CELEX: 32011R0496
Language: en
Date: 2011-05-20 00:00:00
Title: Commission Implementing Regulation (EU) No 496/2011 of 20 May 2011 concerning the authorisation of sodium benzoate as a feed additive for weaned piglets (holder of the authorisation Kemira Oyj)  Text with EEA relevance

21.5.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 134/9
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 496/2011
   of 20 May 2011
   concerning the authorisation of sodium benzoate as a feed additive for weaned piglets (holder of the authorisation Kemira Oyj)
   (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 auåthorisation 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 sodium benzoate. That 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 sodium benzoate as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (the Authority) concluded in its opinion of 1 February 2011 (2) that the substance set out in the Annex, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this additive has shown a significant benefit in terms of a final body weight and an improvement in efficiency of feed conversion of the target 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 the substance 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 substance 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 substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, 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, 20 May 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2011;9(2):2005.
   
      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
               
            
                  mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Zootechnical additives: other zootechnical additives (improvement of performance parameters)
                  
               
            
                  4d 5
               
               
                  Kemira Oyj
               
               
                  Sodium benzoate
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Sodium benzoate: ≥ 99,9 %
                           
                        
                               
                           
                           
                              
                                 Active substance
                              
                              Sodium benzoate
                              C7H5O2Na
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1)
                              
                              
                                           
                                       
                                       
                                          For determination of sodium benzoate in feed additive: Titrimetric method (Monograph 01/2008:0123 European Pharmacopoeia)
                                       
                                    
                                           
                                       
                                       
                                          For determination of sodium benzoate in premixtures and feedstuffs: HPLC method with UV-detection
                                       
                                    
                        
               
                  Piglets (weaned)
               
               
                  —
               
               
                  —
               
               
                  4 000
               
               
                  
                              1.
                           
                           
                              The additive shall not be mixed with other sources of benzoic acid or benzoates.
                           
                        
                              2.
                           
                           
                              Complementary feed containing sodium benzoate may not be fed to piglets as such.
                           
                        
                              3.
                           
                           
                              For piglets (weaned) up to 35 kg.
                           
                        
                              4.
                           
                           
                              Recommended minimum dose 4 000 mg/kg.
                           
                        
                              5.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  10 June 2021
               
            
         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx