Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2024/754of 29 February 2024amending Implementing Regulation (EU) 2020/1762 as regards the terms of the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation: Chr. Hansen A/S)(Text with EEA relevance), 32024R0754, March 1, 2024
Commission Implementing Regulation (EU) 2020/1762of 25 November 2020concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S)(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-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
4b1894Chr. Hansen A/SBacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840Additive compositionPreparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of: 3,2 × 109 CFU/g additive (1,6 × 109 CFU B. subtilis DSM 32324/g; 1,0 × 109 CFU B. subtilis DSM 32325/g and 0,6 × 109 CFU B. amyloliquefaciens DSM 25840/g)All poultry species for fattening or reared for laying or reared for breeding—1,6 × 109—5,4 × 108—1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.3.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid.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. 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.16.12.2030
Characterisation of the active substanceViable spores of cells of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840
Analytical methodEnumeration in the feed additive, premixtures, feedingstuffs and water: Spread plate method on tryptone soya agar (EN 15784).Identification: Pulsed Field Gel Electrophoresis (PFGE) method.
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-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
4b1894Chr. Hansen A/SBacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840Additive compositionPreparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of: 3,2 × 109 CFU/g additive (1,6 × 109 CFU B. subtilis DSM 32324/g; 1,0 × 109 CFU B. subtilis DSM 32325/g and 0,6 × 109 CFU B. amyloliquefaciens DSM 25840/g)All poultry species for fattening or reared for laying or reared for breeding—1,6 × 109—5,4 × 108—1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.3.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid.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. 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.16.12.2030
Characterisation of the active substanceViable spores of cells of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840
Analytical methodEnumeration in the feed additive, premixtures, feedingstuffs and water: Spread plate method on tryptone soya agar (EN 15784).Identification: Pulsed Field Gel Electrophoresis (PFGE) method.