements of the GAP of third countries are 
taken into consideration?  
− A third country can submit an application for an import tolerance with the r equired 
supporting evidence, including the GAP used by that third country.  G/SPS/GEN/1970  
 
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  − The data requirements to set import tolerances are the same as for setting MRLs supporting 
uses in the European Union . Import tolerance requests are assessed against the same strict  
criteria as applications for MRLs based on uses in the European Union . 
− It is the duty of the applicant to prove the safety, and if such evidence cannot be provided 
or if EFSA finds that that there are open points and uncertainties, an application for a ne w 
MRL is not granted or the already existing MRLs are lowered to the limit of quantification 
(technical zero).  
− The data are evaluated first by a member State of the European Union (the "Rapporteur 
member State ") and then by the European Food Safety Authori ty (EFSA). If the outcome of 
this evaluation is favourable, an import tolerance can be established.  
− For any further information, interested parties may consult the section of the European 
Commission  website  specifically  dedicated  to pesticides: 
https://ec.europa.eu/food/plants/pesticides_en . 
EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the 
information and studies required for the evaluatio n. EFSA 's guidance is updated regularly so 
applicants  should  check  at 
https://www.efsa.europa.eu/en/applications/pesticides/regulationsandguidance  that they are us ing 
the latest version before applying.  
3. Further to reply 2(a), provided in document G/SPS/GEN/1896 , the European Union 
indicates the  situations that, in its opinion, are covered by the precautionary principle 
referred to in Article 5.7 of the SPS Agreement. Could the European Union provide 
further details on the difference between its explanation on the measures covered by 
Article 5.7 and on the action that it is actually undertaking with regard to MRLs?  
The European Union would like to kindly refer the Delegations to previous replie s where these issues 
have been explained in detail.  
4. Further to reply 2(b) provided in document G/SPS/GEN/1896:  
a) Could the European Union indicate what is meant by "scientific uncertainty"? 
Is there scientific uncertainty when scientific evidence is insufficient?  
b) Could the European Union indicate what is considered a "reasonable period of 
time", taking into account the difference between the different approvals and their 
duration?  
c) Does the existence of scientific uncertainty and the review of measures within a 
reasonable period of time imply the application of Article 5.7 of the 
SPS Agreement? What is the opinion of the European Union in this regard?  
Regarding the interpretation of Article 5.7 and of other Articles of the SPS Agreement, the 
European  Union would like to kindly refer to relevant Dispute Settlement Body 's rulings.  
5. We welcome the explanation provided by the European Union for its submission of 
reservations concerning the MRLs adopted by Codex Alimentarius (CXLs). However, 
the question posed to the Eu ropean Union sought clarification as to whether the 
submission of reservations exempts it, in its opinion, from the harmonization 
commitments undertaken under Article 3 of the SPS Agreement. We reiterate this 
question.  
As already explained in document G/SPS/GEN/1896 , the purpose of r aising reservations is to 
increase transparency and predictability in international trade, and not to exempt the European 
Union from its obligations under international law.  
6. We thank the European Union for the submission of statistics with regard to its le vel 
of harmonization with the Codex since 2012. However, the information requested was 
specifically for the period from 2017 onwards. We would be pleased if the European 
Union could provide information for the period of time requested.  
Existing information  on the harmonization figures from 2017 onwards is summarised below:  G/SPS/GEN/1970  
 
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  Year Total number of 
CXLs for food 
adopted by CAC  EU MRLs set at 
lower values than 
CXLs  EU MRLs set at the 
same or higher 
values[1] than CXLs  
2017 417 47% 53% 
2018 305 21% 79% 
2019 275 32% 68% 
 
7. Furthermore, we appreciate the fact that the level of harmonization of the European 
Union's MRLs with the CXLs is 70%. We observe, however, that the issue of concern 
is precisely the remaining 30% of cases, in which the European Union de viates from 
the CXLs. In these cases, is there a conclusive risk assessment to support each of the 
MRLs that are not harmonized with the Codex?  
Yes, the European Union positions are based on the scientific reports prepared by EFSA. 
These  reports are availa ble at https://www.efsa.europa.eu/en/publications . For each JMPR 
evaluation, EFSA derived comments on the acceptability of the proposed draft Codex MRLs and the 
toxicological reference values.  
8. We w elcome the confirmation that compliance with MRLs must be ensured in order for 
member States of the European Union to trade with one another. In light of this:  
a) Must the MRLs  established by the European Union be met by the member State 
granting an emergency authorization for a specific substance, with regard to 
imports from other member States of the European Union or third countries?  
Emergency authori zation s are not granted to member States; rather, they are issued by the member 
States themselves – each member State is responsible individually for granting emergency 
authori zation s. The Commission does not issue emergency authori zation s, nor are emergency 
authori zation s issued  at EU level.  
See the guidance which provides more details on the considerations for considering emergency use 
of plant protection products, including product containing substances that are no longer approved in 
the European  Union : https://ec.europa.eu/food/system/files/2021 -
03/pesticides_aas_guidance_wd_emergency_authori zation s_article53_post -210301.pdf . 
It should be recalled that around 90% of emergency authori zation s are for plant protection products 
containing active substances that are approved in the European Union . 
b) On what criteria is the European Union's analysis based to determine the abse nce 
of unacceptable risks for the consumer?  
The criteria are established by Commission Regulation (EU) No 546/2011 of 10 June 2011 
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as 
regards uniform principles for ev aluation and authori zation of plant protection products.  
c) How many countries in the European Union are marketing within their territories 
products that do not comply with the MRLs established by the European Union?  
The vast majority (around 90%) of emergen cy authori zation s are for plant protection products 
containing active substances that are approved in the European Union and most comply with the 
EU MRLs.  
In the event that substances do not comply with the applicable EU MRL, the treated food or feed 
must remain in the territory of the EU member States where the authori zation  was granted.  
In February 2020, the Commission launched a public database containing information on the 
notifications made by member States on emergency authori zation s. Users can search  to identify 
emergency authori zation s granted from June 2016 onwards.  
d) Have the member States of the European Union submitted scientific justification 
to apply MRLs that are higher than those stipulated in European Union standards, 
which demonstrates that t he MRLS do not pose a risk to consumers?  G/SPS/GEN/1970  
 
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  Member States have to apply harmon ized MRLs through European Union . If a different MRL 
application is needed, it should be requested under Article 6 of Regulation 396/2005. The data are 
evaluated first by a member State of the European Union (the "Rapporteur member State ") and 
then by the European Food Safety Authority (EFSA). If the outcome of this evaluation is favourable, 
an import tolerance can be established.  
e) Could the European Union share the evidence submitted by members of the 
European Union to justify the application of MRLs that are higher than those 
stipulated in European Union standards?  
Please see answer to question d).  
f) How does the European Union cond uct controls to ensure that products with higher 
MRLs produced in member States with emergency authorizations are not marketed 
in other member States?  
Enforcement authorities control products on the market for their compliance with harmon ized MRLs. 
The Ra pid Alert System for Food and Feed (RASFF) disseminates information about health risks 
between the members of the network (Commission, member States, Norway, Liechtenstein, Iceland, 
Switzerland).  
g) In view of the absence of border controls and inspections wi thin the European 
Union, could the European Union indicate the mechanism used to ensure 
compliance with the MRLs in intra -Community trade?  
All member States have monitoring programmes to ensure that controls are carried out to ensure 
their compliance with  the Regulation. Around 90000 samples are taken in the European Union 
annually. More information on the results of those inspection programs is available on the dedicated 
European Union report on pesticide residues in food (e.g. link to the 2019 report: 
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6491 ). 
9. As regards trade with third countries:  
a) What mechanisms exist for the control of the MRLs of substa nces authorized only 
for emergencies in the case of exports outside the European Union?  
No exports are allowed in the event that food/feed does not comply with the applicable EU MRL due 
to an emergency authori zation  granted by a member State. In this situ ation, the treated food or 
feed must remain in the territory of the EU member State where the authori zation  was granted and 
this must be controlled by that member State.  
b) Are there products for export with MRLs  that are higher than those authorized for 
the European Union or specific cases in which they have been exported outside the 
European Union? Are these products regulated by other standards? Do the MRLs 
for these products exceed those established by interna tional standards such as 
Codex?  
Please see Article 12(1) of Regulation 178/2002.  
c) When a member States grants an emergency authorization for a substance, does 
the European Union allow the importation of products complying with the same 
MRLs for that substan ce which are imposed for domestic products?  
No, the only applicable MRLs are the ones set by Regulation 396/2005.  
10. Could the European Union explain why there are emergency authorizations for States 
that are not members of the European Union in its database ? Could the European Union 
also explain how this mirror mechanism works in the case of emergency requests from 
producers in non -EU countries? Do the same conditions as those for European 
producers requesting emergency authorizations apply to producers in n on-EU 
countries?  G/SPS/GEN/1970  
 
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  The database only contains information on authori zation s issued by the 27 EU member States plus 
historical authori zation s granted by the United Kingdom when it was a member State of the 
European  Union . Only EU member States can produce authori zation  notifications in the system that 
populates the database (the Plant Protection Products Application Management System).  
Emergency authori zation s granted under Article 53 of Regulation 107/2009 concern the placing on 
the market and the use of plant protection products in the European Union only. Farmers/agricultural 
producers outside the European Union cannot apply for emergency authori zation  since they are not 
part of the European Union . Responsibility for granting authori zation s lies w ith individual 
member  States. Emergency authori zation s have to be granted only where necessary because of a 
danger which cannot be contained by any other reasonable means.  
Reference to ‘same conditions ' for producers outside the European Union is not relev ant. Emergency 
authori zation s are for use of products in the European Union only. 
More information about emergency use under Article 53 can be found in the following guidance:  
https://ec.europa.eu/food/system/files/2021 -
03/pesticides_aas_guidance_wd_emergency_authori zation s_article53_post -210301.pdf . 
11. How does the European Union reconcile the high level of protection fo r its consumers 
with the high number of emergency authorizations issued by its member States? Once 
the time -limit for an emergency authorization has expired, is there another time -frame 
in which a new emergency authorization for the same substance may be r equested?  
There is no time -limit when a request for an emergency authori zation  of a plant protection product 
can be made (including if an emergency authori zation  was previously issued). However, each request 
must be carefully considered by the applicable member State.  
Member States must always ensure protection of consumers when authori zing the use of plant 
protection products, including from emergency use. Article 53 of Regulation 1107/2009 requires that 
member States provide information on measures taken to ensure consumer safety.  
Crops treated with PPPs for which an emergency use is granted must comply with the applicable 
EU MRLs. Exceptionally, if a temporary MRL is required for the particular use, treated produce should 
be restricted to t he territory of the member State granting the authori zation  until such level is set 
at EU level.  
It should be recalled that the vast majority of emergency authori zation s are for products containing 
approved active substances and therefore MRLs are usually already in place.  
More information on emergency use under Article 53, including on consumer safety aspects, can be 
found in the guidance document referred to in reply to question 10.  
12. In light of reply 4(a) in document G/SPS/GEN/1896 , would the European Union 
confirm that Article 5.3 of the SPS Agreement applies to MRLs?  
Please see the reply provided to questions 4(b) and (c) in document G/SPS/GEN/1896 . 
13. The European Union indicated, in reply 4(d) provided in document G/SPS/GEN/1896 , 
that there are no objectives for third countries in the Farm to the Fork Strategy. 
However, this Strategy inc ludes an external dimension as part of the fourth section 
entitled "Promoting the global transition". The section indicates that the European 
Union will achieve this objective "through its external policies, including international 
cooperation and trade po licy". European authorities have also indicated that their 
trade partners must comply with the same standards to level the playing field with 
European competitors. In this context, could the European Union confirm that it will 
not require its trade partner s to meet the same reduction targets as those required of 
its producers?  
As already explained, also during the information sessions on the Farm to Fork Strategy to which 
the WTO Members ' Delegations were invited, the specific targets concerning the reducti on of the 
overall use and risk of chemical pesticides and of more hazardous pesticides, of nutrient losses, of G/SPS/GEN/1970  
 
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  sales of antimicrobials for farmed animals or the target concerning the percentage of land under 
organic farming do not apply to third countries.  
14. Would the European Union explain why the assessment of the impact of the Farm to 
Fork Strategy will be conducted after  the implementation of the Strategy?  
The targets set out in the Farm to Fork Strategy are aspirational targets, based on ambitious but 
realistic pathways. The Commission has used available evidence and data to set them, which also 
includes the 2018 impact assessment for reform of the EU Common Agricultural Policy. 
Any legislative initiative that will result from the Farm to Fork Strategy will be based on public 
consultations and on the identification of the environmental, social and economic impacts. Impact 
assessments will contribute to making efficient and realistic policy choices, based on sound science.  
15. In reply 5(b) prov ided in document G/SPS/GEN/1 896, the European Union recognized 
that "other legitimate factors" fell outside of the scope of the SPS Agreement, even 
though they apply to food products. Could the European Union indicate the provision 
of the multilateral trade rules under which these "o ther legitimate factors" would fall?  
Depending on the content of such measures, other WTO Agreements may apply.  
16. If the possible consideration of "other legitimate factors" could result in MRLs that are 
lower than those determined on strictly sanitary and p hytosanitary grounds, how 
would these MRLs be compatible with those stipulated in the SPS Agreement?  
Please see the EU reply to question 5(b) in document G/SPS/GEN/1896 . 
17. If the majority of emergency authorizations are granted for substances the use of 
which is permitted in the Europe an Union, as stated in document G/SPS/GEN/1894 , 
what is the reason behind the need for these emergency authorizations and their 
frequent use?  
The vast majority of emergency authori zation s are for products containing approved active 
substances.  
The key reasons for the use of emergency  authori zation s are:  
− to overcome procedural delays to author ize PPPs and mutually recogn ize authori zation s; 
− insufficient availability of PPPs for minor uses - member States are not fully using the existing 
provisions to facilitate authori zation  for such us es. 
Various activities are ongoing to improve the authori zation  system, which in turn will lead to less 
need for emergency authori zation s. 
18. Could the European Union indicate which MRLs , among those revised since 2017, have 
been lowered to the limit of detection (LOD)? Could the European Union clarify 
whether the LOD is a variable or fixed number? Would the European Union indicate 
which criterion was used to establish the LOD at 0.01 mg/ kg in its two regulations?  
The MRLs set at LOD are indicated with an asterisk (*) in Regulation 396/2005, as well as in the 
Pesticides Database. The LOD is not a fixed value, as it depends on substance and matrix for which 
it is established.  While for ce rtain complex food matrices or for substances with more than one 
element in their residue definitions, LODs can be higher than the default value of 0.01 mg/kg, there 
are also cases where it can be lower than 0.01 mg/kg, e.g. in the case of highly toxic sub stances. 
The EU reference laboratories for pesticides residues provide the scientific support when proposing 
specific LODs.  
Only where no specific LODs have been established, the general default value of 0.01 mg/kg applies.  
19. We reiterate our question on the  costs at the European level that would result from 
the withdrawal of plant protection products that have not been renewed to date.  G/SPS/GEN/1970  
 
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  As the economic cost is not part of the considerations of the EU pesticides legislation, which has the 
main objective of pr otection of human health and the environment, information on costs is not 
considered when decisions on non -renewal of active substances used in plant protections products 
are made.  
20. Further to reply 9(b) provided in document G/SPS/GEN/1896 , could the European 
Union indicate which crit eria are used to identify sources of data and information?  
The EU regulatory criteria set out in Regulation 2018/605 are based on the WHO definition, which is 
the following:  
'An endocrine disruptor is an exogenous substance or mixture that alters function (s) of the endocrine 
system and consequently causes adverse health effects in an intact organism, or its progeny, or 
(sub) populations. ' 
The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have 
prepared a joint technical guid ance document for the implementation of the criteria that was 
published in 2018.  
21. Further to reply 9(e) provided in document G/SPS/GEN/1896:  
a) Could the European Union establish an MRL of 0.01 mg/kg in view of "global 
concerns", despite the existence of a higher CXL?  
b) Could the Europe an Union provide an exhaustive list of what constitutes its "global 
concerns"?   
c) Could the European Union share the source of its definition of "global concern", 
and a definition of the term "transboundary"?  
Please see the replies to question 10 in document G/SPS/GEN/1896 . 
 
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