Commission Implementing Regulation (EU) 2018/1565 of 17 October 2018 concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds, turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Elanco GmbH) (Text with EEA relevance.)
Corrected by
  • Corrigendum to Commission Implementing Regulation (EU) 2018/1565 of 17 October 2018 concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds, turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Elanco GmbH), 32018R1565R(01), March 13, 2019
Commission Implementing Regulation (EU) 2018/1565of 17 October 2018concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds, turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Elanco GmbH)(Text with EEA relevance)
Article 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in the 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 enzyme which liberates 0,72 micrograms of reducing sugars (mannose equivalents) from a mannan-containing substrate (locust bean gum) per minute at pH 7,0 and 40 °C.Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of zootechnical additives. Functional group: digestibility enhancers
Identi-fication 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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a29Elanco GmbHEndo-1,4-beta-mannanaseEC 3.2.1.78Additive compositionPreparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) having a minimum activity of:1,6 × 108 U/kg solid form;5,9 × 108 U/L liquid form.Characterisation of the active substanceendo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088)Analytical methodsFor the quantification of endo-1,4-beta-mannanase in the feed additive, premixtures and feedingstuffs:colorimetric methods based on enzymatic hydrolysis and the reaction of reducing sugars (mannose equivalent) with 3,5-dinitrosalicylic acid (DNS)Chickens for fatteningChickens reared for layingMinor poultry species other than laying birds—32000 U—1.In the directions for use of the additive and premixtures, the storage conditions and stability heat treatment shall be indicated.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks to 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 skin and breathing protections.3.For use in weaned piglets until approximately 35 kg.8 November 2028
Turkeys for fatteningTurkeys reared for breeding48000 U
Weaned piglets48000 U
Pigs for fatteningMinor porcine species for fattening32000 U
Article 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in the 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 enzyme which liberates 0,72 micrograms of reducing sugars (mannose equivalents) from a mannan-containing substrate (locust bean gum) per minute at pH 7,0 and 40 °C.Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of zootechnical additives. Functional group: digestibility enhancers
Identi-fication 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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a29Elanco GmbHEndo-1,4-beta-mannanaseEC 3.2.1.78Additive compositionPreparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) having a minimum activity of:1,6 × 108 U/kg solid form;5,9 × 108 U/L liquid form.Characterisation of the active substanceendo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088)Analytical methodsFor the quantification of endo-1,4-beta-mannanase in the feed additive, premixtures and feedingstuffs:colorimetric methods based on enzymatic hydrolysis and the reaction of reducing sugars (mannose equivalent) with 3,5-dinitrosalicylic acid (DNS)Chickens for fatteningChickens reared for layingMinor poultry species other than laying birds—32000 U—1.In the directions for use of the additive and premixtures, the storage conditions and stability heat treatment shall be indicated.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks to 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 skin and breathing protections.3.For use in weaned piglets until approximately 35 kg.8 November 2028
Turkeys for fatteningTurkeys reared for breeding48000 U
Weaned piglets48000 U
Pigs for fatteningMinor porcine species for fattening32000 U