title: The FEMA GRAS assessment of furfural used as a flavour ingredient. Flavor and Extract Manufacturers' Association.
abstract: The Expert Panel of the Flavor and Extract Manufacturers' Association (FEMA) has assessed the safety of furfural for its continued use as a flavour ingredient. The safety assessment takes into account the current scientific information on exposure, metabolism, pharmacokinetics, toxicology, carcinogenicity and genotoxicity. Furfural was reaffirmed as GRAS (GRASr) as a flavour ingredient under conditions of intended use based on: (1) its mode of metabolic detoxication in humans; (2) its low level of flavour use compared with higher intake levels as a naturally occurring component of food; (3) the safety factor calculated from results of subchronic and chronic studies, (4) the lack of reactivity with DNA; and (5) the conclusion that the only statistically significant finding in the 2-year NTP bioassays, an increased incidence of hepatocellular adenomas and carcinomas in the high-dose group of male mice, was secondary to pronounced hepatotoxicity. Taken together, these data do not indicate any risk to human health under conditions of use as a flavour ingredient. This evidence of safety is supported by the occurrence of furfural as a natural component of traditional foods, at concentrations in the diet resulting in a 'natural intake' that is at least 100 times higher than the intake of furfural from use as a flavour ingredient.
authors.affiliation: Flavor and Extract Manufacturers' Association, Washington, DC 20006, USA.
authors.forename: T B
authors.initials: TB
authors.lastname: Adams
authors.forename: J
authors.initials: J
authors.lastname: Doull
authors.forename: J I
authors.initials: JI
authors.lastname: Goodman
authors.forename: I C
authors.initials: IC
authors.lastname: Munro
authors.forename: P
authors.initials: P
authors.lastname: Newberne
authors.forename: P S
authors.initials: PS
authors.lastname: Portoghese
authors.forename: R L
authors.initials: RL
authors.lastname: Smith
authors.forename: B M
authors.initials: BM
authors.lastname: Wagner
authors.forename: C S
authors.initials: CS
authors.lastname: Weil
authors.forename: L A
authors.initials: LA
authors.lastname: Woods
authors.forename: R A
authors.initials: RA
authors.lastname: Ford
mesh_terms: D018248:Adenoma, Liver Cell / Q000139:chemically induced / Q000473:pathology; D000818:Animals; D015197:Carcinogenicity Tests; D006528:Carcinoma, Hepatocellular / Q000139:chemically induced / Q000473:pathology; D004341:Drug Evaluation; D005260:Female; D005421:Flavoring Agents / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D005503:Food Additives / Q000592:standards*; D005662:Furaldehyde / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D006801:Humans; D008113:Liver Neoplasms / Q000139:chemically induced / Q000473:pathology; D008297:Male; D051379:Mice; D009152:Mutagenicity Tests; D051381:Rats; D012449:Safety
chemical_list: D005421:Flavoring Agents; D005503:Food Additives; D005662:Furaldehyde