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

Guidance for Industry

Guidance documents contain nonbinding recommendations.

On this page:

Administrative Guidance Documents

General Considerations

Electronic Submissions

Petition Process for Food and Color Additives 

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

Preparation of Notifications for Food Contact Substances (Food Contact Notifications (FCN))

Threshold of Regulation (TOR) Guidance

GRAS Notices 

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.

Microbiology Guidance Documents

Guidance documents available relating to Microbiology are listed below.

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

For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2023).

Contact FDA

Office of Food Additive Safety

Additional Contact Information

Food and Color Additive Petitions


5100 Paint Branch Parkway

College Park, MD 20740

Page Last Updated: 09/29/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.