(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 °C (275 °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]
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