FEMA GRAS assessment of natural flavor complexes: Vanilla extract, Bitter almond oil, Wintergreen oil and related flavoring ingredients

The Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) is conducting a program to re-evaluate the safety of over 250 natural flavor complexes (NFCs) used as flavoring ingredients. This publication, fourteenth in the series, evaluates the safety of NFCs composed primarily of benzaldehyde, methyl salicylate, vanillin and other benzyl derivative compounds. In 2018, the Expert Panel published an update of its safety evaluation procedure for NFCs that was first published in 2005. This procedure relies on a complete constituent characterization of the NFC and organization of the constituents of each NFC into defined congeneric groups. The safety of the NFC is evaluated using the threshold of toxicological concern (TTC) approach using updated estimates of exposure in addition to the evaluation of all relevant safety data on the NFC and its principal constituents. The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food. Eighteen (18) NFCs, derived from the Vanilla, Prunus, Betula, Acacia, Cuminum, Jasminum, Gaultheria, Polianthes and Evernia 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.