[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: 21CFR74.2602a]
 
[Page 421]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                          Subpart C--Cosmetics
 
Sec. 74.2602a  Ext. D&C Violet No. 2.
 
    (a) Identity. The color additive Ext. D&C Violet No. 2 is
principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy -9,10-
dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid.
    (b) Specifications. Ext. D&C Violet No. 2 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:
 
Sum of volatile matter (at 135 deg.C) and chlorides and sulfates
(calculated as sodium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.4 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.
p- Toluidine, not more than 0.1 percent.
p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.
Subsidiary colors, not more than 1 percent.
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, not less than 80 percent.
 
    (c) Uses and restrictions. The color additive Ext. D&C; Violet No. 2
may be safely used for coloring externally applied cosmetics in amounts
consistent with good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
    (e) Certification. All batches of Ext. D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.