gras

(Generally Recognized as Safe) A generally recognized as safe (GRAS) substance is one that has a long, safe history of common use in foods, or that is determined to be safe based on proven science. The designation granted by the American Food and Drug Administration (FDA) exempts the substance from the Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance limitations.

On 1 January 1958, when knowledge about food science and the potential long-term harmful effects of food chemicals on health was just beginning to emerge, Congress passed the Food Additives Amendment to the FFDCA. Congress deemed it was not necessary for the food industry to prove the safety of substances such as salt, sugar, and spices intentionally added to foods if they were already generally regarded as safe by qualified scientists. On 9 December 1958, Congress published a list of seven hundred GRAS substances whose safety was previously established. This list is not all-inclusive nor a permanent guarantee of a substance’s safety. If new evidence suggests a GRAS substance may be unsafe, the FDA can prohibit its use or require further studies to determine its safety. The FDA established a process in 1972 for petitions to evaluate the GRAS status of substances not on this list and published successfully approved GRAS substances in the Federal Register.