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184.1375 Iron, elemental.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1375 Iron, elemental.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1375]

[Page 530-531]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (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,

[[Page 531]]

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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1375


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