[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.40]

[Page 335]
 
                        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.