CELEX: 32019R1977
Language: en
Date: 2019-11-26 00:00:00
Title: Commission Implementing Regulation (EU) 2019/1977 of 26 November 2019 concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs (Text with EEA relevance)

29.11.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 308/45
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1977
         of 26 November 2019
         concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs
         (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)
                  
                  
                     Phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone (‘the substances concerned’) were authorised as feed additives for cats and dogs without a time limit in accordance with Directive 70/524/EEC. Those feed additives 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 for cats and dogs, requesting those feed additives to be classified in the additive category ‛sensory additives’. The 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 27 February 2019 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health or the environment. It also concluded that hazards for users have been identified. The applicant as required produced a safety data sheet for each compound where hazards for users have been identified. No studies to assess the safety for the user were submitted. Therefore, the EFSA cannot conclude on the safety for the users when handling the additives. The hazards described in the safety data sheet are, in particular, hazards for skin and eye contact were recognised for 2,5-dimethylphenol, 12-methyltridecanal, hexa-2(trans),4(trans)-dienal, phenylmethanethiol, benzyl methyl sulfide, 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone and sec-pentylthiophene. Hazard for respiratory exposure was recognised for 12-methyltridecanal, benzyl methyl sulfide and 2-pentylthiophene. In the absence of data, the Authority could not conclude on the risk for the users. Therefore, the Commission considers that appropriate protective measures should be taken to prevent effects on human health, in particular as regards the users of the feed additive. For non-food-producing animals Commission Regulation (EC) No 429/2008 (4), exempted additives intended for those animals from the environmental assessment as they do not have a significant environmental effect. Pets are not raised in large groups of animals so their effect on the environment is considered not significant. The Authority further concluded that since the substances concerned are used in food as flavourings and their function in feed is the same as that in food, no further demonstration of efficacy in feed is necessary.
                  
               
                     (5)
                  
                  
                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
                  
               
                     (6)
                  
                  
                     Restrictions and conditions should be provided for to allow for a better control. For the substances concerned recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures. and in the labelling compound feeds and feed materials.
                  
               
                     (7)
                  
                  
                     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 for the use in feed. Accordingly, the use of those feed additives should be authorised as specified in the Annex to this Regulation.
                  
               
                     (8)
                  
                  
                     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.
                  
               
                     (9)
                  
                  
                     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 the Annex.
         
         
            Article 2
            Transitional Measures
            
               1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 19 December 2019 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until 19 June 2020.
            
            
               2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 19 December 2021 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for cats and dogs.
            
         
         
            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, 26 November 2019.
            
               
                  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 2019;17(3):5649.
         
            (4)  Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).
      
      
         
            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
                        
                     
                  
                        2b5169
                     
                     
                        -
                     
                     
                        12-Methyltridecanal
                     
                     
                        
                           Additive composition:
                        
                        12-Methyltridecanal
                        
                           Characterisation of the active substance:
                        
                        12-Methyltridecanal
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C14H28O
                        CAS number: 75853-49-5
                        FLAVIS: 05.169
                        
                           Method of analysis
                            (1):
                        For the determination of
                        12-methyltridecanal
                        in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 0,5 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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b5057
                     
                     
                        -
                     
                     
                        Hexa-2(trans),4(trans)-dienal
                     
                     
                        
                           Additive composition:
                        
                        Hexa-2(trans),4(trans)-dienal
                        
                           Characterisation of the active substance:
                        
                        Hexa-2(trans),4(trans)-dienal
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C6H8O
                        CAS number: 142-83-6
                        FLAVIS: 05.057
                        
                           Method of analysis
                            (1):
                        For the determination of hexa-2(trans),4(trans)-dienal in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 1,5 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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 1,5 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b5078
                     
                     
                        -
                     
                     
                        Tridec-2-enal
                     
                     
                        
                           Additive composition:
                        
                        Tridec-2-enal
                        
                           Characterisation of the active substance:
                        
                        Tridec-2-enal
                        Produced by chemical synthesis
                        Purity: min. 92 %
                        Chemical formula: C13H24O
                        CAS number: 7774-82-5
                        FLAVIS: 05.078
                        
                           Method of analysis
                            (1):
                        For the determination of tridec-2-enal in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 0,5 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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b13084
                     
                     
                         
                     
                     
                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone
                     
                     
                        
                           Additive composition:
                        
                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone
                        
                           Characterisation of the active substance:
                        
                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C7H10O3
                        
                        CAS number: 27538-09-6
                        FLAVIS: 13.084
                        
                           Method of analysis
                            (1):
                        For the determination of
                        2-ethyl-4-hydroxy-5-methyl-3 (2H)-furanone in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                         
                     
                     
                         
                     
                     
                         
                     
                     
                        
                                    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, 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 %: 2,25 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: 2,25 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b12005
                     
                     
                        -
                     
                     
                        Phenylmethanethiol
                     
                     
                        
                           Additive composition:
                        
                        Phenylmethanethiol
                        
                           Characterisation of the active substance:
                        
                        Phenylmethanethiol
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C7H8S
                        CAS number: 100-53-8
                        FLAVIS: 12.005
                        
                           Method of analysis
                            (1):
                        For the determination of phenylmethanethiol in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 0,05 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: 0,05 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b12077
                     
                     
                        -
                     
                     
                        Benzyl methyl sulfide
                     
                     
                        
                           Additive composition:
                        
                        Benzyl methyl sulfide
                        
                           Characterisation of the active substance:
                        
                        Benzyl methyl sulfide
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C8H10S
                        CAS number: 766-92-7
                        FLAVIS: 12.077
                        
                           Method of analysis
                            (1):
                        For the determination of benzyl methyl sulfide in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 0,05 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: 0,05 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b4019
                     
                     
                        -
                     
                     
                        2,5-Dimethylphenol
                     
                     
                        
                           Additive composition:
                        
                        2,5-Dimethylphenol
                        
                           Characterisation of the active substance:
                        
                        2,5-Dimethylphenol
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C8H10O
                        CAS number: 95-87-4
                        FLAVIS: 04.019
                        
                           Method of analysis
                            (1):
                        For the determination of
                        2,5-dimethylphenol in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 1 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
                        2b15096
                     
                     
                        -
                     
                     
                        sec-Pentylthiophene
                     
                     
                        
                           Additive composition:
                        
                        sec-Pentylthiophene
                        
                           Characterisation of the active substance:
                        
                        sec-Pentylthiophene
                        Produced by chemical synthesis
                        Purity: min. 98 %
                        Chemical formula: C9H14S
                        CAS number: 4861-58-9
                        FLAVIS: 15.096
                        
                           Method of analysis
                            (1):
                        For the determination of sec-
                        -pentylthiophene in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.
                     
                     
                        Cats and dogs
                     
                     
                        -
                     
                     
                        -
                     
                     
                        -
                     
                     
                        
                                    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, 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 %: 0,1 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 premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,1 mg/kg.
                                 
                              
                                    5.
                                 
                                 
                                    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.
                                 
                              
                     
                        19.12.2029
                     
                  
               (1)  Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.