FEMA GRAS assessment of natural flavor complexes: Allspice, anise, fennel-derived and related flavoring ingredients. 2023

Ivonne M C M Rietjens, and Samuel M Cohen, and Gerhard Eisenbrand, and Shoji Fukushima, and Nigel J Gooderham, and F Peter Guengerich, and Stephen S Hecht, and Thomas J Rosol, and Jeanne M Davidsen, and Christie L Harman, and Sean V Taylor
Division of Toxicology, Wageningen University, Stippeneng 6708 WE, Wageningen, the Netherlands.

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.

UI MeSH Term Description Entries
D005421 Flavoring Agents Substances added to foods and medicine to improve the taste. Flavor Additives,Flavor Enhancers,Additive, Flavor,Additives, Flavor,Agent, Flavoring,Agents, Flavoring,Enhancer, Flavor,Enhancers, Flavor,Flavor Additive,Flavor Enhancer,Flavoring Agent
D001499 Bayes Theorem A theorem in probability theory named for Thomas Bayes (1702-1761). In epidemiology, it is used to obtain the probability of disease in a group of people with some characteristic on the basis of the overall rate of that disease and of the likelihood of that characteristic in healthy and diseased individuals. The most familiar application is in clinical decision analysis where it is used for estimating the probability of a particular diagnosis given the appearance of some symptoms or test result. Bayesian Analysis,Bayesian Estimation,Bayesian Forecast,Bayesian Method,Bayesian Prediction,Analysis, Bayesian,Bayesian Approach,Approach, Bayesian,Approachs, Bayesian,Bayesian Approachs,Estimation, Bayesian,Forecast, Bayesian,Method, Bayesian,Prediction, Bayesian,Theorem, Bayes
D018675 Toxicity Tests An array of tests used to determine the toxicity of a substance to living systems. These include tests on clinical drugs, foods, and environmental pollutants. Tests, Toxicity,Test, Toxicity,Toxicity Test
D019587 Dietary Supplements Products in capsule, tablet or liquid form that provide dietary ingredients, and that are intended to be taken by mouth to increase the intake of nutrients. Dietary supplements can include macronutrients, such as proteins, carbohydrates, and fats; and/or MICRONUTRIENTS, such as VITAMINS; MINERALS; and PHYTOCHEMICALS. Food Supplements,Neutraceuticals,Dietary Supplementations,Food Supplementations,Herbal Supplements,Nutraceuticals,Nutriceuticals,Dietary Supplement,Food Supplement,Herbal Supplement,Neutraceutical,Nutraceutical,Nutriceutical,Supplement, Food,Supplement, Herbal,Supplementations, Dietary,Supplements, Dietary,Supplements, Food,Supplements, Herbal
D027841 Pimenta A plant genus in the family MYRTACEAE, order Myrtales, subclass Rosidae. It is best known for allspice from the dried berry of PIMENTA dioica. Allspice,Pimenta dioica,Pimenta pseudocaryophyllus,Pimenta officinalis,Pimentas
D028042 Pimpinella A plant genus in the family APIACEAE (Umbelliferae) that is used in SPICES and is a source of anethole. Anise,Pimpinella anisum,Anises,Pimpinella anisums,Pimpinellas,anisums, Pimpinella
D030001 Foeniculum A plant genus of the family APIACEAE used in SPICES. Fennel,Foeniculum vulgare,Fennels,Foeniculum vulgares,Foeniculums,vulgares, Foeniculum

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