NOTIFICATION
| 1. |
Notifying Member: EUROPEAN UNION If applicable, name of local government involved: |
| 2. |
Agency responsible: European Commission, Health and Food Safety Directorate-General |
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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):Novel food |
| 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: Commission Implementing Regulation (EU) 2025/1513 of 28 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the additional labelling requirements of the novel food Calanus finmarchicus oil (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 4 https://members.wto.org/crnattachments/2025/SPS/EEC/25_05063_00_e.pdf https://members.wto.org/crnattachments/2025/SPS/EEC/25_05063_00_f.pdf https://members.wto.org/crnattachments/2025/SPS/EEC/25_05063_00_s.pdf |
| 6. |
Description of content: The measure concerns an amendment of the conditions of use concerning astaxanthin esters to the level up to 0.25 % for all population groups in food supplements. The increase in the astaxanthin esters in oil from Calanus finmarchicus is expected to result in intakes of astaxanthin which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed, in any population group, the acceptable daily intake of 0.2 mg of astaxanthin/kg body weight established by the European Food Safety Authority. There is also a need to amend the labelling requirements of the novel food Calanus finmarchicus oil in line with the proposed conditions of use, as the statement laid down in Commission Implementing Regulation (EU) 2022/966 that food supplements containing Calanus finmarchicus oil should not be consumed by children younger than 14 years if the ingredient contains ≥ 0.1 % astaxanthin does no longer apply. |
| 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: [ ] Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text): [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number): [ ] International Plant Protection Convention (e.g. ISPM number): [X] None Does this proposed regulation conform to the relevant international standard? [ ] 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: |
| 10. |
Proposed date of adoption (dd/mm/yy):28 July 2025 Proposed date of publication (dd/mm/yy):29 July 2025 |
| 11. |
Proposed date of entry into force: [ ] Six months from date of publication, and/or(dd/mm/yy):This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union [X] Trade facilitating measure |
| 12. |
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 A4-Multilateral International Relations Rue Froissart 101 B-1049 Brussels Tel: +(32 2) 29 54263 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 E-mail: sps@ec.europa.eu |
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