Commission Implementing Regulation (EU) 2021/1411 of 27 August 2021 concerning the renewal of the authorisation of Clostridium butyricum FERM BP-2789 as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, its authorisation for chickens for fattening, suckling piglets and suckling minor porcine species, and repealing Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1411
• Articles: 4

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species is renewed, and for the same category and functional group for chickens for fattening, suckling piglets and suckling minor porcine species is authorised subject to the conditions laid down in that Annex.

Article 2

Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 are repealed.

Article 3

This Regulation shall enter into force on the twentieth day following that of 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: 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 5 × 10 8 CFU/g additive.

Solid form

Chickens for fattening

Chickens reared for laying

Minor avian species (excluding laying birds)

Piglets and piglets of minor porcine species

-

2,5 × 10 8

-

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

May be used in feed containing the permitted coccidiostats: decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramycin sodium.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

19.9.2031

Characterisation of active substance

Viable spores of Clostridium butyricum FERM BP-2789.

Analytical method

( 1 )

Enumeration: pour plate method based on ISO 15213 standard.

Identification: pulsed-field gel electrophoresis (PFGE) method

Turkeys for fattening

Turkeys reared for breeding

-

1,25 × 10 8

-

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports