
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, 13 December 2017.
For the Commission
The President
Jean-Claude JUNCKER
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
4b1820 Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office Bacillus subtilisDSM 15544 
Preparation of Bacillus subtilis C-3102

DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid form

Viable cells of Bacillus subtilis

DSM 15544

Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)

Identification: pulsed-field gel electrophoresis (PFGE).
 SowsSuckling piglets — 3 × 108 — 
1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2. 
'The additive shall be fed to lactating sows and suckling piglets simultaneously'

3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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.
 3 January 2028
Dogs 1 × 109