Commission Implementing Regulation (EU) 2021/2051 of 24 November 2021 concerning the authorisation of a preparation of Bacillus velezensis PTA-6507, Bacillus velezensis NRRL B-50013 and Bacillus velezensis NRRL B-50104 as a feed additive for turkeys for fattening (holder of authorisation: Danisco Animal Nutrition represented by Genencor International B.V.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2051
• 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: zootechnical additives

Functional group: gut flora stabilisers

4b1827i

Danisco Animal Nutrition represented by Genencor International B.V.

Bacillus velezensis PTA-6507 , Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104

Additive composition

Preparation of Bacillus velezensis PTA-6507 , Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 containing a minimum 2,5 × 10 9 CFU/g additive (total) with a minimum of bacterial concentration of 8,3 × 10 8 of each strain/g additive.

Solid form

Turkeys for fattening

-

7,5 × 10 7

-

1.

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

2.

May be used in feed containing the following permitted coccidiostats: lasalocid A sodium, monensin sodium and diclazuril.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 December 2031

Characterisation of the active substance

Viable spores of Bacillus velezensis PTA-6507 , Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104

Analytical method

( 1 )

Identification and enumeration of Bacillus velezensis PTA-6507 , Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 in the feed additive, premixtures and feedingstuffs

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

—

Enumeration: Spread plate method following heat treatment – EN 15784

( 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