Center for Food Safety & Applied Nutrition Office of Premarket Approval 1983; Updated 1997 (Effective June 18, 2001, Office of Premarket Approval is now Office of Food Additive Safety. See updated contact information) |
The latest version of this guidance issued in June 2006. Below is an earlier version.
This document was reformatted in 1997. No substantive changes have been made.
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A. Acute oral study--rodent B. Short-term feeding study (at least 28 days)--rodent C. Subchronic feeding study (90-day)--rodent with in-utero exposure D. Subchronic feeding study (90-day)--rodent E. Subchronic feeding study (90-day)--non-rodent F. Lifetime feeding study (ca 2-year)--rodent with in-utero exposure for carcinogenesis and chronic toxicity G. Lifetime feeding study (ca 2-year)--rodent for carcinogenesis H. Short-term feeding study (at least 1 year)--non-rodent I. Multigenerational reproduction feeding study (minimum of 2 generations) with teratology phase--rodent J. Teratology study K. Short-term tests for carcinogenic potential L. Metabolism studies
References to current guides on these toxicology studies are contained in the "Redbook" |
for Direct Food Additives | |||
Degree of Concern
LOWER |
Structure C
0.25 ppm**
0.0125 ppm
|
Structure B
0.5 ppm
0.025 ppm
|
Structure A
1.0 ppm
0.05 ppm
|
** ppm = parts per million dietary |
The latest version of
this guidance issued in June 2006.
This document was issued in 1983 and updated in 1997.
For more recent information on Guidance and Reference Documents for
Petitions and Notifications
see
http://www.cfsan.fda.gov/~dms/opa-guid.html
Hypertext updated by dms/hrw/emw 2006-JUN-01