CELEX: 32020R1800
Language: en
Date: 2020-11-30 00:00:00
Title: Commission Implementing Regulation (EU) 2020/1800 of 30 November 2020 concerning the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species (Text with EEA relevance)

1.12.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 402/46
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1800
         of 30 November 2020
         concerning the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 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 monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188. This 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 monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.
                  
               
                     (4)
                  
                  
                     The applicant requested the feed additive to be authorised for use also 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 monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 in water for drinking should not be allowed. The fact that the additive is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.
                  
               
                     (5)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2020 (2) that, under the proposed conditions of use monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 does not have adverse effects on animal health, consumer health or the environment. The Authority concluded in the opinion that the additive is not toxic by inhalation, not irritant to skin or eyes and is not a dermal sensitiser. The Authority also concluded, that the effect of monosodium glutamate for increasing the taste of food is well proven, and therefore, no further demonstration of its efficacy in feed is necessary. 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.
                  
               
                     (6)
                  
                  
                     The assessment of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 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.
                  
               
                     (7)
                  
                  
                     Restrictions and conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.
                  
               
                     (8)
                  
                  
                     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 a feed 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, 30 November 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2020;18(4):6085.
      
      
         
            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 of active substance/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        Category: Sensory additives. Functional group: Flavouring compounds
                     
                  
                        2b621i
                     
                     
                        -
                     
                     
                        Monosodium glutamate
                     
                     
                        
                           Additive composition:
                        
                        Monosodium glutamate
                        
                           Characterisation of the active substance:
                        
                        Monosodium L-glutamate
                        Produced by fermentation with Corynebacterium glutamicum KCCM 80188
                        Purity: ≥ 99 % assay
                        Chemical formula:
                        C5H8NaNO4•H2O
                        CAS number 6106-04-3
                        
                           Method of analysis
                            (1)
                           :
                        
                        For the identification of monosodium L-glutamate in the feed additive: Food Chemical Codex ‘Monosodium L-glutamate monograph’.
                        For the quantification of monosodium L-glutamate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), as described in Commission Regulation (EC) No 152/2009 (Annex III, F) (2).
                        For the quantification of monosodium L-glutamate in premixtures: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).
                     
                     
                        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 premixture, the storage conditions and the 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 of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.
                                 
                              
                                    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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.
                                 
                              
                     
                        21.12.2030
                     
                  
               (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).