[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
Subpart D_Medical Devices
Sec. 73.3126 Titanium dioxide.
(a) Identity and specifications. The color additive titanium dioxide
(CAS Reg. No. 13463-67-7), Color Index No. 77891, shall conform in
identity and specifications to the requirements of Sec. 73.575(a)(1)
(b) Uses and restrictions. (1) The substance listed in paragraph (a)
of this section may be used as a color additive in contact lenses in
amounts not to exceed the minimum reasonably required to accomplish the
intended coloring effect.
(2) Authorization and compliance with this use shall not be
construed as waiving any of the requirements of sections 510(k), 515,
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to
the contact lenses in which the additive is used.
(c) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(d) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore the color additive is exempt from the certification
requirements of section 721(c) of the act.
[51 FR 24816, July 9, 1986]
Additives that reference this regulation: