CELEX: 32021R2094
Language: en
Date: 2021-11-29 00:00:00
Title: Commission Implementing Regulation (EU) 2021/2094 of 29 November 2021 concerning the authorisation of decoquinate (Deccox and Avi-Deccox 60G) as a feed additive for chickens for fattening (holder of authorisation Zoetis Belgium SA) and repealing Regulation (EC) No 1289/2004 (Text with EEA relevance)

30.11.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 427/173
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2094
         of 29 November 2021
         concerning the authorisation of decoquinate (Deccox and Avi-Deccox 60G) as a feed additive for chickens for fattening (holder of authorisation Zoetis Belgium SA) and repealing Regulation (EC) No 1289/2004
         (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 Articles 9(2) and 13(3) 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 use of decoquinate was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1289/2004 (3). That additive 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 substance decoquinate as a feed additive for chickens for fattening. The applicant requested that additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (4)
                  
                  
                     In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the composition of the additive decoquinate (Deccox) as a feed additive for chickens for fattening, in particular replacing vegetable components with minerals. The applicant requested to maintain both compositions of the additive on the market. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (5)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 November 2018 (4), 28 January 2021 (5) and 30 October 2014 (6) that, under the proposed conditions of use, the substance decoquinate does not have an adverse effect on animal health, human health or the environment and it is efficacious in preventing coccidiosis. It was also concluded that no withdrawal period is required to ensure consumer safety and no Maximum Residue Limits (MRL) are considered necessary. The Authority also concluded that the requested change of carriers and physical form in Avi-Deccox 60G with respect of Deccox do not affect its safety and its capacity to control coccidiosis. Therefore, both forms of the additive are considered equivalent in terms of controlling coccidiosis. The Authority concluded that a post-market monitoring plan to monitor the Eimeria spp. resistance should be undertaken. 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.
                  
               
                     (6)
                  
                  
                     The assessment of the substance decoquinate 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 substance should be authorised as specified in the Annexes to this Regulation.
                  
               
                     (7)
                  
                  
                     For reasons of legal certainty, Regulation (EC) No 1289/2004 should be repealed.
                  
               
                     (8)
                  
                  
                     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.
                  
               
                     (9)
                  
                  
                     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 substance decoquinate specified in the Annexes, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in those Annexes.
         
         
            Article 2
            Repeal
            Regulation (EC) No 1289/2004 is repealed.
         
         
            Article 3
            Transitional measures
            The substance specified in Annex I and feed containing that substance, which are produced and labelled before 20 June 2022 in accordance with the rules applicable before 20 December 2021 may continue to be placed on the market and used until the existing stocks are exhausted.
         
         
            Article 4
            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, 29 November 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (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 1289/2004 of 14 July 2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats other medicinal substances (OJ L 243, 15.7.2004, p. 15).
         
            (4)  EFSA Journal 2019;17(1):5541.
         
            (5)  EFSA Journal 2021;19(3):6453.
         
            (6)  EFSA Journal 2014;12(11):3905.
      
      
         
            ANNEX I
            
                        Identification number of 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 active substance/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Additive category: coccidiostats and histomonostats
                        
                     
                  
                        51756i
                     
                     
                        Zoetis Belgium SA
                     
                     
                        Decoquinate
                        (Deccox)
                     
                     
                        
                           Additive composition:
                        
                        Decoquinate: 60,0 g/kg
                        Soybean oil: 28,5 g/kg
                        Colloidal silica: 0,6 g/kg
                        Wheat middling: q.s. 1 kg
                        
                           Characterisation of the active substance
                        
                        Decoquinate
                        C24H35NO5
                        
                        Ethyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate
                        CAS number: 18507-89-6
                        Related impurities:
                        6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0,5 %
                        Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1,0 %
                        Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate (aniline compound) < 0,5 %
                        
                           Analytical method
                            (1)
                        
                        For the determination of decoquinate in feed additive, premixtures and feedingstuffs:
                        Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162
                     
                     
                        Chickens for fattening
                     
                     
                         
                     
                     
                        30
                     
                     
                        40
                     
                     
                        
                                    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 incorporated in compound feed in the form of a premixture.
                                 
                              
                                    3.
                                 
                                 
                                    The additive shall not be mixed with other coccidiostats.
                                 
                              
                                    4.
                                 
                                 
                                    Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.
                                 
                              
                                    5.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of 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.
                                 
                              
                     
                        20.12.2031
                     
                  
               (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
         
      
      
         
            ANNEX II
            
                        Identification number of 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 active substance/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Additive category: coccidiostats and histomonostats
                        
                     
                  
                        51756ii
                     
                     
                        Zoetis Belgium SA
                     
                     
                        Decoquinate
                        (Avi-Deccox 60G)
                     
                     
                        
                           Additive composition
                        
                        Decoquinate: 60,0 g/kg
                        Colloidal silica: 0,6 g/kg
                        Silicon dioxide: 4,0 g/kg
                        Carboximethylcellulose sodium 30,0 g/kg
                        Calcium sulphate dihydrate q.s. ad 1 000,0  g
                        
                           Characterisation of the active substance
                        
                        Decoquinate
                        C24H35NO5
                        
                        Ethyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate
                        CAS number: 18507-89-6
                        Related impurities:
                        6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0,5 %
                        Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1,0 %
                        Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate (aniline compound) < 0,5 %
                        
                           Analytical method
                            (1)
                        
                        For the determination of decoquinate in feed additive, premixtures and feedingstuffs:
                        
                                    —
                                 
                                 
                                    Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162
                                 
                              
                     
                        Chickens for fattening
                     
                     
                         
                     
                     
                        30
                     
                     
                        40
                     
                     
                        
                                    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 incorporated in compound feed in the form of a premixture.
                                 
                              
                                    3.
                                 
                                 
                                    The additive shall not be mixed with other coccidiostats.
                                 
                              
                                    4.
                                 
                                 
                                    Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.
                                 
                              
                                    5.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of 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.
                                 
                              
                     
                        20.12.2031
                     
                  
               (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