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.
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 of zootechnical additives. Functional group: gut flora stabilisers
4b1828
HuvePharma NV
Bacillus licheniformis DSM 28710
Additive composition
Preparation of Bacillus licheniformis DSM 28710 containing a minimum of
3,2 × 10 9 CFU/g of additive
Solid form
Characterisation of the active substance
Viable spores of Bacillus licheniformis DSM 28710
Analytical method
( 1 )
For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:
—
Spread plate method EN 15784
For the identification of Bacillus licheniformis DSM 28710:
—
Pulsed Field Gel Electrophoresis (PFGE)
Turkeys for fattening
Turkeys reared for breeding
Minor poultry species for fattening or reared for laying
—
1,6 × 10 9
—
1.
In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
2.
The use is permitted in feed for turkeys containing one of the following authorised coccidiostats: diclazuril, halofuginone, robenidine, lasalocid, maduramicin, or monensin.
3.
The use is permitted in feed for minor poultry species for fattening or reared for laying containing one of the following authorised coccidiostats: diclazuril or lasalocid.
4.
For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.
25 June 2029
( 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