21 CFR 73.3100 - 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.

Status message

There are 2 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
prev | next
§ 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
(a) Identity. The color additives are the copolymers formed as the reaction product of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) (CAS Reg. No. 109561-07-1) with one or more vinyl and/or acrylic monomers to form the contact lens material.
(b) Uses and restrictions.
(1) The substances listed in paragraph (a) of this section may be used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with these uses 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 (the act) with respect to the contact lens made from the color additives.
(c) Labeling. The label of the color additives shall conform to the requirements of § 70.25 of this chapter.
(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health and therefore the color additives are exempt from the certification requirements of section 721(c) of the act.
[61 FR 51586, Oct. 3, 1996, as amended at 78 FR 19415, Apr. 1, 2013]]

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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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
      GPO FDSys XML | Text
      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