[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.100]

[Page 350-351]
 
                        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 A--Foods
 
Sec. 73.100  Cochineal extract; carmine.

    (a) Identity. (1) The color additive cochineal extract is the 
concentrated solution obtained after removing the alcohol from an 
aqueous-alcoholic extract of cochineal (Dactylopius coccus costa (Coccus 
cacti L.)). The coloring principle is chiefly carminic acid.
    (2) The color additive carmine is the aluminum or calcium-aluminum 
lake on an aluminum hydroxide substrate of the coloring principles, 
chiefly carminic acid, obtained by an aqueous extraction of cochineal 
(Dactylopius coccus costa (Coccus cacti L.)).
    (3) Color additive mixtures for food use made with cochineal extract 
or carmine may contain only diluents that are suitable and that are 
listed in this subpart as safe in color additive mixtures for coloring 
foods.
    (b) Specifications. (1) Cochineal extract shall conform to the 
following specifications:

pH, not less than 5.0 and not more than 5.5 at 25  deg.C.
Protein (N x 6.25), not more than 2.2 percent.
Total solids, not less than 5.7 and not more than 6.3 percent.
Methyl alcohol, not more than 150 parts per million.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 1.8 percent.

    (2) Carmine shall conform to the following specifications:

Volatile matter (at 135  deg.C. for 3 hours), not more than 20.0 
percent.
Ash, not more than 12.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 50.0 percent.


Carmine and cochineal extract shall be pasteurized or otherwise treated 
to destroy all viable Salmonella microorganisms. Pasteurization or such 
other treatment is deemed to permit the adding of safe and suitable 
substances (other than chemical preservatives) that are essential to the 
method of pasteurization or other treatment used. For the purposes of 
this paragraph, safe and suitable substances are those substances that 
perform a useful function in the pasteurization or other treatment to 
render the carmine and cochineal extract free of viable Salmonella 
microorganisms, which substances are not food additives as defined in 
section 201(s) of the act or, if they are food additives as so defined, 
are used in conformity with regulations established pursuant to section 
409 of the act.
    (c) Uses and restrictions. Carmine and cochineal extract may be 
safely used for coloring foods generally in amounts consistent with good 
manufacturing practice, except that they may not be used to color foods 
for which standards

[[Page 351]]

of identity have been promulgated under section 401 of the act unless 
added color is authorized by such standards.
    (d) Labeling requirements. The label of the color additives and any 
mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec. 70.25 of this 
chapter.
    (e) Exemption from certification. Certification of these color 
additives 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.