CELEX: 32019R0011
Language: en
Date: 2019-01-03 00:00:00
Title: Commission Implementing Regulation (EU) 2019/11 of 3 January 2019 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance.)

4.1.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 2/17
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/11
         of 3 January 2019
         concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.)
         (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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
                  
               
                     (2)
                  
                  
                     The preparation of Enterococcus faecium NCIMB 10415 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for piglets by Commission Regulation (EC) No 252/2006 (3), for pigs for fattening by Commission Regulation (EC) No 943/2005 (4) and for sows by Commission Regulation (EC) No 1200/2005 (5). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
                  
               
                     (3)
                  
                  
                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, weaned piglets, suckling piglets and pigs for fattening. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 June 2015 (6) and 21 February 2018 (7) that, under the proposed conditions of use, the preparation of Enterococcus faecium NCIMB 10415 does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance parameters in suckling piglets, weaned piglets, pigs for fattening and sows. 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 Enterococcus faecium NCIMB 10415 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)
                  
                  
                     Therefore, Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 should be amended accordingly.
                  
               
                     (7)
                  
                  
                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
                  
               
                     (8)
                  
                  
                     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
            Authorisation
            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
            Amendment to Regulation (EC) No 252/2006
            Regulation (EC) No 252/2006 is amended as follows:
            
                        (1)
                     
                     
                        Article 1 is deleted;
                     
                  
                        (2)
                     
                     
                        Annex I is deleted.
                     
                  
         
            Article 3
            Amendment to Regulation (EC) No 943/2005
            Regulation (EC) No 943/2005 is amended as follows:
            
                        (1)
                     
                     
                        Article 1 is deleted;
                     
                  
                        (2)
                     
                     
                        Annex I is deleted.
                     
                  
         
            Article 4
            Amendment to Regulation (EC) No 1200/2005
            In Annex II to Regulation (EC) No 1200/2005, the entry E 1705 on Enterococcus faecium NCIMB 10415 is deleted.
         
         
            Article 5
            Transitional measures
            The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 24 July 2019 in accordance with the rules applicable before 24 January 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
         
         
            Article 6
            Entry into force
            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, 3 January 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
         
            (3)  Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (OJ L 44, 15.2.2006, p. 3).
         
            (4)  Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs (OJ L 159, 22.6.2005, p. 6).
         
            (5)  Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 195, 27.7.2005, p. 6).
         
            (6)  EFSA Journal 2015; 13(7):4158.
         
            (7)  EFSA Journal 2018; 16(3):5201.
      
      
         
            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.
                        
                     
                  
                        4b1705
                     
                     
                        DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.
                     
                     
                        
                           Enterococcus faecium
                        
                        NCIMB 10415
                     
                     
                        
                           Additive composition
                        
                        Preparation of Enterococcus faecium
                        
                        NCIMB 10415 containing a minimum of:
                        
                                    —
                                 
                                 
                                    coated form (with shellac):
                                    2 × 1010 CFU/g additive, or
                                 
                              
                                    —
                                 
                                 
                                    other coated forms:
                                    1 × 1010 CFU/g additive, or
                                 
                              
                                    —
                                 
                                 
                                    granulated non-coated form:
                                    3,5 × 1010 CFU/g additive.
                                 
                              
                           Characterisation of the active substance
                        
                        Viable cells of Enterococcus faecium
                        
                        NCIMB 10415
                        
                           Analytical method
                            (1)
                        
                        Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                        Identification: Pulsed- Field Gel Electrophoresis (PFGE)
                     
                     
                        Sows
                     
                     
                        —
                     
                     
                        7 × 108
                        
                     
                     
                        —
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    The additive shall be administered to pregnant and lactating sows and simultaneously to the suckling piglets
                                 
                              
                                    3.
                                 
                                 
                                    For use in weaned piglets until approximately 35 kg.
                                 
                              
                                    4.
                                 
                                 
                                    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.
                                 
                              
                     
                        24 January 2029
                     
                  
                        Suckling piglets
                     
                     
                        1 × 109
                        
                     
                     
                        —
                     
                  
                        Weaned piglets
                        Pigs for fattening
                     
                     
                        3,5 × 108
                        
                     
                     
                        —
                     
                  
               (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