G/SPS/N/EU/396  
 
15 July 2020  
(20-4819) 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 Consumers 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 fluxapyroxad, hymexazol, metamitron, penflufen and 
spirotetramat in or on certain pr oducts (Text with EEA relevance) . Language(s):  English  
Number of pages:  33 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4139_01_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4139_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4139_02_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_4139_03_e.pdf  
https://m embers.wto.org/crnattachments/2020/SPS/EEC/20_4139_04_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for fluxapyroxad, hymexazol, metamitron, penflufen and spirotetramat in certain 
food commodities. MRL s 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 heal th 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 disease, [  ] protect terri tory from 
other damage from pests.   G/SPS/N/EU/396  
 
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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 fluxapyroxad and 
Codex Maximum Residue Limits for spirotetramat. 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 published reasoned 
opinions on the review of the ex isting maximum residue levels for fluxapyroxad and for 
spirotetramat. Based on these opinions, Regulation (EC) No 396/2005 should be amended 
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  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for fluxapyroxad according to Article 12 of Re gulation (EC) 
No 396/2005. EFSA Journal 2020;18(1):5984.  
http://www.efsa.europa.eu/fr/efsajournal/pub/5984  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for hymexazol according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2019;17(11):5895.  
https://www.efsa.europa.eu/en/efsajournal/pub/5895  
− European Food Safe ty Authority; Reasoned opinion on the review of the existing 
maximum residue levels for metamitron according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2020;18(1):5959  
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.5959  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for penflufen according to Article 12 of Regulation (EC) No 
396/2005 . EFSA Journal 2019;17(10):5840.  
https://www.efsa.europa.eu/fr/efsajournal/pub/5840  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for  spirotetramat according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2020;18(1):5960.  
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.59 60 
− Reasoned opinion on the modification of the existing maximum residue levels for 
spirotetramat in small fruits and berries. EFSA Journal 2019;17(11):5904.  
http://www.efsa.europa.eu/en/efsajournal/pub/5904  
− Reasoned opinion on the setting of import tolerances for fluxapyroxad in certain root 
crops and coffee beans. EFSA Journal 2020;18(1):5950.  
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2020.5950  
(available in English)   
10. Proposed date of adoption (dd/mm/yy) : February 2021.  
Proposed date of publication (dd/mm/yy) : April 2021.  G/SPS/N/EU/396  
 
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  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: [X]  Sixty days from the date of circula tion of the 
notification and/or (dd/mm/yy) : 13 September 2020  
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 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