Commission Implementing Regulation (EU) 2023/1417 of 5 July 2023 concerning the authorisation of butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate, 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, 5-methylhept-2-en-4-one, dodecano-1,5-lactone, tetradecano-1,5-lactone, 5-methylfurfural, 4-phenylbut-3-en-2-one, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/1417of 5 July 2023concerning the authorisation of butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate, 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, 5-methylhept-2-en-4-one, dodecano-1,5-lactone, tetradecano-1,5-lactone, 5-methylfurfural, 4-phenylbut-3-en-2-one, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether 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 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(2) 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 butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate, 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, 5-methylhept-2-en-4-one, dodecano-1,5-lactone, tetradecano-1,5-lactone, 5-methylfurfural, 4-phenylbut-3-en-2-one, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether were authorised without a time limit in accordance with 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 belonging to the functional group of flavouring compounds, in accordance with Article 10(1), point (b), 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, several applications were submitted for the authorisation of the above-mentioned substances as feed additives for all animal species. The applicant requested the additives to be classified in the additive category "sensory additives" and in the functional group "flavouring compounds". The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of "flavouring compounds" for use in water for drinking. Therefore, the applicant withdrew the application for water for drinking for all the substances concerned.(5)The European Food Safety Authority ("the Authority") concluded in its opinions of 25 April 2012EFSA Journal 2012;10(5):2678., 13 June 2012EFSA Journal 2012;10(7):2785., 26 October 2012EFSA Journal 2012;10(10):2928., 12 March 2013EFSA Journal 2013;11(4):3169., 20 October 2015EFSA Journal 2015;13(11):4268., 26 January 2016EFSA Journal 2016;14(2):4389., 25 May 2016EFSA Journal 2016;14(6):4512., 10 January 2020EFSA Journal 2020;18(2):6002., 28 January 2020EFSA Journal 2020;18(2):6017. and 7 January 2023EFSA Journal 2023;21(1):7713. that, under the proposed conditions of use, the substances concerned are safe for all animal species, consumers and the environment.(6)The Authority also indicated that the safety data sheets required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilRegulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). demonstrate that for butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate and 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, for dodecano-1,5-lactone, tetradecano-1,5-lactone, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether some hazards are identified for skin and eye contact and respiratory exposure. As regards 5-methylhept-2-en-4-one, 5-methylfurfural and 4-phenylbut-3-en-2-one, the Authority concluded that due to the lack of new evidence on the effects of those additives on the respiratory system, skin and eyes it is not in a position to conclude on the safety for the use of those three substances.(7)The Authority finally concluded that all the substances concerned are recognised to flavour food and their function in feed would be essentially the same as that in food. Therefore, no further demonstration of efficacy is considered necessary. The Authority considered that there was no need for specific requirements of post-market monitoring. It also checked the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(8)Certain conditions should be provided for to allow better control. In particular, a recommended maximum content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.(9)The fact that the substances concerned are not authorised for use as flavourings in water for drinking does not preclude their use in compound feed which is administered via water.(10)The assessment of all 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. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.(11)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(12)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: