Commission Implementing Regulation (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2022/271of 23 February 2022correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)(Text with EEA relevance), 32022R0271, February 24, 2022
Commission Implementing Regulation (EU) 2020/1760of 25 November 2020concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in 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-reports
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
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1902Chr. Hansen A/SBacillus subtilisDSM 25841Additive compositionPreparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additiveSolid formCharacterisation of the active substanceViable spores of Bacillus subtilis DSM 25841Analytical methodFor identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784All porcine species, including sows,other than lactating sows in order to have a benefit in suckling piglets-5 × 108-1,7 × 108-1.In the directions for use of the additive and premixtures, 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 the homogenous dispersion of the additive shall be ensured.4.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: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.16.12.2030
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-reports
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
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1902Chr. Hansen A/SBacillus subtilisDSM 25841Additive compositionPreparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additiveSolid formCharacterisation of the active substanceViable spores of Bacillus subtilis DSM 25841Analytical methodFor identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784All porcine species, including sows,other than lactating sows in order to have a benefit in suckling piglets-5 × 108-1,7 × 108-1.In the directions for use of the additive and premixtures, 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 the homogenous dispersion of the additive shall be ensured.4.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: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.16.12.2030