Commission Implementing Regulation (EU) No 1068/2011 of 21 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2017/950of 2 June 2017amending Implementing Regulation (EU) No 1068/2011 as regards the minimum content of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying and all avian species for laying (holder of authorisation BASF SE)(Text with EEA relevance), 32017R0950, June 3, 2017
  • Commission Implementing Regulation (EU) 2021/981of 17 June 2021concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase produced by Aspergillus niger DSM 18404 as a feed additive for poultry species, ornamental birds and weaned piglets (holder of the authorisation: BASF SE), and repealing Regulation (EC) No 271/2009 and Implementing Regulation (EU) No 1068/2011(Text with EEA relevance), 32021R0981, June 18, 2021
Commission Implementing Regulation (EU) No 1068/2011of 21 October 2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE)(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 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.1 TGU is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley ß-glucan per minute at pH 3,5 and 40 °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: 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 %
4a7BASF SEEndo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,4-beta-glucanaseEC 3.2.1.4Additive compositionPreparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) having a minimum activity of:Solid form:5600 TXU and 2500 TGU/gLiquid form:5600 TXU and 2500 TGU/gCharacterisation of the active substanceendo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404)Analytical methodFor quantification of endo-1,4-beta-xylanase activity:viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C.For quantification of endo-1,4-beta-glucanase activity:viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-glucanase on the glucan containing substrate (barley betaglucan) at pH 3,5 and 40 °C.Minor poultry species for fattening (other than ducks for fattening) and ornamental birds—280 TXU125 TGU—1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.Recommended doses per kilogram of complete feedingstuffs:minor poultry species for fattening (other than ducks) and ornamental birds: 280-840 TXU/125- 375 TGU,chickens reared for laying, and all minor avian species for laying: 280-840 TXU/125- 375 TGU,turkeys for breeding purposes, turkeys reared for breeding: 560-840 TXU/250-375 TGU.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 breathing protection and skin protection.11.11.2021
Chickens reared for laying, and all minor avian species for laying280 TXU125 TGU
Turkeys for breeding purposes and turkeys reared for breeding560 TXU250 TGU
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 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.1 TGU is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley ß-glucan per minute at pH 3,5 and 40 °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: 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 %
4a7BASF SEEndo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,4-beta-glucanaseEC 3.2.1.4Additive compositionPreparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) having a minimum activity of:Solid form:5600 TXU and 2500 TGU/gLiquid form:5600 TXU and 2500 TGU/gCharacterisation of the active substanceendo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404)Analytical methodFor quantification of endo-1,4-beta-xylanase activity:viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C.For quantification of endo-1,4-beta-glucanase activity:viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-glucanase on the glucan containing substrate (barley betaglucan) at pH 3,5 and 40 °C.Minor poultry species for fattening (other than ducks for fattening) and ornamental birds—280 TXU125 TGU—1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.Recommended doses per kilogram of complete feedingstuffs:minor poultry species for fattening (other than ducks) and ornamental birds: 280-840 TXU/125- 375 TGU,chickens reared for laying, and all minor avian species for laying: 280-840 TXU/125- 375 TGU,turkeys for breeding purposes, turkeys reared for breeding: 560-840 TXU/250-375 TGU.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 breathing protection and skin protection.11.11.2021
Chickens reared for laying, and all minor avian species for laying280 TXU125 TGU
Turkeys for breeding purposes and turkeys reared for breeding560 TXU250 TGU