Following a request from the European Commission the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) 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 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 208 (FGE.208), corresponding to subgroup 2.2 of FGE.19, concerns three alicyclic aldehydes with the α,β-unsaturation in ring / side-chain and seven precursors for such. The α,β-unsaturated aldehyde structure, which is a structural alerts for genotoxicity and the data on genotoxicity previously available for these 10 substances, did not rule out the concern for genotoxicity.
The Panel identified one flavouring substance, p-mentha-1,8-dien-7-al [FL-no: 05.117], among the 10 substances in the present FGE.19 subgroup 2.2, for which appropriate genotoxicity data could be used for reading across to the other substances in the subgroup; therefore genotoxicity data have been requested for p-mentha-1,8-dien-7-al [FL-no: 05.117] according to the test strategy worked out by the Panel.
The Flavour Industry has provided additional genotoxicity data for p-mentha-1,8-dien-7-al [FL-no: 05.117].
Based on the presently available data, the Panel concluded that some concern for the genotoxic potential of p-mentha-1,8-dien-7-al [FL-no: 05.117] remains. In order to clarify the genotoxic potential of this substance, the Panel considered that further in vivo testing should be performed. To address this, an in vivo Comet assay, considering the first site of contact (e.g. stomach or duodenum) and liver, should be carried out according to the Scientific Report of EFSA on Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports.