Commission Regulation (EU) No 337/2011 of 7 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as feed additive for poultry, weaned piglets and pigs for fattening (holder of the authorisation Danisco Animal Nutrition) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2019/221of 6 February 2019amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives(Text with EEA relevance), 32019R0221, February 7, 2019
  • Commission Implementing Regulation (EU) 2023/1703of 7 September 2023concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 as a feed additive for poultry species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), the authorisation of that preparation for suckling piglets and minor porcine species (suckling piglets) (holder of authorisation: Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.) and repealing Regulation (EU) No 337/2011 and Implementing Regulation (EU) 2016/997(Text with EEA relevance), 32023R1703, September 8, 2023
Commission Regulation (EU) No 337/2011of 7 April 2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as feed additive for poultry, weaned piglets and pigs for fattening (holder of the authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)(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 that Annex.
Article 2This Regulation shall enter into force on the 20th day following 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 releases 0,48 μmol of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH 4,2 and 50 °C.1 U is the amount of enzyme which releases 2,4 μmol of reducing sugar (glucose equivalent) per minute from glucan of barley at pH 5,0 and 50 °C.Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additivesCategory of zootechnical additives. Functional group: digestibility enhancers
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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a15Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Additive compositionPreparation (solid and liquid form) of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (ATCC SD 2106) having respectively a minimum activity of 12200 U/g and 1520 U/gCharacterisation of the active substanceEndo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (ATCC SD 2106)Analytical methodsCharacterisation of the active substance in the additive, premixtures and feedingstuffs:colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates,colorimetric method measuring water soluble dye released by action of endo-1,3(4)-β-glucanase from azurine cross-linked barley β-glucan substrates.Turkeys for fattening and reared for breedingLaying hens—endo-1,4-beta-xylanase1220 Uendo-1,3(4)-beta-glucanase152 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 30 % wheat, barley, rye and/or triticale.3.For safety reasons: breathing protection, glasses and gloves shall be used during handling.4.For piglets (weaned) up to 35 kg.28 April 2021
Other poultryPiglets (weaned)Pigs for fatteningendo-1,4-beta-xylanase610 Uendo-1,3(4)-beta-glucanase76 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 that Annex.
Article 2This Regulation shall enter into force on the 20th day following 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 releases 0,48 μmol of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH 4,2 and 50 °C.1 U is the amount of enzyme which releases 2,4 μmol of reducing sugar (glucose equivalent) per minute from glucan of barley at pH 5,0 and 50 °C.Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additivesCategory of zootechnical additives. Functional group: digestibility enhancers
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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a15Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Additive compositionPreparation (solid and liquid form) of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (ATCC SD 2106) having respectively a minimum activity of 12200 U/g and 1520 U/gCharacterisation of the active substanceEndo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (ATCC SD 2106)Analytical methodsCharacterisation of the active substance in the additive, premixtures and feedingstuffs:colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates,colorimetric method measuring water soluble dye released by action of endo-1,3(4)-β-glucanase from azurine cross-linked barley β-glucan substrates.Turkeys for fattening and reared for breedingLaying hens—endo-1,4-beta-xylanase1220 Uendo-1,3(4)-beta-glucanase152 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 30 % wheat, barley, rye and/or triticale.3.For safety reasons: breathing protection, glasses and gloves shall be used during handling.4.For piglets (weaned) up to 35 kg.28 April 2021
Other poultryPiglets (weaned)Pigs for fatteningendo-1,4-beta-xylanase610 Uendo-1,3(4)-beta-glucanase76 U