This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.2725]
[Page 381]
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 Contents
Subpart C--Cosmetics
Sec. 73.2725 Ultramarines.
(a) Identity. The color additives, ultramarines (blue, green, pink,
red, and violet) are pigments obtained by calcining at temperatures
above 700 [deg]C. a mixture of kaolin, sulfur, sodium carbonate,
silicious matter, sodium sulfate, and carbonaceous matter, but not
necessarily all these substances, to produce a single color. The
ultramarines are complex sodium aluminum sulfosilicates having a typical
formula Na(AlSiO)S with proportions of each element varying with each
color.
(b) Specifications. The ultramarines shall conform to the following
specifications and shall be free from impurities other than those named,
to the extent that such other impurities may be avoided by good
manufacturing practice.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. The ultramarine pigments may be safely
used for coloring externally applied cosmetics, including cosmetics
intended for use in the area of the eye, in amounts consistent with good
manufacturing practice.
(d) Labeling requirements. The color additives and any mixtures
prepared therefrom intended solely or in part for coloring purposes
shall bear, in addition to any other 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.