[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.42]

[Page 329-330]
 
                        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.  70.42  Criteria for evaluating the safety of color additives.

    (a) In deciding whether a petition is complete and suitable for 
filing and in reaching a decision on any petition filed, the 
Commissioner will apply the

[[Page 330]]

``safe-for-use'' principle. This will require the presentation of all 
needed scientific data in support of a proposed listing to assure that 
each listed color additive will be safe for its intended use or uses in 
or on food, drugs, or cosmetics. The Commissioner may list a color 
additive for use generally in or on food, in or on drugs, or in or on 
cosmetics when he finds from the data presented that such additive is 
suitable and may safely be employed for such general use; he may list an 
additive only for more limited use or uses for which it is proven 
suitable and may safely be employed; and he is authorized to prescribe 
broadly the conditions under which the additive may be safely employed 
for such use or uses. This may allow the use of a particular dye, 
pigment, or other substance with certain diluents, but not with others, 
or at a higher concentration with some than with others.
    (b) The safety for external color additives will normally be 
determined by tests for acute oral toxicity, primary irritation, 
sensitization, subacute dermal toxicity on intact and abraded skin, and 
carcinogenicity by skin application. The Commissioner may waive any of 
such tests if data before him otherwise establish that such test is not 
required to determine safety for the use proposed.
    (c) Upon written request describing the proposed use of a color 
additive and the proposed experiments to determine its safety, the 
Commissioner will advise a person who wishes to establish the safety of 
a color additive whether he believes the experiments planned will yield 
data adequate for an evaluation of the safety of the additive.