Summary

The safety evaluation of an essential oil is performed in the context of all available data for congeneric groups of identified constituents and the group of unidentified constituents, data on the essential oil or a related essential oil, and any potential interactions that may occur in the essential oil when consumed as a flavoring substance.

The guide provides a chemically based approach to the safety evaluation of an essential oil. The approach depends on a thorough quantitative analysis of the chemical constituents in the essential oil intended for commerce. The chemical constituents are then assigned to well-defined congeneric groups that are established based on extensive biochemical and toxicologic information, and this is evaluated in the context of intake of the congeneric group resulting from consumption of the essential oil. The intake of unidentified constituents considers the consumption of the essential oil as a food, a highly conservative toxicologic threshold, and toxicity data on the essential oil or an essential oil of similar chemical composition. The flexibility of the guide is reflected in the fact that high intake of major congeneric groups of low toxicologic concern will be evaluated along with low intake of minor congeneric groups of significant toxicological concern (i.e., higher structural class). The guide also provides a comprehensive evaluation of all congeneric groups and constituents that account for the majority of the composition of the essential oil. The overall objective of the guide is to organize and prioritize the chemical constituents of an essential oil in order that no reasonably possible significant risk associated with the intake of essential oil goes unevaluated.

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