NOTIFICATION
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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 |
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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): Food products |
| 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 Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance). Language(s): English.Number of pages: 4 https://members.wto.org/crnattachments/2026/SPS/EEC/26_01242_00_e.pdf |
| 6. |
Description of content: This draft Commission Regulation aims to prohibit the use of monacolins from red yeast rice in food based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question. On 25 June 2018, EFSA adopted a scientific opinion on the safety of monacolins in red yeast rice. In that opinion, it considered that the available information on the adverse effects reported in humans was judged to be sufficient to conclude that monacolins from red yeast rice were of significant safety concern at intake levels as low as 3 mg/day. EFSA was unable to provide advice on a daily intake of monacolins from red yeast rice that does not give rise to concerns for human health. Considering the significant harmful effect on health associated with the use of monacolins at levels as low as 3 mg/day and that no safe daily intake level could be set, the use of the substance in food was restricted and at the same time placed under Union scrutiny by means of Regulation (EU) 2022/860 of 1 June 2022 for a period of four years from the entry into application of that Regulation. On 29 January 2025, EFSA adopted a scientific opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006. In its opinion, EFSA concluded that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins from red yeast rice at intake levels below 3 mg/day or identifying a safe daily intake of monacolins from red yeast rice. Therefore, pursuant to the procedure of Article 8(5) of Regulation (EC) No 1925/2006, monacolins from red yeast rice should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which means that their use in food will be prohibited. |
| 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:
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| 10. |
Proposed date of adoption (dd/mm/yy):Q3 2026 Proposed date of publication (dd/mm/yy):Q3 2026 |
| 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. Foodstuffs containing monacolins from red yeast rice, which were lawfully placed on the market before the entry into force of this Regulation may remain on the market until [entry into force + 12 months]. [ ] Trade facilitating measure |
| 12. |
Final date for comments: [X] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 3 May 2026 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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