[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. 73.200 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
(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
(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
(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
(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.
[42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994]
Additives that reference this regulation: