
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 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, 28 September 2009.
For the Commission
Androulla VASSILIOU
Member of the Commission
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 Mitsui & Co. Deutschland GmbH Clostridium butyricum MIYAIRI 588 (FERM-P 1467) 
 Additive composition:
Preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) containing a minimum of solid form 5 × 108 CFU/g additive
 Characterisation of the active substance:
Clostridium butyricum MIYAIRI 588 (FERM-P 1467)
 Analytical method:
 Quantification: iron sulphite agar for the additive and premixtures and selective Clostridium butyricum MIYAIRI 588 agar for feedingstuffs
 Identification: pulsed-field gel electrophoresis (PFGE) method Chickens for fattening — 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 permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate.

3. For safety reasons: breathing protection shall be used during handling.
 19 October 2019
