Commission Implementing Regulation (EU) 2025/2511 of 11 December 2025 concerning the authorisation of a preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 as a feed additive for ruminants for milk production/reproduction (holder of authorisation: Chr. Hansen A/S)

• CELEX: Implementing Regulation (EU) 2025/2511
• Articles: 3

Article 1 Authorisation

The preparation specified in the Annex, 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 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

ANNEX

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.

4b1896

Chr. Hansen A/S

Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903

Additive composition

Preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 containing a minimum total of Bacillus spp . 3,2 × 10 10 CFU/g additive (1:1 ratio)

Solid form

Characterisation of the active substance

Viable spores of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903.

Analytical method

( 1 )

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

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

Ruminants for milk production/ reproduction

-

3,8 × 10 8

-

7,4 × 10 7

-

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.

When it is used via water for drinking, the additive shall be used ensuring a minimum dose of: 9,6 × 10 9 CFU/animal/day.

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.

1 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 .