[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: 21CFR73.1125]

[Page 361-362]
 
                        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 
 
                             Subpart B_Drugs
 
Sec.  73.1125  Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).

    (a) Identity. (1) The color additive potassium sodium copper 
chlorophyllin is a green to black powder obtained from chlorophyll by 
replacing the methyl and phytyl ester groups with alkali and replacing 
the magnesium with copper. The source of the chlorophyll is dehydrated 
alfalfa.
    (2) Color additive mixtures for drug use made with potassium sodium 
copper chlorophyllin may contain only those diluents that are suitable 
and

[[Page 362]]

that are listed in this subpart as safe for use in color additive 
mixtures for coloring drugs.
    (b) Specifications. Potassium sodium copper chlorophyllin 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 good manufacturing practice:

Moisture, not more than 5.0 percent.
Nitrogen, not more than 5.0 percent.
pH of 1 percent solution, 9 to 11.
Total copper, not less than 4 percent and not more than 6 percent.
Free copper, not more than 0.25 percent.
Iron, not more than 0.5 percent.
Lead (as Pb)), not more than 20 parts per million.
Arsenic (as As), not more than 5 parts per million.
Ratio, absorbance at 405 m[mu] to absorbance at 630 m[mu], not less than 
3.4 and not more than 3.9.
Total color, not less than 75 percent.

    (c) Uses and restrictions. Potassium sodium copper chlorophyllin may 
be safely used for coloring dentifrices that are drugs at a level not to 
exceed 0.1 percent. Authorization for this use shall not be construed as 
waiving any of the requirements of section 505 of the act with respect 
to the drug in which it is used.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
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 batches thereof are exempt from the certification requirements 
of section 721(c) of the act.