[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: 21CFR73.85]
 
 [Page 349-350]
 
                         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. 73.85  Caramel.
 
     (a) Identity. (1) The color additive caramel is the dark-brown
 liquid or solid material resulting from the carefully controlled heat
 treatment of the following food-grade carbohydrates:
 
 Dextrose.
 Invert sugar.
 Lactose.
 Malt sirup.
 Molasses.
 Starch hydrolysates and fractions thereof.
 Sucrose.
 
     (2) The food-grade acids, alkalis, and salts listed in this
 subparagraph may be employed to assist caramelization, in amounts
 consistent with good manufacturing practice.
     (i) Acids:
 
 [[Page 350]]
 
 Acetic acid.
 Citric acid.
 Phosphoric acid.
 Sulfuric acid.
 Sulfurous acid.
 
     (ii) Alkalis:
 
 Ammonium hydroxide.
 Calcium hydroxide U.S.P.
 Potassium hydroxide.
 Sodium hydroxide.
 
     (iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate,
 phosphate (including dibasic phosphate and monobasic phosphate),
 sulfate, and sulfite.
     (3) Polyglycerol esters of fatty acids, identified in Sec. 172.854
 of this chapter, may be used as antifoaming agents in amounts not
 greater than that required to produce the intended effect.
     (4) Color additive mixtures for food use made with caramel 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. Caramel shall conform to the following
 specifications:
 
 Lead (as Pb), not more than 10 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Mercury (as Hg), not more than 0.1 part per million.
 
     (c) Uses and restrictions. Caramel may be safely used for coloring
 foods generally, in amounts consistent with good manufacturing practice,
 except that it 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.
     (d) Labeling. The label of the color additive and any mixtures
 prepared therefrom and 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.