Commission Implementing Regulation (EU) 2021/2050 of 24 November 2021 concerning the authorisation of the preparation of Bacillus velezensis CECT 5940 as a feed additive for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction) (holder of authorisation: Evonik Operations GmbH) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2050
• Articles: 3

Article 1

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

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

Other provisions

End of period of authorisation

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

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

4b1822i

Evonik Operations GmbH

Bacillus velezensis CECT 5940

Additive composition:

Preparation of Bacillus velezensis CECT 5940 containing a minimum of:

—1 × 10 9 CFU/g additive

Solid form

Turkeys for fattening

Turkeys reared for breeding

Minor poultry species for fattening and reared for breeding

Ornamental birds (except for reproduction)

-

1 × 10 9

-

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

May be used in feed containing the permitted coccidiostats: diclazuril and monensin sodium.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

15.12.2031

Characterisation of the active substance:

Viable spores of Bacillus velezensis ECT 5940

Analytical method

( 1 ) :

Enumeration: spread plate method using tryptone soya agar (EN 15784);

Identification: pulsed-field gel electrophoresis (PFGE) method.

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.