Résumé
The European Food Safety Authority (EFSA) asked the Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.
The present Flavouring Group Evaluation 206 (FGE.206), corresponding to subgroup 1.2.3 of FGE.19, concerns seven aliphatic ketones and five precursors for such ketones. The 12 substances under consideration in the present evaluation are alpha,beta-unsaturated ketone structures or can be metabolised to such, which are considered to be structural alerts for genotoxicity and the data on genotoxicity previously available did not rule out the concern for genotoxicity.
The Panel has identified two substances in subgroup 1.2.3 which will represent the other 10 substances in this subgroup. For these two substances, genotoxicity data according to the test strategy worked out by the Panel have been requested.
The Industry has submitted data concerning genotoxicity studies for the two representative substances for this subgroup.
6-Methylhepta-3,5-dien-2-one [FL-no: 07.0991 and pseudo-ionone [FL-no: 07.1981 has been tested for all three genetic endpoints, gene mutations, structural and numerical chromosomal aberrations. The test compounds did not induce gene mutations in bacteria and were not clastogenic and/or aneugenic in mammalian cells in vitro.
The Panel concluded that the in vitro genotoxicity data on these two representative substances do not indicate genotoxic potential. Accordingly, all 12 substances in FGE.19 subgroup 1.2.3 are not considered to be of concern with respect to genotoxicity and will then be evaluated through the Procedure. (C) European Food Safety Authority, 2011