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): 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) 2025/2245 of 7 November 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 5 https://members.wto.org/crnattachments/2025/SPS/EEC/25_09119_00_e.pdf https://members.wto.org/crnattachments/2025/SPS/EEC/25_09119_00_f.pdf https://members.wto.org/crnattachments/2025/SPS/EEC/25_09119_00_s.pdf |
| 6. |
Description of content: The measure concerns an amendment of the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil. In particular, it concerns an increase of the maximum level of DHA in food supplements as defined in Directive 2002/46/EC from a maximum of 250 mg DHA/day for the general population and 450 mg DHA/day for pregnant and lactating women to a maximum of 1 g DHA/day for the general population above three years of age, including pregnant and lactating women, while maintaining 250 mg DHA/day in food supplements for children below three years of age. |
| 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): 7 November 2025 Proposed date of publication (dd/mm/yy): 10 November 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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