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Electronic Code of Federal Regulations

e-CFR Data is current as of April 23, 2014

Title 21: Food and Drugs
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION


Subpart D—Medical Devices


Contents
§73.3100   1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
§73.3105   1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
§73.3106   1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.
§73.3107   Carbazole violet.
§73.3110   Chlorophyllin-copper complex, oil soluble.
§73.3110a   Chromium-cobalt-aluminum oxide.
§73.3111   Chromium oxide greens.
§73.3112   C.I. Vat Orange 1.
§73.3115   2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
§73.3117   16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.
§73.3118   N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
§73.3119   7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
§73.3120   16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.
§73.3121   Poly(hydroxyethyl methacrylate)-dye copolymers.
§73.3122   4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.
§73.3123   6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.
§73.3124   Phthalocyanine green.
§73.3125   Iron oxides.
§73.3126   Titanium dioxide.
§73.3127   Vinyl alcohol/methyl methacrylate-dye reaction products.
§73.3128   Mica-based pearlescent pigments.
§73.3129   Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.

§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]]

§73.3105   1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

(a) Identity. The color additive is 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione (CAS Reg. No. 6737-68-4).

(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 (the act). A person intending to introduce a device containing 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione 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.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[49 FR 30066, July 26, 1984]

§73.3106   1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

(a) Identity. The color additives are the copolymers formed as the reaction product of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) (CAS Reg. No. 121888-69-5) 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 contact lenses 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.

[58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995; 78 FR 19415, Apr. 1, 2013]

§73.3107   Carbazole violet.

(a) Identity. The color additive is carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Colour Index No. 51319).

(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 for 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) with respect to the contact lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[53 FR 41324, Oct. 21, 1988]

§73.3110   Chlorophyllin-copper complex, oil soluble.

(a) Identity. The color additve is chlorophyllin-copper complex, oil soluble. The chlorophyllin is obtained by extraction from a mixture of fescue and rye grasses. The chlorophyll is acid-treated to remove chelated magnesium which is replaced with hydrogen, which is turn is replaced with copper. This mixture is diluted to a 5 percent concentration with a mixture of palm oil, peanut oil, and hydrogenated peanut oil.

(b) Specifications. The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), 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 current good manufacturing practice:

Moisture, not more than 0.5 percent.

Nitrogen, not less than 0.2 percent and not more than 0.3 percent.

Total copper, not less than 0.2 percent and not more than 0.4 percent.

Free copper, not more than 200 parts per million.

Lead, not more than 20 parts per million.

Arsenic, not more than 5 parts per million.

Sulfated ash, not more than 2.5 percent.

Total color, not less than 4.5 percent and not more than 5.5 percent.

(c) Uses and restrictions. (1) The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), may be safely used to color polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be used at levels that do not exceed 0.003 percent by weight of the bone cement.

(2) Authorization for 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 polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used.

(d) Labeling. The label of the color additive shall conform to the requirements of §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 the color additive is exempt from the certification requirements of section 721(c) of the act.

[48 FR 56370, Dec. 21, 1983]

§73.3110a   Chromium-cobalt-aluminum oxide.

(a) Identity. The color additive chromium-cobalt-aluminum oxide (Pigment Blue 36) (CAS Reg. No. 68187-11-1, Colour Index No. 77343) shall conform in identity and specifications to the requirements of §73.1015 (a) and (b).

(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 for 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) with respect to the contact lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[53 FR 41325, Oct. 21, 1988]

§73.3111   Chromium oxide greens.

(a) Identity and specifications. The color additive chromium oxide greens (chromic oxide) (CAS Reg. No. 1308-38-9), Color Index No. 77288, shall conform in identity and specifications to the requirements of §73.1327 (a)(1) and (b).

(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 §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]

§73.3112   C.I. Vat Orange 1.

(a) Identity. The color additive is C.I. Vat Orange 1, Colour Index No. 59105.

(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 for 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) with respect to the contact lens in which the color additive is used. A person intending to introduce a device containing C.I. Vat Orange 1 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.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[50 FR 20407, May 16, 1985]

§73.3115   2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.

(a) Identity. The color additive2-[[2,5-diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol is formed in situ in soft (hydrophilic) contact lenses.

(b) Uses and restrictions. The color additive 2-[[2,5-diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol may be safely used to mark soft (hydrophilic) contact lenses with the letter R or the letter L for identification purposes subject to the following restrictions:

(1) The quantity of the color additive does not exceed 1.1×10−7 grams in a soft (hydrophilic) contact lens.

(2) When used as specified in the labeling, there is no measurable migration of the color additive from the contact lens to the surrounding ocular tissue.

(3) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[48 FR 22706, May 20, 1983]

§73.3117   16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.

(a) Identity. The color additive is 16,23-dihydrodinaphtho [2,3- a:2′,3′-i] napth [2′,3′:6,7] indolo [2, 3-c] carbazole-5,10, 15,17,22,24-hexone (CAS Reg. No. 2475-33-4), Colour Index No. 70800.

(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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[48 FR 31375, July 8, 1983]

§73.3118   N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.

(a) Identity. The color additive is N,N′-(9,10-dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide (CAS Reg. No. 82-18-8), Colour Index No. 61725.

(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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[48 FR 31375, July 8, 1983]

§73.3119   7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

(a) Identity. The color additive is 7,16-dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone (CAS Reg. No. 130-20-1), Colour Index No. 69825.

(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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[48 FR 31376, July 8, 1983]

§73.3120   16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.

(a) Identity. The color additive is 16,17-dimethoydinaphtho[1,2,3,-cd:3′,2′,1′-lm]perylene-5,10-dione (CAS Reg. No. 128-58-5), Colour Index No. 59825.

(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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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.

[48 FR 31376, July 8, 1983]

§73.3121   Poly(hydroxyethyl methacrylate)-dye copolymers.

(a) Identity. The color additives are formed by reacting one or more of the reactive dyes listed in this paragraph with poly(hydroxyethyl methacrylate), so that the sulfate group (or groups) or chlorine substituent of the dye is replaced by an ether linkage to poly(hydroxyethyl methacrylate). The dyes that may be used alone or in combination are

(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).

(b) Uses and restrictions. (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.

(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 these color additives are exempt from the certification requirements of section 721(c) of the act.

[49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR 9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993]

§73.3122   4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.

(a) Identity. The color additive is 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H- pyrazol-3-one (CAS Reg. No. 6407-78-9).

(b) Uses and restrictions. (1) The substances 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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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 11432, Apr. 3, 1986]

§73.3123   6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.

(a) Identity. The color additive is 6-ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien-2(3H)-ylidene)benzo[b]thiophen-3(2H)-one (CAS Reg. No. 3263-31-8), Colour Index No. 73335.

(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 for 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 lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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 11436, Apr. 3, 1986]

§73.3124   Phthalocyanine green.

(a) Identity. The color additive is phthalocyanine green (CAS Reg. No. 1328-53-6), Colour Index No. 74260.

(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 for 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 lens in which the additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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 11433, Apr. 3, 1986]

§73.3125   Iron oxides.

(a) Identity and specifications. The color additive iron oxides (CAS Reg. No. 1332-37-2), Color Index No. 77491, shall conform in identity and specifications to the requirements of §73.2250 (a) and (b).

(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 lens in which the additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of §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, as amended at 69 FR 24511, May 4, 2004]

§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 §73.575(a)(1) and (b).

(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 §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]

§73.3127   Vinyl alcohol/methyl methacrylate-dye reaction products.

(a) Identity. The color additives are formed by reacting the dyes, either alone or in combination, with a vinyl alcohol/methyl methacrylate copolymer, so that the sulfate groups of the dyes are replaced by ether linkages to the vinyl alcohol/methyl methacrylate copolymer. The dyes are:

(1) 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).

(2) C.I. 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).

(3) C.I. 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) C.I. Reactive Yellow 15 [benzenesulfonic 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) C.I. Reactive Blue No. 19 [2-anthracenesulfonic 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) C.I. Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-N29, N30, N31, N32)-, sulfo((4-((2-(sulfooxy) ethyl)sulfonyl)phenyl)amino)sulfonyl derivatives] (CAS Reg. No. 73049-92-0).

(b) Uses and restrictions. (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 dye.

(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 vinyl alcohol/methyl methacrylate-dye reaction product 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.

(c) Labeling. The label of the color additive shall conform to the requirements of §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, this color additive is exempt from the certification requirements of section 721(c) of the act.

[58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993]

§73.3128   Mica-based pearlescent pigments.

(a) Identity and specifications. The color additive is formed by depositing titanium or iron salts from a basic solution onto mica, followed by calcination to produce titanium dioxide or iron oxides on mica. Mica used to manufacture the color additive shall conform in identity and specifications to the requirements of §73.1496(a)(1) and (b).

(b) Uses and restrictions. (1) Mica-based pearlescent pigments 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 (the 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 in §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 batches thereof are exempt from the certification requirements of section 721(c) of the act.

[67 FR 65312, Oct. 24, 2002]

§73.3129   Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.

(a) Identity. The color additive is disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate (Reactive Blue 69) (CAS Reg. No. 70209-99-3, Colour Index No. 612037).

(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 in §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 batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[76 FR 25235, May 4, 2011, as amended at 78 FR 14664, Mar. 7, 2013]



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