Commission Implementing Regulation (EU) 2016/898 of 8 June 2016 concerning the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying and ornamental birds (holder of authorisation Novus Europe SA/NV) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2022/268of 23 February 2022amending Implementing Regulation (EU) 2016/898 as regards the name of the holder of the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive and Implementing Regulation (EU) 2018/982 as regards the name of the holder of the authorisation of a preparation of benzoic acid, calcium formate and fumaric acid as a feed additive(Text with EEA relevance), 32022R0268, February 24, 2022
Commission Implementing Regulation (EU) 2016/898of 8 June 2016concerning the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying and ornamental birds (holder of authorisation Novus Europe NV)(Text with EEA relevance)
Article 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "other zootechnical additives", 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
1 U is the amount of protease that liberates 1 micromole of para-nitroaniline (pNA) from the Succinyl-Ala-Ala-Pro-Phe-pNA (C30H36N6O9) substrate per minute at pH 8,0 and 37 °C.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: other zootechnical additives (improvement of zootechnical performance)
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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 %
4d12Novus Europe NVBacillus licheniformis ATCC 53757 and its protease EC 3.4.21.19Additive compositionPreparation of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19 and containing a minimum of:Bacillus licheniformis (ATCC 53757):1 × 109 CFU/g of additiveprotease 6 × 105 U/g of additiveSolid formCharacterisation of the active substanceViable spores of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19Analytical methodIdentification and enumeration of Bacillus licheniformis ATCC 53757 in the feed additive, premixtures and feedingstuffs:Identification: Pulsed field gel electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784Quantification of protease in the feed additive, premixtures and feedingstuffs:Colorimetric method measuring para-nitroaniline (pNA) released by the enzymatic reactionof protease on Suc-Ala-Ala-Pro-Phe-pNA substrate at 37 °CChickens for fattening and reared for layingMinor poultry species for fattening and reared for layingOrnamental birds—5 × 108 CFUBacillus licheniformis3 × 105 U protease—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended minimum dose 500 mg of additive/kg of complete feed.3.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment4.The use is permitted in feed containing the following authorised coccidiostats: diclazuril, nicarbazin, decoquinate, semduramycin sodium, lasalocid sodium, monensin sodium robenidine hydrochloride, maduramicin ammonium, narasin or salinomycin sodium5.Recommended use in protein-reduced rations.29 June 2026
Article 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "other zootechnical additives", 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
1 U is the amount of protease that liberates 1 micromole of para-nitroaniline (pNA) from the Succinyl-Ala-Ala-Pro-Phe-pNA (C30H36N6O9) substrate per minute at pH 8,0 and 37 °C.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: other zootechnical additives (improvement of zootechnical performance)
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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 %
4d12Novus Europe NVBacillus licheniformis ATCC 53757 and its protease EC 3.4.21.19Additive compositionPreparation of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19 and containing a minimum of:Bacillus licheniformis (ATCC 53757):1 × 109 CFU/g of additiveprotease 6 × 105 U/g of additiveSolid formCharacterisation of the active substanceViable spores of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19Analytical methodIdentification and enumeration of Bacillus licheniformis ATCC 53757 in the feed additive, premixtures and feedingstuffs:Identification: Pulsed field gel electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784Quantification of protease in the feed additive, premixtures and feedingstuffs:Colorimetric method measuring para-nitroaniline (pNA) released by the enzymatic reactionof protease on Suc-Ala-Ala-Pro-Phe-pNA substrate at 37 °CChickens for fattening and reared for layingMinor poultry species for fattening and reared for layingOrnamental birds—5 × 108 CFUBacillus licheniformis3 × 105 U protease—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended minimum dose 500 mg of additive/kg of complete feed.3.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment4.The use is permitted in feed containing the following authorised coccidiostats: diclazuril, nicarbazin, decoquinate, semduramycin sodium, lasalocid sodium, monensin sodium robenidine hydrochloride, maduramicin ammonium, narasin or salinomycin sodium5.Recommended use in protein-reduced rations.29 June 2026