[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: 21CFR184.1199]
[Page 505]
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. 184.1199 Calcium gluconate.
(a) Calcium gluconate
([CH2OH(CHOH)4COO]2Ca, CAS Reg. No.
299-28-5) is the calcium salt of gluconic acid which may be produced by
neutralization of gluconic acid with lime or calcium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 51, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
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) The ingredient is used as a firming agent as defined in Sec.
170.3(o)(10) of this chapter; formulation aid as defined in Sec.
170.3(o)(14) of this chapter; sequestrant as defined in Sec.
170.3(o)(26) of this chapter; stabilizer or thickener as defined in
Sec. 170.3(o)(28) of this chapter; and texturizer as defined in Sec.
170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practices in accordance with Sec. 184.1(b)(1).
Current good manufacturing practices result in a maximum level, as
served, of 1.75 percent for baked goods as defined in Sec. 170.3(n)(1)
of this chapter; 0.4 percent for dairy product analogs as defined in
Sec. 170.3(n)(10) of this chapter; 4.5 percent for gelatins and
puddings as defined in Sec. 170.3(n)(22) of this chapter; and 0.01
percent for sugar substitutes as defined in Sec. 170.3(n)(42) of this
chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 27808, June 25, 1982]
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