The FEMA GRAS assessment of furfural used as a flavour ingredient. Flavor and Extract Manufacturers' Association.
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.
Adams
T B
TB
Flavor and Extract Manufacturers' Association, Washington, DC 20006, USA.
Doull
J
J
Goodman
J I
JI
Munro
I C
IC
Newberne
P
P
Portoghese
P S
PS
Smith
R L
RL
Wagner
B M
BM
Weil
C S
CS
Woods
L A
LA
Ford
R A
RA
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
D005421:Flavoring Agents; D005503:Food Additives; D005662:Furaldehyde