CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR74]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
					
SUBCHAPTER A - GENERAL
					
							PART 74LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

Subpart D - Medical Devices

Sec. 74.3045 [Phthalocyaninato(2-)] copper.

(a) Identity. The color additive is [phthalocyaninato(2-)] copper (CAS Reg. No. 147-14-8) having the structure shown in Colour Index No. 74160.

(b) Specifications. The color additive [phthalocyaninato(2-)] copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:

Volatile matter 135 deg.C (275 deg.F), not more than 0.3 percent.

Salt content (as NaC1), not more than 0.3 percent.

Alcohol soluble matter, not more than 0.5 percent.

Organic chlorine, not more than 0.5 percent.

Aromatic amines, not more than 0.05 percent.

Lead (as Pb), not more than 40 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 1 part per million.

Total color, not less than 98.5 percent.

(c) Uses and restrictions. (1) The color additive [phthalocyaninato(2-)] copper may be safely used to color polypropylene sutures, polybutester (the generic designation for the suture fabricated from 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol and alpha -hydro-omega -hydroxypoly(oxy-1,4-butanediyl), CAS Reg. No. 37282-12-5) nonabsorbable sutures for use in general and ophthalmic surgery, polybutylene terephthalate nonabsorbable monofilament sutures for general and ophthalmic surgery, nonabsorbable sutures made from poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene) for general and ophthalmic surgery, polymethylmethacrylate monofilament used as supporting haptics for intraocular lenses, and polymers used in orientation marks for intraocular lenses, subject to the following restrictions:

(i) The quantity of the color additive does not exceed 0.5 percent by weight of the suture, haptic material, or orientation mark.

(ii) The dyed suture shall conform in all respects to the requirements of the U.S. Pharmacopeia.

(2) The color additive [phthalocyaninato(2-)] copper may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(3) Authorization for these uses shall not be construed as waiving any of the requirements of section 510(k), 515, or 520(g) the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which [phthalocyaninato(2-)] copper is used.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of [phthalocyaninato (2-)] copper shall be certified in accordance with regulations in part 80 of this chapter.

[48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985; 51 FR 22929, June 24, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR 19620, May 10, 1990; 64 FR 23186, Apr. 30, 1999; 81 FR 75692, Nov. 1, 2016]

Sec. 74.3054 D&C Black No. 4.

(a) Identity. The color additive D&C Black No. 4 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 50 to 260 meters (m) ²/gram.

(b) Specifications. D&C Black No. 4 must conform to the following specifications and must be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

(1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 50 to 260 m ²/gram.

(2) Weight loss on heating at 950 deg.C for 7 minutes (predried for 1 hour at 125 deg.C), not more than 2 percent.

(3) Ash content, not more than 0.15 percent.

(4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).

(5) Lead (total), not more than 10 mg/kg (10 parts per million).

(6) Mercury (total), not more than 1 mg/kg (1 part per million).

(7) Total sulfur, not more than 0.65 percent.

(8) Total polycyclic aromatic hydrocarbons (PAHs), not more than 0.5 mg/kg (500 parts per billion).

(9) Benzo[a ]pyrene, not more than 0.005 mg/kg (5 parts per billion).

(10) Dibenz[a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion).

(11) Total color (as carbon), not less than 95 percent.

(c) Uses and restrictions. (1) D&C Black No. 4 may be safely used at a level not to exceed 1.0 percent by weight of the suture material for coloring ultra-high molecular weight polyethylene non-absorbable sutures for general surgical use.

(2) Authorization and compliance with this use must 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 ultra-high molecular weight polyethylene surgical sutures in which D&C Black No. 4 is used.

(d) Labeling. The label of the color additive must conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Black No. 4 must be certified in accordance with regulations in part 80 of this chapter.

[83 FR 26359, June 7, 2018]

Sec. 74.3102 FD&C Blue No. 2.

(a) Identity. The color additive FD&C Blue No. 2 shall conform in identity to the requirements of § 74.102(a)(1).

(b) Specifications. (1) The color additive FD&C Blue No. 2 for use in coloring surgical sutures shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:

Sum of volatile matter at 135 deg.C (275 deg.F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.

Water insoluble matter, not more than 0.4 percent.

Isatin-5-sulfonic acid, not more than 0.4 percent.

Isomeric colors, not more than 18 percent.

Lower sulfonated subsidiary colors, not more than 5 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total color, not less than 85 percent.

(2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina for use in bone cement shall be prepared in accordance with the requirements of § 82.51 of this chapter.

(c) Uses and restrictions. (1) The color additive FD&C Blue No. 2 may be safely used for coloring nylon (the copolymer of adipic acid and hexamethylene diamine) surgical sutures for use in general surgery subject to the following restrictions:

(i) The quantity of color additive does not exceed 1 percent by weight of the suture;

(ii) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980); and

(iii) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissues.

(2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina may be safely used for coloring bone cement at a level not to exceed 0.1 percent by weight of the bone cement.

(3) 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 with respect to the medical device in which the color additive FD&C Blue No. 2 and the color additive FD&C Blue No. 2-Aluminum Lake on alumina are used.

(d) Labeling. The labels of the color additive FD&C Blue No. 2 and the color additive FD&C Blue No. 2-Aluminum Lake on alumina shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of FD&C Blue No. 2 and its lake shall be certified in accordance with regulations in part 80 of this chapter.

[64 FR 48290, Sept. 3, 1999]

Sec. 74.3106 D&C Blue No. 6.

(a) Identity. The color additive D&C Blue No. 6 is principally

(b) Specifications. D&C Blue No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Volatile matter at 135 deg.C (275 deg.F), not more than 3 percent.

Matter insoluble in N,N- dimethylformamide, not more than 1 percent.

Isatin, not more than 0.3 percent.

Anthranilic acid, not more than 0.3 percent.

Indirubin, not more than 1 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 1 part per million.

Total color, not less than 95 percent.

(i) Not to exceed 0.2 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures for general surgical use;

(ii) Not to exceed 0.25 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for general surgical use;

(iii) Not to exceed 0.5 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for ophthalmic surgical use;

(iv) Not to exceed 0.5 percent by weight of the suture material for coloring polypropylene surgical sutures for general surgical use; and

(v) Not to exceed 0.5 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use.

(2) Authorization for 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 with respect to the medical device in which the color additive is used.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Blue No. 6 shall be certified in accordance with regulations in part 80 of this chapter.

[49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985]

Sec. 74.3206 D&C Green No. 6.

(a) Identity. The color additive D&C Green No. 6 shall conform in identity to the requirements of § 74.1206(a).

(b) Specifications. The color additive D&C Green No. 6 for use in medical devices shall conform to the specifications of § 74.1206(b).

(i) Not to exceed 0.03 percent by weight of the lens material for coloring contact lenses;

(ii) Not to exceed 0.75 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures, including sutures for ophthalmic use;

(iii) Not to exceed 0.1 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter greater than U.S.P. size 8-0, including sutures for ophthalmic use;

(iv) Not to exceed 0.5 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter not greater than U.S.P. size 8-0, including sutures for ophthalmic use;

(v) Not to exceed 0.21 percent by weight of the suture material for coloring poly(glycolic acid-co -trimethylene carbonate) sutures (also referred to as 1,4-dioxan-2,5-dione polymer with 1,3-dioxan-2-one) for general surgical use; and

(vi) Not to exceed 0.10 percent by weight of the haptic material for coloring polymethylmethacrylate support haptics of intraocular lenses.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations in part 80 of this chapter.

[48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993]

Sec. 74.3230 D&C Red No. 17.

(a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(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 lens 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 section 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.

(d) Certification. All batches of D&C Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter.

[55 FR 22898, June 5, 1990]

Sec. 74.3602 D&C Violet No. 2.

(a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b).

(b) Uses and restrictions. (1) The color additive, D&C Violet No. 2, may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(2) D&C Violet No. 2 may be safely used for coloring sutures for use in surgery subject to the following conditions:

(i) At a level not to exceed 0.2 percent by weight of the suture material for coloring copolymers of 90 percent glycolide and 10 percent L-lactide synthetic absorbable sutures for use in general and ophthalmic surgery; and

(ii) At a level not to exceed 0.3 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for use in general and ophthalmic surgery.

(iii) At a level not to exceed 0.25 percent by weight of the suture material for coloring poliglecaprone 25 (Îµ-caprolactone/glycolide copolymer) synthetic absorbable sutures for use in general surgery.

(iv) At a level not to exceed 0.1 percent by weight of the suture material for coloring poly(Îµ-caprolactone) absorbable sutures for use in general surgery.

(v) At a level not to exceed 0.2 percent by weight of the suture material for coloring glycolide/dioxanone/trimethylene carbonate tripolymer absorbable sutures for use in general surgery.

(vi) At a level not to exceed 0.2 percent by weight of the suture material for coloring absorbable sutures prepared from homopolymers of glycolide for use in general surgery.

(3) The color additive, D&C Violet No. 2, may be safely used for coloring polymethylmethacrylate intraocular lens haptics at a level not to exceed 0.2 percent by weight of the haptic material.

(4) The color additive, D&C Violet No. 2, may be safely used for coloring absorbable meniscal tacks made from poly (L-lactic acid) at a level not to exceed 0.15 percent by weight of the tack material.

(5) Authorization for 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 with respect to the medical devices in which the color additive is used.

(d) Certification. All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.

[52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000]

Sec. 74.3708 D&C Yellow No. 8.

(a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1708(a)(1) and (b).

(b) Uses and restrictions. (1) D&C Yellow No. 8 may be safely used for coloring contact lens solution for coloring disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses at a level not to exceed 0.044 percent in the contact lens solution. Following excitation by ultraviolet light, the colored contact lenses fluoresce a yellow-green color. The contact lens solution colored with D&C Yellow No. 8 is distributed by prescription only and used in accordance with the supplied directions for use. Contact lens solutions containing D&C Yellow No. 8 are intended for use only for coloring contact lenses that are worn for infrequent, celebratory occasions, and not for regular or daily use.

(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 solution in which the color additive is used.

(d) Certification. All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

[83 FR 48375, Sept. 25, 2018]

Sec. 74.3710 D&C Yellow No. 10.

(a) Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of § 74.1710(a).

(b) Specifications. The color additive D&C Yellow No. 10 for use in contact lenses shall conform to the specifications of § 74.1710(b).

(c) Uses and restrictions. (1) The color additive D&C Yellow No. 10 may be used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter.

[52 FR 28690, Aug. 3, 1987]

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.

CFR - Code of Federal Regulations Title 21

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