[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: 21CFR73.2110]
 
 [Page 375]
 
                         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. 73.2110  Bismuth citrate.
 
     (a) Identity. The color additive bismuth citrate is the
 synthetically prepared crystalline salt of bismuth and citric acid,
 consisting principally of BiC<INF>6</INF>H<INF>5</INF>O<INF>7</INF>.
     (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:
     (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]