Application for GRAS in the US


I. What is GRAS?

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 excepted from the definition of a food additive.

II. How to Obtain GRAS in US?

There are two ways that a substance can be designated as generally recognized as safe (GRAS) by the Food and Drug Administration (FDA): self-affirmed GRAS and FDA GRAS notice.

Self-affirmed GRAS refers to a situation where a company, manufacturer, or supplier has conducted their own research and concludes that a substance is safe for its intended use in food without involving the FDA. They can then market the substance as GRAS without FDA approval or notification. However, the FDA can review and question the safety assessments made by the company, potentially leading to the substance losing its GRAS status.

FDA GRAS notice, on the other hand, involves a company submitting a GRAS notice to the FDA, providing information about the safety of the substance and the basis for the GRAS determination. The FDA then reviews the notice and can either issue a "no objection letter" that acknowledges the substance is GRAS, or it can question the safety of the substance and require additional data to be submitted.

While self-affirmed GRAS may appear to be a quicker and easier process, it does come with some risks. Companies that use self-affirmed GRAS do not have the assurance of the FDA's approval or notice. Additionally, the FDA has stated that it intends to review GRAS substances more closely in the future and may take action against companies that have not met sufficient safety standards.

III. Timeline

It takes approximately 6-9 months to obtain Self-Affirmed GRAS, and 1-3 years to obtain FDA GRAS notice.

IV. Required Dossier

1. Signed statements and certification

2. Identity, method of manufacture, specifications, and physical or technical effect

3. Dietary exposure

4. Self-limiting levels of use

5. Experience based on common use in food before 1958

6. Narrative

7. List of supporting data and information in the GRAS notice

V. Our Service

* Feasibility Analysis

* Self-Affirmed GRAS Submission

* FDA GRAS Notice Submission

* Safety Assessment

* Other Customized Consultation

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