USA - FDA Announces Start of Generally Recognized as Safe (GRAS) Notification Pilot Program for Ingredients in Animal Food

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced the beginning of a Pilot Program to accept and review GRAS notices for substances used in animal food

FDA is implementing a voluntary pilot program to accept submission of notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the individual’s determination that such use is GRAS.

The GRAS notification pilot program will now provide a voluntary mechanism for an individual, called the notifier, to inform FDA of their determination that the use of a substance is GRAS, rather than petition FDA to affirm that the use of a substance is GRAS.  A substance is GRAS only for its particular intended purpose.  The scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.  Alternatively, a GRAS determination can be made through experience based on common use in food prior to 1958.

Notices of a determination that the use of a substance in animal food is GRAS should include:  a 'GRAS exemption claim' providing a succinct description of the substance, the applicable conditions of use, and the basis for the GRAS determination (scientific procedures or common use in food). The applicable conditions of use of the substance include the foods in which the substance is to be used, levels of use in such foods, the purposes for which the substance is used, and the specific animal species intended to consume the substance. If the intended use of the substance includes administration to food-producing animals, a human food safety component must be included.  The notice should also include information about the identity and properties of the substance and a discussion of the notifier's reasons for concluding that the substance is GRAS for its intended use. The information about the substance generally is chemical, toxicological, and, if applicable, microbiological in nature. The notifier should discuss information supporting the GRAS determination, as well as any information that would appear to be inconsistent with a GRAS determination, and explain why, in light of the totality of the information, the notifier concludes the substance is GRAS under the intended conditions of use.

FDA will evaluate whether the submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice, or otherwise available to FDA, raises issues that lead the agency to question whether use of the substance is GRAS.  Following this evaluation FDA generally responds to the notifier with one of two types of letters. The first type of letter states that FDA does not question the basis for the notifier's GRAS determination.  In the second type of letter, the agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information, or because the available data and information raise questions about the safety of the substance).

An inventory of GRAS notices and the agency's response to those notices will be maintained on the CVM website.

Potential participants in the animal food pilot program are strongly encouraged to contact the CVM’s Division of Animal Feeds prior to submitting notices, to discuss their submission plans.

Generally Recognized as Safe (GRAS) Notifications
"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 570.3 and 21 CFR 570.30, the use of a food additive may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

Under 21 CFR 570.30(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 and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
Under 21 CFR 570.30(c) and 570.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of animals in the United States.

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