CELEX: 32021R2093
Language: en
Date: 2021-11-29 00:00:00
Title: Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance)

30.11.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 427/169
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2093
         of 29 November 2021
         concerning the authorisation of disodium 5'-guanylate 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 disodium 5'-guanylate. 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 disodium 5'-guanylate as a feed additive for all animal species, to be classified in the category ‘sensory additives’ and in the functional group ‘flavouring compounds’.
                  
               
                     (4)
                  
                  
                     The applicant requested disodium 5'-guanylate to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of disodium 5'-guanylate in water for drinking should not be allowed.
                  
               
                     (5)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (2) that, under the proposed conditions of use, disodium 5'-guanylate does not have adverse effects on animal health, human health or the environment.
                  
               
                     (6)
                  
                  
                     The Authority further concluded, that disodium 5'-guanylate is efficacious to contribute to the flavour of feed. The Authority 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.
                  
               
                     (7)
                  
                  
                     The assessment of disodium 5'-guanylate 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.
                  
               
                     (8)
                  
                  
                     Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.
                  
               
                     (9)
                  
                  
                     The fact that disodium 5'-guanylate is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed which is administered via water.
                  
               
                     (10)
                  
                  
                     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 ‘sensory additives’ and to the functional group ‘flavouring compounds’, 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(6):6619.
      
      
         
            ANNEX
            
                        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 active substance/kg of complete feed with a moisture content of 12 %
                     
                  
                        
                           Category: Sensory additives
                        
                        
                           Functional group: Flavouring compounds
                        
                     
                  
                        2b627i
                     
                     
                        -
                     
                     
                        Disodium 5'-guanylate
                     
                     
                        
                           Additive composition
                        
                        Disodium 5'-guanylate (GMP).
                        Powder form
                        
                           Characterisation of the active substance
                        
                        Disodium 5'-guanylate (hydrated form) produced with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067.
                        Produced by fermentation
                        Purity: min.: 97 %
                        Chemical formula:
                        C10H12N5Na2O8P
                        CAS number: 5550-12-9
                        Einecs number: 226-914-1
                        
                           Analytical method
                            (1)
                        
                        For the identification of disodium 5'-guanylate (GMP) in the feed additive:
                        
                                    —
                                 
                                 
                                    FAO JECFA monograph ‘disodium 5'-guanylate’
                                 
                              For the determination of disodium 5'-guanylate (GMP) in the feed additive, flavouring premixtures and water:
                        
                                    —
                                 
                                 
                                    High performance liquid chromatography coupled to UV detection (HPLC-UV)
                                 
                              
                     
                        All animal species
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    1.
                                 
                                 
                                    The additive shall be incorporated into the feed in the form of a premixture.
                                 
                              
                                    2.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    3.
                                 
                                 
                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg of complete feedingstuff with a moisture content of 12 %: 50 mg’.
                                 
                              
                                    4.
                                 
                                 
                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level of active substance in complete feedingstuff referred to in point 3.
                                 
                              
                     
                        20 December 2031
                     
                  
               (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