Commission Implementing Regulation (EU) No 91/2012 of 2 February 2012 concerning the authorisation of Bacillus subtilis (CBS 117162) as a feed additive for weaned piglets and pigs for fattening (holder of authorisation Krka d.d.) Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 91/2012
• 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 20th day following 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.

4b1824

Krka d.d.

Bacillus subtilis

(CBS 117162)

Additive composition:

Preparation of Bacillus subtilis (CBS 117162) containing a minimum of 4 × 10 9 CFU/g additive (granulated form)

Characterisation of the active substance:

Spores Bacillus subtilis (CBS 117162)

Analytical method

( 1 ) :

Enumeration: spread plate method (EN 15787)

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

Piglets (weaned)

Pigs for fattening

—

2 × 10 9

—

1.

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

2.

For piglets (weaned) up to 35 kg.

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

23 February 2022

( 1 )   Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx