| 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 Parliament 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 information 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 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 bifenazate (219). [ ] 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 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 consumer 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
- 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 Council 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)
- 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
(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 International 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 |
