The Generally Recognized as Safe list was established in 1958 by Congress. Those substances that were being added to food over a long time, which under conditions of their intended use were generally recognized as safe by qualified scientists, would be exempt from premarket clearance.
After questions were raised about the safety of some GRAS ingredients, FDA initiated a review of these ingredients in 1972.
FDA utilized the scientific expertise of an independent organization, the Federation of American Societies for Experimental Biology, to assist in the evaluation, which spanned a decade.
Substances on the GRAS list are not officially considered food additives, so they are exempt from the legal requirement of proving their safety.
However, GRAS substances are continually reevaluated, and as new methods for testing are developed, some substances are removed from the GRAS list.
GRAS status requires consensus, but not unanimity, among epxo9erts qualified by scientific training and experience.
Under the FD&C Act, GRAS determination must be made ‘among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures’.
GRAS (Generally Recognized as Safe)
