CELEX: 32009R0101
Language: en
Date: 2009-02-03 00:00:00
Title: Commission Regulation (EC) No 101/2009 of 3 February 2009 amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed additive Cycostat 66G (Text with EEA relevance)

4.2.2009   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 34/5
            
         
      COMMISSION REGULATION (EC) No 101/2009
   of 3 February 2009
   amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed additive Cycostat 66G
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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 13(3) thereof,
   Whereas:
   
               (1)
            
            
               The additive robenidine hydrocloride 66 g/kg (Cycostat 66G), hereinafter referred to as Cycostat 66G, linked to the holder of authorisation, Alpharma (Belgium) BVBA, belonging to the group of coccidiostats and other medicinal substances, was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulation (EC) No 1800/2004 (3) authorised that additive for 10 years for use for chickens for fattening, turkeys and rabbits for fattening. That additive was notified as an existing product in accordance with Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives.
            
         
               (2)
            
            
               Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). Alpharma (Belgium) BVBA, holder of the authorisation of Cycostat 66G, has submitted an application with which it proposes changing the conditions of the authorisation for chickens for fattening and for turkeys by introducing a maximum residue limit (MRL) and by modifying the withdrawal period, as evaluated by the Authority. At the same time it provided data to support that request.
            
         
               (3)
            
            
               In its opinion adopted on 16 September 2008 (4), the Authority concluded that, based on safety considerations, there is no necessity for setting a withdrawal period for chickens for fattening and consequently for MRLs. It came to the same conclusions concerning turkeys. However, in case MRLs are required, it suggested values. It further proposed to maintain the five-day withdrawal period, to avoid off-flavours in edible tissues from poultry treated with Cycostat 66G.
            
         
               (4)
            
            
               To ensure a high level of safety for the consumers and to improve the control of the correct use of Cycostat 66G, it is appropriate to establish MRLs as proposed by the Authority. To keep acceptable organoleptic properties of meat, the withdrawal period should be maintained at five days.
            
         
               (5)
            
            
               Regulation (EC) No 1800/2004 should therefore be amended accordingly.
            
         
               (6)
            
            
               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 Annex to Regulation (EC) No 1800/2004 is replaced by the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the 20th 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, 3 February 2009.
      
         
            For the Commission
         
         Androulla VASSILIOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 270, 14.12.1970, p. 1.
   
      (3)  OJ L 317, 16.10.2004, p. 37.
   
      (4)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on a proposal for Maximum Residue Limits and withdrawal period for Cycostat 66G for chickens for fattening and turkeys for fattening. The EFSA Journal (2008) 798, 1-15.
   
      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 758
               
               
                  Alpharma (Belgium) BVBA
               
               
                  Robenidine hydrochloride 66 g/kg
                  (Cycostat 66G)
               
               
                  
                               
                           
                           
                              Additive composition:
                              Robenidine hydrochloride: 66 g/kg
                              Lignosulfonate: 40 g/kg
                              Calcium sulfate dihydrate: 894 g/kg
                           
                        
                               
                           
                           
                              Active substance:
                              Robenidine hydrochloride, C15H13Cl2N5 . HCl,
                              1,3-bis[(p-chlorobenzylidene) amino]-guanidine hydrochloride,
                              CAS number: 25875-50-7,
                           
                        
                               
                           
                           
                              Related impurities:
                              N,N′,N″-Tris[(p-Cl-benzylidene)amino]guanidine: ≤ 0,5 %
                              Bis-[4-Cl-benzylidene]hydrazine: ≤ 0,5 %
                           
                        
               
                  Chickens for fattening
               
               
                  —
               
               
                  30
               
               
                  36
               
               
                  Use prohibited at least five days before slaughter.
               
               
                  29.10.2014
               
               
                  800 μg robenidine hydrochloride/kg of wet liver.
                  350 μg robenidine hydrochloride/kg of wet kidney.
                  200 μg robenidine hydrochloride/kg of wet muscle.
                  1 300 μg robenidine hydrochloride/kg of wet skin/fat.
               
            
                  Turkeys
               
               
                  —
               
               
                  30
               
               
                  36
               
               
                  Use prohibited at least five days before slaughter.
               
               
                  29.10.2014
               
               
                  400 μg robenidine hydrochloride/kg of skin/fat.
                  400 μg robenidine hydrochloride/kg of wet liver.
                  200 μg robenidine hydrochloride/kg of wet kidney.
                  200 μg robenidine hydrochloride/kg of wet muscle.
               
            
                  Rabbits for fattening
               
               
                  —
               
               
                  50
               
               
                  66
               
               
                  Use prohibited at least five days before slaughter.
               
               
                  29.10.2014
               
               
                  —