[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
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:
Starch hydrolysates and fractions thereof.
(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.
Calcium hydroxide U.S.P.
(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
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.
Additives that reference this regulation: