The FEMA GRAS assessment of aliphatic and aromatic terpene hydrocarbons used as flavor ingredients

• Published in: Food and chemical toxicology Vol. 49; no. 10; pp. 2471 - 2494
• Main Authors: Adams, T.B., Gavin, C. Lucas, McGowen, M.M., Waddell, W.J., Cohen, S.M., Feron, V.J., Marnett, L.J., Munro, I.C., Portoghese, P.S., Rietjens, I.M.C.M., Smith, R.L.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.10.2011; Elsevier
• Subjects: 3 continental sites; absorption; Aliphatic compounds; Aliphatic hydrocarbons; alpha-pinene; Animals; beta-myrcene; Biological and medical sciences; chronic progressive nephropathy; d-limonene para-mentha-1,8-diene; excretion; FEMA GRAS; flavor; Flavoring Agents - analysis; Flavoring Agents - pharmacokinetics; Flavoring Agents - toxicity; Flavoring ingredients; food-additives amendment; Foods; genotoxicity; GRAS substances; human risk-assessment; Humans; hyaline droplet nephropathy; Hydrocarbons; Ingredients; Medical sciences; metabolic detoxification; organic anion transporters; Panels; pharmacokinetics; Safety; sister-chromatid exchanges; Terpene hydrocarbons; Terpenes; Terpenes - analysis; Terpenes - pharmacokinetics; Terpenes - toxicity; Toxicity Tests - methods; Toxicology; United States; United States; Flavoring ingredients; Terpene hydrocarbons; Aliphatic hydrocarbons; FEMA GRAS; Terpene; Hydrocarbon; Flavoring agent; Food additive; Isoprenoid; Organic compounds
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2011.06.011

► Aliphatic and aromatic terpene hydrocarbons used as flavor ingredients and resultant exposure are reported. ► Review of absorption, distribution, metabolism and elimination of terpene hydrocarbons. ► Review of short- and long-term toxicology and reproductive toxicology of terpene hydrocarbons. ► Discussion of effects in bioassays and the relevance to humans. ► Review of genotoxicity data on aliphatic and aromatic terpene hydrocarbons. This publication is the thirteenth 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. Since then, the number of flavoring substances has grown to more than 2600 substances. 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 aliphatic and aromatic terpene hydrocarbons as flavoring ingredients are evaluated. The group of aliphatic and aromatic terpene hydrocarbons 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 potential.