CELEX: 32018R0244
Language: en
Date: 2018-02-15 00:00:00
Title: Commission Implementing Regulation (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol (Text with EEA relevance. )

23.2.2018   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 53/81
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2018/244
      of 15 February 2018
      concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol
      (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
               
            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Denial
      The authorisation of 1-phenylethan-1-ol, as additive belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is denied.
      Article 3
      Transitional measures
      1.   Vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 4
      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, 15 February 2018.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (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 2016;14(8):4557.
      
         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
                     
                  
               
                     2b07005
                  
                  
                     —
                  
                  
                     Vanillyl acetone
                  
                  
                     
                        Additive composition
                     
                     Vanillyl acetone
                     
                        Characterisation of the active substance
                     
                     Vanillyl acetone
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C11H14O3
                     
                     CAS number: 122-48-5
                     FLAVIS No: 07.005
                     
                        Method of analysis
                         (1)
                     
                     For the determination of vanillyl acetone in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                  
                  
                     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 and stability conditions shall be indicated.
                              
                           
                                 3.
                              
                              
                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
                              
                           
                                 4.
                              
                              
                                 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 %: 5 mg/kg.’
                              
                           
                                 5.
                              
                              
                                 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 and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.
                              
                           
                                 6.
                              
                              
                                 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 breathing protection, safety glasses and gloves.
                              
                           
                  
                     15.3.2028
                  
               
                     2b07029
                  
                  
                     —
                  
                  
                     4-(4-Methoxyphenyl) butan-2-one
                  
                  
                     
                        Additive composition
                     
                     4-(4-Methoxyphenyl) butan-2-one
                     
                        Characterisation of the active substance
                     
                     4-(4-Methoxyphenyl) butan-2-one
                     Produced by chemical synthesis
                     Purity: min. 96 % assay
                     Chemical formula: C11H14O2
                     
                     CAS number 104-20-1
                     FLAVIS No 07.029
                     
                        Method of analysis
                         (1)
                     
                     For the determination of 4-(4-methoxyphenyl) butan-2-one in the feed additive and in feed flavouring premixtures:
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                  
                  
                     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 and stability conditions shall be indicated.
                              
                           
                                 3.
                              
                              
                                 The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.
                              
                           
                                 4.
                              
                              
                                 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 %: 5 mg/kg.’
                              
                           
                                 5.
                              
                              
                                 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 and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.
                              
                           
                                 6.
                              
                              
                                 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 breathing protection, safety glasses and gloves.
                              
                           
                  
                     15.3.2028
                  
               
            (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.