G/SPS/N/EU/397/Rev.1  
 
7 May 2021  
(21-3919) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Revision1 
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 
III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for acequinocyl, cycloxydim, diclofop, fluopyram, 
ipconazole and terbuthylazine in or on  certain products (Text with EEA relevance) . 
Language(s):  English . Number of pages:  34 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3203_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3203_01_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3203_02_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3203_03_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3203_04_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for acequinocyl, cycloxydim, diclofop, fluopyram, ipconazole and terbuthylazine in 
certain food commodities. MRLs for these substances in certain commodities are changed: 
either increased or lowered. Lower MRLs are set after updating the limits of determination 
and/or deleting old uses which are not authorised any more in the European Union or for 
which a human health concern may not be excluded. The residue definition for some 
substances has also been updated.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or d isease, [  ] protect territory from 
other damage from pests.   
 
1 This revision contains the information notified in G/SPS/N/EU/397/C orr.1, circulated in English only, on 
20 July 2020. The French and Spanish versions of G/SPS/N/EU/397  have not been modified in this revision.  G/SPS/N/EU/397/Rev.1  
 
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  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 cycloxydim and 
fluopyram. The list of Codex MRLs is available at: http://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 Protection Convention (e.g.  ISPM number) :  
[ ] None  
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 (EFSA) published a 
reasoned opinion on the review of the existing maxim um residue levels for fluopyram. 
EFSA identified a possible chronic risk to consumers if all available CXLs were maintained. 
Therefore, the CXLs which were higher than the derived EU MRL were disregarded. 
EU MRLs for oranges, lemons, limes, tree nuts, wine  grapes, currants (red, black and 
white), gooseberries, rose hips, potatoes, spring onions, sweet peppers/bell peppers, 
aubergines/eggplants, basil, beans (without pods), peas (without pods), beans (dry), 
lentils (dry), peanuts, soyabean, rice, rye, swine (muscle, fat tissue, liver, kidney), bovine 
(muscle, fat tissue, liver, kidney), sheep (muscle, fat tissue, liver, kidney), goat (muscle, 
fat tissue, liver, kidney), equine (muscle, fat tissue, liver, kidney), milk (cattle, sheep, 
goat, horse) and birds eg gs have been lowered and do not correspond to CXLs.  
The proposed regulation conforms to the relevant international standard for cycloxydim.  
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  
− "European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for acequinocyl according to Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(1): 5983."  
https://www.efsa.europa.eu/en/efsajournal/pub/5983  
− "European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for cycloxydim according to Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(1): 5962."  
https://www.efsa.europa.eu/en/efsajournal /pub/5962  
− "European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for diclofop according to Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(1): 5981."  
https://www.efsa.europa.eu/en/efsajournal/pub/5981  
− "European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for fluopyram according t o Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(4): 6059."  
https://www.efsa.europa.eu/en/efsajournal/pub/6059  
− "European Food Safety Authority; Reasoned opinio n on the review of the existing 
maximum residue levels for ipconazole according to Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(1): 5961."  
https://www.efsa.e uropa.eu/en/efsajournal/pub/5961  
− "European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for terbuthylazine according to Article 12 of Regulation 
(EC) No /2005. EFSA Journal 2020; 18(1): 5980."  
https://www.efsa.europa.eu/en/efsajournal/pub/5980  
(available in English)  G/SPS/N/EU/397/Rev.1  
 
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  10. Proposed date of adoption (dd/mm/yy) : September 2020  
Proposed date of publication (dd/mm/yy) : October 2020  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : Twenty days after publication in the Official Journal of the 
European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if av ailable) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 - Multilateral International Relations  
Rue Froissart 101  
B 1049 Brussels  
Tel: +(322) 295 4263  
Fax: +(322) 299 8090  
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 D2 - Multilateral International Relations  
Rue Froissart 101  
B 1049 Brussels  
Tel: +(322) 295 4263  
Fax: +(322) 299 8090  
E-mail: sps@ec.europa.eu