CELEX: 32012R0841
Language: en
Date: 2012-09-18 00:00:00
Title: Commission Implementing Regulation (EU) No 841/2012 of 18 September 2012 concerning the authorisation of Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives for all animal species  Text with EEA relevance

19.9.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 252/17
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 841/2012
   of 18 September 2012
   concerning the authorisation of Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives 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. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable.
            
         
               (2)
            
            
               In accordance with Article 10(1)(b) and Article 7 of Regulation (EC) No 1831/2003, the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) were entered in the Community Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species.
            
         
               (3)
            
            
               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               The applications concern the authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives for all animal species, to be classified in the additive category ‘technological additives’.
            
         
               (5)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 December 2011 (2) that, under the proposed conditions of use, the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) do not have an adverse effect on animal health, human health or the environment, and that these micro-organisms have the potential to improve the production of silage from all forages by increasing the preservation of dry matter and reducing the loss of protein. The Authority 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.
            
         
               (6)
            
            
               The assessment of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those micro-organisms should be authorised as specified in the Annexes to this Regulation.
            
         
               (7)
            
            
               Since modifications to the conditions of authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) are introduced and as there are no direct immediate effects on safety, a reasonable period should be allowed to elapse before authorisation in order to allow the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. In addition, it is appropriate to allow a transitional period for the disposal of existing stocks of those micro-organisms and of feed containing them.
            
         
               (8)
            
            
               It is disproportionately complex for operators to adapt repeatedly and from one day to the other labels of feed containing different additives which have been successively authorised according to the procedure laid down in Article 10(2) of Regulation (EC) No 1831/2003 and for which new labelling rules are to be complied with. It is therefore appropriate to reduce the administrative burden on the operators by providing a period of time allowing a smooth conversion of labelling.
            
         
               (9)
            
            
               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 micro-organism specified in Annex I, 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
   The micro-organism specified in Annex II, 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 3
   Labelling requirements
   Feed containing the micro-organisms referred to in Article 1 and in Article 2 shall be labelled in accordance with this Regulation at the latest by 19 May 2013.
   However, feed containing the micro-organisms referred to in Article 1 and in Article 2 which has been labelled in accordance with the previous conditions of authorisation before 19 May 2013 may continue to be placed on the market until stocks are exhausted.
   Article 4
   Transitional measures
   Existing stocks of the micro-organisms referred to in Article 1 and in Article 2 and of feed containing them at the date of entry into force of this Regulation may continue to be placed on the market and used under the previous conditions of authorisation until they are exhausted.
   Article 5
   This Regulation shall enter into force on 19 November 2012.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 September 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2012; 10(1):2529.
   
      ANNEX I
      
                  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
                  
               
            
                  1k20713
               
               
                  —
               
               
                  
                     Lactobacillus plantarum
                  
                  (NCIMB 41028)
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of Lactobacillus plantarum NCIMB 41028 containing a minimum of 7 × 1010 CFU/g additive
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              
                                 Lactobacillus plantarum NCIMB 41028
                           
                        
                               
                           
                           
                              
                                 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 not in combination with other micro-organisms as silage additive: 1 × 109 CFU/kg fresh material.
                           
                        
                              3.
                           
                           
                              For safety: it is recommended to use breathing protection and gloves during handling.
                           
                        
               
                  19 November 2022
               
            
         (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
   
   
      ANNEX II
      
                  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
                  
               
            
                  1k20714
               
               
                  —
               
               
                  
                     Lactobacillus plantarum
                  
                  (NCIMB 30148)
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of Lactobacillus plantarum NCIMB 30148 containing a minimum of 7 × 1010 CFU/g additive
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              
                                 Lactobacillus plantarum NCIMB 30148
                           
                        
                               
                           
                           
                              
                                 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 not in combination with other micro-organisms as silage additive: 1 × 109 CFU/kg fresh material.
                           
                        
                              3.
                           
                           
                              For safety: it is recommended to use breathing protection and gloves during handling.
                           
                        
               
                  19 November 2022
               
            
         (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