Commission Implementing Regulation (EU) 2017/2308 of 13 December 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2023/2647of 28 November 2023concerning the authorisation of the preparation of Bacillus subtilis DSM 5750 and Bacillus paralicheniformis DSM 5749 as a feed additive for calves for fattening, lambs for rearing and for fattening and minor ruminant species for rearing and for fattening, and amending Implementing Regulation (EU) 2017/2308 as regards the terms of the authorisation of that preparation for suckling piglets (holder of authorisation: Chr. Hansen A/S)(Text with EEA relevance), 32023R2647, November 29, 2023
Commission Implementing Regulation (EU) 2017/2308of 13 December 2017concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S)(Text with EEA relevance)
Article 1AuthorisationThe 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 2Entry into forceThis 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 contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
4b1700iChr.Hansen A/SBacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749)Additive compositionPreparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive(1:1 ratio)Solid formCharacterisation of the active substanceViable spores of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Analytical methodIdentification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:Identification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784.Suckling piglets—1,3 × 109—6,5 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used in water for drinking.3.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.Indicate in the instructions for use:"It is recommended to feed the additive to lactating sows and suckling piglets simultaneously."5.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 and skin protection.3 January 2028
Article 1AuthorisationThe 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 2Entry into forceThis 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 contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
4b1700iChr.Hansen A/SBacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749)Additive compositionPreparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive(1:1 ratio)Solid formCharacterisation of the active substanceViable spores of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Analytical methodIdentification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:Identification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784.Suckling piglets—1,3 × 109—6,5 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used in water for drinking.3.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.Indicate in the instructions for use:"It is recommended to feed the additive to lactating sows and suckling piglets simultaneously."5.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 and skin protection.3 January 2028