[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: 21CFR73.1496]
 
 [Page 371]
 
                         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 B--Drugs
 
 Sec. 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,
 K<INF>2</INF>Al<INF>4</INF>(Al<INF>2</INF>Si<INF>6</INF>O<INF>20</INF>)(O
 H)<INF>4</INF> or, alternatively, H<INF>2</INF>KAl<INF>3</INF>
 (SiO<INF>4</INF>)<INF>3.</INF> 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 deg.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 Sec. 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]