Generally Recognized as Safe (GRAS) Notices

The definition of a GRAS substance as determined by the FDA is as follows: “A substance that will be added to food is subject to premarket approval by the FDA unless its use is generally recognized as safe (GRAS) by qualified experts. In addition, a substance that is used in accordance with a sanction granted prior to 6 September 1958 is not subject to premarket approval.

In 1997, the US Food and Drug Administration (FDA) proposed a new system known as GRAS notification. This process allows a food manufacturer to submit a dossier to the FDA, which would then determine whether this information supported the GRAS determination.

It is important to note that a food manufacturer is not obligated to notify the FDA. An alternative route, known as “self-affirmed GRAS,” allows the GRAS determination to be made by the food manufacturer. However, the FDA can request access to the information that supports the “self-affirmed GRAS” determination at any time.

Types of Procedures

1. Self-affirmed. The manufacturer of this chemical or substance had performed all necessary research, including the formation of an expert panel to review safety concerns, and is prepared to use these findings to defend its product’s GRAS status.
2. FDA-pending. The manufacturer has performed all of the aforementioned due diligence, and submitted to the Food & Drug Administration for GRAS approval.
3. No comment. The FDA has reviewed a product’s GRAS claim and responded with “no comment”; i.e., no further challenges on the product’s GRAS status.

Important Concepts About Gras

1. A substance can be GRAS even if not listed by the FDA.
2. GRAS status does not mean that the ingredient is safe to add to food indiscriminately.
3. GRAS status can apply to a defined low level of an ingredient added to foods or to a limited set of foods.
4. GRAS can apply to substances for direct addition to food, used in food processing or in food packaging or other food contact materials.
5. GRAS status can also apply to ingredients used in animal feed.
6. There is no GRAS exemption for color additives.

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