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CFSAN/Office of Food Additive Safety
September 2007
Guidance and Reference Documents for Petitions and Notifications
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
- Electronic Submissions (Draft Guidance)
-
Preparing Petitions
- Food Additives
- Color Additives
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Submissions for Food Contact Articles, Generally Recognized As Safe (GRAS) Substances and Biotechnology
- Preparation of Notifications for Food Contact Substances (Food Contact Notifications (FCN))
- Threshold of Regulation (TOR) Guidance
- Preparation of GRAS Notices
- Preparation of Biotechnology Submissions
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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.
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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.
- Methods of analysis and identification incorporated by reference
into Title 21, Code of Federal Regulations. Currently
available from the Office of Food Additive Safety.
- Citations to the second through fifth editions of the Food Chemicals Codex are incorporated by reference in the Code of Federal Regulations. The most recent edition (5th) was published in 2003. May be purchased from: National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, D.C. 20055; 1-800-624-6242, or 202-334-3313 (in the Washington metropolitan area); internet: www.nap.edu.
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Microbiology
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.
- Preparation of Food Contact Notifications
for Food Contact Substances: Toxicology Recommendations
- Summary Table of Recommended Toxicological Testing for Additives Used in Food, June 2006
- 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 Assessment of Direct Food Additives and Color Additives: 1993 Draft Redbook II. The Agency is in the process of finalizing the chapters of the 1993 Draft Redbook II. Sections of Draft Redbook II not yet finalized in Redbook 2000 are now available for your reference.
- Toxicological Principles for the Safety Assessment of Food Ingredients:
Redbook 2000 July 7, 2000; updated October 2001, November 2003, April 2004, February 2006, and July 2007. 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; April 2005
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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.
- Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition, May 2006
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. 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 for assistance in preparing a claim of categorical exclusion or an EA and before doing environmental fate and effects testing.
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