[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: 21CFR73.2110]
[Page 371-372]
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. 73.2110 Bismuth citrate.
(a) Identity. The color additive bismuth citrate is the
synthetically prepared crystalline salt of bismuth and citric acid,
consisting principally of BiC6H5O7.
(b) Specifications. The color additive bismuth citrate shall conform
to the following specifications and shall be free from impurities other
than those named to the extent that those impurities may be avoided by
good manufacturing practice:
Bismuth citrate, not less than 97 percent.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Volatile matter, not more than 1 percent.
(c) Uses and restrictions. The color additive bismuth citrate may be
safely used in cosmetics intended for coloring hair on the scalp,
subject to the following restrictions:
[[Page 372]]
(1) The amount of bismuth citrate in the cosmetic shall not be in
excess of 0.5 percent (w/v).
(2) The cosmetic may not be used for coloring eyelashes, eyebrows,
or hair on parts of the body other than the scalp.
(d) Labeling. (1) The label of the color additive bismuth citrate
shall bear, in addition to any information required by law, labeling in
accordance with the provisions of Sec. 70.25 of this chapter.
(2) The label of a cosmetic containing the color additive bismuth
citrate shall bear, in addition to other information required by law,
the following statement, conspicuously displayed thereon:
Keep this product out of children's reach. Do not use on cut or
abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts
of the body other than the scalp. Wash hands thoroughly after each use.
(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
certification requirements of section 721(c) of the act.
[43 FR 44831, Sept. 29, 1978]
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