[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.22]

[Page 12]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 170--FOOD ADDITIVES--Table of Contents
 
                     Subpart B--Food Additive Safety
 
Sec. 170.22  Safety factors to be considered.

    In accordance with section 409(c)(5)(C) of the Act, the following 
safety factors will be applied in determining whether the proposed use 
of a food additive will be safe: Except where evidence is submitted 
which justifies use of a different safety factor, a safety factor in 
applying animal experimentation data to man of 100 to 1, will be used; 
that is, a food additive for use by man will not be granted a tolerance 
that will exceed \1/100\th of the maximum amount demonstrated to be 
without harm to experimental animals.