CELEX: 32020R0996
Language: en
Date: 2020-07-09 00:00:00
Title: Commission Implementing Regulation (EU) 2020/996 of 9 July 2020 concerning the authorisation of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying (holder of authorisation Biomin GmbH) (Text with EEA relevance)

10.7.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 221/87
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/996
         of 9 July 2020
         concerning the authorisation of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying (holder of authorisation Biomin GmbH)
         (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 a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
                  
               
                     (3)
                  
                  
                     That application concerns the authorisation of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying, to be classified in the additive category ‛zootechnical additives’.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2019 (2) that, under the proposed conditions of use, the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that exposure to users by inhalation is unlikely and that no conclusion could be drawn on skin or eyes sensitisation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive has the potential to be efficacious in improving zootechnical performance in chickens for fattening and this conclusion can be extended to chickens reared for laying and to be extrapolated to minor poultry species reared for laying. 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 carvacrol, thymol, D-carvone, methyl salicylate and L-menthol 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 ‘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, 9 July 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2019;17(6):5724.
      
      
         
            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 parameters)
                        
                     
                  
                        4d20
                     
                     
                        Biomin GmbH
                     
                     
                        Preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol
                     
                     
                        
                           Additive composition
                        
                        Preparation of:
                        
                                    —
                                 
                                 
                                    carvacrol (120–160 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    thymol (1–3 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    
                                       D-carvone (3–6 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    methyl salicylate (10–35 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    
                                       L-menthol (30–55 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    amorphous silica (maximum 100 mg/g)
                                 
                              
                                    —
                                 
                                 
                                    hydrogenated vegetable oil (maximum 700 mg/g)
                                 
                              Solid encapsulated form
                     
                     
                        Chickens for fattening
                        Chickens reared for laying
                        Minor poultry species reared for laying
                     
                     
                        —
                        —
                        —
                     
                     
                        65
                     
                     
                        105
                     
                     
                        
                                    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 not be used with other sources of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol.
                                 
                              
                                    3.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 skin and eye protections.
                                 
                              
                     
                        30.7.2030
                     
                  
                        
                           Characterisation of the active substance:
                        
                        Carvacrol (CAS number: 499-75-2)
                        Thymol (CAS number: 89-83-8)
                        
                           D-Carvone (CAS number:2244-16-8) Methyl salicylate (CAS number: 119-36-8)
                        
                                    —
                                 
                                 
                                    
                                       L-Menthol (CAS number: 2216-51-8)
                                 
                              
                  
                        
                           Analytical method
                            (1)
                        
                        For the quantification of the active substances:
                        Gas chromatography coupled with flame ionisation detection (GC-FID).
                     
                  
               (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