Oskarsson, Agneta
- Department of Animal Biosciences, Swedish University of Agricultural Sciences
Research article2019Peer reviewedOpen access
Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl-Heinz; Fowler, Paul; Fernandez, Maria Jose Frutos; Furst, Peter; Gundert-Remy, Ursula; Gurtler, Rainer; Husoy, Trine; Moldeus, Peter; Oskarsson, Agneta; Shah, Romina; Waalkens-Berendsen, Ine; Wolfle, Detlef; Benigni, Romualdo; Bolognesi, Claudia; Chipman, Kevin; Cordelli, Eugenia; Degen, Gisela;
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The Panelon 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 Panelconcluded that [FL-no: 10.066] is genotoxic invivo. 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 Panelrequests results from an invivo comet assay in duodenum. In addition, [FL-no: 10.042] has also been identified as an aneugenic substance invitro. 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.
FGE; 217; alpha; beta-unsaturated ketones; lactones; flavouring substances; safety evaluation; Subgroup 4; 1; FGE; 19
EFSA Journal
2019, Volume: 17, number: 1, article number: 5568
Public Health, Global Health, Social Medicine and Epidemiology
DOI: https://doi.org/10.2903/j.efsa.2019.5568
https://res.slu.se/id/publ/104742