Commission Implementing Regulation (EU) No 306/2013 of 2 April 2013 concerning the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.) (Text with EEA relevance)

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
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1823	Kemin Europa N.V.	Bacillus velezensis ATCC PTA-6737	Additive composition Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 1 × 10¹⁰ CFU/g additive Characterisation of the active substance Viable spores of Bacillus velezensis ATCC PTA-6737 Analytical method⁽¹⁾ Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples. Identification: pulsed-field gel electrophoresis (PFGE) method.	(Weaned) piglets and (weaned) Suidae other than Sus scrofa domesticus	—	1 × 10⁷	—	(1) In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. (2) For use in (weaned) piglets up to approximately 35 kg.	23 April 2023

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

4b1823

Kemin Europa N.V.

Bacillus velezensis

ATCC PTA-6737

Additive composition

Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 1 × 10¹⁰ CFU/g additive
Characterisation of the active substance

Viable spores of Bacillus velezensis ATCC PTA-6737
Analytical method⁽¹⁾
- Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.
- Identification: pulsed-field gel electrophoresis (PFGE) method.

(Weaned) piglets and (weaned) Suidae other than Sus scrofa domesticus

—

1 × 10⁷

—

(1) In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

(2) For use in (weaned) piglets up to approximately 35 kg.

23 April 2023