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Scientific Opinion on Flavouring Group Evaluation 217, Revision 1 (FGE.217Rev1). Consideration of genotoxic potential for α,β-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: Lactones

on the Wiley Online Library


Panel members at the time of adoption

Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Poças, Fidel Toldra and Detlef Wölfle


The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). In FGE.217, 6-methylcoumarin [FL-no: 13.012] was not considered genotoxic and was therefore evaluated through the Procedure in FGE.80Rev1. For the remaining 11 substances, the Panel concluded that based on the data available, a genotoxic potential could not be excluded and accordingly they could not be evaluated through the Procedure. Additional data on genotoxicity for the three representative substances, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023], 3,4-dimethyl-5-pentylidenefuran-2(5H)-one [FL-no: 10.042] and furan-2(5H)-one [FL-no: 10.066], have now been provided. Based on the new data, the Panel concluded that 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023] does not give rise to concern with respect to genotoxicity and can accordingly, together with the structurally related substance, 3-hydroxy-4,5-dimethylfuran-2(5H)-one [FL-no: 10.030] for which it is a representative, be evaluated using the Procedure. For 3,4-dimethyl-5-pentylidenefuran-2(5H)-one [FL-no: 10.042] and furan-2(5H)-one [FL-no: 10.066] the concern for genotoxicity could not be ruled out and a combined micronucleus and Comet assay is requested for these two substances, covering the remaining seven substances [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057 and 10.060].

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