FEMA GRAS assessment of natural flavor complexes: Lavender, Guaiac Coriander-derived and related flavoring ingredients

Shoji Fukushima; Samuel M Cohen; Gerhard Eisenbrand; Nigel J Gooderham; F Peter Guengerich; Stephen S Hecht; Ivonne M C M Rietjens; Thomas J Rosol; Jeanne M Davidsen; Christie L Harman; Vivian Lu; Sean V Taylor

doi:10.1016/j.fct.2020.111584

FEMA GRAS assessment of natural flavor complexes: Lavender, Guaiac Coriander-derived and related flavoring ingredients

Food Chem Toxicol. 2020 Nov:145:111584. doi: 10.1016/j.fct.2020.111584. Epub 2020 Jul 16.

Authors

Affiliations

¹ Japan Bioassay Research Center ,2445 Hirasawa, Hadano, Kanagawa 257-0015, Japan.
² Havlik-Wall Professor of Oncology, Dept. of Pathology and Microbiology, University of Nebraska Medical Center., 983135 Nebraska Medical Center, Omaha, NE 68198-3135, USA.
³ Senior Research Professor of Food Chemistry & Toxicology, University of Kaiserslautern (Retired), Kühler Grund 48/1, 69126 Heidelberg, Germany.
⁴ Dept. of Metabolism, Digestion and Reproduction, Imperial College London, Sir Alexander Fleming Building, London SW7 2AZ, United Kingdom.
⁵ Tadashi Inagami Professor of Biochemistry, Dept. of Biochemistry, Vanderbilt University School of Medicine, Nashville, TN 37232-0146, USA.
⁶ Wallin Professor of Cancer Prevention, Masonic Cancer Center, Dept. of Laboratory Medicine and Pathology, University of Minnesota, MMC 806, 420 Delaware St., S.E., Minneapolis, MN 55455, USA.
⁷ Division of Toxicology, Wageningen University, Stippeneng 4, 6708 WE Wageningen, The Netherlands.
⁸ Department of Biomedical Sciences, Heritage College of Osteopathic Medicine, Ohio University, 1 Ohio University, Athens, OH 45701, USA.
⁹ Flavor and Extract Manufacturers Association, 1101 17th Street NW, Suite 700, Washington, DC 20036, USA.
¹⁰ Flavor and Extract Manufacturers Association, 1101 17th Street NW, Suite 700, Washington, DC 20036, USA. Electronic address: staylor@vertosolutions.net.

PMID: 32682832
DOI: 10.1016/j.fct.2020.111584

Abstract

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, fifth in the series, evaluates the safety of NFCs containing linalool and/or other characteristic mono- and sesquiterpenoid tertiary alcohols and esters using the safety evaluation procedure published by the FEMA Expert Panel in 2005 and updated in 2018. The procedure relies on a complete chemical characterization of the NFC intended for commerce and organization of the chemical constituents of each NFC into well-defined congeneric groups. The safety of each 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 both the constituent congeneric groups and the NFCs. Sixteen NFCs, derived from the Lavandula, Aniba, Elettaria, Daucus, Salvia, Coriandrum, Ribes, Guaiacum/Bulnesia, Citrus, Pogostemon, Melaleuca and Michelia genera, were affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients based on an evaluation of each NFC and the constituents and congeneric groups therein.

MeSH terms

Animals
Consumer Product Safety
Escherichia coli / drug effects
Female
Flavoring Agents / chemistry
Flavoring Agents / toxicity*
Humans
Male
Mice
Monoterpenes / chemistry
Monoterpenes / toxicity*
Mutagenicity Tests
No-Observed-Adverse-Effect Level
Plant Oils / chemistry
Plant Oils / toxicity
Plants / chemistry*
Rats
Salmonella typhimurium / drug effects
Sesquiterpenes / chemistry
Sesquiterpenes / toxicity*

Substances

Flavoring Agents
Monoterpenes
Plant Oils
Sesquiterpenes