[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. 73.575 Titanium dioxide.
(a) Identity. (1) The color additive titanium dioxide is
synthetically prepared TiO2, free from admixture with other
(2) Color additive mixtures for food use made with titanium dioxide
may contain only those diluents that are suitable and that are listed in
this subpart as safe in color additive mixtures for coloring foods, and
the following: Silicon dioxide, SiO2 and/or aluminum oxide,
Al2 O3, as dispersing aids--not more than 2
(b) Specifications. Titanium dioxide shall conform to the following
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Antimony (as Sb), not more than 2 parts per million.
Mercury (as Hg), not more than 1 part per million.
Loss on ignition at 800 [deg]C. (after drying for 3 hours at 105
[deg]C.), not more than 0.5 percent.
Water soluble substances, not more than 0.3 percent.
Acid soluble substances, not more than 0.5 percent.
TiO2, not less than 99.0 percent after drying for 3 hours at
Lead, arsenic, and antimony shall be determined in the solution obtained
by boiling 10 grams of the titanium dioxide for 15 minutes in 50
milliliters of 0.5N hydrochloric acid.
(c) Uses and restrictions. The color additive titanium dioxide may
be safely used for coloring foods generally, subject to the following
(1) The quantity of titanium dioxide does not exceed 1 percent by
weight of the food.
(2) 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
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 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: