Commission Regulation (EC) No 903/2009 of 28 September 2009 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for chickens for fattening ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)

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.

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
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1830	Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium	Clostridium butyricum FERM-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⁽¹⁾: Quantification: iron sulphite agar for the additive and premixtures and selective Clostridium butyricum FERM-BP 2789 agar for feedingstuffs Identification: pulsed-field gel electrophoresis (PFGE) method	Chickens for fattening	—	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 permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate, monensin sodium or lasalocid. 3. For safety reasons: breathing protection shall be used during handling.	19 October 2019

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 Huvepharma NV Belgium

Clostridium butyricum FERM-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⁽¹⁾:
- Quantification: iron sulphite agar for the additive and premixtures and selective Clostridium butyricum FERM-BP 2789 agar for feedingstuffs
- Identification: pulsed-field gel electrophoresis (PFGE) method

Chickens for fattening

—

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 permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate, monensin sodium or lasalocid.

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

19 October 2019