Title 21

SECTION 170.203

170.203 Definitions.

§ 170.203 Definitions.

The definitions and interpretations of terms in § 170.3 apply to such terms when used in this subpart. The following definitions also apply:

Amendment means any data and information that you submit regarding a filed GRAS notice before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

GRAS means generally recognized as safe.

GRAS notice means a submission that informs us of your view that a substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the substance is GRAS under the conditions of its intended use in accordance with § 170.30.

Notified substance means the substance that is the subject of your GRAS notice.

Notifier means the person (e.g., an individual, partnership, corporation, association, or other legal entity) who is responsible for the GRAS notice, even if another person (such as an attorney, agent, or qualified expert) prepares or submits the notice or provides an opinion about the basis for a conclusion of GRAS status.

Qualified expert means an individual who is qualified by scientific training and experience to evaluate the safety of substances under the conditions of their intended use in food.

Supplement means any data and information that you submit regarding a filed GRAS notice after we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).

We, our, and us refer to the United States Food and Drug Administration (FDA).

You and your refer to a notifier.

---