Generally recognized as safe

Generally recognized as safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements [1].

GRAS exemptions are granted for substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use.

The substance must be shown to be "generally recognized" as safe under the conditions of its intended use. The proponent of the exemption has the burden of proving that the use of the substance is "generally recognized" as safe. To establish such recognition, the proponent must show that there is a consensus of expert opinion regarding the safety of the use of the substance. The existence of a severe conflict among experts regarding the safety of a substance precludes a finding of general recognition.

When a use of a substance does not qualify for the GRAS exemption, that use of the substance is subject to the premarket approval mandated by the FFDCA. In such circumstances, the FDA can take enforcement action to stop distribution of the food substance and foods containing it on the grounds that such foods are or contain an unlawful food additive.

A GRAS designation typically exists in one of three forms:

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 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.

According to the FDA, as described under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive [2] and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information. It is important to note that this guidance only.

A recent GRAS notification for Baobab Dried Fruit Pulp [3] successfully demonstrated safety to the FDA by utilising detailed analyses of the nutritional and phytochemical components in Baobab, without resorting to animal safety data.

A list of the GRAS notices filed since 1998 can be found on the FDA website GRAS inventory.

See also

• Food and Drug Administration
• Substantial equivalence
• Life Sciences Research Office
• Generally recognized as safe and effective
• Grandfather clause

References

• U.S. Food and Drug Administration. (1993). Everything Added to Food in the United States. Boca Raton, FL: C.K. Smoley (c/o CRC Press, Inc.).

External links

• FDA's online database of "Everything" Added to Food in the United States (EAFUS): A Food Additive Database
• More information from the Food and Drug Administration (FDA).