Code of Federal Regulations Title 21. Food and Drugs § 21.73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers

(1) Reactive Black 5 [2,7–naphthalenedisulfonic acid, 4–amino–5–hydroxy–3,6–bis((4–((2–(sulfooxy)ethyl)sulfonyl)phenyl)azo)- tetrasodium salt] (CAS Reg. No. 17095–24–8);

(2) Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2–)–N²⁹,N³⁰,N³¹,N³²)-, sulfo((4–((2–sulfooxy)ethyl)sulfonyl)phenyl)amino)sulfonyl derivs] (CAS Reg. No. 73049–92–0);

(3) Reactive Orange 78 [2–naphthalenesulfonic acid, 7–(acetylamino)–4–hydroxy–3–((4–((2–(sulfooxy)ethyl)sulfonyl)phenyl)azo)-] CAS Reg. No. 68189–39–9);

(4) Reactive Yellow 15 [benzensulfonic acid, 4–(4,5–dihydro–4–((2–methoxy–5–methyl–4–((2–(sulfooxy)ethyl)sulfonyl)phenyl) azo)–3–methyl–5–oxo–1H-pyrazol–1–yl)-] (CAS Reg. No. 60958–41–0);

(5) Reactive Blue No. 19 [2–anthracene-sulfonic acid, 1–amino–9, 10–dihydro–9,10–dioxo–4–((3–((2–(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580–78–1);

(6) Reactive Blue No. 4 [2–anthracenesulfonic acid, 1–amino–4–(3–((4,6–dichloro-s-triazin–2–yl)amino)–4–sulfoanilino)– 9,10–dihydro–9,10–dioxo, disodium salt] (CAS Reg. No. 4499–01–8);

(7) C.I. Reactive Red 11 [5–((4,6–dichloro–1,3,5–triazin–2–yl)amino)–4–hydroxy– 3–((1–sulfo–2–naphthalenyl)azo)–2, 7–naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226–08–3);

(8) C.I. Reactive Yellow 86 [1,3–benzenedisulfonic acid, 4–((5–aminocarbonyl–1–ethyl–1,6–dihydro–2–hydroxy–4–methyl–6–oxo– 3–pyridinyl)azo)–6–(4,6–dichloro–1,3,5–triazin–2–yl)amino)-, disodium salt] (CAS Reg. No. 61951–86–8);

(9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13–dichloro–3, 10–bis((4–((4.6–dichloro–1,3,5–triazin–2–yl)amino) sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847–56–4);  and

(10) C.I. Reactive Red 180 [5–(benzoylamino)–4–hydroxy–3–((1–sulfo–6–((2–(sulfooxy)ethyl)sulfonyl) –2–naphthalenyl)azo)–2,7–naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114–32–0).

(1) The substances listed in paragraph (a) of this section may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dyes.

(3) 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 (the act). A person intending to introduce a device containing a poly(hydroxyethyl methacrylate)-dye copolymer listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.