[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.40]
[Page 329]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70 COLOR ADDITIVES--Table of Contents
Subpart C Safety Evaluation
Sec. 70.40 Safety factors to be considered.
In accordance with section 721(b)(5)(A)(iii) of the act, the
following safety factor will be applied in determining whether the
proposed use of a color additive will be safe: Except where evidence is
submitted which justifies use of a different safety factor, a safety
factor of 100 to 1 will be used in applying animal experimentation data
to man; that is, a color additive for use by man will not be granted a
tolerance that will exceed 1/100th of the maximum no-effect level for
the most susceptible experimental animals tested. The various species of
experimental animals used in the tests shall conform to good
pharmacological practice.
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