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 In this section:

        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information

                        
                Food and Color Additives Final Rules Home
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          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information
  	
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*Guidance documents contain nonbinding recommendations.*

**Administrative Guidance Documents**

General Considerations
	Electronic Submissions
	Food and Color Additive Petitions**Submissions for Food Contact Articles and Generally Recognized As Safe (GRAS) Substances**

Food Contact Notifications
	Threshold of Regulation (TOR) Guidance
	Generally Recognized as Safe Notices**Scientific Guidance Documents**

Chemistry Guidance Documents
	Microbiology Guidance Documents
	Toxicology Guidance Documents**Environmental Guidance Documents**

**Color Additives Guidance Documents**

**Contact Us**

Administrative Guidance Documents

**General Considerations**

WITHDRAWN - Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food December 2016
	Guidance for Industry: Voluntary Sodium Reduction Goals October 2021
	Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements January 2014
	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 June 2014
	Fact Sheet: Nanotechnology
	Code of Federal Regulations (CFR) Citations for Color Additives, Food Ingredients and Packaging**Electronic Submissions**

Providing Regulatory Submissions to OFAS
	CFSAN Online Submission Module (COSM)**Petition Process for Food and Color Additives**

Pre-Petition Consultations for Food Additives and Color Additives for the Preparation of Petition Submissions (April 2005)
	Food and Color Additives Final Rules
	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 Notifications for Food Contact Substances (Food Contact Notifications (FCN))**

Proposed Rule: Food Contact Substance Notification That Is No Longer Effective (January 2022)
	Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk (May 2019)
	Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative) (June 2000; Revised May 2002)
	Providing Regulatory Submissions to OFAS
	CFSAN Online Submission Module (COSM)**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)**GRAS Notices******

Guidance for Industry: Best Practices for Convening a GRAS Panel (December 2022)
	Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act (November 2017)
	Frequently Asked Questions about GRAS (October 2016)Scientific Guidance Documents

**Chemistry 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)
	Use of Recycled Plastics in Food Packaging (Chemistry Considerations) (July 2021)
	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)
	Microbiological Considerations for Antimicrobial Agents Used in Food Applications (September 2007; Revised June 2008; Revised September 2021)**Toxicology Guidance Documents**

*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 Substance Notifications (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)Environmental Guidance Documents

Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition (May 2006) - When testing is necessary, consult the Environmental Assessment Technical Assistance Handbook for testing guidelines.
	Environmental Assessment Technical Assistance Handbook - 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.Color Additives Guidance Documents

Guidance for Industry: Colored Sea Salt
	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
	Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact LensesRelated Content

Biotechnology Guidance Documents
	Food Ingredient Chemistry Reference DocumentsContact Us

240-402-1200premarkt@fda.hhs.gov

Office of Food Additive Safety
Additional Contact Information
Food and Color Additive Petitions
CFSAN
5001 Campus Drive
College Park, MD 20740

                                                                                  Content current as of:
      10/17/2023
                  
                   
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Food & Color AdditivesIngredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information                
                          

                        Food and Color Additives Final Rules
 
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