CELEX: 32019R0898
Language: en
Date: 2019-05-29 00:00:00
Title: Commission Implementing Regulation (EU) 2019/898 of 29 May 2019 concerning the authorisation of the preparation of eugenol as a feed additive for chickens for fattening (holder of authorisation Lidervet SL) (Text with EEA relevance.)

3.6.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 144/29
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/898
         of 29 May 2019
         concerning the authorisation of the preparation of eugenol as a feed additive for chickens for fattening (holder of authorisation Lidervet SL)
         (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 eugenol. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
                  
               
                     (3)
                  
                  
                     That application concerns the authorisation of the preparation eugenol 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 opinions of 21 October 2015 (2) and 4 July 2017 (3) that, under the proposed conditions of use, eugenol does not have an adverse effect on animal health, human health or the environment. The Authority concluded that the additive is considered efficacious in improving the growth of chickens for fattening. The Authority did not consider that there was 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 eugenol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of eugenol 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 ‘other zootechnical 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 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, 29 May 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2015;13(11):4273.
         
            (3)  EFSA Journal 2017;15(7):4931.
      
      
         
            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
                     
                  
                        mg of additive/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical performance).
                        
                     
                  
                        4d18
                     
                     
                        Lidervet SL
                     
                     
                        Preparation of Eugenol
                     
                     
                        
                           Additive composition
                        
                        Preparation of:
                        
                                    —
                                 
                                 
                                    eugenol 5 %;
                                 
                              
                                    —
                                 
                                 
                                    glyceryl polyethyleneglycol ricinoleate 55-56 %;
                                 
                              
                                    —
                                 
                                 
                                    silica amorphous 33 %;
                                 
                              
                                    —
                                 
                                 
                                    poly(methacrylic acid-co-ethyl acrylate) 6 %.
                                 
                              Granulated form
                        
                           Characterisation of active substance
                        
                        Eugenol (2-methoxy-4-(2-propenyl)phenol, 4-allyl-2-methoxyphenol, 4-allylguaiacol.) (99,5 %);
                        CAS no 97-53-0
                        C10H12O2
                        
                        
                           Analytical method
                            (1)
                        
                        For the quantification of eugenol in the feed additive and feedingstuffs:
                        
                                    —
                                 
                                 
                                    Gas Chromatography coupled to a Flame Ionization Detector (GC-FID)
                                 
                              
                     
                        Chickens for fattening
                     
                     
                        —
                     
                     
                        100
                     
                     
                        100
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixture, the storage conditions and stability to heating treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    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.
                                 
                              
                                    3.
                                 
                                 
                                    The mixing with other sources of eugenol is not permitted.
                                 
                              
                     
                        23 June 2029
                     
                  
               (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