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SPS Notification: Concerning the renewal of the authorisation of biotin and two preparations of biotin as feed additives for all animal species and etc. G/SPS/N/EU/867

Issue Date:2025-08-01 Source:WTO/TBT-SPS National Notification and Enquiry of China Scan QrCode to View

 

 

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): 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) 2025/1424 of 17 July 2025 concerning the renewal of the authorisation of biotin and two preparations of biotin as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/723 (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 6

https://members.wto.org/crnattachments/2025/SPS/EEC/25_04808_00_e.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_04808_00_f.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_04808_00_s.pdf

6.

Description of content: The substance and the preparations covered by the Act were authorised for a period of ten years as feed additives for all animal species in the additive category 'nutritional additives' and in the functional group 'vitamins, pro-vitamins and chemically well-defined substances having similar effect'. An application was submitted for the renewal of the authorisation of this substance and the preparations in accordance with article 14 of Regulation (EC) No 1831/2003. 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 authorisation of this substance and the preparations as feed additives for all animal species is renewed under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

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:

  • Assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (ADISSEO, DSM Nutritional Products Ltd., NHU Europe GmbH)

EFSA Journal. 2025;23:e9250.

10.

Proposed date of adoption (dd/mm/yy): 17 July 2025

Proposed date of publication (dd/mm/yy): 18 July 2025

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or(dd/mm/yy): This Regulation will enter into force on the twentieth day following 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