CELEX: 32004R1356
Language: en
Date: 2004-07-26 00:00:00
Title: Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive «Elancoban» in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)

27.7.2004   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 251/6
            
         
      COMMISSION REGULATION (EC) No 1356/2004
   of 26 July 2004
   concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances
   (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 9g(5)(b) thereof,
   Whereas:
   
               (1)
            
            
               In accordance with Directive 70/524/EEC, coccidiostats included in Annex I to that Directive before 1 January 1988 were provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation. The monensin sodium product, Elancoban, is an additive belonging to the group ‘Coccidiostats and other medicinal substances’ listed in Chapter I of Annex B to Directive 70/524/EEC.
            
         
               (2)
            
            
               The person responsible for putting into circulation Elancoban submitted an application for authorisation and a dossier, according to Article 9g(2) and (4) of that Directive.
            
         
               (3)
            
            
               Article 9g(6) of Directive 70/524/EEC allows the automatic extension of the period of authorisation of the additives concerned until the Commission takes a decision in case of, for reasons beyond the control of the authorisation holder, no decision may be taken on the application before the expiry date of the authorisation. This provision is applicable to the authorisation of Elancoban. On 26 April 2001, the Commission requested the Scientific Committee for Animal Nutrition for a full risk evaluation and this request was consequently transferred to the European Food Safety Authority. Several requests for additional information were made during the re-evaluation process making it impossible to complete the re-evaluation within the time limits required by Article 9g.
            
         
               (4)
            
            
               The Scientific Panel on Additives and Products or Substances used in Animal Feed attached to the European Food Safety Authority has delivered a favourable opinion with regard to the safety and to the efficacy of Elancoban for chickens for fattening, for chickens reared for laying and for turkeys.
            
         
               (5)
            
            
               The re-evaluation of Elancoban carried out by the Commission showed that the relevant conditions laid down in Directive 70/524/EEC are satisfied. Elancoban should therefore be authorised for 10 years as an additive linked to the person responsible for putting it into circulation and included in Chapter I of the list referred to Article 9t(b) of that Directive.
            
         
               (6)
            
            
               As the authorisation for the additive is now linked to a person responsible for putting it into circulation, and replaces the previous authorisation which was not linked to any specific person, it is appropriate to delete the latter authorisation.
            
         
               (7)
            
            
               Since there are no safety reasons for withdrawing the product monensin sodium from the market immediately, it is appropriate to allow a transitional period of six months for the disposal of existing stocks of the additive.
            
         
               (8)
            
            
               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
   Chapter I of Annex B to Directive 70/524/EEC is amended as follows:
   The additive monensin sodium, belonging to the group ‘Coccidiostats and other medical substances’, shall be deleted.
   Article 2
   The additive Elancoban belonging to the group ‘Coccidiostats and other medical substances’, as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
   Article 3
   A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of monensin sodium.
   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, 26 July 2004.
      
         
            For the Commission
         
         David BYRNE
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 270, 14.12.1970, p. 1. Regulation as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).
   
      ANNEX
      
         
                     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
                  
                  
                     Period of authorisation
                  
               
                     mg of active substance/kg of complete feedingstuff
                  
               
                     Coccidiostats and other medicinal substances
                  
               
                     ‘E 757
                  
                  
                     Eli Lilly and Company Limited
                  
                  
                     Monensin sodium
                  
                  
                     
                        
                           Active substance:
                        
                     
                     
                                  
                              
                              
                                 C36H61O11Na
                                 sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis, ATCC 15413 in granular form.
                              
                           
                                  
                              
                              
                                 Factor composition:
                                 
                                              
                                          
                                          
                                             Monensin A: not less than 90 %
                                          
                                       
                                              
                                          
                                          
                                             Monensin: A + B: not less than 95 %
                                          
                                       
                           
                  
                     Chickens for fattening
                  
                  
                     —
                  
                  
                     100
                  
                  
                     125
                  
                  
                     Use prohibited at least three days before slaughter.
                     Indicate in the instructions for use: Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances.
                  
                  
                     30.7.2014’
                  
               
                     Elancoban G100
                     Elancoban 100
                     Elancogran 100
                  
                  
                     
                        
                           Additive composition:
                        
                     
                     
                                  
                              
                              
                                 Granular monensin (dried fermentation product) equivalent to Monensin activity 10 % w/w
                              
                           
                                  
                              
                              
                                 Mineral oil 1-3 % w/w
                              
                           
                                  
                              
                              
                                 Limestone granular 13-23 % w/w
                              
                           
                                  
                              
                              
                                 Rice hulls or limestone granular qs 100 % w/w
                              
                           
                  
                     Chickens reared for laying
                  
                  
                     16 weeks
                  
                  
                     100
                  
                  
                     120
                  
                  
                     Indicate in the instructions for use: Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances.
                  
               
                     Elancoban G200
                     Elancoban 200
                  
                  
                     
                                  
                              
                              
                                 Granular monensin (dried fermentation product) equivalent to Monensin activity 20 % w/w
                              
                           
                                  
                              
                              
                                 Mineral oil 1-3 % w/w
                              
                           
                                  
                              
                              
                                 Rice hulls or limestone granular qs 100 % w/w
                              
                           
                  
                     Turkeys
                  
                  
                     16 weeks
                  
                  
                     60
                  
                  
                     100
                  
                  
                     Use prohibited at least three days before slaughter.
                     Indicate in the instructions for use: Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances.