G/SPS/GEN/2171   
13 November 2023 
(23-7610) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
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 THE EUROPEAN UNION  
The following communication, received on 10 November 2023,  is being circulated at the request of 
the delegation of the European Union  in reply to Colombia , Ecuador , Guatemala  and Paraguay . 
This document provides the European Union response to the questions raised in G/SPS/GEN/2140 . 
 
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According to the minutes of the Standing Committee on Plants, Animals and Food and  Feed (PAFF) 
of 10-11 May 2023, " [t]he Commission presented Revision  4 of the draft Regulation, which clarifies 
that the MRLs for tricyclazole should be set in Annex  II to Re gulation (EC) No  396/2005. [The 
Commission] proposes modifying the MRL for tricyclazole in rice from 0.01*  mg/kg to 0.09  mg/kg, 
based on an import tolerance request based on a Brazilian GAP, for which EFSA confirmed that the 
proposed MRL is fully supported  by data and safe for consumers ". Despite this, several EU member 
States did not support the draft Regulation presented by the Commission, and no qualified majority 
was reached. The following reasons were given by those member States voting against the mea sure: 
(i) the non -acceptability of import tolerances for substances no longer approved in the 
European  Union; and (ii)  a negative impact on the competitiveness of European rice farmers that 
are deprived of using the same tools as third countries for effect ive control of certain pests.  
1.  In the light of the above, could the European Union please indicate:  
a) Which Annex(es) of Regulation (EC) No  396/2005 did the Commission propose to amend? 
We note that the text of the minutes of the PAFF refers to Annex  II (EU MRLs), but the title 
of the minutes refers to Annex  III (Temporary MRLs).  
b) In practical terms, what i s the difference between Annex  II and Annex  III of 
Regulation  (EC) No 396/2005?  
c) How are temporary MRLs established? What is their period of validity?  
d) When an import tolerance is accepted, does this generate a new EU MRL that is set in 
Annex  II to Regulatio n (EC) No  396/2005?  
e) If an import tolerance is accepted for a given substance and crop, what MRL applies to 
domestic crops in the European Union? 
f) If an import tolerance is granted and an emergency authorization is granted by a member 
State:  
− Is the establish ment of a temporary MRL necessary — as indicated in item  11 of the 
emergency authorization notification form — or does the MRL set for the import tolerance 
apply?  
− If the MRL for import tolerance is applied, is the product authorized to be placed on the 
market throughout the European Union? G/SPS/GEN/2171  
 
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  EU reply:  
a) The draft Commission Regulation intended amending Annex II of Regulation 
(EC) 396/2005, as the safety of the MRL was recently confirmed by the European Food 
Safety Authority (EFSA). The agenda mentioned Annex II I erroneously.  
b) Annex II mostly contains 'definitive ' MRLs following the full review of existing active 
substances according to Article 12 of Regulation (EC) No 396/2005. Annex IIIA contains 
'temporary ' MRLs that were to a large extent taken over from the p revious MRL Directives 
in the past, mostly for active substances that are awaiting a decision on the inclusion in 
the Annex to Commission Implementing Regulation (EU) No 540/2011 and/or the 
evaluation according to Article 12 of Regulation (EC) No 396/2005.  
c) The temporary MRLs that are set in Annex IIIA were established at the moment of the 
entry into force of Regulation (EC) 396/2005 for active substances that were awaiting a 
decision on the inclusion in the Annex to Commission Implementing Regulation (EU) 
No 540/2011 and the evaluation according to Article 12 of Regulation (EC) No 396/2005. 
No specific period of validity is defined for the temporary MRLs that are set in Annex IIIA.  
d) e) and f) When a Regulation setting a new MRL based on an import tolerance is  adopted, 
the MRL established in Regulation (EC) No 396/2005 is modified accordingly and this new 
MRL applies to domestic and imported products equally. However, if the import tolerance 
concerns a substance not approved in the E uropean Union whatever the r easons, health 
or environmental concerns, the use of that substance is nevertheless not authorized in 
the European Union and EU producers cannot benefit from it.  
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 E uropean Union and the 
uses are covered by already existing EU MRLs. In exceptional cases, and only if t he uses 
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 member 
State must make sure that the products are safe for consumers, remain on its nation al 
market, and enforcement authorities control that this is the case.  
 
2.  If an import tolerance is proposed for an MRL  that " is fully supported by data and safe for 
consumers ", how would rejecting such an import tolerance because of  "a negative impact on th e 
competitiveness of European producers " be compatible with the obligations of the SPS  Agreement?  
EU reply:  
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 wi th its obligations under 
the SPS Agreement, drafts a Regulation to set, or modify 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 m ust then be presented for vote to EU member States 
representatives in a regulatory 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 European 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.  
 
3.  With respect to MRLs set with the objective of protecting human health, if member States do not 
vote in favour of import tolerances, how can the Commission argue that requesting import tolerances 
is a feasible way forward  for MRLs set with environmental outcomes (e.g. neonicotinoid substances)?  G/SPS/GEN/2171  
 
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  EU reply:  
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 t he 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 
scientific 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 rel ated 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 described in the reply to question 2.  
 
4.  In response to repeated challenges to the excessive use of emergency authorizations by member 
States, the European Union indicated, in this and other committees and councils at the WTO, that in 
light of the ruling of the Court of Justice of the European Un ion (CJEU) of 19  January  2023 (Case  C-
162/21), member States may no longer grant emergency authorizations for plant protection 
products containing banned neonicotinoids. In this regard, we note the following:  
a) There are a number of emergency authorizations that were approved before  the CJEU 
judgment, but whose application covers a period subsequent  to that ruling. Will these 
emergency authorizations remain valid for the entire period for which they were approved, 
in light of the CJEU judgment?  
b) On 4 April 2023, subsequent to the CJEU ruling, the Czech  Republic granted an emergency 
authorization for the banned substance thiamethoxam between 20  April 2023 and 
16 July 2023, using as justification and as a mitigation measure  that " the product will only 
be used on the crop intended for export to countries outside the European Union ". 
i. How can the export of the crop for which thiamethoxam has been used be considered a 
mitigation measure that protects European pollinators?  
ii. How is the emergency authorization granted by the Czech  Republic compatible with the 
outcome that the European Union claims to pursue with Regulation (EU) No  2023/334, 
i.e. to protect pollinator populations worldwide?  
iii. Regulation (EU)  No 2023/334 refers to the ban of outdoor  uses of clothianidin and 
thiamethoxam in the Union and sets MRLs for these substances. At what point and in 
what way does it take into account the fact that the imported products may have been 
produced in greenhouses ? 
EU reply:  
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 r esponsibility of member States. Nonetheless, 
the Commission may act if member States grant emergency authori zations that are 
unjustified or contravene the applicable legislation. Thus, the Commission has in the past 
requested two member States to stop gran ting emergency authori zations for the two 
neonicotinoids and has requested EFSA to analyse if other emergency authori zations were 
justified. Regarding this instance, in principle, member States ' administrative bodies must G/SPS/GEN/2171  
 
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  apply the Court 's interpretation to emergency authorizations  granted before the Court 
ruling. However, whether emergency authorizations  already granted may/need to be 
withdrawn depends, essentially, on national administrative provisions and on the 
application of the princ iples 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 procedural 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 authorization  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 question 3 . 
 
5.  We remind the European Union that it has not yet responded to the ques tions submitted in 
document G/SPS/GEN/2076 , dated 2  November  2022.  
EU reply:  
The European Union informs that its reply to G/SPS/GEN/2076  was provided through 
G/SPS/GEN/2139 . 
 
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