
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.Done at Brussels, 16 August 2013.
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
4b1823 Kemin Europa N.V. Bacillus subtilis (ATCC PTA-6737) 
 Additive composition
Preparation of Bacillus subtilis (ATCC PTA-6737) containing a minimum of 1 × 1010 CFU/g additive
Solid form
 Characterisation of the active substance
Viable spores of Bacillus subtilis (ATCC PTA-6737)
 Analytical method
Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.
Identification: pulsed-field gel electrophoresis (PFGE) method. Turkeys for fattening and turkeys reared for breeding — 1 × 108 — 
1. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.

2. The use is permitted in feed containing the authorised coccidiostats: diclazuril, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, or monensin sodium, on conditions that this coccidiostat is authorised for the relevant species.
 6 September 2023
