Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information
Guidance for Industry
Guidance documents contain nonbinding recommendations.
On this page:
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives April 2012
Regulatory Submissions: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Draft Guidance, March 2010)
Guidance for Industry: Questions and Answers About the Petition Process (September 2003; Revised April 2006 and April 2011)
Guidance for Industry: Food Additive Petition Expedited Review (January 1999; Revised October 2010)
Submissions for Food Contact Articles and Generally Recognized As Safe (GRAS) Substances
Preparation of Food Contact Notifications: Administrative (June 2000; Revised May 2002)
Threshold of Regulation (TOR) Guidance
Guidance for Submitting Requests under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Contact Articles (March 1996; Revised April 2005)
Frequently Asked Questions about GRAS (December 2004)
Scientific Guidance Documents
Guidance documents available for specific subject areas are listed below. The directions in the documents have been prepared as an informal guide; however, other approaches may be appropriate. Interested individuals are asked to contact the Office of Food Additive Safety if other approaches are being considered.
Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices (January 1993; Revised July 2010)
Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations (April 2002; Revised December 2007)
Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (March 2006; Revised March 2009)
Estimating Dietary Intake of Substances in Food (September 1995; Revised August 2006)
Microbiology Guidance Documents
Guidance documents available relating to Microbiology are listed below.
Guidance for Antimicrobial Food Additives (July 1999)
The guidance documents listed below have been prepared to assist in the design of protocols for animal studies conducted to test the safety of food ingredients.
Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (September 1999; April 2002)
Summary Table of Recommended Toxicological Testing for Additives Used in Food (1983; Revised June 2006)
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I), U.S. Food and Drug Administration, Bureau of Foods (now CFSAN), 1982. May be purchased from: National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield, VA 22161, Telephone (703) 605-6000, NTIS Order Number PB83-170696.
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives: 1993 Draft Redbook II. Sections of Draft Redbook II not yet finalized in Redbook 2000 are available.
Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000 (July 7, 2000; Revised October 2001, November 2003, April 2004, February 2006, and July 2007)
(Redbook 2000 chapters now substitute for or supplement guidance available in the 1982 Redbook I and in the 1993 Draft Redbook II, which can be obtained from the Office of Food Additive Safety. Additional chapters of Redbook 2000 will become available electronically upon their completion.)
Templates for reporting toxicology data (March 2004; April 2005)
When testing is necessary, consult the Environmental Assessment Technical Assistance Handbook for testing guidelines.
Please contact the Environmental Review Group at Premarkt@fda.hhs.gov for assistance in preparing a claim of categorical exclusion or an EA and before doing environmental fate and effects testing.
For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2023).
Color Additives Guidance Documents
Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses