Commission Implementing Regulation (EU) 2018/338 of 7 March 2018 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2019/1290of 31 July 2019amending Implementing Regulation (EU) 2018/338 as regards the minimum content of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening or reared for laying (holder of authorisation BASF SE)(Text with EEA relevance), 32019R1290, August 1, 2019
Commission Implementing Regulation (EU) 2018/338of 7 March 2018concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the 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 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 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °CDetails 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 %
4a27BASF SE6-phytaseEC 3.1.3.26Additive composition:Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:Solid form: 5000 FTU/gLiquid form: 5000 FTU/gCharacterisation of the active substance:6-phytase produced by Aspergillus. niger (DSM 25770)Analytical method:For the quantification of phytase activity in the feed additive:colorimetric method based on the enzymatic reaction of phytase on the phytateFor the quantification of phytase activity in premixtures:colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3For the quantification of phytase activity in feedingstuffs:colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024Pigs for fatteningSowsMinor porcine species for fattening or for reproduction—100 FTU1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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.3.For use in weaned piglets up to 35 kg.28.3.2028
Weaned piglets125 FTU
Chickens for fatteningChickens reared for laying125 FTU
Turkeys for fatteningTurkeys reared for breedingAll other avian species (excluding laying birds)125 FTU
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 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °CDetails 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 %
4a27BASF SE6-phytaseEC 3.1.3.26Additive composition:Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:Solid form: 5000 FTU/gLiquid form: 5000 FTU/gCharacterisation of the active substance:6-phytase produced by Aspergillus. niger (DSM 25770)Analytical method:For the quantification of phytase activity in the feed additive:colorimetric method based on the enzymatic reaction of phytase on the phytateFor the quantification of phytase activity in premixtures:colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3For the quantification of phytase activity in feedingstuffs:colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024Pigs for fatteningSowsMinor porcine species for fattening or for reproduction—100 FTU1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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.3.For use in weaned piglets up to 35 kg.28.3.2028
Weaned piglets125 FTU
Chickens for fatteningChickens reared for laying125 FTU
Turkeys for fatteningTurkeys reared for breedingAll other avian species (excluding laying birds)125 FTU