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  5. Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information
  1. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

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

Guidance for Industry

Guidance documents contain nonbinding recommendations.

Administrative Guidance Documents

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

Scientific Guidance Documents

Environmental Guidance Documents

Color Additives Guidance Documents

Contact Us


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

Color Additives Guidance Documents

Related Content

Contact Us

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

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