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)

Authorisation

Article 1

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.

Entry into force

Article 2

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

ANNEXSupplementary provisions

ANNEX PART I Identification number of the feed additive Name of the holder of authorisation Name of the additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation CFU/kg of complete feed with a moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers. 4b1897 Biomin GmbH Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 Additive composition Preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 containing a minimum of: 4 × 10 10 CFU/g (total) with a minimum of bacterial concentration of 1,3 x 10 10 Enterococcus faecium DSM 33761 1,3 x 10 10 Pediococcus acidilactici DSM 33758 1,2 x 10 10 Bifidobacterium animalis DSM 16284; 1,0 x 10 9 Limosilactobacillus reuteri DSM 33751 and 1,0 x 10 9 Ligilactobacillus salivarius DSM 16351. Solid coated form Characterisation of the active substance Viable cells of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. Analytical method  ( 1 ) For the identification of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351: — DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE)-CEN/TS 17697 For the enumeration of Enterococcus faecium DSM 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) For the enumeration of Pediococcus acidilactici DSM 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 animalis DSM 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 reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 in the feed additive, premixtures and compound feed: — Spread plate (or pour plate) method on MRS agar (EN 15787) Poultry for fattening and reared for laying or reproduction - 1 × 10 8 - 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: nicarbazin, diclazuril, decoquinate or halofuginone. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to 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. 31 December 2035 PART II Identification number of the feed additive Name of the holder of authorisation Name of the additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation CFU/l of water for drinking Category: zootechnical additives. Functional group: gut flora stabilisers. 4b1897i Biomin GmbH Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 Additive composition Preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 containing a minimum of: 1 × 10 11 CFU/g (total) with a minimum of bacterial concentration of 3,25 × 10 10 Enterococcus faecium DSM 33761 3,25 × 10 10 Pediococcus acidilactici DSM 33758 3,0 × 10 10 Bifidobacterium animalis DSM 16284; 2,0 × 10 9 Limosilactobacillus. reuteri DSM 33751 and 2,0 × 10 9 Ligilactobacillus salivarius DSM 16351. Solid (non coated) form Characterisation of the active substance Viable cells of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. Analytical method  ( 2 ) For the identification of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351: — DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE)-CEN/TS 17697 For the enumeration of Enterococcus faecium DSM 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) For the enumeration of Pediococcus acidilactici DSM 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 animalis DSM 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 reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 in the feed additive, premixtures, compound feed and water for drinking: — Spread plate (or pour plate) method on MRS agar (EN 15787) Poultry for fattening and reared for laying or reproduction - 5 × 10 7 - 1. In the directions for use of the additive, the storage conditions and the stability in water for drinking shall be indicated. 2. The additive shall be used via water for drinking. 3. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: nicarbazin, diclazuril, decoquinate or halofuginone. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to 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. 31 December 2035 ( 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 . ( 2 )   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 .