Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19

The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p-mentha-1,8-dien-7-al [FL-no: 05.117], which was found to be genotoxic in vivo. The Panel concluded that there was a potential safety concern for the nine substances in this FGE that were all represented by [FL-no: 05.177]. Consequently, substance [FL-no: 05.117], as well as four substances ([FL-no: 05.121, 09.272, 09.899 and 09.900]), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panel assessed genotoxicity studies submitted on five flavouring substances [FL-no: 02.060, 02.091, 05.106, 09.278 and 09.302] and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal [FL-no: 05.106] for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined in vivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panel concluded that the concern for genotoxicity could be ruled out for myrtenal [FL-no: 05.106]. Subsequently, this substance can be evaluated through the Procedure.