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.
Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 are repealed.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
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
