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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): Ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) as a feed additive and all types of animal feed containing ethoxyquin |
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Regions or countries likely to be affected, to the extent relevant or practicable: [X] All trading partners [ ] Specific regions or countries: |
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Title of the notified document: Commission Implementing Regulation (EU) 2022/1375 of 5 August 2022 concerning the denial of authorisation of ethoxyquin as a feed additive belonging to the functional group of antioxidants and repealing Implementing Regulation (EU) 2017/962 (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 3 https://members.wto.org/crnattachments/2022/SPS/EEC/22_5659_00_e.pdf https://members.wto.org/crnattachments/2022/SPS/EEC/22_5659_00_f.pdf https://members.wto.org/crnattachments/2022/SPS/EEC/22_5659_00_s.pdf |
| 6. |
Description of content: The authorisation of ethoxyquin used as an antioxidant feed additive for all animal species had been suspended by Commission Implementing Regulation (EU) 2017/962 of 7 June 2017, as amended by Commission Implementing Regulation (EU) 2021/412, on the basis of the opinion of the European Food Safety Authority (EFSA) of 21 October 2015 (cf notification G/SPS/N/EU/190). The authorisation of the additive was suspended pending the submission and assessment of supplementary data to be produced by the applicant for authorisation, in accordance with a time schedule listing the necessary studies to be carried out. Implementing Regulation (EU) 2017/962 provided for a review of the suspension measure by 31 December 2022 at the latest and in any event after the adoption by EFSA of a non-favourable opinion on the safety and efficacy of the additive ethoxyquin. After assessment of the submitted supplementary data, EFSA adopted on 27 January 2022 a new opinion, which was not favourable as regards the safety of the additive, in particular for long-living and reproductive animals, for consumers and for the environment. Therefore, since the conditions for authorisation of the additive laid down by the relevant EU legislation are still not met, the authorisation of ethoxyquin had to be denied, which is the subject matter of Commission Implementing Regulation (EU) 2022/1375. The notified measure therefore confirms the withdrawal from the EU market of the feed additive ethoxyquin for use for all animal species. |
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Objective and rationale: [X] food safety, [X] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests. |
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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): Code of practice on Good Animal Feeding CAC/RCP 54-2004 [ ] 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: |
| 9. |
Other relevant documents and language(s) in which these are available: Opinion of EFSA of 27 January 2022, published in the EFSA Journal 2022;20(3):7166 (available in English) |
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Proposed date of adoption (dd/mm/yy): 5 August 2022 Proposed date of publication (dd/mm/yy): 8 August 2022 |
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Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): 28 August 2022. Commission Implementing Regulation (EU) 2022/1375 enters into force on the twentieth day following its publication in the Official Journal of the European Union. [ ] Trade facilitating measure |
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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 available) of other body: European Commission DG Health and Food Safety, Unit D2-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 D2-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 |
