FEMA GRAS assessment of natural flavor complexes: Cinnamomum and Myroxylon-derived flavoring ingredients

• Published in: Food and chemical toxicology Vol. 135; p. 110949
• Main Authors: Rietjens, Ivonne M.C.M., Cohen, Samuel M., Eisenbrand, Gerhard, Fukushima, Shoji, Gooderham, Nigel J., Guengerich, F. Peter, Hecht, Stephen S., Rosol, Thomas J., Davidsen, Jeanne M., Harman, Christie L., Murray, Ian J., Taylor, Sean V.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.01.2020
• Subjects: Animals; Balsam essential oil and extract; Cell Line; Cinnamomum - chemistry; Cinnamon and cassia essential oils and extracts; Consumer Product Safety; Flavoring Agents - chemistry; Flavoring Agents - toxicity; GRAS; Humans; Myroxylon - chemistry; Natural flavor complex; No-Observed-Adverse-Effect Level; Oils, Volatile - chemistry; Oils, Volatile - toxicity; Plant Extracts - chemistry; Plant Extracts - toxicity; Risk Assessment; Safety evaluation; Balsam essential oil and extract; GRAS; Natural flavor complex; Cinnamon and cassia essential oils and extracts; Safety evaluation
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2019.110949

In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a program for the re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavor ingredients. This publication, third in the series, considers NFCs composed primarily of constituents with the 3-phenyl-2-propenyl or a cinnamyl functional group, using the procedure outlined in 2005 and updated in 2018 to evaluate the safety of naturally-occurring mixtures for their intended use as flavor ingredients. The procedure relies on a complete chemical characterization of the NFC intended for commerce and organization of each NFC's chemical constituents into well-defined congeneric groups. The safety of the NFC is evaluated using the well-established and conservative threshold of toxicological concern (TTC) concept in addition to data on absorption, metabolism and toxicology of members of the congeneric groups and the NFC under evaluation. Six NFCs from the Myroxylon and Cinnamomum genera, Balsam Oil, Peru (FEMA 2117), Tolu Balsam Extract (FEMA 3069), Cassia Bark Extract (FEMA 2257), Cassia Bark Oil (FEMA 2258), Cinnamon Bark Extract (FEMA 2290) and Cinnamon Bark Oil (FEMA 2291) were evaluated and affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients. •Safety evaluation of Cinnamomum and Myroxylon-derived flavoring ingredients .•Evaluation used procedure for naturals developed by the FEMA Expert Panel .•FEMA GRAS status determined/affirmed for 6 natural flavor complexes .