[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.85]

[Page 371-372]
 
                        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.


[[Page 372]]


    (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:

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.