Scientific Opinion on Flavouring Group Evaluation 82, Revision 1 (FGE.82Rev1): Consideration of Epoxides evaluated by the JECFA (65th meeting)

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of five epoxides evaluated by the JECFA at the 65th meeting in 2005. This revision is made due to inclusion of one additional substance, beta-ionone epoxide [FL-no: 07.170], cleared for genotoxicity concern and due to additional toxicity data have become available for beta-caryophyllene epoxide [FL-no: 16.043]. Since publication of FGE.82 one substance epoxy oxophorone [FL-no: 16.051] is no longer supported for use as flavouring substances in Europe by Industry and will therefore not be considered any further. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. For four substances [FL-no: 16.015, 16.018, 16.040 and 16.043] the Panel agreed with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For one substance [FL-no: 07.170] additional toxicity data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for four substances, the information is adequate; but for the substance [FL-no: 07.170] further information on stereoisomerism is required.