21 C.F.R. § 70.40 Safety factors to be considered.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 70—COLOR ADDITIVES
Subpart C—Safety Evaluation
§ 70.40 Safety factors to be considered.
