CELEX: 32015R1416
Language: en
Date: 2015-08-20 00:00:00
Title: Commission Implementing Regulation (EU) 2015/1416 of 20 August 2015 concerning the authorisation of sodium bisulphate as feed additive for all animal species (Text with EEA relevance)

21.8.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 220/11
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1416
   of 20 August 2015
   concerning the authorisation of sodium bisulphate as feed additive for all animal species
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   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 9(2) thereof,
   Whereas:
   
               (1)
            
            
               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
            
         
               (2)
            
            
               The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 (2).
            
         
               (3)
            
            
               In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of sodium bisulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               The application concerns the authorisation of sodium bisulphate as a feed additive for all animal species, to be classified in the additive categories ‘technological additives’.
            
         
               (5)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 October 2011 (3) and of 22 May 2014 (4) that, under the proposed conditions of use, sodium bisulphate does not have an adverse effect on animal health, human health or the environment, and that its use is considered efficacious as preservative and acidity regulator for all animal species. The Authority does not consider that there is a need for specific requirement of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (6)
            
            
               The assessment of sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes to this Regulation.
            
         
               (7)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   The substance specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   Article 2
   The substance specified in Annex II, belonging to the additive category ‘technological additives’ and to the functional group ‘acidity regulators’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   Article 3
   This Regulation shall enter into force on the twentieth 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, 20 August 2015.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food producing animals (OJ L 46, 17.2.2012, p. 33).
   
      (3)  EFSA Journal 2011; 9(11):2415.
   
      (4)  EFSA Journal 2014; 12(6):3731.
   
      ANNEX I
      
                  Identification number of the additive
               
               
                  Name of the holder of authorisation
               
               
                  Additive
               
               
                  Composition, chemical formula, description, analytical method
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
            
                  mg/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of technological additives. Functional group: preservatives
                  
               
            
                  1j514ii
               
               
                  —
               
               
                  Sodium bisulphate
               
               
                  
                     Additive composition
                  
                  Sodium bisulphate: ≥ 95,2 %
                  
                     Characterisation of the active substance
                  
                  Sodium bisulphate CAS No 7681-38-1
                  NaHSO4
                  
                  Na 19,15 %
                  SO4 80,01 %
                  Produced by chemical synthesis
                  
                     Method of Analysis
                      (1)
                  
                  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.
               
               
                  All animal species other than cats and mink
               
               
                  —
               
               
                  —
               
               
                  4 000
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For safety: breathing protection, eye protection and gloves shall be used during handling.
                           
                        
                              3.
                           
                           
                              The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.
                           
                        
               
                  10 September 2025
               
            
                  Cats
               
               
                  20 000
               
            
                  Mink
               
               
                  10 000
               
            
         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
   
   
      ANNEX II
      
                  Identification number of the additive
               
               
                  Name of the holder of authorisation
               
               
                  Additive
               
               
                  Composition, chemical formula, description, analytical method
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
            
                  mg/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of technological additives. Functional group: acidity regulators
                  
               
            
                  1j514ii
               
               
                  —
               
               
                  Sodium bisulphate
               
               
                  
                     Additive composition
                  
                  Sodium bisulphate: ≥ 95,2 %
                  
                     Characterisation of the active substance
                  
                  Sodium bisulphate CAS No 7681-38-1
                  NaHSO4
                  
                  Na 19,15 %
                  SO4 80,01 %
                  Produced by chemical synthesis
                  
                     Method of Analysis
                      (1)
                  
                  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.
               
               
                  All animal species other than cats, mink, pet and other non-food producing animals
               
               
                  —
               
               
                  —
               
               
                  4 000
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For safety: breathing protection, eye protection and gloves shall be used during handling.
                           
                        
                              3.
                           
                           
                              The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.
                           
                        
               
                  10 September 2025
               
            
         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports