Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
9030661 | Food and Chemical Toxicology | 2005 | 28 Pages |
Abstract
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.
Keywords
PEAFEMA GRASS. typhimurium, Salmonella typhimuriumGOT, glutamic oxaloacetic transaminasePCE, polychromatic erythrocytesB. subtilis, Bacillus subtilisbw, body weightCHO, Chinese hamster ovaryE. coli, Escherichia coliFDA, United States Food and Drug AdministrationF, femaleGPT, glutamic pyruvic transaminaseGRAS, Generally Recognized as SafeIP, intraperitonealNR, not reportedNTP, National Toxicology Programppm, parts per millionSCE, sister chromatid exchangesSRBC, sheep red blood cellUDS, unscheduled DNA synthesisAST, aspartate aminotransferaseALT, alanine aminotransferaseDNA, deoxyribonucleic acidAUC, area under the curveM, maleFlavoring ingredients
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Authors
T.B. Adams, S.M. Cohen, J. Doull, V.J. Feron, J.I. Goodman, L.J. Marnett, I.C. Munro, P.S. Portoghese, R.L. Smith, W.J. Waddell, B.M. Wagner,