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Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl‐Heinz; Fowler, Paul; Frutos Fernandez, Maria Jose; Fürst, Peter; Gundert‐Remy, Ursula; Gürtler, Rainer; Husøy, Trine; Moldeus, Peter; Oskarsson, Agneta; Shah, Romina; Waalkens‐Berendsen, Ine; Wölfle, Detlef; Benigni, Romualdo; Bolognesi, Claudia; Chipman, Kevin; Cordelli, Eugenia; Degen, Gisela; Marzin, Daniel; Svendsen, Camilla; Carfì, Maria; Vianello, Giorgia; Mennes, Wim
EFSA journal, January 2019, Letnik: 17, Številka: 1Journal Article
The Panel on Food Additives and Flavourings 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). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin FL‐no: 13.012 and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one FL‐no: 10.023 the concern for genotoxicity was ruled out. 6‐Methylcoumarin was evaluated using the Procedure in FGE.80Rev1. For 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one FL‐no: 10.023 and the structurally related substance 3‐hydroxy‐4,5‐dimethylfuran‐2(5H)‐one FL‐no: 10.030, no further EFSA considerations were needed because these substances were evaluated by JECFA before 2000. Also based on experimental data, in FGE217Rev1, the concern for genotoxicity could not be ruled out for furan‐2(5H)‐one FL‐no: 10.066 and 3,4‐dimethyl‐5‐pentylidenefuran‐2(5H)‐one FL‐no: 10.042, which later substance represents the following flavourings: FL‐no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170. In the current revision of this FGE (FGE217Rev2), based on the results of additional genotoxicity studies, the FAF Panel concluded that FL‐no: 10.066 is genotoxic in vivo. Therefore, furan‐2(5H)‐one FL‐no: 10.066 cannot be evaluated according to the Procedure. For FL‐no: 10.042 in order to rule out a concern for clastogenicity at site of first contact, the FAF Panel requests results from an in vivo comet assay in duodenum. In addition, FL‐no: 10.042 has also been identified as an aneugenic substance in vitro. Until the concern for clastogenicity at site of first contact for FL‐no: 10.042 and the concern for aneugenicity can be ruled out, this substance and FL‐no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170 cannot be evaluated through the Procedure.
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