CELEX: 32021R2092
Language: en
Date: 2021-11-29 00:00:00
Title: Commission Implementing Regulation (EU) 2021/2092 of 29 November 2021 concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets (Text with EEA relevance)

30.11.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 427/166
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2092
         of 29 November 2021
         concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets
         (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 an authorisation.
                  
               
                     (2)
                  
                  
                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium diformate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (3)
                  
                  
                     The application concerns the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets, to be classified in the category ‘technological additives’.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (2) that, under the proposed conditions of use, potassium diformate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the substance does not raise concerns regarding the effects on the respiratory system and the skin but is an eye irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the substance has the potential to be efficacious as a technological additive in feedingstuffs. 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 potassium diformate 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 substance 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 substance specified in the Annex, 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 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, 29 November 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2021;19(5):6617.
      
      
         
            ANNEX
            
                        Identification number of the additive
                     
                     
                        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
                        
                     
                  
                        1j001
                     
                     
                        Potassium diformate
                     
                     
                        
                           Additive composition:
                        
                        Potassium diformate ≥ 98 %
                     
                     
                        Pigs for fattening
                        Weaned piglets
                     
                     
                        -
                     
                     
                        -
                     
                     
                        6 000 
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    The maximum content of potassium diformate shall be 6 000  mg/kg of complete feedingstuff with a moisture content of 12 %, whether used alone as an acidity regulator or used in combination with other sources of potassium diformate.
                                 
                              
                                    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 eyes protection.
                                 
                              
                     
                        20 December 2031
                     
                  
                        
                           Characterisation of the active substance:
                        
                        Potassium diformate
                        CAS No: 20642-05-1
                        Einecs No: 243-934-6
                        C2H3O4K
                     
                  
                        
                           Analytical method
                            (1)
                        
                        For the determination of potassium diformate (as total formic acid) in the feed additive, premixture, feedingstuffs:
                        
                                    —
                                 
                                 
                                    Ion chromatography with conductivity detection (IC-CD) – EN 17294;
                                 
                              For the determination of potassium in the feed additive:
                        
                                    —
                                 
                                 
                                    Atomic absorption spectrometry (AAS) – EN ISO 6869; or
                                 
                              
                                    —
                                 
                                 
                                    Inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN15510.
                                 
                              
                  
               (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.