CELEX: 32012R0098
Language: en
Date: 2012-02-07 00:00:00
Title: Commission Implementing Regulation (EU) No 98/2012 of 7 February 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)  Text with EEA relevance

8.2.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 35/6
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 98/2012
   of 7 February 2012
   concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)
   (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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036). The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               The application concerns the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 October 2011 (2) that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus digestibility in all target species and performance parameters in avian species. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) 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.
            
         
               (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:
   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, 7 February 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2011; 9(11):2414.
   
      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
                  
               
            
                  4a16
               
               
                  Huvepharma AD
               
               
                  6-phytase
                  (EC 3.1.3.26)
               
               
                  
                               
                           
                           
                              
                                 Additive composition:
                              
                              Preparation 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) with a minimum activity of:
                              
                                           
                                       
                                       
                                          4 000 OUT (1)/g in solid form
                                       
                                    
                                           
                                       
                                       
                                          8 000 OTU/g in liquid form
                                       
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance:
                              
                              6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036)
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (2):
                              Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate
                           
                        
               
                  Chickens for fattening
                  Chickens reared for laying
                  Laying hens
                  Other avian species other than turkeys for fattening and turkeys reared for breeding
                  Sows
               
               
                  —
               
               
                  125 OTU
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              Recommended maximum dose for all authorised species: 500 OTU/kg of complete feedingstuff.
                           
                        
                              3.
                           
                           
                              For use in feed containing more than 0,23 % phytin-bound phosphorus.
                           
                        
                              4.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  28 February 2022
               
            
                  Turkeys for fattening
                  Turkeys reared for breeding
                  Pigs for fattening
                  Piglets (weaned)
               
               
                  250 OTU
               
            
         (1)  1 OTU is the amount of enzyme that catalyses the release of 1 micromole of inorganic phosphate per minute from 5,1 mM sodium phytate in pH 5,5 citrate buffer at 37 °C, measured as the blue P-molybdate complex colour at 820 nm.
      
         (2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx