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, the sixth in the series, will summarize the re-evaluation of eight NFCs whose constituent profiles are characterized by significant amounts of eucalyptol and/or other cyclic ethers. This re-evaluation was based on a procedure first published in 2005 and subsequently updated in 2018 that evaluates the safety of naturally occurring mixtures for their intended use as flavoring ingredients. The procedure relies on a complete chemical characterization of the NFC intended for commerce and the organization of its 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 the constituents of the congeneric groups and the NFC under evaluation. Eight NFCs derived from the Eucalyptus, Melaleuca, Origanum, Laurus, Rosmarinus and Salvia 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.
Bibliographical noteFunding Information:
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).
In addition, the FEMA Expert Panel is aware of accidental poisonings from direct oral consumption of eucalyptus oil in its neat or concentrated liquid form by children and adults and further discusses this issue below under ?Additional considerations? for Eucalyptus Oil in the Biochemical and Toxicological Supporting Information Relevant to the Safety Evaluation section of this manuscript. These accidental poisonings are not from its use as a flavoring ingredient. The per capita estimated intake for Eucalyptus Oil (FEMA 2466) is 260 ?g/person/day when used as a flavoring ingredient. From this estimated intake, a MoS of greater than 69,000 was calculated for Eucalyptus Oil (FEMA 2466) when used as a flavoring ingredient, based on a NOAEL of 300 mg/kg bw/day determined for eucalyptus oil administered to female rats in an OECD guideline 422 combined repeated dose oral gavage toxicity study with a reproduction/developmental toxicity screening test (ECHA, 2013g). The FEMA Expert Panel concluded that under conditions of intended use as a flavoring ingredient, consumption of Eucalyptus Oil (FEMA 2466) in food is safe for both adults and children.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 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 have been published (Marnett et al., 2013) and 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).
© 2021 The Authors
- Cyclic ethers
- Essential oils
- Natural flavor complexes
- Safety evaluation