Commission Implementing Regulation (EU) 2025/2500 of 11 December 2025 concerning the authorisation of a preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 as a feed additive for poultry for fattening and ornamental birds (holder of authorisation: S.I.Lesaffre)

• CELEX: Implementing Regulation (EU) 2025/2500
• 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

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.

4b1898

S.I.Lesaffre

Preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649

Additive composition

Preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and

Bacillus licheniformis NRRL B-67649 containing a minimum total of Bacillus spp. (ratio 1:1:1):

2 × 10 8 CFU/g additive.

Solid forms

Characterisation of the active substance

Viable cells of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and

Bacillus licheniformis NRRL B-67649.

Analytical method

( 1 )

—

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

—

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

Poultry for fattening

Ornamental birds

-

3 × 10 7

-

1.

In the directions for use of the additive and premixture, 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: diclazuril, narasin, maduramicin ammonium, salinomycin sodium, monensin sodium, robenidine hydrochloride, the combination narasin with nicarbazin, lasalocid 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, 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