CELEX: 32005R1200
Language: en
Date: 2005-07-26
Title: Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs Text with EEA relevance

27.7.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 195/6
            
         
      COMMISSION REGULATION (EC) No 1200/2005
   of 26 July 2005
   concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised 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, 9a, and 9d(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 the 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 use of the growth promoter Formi LHS (potassium diformate) was provisionally authorised, for the first time, for piglets and pigs for fattening by Commission Regulation (EC) No 1334/2001 (3). The person responsible for putting into circulation Formi LHS (potassium diformate) submitted an application to obtain a provisional authorisation for extension of use for four years, as a growth promoter for sows, 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 environment, under the conditions set out in Annex I to this Regulation. The assessment shows that the conditions laid down in Article 9a(1) 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 four years.
            
         
               (6)
            
            
               The use of the micro-organism Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012 was provisionally authorised, for the first time, for chickens for fattening and for rabbits for fattening by Commission Regulation (EC) No 1411/1999 (4). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (7)
            
            
               The use of the micro-organism Enterococcus faecium NCIMB 10415 was provisionally authorised, for the first time, for sows by Commission Regulation (EC) No 866/1999 (5). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (8)
            
            
               The use of the micro-organism Enterococcus faecium DSM 10663/NCIMB 10415 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (9)
            
            
               The use of the micro-organism Saccharomyces cerevisiae MUCL 39885 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (10)
            
            
               The use of the micro-organism Saccharomyces cerevisiae CNCM I-1077 was provisionally authorised, for the first time, for dairy cows and cattle for fattening by the Commission Regulation (EC) No 1436/98 (6). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (11)
            
            
               The use of the micro-organism Pediococcus acidilactici CNCM MA 18/5M was provisionally authorised, for the first time, for chickens for fattening by Regulation (EC) No 866/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. 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 II, should be authorised without a time-limit.
            
         
               (12)
            
            
               The assessment of these applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. 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 (7).
            
         
               (13)
            
            
               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 ‘Growth promoters’, as specified in Annex I, is authorised provisionally for four years for use as an additive in animal nutrition under the conditions laid down in that Annex.
   Article 2
   The preparations belonging to the group ‘Micro-organisms’, as specified in Annex II, are authorised without a time-limit for use as additives in animal nutrition under the conditions laid down in that Annex.
   Article 3
   This Regulation shall enter into force on the third day following 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 2005.
      
         
            For the Commission
         
         Markos KYPRIANOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 270, 14.12.1970, p. 1. Directive as last amended by 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 180, 3.7.2001, p. 18. Regulation as amended by Regulation (EC) No 676/2003 (OJ L 97, 15.4.2003, p. 29).
   
      (4)  OJ L 164, 30.6.1999, p. 56.
   
      (5)  OJ L 108, 27.4.1999, p. 21.
   
      (6)  OJ L 191, 7.7.1998, p. 15.
   
      (7)  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
               
            
                  Growth promoters
               
            
                  1
               
               
                  BASF Aktiengesellschaft
               
               
                  Potassium diformate (Formi LHS)
               
               
                  
                     Additive composition:
                  
                               
                           
                           
                              Potassium diformate, solid min. 98 %,
                           
                        
                               
                           
                           
                              Silicate max. 1,5 %,
                           
                        
                               
                           
                           
                              Water max. 0,5 %
                           
                        
                     Active substance:
                  
                  
                               
                           
                           
                              Potassium diformate, solid
                           
                        
                               
                           
                           
                              KH(COOH)2
                              
                           
                        
                               
                           
                           
                              CAS No 20642-05-1
                           
                        
               
                  Sows
               
               
                  —
               
               
                  8 000
               
               
                  12 000
               
               
                  —
               
               
                  30 July 2009
               
            
   
      ANNEX II
      
                  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 1701
               
               
                  
                     Bacillus cereus var. toyoi
                  
                  NCIMB 40112/CNCM I-1012
               
               
                  Preparation of Bacillus cereus var. toyoi containing a minimum of: 1 × 1010 CFU/g additive
               
               
                  Rabbits for fattening
               
               
                  —
               
               
                  0,1 × 109
                  
               
               
                  5 × 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 compound feed containing the permitted coccidiostats: robenidine, salinomycin sodium.
               
               
                  Without a time-limit
               
            
                  Chickens for fattening
               
               
                  —
               
               
                  0,2 × 109
                  
               
               
                  1 × 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 compound feed containing the permitted coccidiostats: monensin sodium, lasalocid sodium, salinomycin sodium, decoquinate, robenidine, narasin, halofuginone.
               
               
                  Without a time-limit
               
            
                  E 1705
               
               
                  
                     Enterococcus faecium
                  
                  NCIMB 10415
               
               
                  Preparation of Enterococcus faecium containing a minimum of:
                  
                               
                           
                           
                              Microencapsulated form:
                              
                                           
                                       
                                       
                                          1,0 × 1010 CFU/g additive
                                       
                                    
                        
                               
                           
                           
                              Granulated form:
                              
                                           
                                       
                                       
                                          3,5 × 1010 CFU/g additive
                                       
                                    
                        
               
                  Sows
               
               
                  —
               
               
                  0,7 × 109
                  
               
               
                  1,25 × 109
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                  Sows 2 weeks before farrowing and during lactation.
               
               
                  Without time-limit
               
            
                  E 1707
               
               
                  
                     Enterococcus faecium
                  
                  DSM 10663/NCIMB 10415
               
               
                  Preparation of Enterococcus faecium containing a minimum of:
                  
                               
                           
                           
                              Powder and granulated forms:
                              
                                           
                                       
                                       
                                          3,5 × 1010 CFU/g additive
                                       
                                    
                        
                               
                           
                           
                              Coated form:
                              
                                           
                                       
                                       
                                          2,0 × 1010 CFU/g additive
                                       
                                    
                        
                               
                           
                           
                              Liquid form:
                              
                                           
                                       
                                       
                                          1 × 1010 CFU/ml additive
                                       
                                    
                        
               
                  Piglets
               
               
                  —
               
               
                  1 × 109
                  
               
               
                  1 × 1010
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                  For use in piglets until approximately 35 kg.
               
               
                  Without a time-limit
               
            
                  E 1710
               
               
                  
                     Saccharomyces cerevisiae MUCL 39885
               
               
                  Preparation of Saccharomyces cerevisiae containing a minimum of:
                  
                               
                           
                           
                              Powder, spheric and oval granulated forms:
                              
                                           
                                       
                                       
                                          1 × 109 CFU/g additive
                                       
                                    
                        
               
                  Piglets (weaned)
               
               
                  —
               
               
                  3 × 109
                  
               
               
                  3 × 109
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                  For use in weaned piglets until approximately 35 kg.
               
               
                  Without a time-limit
               
            
                  E 1711
               
               
                  
                     Saccharomyces cerevisiae CNCM I-1077
               
               
                  Preparation of Saccharomyces cerevisiae containing a minimum of:
                  
                               
                           
                           
                              Granulated powder form:
                              
                                           
                                       
                                       
                                          2 × 1010 CFU/g additive
                                       
                                    
                        
                               
                           
                           
                              Coated form:
                              
                                           
                                       
                                       
                                          1 × 1010 CFU/g additive
                                       
                                    
                        
               
                  Dairy cows
               
               
                  —
               
               
                  4 × 108
                  
               
               
                  2 × 109
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                  The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 8,4 × 109 CFU for 100 kg body weight. Add 1,8 × 109 CFU for each additional 100 kg body weight.
               
               
                  Without a time-limit
               
            
                  Cattle for fattening
               
               
                  —
               
               
                  5 × 108
                  
               
               
                  1,6 × 109
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                  The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 4,6 × 109 CFU for 100 kg body weight. Add 2 × 109 CFU for each additional 100 kg body weight.
               
               
                  Without a time-limit
               
            
                  E 1712
               
               
                  
                     Pediococcus acidilactici CNCM MA 18/5M
               
               
                  Preparation of Pediococcus acidilactici containing a minimum of 1 × 1010 CFU/g additive
               
               
                  Chickens for fattening
               
               
                  —
               
               
                  1 × 109
                  
               
               
                  1 × 1010
                  
               
               
                  In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                  May be used in compound feed containing the permitted coccidiostats:decoquinate, halofuginone, narasin, salinomycin sodium, maduramicin ammonium, diclazuril.
               
               
                  Without a time-limit