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

23.2.2018 EN Official Journal of the European Union L 53/81 COMMISSION IMPLEMENTING REGULATION (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re- evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (2) The substances vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol 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 vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol as feed additives for all animal a species. The applicant requested that 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 12 July 2016 (3) that, under the proposed conditions of use, vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one do not have adverse effects on animal health, human health or the environment. The Authority could not conclude on the safety of 1-phenylethan-1-ol in the terrestrial compartment. The Authority has concluded that, since vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one 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 was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one within compound feeds which are subsequently administered via water. (5) Restrictions and conditions should be provided to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed. (6) The Authority noted that, vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one should be recognised as hazardous to the respiratory tract, skin and eyes and also 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. (7) The assessment of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one shows that the conditions for authoris­ ation, 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. (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2016;14(8):4557.L 53/82 EN Official Journal of the European Union 23.2.2018 (8) The assessment of 1-phenylethan-1-ol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied. The Authority could not conclude on the safety of 1-phenylethan-1-ol for the terrestrial compartment, as no experimental data was provided by the applicant and therefore application of the Ecological Structure Activity Relationships (ECOSAR) Predictive Model was not able to provide the needed parameters. (9) Since safety reasons do not require the immediate application of the modifications to the conditions of authoris­ ation for vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation and denial. (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 Denial The authorisation of 1-phenylethan-1-ol, as additive belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is denied. Article 3 Transitional measures 1. Vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted. 2. Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3. Feed materials and compound feed containing vanillyl acetone, 4-(4-methoxyphenyl) butan-2-one and 1-phenylethan-1-ol which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals. Article 4 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.23.2.2018 EN Official Journal of the European Union L 53/83 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 JUNCKERANNEX Minimum Maximum content content Identifica­ Name of End of pe­ Species or tion the holder Composition, chemical formula, Maximum riod Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b07005 — Vanillyl acet­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 one species into the feed in the form of a pre­ Vanillyl acetone mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Vanillyl acetone and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 95 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 11 14 3 CAS number: 122-48-5 with a moisture content of 12 %. FLAVIS No: 07.005 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of vanillyl of the active substance of complete acetone in the feed additive and in feedingstuff with a moisture content feed flavouring premixtures: of 12 %: 5 mg/kg.’ Gas chromatography mass spec­ 5. The functional group, the identifica­ trometry with retention time lock­ tion number, the name and the ing GC-MS-RTL. added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. L 53/84 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of pe­ Species or tion the holder Composition, chemical formula, Maximum riod Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b07029 — 4-(4-Methoxy­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 phenyl) bu­ species into the feed in the form of a pre­ 4-(4-Methoxyphenyl) butan-2-one tan-2-one mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 4-(4-Methoxyphenyl) butan-2-one and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 96 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 11 14 2 CAS number 104-20-1 with a moisture content of 12 %. FLAVIS No 07.029 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of 4-(4- of the active substance of complete methoxyphenyl) butan-2-one in feedingstuff with a moisture content the feed additive and in feed fla­ of 12 %: 5 mg/kg.’ vouring premixtures: Gas chromatography mass spec­ trometry with retention time lock­ ing GC-MS-RTL. 23.2.2018 EN Official Journal of the European Union L 53/85Minimum Maximum content content Identifica­ Name of End of pe­ Species or tion the holder Composition, chemical formula, Maximum riod Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age of authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. (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. L 53/86 EN Official Journal of the European Union 23.2.2018