[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: 21CFR184.1296]
[Page 516]
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. 184.1296 Ferric ammonium citrate.
(a) Ferric ammonium citrate (iron (III) ammonium citrate) is
prepared by the reaction of ferric hydroxide with citric acid, followed
by treatment with ammonium hydroxide, evaporating, and drying. The
resulting product occurs in two forms depending on the stoichiometry of
the initial reactants.
(1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1332-98-5) is a complex salt of undetermined structure composed of
16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65
percent citric acid and occurs as reddish brown or garnet red scales or
granules or as a brownish-yellowish powder.
(2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1333-00-2) is a complex salt of undetermined structure composed of
14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75
percent citric acid and occurs as thin transparent green scales, as
granules, as a powder, or as transparent green crystals.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and
p. 117 (Ferric ammonium citrate, green), 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 ingredients are used
in food as nutrient supplements as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredients may also be used in infant formula 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(a)(2)).
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
[53 FR 16864, May 12, 1988]
[[Page 517]]
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