Download the Code of Federal Regulations in XML.
The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.
Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF
Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.
Purchase individual CFR titles from the U.S. Government Online Bookstore.
Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.
Electronic Code of Federal Regulations
Title 21: Food and Drugs
§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:
(1) The amount of bismuth citrate in the cosmetic shall not be in excess of 2.0 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 §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, as amended at 75 FR 14493, Mar. 26, 2010]