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184.1298 Ferric citrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1298 Ferric 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: 21CFR184.1298]

[Page 517]
 
                        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.  184.1298  Ferric citrate.

    (a) Ferric citrate (iron (III) citrate, 
C6H5FeO7, CAS Reg. No. 2338-05-8) is 
prepared from reaction of citric acid with ferric hydroxide. It is a 
compound of indefinite ratio of citric acid and iron.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferric citrate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (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 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 this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1298


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