FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
September 2007

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Guidance and Reference Documents for Petitions and Notifications

Biotechnology Electronic Submissions Chemistry Guidance and Reference Documents Microbiology documents
Food and Color Additives Food Contact Substances Environmental Guidance Documents Redbook 2000
GRAS Notices Threshold of Regulation Templates for Reporting Toxicology DataToxicology Guidance Documents

Stakeholder's Letter October 5, 2000
(describing improvements to the food and color additive petition review process)

Administrative Guidance Documents

Petition Process for Food and Color Additives


Submissions for Food Contact Articles, Generally Recognized As Safe (GRAS) Substances and Biotechnology


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.


Chemistry Reference Documents

The purity specifications for manufacture of food ingredients and methods for detecting these ingredients in food can be found in the following documents.



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.


Environmental Guidance Documents

The guidance listed below is intended to assist submitters in the preparation of claims of categorical exclusion and environmental assessments (EA). The 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.


Additional Contact Information
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