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184.1296 Ferric ammonium citrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1296 Ferric ammonium citrate.



[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]]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1296


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