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U.S. Department of Health and Human Services

Food

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

Guidance for Industry

Guidance documents contain nonbinding recommendations.


On this page:

Food and Color Additive Petitions

Food Contact Notifications

Generally Recognized as Safe Notices

Color Additives Giudance Documents

 

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

240-402-1200
Office of Food Additive Safety

Additional Contact Information

Food and Color Additive Petitions

CFSAN

5100 Paint Branch Parkway

College Park, MD 20740
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