Guidance and Reference Documents for Petitions and Notifications
Introduction to Guidance for Submitting Petitions and Notifications
Petition Process for Food Ingredients
Exceptions to the Petition Process
for Food Ingredients
Chemistry Guidance Documents |
Chemistry Reference Documents
Toxicology Guidance Documents
Environmental Documents
Templates for Reporting Toxicology Data
Petition Process for Food Ingredients Documents
- Electronic Submissions (Draft Guidance)
- Providing Regulatory Submissions in Electronic Format--General Considerations
- Providing Food and Color Additive Petitions in Electronic Format
- Submission Forms
- Providing Regulatory Submissions in Electronic Format--General Considerations
- Preparing Petitions
- Guidelines for the Preparation of Petition Submissions
- Frequently Asked Questions About the Petition Process
- Color Additives
- Summary of Color Additives Listed for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
- Color Additive Petitions: FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, or Cosmetics
- Food Additives Top
Exceptions to the Petition Process for Food Ingredients
- Threshold of Regulation (TOR) Guidance
- Preparation of Notifications for Food Contact Substances (Food Contact Notifications (FCN))
- Preparation of Food Contact Notifications: Administrative
- Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations
- Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations
- Additional Information
- Preparation of GRAS Notices
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.
- Sanitizing Solutions: Chemistry
Guidelines for Food Additive Petitions; January 1993
- Points to Consider for the Use of
Recycled Plastics in Food Packaging: Chemistry Considerations,
Version 1.1; December 1992.
- Recommendations for Submission of Chemical and Technological
Data for Direct Food Additive and
GRAS Food Ingredient Petitions, 1993.
- Recommendations for Preparation of Food
Contact Notifications and Food Additive Petitions for Food Contact
Substances, April 2002.
- Enzyme Preparations: Chemistry
Recommendations for Food Additive and GRAS Affirmation
Petitions.
- Estimating Exposure to Direct Food Additives and Chemical Contaminants in the Diet.
The purity specifications for manufacture of food ingredients and methods for detecting these ingredients in food can be found in the following documents.
- Methods of analysis and identification incorporated by reference
into Title 21, Code of Federal Regulations. Currently
available from the Office of Food Additive Safety.
- Food Chemicals Codex 3rd Ed. (1981), Food Chemicals Codex 4th Ed. (1996) and First Supplement (1997). May be purchased from: National Academy Press, 2101 Constitution Avenue, N.W., Lockbox 285, Washington, D.C. 20055; 1-800-624-6242, or 202-334-3313 (in the Washington metropolitan area). Currently, Food Chemicals Codex 3rd Ed. is incorporated by reference in the Code of Federal Regulations.
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.
- Toxicological
Testing of Food Additives, 1997
- 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 of Food Ingredients:
Redbook 2000 July 7, 2000; updated October 2001, November 2003, and April 2004.
The Agency is in the process of updating the Redbook and is now making Redbook 2000 chapters available electronically. The Redbook 2000 chapters now substitute for, or supplement, guidance available in the 1982 Redbook I (see above) and in the 1993 Draft Redbook II, which can be obtained from the Office of Food Additive Safety. As additional chapters of Redbook 2000 are completed they will become available electronically. - Templates for reporting toxicology data March 2004
Environmental Guidance
The draft guidance listed below is intended to assist submitters in the preparation of claims of categorical exclusion and environmental assessments (EA). The draft guidance recommends the types of information that would be helpful to the agency's review of environmental submissions and refers to the NEPA-implementing regulations in 21 CFR Part 25 that were revised in July 29, 1997.
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.
If extraordinary circumstances indicate that the proposed action might have significant environmental impacts, the agency will require the preparation of an EA for any normally excluded action. Examples of extraordinary circumstances are listed under Council on Environmental Quality regulations (40 CFR 1508.27) at http://ceq.eh.doe.gov/nepa/regs/ceq/1508.htm. In most instances, a categorical exclusion can be determined or confirmed by review of other information in the submission. In limited instances, CFSAN will recommend additional information to establish that the criteria for a categorical exclusion have been met, particularly for exclusions claimed under 21 CFR 25.32(i) and (q).
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 ERG@CFSAN.FDA.GOV for assistance in preparing a claim of categorical exclusion or an EA and before doing environmental fate and effects testing.
