FEMA GRAS assessment of derivatives of basil, nutmeg, parsley, tarragon and related allylalkoxybenzene-containing natural flavor complexes
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a program for the re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavoring ingredients in food. In this publication, ninth in the series, NFCs containing a high percentage of least one naturally occurring allylalkoxybenzene constituent with a suspected concern for genotoxicity and/or carcinogenicity are evaluated. In a related paper, tenth in the series, NFCs containing anethole and/or eugenol and relatively low percentages of these allylalkoxybenzenes are evaluated. The Panel applies the threshold of toxicological concern (TTC) concept and evaluates relevant toxicology data on the NFCs and their respective constituent congeneric groups. For NFCs containing allylalkoxybenzene constituent(s), the estimated intake of the constituent is compared to the TTC for compounds with structural alerts for genotoxicity and when exceeded, a margin of exposure (MOE) is calculated. BMDL10 values are derived from benchmark dose analyses using Bayesian model averaging for safrole, estragole and methyl eugenol using EPA's BMDS software version 3.2. BMDL10 values for myristicin, elemicin and parsley apiole were estimated by read-across using relative potency factors. Margins of safety for each constituent congeneric group and MOEs for each allylalkoxybenzene constituent for each NFC were determined that indicate no safety concern. The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food. Ten NFCs, derived from basil, estragon (tarragon), mace, nutmeg, parsley and Canadian snakeroot were determined or affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients based on an evaluation of each NFC and the constituents and congeneric groups therein.
Date Issued
2023-05
Date Acceptance
2023-01-30
Citation
Food and Chemical Toxicology, 2023, 175, pp.113646-113646
ISSN
0278-6915
Publisher
Elsevier
Start Page
113646
End Page
113646
Journal / Book Title
Food and Chemical Toxicology
Volume
175
Copyright Statement
© 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND licence
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/36804339
PII: S0278-6915(23)00048-0
Publication Status
Published
Coverage Spatial
England
Article Number
113646
Date Publish Online
2023-02-17