G/SPS/N/EU/763  
8 May 2024  
(24-3641) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Cereals (HS codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008), foodstuffs of animal origin (HS codes: 0201, 0202, 0203,  0204, 0205, 0206, 0207, 
0208, 0209, 0210) and certain products of plant origin, including fruit and vegetables  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Regulation amending Annexes II and 
V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for thiacloprid in or on certain products ( Text with EEA 
relevance) . Language(s):  English . Number of pages:  4+1+8  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03130_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03130_01_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03130_02_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for thiacloprid  in certain food commodities following the non -approval of thiacloprid 
in the European Union. The proposed Draft Regulation proposes to provisionally lower to 
the limit of determination all the MRLs for thiacloprid, ensuring a precautionary approach 
toward s consumer protection based on the indications that the substance may be an 
endocrine disruptor, while seeking to obtain additional information.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits for thiacloprid in 
some commodities. CODEX MRLs LIST is available at https://www.fao.o rg/fao -
who-codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=223 . 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  G/SPS/N/EU/763  
 
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  Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international stand ard: The European Food Safety Authority published a peer review in 
the framework of the renewal of the approval of thiacloprid in the European Union. 
It identified several areas of concern, and it was considered no necessary to finalize the 
assessment of t he possible endocrine disrupting properties of thiacloprid on the basis of 
the most recent criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) 
No 1107/2009. The recent MRL risk assessment carried out by the European Food Safety 
Authority did not identify an acute risk for the consumers but concluded that further 
consideration by risk managers was required. Since this assessment was based on the 
existing toxicological reference values which were established before the most recent 
Union criteria  on endocrine disruptors were adopted, they do not necessarily reflect 
endocrine -related effects. Therefore, there remain reasonable grounds for concern that the 
existing MRLs have potentially harmful effects on human health and are inconsistent with 
the h igh level of consumer protection in the E uropean Union. Pending the conclusion of an 
additional risk assessment by the European Food Safety Authority, and given the available 
pertinent information with regard to potentially harmful effects on human health,  it is 
appropriate to provisionally lower the all the MRLs for thiacloprid to the product -specific 
limits of determination.  
9. Other relevant documents and language(s) in which these are available:   
− 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  
https://eur -lex.europa.eu/eli/reg/2005/396/oj  
− Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Direct ives 79/117/EEC and 91/414/EEC  
https://eur -lex.europa.eu/eli/reg/2009/1107/oj  
− EFSA (European Food Safety Authority), 2019. Conclusion on pesticides peer review. 
Peer review of the pesticide risk assessment of the active substance thiacloprid. EFSA 
Journal 2019;17(3): e05595  
https://www.efsa.europa.eu/en/efsajournal/pub/5595  
− EFSA (European Food Safety Authority) 2023; Statement on the short -term (acute) 
dietary risk assessment and evaluation of confir matory data for certain maximum 
residue levels (MRLs) for thiacloprid. EFSA Journal 2023;21(3):7888  
https://www.efsa.europa.eu/en/efsajournal/pub/7888  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 11 November 2024  
Proposed date of publication (dd/mm/yy) : 11 December 2024  
11. Proposed date of entry into force: [X]  Six months from date of publication , 
and/or  (dd/mm/yy) :  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 7 July 2024  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/763  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu