CELEX: 32011R1111
Language: en
Date: 2011-11-03 00:00:00
Title: Commission Implementing Regulation (EU) No 1111/2011 of 3 November 2011 concerning the authorisation of Lactobacillus plantarum (NCIMB 30236) as a feed additive for all animal species Text with EEA relevance

4.11.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 287/30
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 1111/2011
   of 3 November 2011
   concerning the authorisation of Lactobacillus plantarum (NCIMB 30236) as a feed additive for all animal species
   (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 Lactobacillus plantarum (NCIMB 30236). 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 Lactobacillus plantarum (NCIMB 30236) as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 June 2011 (2) that Lactobacillus plantarum (NCIMB 30236), under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this preparation has the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of dry matter and protein. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of Lactobacillus plantarum (NCIMB 30236) 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 the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   The preparation specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage 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, 3 November 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2011; 9(6):2275.
   
      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 fresh material
               
            
                  
                     Category of technological additives. Functional group: silage additives.
                  
               
            
                  1k2073
               
               
                  —
               
               
                  
                     Lactobacillus plantarum (NCIMB 30236)
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of Lactobacillus plantarum (NCIMB 30236) containing a minimum of 1,2 × 1011 CFU/g additive.
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              
                                 Lactobacillus plantarum (NCIMB 30236).
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1)
                              
                              
                                           
                                       
                                       
                                          Enumeration in the feed additive: spread plate method: EN 15787.
                                       
                                    
                                           
                                       
                                       
                                          Identification: Pulsed Field Gel Electrophoresis (PFGE).
                                       
                                    
                        
               
                  All animal species
               
               
                  —
               
               
                  —
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature and storage life.
                           
                        
                              2.
                           
                           
                              Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2,4 × 108 CFU/kg fresh material.
                           
                        
                              3.
                           
                           
                              For Safety: it is recommended to use breathing protection and gloves during handling.
                           
                        
               
                  24.11.2021
               
            
         (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