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SPS Notification: Concerning the authorisation of a preparation of Enterococcus faecium ATCC 53519 and a preparation of Enterococcus faecium ATCC 55593 as feed additives for all animal species G/SPS/N/EU/877

Issue Date:2025-12-10 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): Preparation of a kind used in animal nutrition (HS code: 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) 2025/1465 of 22 July 2025 concerning the authorisation of a preparation of Enterococcus faecium ATCC 53519 and a preparation of Enterococcus faecium ATCC 55593 as feed additives for all animal species (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 4

https://members.wto.org/crnattachments/2025/SPS/EEC/25_05730_00_e.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_05730_00_f.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_05730_00_s.pdf

6.

Description of content: The preparations covered by the Act were authorised as feed additives for all animal species. An application was submitted for the reauthorisation of these preparations in accordance with article 10 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 preparations are reauthorised as feed additives for all animal species in the additive category 'technological additives' and in the functional group 'silage additives', under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation's 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 on the safety and efficacy of Enterococcus faecium (NCIMB 10415, DSM 22502, ATCC 53519 and ATCC 55593) as silage additives for all animal species

EFSA Journal 2013; 11 (10):3363;

  • Assessment of the efficacy of two feed additives consisting of Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 for all animal species (FEFANA asbl)

EFSA Journal 2022; 20(10):7603;

  • Efficacy of the feed additives consisting of Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 for all animal species (FEFANA asbl)

EFSA Journal 2023;21(7):8166; Efficacy of the feed additives consisting of Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 as silage additives for all animal species (FEFANA asbl)

EFSA Journal, 22(11), e9071.

10.

Proposed date of adoption (dd/mm/yy): 22 July 2025

Proposed date of publication (dd/mm/yy): 23 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 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