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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number111584
JournalFood and Chemical Toxicology
Volume145
DOIs
StatePublished - Nov 2020

Bibliographical note

Funding Information:
This work was financially supported by the International Organization of the Flavor Industry (IOFI) , Geneva, Switzerland, the Flavor and Extract Manufacturers Association (FEMA) , USA and the International Federation of Essential Oils and Aroma Trades (IFEAT), London, UK .

Funding Information:
The NFCs discussed here were determined to be generally recognized as safe (GRAS) under conditions of intended use as flavor ingredients by the Flavor and Extract Manufacturers Association (FEMA) Expert Panel in 1965 and in subsequent years. Upon application of the safety procedure, it was concluded that the NFCs listed in Table 7 do not present safety concerns. There are adequate margins of safety using conservative estimates of exposure and NOAEL values from short and long-term toxicity studies. Also, the weight of evidence indicates a lack of genotoxic potential for these flavorings. These data indicate that there is no significant safety concern and support the FEMA Expert Panel's affirmation of GRAS status for these NFCs as flavoring ingredients in food under conditions of intended use.Drs. Fukushima, Cohen, Eisenbrand, Gooderham, Guengerich, Hecht, Rietjens and Rosol are members of the Expert Panel of the Flavor and Extract Manufacturers Association. The FEMA Expert Panel's Statement on Conflict of Interest Protections and Procedures is available at https://www.femaflavor.org/gras#conflict. Authors Davidsen, Harman, Lu and Taylor are employed by Verto Solutions, which provides scientific and management support services to FEMA.This work was financially supported by the International Organization of the Flavor Industry (IOFI), Geneva, Switzerland, the Flavor and Extract Manufacturers Association (FEMA), USA and the International Federation of Essential Oils and Aroma Trades (IFEAT), London, UK.

Publisher Copyright:
© 2020 The Author(s)

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