On Dec. 9, 1958, the U.S. Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). as a result, the U.S. Food and Drug Administration (FDA) published a list of nearly 200 “Substances Generally Recognized as Safe” (GRAS).

The amendment and/or supporting legislative documents defined the term ‘food additive’; required premarket approval for new uses of food additives; and established the standard of review (‘fair evaluation of the data…’), the standard of safety, and formal rulemaking procedures for food additives.  The food additives on the GRAS list were judged to be safe based on a long history of safe use in food before that date.

For a substance to be GRAS, the scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use. GRAS determinations made in this manner are said to be made through scientific procedures. For a food additive, privately held data and information about the use of a substance are sent by the sponsor to FDA, which evaluates those data and information to determine whether they establish that the substance is safe under the conditions of its intended us.