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The FEMA GRAS assessment of benzyl derivatives used as flavor ingredients

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Author: Adams, T.B. · Cohen, S.M. · Doull, J. · Feron, V.J. · Goodman, J.I. · Marnett, L.J. · Munro, I.C. · Portoghese, P.S. · Smith, R.L. · Waddell, W.J. · Wagner, B.M.
Institution: TNO Kwaliteit van Leven
Source:Food and Chemical Toxicology, 8, 43, 1207-1240
Identifier: 238637
doi: doi:10.1016/j.fct.2004.11.014
Keywords: Nutrition Toxicology · Toxicology and Applied Pharmacology · Benzyl derivatives · FEMA GRAS · Flavoring ingredients · 2,4 dimethylbenzaldehyde · benzaldehyde · benzaldehyde derivative · benzoic acid · benzoic acid derivative · benzyl acetate · benzyl alcohol derivative · benzyl benzoate · benzyl butyrate · benzyl derivative · ester derivative · flavoring agent · glyceryl tribenzoate · propylene glycol dibenzoate · unclassified drug · absorption · acute toxicity · carcinogenicity · chemical structure · chronic toxicity · concentration (parameters) · data analysis · detoxification · evaluation · excretion · experimental test · exposure · flavor · food analysis · food composition · food intake · food poisoning · food safety · genotoxicity · health care organization · human · hydrolysis · in vitro study · in vivo study · information · metabolism · mortality · mutagenesis · nonhuman · reproduction · review · risk assessment · science · structure analysis · teratology · toxicity · Animals · Benzaldehydes · Benzoic Acid · Benzyl Alcohol · Flavoring Agents · Food Industry · Humans · Toxicity Tests · United States · United States Food and Drug Administration · Animalia


This publication is the eighth in a series of safety evaluations performed by the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA). In 1993, the panel initiated a comprehensive program to re-evaluate the safety of more than 1700 GRAS flavoring substances under conditions of intended use. Elements that are fundamental to the safety evaluation of flavor ingredients include exposure, structural analogy, metabolism, pharmacokinetics and toxicology. Flavor ingredients are evaluated individually and in the context of the available scientific information on the group of structurally related substances. Scientific data relevant to the safety evaluation of the use of benzyl derivatives as flavoring ingredients is evaluated. The group of benzyl derivatives was reaffirmed as GRAS (GRASr) based, in part, on their self-limiting properties as flavoring substances in food; their rapid absorption, metabolic detoxication, and excretion in humans and other animals, their low level of flavor use, the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels determined from subchronic and chronic studies and the lack of significant genotoxic and mutagenic potential. This evidence of safety is supported by the fact that the intake of benzyl derivatives as natural components of traditional foods is greater than their intake as intentionally added flavoring substances. © 2004 Elsevier Ltd. All rights reserved.