Commission Implementing Regulation (EU) 2023/605 of 9 March 2023 concerning the authorisation of ethyl oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/605of 9 March 2023concerning the authorisation of ethyl oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene 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 ethyl oleate, nona-2,6-dien-1-ol, pent-2-en-1-ol, trans-2,cis-6-nonadien-1-ol, 2-dodecenal, nona-2(trans),6(cis)-dienal, nona-2,4-dienal, trans-2-nonenal, 2,4-decadienal, hepta-2,4-dienal, deca-2(trans),4(trans)-dienal, dodec-2(trans)-enal, hept-2(trans)-enal, non-2-enal, nona-2(trans),6(trans)-dienal, undec-2(trans)-enal, trans-2-octenal, trans-2-decenal, tr-2, tr-4-nonadienal, tr-2, tr-4-undecadienal, hex-2(trans)-enyl acetate, hex-2-enyl butyrate, oct-1-en-3-one, isopulegol, 4-terpinenol, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, 3-methyl-2-cyclopenten-1-one, methyl 3-oxo-2-pentyl-1-cyclopentylacetate, benzophenone, benzyl cinnamate, ethyl salicylate, 1,2-dimethoxy-4-(prop-1-enyl)-benzene, myrcene and β-ocimene 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., 13 November 2012EFSA Journal 2012;10(11):2966., 12 March 2013EFSA Journal 2013;11(4):3169., 1 December 2015EFSA Journal 2016;14(1):4339., 20 April 2016EFSA Journal 2016;14(6):4475., 28 February 2019EFSA Journal 2019;17(3):5654., 10 January 2020EFSA Journal 2020;18(2):6002., 28 January 2020EFSA Journal 2020;18(2):6017. and 23 March 2022EFSA Journal 2022;20(4):7249. that, under the proposed conditions of use, the substances do not have adverse effects on animal health, consumer safety or the environment. In the absence of relevant studies, the Authority could not conclude on the safety for the users when handling the additives concerned, or concluded that the substances should be considered as irritants to skin and eyes and as potential skin and respiratory sensitisers.(6)The Authority 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. It also verified 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.(7)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. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.(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 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)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.(11)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: