[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: 21CFR73.575]
 
 [Page 360]
 
                         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. 73.575  Titanium dioxide.
 
     (a) Identity. (1) The color additive titanium dioxide is
 synthetically prepared TiO2, free from admixture with other
 substances.
     (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
 percent total.
     (b) Specifications. Titanium dioxide shall conform to the following
 specifications:
 
 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
 105 [deg]C.
 
 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
 restrictions:
     (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.