[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: 21CFR73.2180]
[Page 373]
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. 73.2180 Guaiazulene.
(a) Identity. (1) The color additive, guaiazulene, is principally
1,4-dimethyl-7-isopropyl-azulene.
(2) Color additive mixtures of guaiazulene for cosmetic use may
contain the following diluent:
Polyethylene glycol-40 castor oil (PEG-40 castor oil).
Saponification No., 60 to 70.
Hydroxyl No., 63 to 78.
Acid No., 2.
Specific gravity, 1.05 to 1.07.
(b) Specifications. Guaiazulene 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.
Melting point, 30.5 [deg]C to 31.5 [deg]C.
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 99 percent.
(c) Uses and restrictions. Guaiazulene may be safely used in
externally applied cosmetics in amounts consistent with good
manufacturing practice.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom intended solely or in part for coloring purposes
shall conform to the requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive for the prescribed use is not necessary for the protection of
the public health and therefore batches thereof are exempt from the
certification requirements of section 721(c) of the act.
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