In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association initiated the safety re-evaluation of over 250 natural flavor complexes (NFCs) used as flavor ingredients. This publication, 4th in a series focusing on the safety evaluation of NFCs, presents an evaluation of NFCs rich in hydroxyallylbenzene and hydroxypropenylbenzene constituents using a procedure initially published in 2005 and updated in 2018 that evaluates the safety of naturally occurring mixtures for their intended use as flavoring ingredients. The procedure requires the characterization of the chemical composition for each NFC and subsequent organization of the constituents into defined congeneric groups. The safety of each NFC is evaluated using the conservative threshold of toxicological concern (TTC) approach together with studies on absorption, metabolism and toxicology of the NFC and its constituent congeneric groups. By the application of this procedure, seven NFCs, derived from clove, cinnamon leaf and West Indian bay leaf were affirmed as “generally recognized as safe (GRAS)” under their conditions of intended use as flavor ingredients. An eighth NFC, an oleoresin of West Indian bay leaf, was affirmed based on its estimated intake, which is below the TTC of 0.15 μg/person per day for compounds with structural alerts for genotoxicity.
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The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Drs. Cohen, Eisenbrand, Fukushima, Gooderham, Guengerich, Hecht, Rietjens and Rosol are members of the Expert Panel of the Flavor and Extract Manufacturers Association. Authors Davidsen, Harman, Murray and Taylor are employed by Verto Solutions which provides scientific and management support services to FEMA. A full description of the conflict of interest protections and procedures used to ensure that the FEMA Expert Panel decisions are fully objective and based solely on the merits of the available information are available on the FEMA website at https://www.femaflavor.org/gras#conflict.This work was financially supported by the International Organization of the Flavor Industry (IOFI), the Flavor and Extract Manufacturers Association (FEMA) and the International Federation of Essential Oils and Aroma Trades (IFEAT).
This work was financially supported by the International Organization of the Flavor Industry (IOFI) , the Flavor and Extract Manufacturers Association (FEMA) and the International Federation of Essential Oils and Aroma Trades (IFEAT) .
© 2020 The Author(s)
- Cinnamon leaf oil
- Clove essential oils, extract and oleoresin
- Natural flavor complex
- Safety evaluation
- West Indian bay leaf oil and oleoresin