
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 2 February 2012.
For the Commission
The President
José Manuel BARROSO
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 × 109 CFU/g additive (granulated form)
 Characterisation of the active substance:
Spores Bacillus subtilis (CBS 117162)
 Analytical method:
 Enumeration: spread plate method (EN 15787)
 Identification: pulsed-field gel electrophoresis (PFGE) method. Piglets (weaned)Pigs for fattening — 2 × 109 — 
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
