CELEX: 32008R1293
Language: en
Date: 2008-12-18 00:00:00
Title: Commission Regulation (EC) No 1293/2008 of 18 December 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (Text with EEA relevance)

19.12.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 340/38
            
         
      COMMISSION REGULATION (EC) No 1293/2008
   of 18 December 2008
   concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive
   (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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
            
         
               (3)
            
            
               The application concerns the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME), as a feed additive for lambs, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of Saccharomyces cerevisiae CNCM I-1077 was authorised without a time limit for dairy cows and cattle for fattening by Commission Regulation (EC) No 1200/2005 (2) and, until 22 March 2017, for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 (3).
            
         
               (5)
            
            
               New data were submitted in support of an application for authorisation for lambs. The European Food Safety Authority (the Authority) concluded in its opinion of 16 July 2008 (4) that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not have an adverse effect on animal health, human health or the environment. It further concluded that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation is safe for lambs. That opinion also states that that preparation can produce a beneficial effect on final weight and average daily gain. 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 ‘gut flora stabilisers’, 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, 18 December 2008.
      
         
            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 64, 2.3.2007, p. 26.
   
      (4)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the safety and efficacy of Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as feed additive for lambs for fattening. The EFSA Journal (2008) 772, 1-11.
   
      ANNEX
      
         
                     Identification number of the additive
                  
                  
                     Name of the holder of authorisation
                  
                  
                     Additive
                     (trade name)
                  
                  
                     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: gut flora stabilisers
                  
               
                     ‘4b1711
                  
                  
                     LALLEMAND SAS
                  
                  
                     
                        Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME)
                  
                  
                     
                                  
                              
                              
                                 Additive composition:
                                 
                                              
                                          
                                          
                                             Solid form:
                                             Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 2 × 1010 CFU/g.
                                          
                                       
                                              
                                          
                                          
                                             Coated form:
                                             Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 1 × 1010 CFU/g
                                          
                                       
                           
                                  
                              
                              
                                 Characterisation of the active substance:
                                 
                                    Saccharomyces cerevisiae CNCM I-1077: 80 % of viable dried cells and 14 % of not viable cells.
                              
                           
                                  
                              
                              
                                 Analytical method (1):
                                 Pour plate method and molecular identification (PCR).
                              
                           
                  
                     Lambs
                  
                  
                     —
                  
                  
                     3,0 × 109
                     
                  
                  
                     7,3 × 109
                     
                  
                  
                     
                                 1.
                              
                              
                                 In the directions for use of the additive and premixtures, indicate the storage temperature, storage life, and stability to pelleting.
                              
                           
                                 2.
                              
                              
                                 In complementary feedingstuffs, do not exceed 50 °C with Levucell SC20 and 80 °C with Levucell SC10ME.
                              
                           
                                 3.
                              
                              
                                 Coated form, only for inclusion through a pelleted feed.
                              
                           
                                 4.
                              
                              
                                 Recommended dose: 7,3 × 109 CFU/kg of complete feedingstuff.
                              
                           
                                 5.
                              
                              
                                 If the product is handled or mixed in confined atmosphere, it is recommended to use safety glasses and masks for mixing if the mixers are not equipped with exhaust systems.
                              
                           
                  
                     8.1.2019
                  
               
      
         (1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives’