Commission Implementing Regulation (EU) No 389/2011 of 19 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (holder of 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) No 389/2011of 19 April 2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (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 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 liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt xylan substrate per minute at pH 5,3 and 50 °C.1 U is the amount of enzyme which liberates 1 μmol of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.1 U is the amount of enzyme which liberates 1 μmol of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °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/eurl-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 %
4a10Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.Endo-1,4-beta-xylanaseEC 3.2.1.8SubtilisinEC 3.4.21.62Alpha-amylaseEC 3.2.1.1Additive compositionPreparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107), solid form having a minimum activity of:endo-1,4-beta-xylanase 1500 U/g,subtilisin 20000 U/g,alpha-amylase 2000 U/g.Characterisation of the active substanceEndo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107).Analytical methodsDetermination of the active substance in the additive, premixtures and feedingstuffs.Endo-1,4-beta-xylanase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on commercially available azurine cross-linked wheat arabinoxylan substances.Alpha-amylase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of alpha-amylase on commercially available azurine cross-linked starch polymer substances.Subtilisin: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of subtilisin on commercially available cross-linked casein substances.Laying hens—endo-1,4-beta-xylanase300 Usubtilisin4000 Ualpha-amylase400 U—1.In the directions for use of the additive, indicate the storage temperature, storage life, and stability to pelleting.2.For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.3.For safety reasons: breathing protection, glasses and gloves shall be used during handling.10 May 2021
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 liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt xylan substrate per minute at pH 5,3 and 50 °C.1 U is the amount of enzyme which liberates 1 μmol of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.1 U is the amount of enzyme which liberates 1 μmol of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °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/eurl-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 %
4a10Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.Endo-1,4-beta-xylanaseEC 3.2.1.8SubtilisinEC 3.4.21.62Alpha-amylaseEC 3.2.1.1Additive compositionPreparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107), solid form having a minimum activity of:endo-1,4-beta-xylanase 1500 U/g,subtilisin 20000 U/g,alpha-amylase 2000 U/g.Characterisation of the active substanceEndo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107).Analytical methodsDetermination of the active substance in the additive, premixtures and feedingstuffs.Endo-1,4-beta-xylanase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on commercially available azurine cross-linked wheat arabinoxylan substances.Alpha-amylase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of alpha-amylase on commercially available azurine cross-linked starch polymer substances.Subtilisin: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of subtilisin on commercially available cross-linked casein substances.Laying hens—endo-1,4-beta-xylanase300 Usubtilisin4000 Ualpha-amylase400 U—1.In the directions for use of the additive, indicate the storage temperature, storage life, and stability to pelleting.2.For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.3.For safety reasons: breathing protection, glasses and gloves shall be used during handling.10 May 2021