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
4b1827
Danisco (UK) Ltd (trading as Danisco Animal Nutrition),
Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRL
B-50013 and Bacillus amyloliquefaciens NRRL B-50104
Additive composition
Preparation of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRL
B-50013 and Bacillus amyloliquefaciens NRRL B-50104 containing a minimum of 2,5 × 10 9 CFU/g (total) with a minimum of bacterial concentration of 8,3 × 10 8 of each strain/g additive.
Solid form
Characterisation of the active substance
Viable spores of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRL
B-50013 and Bacillus amyloliquefaciens NRRL B-50104
Analytical method
( 1 )
Identification and enumeration of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRL
B-50013 and Bacillus amyloliquefaciens NRRL B-50104 in the feed additive, premixtures and feedingstuffs
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Identification: Pulsed Field Gel Electrophoresis (PFGE)
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Enumeration: Spread plate method following heat treatment — EN 15784
Chickens for fattening
Chickens reared for laying
Minor poultry species for fattening and reared for laying
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7,5 × 10 7
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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 compatible in feed containing the following authorised coccidiostats: narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, decoquinate, semduramycin sodium or nicarbazin.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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.
3 April 2027
( 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