G/SPS/N/EU/609  
 
17 January 2023  
(23-0410) 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):  Meat and edible meat offal (HS code(s): 02); Cereals 
(HS code(s):  10) 
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 Parliame nt and of the Council as 
regards maximum residue levels for bifenazate in or on certain products (Text with EEA 
relevance) . Language(s):  English . Number of pages:  3+25  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0456_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0456_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0456_02_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0456_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the update of existing 
MRLs for bifenazate in certain food commodities. MRLs in certain commodities are 
changed. The consumer risk assessment for edible crops could not be finalised, as relevant 
informatio n needed to ensure consumer safety was not provided and the toxicity of a 
relevant metabolite could not be determined . Therefore bifenazate is approved only to use 
in non -edible crops in permanent greenhouses and lower MRLs are set.  
7. Objective and ratio nale: [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 bifenazate (219). 
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  G/SPS/N/EU/609  
 
- 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 stand ard: The approval of bifenazate for its use in plant protection 
products was renewed to non -edible crops in permanent greenhouses because the 
consumer risk assessment for edible crops could not be finalised, as relevant information 
needed to ensure consume r safety was not provided and the toxicity of a relevant 
metabolite could not be determined.  
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  
− Commission Implementing Regulation (EU) 2022/698 of 3 May 2022 renewing the 
approval of the active substance bifenazate in accordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Coun cil concerning the placing of 
plant protection products on the market, and amending the Annex to Commission 
Implementing Regulation (EU) No 540/2011 (OJ L 130, 4 May 2022, p. 3)  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:32022R0698  
− European Food Safety Authority's conclusion on the updated peer review of the 
pesticide risk assessment of the active substance bifenazate. EFSA Journal 
2021;19(8):6818  
https://www.efsa.europa.eu/en/efsajournal/pub/6818  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : May 2023  
Proposed date of publication (dd/mm/yy) : July 2023  
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) : 18 March 2023  
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 Internationa l Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
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  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu