Commission Regulation (EC) No 243/2007 of 6 March 2007 concerning the authorisation of 3-phytase (Natuphos) as a feed additive (Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 516/2008of 10 June 2008amending Regulations (EC) No 1200/2005, (EC) No 184/2007, (EC) No 243/2007, (EC) No 1142/2007, (EC) No 1380/2007 and (EC) No 165/2008 as regards the terms of the authorisation of certain additives for use in animal nutrition(Text with EEA relevance), 308R0516, June 11, 2008
Corrected by
  • Corrigendum to Commission Regulation (EC) No 243/2007 of 6 March 2007 concerning the authorisation of 3-phytase (Natuphos) as a feed additive, 307R0243R(01), May 22, 2007
Commission Regulation (EC) No 243/2007of 6 March 2007concerning the authorisation 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 nutritionOL 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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.(3)The application concerns authorisation of the enzyme preparation 3-phytase produced by Aspergillus niger (CBS 101.672) for weaned piglets, pigs for fattening, and chickens for fattening to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority (the Authority) concluded in its opinions of 15 June 2006 and of 17 May 2006 that 3-phytase produced by Aspergillus niger (CBS 101.672) does not have an adverse effect on animal health, human health or the environmentOpinion 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. Adopted by FEEDAP Panel on 15 June 2006 and by the GMO Panel on 17 May 2006. The EFSA Journal (2006) 369, p. 1.. It further concluded that the enzyme preparation 3-phytase produced by Aspergillus niger (CBS 101.672) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies 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. 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.(5)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.ANNEX
Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/
Identi-fication number of the additiveName of the holder of authorisationAdditive (trade name)Composition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Unit of activity/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers.
4a 1600BASF SE3-phytaseEC 3.1.3.8(Natuphos 5000 GNatuphos 5000 LNatuphos 10000 GNatuphos 10000 L)Additive composition3-phytase producedby Aspergillus niger (CBS 101.672)having a minimum activity of:Solid form: 5000 FTU/gLiquid form: 5000 FTU/mlCharacterisation of the active substance3-phytase producedby Aspergillus niger (CBS 101.672)Analytical methodColorimetric method measuring inorganic phosphate released by the enzyme from phytate substrate.Piglets (weaned)—500 FTU1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.For use in weaned piglets up to 35 kg.3.Recommended dose per kilogram of complete feedingstuff: 500 FTU.4.For use in feed containing more than 0,23 % phytin bound phosphorus.2.4.2017
Pigs for fattening280 FTU1.In the direction of use of the additive and premixtures, indicate the storage life and stability in pelleting.2.Recommended dose per kilogram of complete feedingstuff: 400–500 FTU.3.For use in feed containing more than 0,23 % phytin bound phosphorus.
Chickens for fattening—375 FTU1.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: 500–700 FTU.3.For use in feed containing more than 0,23 % phytin bound phosphorus.