[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.3045]
[Page 420-421]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
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
[[Page 421]]
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, and
polymethylmethacrylate monofilament used as supporting haptics 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 or haptic material.
(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 Sec. 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]
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