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184.1308 Ferrous gluconate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1308 Ferrous gluconate.



[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: 21CFR184.1308]

[Page 519-520]
 
                        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.  184.1308  Ferrous gluconate.

    (a) Ferrous gluconate (iron (II) gluconate dihydrate, 
C12H22FeO14[middot]2H2O, CAS 
Reg. No. 6047-12-7) is a fine yellowish-gray or pale greenish-yellow 
powder or granules. It is prepared by reacting hot solutions of barium 
or calcium gluconate with ferrous sulfate or by heating freshly prepared 
ferrous carbonate with gluconic acid in aqueous solution.
    (b) The ingredient meets the specifications of the Food Chemcials 
Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Avenue 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

[[Page 520]]

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 16866, May 12, 1988; 53 FR 20939, June 7, 1988]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1308


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