Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2024/1054of 10 April 2024concerning the authorisation of a preparation of Weizmannia faecalis DSM 32016 as a feed additive for use in feed and in water for drinking for all poultry species reared for laying or breeding and for use in water for drinking for all poultry species for fattening, ornamental birds, suckling and weaned Suidae piglets (holder of the authorisation: Biochem Zusatzstoffe Handels- und Produktionsges. mbH), and amending Implementing Regulation (EU) 2020/1755 as regards the terms of the authorisation of that preparation(Text with EEA relevance), 32024R1054, April 11, 2024
Commission Implementing Regulation (EU) 2020/1755of 24 November 2020concerning the authorisation of a preparation of Weizmannia faecalis DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry species for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH)(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 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
4b1900Biochem Zusatzstoffe Handels- und Produktionsges. mbHWeizmannia faecalis DSM 32016Additive compositionPreparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 1010 CFU/g additiveSolid formSuckling and weaned Suidae piglets-1 × 109-1.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 simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, a combination of monensin sodium with 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.15.12.2030
Characterisation of the active substanceViable spores of cells of Weizmannia faecalis DSM 32016Poultry for fattening
Analytical methodEnumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on MRS agar (based on EN 15787 method).Identification: Pulsed Field Gel Electrophoresis (PFGE).Ornamental birds
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 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
4b1900Biochem Zusatzstoffe Handels- und Produktionsges. mbHWeizmannia faecalis DSM 32016Additive compositionPreparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 1010 CFU/g additiveSolid formSuckling and weaned Suidae piglets-1 × 109-1.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 simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, a combination of monensin sodium with 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.15.12.2030
Characterisation of the active substanceViable spores of cells of Weizmannia faecalis DSM 32016Poultry for fattening
Analytical methodEnumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on MRS agar (based on EN 15787 method).Identification: Pulsed Field Gel Electrophoresis (PFGE).Ornamental birds