CELEX: 32015R0502
Language: en
Date: 2015-03-24 00:00:00
Title: Commission Implementing Regulation (EU) 2015/502 of 24 March 2015 concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)  Text with EEA relevance

25.3.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 79/57
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2015/502
   of 24 March 2015
   concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)
   (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 a preparation of Saccharomyces cerevisiae NCYC R404. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               That application concerns the authorisation of a preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae NCYC R404 does not have an adverse effect on animal health, human health or the environment. It was also concluded that the additive has the potential to improve milk production of dairy cows. 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 preparation of Saccharomyces cerevisiae NCYC R404 shows that the conditions for authorisation, as 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.
            
         
               (6)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
         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 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, 24 March 2015.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2014; 12(9):3830.
   
      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: gut flora stabilisers
                  
               
            
                  4b1871
               
               
                  Micron Bio-Systems Ltd
               
               
                  
                     Saccharomyces cerevisiae NCYC R404
               
               
                  
                     Additive composition
                  
                  Preparation of Saccharomyces cerevisiae NCYC R404 containing a minimum of:
                  solid form 1 × 1010 CFU/g additive
                  
                     Characterisation of the active substance
                  
                  
                     Saccharomyces cerevisiae NCYC R404
                  
                     Analytical method
                      (1)
                  
                  Identification: Polymerase Chain Reaction (PCR)
                  
                              —
                           
                           
                              Enumeration: Pour plate method using yeast extract dextrose chloramphenicol (CGYE) agar — EN 15789
                           
                        
               
                  Dairy cows
               
               
                  —
               
               
                  4,4 × 108
                  
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
                           
                        
                              2.
                           
                           
                              Recommended dose of the additive: 1 × 1010 CFU/head/day.
                           
                        
                              3.
                           
                           
                              For safety: breathing and skin protection shall be used during handling.
                           
                        
               
                  14 April 2025
               
            
         (1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports