TY - JOUR
T1 - FEMA GRAS assessment of natural flavor complexes
T2 - Allspice, anise, fennel-derived and related flavoring ingredients
AU - Rietjens, Ivonne M.C.M.
AU - Cohen, Samuel M.
AU - Eisenbrand, Gerhard
AU - Fukushima, Shoji
AU - Gooderham, Nigel J.
AU - Guengerich, F. Peter
AU - Hecht, Stephen S.
AU - Rosol, Thomas J.
AU - Davidsen, Jeanne M.
AU - Harman, Christie L.
AU - Taylor, Sean V.
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - The FEMA Expert Panel program to re-evaluate the safety of natural flavor complexes (NFCs) used as flavoring ingredients in food has resulted in the publication of an updated constituent-based procedure as well as publications on the safety evaluation of many botanical-derived NFCs. This publication, ninth in the series and related to the ninth publication, describes the affirmation of the generally recognized as safe (GRAS) status for NFCs with propenylhydroxybenzene and allylalkoxybenzene constituents under their conditions of intended use as flavoring ingredients added to food. The Panel's procedure applies the threshold of toxicological concern (TTC) concept and evaluates relevant data on absorption, metabolism, genotoxic potential and toxicology for the NFCs themselves and their respective constituent congeneric groups. For NFCs containing allylalkoxybenzene constituent(s) with suspected genotoxic potential, the estimated intake of the individual constituent is compared to the TTC for compounds with structural alerts for genotoxicity and if exceeded, a margin of exposure is calculated using BMDL10 values derived from benchmark dose analyses using Bayesian model averaging, as presented in the tenth article of the series. Safety evaluations for NFCs derived from allspice, anise seed, star anise, sweet fennel seed and pimento leaves were conducted and their GRAS status was affirmed for use as flavoring ingredients. The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food.
AB - The FEMA Expert Panel program to re-evaluate the safety of natural flavor complexes (NFCs) used as flavoring ingredients in food has resulted in the publication of an updated constituent-based procedure as well as publications on the safety evaluation of many botanical-derived NFCs. This publication, ninth in the series and related to the ninth publication, describes the affirmation of the generally recognized as safe (GRAS) status for NFCs with propenylhydroxybenzene and allylalkoxybenzene constituents under their conditions of intended use as flavoring ingredients added to food. The Panel's procedure applies the threshold of toxicological concern (TTC) concept and evaluates relevant data on absorption, metabolism, genotoxic potential and toxicology for the NFCs themselves and their respective constituent congeneric groups. For NFCs containing allylalkoxybenzene constituent(s) with suspected genotoxic potential, the estimated intake of the individual constituent is compared to the TTC for compounds with structural alerts for genotoxicity and if exceeded, a margin of exposure is calculated using BMDL10 values derived from benchmark dose analyses using Bayesian model averaging, as presented in the tenth article of the series. Safety evaluations for NFCs derived from allspice, anise seed, star anise, sweet fennel seed and pimento leaves were conducted and their GRAS status was affirmed for use as flavoring ingredients. The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food.
KW - Essential oils and oleoresins
KW - GRAS
KW - Natural flavor complex
KW - Propenylbenzene constituents
KW - Safety evaluation
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U2 - 10.1016/j.fct.2023.113643
DO - 10.1016/j.fct.2023.113643
M3 - Article
C2 - 36739890
AN - SCOPUS:85148340403
SN - 0278-6915
VL - 174
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 113643
ER -