[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: 21CFR73.2250]
[Page 374]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of
Subpart C Cosmetics
Sec. 73.2250 Iron oxides.
(a) Identity. The color additives iron oxides consist of any one or
any combination of synthetically prepared iron oxides, including the
hydrated forms. It is free from admixture with other substances.
(b) Specifications. Iron oxides shall conform to the following
specifications, all on an ``as is'' basis:
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Uses and restrictions. Iron oxides are safe for use in coloring
cosmetics generally, including cosmetics applied to the area of the eye,
in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom
intended solely or in part for coloring purposes shall bear, in addition
to any information required by law, labeling in accordance with Sec.
70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from certification pursuant to
section 721(c) of the act.
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