
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, 23 April 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
4b1830 Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U. Clostridium butyricum(FERM BP-2789) 
 Additive composition
Preparation of Clostridium butyricum (FERM BP-2789) containing in solid form a minimum of 5 × 108 CFU/g additive.
 Characterisation of the active substance
Viable spores of Clostridium butyricum FERM BP-2789.
 Analytical method
Quantification: pour plate method based on ISO 15213 standard.
Identification: pulsed-field gel electrophoresis (PFGE) method. Chickens reared for laying — 2,5 × 108 — 
1.. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
2.. The use is allowed in feed containing the authorised coccidiostats: monensin sodium, diclazuril, salinomycin sodium or lasalocid sodium.
3.. For safety: breathing protection and safety glasses shall be used during the handling. 14 May 2023
