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 flavouring substances using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.
The Flavouring Group Evaluation 203 (FGE.203) concerned 17 substances, corresponding to subgroup 1.1.4 of FGE.19. Twelve of these substances are α,β-unsaturated aldehydes with two or more conjugated double-bonds with and without additional non-conjugated double-bonds [FL-no: 05.057, 05.064, 05.071, 05.084, 05.101, 05.108, 05.125, 05.127, 05.140, 05.141, 05.173 and 05.196] and five are precursors for such aldehydes [FL-no: 02.139, 02.153, 02.162, 02.188 and 09.573]. Since FGE.203 was published, three additional substances have been included in the subgroup 1.1.4 of FGE.19 (2,4-decadienal [FL-no: 05.081], 2,4-octadienal [FL-no: 05.186] and tr-2, tr-4-nonadienal [FL-no: 05.194]), accordingly the present FGE concerns the genotoxicity evaluation of 20 flavouring substances.
New data on the representative substance 2,4-decadienal [FL-no: 05.140] and literature data on the representative substance hexa-2(trans),4(trans)-dienal [FL-no: 05.057] which have been submitted by Industry were considered in this revision of FGE.203, i.e. FGE.203Rev1.
On the basis of the genotoxicity data of 2,4-decadienal showing some indication for genotoxicity in vivo and considering the evidence from in vitro studies for the induction of different types of DNA damage (oxidised DNA bases and bulky adducts) a non-threshold mechanism of genotoxicity cannot be excluded for 2,4-decadienal.
Based on the evidence from publications reporting the induction of DNA adducts in different systems in vitro and in vivo and of the IARC classification of 2,4-hexadienal as “possible carcinogen to humans” and considering the conclusion drawn by IARC that “mechanistic data provide additional support for the relevance of the animal carcinogenicity data to humans” and that “there is a moderate evidence that tumour induction occurs via a genotoxic mechanism” the Panel confirms the safety concern for 2,4-hexadienal.
Overall, the Panel considered that a non-threshold mechanism of action cannot be excluded for both representative substances based on the data available and the Panel concluded that the safety concern cannot be ruled out for hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and for 2,4-decadienal [FL-no: 05.140]. This conclusion is likewise applicable to the other substances of this FGE.
Therefore, the substances of this FGE cannot be evaluated through the Procedure.