Commission Implementing Regulation (EU) 2023/2736 of 7 December 2023 concerning the authorisation of a preparation of Bacillus velezensis NITE BP-01844 as a feed additive for all poultry species for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or for breeding and ornamental birds (holder of authorisation: Toa Biopharma Co., Ltd)

• CELEX: Implementing Regulation (EU) 2023/2736
• 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 additive

Name of the holder of authorisation

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 feedingstuff with a moisture content of 12 %

CFU/l of water for drinking

Category of zootechnical additives. Functional groups: gut flora stabilisers

4b1903

Toa Biopharma Co., Ltd., Japan, represented by Toa Biopharma Co., Ltd., Europe Representative Office

Bacillus velezensis NITE BP-01844

Additive composition:

Preparation of viable spores of Bacillus velezensis NITE BP-01844 with a minimum concentration of 1 × 10 8 CFU/g of additive

Solid form

Characterisation of the active substance:

Viable spores of Bacillus velezensis NITE BP-01844

Analytical method

( 1 ) :

Identification:

—

Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697, or

—

DNA sequencing methods.

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

All poultry species for fattening

Chickens reared for laying

Turkeys reared for breeding

Minor poultry species reared for laying or for breeding

Ornamental birds

—

2 × 10 8

—

1 × 10 8

—

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 in compound feed containing the following coccidiostats, where authorised as feed additives for the same animal species and categories: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, robenidine and maduramicin.

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.

28 December 2033

( 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