CELEX: 32009R0911
Language: en
Date: 2009-09-29 00:00:00
Title: Commission Regulation (EC) No 911/2009 of 29 September 2009 concerning the authorisation of a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps (holder of authorisation Lallemand SAS) (Text with EEA relevance)

30.9.2009   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 257/10
            
         
      COMMISSION REGULATION (EC) No 911/2009
   of 29 September 2009
   concerning the authorisation of a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps (holder of authorisation Lallemand SAS)
   (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 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 preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of that micro-organism preparation has been authorised without a time limit by Commission Regulation (EC) No 1200/2005 (2) for chickens for fattening and by Commission Regulation (EC) No 2036/2005 (3) for pigs for fattening.
            
         
               (5)
            
            
               New data were submitted in support of the application for authorisation for salmonids and shrimps. The European Food Safety Authority (the Authority) concluded in its opinions of 1 April 2009 (4) that the preparation of Pediococcus acidilactici CNCM MA 18/5M does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have beneficial effects, increasing the number of well-conformed salmonids and improving survivability and growth performance in shrimps. 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 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.
            
         
               (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 ‘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, 29 September 2009.
      
         
            For the Commission
         
         Androulla VASSILIOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 195, 27.7.2005, p. 6.
   
      (3)  OJ L 328, 15.12.2005, p. 13.
   
      (4)  The EFSA Journal (2009) 1038, p. 2 and 1037, p. 1.
   
      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
               
            
                  CFU/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect animal growth)
                  
               
            
                  4d1712
               
               
                  Lallemand
                  SAS
               
               
                  
                     Pediococcus acidilactici
                  
                  CNCM MA 18/5M
               
               
                  
                               
                           
                           
                              Additive composition:
                              Preparation of viable cells of Pediococcus acidilactici CNCM MA 18/5M containing a minimum of 1 × 1010 CFU/g additive
                           
                        
                               
                           
                           
                              Characterisation of the active substance:
                              Viable cells Pediococcus acidilactici CNCM MA 18/5M
                           
                        
                               
                           
                           
                              Analytical method (1):
                              
                                           
                                       
                                       
                                          Quantification: spread plate method using MRS agar and 37 °C as incubation temperature.
                                       
                                    
                                           
                                       
                                       
                                          Identification: pulsed-field gel electrophoresis (PFGE) method.
                                       
                                    
                        
               
                  Salmonids
               
               
                  —
               
               
                  3 × 109
                  
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                           
                        
                              2.
                           
                           
                              Recommended dose for Salmonids 3 × 109 CFU/kg complete feed.
                           
                        
                              3.
                           
                           
                              For safety reasons: breathing protection shall be used during handling.
                           
                        
               
                  20.10.2019
               
            
                  Shrimps
               
               
                  1 × 109
                  
               
            
         (1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives