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The FEMA GRAS assessment of phenethyl alcohol, aldehyde, acid, and related acetals and esters 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, 1179-1206
Identifier: 238641
doi: doi:10.1016/j.fct.2004.11.013
Keywords: Nutrition Toxicology · Toxicology and Applied Pharmacology · FEMA GRAS · Flavoring ingredients · PEA · acetal derivative · acid · aldehyde · ester derivative · ethyl(4 tolyloxy)acetate · flavoring agent · isopropylphenylacetaldehyde · phenethyl alcohol · phenethyl phenylacetate · phenethyl senecioate · phenoxyacetic acid · phenoxyacetic acid derivative · phenoxyethyl alcohol · phenylacetic acid · sodium 2 (4 methoxyphenoxy)propanoate · unclassified drug · absorption · carcinogenicity · chemical analysis · chemical structure · data analysis · detoxification · evaluation · excretion · 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 · mutagenesis · nonhuman · review · risk assessment · science · structure analysis · toxicity · Acetaldehyde · Acetals · Animals · Esters · Flavoring Agents · Food Industry · Humans · Phenylacetates · Phenylethyl Alcohol · Toxicity Tests · United States · United States Food and Drug Administration · Animalia


This publication is the ninth 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 phenethyl alcohol, aldehyde, acid, and related acetals and esters as flavoring ingredients is evaluated. The group of phenethylalcohol, aldehyde, acid, and related acetals and esters 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 phenethyl alcohol, aldehyde, acid, and related acetals and esters as natural components of traditional foods is greater than their intake as intentionally added flavoring substances. © 2004 Elsevier Ltd. All rights reserved.