[Title 21 CFR 184.1308]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE]
[Subpart B - Listing of Specific Substances Affirmed as GRAS]
[Sec. 184.1308 - Ferrous gluconate.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  3
  1996-04-01
  1996-04-01
  false
  
  184.1308
  Sec. 184.1308
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
    FOOD FOR HUMAN CONSUMPTION
    DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
    Listing of Specific Substances Affirmed as GRAS
  


Sec. 184.1308   Ferrous gluconate.

    (a) Ferrous gluconate (iron (II) gluconate dihydrate, 
C12H22FeO142H2O, 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 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (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 16866, May 12, 1988; 53 FR 20939, June 7, 1988]