CELEX: 32018R0245
Language: en
Date: 2018-02-15 00:00:00
Title: Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (Text with EEA relevance. )

23.2.2018   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 53/87
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2018/245
      of 15 February 2018
      concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives 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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
               
            
                  (2)
               
               
                  The substances menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) 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 the substances concerned as feed additives for all animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 April 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for the use of the substances concerned in water for drinking.
               
            
                  (5)
               
               
                  The Authority further noted that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
               
            
                  (6)
               
               
                  The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.
               
            
                  (7)
               
               
                  The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.
               
            
                  (8)
               
               
                  The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their use in compound feed which is administered via water.
               
            
                  (9)
               
               
                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
               
            
                  (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
      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
      Transitional measures
      1.   The substances specified in the Annex 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 the substances as specified in the Annex 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 the substances as specified in the Annex 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 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, 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(6):4475.
      
         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
                     
                  
               
                     2b02015
                  
                  
                     —
                  
                  
                     Menthol
                  
                  
                     
                        Additive composition
                     
                     Menthol
                     
                        Characterisation of the active substance
                     
                     Menthol
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C10H20O
                     CAS number: 89-78-1
                     FLAVIS No: 02.015
                     
                        Method of analysis
                         (1)
                     
                     For the determination of menthol 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.
                              
                              
                                 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 premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 25 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
                  
               
                     2b07146
                  
                  
                     —
                  
                  
                     d-Carvone
                  
                  
                     
                        Additive composition
                     
                     d-Carvone
                     
                        Characterisation of the active substance
                     
                     d-Carvone
                     Produced by chemical synthesis
                     Purity: min. 95 % assay
                     Chemical formula: C10H14O
                     CAS number: 2244-16-8
                     FLAVIS No: 07.146
                     
                        Method of analysis
                         (1)
                     
                     For the determination of d-carvone 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.
                              
                              
                                 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.’
                              
                           
                                 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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the 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
                  
               
                     2b09016
                  
                  
                     —
                  
                  
                     Menthyl acetate
                  
                  
                     
                        Additive composition
                     
                     Menthyl acetate
                     
                        Characterisation of the active substance
                     
                     Menthyl acetate
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C12H22O2
                     
                     CAS number: 29066-34-0
                     FLAVIS No: 09.016
                     
                        Method of analysis
                         (1)
                     
                     For the determination of menthyl acetate 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.
                              
                              
                                 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.’
                              
                           
                                 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 suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the 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
                  
               
                     2b07078
                  
                  
                     —
                  
                  
                     d,l-Isomenthone
                  
                  
                     
                        Additive composition
                     
                     d,l-Isomenthone
                     
                        Characterisation of the active substance
                     
                     d,l-Isomenthone
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C10H18O
                     CAS number: 491-07-6
                     FLAVIS No: 07.078
                     
                        Method of analysis
                         (1)
                     
                     For the determination of d,l-isomenthone 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.
                              
                              
                                 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 %:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories.’
                                          
                                       
                           
                                 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories
                                          
                                       
                           
                                 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
                  
               
                     2b07094
                  
                  
                     —
                  
                  
                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
                  
                  
                     
                        Additive composition
                     
                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
                     
                        Characterisation of the active substance
                     
                     3-Methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C11H16O
                     CAS number: 488-10-8
                     FLAVIS No: 07.094
                     
                        Method of analysis
                         (1)
                     
                     For the determination of 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-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.
                              
                              
                                 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 %:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories.’
                                          
                                       
                           
                                 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories.
                                          
                                       
                           
                                 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
                  
               
                     2b07126
                  
                  
                     —
                  
                  
                     3,5,5-Trimethylcyclohex-2-en-1-one
                  
                  
                     
                        Additive composition
                     
                     3,5,5-Trimethylcyclohex-2-en-1-one
                     
                        Characterisation of the active substance
                     
                     3,5,5-Trimethylcyclohex-2-en-1-one
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C9H14O
                     CAS number: 78-59-1
                     FLAVIS No: 07.126
                     
                        Method of analysis
                         (1)
                     
                     For the determination of 3,5,5-trimethylcyclohex-2-en-1-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.
                              
                              
                                 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 %:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories.’
                                          
                                       
                           
                                 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3.
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories
                                          
                                       
                           
                                 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 glove.
                              
                           
                  
                     15.3.2028
                  
               
                     2b07159
                  
                  
                     —
                  
                  
                     d-Fenchone
                  
                  
                     
                        Additive composition
                     
                     d-Fenchone
                     
                        Characterisation of the active substance
                     
                     d-Fenchone
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C10H16O
                     CAS number: 4695-62-9
                     FLAVIS No: 07.159
                     
                        Method of analysis
                         (1)
                     
                     For the determination of d-fenchone 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.
                              
                              
                                 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 %:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories.’
                                          
                                       
                           
                                 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 suggested on the label of the premixture would result in exceeding the levels referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds:
                                 
                                             —
                                          
                                          
                                             0,3 mg/kg for pigs and poultry;
                                          
                                       
                                             —
                                          
                                          
                                             0,5 mg/kg for other species and categories
                                          
                                       
                           
                                 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
                  
               
                     2b02038
                  
                  
                     —
                  
                  
                     Fenchyl alcohol
                  
                  
                     
                        Additive composition
                     
                     Fenchyl alcohol
                     
                        Characterisation of the active substance
                     
                     Fenchyl alcohol
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C10H18O
                     CAS number: 1632-73-1
                     FLAVIS No: 02.038
                     
                        Method of analysis
                         (1)
                     
                     For the determination of fenchyl alcohol 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.
                              
                              
                                 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 %: 1 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 premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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
                  
               
                     2b09215
                  
                  
                     —
                  
                  
                     Carvyl acetate
                  
                  
                     
                        Additive composition
                     
                     Carvyl acetate
                     
                        Characterisation of the active substance
                     
                     Carvyl acetate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C12H18O2
                     
                     CAS number: 97-42-7
                     FLAVIS No: 09.215
                     
                        Method of analysis
                         (1)
                     
                     For the determination of carvyl acetate 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.
                              
                              
                                 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 %: 1 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 premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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
                  
               
                     2b09216
                  
                  
                     —
                  
                  
                     Dihydrocarvyl acetate
                  
                  
                     
                        Additive composition
                     
                     Dihydrocarvyl acetate
                     
                        Characterisation of the active substance
                     
                     Dihydrocarvyl acetate
                     Produced by chemical synthesis
                     Purity: min. 97 % assay
                     Chemical formula: C12H20O2
                     
                     CAS number: 20777-49-5
                     FLAVIS No: 09.216
                     
                        Method of analysis
                         (1)
                     
                     For the determination of dihydrocarvyl acetate 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.
                              
                              
                                 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 %: 1 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 premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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
                  
               
                     2b09269
                  
                  
                     —
                  
                  
                     Fenchyl acetate
                  
                  
                     
                        Additive composition
                     
                     Fenchyl acetate
                     
                        Characterisation of the active substance
                     
                     Fenchyl acetate
                     Produced by chemical synthesis
                     Purity: min. 98 % assay
                     Chemical formula: C12H20O2
                     
                     CAS number: 13851-11-1
                     FLAVIS No: 09.269
                     
                        Method of analysis
                         (1)
                     
                     For the determination of fenchyl acetate 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.
                              
                              
                                 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 %: 1 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 premixture where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 1 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