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)

Current text a fecha 2021-11-25

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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 × 10⁹ 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 × 10⁹	-	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 CECT 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.