G/SPS/N/EU/443  
 
13 November 2020  
(20-8122) 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 Par liament and of the Council as 
regards maximum residue levels for ametoctradin, bixafen, fenazaquin, spinetoram, 
tefluthrin and thiencarbazone -methyl in or on certain products (Text with EEA relevance) . 
Language(s):  English . Number of pages:  31 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_6934_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_6934_01_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_6934_02_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_6934_03_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_6934_04_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for ametoctradin, bixafen, fenazaquin, spinetoram, tefluthrin and 
thiencarbazone -methyl  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 Europea n 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 p est 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 ametoctradin, 
bixafen, fenazaquin and spinetoram, the list of Codex MRLs is available at: 
http://www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pesticides/en/.  G/SPS/N/EU/443  
 
- 2 - 
 
  [ ] 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?  
[X] Yes   [ ] 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 existing maximum residue levels for fenazaquin and for 
spinetoram. Based on these opin ions, Regulation (EC) No 396/2005 should be amended 
accordingly.  
The proposed regulation conforms to the relevant international standard for ametoctradin, 
bixafen.  
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 ametoctr adin according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2020; 18(1): 5990."  
https://www.efsa.europa.eu/en/efsajournal/pub/5990  
"European Food Safety Authority;  Reasoned opinion on the review of the existing 
maximum residue levels for bixafen according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2020; 18(1): 5998."  
https://www.efsa.europa.eu/en/efsajournal/pub/5998  
"European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for fenazaquin according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2020; 18(1): 5955."  
https://www.efsa.europa.eu/en/efsajournal/pub/5955   
"European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for spinetoram according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2020; 18(1): 5997."  
https://www.efsa.europa.eu/en/efsajournal/pub/5997   
"European Food Safety Authority; Reasoned opin ion on the review of the existing 
maximum residue levels for tefluthrin according to Article 12 of Regulation (EC) No 
396/2005. EFSA Journal 2020; 18(1): 5995."  
https://www.efsa.europa.eu/en/efsajournal/pub/5995  
"European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for thiencarbazone -methyl  according to Article 12 of Regulation 
(EC) No 396/2005. EFSA Journal 2020; 18(1): 5957."  
https://www.efsa.europa.eu/en/efsajournal/pub/5957  
(available in English)   
10. Proposed date of adoption (dd/mm/yy) : February 2021.  
Proposed date of publication (dd/mm/yy) : March 2021.  
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 Jour nal of the 
European Union.  
[ ] Trade facilitating measure   G/SPS/N/EU/443  
 
- 3 - 
 
  12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 12 January 2021  
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 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