CELEX: 32008R0167
Language: en
Date: 2008-02-22 00:00:00
Title: Commission Regulation (EC) No 167/2008 of 22 February 2008 concerning a new authorisation for ten years of a coccidiostat as an additive in feedingstuffs (Text with EEA relevance)

23.2.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 50/14
            
         
      COMMISSION REGULATION (EC) No 167/2008
   of 22 February 2008
   concerning a new authorisation for ten years of a coccidiostat as an additive in feedingstuffs
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), and in particular Article 3, and 9 thereof,
   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 (2), and in particular Article 25 thereof,
   Whereas:
   
               (1)
            
            
               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.
            
         
               (2)
            
            
               Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               The application for authorisation of the additive set out in the Annex to this Regulation was submitted before the date of application of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               Initial comments on that application, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. That application is therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.
            
         
               (5)
            
            
               The person responsible for putting into circulation Kokcisan 120G submitted an application for authorisation for ten years, as a coccidiostat for chickens for fattening, according to Article 4 of that Directive. The European Food Safety Authority (EFSA) has delivered an opinion on the safety of the use of this preparation for human, animals and environment, under the conditions set out in the Annex to this Regulation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of this preparation, as specified in Annex, should be authorised for ten years.
            
         
               (6)
            
            
               The assessment of this application shows that certain procedures should be required to protect workers from exposure to the additive set out in the Annex. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (3).
            
         
               (7)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   The preparation belonging to the group ‘Coccidiostats and other medicinal substances’, as specified in the Annex, is authorised for use for ten years as additive in animal nutrition under the conditions laid down in that Annex.
   Article 2
   This Regulation shall enter into force on the third 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, 22 February 2008.
      
         
            For the Commission
         
         Markos KYPRIANOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).
   
      (2)  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
   
      (3)  OJ L 183, 29.6.1989, p. 1. Directive as last amended by Directive 2007/30/EC of the European Parliament and of the Council (OJ L 165, 27.6.2007, p. 21).
   
      ANNEX
      
                  Registration number of additive
               
               
                  Name and registration number of person responsible for putting additive into circulation
               
               
                  Additive
                  (Trade name)
               
               
                  Composition, chemical formula, description
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
               
                  Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
               
            
                  mg of active substance/kg of complete feedingstuff
               
            
                  Coccidiostats and other medicinal substances
               
            
                  E 766
               
               
                  KRKA, d.d
                  Novo mesto, Slovenia
               
               
                  Salinomycin sodium
                  (Kokcisan 120G)
               
               
                  
                               
                           
                           
                              Additive composition:
                              
                                           
                                       
                                       
                                          Salinomycin sodium: 120 g/kg
                                       
                                    
                                           
                                       
                                       
                                          Calcium carbonate to 1 000 g/kg
                                       
                                    
                                           
                                       
                                       
                                          Sucrose: 80-100 g/kg
                                       
                                    
                                           
                                       
                                       
                                          Corn starch: 20 g/kg
                                       
                                    
                        
                               
                           
                           
                              Active substance:
                              
                                           
                                       
                                       
                                          Salinomycin sodium,
                                       
                                    
                                           
                                       
                                       
                                          C42H69O11Na,
                                       
                                    
                                           
                                       
                                       
                                          CAS number: 55721-31-8,
                                       
                                    
                                           
                                       
                                       
                                          sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (CBS 101071)
                                       
                                    
                        
                               
                           
                           
                              Related impurities:
                              
                                           
                                       
                                       
                                          < 42 mg elaiophylin/kg salinomycin sodium
                                       
                                    
                                           
                                       
                                       
                                          < 40 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodium
                                       
                                    
                        
               
                  Chickens for fattening
               
               
                  —
               
               
                  60
               
               
                  70
               
               
                  Use prohibited at least three days before slaughter.
                  Indicate in the instructions for use of compound feedingstuffs:
                  
                               
                           
                           
                              ‘Dangerous for equines and turkeys’
                           
                        
                               
                           
                           
                              ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated’
                           
                        
               
                  26 February 2018
               
               
                  5 μg salinomycin sodium/kg of all wet tissues