[Title 21 CFR 73.575]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES]
[Subchapter A - GENERAL]
[Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION]
[Subpart A - Foods]
[Sec. 73.575 - Titanium dioxide.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  1
  1996-04-01
  1996-04-01
  false
  
  73.575
  Sec. 73.575
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    GENERAL
    LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
    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, 
Al2O3, 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.