CELEX: 32010R0999
Language: en
Date: 2010-11-05 00:00:00
Title: Commission Regulation (EU) No 999/2010 of 5 November 2010 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd)  Text with EEA relevance

6.11.2010   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 290/24
            
         COMMISSION REGULATION (EU) No 999/2010
   of 5 November 2010
   concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd)
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   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 nutrition (1), 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 pursuant to Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               The application concerns the authorisation of a new use of the enzyme preparation 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) as a feed additive for sows, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) has been authorised for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying by Commission Regulation (EC) No 1088/2009 (2).
            
         
               (5)
            
            
               New data were submitted to support the application. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2010 (3) that 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594), under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that its use can improve the digestibility of phosphorus. 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 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this 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 1
   The 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 2
   This 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, 5 November 2010.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 297, 13.11.2009, p. 6.
   
      (3)  The EFSA Journal 2010; 8(6):1634.
   
      ANNEX
      
                  Identification number of the additive
               
               
                  Name of the holder of authorisation
               
               
                  Additive
               
               
                  Composition, chemical formula, description, analytical method
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
            
                  Units of activity/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of zootechnical additives. Functional group: digestibility enhancers
                  
               
            
                  4a6
               
               
                  DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o
               
               
                  6-phytase
                  EC 3.1.3.26
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) having a minimum activity of:
                              
                                           
                                       
                                       
                                          Coated form: 10 000 FYT (1)/g
                                       
                                    
                                           
                                       
                                       
                                          Other solid form: 50 000 FYT/g
                                       
                                    
                                           
                                       
                                       
                                          Liquid form: 20 000 FYT/g
                                       
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              6-phytase produced by Aspergillus oryzae (DSM 17594)
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (2)
                              
                              Colorimetric method based on reaction of vanadomolybdate on inorganic phosphate produced by action of 6-phytase on a phytate-containing substrate (sodium phytate) at pH 5,5 and 37 °C, quantified against a standard curve from inorganic phosphate.
                           
                        
               
                  Sows
               
               
                  —
               
               
                  1 500 FYT
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For use in feed containing more than 0,23 % phytin-bound phosphorus.
                           
                        
                              3.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  26 November 2020
               
            
         (1)  One FYT is the amount of enzyme that releases 1 μmol of inorganic phosphate from sodium phytate per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and a temperature of 37 °C during 30 minutes incubation.
      
         (2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives