CELEX: 32022R0320
Language: en
Date: 2022-02-25 00:00:00
Title: Commission Implementing Regulation (EU) 2022/320 of 25 February 2022 concerning the authorisation of expressed mandarin essential oil as a feed additive for poultry, pigs, ruminants, horses, rabbits and salmonids (Text with EEA relevance)

28.2.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 55/41
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2022/320
         of 25 February 2022
         concerning the authorisation of expressed mandarin essential oil as a feed additive for poultry, pigs, ruminants, horses, rabbits and salmonids
         (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. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
                  
               
                     (2)
                  
                  
                     Mandarin essential oil was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
                  
               
                     (3)
                  
                  
                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of expressed mandarin essential oil for all animal species.
                  
               
                     (4)
                  
                  
                     The applicant requested expressed mandarin essential oil 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 expressed mandarin essential oil in water for drinking should not be allowed.
                  
               
                     (5)
                  
                  
                     The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (6)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (3) that, under the proposed conditions of use, expressed mandarin essential oil does not have adverse effects on animal health, consumer health or the environment. However, no conclusions could be drawn for companion animals and ornamental fish not normally exposed to citrus by-products. The Authority also concluded that expressed mandarin essential oil should be considered as a skin sensitiser and as an irritant to skin, eyes and the respiratory tract. 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.
                  
               
                     (7)
                  
                  
                     The Authority also concluded, that expressed mandarin essential oil is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. 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.
                  
               
                     (8)
                  
                  
                     The assessment of expressed mandarin essential oil shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the substance should be authorised as specified in the Annex to this Regulation.
                  
               
                     (9)
                  
                  
                     The fact that expressed mandarin essential oil 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)
                  
                  
                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
                  
               
                     (11)
                  
                  
                     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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as feed additive in animal nutrition, subject to the conditions laid down in that Annex.
         
         
            Article 2
            Transitional measures
            
               1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 20 September 2022 in accordance with the rules applicable before 20 March 2022 may continue to be placed on the market and used until the existing stocks are exhausted.
            
            
               2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 20 March 2023 in accordance with the rules applicable before 20 March 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
            
         
         
            Article 3
            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, 25 February 2022.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs
         (OJ L 270, 14.12.1970, p. 1).
         
            (3)  EFSA Journal 2021;19(6):6625.
      
      
         
            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
                        
                     
                  
                        2b142-eo
                     
                     
                        -
                     
                     
                        Expressed mandarin essential oil
                     
                     
                        
                           Additive composition
                        
                        Mandarin essential oil obtained from fruit peel of Citrus reticulata Blanco.
                        Liquid form
                        
                           Characterisation of the active substance
                        
                        Expressed mandarin essential oil obtained by cold expression from fruit peel of Citrus reticulata Blanco as defined by the Council of Europe (1).
                        d-Limonene: 65-80 %
                        γ-Terpinene: 13-22 %
                        α-Pinene (pin-2(3)-ene):
                        1-3,5 %
                        Myrcene:1-2 %
                        β-Pinene (pin-2(10)-ene):
                        1-2 %.
                        Methyl N-methyl anthranilate: 0,15-0,7 %
                        Perillaldehyde: ≤ 0,063 %
                        CAS number: 8008-31-9
                        FEMA number: 2657
                        CoE number: 142
                        
                           Analytical method
                            (2)
                        
                        For the quantification of phytochemical marker d-limonene in the feed additive or in mixture of flavouring compounds:
                        
                                    —
                                 
                                 
                                    Gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 3528)
                                 
                              
                     
                        Poultry
                        Rabbits
                        Salmonids
                     
                     
                        -
                     
                     
                        -
                     
                     
                        15
                     
                     
                        
                                    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.
                                 
                                 
                                    Mixture of expressed mandarin essential oil with other botanical additives is permitted provided that the amounts of perillaldehyde in feed materials and compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or animal category.
                                 
                              
                                    4.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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 skin, eye and breathing protection.
                                 
                              
                     
                        20 March 2032
                     
                  
                        Pigs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        33
                     
                  
                        Ruminants
                     
                     
                        -
                     
                     
                        -
                     
                     
                        30
                     
                  
                        Horses
                     
                     
                        -
                     
                     
                        -
                     
                     
                        40
                     
                  
               (1)  Natural sources of flavourings – Report No 2 (2007).
            
               (2)  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