CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR170.235]

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. 170.235 Part 3 of a GRAS notice: Dietary exposure.

In part 3 of your GRAS notice, you must provide data and information about dietary exposure (i.e., the amount of relevant substances that consumers are likely to eat or drink as part of a total diet), regardless of whether your conclusion of GRAS status is through scientific procedures or through experience based on common use in food, as follows:

(a) You must provide an estimate of dietary exposure to the notified substance that includes exposure from its intended use and all sources in the diet; and

(b) When applicable, you must provide an estimate of dietary exposure to any other substance that is expected to be formed in or on food because of the use of the notified substance (e.g., hydrolytic products or reaction products);

(c) When applicable, you must provide an estimate of dietary exposure to any other substance that is present with the notified substance either naturally or due to its manufacture (e.g., contaminants or by-products);

(d) You must describe the source of any food consumption data that you use to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section; and

(e) You must explain any assumptions you made to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section.