[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: 21CFR70.42]
[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 ``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
[[Page 330]]
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.
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