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): Preparations of a kind used in animal feeding (HS code(s): 2309)

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) 2025/2491 of 10 December 2025 concerning the authorisation of a preparation of 25‑hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 as a feed additive for all animal species except poultry, pigs and ruminants (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 4

https://members.wto.org/crnattachments/2026/SPS/EEC/26_00230_00_e.pdf

https://members.wto.org/crnattachments/2026/SPS/EEC/26_00230_00_f.pdf

https://members.wto.org/crnattachments/2026/SPS/EEC/26_00230_00_s.pdf

6.

Description of content: This Regulation authorises for the first time in the European Union and for a period of ten years 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 as a feed additive belonging to the additive category 'nutritional additives' and in the functional group 'vitamins, pro-vitamins and chemically well-defined substances having similar effect' for all animal species except poultry, pigs and ruminants. This authorisation is based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA). The terms of the authorisation are detailed in the Annex to the Act.

7.

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.

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): 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: Scientific Opinion: Safety and efficacy of a feed additive consisting of 25‑hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants) (DSM Nutritional Products Ltd.) EFSA Journal.2025;23:e9479. https://doi.org/10.2903/j.efsa.2025.9479 (available in English)

10.

Proposed date of adoption (dd/mm/yy): 10 December 2025

Proposed date of publication (dd/mm/yy): 11 December 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