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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. )

Commission Implementing Regulation (EU) 2018/244of 15 February 2018concerning 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(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 2016EFSA Journal 2016;14(8):4557. 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 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.(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 authorisation 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 1AuthorisationThe 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 2DenialThe 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 3Transitional measures1.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 4Entry into forceThis 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 CommissionThe PresidentJean-Claude JunckerANNEX

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.Category: Sensory additives. Functional group: Flavouring compounds

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg of active substance/kg of complete feedingstuff with a moisture content of 12 %		Other provisions	End of period of authorisation
2b07005	—	Vanillyl acetone	Additive compositionVanillyl acetoneCharacterisation of the active substanceVanillyl acetoneProduced by chemical synthesisPurity: min. 95 % assayChemical formula: C11H14O3CAS number: 122-48-5FLAVIS No: 07.005Method of analysisFor the determination of vanillyl acetone in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.	All animal species	—	—	—	1.The additive shall be incorporated into the feed in the form of a premixture.2.In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.6.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.	15.3.2028
2b07029	—	4-(4-Methoxyphenyl) butan-2-one	Additive composition4-(4-Methoxyphenyl) butan-2-oneCharacterisation of the active substance4-(4-Methoxyphenyl) butan-2-oneProduced by chemical synthesisPurity: min. 96 % assayChemical formula: C11H14O2CAS number 104-20-1FLAVIS No 07.029Method of analysisFor the determination of 4-(4-methoxyphenyl) butan-2-one in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.	All animal species	—	—	—	1.The additive shall be incorporated into the feed in the form of a premixture.2.In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.6.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.	15.3.2028