CELEX: 32017R0940
Language: en
Date: 2017-06-01 00:00:00
Title: Commission Implementing Regulation (EU) 2017/940 of 1 June 2017 concerning the authorisation of formic acid as a feed additive for all animal species (Text with EEA relevance. )

2.6.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 142/40
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/940
      of 1 June 2017
      concerning the authorisation of formic acid 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 formic acid. 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 formic acid as a feed additive for all animal species to be classified in the 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 of formic acid does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparation is effective in inhibiting or reducing the number of bacterial pathogens in feed material and compound feed. 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 the preparation of formic acid 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
      Authorisation
      The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘hygiene condition enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
      Article 2
      Entry into force
      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, 1 June 2017.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  EFSA Journal 2015; 13(5):4113.
      
         ANNEX
         
                     Identification number of the additive
                  
                  
                     Additive
                  
                  
                     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 formic acid/kg of complete feedingstuff with a moisture content of 12 %
                  
               
                     
                        Technological additives: hygiene condition enhancers
                     
                  
               
                     1k236
                  
                  
                     Formic acid
                  
                  
                     
                        Additive composition
                     
                     Formic acid (≥ 84,5 %)
                     Liquid form
                     
                        Characterisation of the active substance
                     
                     Formic acid ≥ 84,5 %
                     H2CO2
                     
                     CAS No: 64-18-6
                     
                        Analytical method
                         (1)
                     
                     For the determination of formic acid: ion chromatography method equipped with electrical conductivity detection (IC-ECD).
                  
                  
                     All animal species
                  
                  
                     —
                  
                  
                     —
                  
                  
                     10 000 
                  
                  
                     
                                 1.
                              
                              
                                 In the directions for use of the additive and premixture, the storage conditions shall be indicated.
                              
                           
                                 2.
                              
                              
                                 The mixture of different sources of formic acid shall not exceed the permitted maximum content in complete feedingstuffs.
                              
                           
                                 3.
                              
                              
                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
                              
                           
                  
                     21.6.2027
                  
               
            (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