GRAS Notification Program

Overview

• About the GRAS Notification Program
  (Background on the GRAS Notification Program, How FDA responds to GRAS Notices, and the Inventory of GRAS Notices)
• How U.S. FDA's GRAS Notification Program Works
  (Reprinted from Food Safety Magazine, December/January 2006)
• FDA's Approach to the GRAS Provision: A History of Processes
  (Excerpted from Poster Presentation at the FDA Science Forum - April 2006)

Inventories

• List of All GRAS Notices
  (Includes the subject of each GRAS notice, the FDA assigned number and FDA's response letter)
  • FDA Numerical Listing        Alphabetical Listing
• Yearly tables of GRAS Notices
  (Further details about GRAS notices)
• List of GRAS Notifiers' Names and Addresses

Database

• Select Committee on GRAS Substances (SCOGS) Database
  (Opinions and conclusions from SCOGS reports 1972-1980)

Information about the GRAS Proposal

• Summary paper
  (FDA Talk Paper April 17, 1997)
• Federal Register Notice
  (FDA proposed Simplified GRAS Notification System 62 FR 18937- April 17, 1997)
• How to Submit a GRAS Notice
  (Excerpted from 62 FR 18937- April 17, 1997)

Guidance and Regulations

• Frequently Asked Questions about "Generally Recognized as Safe" (GRAS)
• Frequently Asked Questions about Infant Formula
• Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions
• Estimating Dietary Intake of Substances in Food
• Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
• Summary Table of Recommended Toxicological Testing for Additives Used in Food
• Direct Links to
  • 21 CFR 181 Prior Sanctioned Food Ingredients
  • 21 CFR 182 Substances Generally Recognized as Safe
  • 21 CFR 184 Direct Food Substances Affirmed As Generally Recognized As Safe
  • 21 CFR 186 Indirect Food Substances Affirmed As Generally Recognized As Safe

• Related Links
• Contact Information