[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.22]

[Page 12-13]
 
                        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

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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.