G/SPS/N/EU/701  
12 December 2023  
(23-8506) Page: 1/2 
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):  Preparations of a kind used in animal feeding (HS code(s): 2309)  
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 Annex II to 
Regulation (EC) No. 396/2005 of the European Parliament and of the Council as  regards 
maximum residue levels for 1,4 -dimethylnaphthalene, difluoroacetic acid (DFA), fluopyram 
and flupyradifurone in or on certain products (text with EEA relevance) . Language(s):  
English . Number of pages:  38 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_14475_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_14475_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_14475_02_e.pdf  
https://member s.wto.org/crnattachments/2023/SPS/EEC/23_14475_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the update of existing 
MRLs for 1,4 -dimethylnaphthalene, difluoroacetic acid (DFA), fluopyram and  
flupyradifurone in certain food commodities. MRLs for these substances in certain 
commodities are lowered or raised. For 1,4 -dimethylnaphthalene, MRLs were revised 
following the evaluation and/or the lack of confirmatory data.  
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 pesticide 
fluopyram (243) and flupyradifurone (285) in some commodities. CODEX MRLs 
LIST is available at https:/ /www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pesticides/en/  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Prot ection Convention (e.g.  ISPM number) :  
[ ] None  G/SPS/N/EU/701  
 
- 2 - 
 
  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 standard:   
The European Food Safety Authority published reasoned opinions on the modification of 
the existing maximum residue (MRLs) for 1,4-dimethylnaphthalene, difluoroacetic acid 
(DFA), fluopyram and flupyradifurone. Based on the above, Regulation (EC) No. 396/2005 
should be amende d accordingly.  
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  
 http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
- EFSA 2023. Modification of the existing maximum residue levels for 1,4 -
dimethylnaphthalene in potatoes. EFSA Journal, 21(8), 1 –37. 
https://doi.org/10.2903/j.efsa.2023.8190  
- EFSA 2020. Reasoned opinion on the review of the existing maximum residue levels for 
fluopyram according to Article 12 of Regulation (EC) No. 396/2005. EFSA Journal 
2020;18(4):6059. https://doi .org/10.2903/j.efsa.2020.6059  
- EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue levels 
and setting of import tolerances for flupyradifurone and DFA in various crops and animal 
commodities. E FSA Journal 2023;21(7):8081.  https://doi.org/10.2903/j.efsa.2023.8081  
- EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue 
levels and setti ng import tolerances for flupyradifurone and difluoroacetic acid (DFA) in 
various plant commodities. EFSA Journal 2023  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 2 July 2024  
Proposed date of publication (dd/mm/yy) : 2 August 2024  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on the twentieth day following that of 
its publication in the Official Journal of the European Union, and apply 6 months thereafter.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 10 February 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: +(3 2 2) 29 54263  
E-mail: sps@ec.europa.eu  
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