[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1308]
[Page 520-521]
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
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 521]]
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]
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