Commission Implementing Regulation (EU) 2020/1395 of 5 October 2020 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2021/733of 5 May 2021amending Implementing Regulation (EU) No 887/2011 and Implementing Regulation (EU) 2017/961 as regards the name of the holder of the authorisation of Enterococcus faecium CECT 4515 as a feed additive and amending Implementing Regulation (EU) 2020/1395 as regards the name of the holder of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive(Text with EEA relevance), 32021R0733, May 6, 2021
Commission Implementing Regulation (EU) 2020/1395of 5 October 2020concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of the authorisation Evonik Operations GmbH)(Text with EEA relevance)
Article 1The authorisation of the additive specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers" for chickens reared for laying, and for the same category and functional group for chickens for fattening is renewed subject to the conditions laid down in that Annex.
Article 2Regulation (EC) No 1292/2008 is repealed.
Article 3This 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-reports
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 %
Category of zootechnical additives. Functional group: gut flora stabilisers.
4b1822Evonik Operations GmbHBacillus amyloliquefaciens CECT 5940Additive compositionPreparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of:1 × 109 CFU/g additiveSolid formsChickens for fatteningChickens reared for laying-1 × 109-1.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: diclazuril, monensin 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 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, glasses and gloves.26.10.2030
Characterisation of active substanceSpores of Bacillus amyloliquefaciens CECT 5940
Analytical methodEnumeration: spread plate method using tryptone soya agar (EN 15784)Identification: pulsed-field gel electrophoresis (PFGE) method.
Article 1The authorisation of the additive specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers" for chickens reared for laying, and for the same category and functional group for chickens for fattening is renewed subject to the conditions laid down in that Annex.
Article 2Regulation (EC) No 1292/2008 is repealed.
Article 3This 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-reports
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 %
Category of zootechnical additives. Functional group: gut flora stabilisers.
4b1822Evonik Operations GmbHBacillus amyloliquefaciens CECT 5940Additive compositionPreparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of:1 × 109 CFU/g additiveSolid formsChickens for fatteningChickens reared for laying-1 × 109-1.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: diclazuril, monensin 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 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, glasses and gloves.26.10.2030
Characterisation of active substanceSpores of Bacillus amyloliquefaciens CECT 5940
Analytical methodEnumeration: spread plate method using tryptone soya agar (EN 15784)Identification: pulsed-field gel electrophoresis (PFGE) method.