The FEMA GRAS Program
The Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) has served as the primary body for the safety evaluation of food flavorings for the flavor industry, and the public through its "generally recognized as safe" (GRAS) assessment of flavoring substances. Flavoring substances are determined to be GRAS by the FEMA Expert Panel pursuant to the authority granted in Section 201(s) of the U.S. Federal Food, Drug, and Cosmetic Act, which is administered by the FDA.
The FEMA GRAS assessment program continually incorporates the latest scientific advances for evaluating the safety of flavoring substances. The Expert Panel has operated continuously since it was first appointed in 1960. The Expert Panel's primary goal is to ensure that flavoring substances added to foods are safe for their intended use -- the conclusions of the Expert Panel on GRAS status apply only to the use of a flavoring substance in food. The Expert Panel is comprised of experts in the fields of chemistry, toxicology, pharmacology, medicine, pathology, and statistics; all are also experts in flavor safety assessment.
A critical part of the FEMA GRAS assessment program is the dissemination of the Expert Panel's decisions. Since 1965, lists of flavoring substances that have been determined to be GRAS have been published in a series of publications in the journal Food Technology. A comprehensive list of all the FEMA GRAS flavor ingredients and a list of (GRAS publications) is available. A small number of other flavoring substances are also permitted for use in the U.S. under separate authority as provided for in the U.S. Code of Federal Regulations (CFR); these substances, as well as a comprehensive list of all flavor ingredients listed in the CFR are available. Please note that the vast majority of the substances listed in the CFR are FEMA GRAS substances.
A number of articles have been published on the FEMA GRAS program. These include descriptions of the legal and scientific bases for the program (Hallagan and Hall, 1995); the history and operations of the Expert Panel (Oser and Ford, 1991); and scientific criteria employed by the Expert Panel (Oser and Hall, 1977, Woods and Doull, 1991 and Smith et al., 2005).
In addition to evaluating new substances for GRAS status, the Expert Panel carries out comprehensive, periodic reviews of all FEMA GRAS flavoring substances to reaffirm GRAS status. Recent publications on the GRAS reaffirmation of flavoring substances include reviews of alicyclic sustances, and lactones. Reviews of additional groups of substances will be published as the Expert Panel continues the GRAS reaffirmation program.
Based on the conclusions of the Expert Panel, FEMA GRAS flavoring substances are accepted as safe food ingredients in many countries around the world.
Recent developments in the safety assessment of flavoring substances are reviewed by Munro, et al. 1998, who note the consistent application of safety assessment principles by the FEMA Expert Panel and other groups that perform safety assessments of flavoring substances. Another important publication is a review of the role of flavoring substances in food allergy and intolerance.
Additional information on the FEMA GRAS assessment program is available from Tim Adams in the FEMA office.
There are a total of 21 FEMA GRAS publications referred to as "GRAS 3" through "GRAS 23" . The "GRAS 1" and "GRAS 2" publications were notices that did not contain lists of GRAS substances or other relevant information. All FEMA GRAS publications are available.