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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR170.203]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170 -- FOOD ADDITIVES

Subpart E--Generally Recognized as Safe (GRAS) Notice

Sec. 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.

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