| Terms | |
|---|---|
| Foodborne illness | |
| Hazard Analysis and Critical Control Points (HACCP) | |
| Critical control point | |
| Critical factors | |
| Food, acidity, time, temperature, oxygen and moisture | |
| pH | |
| Water activity (aw) | |
| Pathogens | |
| Clostridium botulinum | |
| E. coli | |
| Hepatitis A | |
| Norovirus | |
| Parasitic infections | |
| Blastocystis | |
| Cryptosporidiosis | |
| Trichinosis | |
Generally recognized as safe (GRAS)[1] is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts,[2] and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.[2]
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On January 1, 1958, the FDA established the Food Additives Amendment of 1958, with a list of 700 food substances that were exempt from the then new requirement that manufacturers test food additives before putting them on the market.[3] On August 31, 1960, William W. Goodrich, assistant general council of the FDA, addressed the annual meeting (16 Bus. Law. 107 -1960-1961) of the FFDCA. The purpose of the meeting was the forthcoming March 6, 1961, effective date of the enforcement provisions of the "Food Additives Amendment of 1958", referred to as GRAS.[4]
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 Code of Federal Regulations, Revised as of April 1, 2010,[5] includes (CFR) title 21 170.30(b) that provides 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of the substance as a food additive[6] and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
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.[7]
A GRAS designation typically exists in one of three forms:
A recent GRAS notification for baobab dried fruit pulp[8] 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.[9]
The term GRAS is also used in the arena of free and open source software, with a similar meaning to that used by the FDA.