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FDA Updates Policies for Generally Recognized as Safe Substances in Food
Practical Law Legal Update w-003-1828 (Approx. 4 pages)
FDA Updates Policies for Generally Recognized as Safe Substances in Food
by Practical Law Commercial Transactions
| Law stated as of 23 Aug 2016 • USA (National/Federal) |
The Food and Drug Administration (FDA) has issued a final rule that amends and clarifies the criteria for generally recognized as safe (GRAS) substances in foods, which exempts certain substances from the FDA's premarket approval requirements.
On August 17, 2016, the Food and Drug Administration (FDA) issued a final rule that clarifies the criteria for when a substance used in food is generally recognized as safe (GRAS) under the conditions of its intended use. Food additives classified as GRAS are exempt from the FDA's premarket approval requirements. The final rule also eliminates the GRAS petition process and replaces it with a notification procedure. This rule becomes effective on October 17, 2016.
Under the new rule, the FDA clarified that:
- A substance cannot be classified as GRAS if the available information does not satisfy the safety standard for a food additive under the Food, Drug, and Cosmetic Act.
- General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is reasonable certainty that the substance is not harmful under the conditions of its intended use.
- Common knowledge can be based on scientific procedures or on experience based on common use of a substance in food.
- General recognition of safety through scientific procedures must be based on the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
The final rule also creates a new notification process, which establishes an administrative process that allows any person to notify the FDA of the basis for a conclusion that a substance is GRAS under the conditions of its intended use, and provides:
- Information on available formats (electronic and paper) and where to send a GRAS notice.
- What data and other information may be incorporated into a GRAS notice;
- Specific information that must be provided in a GRAS notice, including:
- Part 1: signed statements and a certification;
- Part 2: the identity, method of manufacture, specifications, and physical or technical effect of the notified substance;
- Part 3: dietary exposure;
- Part 4: self-limiting levels of use;
- Part 5: the history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food);
- Part 6: a narrative that provides the basis for the conclusion of the GRAS status, including why the scientific data, information, methods, and principles described in the notice provide a basis for the conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use; and
- Part 7: a list of data and information that is discussed in the narrative of the GRAS notice, specifying which of these data and information are generally available, and which of these data and information are not generally available.
- A process to submit an amendment or to request that the FDA cease evaluating a GRAS notice.
The final rule also specifies that the FDA is committed to responding to each GRAS notice within 180 days of filing, with a possible 90 day extension. For more information on the FDA's regulation of food, see Practice Notes, FDA Food and Dietary Supplement Regulations and FSMA Regulation on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.