title: GRASr2 evaluation of aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances used as flavoring ingredients.
abstract: This publication is the 1st in a series of publications by the Expert Panel of the Flavor and Extract Manufacturers Assoc. summarizing the Panel's 3rd re-evaluation of Generally Recognized as Safe (GRAS) status referred to as the GRASr2 program. In 2011, the Panel initiated a comprehensive program to re-evaluate the safety of more than 2700 flavor ingredients that have previously met the criteria for GRAS status under conditions of intended use as flavor ingredients. 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 acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances as flavoring ingredients are evaluated. The group of aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances was reaffirmed as GRAS (GRASr2) based, in part, on 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 studies and the lack of significant genotoxic and mutagenic potential.
authors.affiliation: Dept. of Biochemistry, Center in Molecular Toxicology, Vanderbilt University, School of Medicine, Nashville, TN 37232-0146, U.S.A.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Marnett
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Cohen
authors.forename: Shoji
authors.initials: S
authors.lastname: Fukushima
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Gooderham
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Hecht
authors.forename: Ivonne M C M
authors.initials: IM
authors.lastname: Rietjens
authors.forename: Robert L
authors.initials: RL
authors.lastname: Smith
authors.forename: Timothy B
authors.initials: TB
authors.lastname: Adams
authors.forename: Maria
authors.initials: M
authors.lastname: Bastaki
authors.forename: Christie L
authors.initials: CL
authors.lastname: Harman
authors.forename: Margaret M
authors.initials: MM
authors.lastname: McGowen
authors.forename: Sean V
authors.initials: SV
authors.lastname: Taylor
mesh_terms: D000438:Alcohols / Q000032:analysis*; D000818:Animals; D004032:Diet; D005421:Flavoring Agents / Q000633:toxicity*; D019649:Food Industry; D006801:Humans; D009153:Mutagens; D019055:No-Observed-Adverse-Effect Level; D012449:Safety; D013729:Terpenes / Q000633:toxicity*; D018675:Toxicity Tests
chemical_list: D000438:Alcohols; D005421:Flavoring Agents; D009153:Mutagens; D013729:Terpenes
keywords: FEMA GRAS; flavoring ingredients; terpene tertiary alcohols