Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked to deliver a scientific opinion 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 asked to evaluate seven a,b-unsaturated substances in the Flavouring Group Evaluation 215 (FGE.215) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.
The present FGE.215, corresponding to subgroup 3.2 of FGE.19, concerns six cinnamyl ketones with the a,b-unsaturation in the side-chain [FL-no: 07.024, 07.027, 07.030, 07.046, 07.049 and 07.206] and one precursor [FL-no: 02.066] for such ketones.
he seven substances under consideration in FGE.215 are listed in Table 3.
The α,β-unsaturated ketone structure is a structural alert for genotoxicity and the data previously available did not rule out the concern for genotoxicity for these seven flavouring substances.
The Flavour Industry has now submitted in vitro data for two representative substances (4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]) which are going to cover the evaluation of the other five substances in this subgroup 3.2 of FGE.19.
The Panel has evaluated these data and concluded that the genotoxicity concern could not be ruled out. To further assess the genotoxic potential of both representative substances (4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]) of subgroup 3.2 of FGE.19, a combined in vivo micronucleus and Comet assays in liver and duodenum are requested.