Commission Implementing Regulation (EU) 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2023/366of 16 February 2023concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.)(Text with EEA relevance), 32023R0366, February 17, 2023
Commission Implementing Regulation (EU) 2017/2276of 8 December 2017concerning the authorisation of a new use of the preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for sows (holder of the authorisation Kemin Europa N.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 %
4b1823Kemin Europa N.V.Bacillus velezensis ATCC PTA-6737Additive composition:Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substance:Viable spores of Bacillus velezensis ATCC PTA-6737Analytical methodEnumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.Identification: pulsed-field gel electrophoresis (PFGE) method.Sows—1 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.For the use in sows from three weeks before farrowing to whole lactation period.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, including breathing protection.29.12.2027
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 %
4b1823Kemin Europa N.V.Bacillus velezensis ATCC PTA-6737Additive composition:Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substance:Viable spores of Bacillus velezensis ATCC PTA-6737Analytical methodEnumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.Identification: pulsed-field gel electrophoresis (PFGE) method.Sows—1 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.For the use in sows from three weeks before farrowing to whole lactation period.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, including breathing protection.29.12.2027