21 CFR 73.1496 - Mica.

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There are 2 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
§ 73.1496 Mica.
(a) Identity.
(1) The color additive mica is a white powder obtained from the naturally occurring mineral, muscovite mica, consisting predominantly of a potassium aluminum silicate, K2Al4(Al2Si6O20)(OH)4 or, alternatively, H2KAl3 (SiO4)3. Mica may be identified and semiquantitatively determined by its characteristic X-ray diffraction pattern and by its optical properties.
(2) Color additive mixtures for drug use made with mica may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Mica 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:
Fineness, 100 percent shall pass through a 100-mesh sieve.
Loss on ignition at 600-650 °C, not more than 2 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.
(c) Uses and restrictions. Mica may be safely used in amounts consistent with good manufacturing practice to color dentifrices and externally applied drugs, including those for use in the area of the eye.
(d) Labeling requirements. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 38561, July 29, 1977, as amended at 52 FR 29665, Aug. 11, 1987]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2014-10-22; vol. 79 # 204 - Wednesday, October 22, 2014
    1. 79 FR 63062 - Colorcon, Inc.; Filing of Color Additive Petition
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      The color additive petition was filed on September 22, 2014.
      21 CFR Part 73