[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1195]

[Page 492]
 
                        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. 184.1195  Calcium citrate.

    (a) Calcium citrate 
(Ca3(C6H5O7)2[midd
ot]4H2O, CAS Reg. No. 813-0994-095) is the calcium salt of 
citric acid. It is prepared by neutralizing citric acid with calcium 
hydroxide or calcium carbonate. It occurs as a fine white, odorless 
powder and usually contains four moles of water per mole of calcium 
citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
Calcium citrate may also be used in infant formula in accordance with 
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or 
with regulations promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]