[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: 21CFR73.100]
 
 [Page 351-352]
 
                         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 352]]
 
     (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.