[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: 21CFR184.1260]
[Page 512-513]
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. 184.1260 Copper gluconate.
(a) Copper gluconate (cupric gluconate
(CH2OH(CHOH)4COO)2Cu, CAS Reg. No. 527-
09-3) is a substance that occurs as light blue to bluish-green,
[[Page 513]]
odorless crystals, or as a fine, light blue powder. It is prepared by
the reaction of gluconic acid solutions with cupric oxide or basic
cupric carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 90, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter and as a synergist as defined in
Sec. 170.3(o)(31) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Copper gluconate may 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.
[49 FR 24119, June 12, 1984]
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