CELEX: 32016R0896
Language: en
Date: 2016-06-08 00:00:00
Title: Commission Implementing Regulation (EU) 2016/896 of 8 June 2016 concerning the authorisation of iron sodium tartrates as a feed additive for all animal species (Text with EEA relevance)

9.6.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 152/3
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2016/896
   of 8 June 2016
   concerning the authorisation of iron sodium tartrates as a 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)
            
            
               In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of iron sodium tartrates. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               That application concerns the authorisation of iron sodium tartrates as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 April 2015 (2) that, under the proposed conditions of use, the preparation concerned does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparation has the potential to be efficacious as an anti-caking agent in salt. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of iron sodium tartrates shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
            
         
               (6)
            
            
               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 preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘anti-caking agents’ is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   Article 2
   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, 8 June 2016.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2015; 13(5):4114.
   
      ANNEX
      
                  Identification number of the additive
               
               
                  Additive
               
               
                  Composition, chemical formula, description, methods of analysis
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
            
                  mg of active substance/kg of NaCl
               
            
                  
                     Technological additives: anti-caking agents
                  
               
            
                  1i534
               
               
                  Iron sodium tartrates
               
               
                  
                     Additive composition
                  
                  Preparation of complexation products of sodium tartrates with iron(III) chloride in water solution ≤ 35 % (by weight).
                  
                     Characterisation of active substance
                  
                  Iron(III) complexation product of D(+)-, L(-)- and meso-2,3-dihydroxybutanedioic acids
                  
                               
                           
                           
                              Ratio: iron to meso-tartrate 1:1;
                           
                        
                               
                           
                           
                              Ratio: iron to total tartrate isomers 1:1,5
                           
                        CAS number 1280193-05-9
                  Fe(OH)2C4H4O6Na
                  
                               
                           
                           
                              Chloride: ≤ 25 %
                           
                        
                               
                           
                           
                              Oxalates: ≤ 1,5 % expressed as oxalic acid
                           
                        
                               
                           
                           
                              Iron: ≥ 8 % iron(III)
                           
                        
                     Analytical method
                      (1)
                  
                  Quantification of meso-tartrate and D(-), L(+)-tartrates in the feed additive:
                  
                              —
                           
                           
                              High Performance Liquid Chromatography with Refraction Index detection (HPLC-RI);
                           
                        Quantification of total iron in the feed additive:
                  
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN 15510, or
                           
                        
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621,or
                           
                        
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885, or
                           
                        
                              —
                           
                           
                              Atomic Absorption Spectrometry (AAS) — EN ISO 6869, or
                           
                        
                              —
                           
                           
                              Atomic Absorption Spectrometry (AAS) — Commission Regulation (EC) No 152/2009 (2); and
                           
                        Quantification of total sodium in the feed additive:
                  
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN 15510; or
                           
                        
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy after pressure digestion (ICP-AES) — EN 15621; or
                           
                        
                              —
                           
                           
                              Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) — EN ISO 11885; or
                           
                        
                              —
                           
                           
                              Atomic Absorption Spectrometry (AAS) — EN ISO 6869; and
                           
                        Quantification of total chloride in the feed additive:
                  
                              —
                           
                           
                              Titrimetry —Regulation (EC) No 152/2009 or ISO 6495.
                           
                        
               
                  All animals species
               
               
                  —
               
               
                  —
               
               
                  —
               
               
                  
                              1.
                           
                           
                              The additive shall be used only in NaCl (sodium chloride).
                           
                        
                              2.
                           
                           
                              Minimum recommended dose: 26 mg of iron sodium tartrates/kg NaCl (equivalent to 3 mg iron/kg of NaCl).
                           
                        
                              3.
                           
                           
                              Maximum recommended dose: 106 mg of iron sodium tartrates/kg NaCl.
                           
                        
               
                  29 June 2026
               
            
         (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
      
         (2)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).