Commission Regulation (EC) No 903/2009 of 28 September 2009 concerning the authorisation of the preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Mitsui & Co. Deutschland GmbH) (Text with EEA relevance)
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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| (1) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives |
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