This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.3110]
[Page 384-385]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
Subpart D--Medical Devices
Sec. 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.
[[Page 385]]
(d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 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]