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)

• CELEX: Regulation (EC) No 903/2009
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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 × 10 8  CFU/g additive

Characterisation of the active substance:

Clostridium butyricum MIYAIRI 588 (FERM-P 1467)

Analytical method  ( 1 ) :

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 × 10 8  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

( 1 )   Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives