CELEX: 32017R1008
Language: en
Date: 2017-06-15 00:00:00
Title: Commission Implementing Regulation (EU) 2017/1008 of 15 June 2017 concerning the authorisation of the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening (holder of authorisation JHJ Ltd) (Text with EEA relevance. )

16.6.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 153/16
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/1008
      of 15 June 2017
      concerning the authorisation of the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening (holder of authorisation JHJ 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 the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p. 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 the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (2) that, under the proposed conditions of use, the preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve zootechnical performance in chickens for fattening. 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 of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p 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.
      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, 15 June 2017.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  EFSA Journal 2016;14(9):4555.
      
         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
                     
                  
               
                     4b1892
                  
                  
                     JHJ Ltd
                  
                  
                     
                        Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p
                  
                  
                     
                        Additive composition
                     
                     Preparation of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p containing a minimum of 1,2 × 109 CFU/g of total Lactic Acid Bacteria (LAB) and Saccharomyces cerevisiae PCM KKP 2059p 1 × 107 CFU/g
                     having a minimum of:
                     
                                  
                              
                              
                                 
                                    Lactococcus lactis PCM B/00039 ≥ 5 × 108 CFU/g
                              
                           
                                  
                              
                              
                                 
                                    Carnobacterium divergens PCM KKP 2012p ≥ 3 × 108 CFU/g
                              
                           
                                  
                              
                              
                                 
                                    Lactobacillus casei PCM B/00080 ≥ 1 × 108 CFU/g
                              
                           
                                  
                              
                              
                                 
                                    Lactobacillus plantarum PCM B/00081 ≥ 3 × 108 CFU/g
                              
                           
                                  
                              
                              
                                 
                                    Saccharomyces cerevisiae PCM KKP 2059p ≥ 1 × 107 CFU/g
                              
                           
                        Characterisation of the active substance
                     
                     Viable cells of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p
                     
                        Analytical method
                         (1)
                     
                     For the enumeration of Lactococcus lactis PCM B/00039 and Carnobacterium divergens PCM KKP 2012p in the feed additive and feedingstuffs:
                     
                                 —
                              
                              
                                 Poured-plate method using de Man, Rogosa and Sharpe (MRS) agar ISO 15214
                              
                           For the enumeration of Lactobacilli in the feed additive and feedingstuffs:
                     
                                 —
                              
                              
                                 Poured-plate method using MRS agar EN 15787
                              
                           For the enumeration of Saccharomyces cerevisiae PCM KKP 2059p in the feed additive and feedingstuffs:
                     
                                 —
                              
                              
                                 Poured-plate method using chloramphenicol glucose yeast extract (CGYE) agar EN 15789
                              
                           For the identification of Lactobacilli, Lactococcus lactis PCM B/00039 and Carnobacterium divergens PCM KKP 2012p:
                     
                                 —
                              
                              
                                 Identification: Pulsed-Field Gel Electrophoresis (PFGE)
                              
                           For the identification of Saccharomyces cerevisiae PCM KKP 2059p:
                     
                                 —
                              
                              
                                 Polymerase Chain Reaction (PCR)
                              
                           
                  
                     Chickens for fattening
                  
                  
                     —
                  
                  
                     5 × 108 (LAB)
                     5 × 106 (Saccharomyces cerevisiae PCM KKP 2059p)
                  
                  
                     —
                  
                  
                     
                                 1.
                              
                              
                                 In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.
                              
                           
                                 2.
                              
                              
                                 The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, diclazuril, decoquinate, or maduramicin ammonium.
                              
                           
                                 3.
                              
                              
                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing and skin protection.
                              
                           
                  
                     6 July 2027
                  
               
            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports