
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, 20 October 2014.
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
4b1830 Miyarisan Pharmaceutical Co.Ltd represented by Miyarisan Pharmaceutical Europe S.L.U. Clostridium butyricumFERM BP-2789 
Preparation of Clostridium butyricum FERM BP-2789 containing in solid form a minimum of 5 × 108 CFU/g of additive.

Viable spores of Clostridium butyricum FERM BP-2789.

Enumeration: pour plate method based on ISO 15213 standard.

Identification: pulsed-field gel electrophoresis (PFGE) method.
 Turkeys for fatteningTurkeys reared for breeding — 1,25 × 108 — 
1. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.

2. Use is allowed in feed containing (for the animal category) the authorised coccidiostats: monensin sodium, robenidine, maduramicin ammonium, lasalocid sodium or diclazuril.

3. For safety: breathing protection and safety glasses shall be used during handling.
 10 November 2024
