Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.170.235 Part 3 of a GRAS notice:  Dietary exposure

Current as of January 02, 2025 | Updated by Findlaw Staff

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.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.170.235 Part 3 of a GRAS notice:  Dietary exposure - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-170-235/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard