Commission Regulation (EC) No 505/2008 of 6 June 2008 concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive (Text with EEA relevance)
Commission Regulation (EC) No 505/2008of 6 June 2008concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8)., and in particular Article 9(2) thereof,Whereas:(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns authorisation of a new use of the enzyme preparation 3-phytase (Natuphos 5000, Natuphos 5000 G, Natuphos 5000 L, Natuphos 10000 G and Natuphos 10000 L) produced by Aspergillus niger (CBS 101.672) as a feed additive for sows, to be classified in the additive category "zootechnical additives".(4)The use of that preparation was authorised for weaned piglets, pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007OJ L 73, 13.3.2007, p. 4., for laying hens and turkeys for fattening by Commission Regulation (EC) No 1142/2007OJ L 256, 2.10.2007, p. 20. and for ducks by Commission Regulation (EC) No 165/2008OJ L 50, 23.2.2008, p. 8..(5)New data were submitted in support of the application for authorisation for sows. The European Food Safety Authority ("the Authority") concluded in its opinion of 15 June 2006Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed and of the Scientific Panel on Genetically Modified Organisms on the safety and efficacy of the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger. The EFSA Journal (2006) 369, 1-19. that the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger (CBS 101.672) does not have an adverse effect on consumers, users or the environment and that it is efficacious in improving digestibility of feedingstuffs. In its opinion of 12 December 2007Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed on "Safety of the enzymatic preparation of Natuphos (3-phytase) for sows". The EFSA Journal (2007) 614, 1-5. the Authority concluded that the use of that preparation is safe for sows. The Authority does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.(6)The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:
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.Done at Brussels, 6 June 2008.For the CommissionAndroulla VassiliouMember of the CommissionANNEX
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 °C.Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additivesCategory of zootechnical additives. Functional group: digestibility enhancers
Identification number of the additiveName of the holder of authorisationAdditive(trade name)Composition, 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 %
4a1600BASF SE3-phytaseEC 3.1.3.8(Natuphos 5000 Natuphos 5000 G Natuphos 5000 L Natuphos 10000 G Natuphos 10000 L)Additive composition3-phytase produced by Aspergillus niger (CBS 101.672) having a minimum activity of:Solid form: 5000 FTU/gLiquid form: 5000 FTU/mlCharacterisation of the active substance3-phytase produced by Aspergillus niger (CBS 101.672)Analytical methodColorimetric method measuring inorganic phosphate released by the enzyme from phytate substrateSows—500 FTU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kilogram of complete feedingstuff: 500 FTU.3.For use in feed containing more than 0,36 % phytin bound phosphorus.27 June 2018