[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: 21CFR70.50]

[Page 330-331]
 
                        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.  70.50  Application of the cancer clause of section 721 of the act.

    (a) Color additives that may be ingested. Whenever (1) the 
scientific data before the Commissioner (either the reports from the 
scientific literature or the results of biological testing) suggest the 
possibility that the color additive including its components or 
impurities has induced cancer when ingested by man or animal; or (2) 
tests which are appropriate for the evaluation of the safety of 
additives in food suggest that the color additive, including its 
components or impurities, induces cancer in man or animal, the 
Commissioner shall determine whether, based on the judgment of 
appropriately qualified scientists, cancer has been induced and whether 
the color additive, including its components or impurities, was the 
causative substance. If it is his judgment that the data do not 
establish these facts, the cancer clause is not applicable; and if the 
data considered as a whole establish that the color additive will be 
safe under the conditions that can be specified in the applicable 
regulation, it may be listed for such use. But if in the judgment of the 
Commissioner, based on information from qualified scientists, cancer has 
been induced, no regulation may issue which permits its use.
    (b) Color additives that will not be ingested. Whenever the 
scientific data before the Commissioner suggest the possibility that the 
color additive, including its components or impurities, has induced 
cancer in man or animals by routes other than ingestion, the 
Commissioner shall determine whether, based on the judgment of 
appropriately qualified scientists, the test suggesting the possibility 
of carcinogenesis is appropriate for the evaluation of the

[[Page 331]]

color additive for a use which does not involve ingestion, cancer has 
been induced, and the color additive, including its components or 
impurities, was the causative substance. If it is his judgment that the 
data do not establish these facts, the cancer clause is not applicable 
to preclude external drug and cosmetic uses, and if the data as a whole 
establish that the color additive will be safe under conditions that can 
be specified in the regulations, it may be listed for such use. But if, 
in the judgment of the Commissioner, based on information from qualified 
scientists, the test is an appropriate one for the consideration of 
safety for the proposed external use, and cancer has been induced by the 
color additive, including its components or impurities, no regulation 
may issue which permits its use in external drugs and cosmetics.
    (c) Color additives for use as an ingredient of feed for animals 
that are raised for food production. Color additives that are an 
ingredient of the feed for animals raised for food production and that 
have the potential to contaminate human food with residues whose 
consumption could present a risk of cancer to people must satisfy the 
requirements of subpart E of part 500 of this chapter.

[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 
FR 49586, Dec. 31, 1987]