
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 
In Regulation (EC) No 903/2009 the words ‘Clostridium butyricum MIYAIRI 588 (FERM-P 1467)’ and the words ‘Mitsui & Co. Deutschland GmbH’ are replaced respectively by the words ‘Clostridium butyricum FERM-BP 2789’ and by the words ‘Miyarisan Pharmaceutical Europe S.L.U’.
In point 2 of the ‘Other provisions’ column of the Annex to Regulation (EC) No 903/2009 the words ‘monensin sodium or lasalocid’ are added.
Article 3 
Feed containing Clostridium butyricum MIYAIRI 588 (FERM-P 1467) labelled in accordance with Regulation (EC) No 903/2009 may continue to be placed on the market and used until stocks are exhausted.
Article 4 
This Regulation shall enter into force on the 20th day following 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, 15 April 2011.
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 
 Additive composition
Preparation of Clostridium butyricum FERM BP-2789 containing a minimum of solid form 5 × 108 CFU/g additive.
 Characterisation of the active substance
Clostridium butyricum FERM BP-2789.
 Analytical method
 Quantification: pour plate method based on ISO 15213 standard.
 Identification: pulsed-field gel electrophoresis (PFGE) method. Minor avian species (excluding laying birds). — 5 × 108 CFU — 
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, maduramycin ammonium, robenidine, narasin, narasin/nicarbazin, semduramicin, decoquinate, salinomycin sodium or lasalocid sodium.

3. For safety: breathing protection shall be used during the handling.
 6 May 2021
Piglets (weaned) and minor porcine species (weaned). 2,5 × 108 CFU
