Commission Implementing Regulation (EU) 2016/997 of 21 June 2016 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) as a feed additive for lactating sows and minor porcine species (holder of authorisation Danisco (UK) Ltd) (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) 2016/997of 21 June 2016concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) as a feed additive for lactating sows and minor porcine species (holder of 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 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 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 Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory: 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 active substance/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 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/g.Solid and liquid form.Characterisation 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.Lactating sows(including minor porcine species)—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 conditions and stability to heating treatment.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.12 July 2026
Minor porcine species weaned and 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 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 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 Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory: 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 active substance/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 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/g.Solid and liquid form.Characterisation 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.Lactating sows(including minor porcine species)—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 conditions and stability to heating treatment.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.12 July 2026
Minor porcine species weaned and for fatteningEndo-1,4- beta-xylanase610 UEndo-1,3(4)-beta-glucanase76 U