[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1195]
[Page 486]
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 x 4H
2O, 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]