G/SPS/GEN/2212   
20 March 2024  
(24-2430) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: Spanish  
 
  
SPECIFIC TRADE CONCERNS - EUROPEAN UNION MAXIMUM RESIDUE LEVELS (MRLS), 
EUROPEAN LEGISLATION ON ENDOCRINE DISRUPTORS AND IMPORT TOLERANCES  
FOR CERTAIN PESTICIDES TO ACHIEVE ENVIRONMENTAL  
OUTCOMES IN THIRD COUNTRIES  
- STC NOS. 448, 382 AND 534 
COMMUNICATION FROM COLOMBIA, ECUADOR, GUATEMALA AND PARAGUAY  
The following communication, receiv ed on 19 March 2024, is being circulated at the request of the 
delegations of Colombia , Ecuador , Guatemala  and Paraguay  in response to document 
G/SPS/GEN/2171  from the European Union.  
 
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Reply of the European Union:  
If an emergency authorization is established by an EU member State, in the vast majority of cases 
(around 85%) this concerns substances approved in the European Union and the uses are covered 
by already existing EU MRLs. In exceptional cases, and only if the use s are not covered by the 
existing MRL (including MRLs based on import tolerances), a  temporary national MRL according to 
Article 18(4) of Regulation (EC) No 396/2005 may be necessary, but this is only very rarely the 
case. In this case, the concerned membe r State must make sure that the products are safe for 
consumers, remain on its national market, and enforcement authorities control that this is the case.  
1.  According to the European Union's reply, "in the vast majority of cases (around 85%) this 
concerns su bstances approved in the European Union and the uses are covered by already existing 
EU MRLs". Could the European Union clarify why an emergency authorization would be necessary 
for substances already approved for use and for which there is already an MRL?  
Reply of the European Union:  
In cases when EFSA concludes that an MRL based on an import tolerance is safe, 
the European  Commission, in accordance with the EU legislation and with its obligations under 
the SPS Agreement, drafts a Regulation to set, or mod ify the relevant MRLs. However, under 
EU legislation on the control by member States of the Commission's exercise of powers conferred 
on it by the Council, the draft Regulation must then be presented for vote to EU member States 
representatives  in a regula tory committee. In case of a favourable opinion by the 
EU member  States , and if subsequently no objection is received from either the 
European  Parliament or the Council of the European Union, the draft regulation shall be adopted 
by the Commission. In case  of a negative opinion by the member States on the draft Regulation, 
or in case of a "no opinion" (neither an opinion in favour, nor against the draft Regulation with a 
qualified majority), the Commission shall submit the draft to the Council of the Europe an Union 
and to the European Parliament for their opinion. If either the Council of the European Union or 
the European Parliament deliver a negative opinion, the Commission shall not adopt the draft 
Regulation.  
2.  We understand that, even if the EFSA conclud es that an MRL based on an import tolerance is 
completely safe, that import tolerance may be rejected for reasons unrelated to food security. Is 
this correct? What are the reasons why the use of a harmless product would be rejected?  G/SPS/GEN/2212  
 
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  3.  Could the European Unio n clarify how the failure to approv e a regulation to establish or modify 
the relevant MRLs to include an import tolerance , that is supported by scientific data and is safe for 
consumers , is consistent with Article 2.2 of the SPS Agreement?  
4.  We are aware of an import tolerance request submitted by Brazil concerning the substance 
tricyclazole in rice, for which the EFSA found that "the proposed MRL is fully supported by data and 
safe for co nsumers". However, this was not endorsed by the SCoPAFF, nor by the Council or by the 
Parliament. Could the European Union confirm in how many other cases scientific information was 
not acknowledged and import tolerances with sufficient scientific evidence  were rejected, in violation 
of the SPS Agreement?  
5.  Further to document G/SPS/GEN/2038 , could the European Union update the number of 
emergency authorizations and import tolerances requested and rejected, as well as the average time 
for processing s uch applications?  
Reply of the European Union:  
If after assessment EFSA confirms that a new MRL does not pose a risk to EU consumers, the 
Commission has the obligation to draft a Regulation and submit it to the member States in the 
respective committee.  
In addition, the recent Regulation lowering MRLs for clothianidin and thiamethoxam takes into 
account the risk for pollinators which is an environmental concern of global nature. As indicated 
in the Recital 20 of the Regulation (EU) No 2023/334 " applications  for import tolerances for 
clothianidin or thiamethoxam maybe be submitted pursuant to Article 7 of Regulation (EC) 
No 396/2005 and should provide relevant information to demonstrate that the GAPs applying for 
the specific uses of the active substances are  safe for pollinators.  That information, if submitted, 
would be assessed on a case-by-case basis within the time period provided for in that Regulation. 
In the context of the assessment of a request for an import tolerance, if an applicant provides 
scienti fic evidence that the use of these neonicotinoids does not adversely impact pollinators, if 
all requirements are met, an import tolerance could be set by the Commission."  
Hence, if an import tolerance request related to a specific Good Agricultural Practice is submitted 
in which it is proven by scientific evidence that such risks to pollinators can be excluded, such an 
import tolerance can be proposed by the Commission in a draft Regulation, whose adoption will 
follow the procedure descr ibed in the reply to question 2.  
6.  Could the European Union indicate whether any import tolerance request has been made for 
MRLs set with environmental objectives?  
7.  If an import tolerance request is submitted "related to a specific Good Agricultural Practice  ... in 
which it is proven by scientific evidence that [the] risks to pollinators can be excluded", can the 
import tolerance, by the same token, be rejected for reasons not related to the safety of pollinators? 
How would this be consistent with Article 2.2  of the TBT Agreement?  
Reply of the European Union:  
a) The granting of emergency authorizations is the responsibility of member States and 
therefore it is primarily the role of member States' judicial systems to ensure the 
compliance with applicable rules which is a general principle of European Union law.  
The judgment of the Court answers questions about the interpretation of Article 53 
of Regulation 1107/2009 by a national court. The Court's judgment clarifies the 
meaning of that rule as it ought to have been understood and applied from the time 
of its coming into force. Compliance with it is the responsibility of member States. 
Nonetheless, the  Commission may act if member States grant emergency 
authorizations that are unjustified or contravene the applic able legislation. Thus, the 
Commission has in the past requested two member States to stop granting 
emergency authorizations for the two neonicotinoids and has requested EFSA to 
analyse if other emergency authorizations were justified. Regarding this insta nce, in 
principle, member States' administrative bodies must apply the Court's interpretation G/SPS/GEN/2212  
 
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  to emergency authorizations granted before the Court ruling. However, whether 
emergency authorizations already granted may/need to be withdrawn depends, 
essential ly, on national administrative provisions and on the application of the 
principles of primacy of EU law and legal certainty. The essential element is whether 
review of a decision is possible, or even mandatory, under national law, which is left 
to the proc edural autonomy of member States. Thus, the Commission has invited the 
member States concerned to withdraw those emergency authorizations in compliance 
with their national law as soon as possible.  
b) I and II. The Commission agrees that an emergency author ization for the outdoor use of 
thiamethoxam seems not compatible with Article 53 of Regulation (EU) No 1107/2009 
as interpreted by the Court of Justice in the above -mentioned judgement and will 
follow this up with the Czech Republic.  
III. See reply to ques tion 3.  
8.  Given that, according to the European Union, the granting of emergency authorizations is the 
responsibility of member States, could the European Union member States provide detailed 
information on the number of emergency authorizations granted and subsequently renewed, as well 
as information on the procedure, cost and average processing time  for these authorizations ? 
9.  The European Commission has indicated that it "agrees that an emergency authorization for the 
outdoor use o f thiamethoxam seems not compatible with Article 53 of Regulation (EU) No 1107/2009 
as interpreted by the Court of Justice ... and will follow this up with the Czech Republic". Could the 
European Union report on the follow -up with the Czech Republic and ho w it intends to address similar 
cases in the future?  
10.  In document G/SPS/GEN/2139 , the European Union stated that the European Commission had 
mandated the EFSA to develop fit -for-purpose protocols for evaluating emergency authorizations 
starting with  a protocol for insecticides and acaricides by May  2025. If these protocols are not 
currently in place for evaluating emergency authorizations, could the European Union clarify which 
parameters form the basis for member States' opinions? In addition, could  the European Union 
indicate whether the criteria to be established in these protocols will also apply to the evaluation of 
import tolerances?  
11.  On 18 November 2021, the EFSA published a news item on its web page, entitled 
"Neonicotinoids: EFSA assess emerge ncy uses on sugar beet in 2020/21". It says in that article that 
"[t]he authorisations were evaluated using a protocol published by EFSA in 2017 to evaluate requests 
for use of an insecticide on the grounds that it is necessary to control a serious danger to plant 
health", and that "[t]he protocol requires all available insecticide and non -insecticide control 
methods to be included in the assessment". According to this EFSA article, a protocol for insecticides 
already exists, which was used for the sugar be et evaluation in 2021. Is this correct? Could the 
European Union indicate whether this protocol has been applied to import tolerance evaluations? 
Could the European Union also clarify its reply, given in document G/SPS/GEN/2139 , in which it 
refers to the development of fit -for-purpose protocols, starting with a protocol for insecticides and 
acaricides by May 2025?  
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