CELEX: 32013R0095
Language: en
Date: 2013-02-01 00:00:00
Title: Commission Implementing Regulation (EU) No 95/2013 of 1 February 2013 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish other than salmonids (holder of authorisation Lallemand SAS)  Text with EEA relevance

2.2.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 33/19
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 95/2013
   of 1 February 2013
   concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish other than salmonids (holder of authorisation Lallemand SAS)
   (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 a new use of a preparation of Pediococcus acidilactici CNCM MA 18/5M. 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 a new use of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of Pediococcus acidilactici CNCM MA 18/5M was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1200/2005 (2) and for pigs for fattening by Commission Regulation (EC) No 2036/2005 (3), for 10 years for salmonids and shrimps by Commission Regulation (EC) No 911/2009 (4), for weaned piglets by Commission Regulation (EU) No 1120/2010 (5) and for laying hens by Commission Regulation (EU) No 212/2011 (6).
            
         
               (5)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2012 (7) that, under the proposed conditions of use, Pediococcus acidilactici CNCM MA 18/5M has the potential to produce beneficial effect in development for all fish increasing the proportion of well conformed fish, reducing bone deformation.
            
         
               (6)
            
            
               The assessment of Pediococcus acidilactici CNCM MA 18/5M 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 ‘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 twentieth day following that of 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, 1 February 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (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)  OJ L 257, 30.9.2009, p. 10.
   
      (5)  OJ L 317, 3.12.2010, p. 12.
   
      (6)  OJ L 59, 4.3.2011, p. 1.
   
      (7)  EFSA Journal 2012; 10(9):2886.
   
      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: other zootechnical additives (favourably affect growth).
                  
               
            
                  4d1712
               
               
                  Lallemand SAS
               
               
                  
                     Pediococcus acidilactici CNCM MA 18/5M
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of Pediococcus acidilactici CNCM MA 18/5M containing a minimum of 1 × 1010 CFU/g of additive
                           
                        
                               
                           
                           
                              
                                 Characterisation of active substance
                              
                              Viable cells of Pediococcus acidilactici CNCM MA 18/5 M
                           
                        
                               
                           
                           
                              
                                 Analytical methods
                                  (1)
                              
                              
                                           
                                       
                                       
                                          Enumeration: spread plate method using MRS agar (EN 15786:2009)
                                       
                                    
                                           
                                       
                                       
                                          Identification: Pulsed-Field Gel Electrophoresis (PFGE)
                                       
                                    
                        
               
                  All fish other than salmonids
               
               
                  —
               
               
                  1 × 109
                  
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  22 February 2023
               
            
         (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