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]


Color Additive Regulations
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