CELEX: 32020R1398
Language: en
Date: 2020-10-05 00:00:00
Title: Commission Implementing Regulation (EU) 2020/1398 of 5 October 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses and repealing Regulation (EC) No 886/2009 (holder of authorisation All-Technology Ireland Ltd) (Text with EEA relevance)

6.10.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 324/26
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1398
         of 5 October 2020
         concerning the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses and repealing Regulation (EC) No 886/2009 (holder of authorisation All-Technology Ireland 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 and renewing such authorisation.
                  
               
                     (2)
                  
                  
                     The preparation of Saccharomyces cerevisiae CBS 493.94 was authorised for 10 years as a feed additive for horses by Commission Regulation (EC) No 886/2009 (2).
                  
               
                     (3)
                  
                  
                     In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 November 2019 (3) that, Saccharomyces cerevisiae CBS 493.94 does not have an adverse effect under the authorised conditions of use for the animal health, consumer health or the environment. It also concluded that the additive should be considered as a moderate eye irritant and a potential skin and respiratory sensitiser. 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. Since the Authority was unable to conclude on the new proposed minimum dose, the previous doses should be maintained.
                  
               
                     (5)
                  
                  
                     The assessment of Saccharomyces cerevisiae CBS 493.94 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.
                  
               
                     (6)
                  
                  
                     As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 886/2009 should be repealed.
                  
               
                     (7)
                  
                  
                     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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.
         
         
            Article 2
            Regulation (EC) No 886/2009 is repealed.
         
         
            Article 3
            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, 5 October 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Commission Regulation (EC) No 886/2009 of 25 September 2009 concerning the authorisation of the preparation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses (holder of authorisation Alltech France) (OJ L 254, 26.9.2009, p. 66).
         
            (3)  EFSA Journal 2019; 17(12):5918.
      
      
         
            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: digestibility enhancer.
                        
                     
                  
                        4a1704
                     
                     
                        All-Technology Ireland Ltd.
                     
                     
                        
                           Saccharomyces cerevisae
                        
                        CBS 493.94
                     
                     
                        
                           Additive composition
                        
                        Preparation of Saccharomyces cerevisae CBS 493.94 containing a minimum of:
                        1 × 109 CFU/g additive
                        Powder and granulated form
                     
                     
                        Horses
                     
                     
                        -
                     
                     
                        1,6 × 109
                        
                     
                     
                        -
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat 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, including eyes, skin and breathing protection.
                                 
                              
                     
                        26.10.2030
                     
                  
                        
                           Characterisation of active substance
                        
                        Viable cells of Saccharomyces cerevisae CBS 493.94
                     
                  
                        
                           Analytical method
                            (1)
                        
                        Enumeration: pour plate method
                        using chloramphenicol glucose yeast
                        extract agar (EN 15789:2009).
                        Identification: polymerase chain
                        reaction (PCR) method (CEN/TS 15790:2008)
                     
                  
               (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