Commission Implementing Regulation (EU) 2025/2576 of 18 December 2025 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for laying or for breeding (holder of authorisation: Chr. Hansen A/S) and amending Implementing Regulation (EU) 2020/1762 as regards the terms of the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding

• CELEX: Implementing Regulation (EU) 2025/2576
• Articles: 6

Article 1 Authorisation

The preparation specified in Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendment to Implementing Regulation (EU) 2020/1762

The Annex to Implementing Regulation (EU) 2020/1762 is replaced by the Annex II to this Regulation.

Article 3 Transitional measures

1.   The feed additive Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840, as authorised by Implementing Regulation (EU) 2020/1762 and premixtures containing that additive, which are intended for all poultry species for fattening or reared for laying or reared for breeding, and which are produced and labelled before 8 July 2026 in accordance with the rules applicable before 8 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for all poultry species for fattening or reared for laying or reared for breeding, and which are produced and labelled before 8 January 2027 in accordance with the rules applicable before 8 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 4 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.

Schedules & Appendices

ANNEX I

ANNEX 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feed with a moisture content of 12 %

CFU/l of water for

drinking

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

4b1894

Chr. Hansen A/S

Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

Additive composition

Preparation of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of 3,2 × 10 9 CFU/g additive (1,6 × 10 9 CFU B. subtilis DSM 32324/g; 1,0 × 10 9 CFU B. subtilis DSM 32325/g and 0,6 × 10 9 CFU B. amyloliquefaciens DSM 25840/g) (ratio 1.6:1.0:0.6)

Solid forms

Characterisation of the active substance

Viable spores of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840.

Analytical method

( 1 )

Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)

Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on tryptone soya agar (EN 15784)

All poultry species for laying or for breeding

-

1,6 × 10 9

-

5,4 × 10 8

-

1.

The additive may be used via water for drinking.

2.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

3.

The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin or lasalocid.

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 and skin protective equipment.

8 January 2036

( 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

ANNEX II

ANNEX 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feed with a moisture content of 12 %

CFU/l of water for

drinking

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

4b1894

Chr. Hansen A/S

Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

Additive composition

Preparation of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of 3,2 × 10 9 CFU/g additive (1,6 × 10 9 CFU B. subtilis DSM 32324/g; 1,0 × 10 9 CFU B. subtilis DSM 32325/g and 0,6 × 10 9 CFU B. amyloliquefaciens DSM 25840/g) (ratio 1.6:1.0:0.6)

Solid forms

Characterisation of the active substance

Viable spores of cells of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840.

Analytical method

( 1 )

Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)

Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on tryptone soya agar (EN 15784).

All poultry species for fattening or reared for laying or reared for breeding

-

1,6 × 10 9

-

5,4 × 10 8

-

1.

The additive may be used via water for drinking.

2.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

3.

The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, or lasalocid.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, glasses and gloves.

16.12.2030

( 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