Generally recognized as safe
) is an American
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
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
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
(FFDCA) food additive tolerance requirements.
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. 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.
GRAS exemptions are granted for substances that are generally recognized, among experts qualified by scientific
Science is a systematic enterprise that builds and organizes knowledge in the form of testable explanations and predictions about the universe...
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.
Code of Regulations
The Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
, Revised as of April 1, 2010, 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 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.
Failure to qualify
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:
- 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.
- FDA-pending. The manufacturer has performed all the aforementioned due diligence, and submitted to the Food & Drug Administration for GRAS approval.
- 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.
A recent GRAS notification for baobab
Adansonia is a genus of eight species of tree, six native to Madagascar, one native to mainland Africa and the Arabian Peninsula and one to Australia. The mainland African species also occurs on Madagascar, but it is not a native of that island....
dried fruit pulp 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.
Usage in computing
The term GRAS is also used in the arena of free and open source software
Free and open-source software or free/libre/open-source software is software that is liberally licensed to grant users the right to use, study, change, and improve its design through the availability of its source code...
, with a similar meaning to that used by the FDA.
- Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
- Generally recognized as safe and effective
Generally recognized as safe and effective is a legal term used to describe certain old drugs that do not require prior approval from the U.S...
- Grandfather clause
Grandfather clause is a legal term used to describe a situation in which an old rule continues to apply to some existing situations, while a new rule will apply to all future situations. It is often used as a verb: to grandfather means to grant such an exemption...
- Life Sciences Research Office
Life Sciences Research Organization is a non-profit organization based in Maryland, USA, that specializes in assembling "ad hoc" expert panels to evaluate scientific literature, data, systems, and proposals in the biomedical sciences.- Overview :...
- List of drug interactions
- Novel food
Novel food is defined as a type of food that does not have a significant history of consumption or is produced by a method that has not previously been used for food.-European Union:...
- Substantial equivalence
Substantial equivalence is a concept, developed by OECD in 1991, that maintains that a novel food should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food. Substantial equivalence is important from a...
- Use of Free and Open Source Software (FOSS) in the U.S. Department of Defense
Use of Free and Open-Source Software in the U.S. Department of Defense is a 2003 report by The MITRE Corporation that documented widespread use of and reliance on free software within the United States Department of Defense . The report helped end a debate about whether FOSS should be banned from...
- 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.).