Commission Implementing Regulation (EU) 2017/440 of 13 March 2017 concerning the authorisation of the preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2019/221of 6 February 2019amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives(Text with EEA relevance), 32019R0221, February 7, 2019
Commission Implementing Regulation (EU) 2017/440of 13 March 2017concerning the authorisation of the preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)(Text with EEA relevance)
Article 1The 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 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
4b1827Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.,Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104Additive compositionPreparation of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104 containing a minimum of 2,5 × 109 CFU/g (total) with a minimum of bacterial concentration of 8,3 × 108 of each strain/g additive.Solid formCharacterisation of the active substanceViable spores of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104Analytical methodIdentification and enumeration of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104 in the feed additive, premixtures and feedingstuffsIdentification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method following heat treatment — EN 15784Chickens for fatteningChickens reared for layingMinor poultry species for fattening and reared for laying—7,5 × 107—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
Article 1The 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 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
4b1827Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.,Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104Additive compositionPreparation of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104 containing a minimum of 2,5 × 109 CFU/g (total) with a minimum of bacterial concentration of 8,3 × 108 of each strain/g additive.Solid formCharacterisation of the active substanceViable spores of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104Analytical methodIdentification and enumeration of Bacillus amyloliquefaciens PTA-6507, Bacillus amyloliquefaciens NRRLB-50013 and Bacillus amyloliquefaciens NRRL B-50104 in the feed additive, premixtures and feedingstuffsIdentification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method following heat treatment — EN 15784Chickens for fatteningChickens reared for layingMinor poultry species for fattening and reared for laying—7,5 × 107—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