CELEX: 32005R0600
Language: en
Date: 2005-04-18
Title: Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (Text with EEA relevance)

19.4.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 99/5
            
         
      COMMISSION REGULATION (EC) No 600/2005
   of 18 April 2005
   concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives 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 Articles 3, 9d(1) and 9e(1) 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 applications for authorisation of the additives listed in the Annexes to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               Initial comments on those applications, 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. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.
            
         
               (5)
            
            
               The person responsible for putting into circulation Salinomax 120G submitted an application for authorisation for 10 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 humans, animals and the environment, under the conditions set out in Annex I 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 I, should be authorised for 10 years.
            
         
               (6)
            
            
               Data were submitted in support of an application of the new additive Lactobacillus acidophilus DSM 13241 for dogs and cats. The EFSA delivered favourable opinions on 15 April 2004 and 27 October 2004 on the safety for the target animals, the user and the environment. The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be provisionally authorised.
            
         
               (7)
            
            
               The use of the micro-organism preparation Enterococcus faecium ATCC 53519 and Enterococcus faecium ATCC 55593 was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1436/98 (3). New data were submitted in support of an application for authorisation without time limit of that micro-organism preparation. 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 that micro-organism preparation, as specified in Annex III, should be authorised without a time limit.
            
         
               (8)
            
            
               The use of the micro-organism preparation Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 was provisionally authorised, for the first time, for turkeys for fattening by Commission Regulation (EC) No 2437/2000 (4) and for calves by Commission Regulation (EC) No 418/2001 (5). New data were submitted in support of an application for authorisation without time limit of that micro-organism preparation. 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 that micro-organism preparation, as specified in Annex III, should be authorised without a time limit.
            
         
               (9)
            
            
               The use of the micro-organism preparation Saccharomyces cerevisiae NCYC Sc 47 was provisionally authorised, for the first time, for rabbits by the Regulation (EC) No 1436/98. New data were submitted in support of an application for authorisation without time limit of that micro-organism preparation. 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 that micro-organism preparation, as specified in Annex III, should be authorised without a time limit.
            
         
               (10)
            
            
               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 (6).
            
         
               (11)
            
            
               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 Annex I, is authorised for use for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
   Article 2
   The preparation belonging to the group ‘Micro-organisms’, as specified in Annex II, is authorised provisionally for four years as an additive in animal nutrition under the conditions laid down in that Annex.
   Article 3
   The preparations belonging to the group ‘Micro-organisms’, as specified in Annex III, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
   Article 4
   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, 18 April 2005.
      
         
            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 191, 7.7.1998, p. 15.
   
      (4)  OJ L 280, 4.11.2000, p. 28.
   
      (5)  OJ L 62, 2.3.2001, p. 3.
   
      (6)  OJ L 183, 29.6.1989, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
   
      ANNEX I
      
         
                     Registration number of additive
                  
                  
                     Name and registration number of person responsible for putting the 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
                  
               
                     mg of active substance/kg of complete feedingstuff
                  
               
                     Coccidiostats and other medicinal substances
                  
               
                     ‘E 766
                  
                  
                     Alpharma (Belgium) BVBA
                  
                  
                     Salinomycin sodium 120 g/kg
                     (Salinomax 120G)
                  
                  
                     
                                  
                              
                              
                                 Additive composition:
                                 
                                              
                                          
                                          
                                             Salinomycin sodium 120 g/kg
                                          
                                       
                                              
                                          
                                          
                                             Calcium lignosulfonate: 40 g/kg
                                          
                                       
                                              
                                          
                                          
                                             Calcium sulphate dihydrate to 1 000 g/kg
                                          
                                       
                           
                                  
                              
                              
                                 Active substance:
                                 
                                              
                                          
                                          
                                             Salinomycin sodium,
                                             C42H69O11Na,
                                             Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06),
                                             CAS No: 55 721-31-8
                                          
                                       
                           
                                  
                              
                              
                                 Related impurities:
                                 
                                              
                                          
                                          
                                             < 42 mg elaiophylin/kg salinomycin sodium.
                                          
                                       
                                              
                                          
                                          
                                             < 40 g 17-epi-20 desoxysalinomycin /kg salinomycin sodium
                                          
                                       
                           
                  
                     Chickens for fattening
                  
                  
                     —
                  
                  
                     50
                  
                  
                     70
                  
                  
                     Use prohibited at least 5 days before slaughter.
                     Indicate in the instructions for use:
                     
                                  
                              
                              
                                 “Dangerous for equines and turkeys”
                              
                           
                                  
                              
                              
                                 “This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g.tiamulin) can be contra-indicated”
                              
                           
                  
                     22.4.2015’
                  
               
   
   
      ANNEX II
      
         
                     No (or EC No)
                  
                  
                     Additive
                  
                  
                     Chemical formula, description
                  
                  
                     Species or category of animal
                  
                  
                     Maximum age
                  
                  
                     Minimum content
                  
                  
                     Maximum content
                  
                  
                     Other provisions
                  
                  
                     End of period of authorisation
                  
               
                     CFU/kg of complete feedingstuff
                  
               
                     Micro-organisms
                  
               
                     ‘25
                  
                  
                     
                        Lactobacillus acidophilus DSM 13241
                  
                  
                     Preparation of Lactobacillus acidophilus containing a minimum of:
                     
                                  
                              
                              
                                 1 × 1011 CFU/g additive
                              
                           
                  
                     Dogs
                  
                  
                     —
                  
                  
                     6 × 109
                     
                  
                  
                     2 × 1010
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                     For use in dry feed with a water content at or below 2 %.
                  
                  
                     22.4.2009
                  
               
                     Cats
                  
                  
                     —
                  
                  
                     3 × 109
                     
                  
                  
                     2 × 1010
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                     For use in dry feed with a water content at or below 2 %.
                  
                  
                     22.4.2009’
                  
               
   
   
      ANNEX III
      
         
                     EC No
                  
                  
                     Additive
                  
                  
                     Chemical formula, description
                  
                  
                     Species or category of animal
                  
                  
                     Maximum age
                  
                  
                     Minimum content
                  
                  
                     Maximum content
                  
                  
                     Other provisions
                  
                  
                     End of period of authorisation
                  
               
                     CFU/kg of complete feedingstuff
                  
               
                     Micro-organisms
                  
               
                     ‘E 1709
                  
                  
                     
                        Enterococcus faecium ATCC 53519
                     
                        Enterococcus faecium ATCC 55593
                     (In a 1/1 ratio)
                  
                  
                     Mixture of encapsulated Enterococcus faecium and Enterococcus faecium containing a minimum of 2 × 108 CFU/g additive.
                     (i.e. a minimum of 1 × 108 CFU/g of each bacterium)
                  
                  
                     Chickens for fattening
                  
                  
                     —
                  
                  
                     1 × 108
                     
                  
                  
                     1 × 108
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                     May be used in compounded feed containing coccidiostats: decoquinate, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, narasin, narasin/nicarbazin, and salinomycin sodium.
                  
                  
                     Without a time limit
                  
               
                     E 1700
                  
                  
                     
                        Bacillus licheniformis DSM 5749
                     
                        Bacillus subtilis DSM 5750
                     (In a 1/1 ratio)
                  
                  
                     Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of 3,2 × 109 CFU/g additive (1,6 × 109 of each bacterium)
                  
                  
                     Turkeys for fattening
                  
                  
                     —
                  
                  
                     1,28 × 109
                     
                  
                  
                     1,28 × 109
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                     May be used in compounded feed containing coccidiostats: diclazuril, halofuginone, monensin sodium and robenidine.
                  
                  
                     Without a time limit
                  
               
                     Calves
                  
                  
                     3 months
                  
                  
                     1,28 × 109
                     
                  
                  
                     1,28 × 109
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                  
                  
                     Without a time limit
                  
               
                     E 1702
                  
                  
                     
                        Saccharomyces cerevisiae
                     
                     NCYC Sc 47
                  
                  
                     Preparation of Saccharomyces cerevisiae containing 5 × 109 CFU/g additive
                  
                  
                     Rabbits for fattening
                  
                  
                     —
                  
                  
                     2,5 × 109
                     
                  
                  
                     7,5 × 109
                     
                  
                  
                     In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting
                  
                  
                     Without a time limit’