
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 Minimum content Maximum content Other provisions End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 % CFU/l of water for drinking
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1700i Chr.Hansen A/S Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) 
Preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive

(1:1 ratio)

Solid form

Viable spores of Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749)

Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:


— Identification: Pulsed Field Gel Electrophoresis (PFGE)
— Enumeration: Spread plate method using tryptone soya agar — EN 15784.
 Suckling piglets — 1,3 × 109 — 6,5 × 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 may be used in water for drinking.

3. For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

4. 
'The additive shall be fed to lactating sows and suckling piglets simultaneously'

5. 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 and skin protection.
 3 January 2028
