[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.200]

[Page 354-355]
 
                        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. 73.200  Synthetic iron oxide.

    (a) Identity. (1) The color additive synthetic iron oxide consists 
of any one or any combination of synthetically prepared iron oxides, 
including the hydrated forms. It is free from admixture with other 
substances.
    (2) Color additive mixtures for food use made with synthetic iron 
oxide may contain only those diluents that are suitable and that are 
listed in this subpart as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. (1) Synthetic iron oxide for human food use 
shall conform to the following specifications:

Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg) , not more than 1 part per million.

    (2) Synthetic iron oxide for dog and cat food use shall conform to 
the following specifications:

Arsenic (as As), not more than 5 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 3 parts per million.

    (c) Uses and restrictions. (1) Synthetic iron oxide may be safely 
used for the coloring of sausage casings intended for human consumption 
in an amount not exceeding 0.10 percent by weight of the finished food.
    (2) Synthetic iron oxide may be safely used for the coloring of dog 
and cat foods in an amount not exceeding 0.25 percent by weight of the 
finished food.
    (d) Labeling requirements. The label of the color additive and any 
mixture prepared therefrom 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

[[Page 355]]

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.

[42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994]