Commission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive (Text with EEA relevance)
Modified by
Commission Regulation (EU) No 879/2010of 6 October 2010amending Regulation (EC) No 554/2008 as regards the minimum content of 6-phytase (Quantum Phytase) as a feed additive in feed for laying hens(Text with EEA relevance), 32010R0879, October 7, 2010
Commission Implementing Regulation (EU) No 414/2012of 15 May 2012amending Regulation (EC) No 554/2008 as regards the minimum content and the minimum recommended dose of an enzyme preparation of 6-phytase as a feed additive in feed for turkeys for fattening(Text with EEA relevance), 32012R0414, May 16, 2012
Corrected by
Corrigendum to Commission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive, 32008R0554R(01), July 3, 2008
Commission Regulation (EC) No 554/2008of 17 June 2008concerning the authorisation of 6-phytase (Quantum Phytase) 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 the enzyme preparation 6-phytase (Quantum Phytase) produced by Pichia pastoris (DSM 15927) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned), to be classified in the additive category "zootechnical additives".(4)The European Food Safety Authority (the Authority) concluded in its opinion adopted on 1 February 2007 and on 30 January 2008Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and of the Panel on Genetically Modified Organisms (GMO) on "Safety and efficacy of the product Quantum Phytase 5000 L and Quantum Phytase 2500 D (6-phytase) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned)". The EFSA Journal (2008) 627, pp. 1-27. that the enzyme preparation 6-phytase (Quantum Phytase) produced by Pichia pastoris (DSM 15927) does not have an adverse effect on animals, consumers, or the environment and that it is efficacious in improving digestibility of feedingstuffs, based on the data provided by the applicant. It further concluded that the product is a mild irritant and a dermal sensitiser and that it may be a potential respiratory sensitiser. 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.(5)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 a digestibility enhancer, as specified in the Annex to this Regulation. Measures should be provided for the protection of users from the risks identified in the opinion of the Authority.(6)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: