EFSA Journal (Apr 2023)

Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

  • EFSA Panel on Food Additives and Flavourings (FAF),
  • Maged Younes,
  • Gabriele Aquilina,
  • Laurence Castle,
  • Gisela Degen,
  • Karl‐Heinz Engel,
  • Paul J Fowler,
  • Maria José Frutos Fernandez,
  • Peter Fürst,
  • Ursula Gundert‐Remy,
  • Rainer Gürtler,
  • Trine Husøy,
  • Melania Manco,
  • Peter Moldeus,
  • Sabina Passamonti,
  • Romina Shah,
  • Ine Waalkens‐Berendsen,
  • Matthew Wright,
  • Romualdo Benigni,
  • Claudia Bolognesi,
  • Kevin Chipman,
  • Eugenia Cordelli,
  • Maria Carfì,
  • Wim Mennes

DOI
https://doi.org/10.2903/j.efsa.2023.7967
Journal volume & issue
Vol. 21, no. 4
pp. n/a – n/a

Abstract

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Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL‐no: 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL‐no: 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL‐no: 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL‐no: 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 10.057]. Consequently, it can be evaluated through the Procedure.

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