Commission Implementing Regulation (EU) 2016/899 of 8 June 2016 concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (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) 2016/899of 8 June 2016concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (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 liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °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: 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 %
4a24Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.6-phytase EC 3.1.3.26Additive compositionPreparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) having a minimum activity of 15000 U/g.Liquid formCharacterisation of the active substance6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (ATCC SD-6528)Analytical methodFor the quantification of 6-phytase activity in the feed additive:colorimetric method based on the enzymatic reaction of phytase on the phytate.For the quantification of 6-phytase activity in premixtures and feedingstuffs:colorimetric method based on the enzymatic reaction of phytase on the phytate EN ISO 30024.All poultry speciesAll porcine species (other than suckling piglets)—250 U—1.In the directions for use of the additive and premixture the storage conditions and stability to pelleting shall be indicated.2.Maximum recommended dose: 2000 U/kg feed.3.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.29 June 2026
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 liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °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: 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 %
4a24Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.6-phytase EC 3.1.3.26Additive compositionPreparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) having a minimum activity of 15000 U/g.Liquid formCharacterisation of the active substance6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (ATCC SD-6528)Analytical methodFor the quantification of 6-phytase activity in the feed additive:colorimetric method based on the enzymatic reaction of phytase on the phytate.For the quantification of 6-phytase activity in premixtures and feedingstuffs:colorimetric method based on the enzymatic reaction of phytase on the phytate EN ISO 30024.All poultry speciesAll porcine species (other than suckling piglets)—250 U—1.In the directions for use of the additive and premixture the storage conditions and stability to pelleting shall be indicated.2.Maximum recommended dose: 2000 U/kg feed.3.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.29 June 2026