[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.100]
[Page 344-345]
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 of identity have been promulgated under section 401
of the act unless added color is authorized by such standards.
[[Page 345]]
(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.
Additives that reference this regulation: |
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