General Recognized As Safe (GRAS)
Some components are recognized as safe for general or specific uses.
(a) General recognition of safety may be based only on the views of experts
qualified by scientific training and experience to evaluate the safety of
substances directly or indirectly added to food. The basis of such views may be
either (1) scientific procedures or (2) in
the case of a substance used in food prior to January 1, 1958, through
experience based on common use in food. General recognition of safety requires
common knowledge about the substance throughout the scientific community
knowledgeable about the safety of substances directly or indirectly added to
food.
(b) General recognition of safety based upon scientific procedures shall require
the same quantity and quality of scientific evidence as is required to obtain
approval of a food additive regulation for the ingredient. General recognition
of safety through scientific procedures shall ordinarily be based upon published
studies which may be corroborated by unpublished studies and other data and
information.
Persons claiming GRAS status for a substance based on its common use in food
outside of the United States should obtain FDA concurrence that the use of the
substance is GRAS.
More information about the GRAS status can be found at:
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21 CFR 170.30 | Eligibility for classification as generally recognized as safe (GRAS). |
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21 CFR 170.35 | Affirmation of generally recognized as safe (GRAS) status. |
The components already recognized can be found at:
| - 21 CFR 182 |
| - 21 CFR 184 |
| - 21 CFR 186 |
| - internet |
Information regarding the process in obtaining the GRAS status can be found on the following websites:
| GRAS (Generally Recognized as Safe) Notification Program | |
| - Summary of all GRAS Notices | |
| - Proposed GRAS Regulation | |
| - How to submit a GRAS Notice | |
| - Frequently Asked Questions--GRAS | |