---
kind: "section"
citation: "21 C.F.R. § 73.3100"
title: "21"
number: "73.3100"
heading: "1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers."
url: "https://uscodex.org/cfr/21/73.3100"
---

# §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)](#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)](/cfr/21/510.md?p=k), [515](/cfr/21/515.md), and [520(g)](/cfr/21/520.md?p=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](/cfr/21/70.25.md) 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)](/cfr/21/721.md?p=c) of the act.

## Notes

### Amendments

[61 FR 51586, Oct. 3, 1996, as amended at 78 FR 19415, Apr. 1, 2013]]

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.

### Amendments

[61 FR 51586, Oct. 3, 1996, as amended at 78 FR 19415, Apr. 1, 2013]]