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: Draft Commission Implementing Regulation amending Regulation (EC) No 429/2008 as regards the application form for authorisations of feed additives and the designation of target animal species and categories (Text with EEA relevance). Language(s): English. Number of pages: 5+33

https://members.wto.org/crnattachments/2025/SPS/EEC/25_08157_00_e.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_08157_01_e.pdf

6.

Description of content: Regulation (EC) No 429/2008 provides for the detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications, the assessment and the authorisation of feed additives.

It lays down in Article 2(1) that an application shall be submitted using the form set out in Annex I. This Annex I is currently unnecessarily detailed. In addition, it duplicates information that applicants are required to provide anyway in the electronic submission system provided by the Commission (E-SUBMISSION Food Chain platform). This initiative therefore proposes to simplify and shorten Annex I, and to allow for the system to have an automatically generated application form by extracting the necessary information from the electronic submission, thus reducing administrative burden.

Experience shows that there is a real need to propose a comprehensive list of target animal species and categories that can be used consistently by applicants and EFSA throughout the application and assessment process, in order to avoid uncertainties or misunderstandings which complexify and sometimes even delay the outcome of the authorisation process. This comprehensive list of animal species with appropriate definitions to ensure common understanding is to be laid down in a new Annex V to Regulation (EC) No 429/2008, while Annex IV thereto is expanded to provide a comprehensive list of animal categories.

Additional adjustments are proposed in other parts of Regulation (EC) No 429/2008, such as the addition of a new definition of major species, or to ensure wording consistency.

Furthermore, a concordance table is provided, in Annex III to this draft Implementing Regulation, offering a correspondence between the terms commonly used for the designation of animal species and categories in the current authorisations of feed additives and the new terminology, with a view to help applicants prepare applications for the renewal of existing authorisations.

Finally, in order to enable business operators to adapt to the new requirements set by this draft Implementing Regulation, it is proposed that it starts applying six months after its date of entry into force.

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:  

10.

Proposed date of adoption (dd/mm/yy): March 2026

Proposed date of publication (dd/mm/yy): March 2026

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, and will become applicable six months later.

[ ]      Trade facilitating measure

12.

Final date for comments: [X] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 24 January 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