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73.100 Cochineal extract; carmine.

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[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






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 


    (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 


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 


    (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:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 100

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