[Code of Federal Regulations]
[Title 21, Volume 3]
[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 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1375 Iron, elemental.
(a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron
obtained by any of the following processes: reduced iron, electrolytic
iron, and carbonyl iron.
(1) Reduced iron is prepared by reacting ground ferric oxide with
hydrogen or carbon monoxide at an elevated temperature. The process
results in a grayish-black powder, all of which should pass through a
100-mesh sieve. It is lusterless or has not more than a slight luster.
When viewed under a microscope, it appears as an amorphous powder free
from particles having a crystalline structure. It is stable in dry air.
(2) Electrolytic iron is prepared by electrodeposition. It is an
amorphous, lusterless, grayish-black powder. It is stable in dry air.
(3) Carbonyl iron is prepared by the decomposition of iron
pentacarbonyl. It occurs as a dark gray powder. When viewed under a
microscope, it appears as spheres built up with concentric shells. It is
stable in dry air.
(b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the
specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron,
carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp.
152-153), which is incorporated by reference. Copies are available from
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in accordance with section
412(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations
promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16867, May 12, 1988]
Additives that reference this regulation: