[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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 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
[[Page 331]]
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]
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