The FEMA GRAS assessment of hydroxy- and alkoxy-substituted benzyl derivatives used as flavor ingredients
article
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 hydroxy- and alkoxy-substituted benzyl derivatives as flavoring ingredients is evaluated. The group of hydroxy- and alkoxy-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 hydroxy- and alkoxy-substituted benzyl derivatives as natural components of traditional foods is greater than their intake as intentionally added flavoring substances. © 2005 Elsevier Ltd. All rights reserved.
Topics
Toxicology and Applied PharmacologyAlkoxybenzylderivativesFEMA GRASFlavoring ingredientsHydroxybenzyl derivatives3 ethoxy 4 hydroxybenzaldehydeAcetalAlcoholAldehydeAnisaldehydeBenzyl derivativeButyl parabenEsterFlavoring agentMethyl 2 methoxybenzoatePiperonalSalicylic acid isopentyl esterSalicylic acid methyl esterUnclassified drugVanillinAcute toxicityCarcinogenicityChemical structureConcentration (parameters)Data analysisDetoxificationDogEvaluationExcretionExposureFeedingFlavorFood analysisFood compositionFood intakeFood safetyGenotoxicityHealth care organizationHumanHydrolysisIn vitro studyIn vivo studyInformationMetabolismMutagenesisNonhumanRabbitReproductionReviewRisk assessmentScienceStructure analysisAlcoholsAnimalsBenzyl CompoundsFlavoring AgentsFood IndustryHumansToxicity TestsUnited StatesUnited States Food and Drug AdministrationAnimalia
TNO Identifier
238620
ISSN
02786915
Source
Food and Chemical Toxicology, 43(8), pp. 1241-1271.
Pages
1241-1271
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