[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: 21CFR73.2775]
[Page 378-379]
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. 73.2775 Manganese violet.
(a) Identity. The color additive manganese violet is a violet
pigment obtained by reacting phosphoric acid, ammonium dihydrogen
orthophosphate, and manganese dioxide at temperatures above 450 [deg]F.
The pigment is a manganese ammonium pyrophosphate complex having the
approximate formula: Mn(III)NH4P2O7.
(b) Specifications. Manganese violet 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:
Ash (at 600 [deg]C), not less than 81 percent.
Volatile matter at 135 [deg]C for 3 hours, not more than 1 percent.
Water soluble substances, not more than 6 percent.
pH of filtrate of 10 grams color additive (shaken occasionally for 2
hours with 100 milliliters of freshly boiled distilled water), not more
than 4.7 and not less than 2.5.
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.
Total color, based on Mn content in ``as is'' sample, not less than 93
percent.
(c) Uses and restrictions. Manganese violet is 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
[[Page 379]]
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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