In the Federal Food, Drug and Cosmetic Act, a food additive is “any substance which is or may become a part of food.” Section 210(s) provides an exception with respect to each substance which is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown to be safe under the conditions of its intended use...". We call GRAS those substances which are generally recognized as safe by the experts.
In 1971, the FDA published its interpretation of that definition in 21 CFR section 121.3. You should expect in early 1976 a publication of a final regulation amending Section 121.3. Despite FEMA’s protestations, the definition will he a narrow interpretation of the statutory provisions, roughly equivalent to the proposed regulation published September 30, 1974. You should expect the interpretation to be so narrow as to provide that while a substance may be considered as GRAS, any new manufacturing process for that substance must be cleared through the FDA with a food additive petition.
Shortly after the Food Additives Amendment was enacted in 1958, FEMA established an Expert Panel of distinguished scientists who undertook to review the safety of flavors within the meaning of the GRAS concept. After 17 years, we find that no other organization has reviewed the thousands of flavor materials in use. During those years, the FDA was concentrating on more urgent matters, reviewing the food additives with higher priorities. The FEMA Expert Panel is the first body in the world to develop a comprehensive methodology for evaluating the safety of flavors. Neither the Food Additive Petition process nor the GRAS Affirmation Petition process of the FDA really relate themselves to the specific distinguishing characteristics of the flavor industry, namely that flavors are used in relatively small quantities in foods, the amount of each flavor used per year is relatively small, and flavors have for the most part been found naturally in foods.