Commission Implementing Regulation (EU) 2025/2497 of 10 December 2025 concerning the authorisation of preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 as a feed additive for poultry for fattening and reared for laying or reproduction (holder of authorisation: Biomin GmbH)

Official Journal EN of the European Union L series 2025/2497 11.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2497 of 10 December 2025 concerning the authorisation of preparations of Enterococcus faeciumDSM 33761, Pediococcus acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 as a feed additive for poultry for fattening and reared for laying or reproduction (holder of authorisation: Biomin GmbH) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivarius DSM 16351 as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying or breeding, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 September 2023(2)that, under the proposed conditions of use, the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 are safe for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying or breeding, as well as for consumers and the environment. The Authority also concluded that the preparation of Enterococcus faecium DSM 33761, Pediococcus acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivarius DSM 16351 in both formulations is considered respiratory sensitiser but it is not irritant to the skin. No conclusion could be made on the potential of the additive to be an eye irritant or dermal sensitiser. After the assessment of supplementary information submitted by the applicant, the Authority concluded in its opinion of 6 May 2025(3) that the preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 has the potential to be efficacious in all poultry for fattening and reared for laying or breeding at 1 × 108 CFU/kg complete feed and 5 × 107CFU/L water for drinking. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal2023;21(10):8354. https://doi.org/10.2903/j.efsa.2023.8354.

(3) EFSA Journal. 2025;23:e9459. https://doi.org/10.2903/j.efsa.2025.9459.

ELI: http://data.europa.eu/eli/reg_impl/2025/2497/oj 1/8EN OJ L, 11.12.2025

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 26 September 20232 are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory was therefore not required.

(6) In view of the above, the Commission considers that the preparations of Enterococcus faeciumDSM 33761, Pediococcus acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of these preparations should be authorised for poultry for fattening and reared for laying or reproduction. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Authorisation The preparations specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, are authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 December 2025.

For the Commission The President Ursula VON DER LEYEN

(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/8 ELI: http://data.europa.eu/eli/reg_impl/2025/2497/ojANNEX PART I Minimum Maximum content content Identification Name of the Species or Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age CFU/kg of complete feed authorisation feed additive authorisation animal with a moisture content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers.

4b1897 Biomin Enterococcus faecium Additive composition Poultry for - 1 × 108 - 1. In the directions for use of 31 December GmbH DSM 33761, Preparation of Enterococcus fattening the additive and 2035 Pediococcus faeciumDSM 33761, and reared premixtures, the storage acidilactici Pediococcus acidilactici for laying or conditions and stability to DSM 33758, DSM 33758, Bifidobacterium reproduc­ heat treatment shall be Bifidobacterium animalisDSM 16284, tion indicated.

animalisDSM Limosilactobacillus reuteriDSM 2. The additive may be used 16284, 33751 and Ligilactobacillus simultaneously with the Limosilactobacillus salivariusDSM 16351 following coccidiostats, in

reuteriDSM containing a minimum of: accordance with their 33751 and 4 × 1010CFU/g (total) with a respective conditions of Ligilactobacillus minimum of bacterial authorisation as feed

salivariusDSM concentration of additives: nicarbazin, 16351 1,3 x 1010Enterococcus faecium diclazuril, decoquinate or DSM 33761 halofuginone.

1,3 x 1010Pediococcus acidilacticiDSM 33758 3. For users of the additive 1,2 x 1010Bifidobacterium and premixtures, feed animalisDSM 16284; business operators shall 1,0 x 109Limosilactobacillus establish operational reuteriDSM 33751 and procedures and 1,0 x 109Ligilactobacillus organisational measures to salivariusDSM 16351. address potential risks resulting from their use.

Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj 3/8 OJ L,

11.12.2025 ENMinimum Maximum content content Identification Name of the Species or Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age CFU/kg of complete feed authorisation feed additive authorisation animal with a moisture content of 12 % Solid coated form Characterisation of the active substance Viable cells of Enterococcus faeciumDSM 33761, Pediococcus acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351.

Analytical method(1) For the identification of Enterococcus faeciumDSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351:

— DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE)- CEN/TS 17697 For the enumeration of Enterococcus faeciumDSM 33761 in the feed additive, premixtures and compound

feed: — Spread plate (or pour plate) method on bile esculin azide agar or on Slanetz and Bartley agar (EN 15788) 4/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj EN OJ L,

11.12.2025Minimum Maximum content content Identification Name of the Species or Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age CFU/kg of complete feed authorisation feed additive authorisation animal with a moisture content of 12 % For the enumeration of Pediococcus acidilacticiDSM 33758 in the feed additive, premixtures and compound

feed: — Spread plate (or pour plate) method on MRS agar (EN 15786) For the enumeration of Bifidobacterium animalisDSM 16284 in the feed additive, premixtures and compound

feed: — Spread plate (or pour plate) method on MRS agar (EN 15785) For the enumeration of Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 in the feed additive, premixtures and

compound feed: — Spread plate (or pour plate) method on MRS agar (EN 15787)

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj 5/8 OJ L,

11.12.2025 ENPART II Minimum Maximum Identification Name of the Species or content content Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age authorisation feed additive authorisation animal CFU/l of water for drinking

Category: zootechnical additives. Functional group: gut flora stabilisers.

4b1897i Biomin Enterococcus faecium Additive composition Poultry for - 5 × 107 - 1. In the directions for use of 31 December GmbH DSM 33761, Preparation of Enterococcus fattening the additive, the storage 2035 Pediococcus faeciumDSM 33761, and reared conditions and the stability acidilactici Pediococcus acidilactici for laying or in water for drinking shall DSM 33758, DSM 33758, Bifidobacterium reproduc­ be indicated.

Bifidobacterium animalisDSM 16284, tion

2. The additive shall be used animalisDSM Limosilactobacillus reuteriDSM via water for drinking.

16284, 33751 and Ligilactobacillus Limosilactobacillus salivariusDSM 16351 3. The additive may be used

reuteriDSM containing a minimum of: simultaneously with the 33751 and 1 × 1011CFU/g (total) with a following coccidiostats, in Ligilactobacillus minimum of bacterial accordance with their salivariusDSM concentration of respective conditions of 16351 3,25 × 1010Enterococcus authorisation as feed faeciumDSM 33761 additives: nicarbazin, 3,25 × 1010Pediococcus diclazuril, decoquinate or acidilacticiDSM 33758 halofuginone.

3,0 × 1010Bifidobacterium

4. For users of the additive animalisDSM 16284; and premixtures, feed 2,0 × 109Limosilactobacillus. business operators shall reuteriDSM 33751 and establish operational 2,0 × 109Ligilactobacillus procedures and salivariusDSM 16351.

organisational measures to Solid (non coated) form address potential risks resulting from their use.

Where those risks cannot be eliminated by such 6/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj EN OJ L,

11.12.2025Minimum Maximum Identification Name of the Species or content content Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age authorisation feed additive authorisation animal CFU/l of water for drinking Characterisation of the active procedures and measures, substance the additive and Viable cells of Enterococcus premixtures shall be used faeciumDSM 33761, with personal breathing, Pediococcus acidilacticiDSM eye and skin protective 33758, Bifidobacterium equipment.

animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351.

Analytical method(1) For the identification of Enterococcus faeciumDSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351:

— DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE)- CEN/TS 17697 For the enumeration of Enterococcus faeciumDSM 33761 in the feed additive, premixtures, compound feed

and water for drinking: — Spread plate (or pour plate) method on bile esculin azide agar or on Slanetz and Bartley agar (EN 15788)

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj 7/8 OJ L,

11.12.2025 ENMinimum Maximum Identification Name of the Species or content content Composition, chemical formula, Maximum End of period of number of the holder of Name of the additive category of Other provisions description, analytical method age authorisation feed additive authorisation animal CFU/l of water for drinking For the enumeration of Pediococcus acidilacticiDSM 33758 in the feed additive, premixtures, compound feed

and water for drinking: — Spread plate (or pour plate) method on MRS agar (EN 15786) For the enumeration of Bifidobacterium animalisDSM 16284 in the feed additive, premixtures, compound feed

and water for drinking: — Spread plate (or pour plate) method on MRS agar (EN 15785) For the enumeration of Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351 in the feed additive, premixtures, compound feed and water for

drinking: — Spread plate (or pour plate) method on MRS agar (EN 15787)

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en.

8/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/2497/oj EN OJ L,

11.12.2025