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184.1260 Copper gluconate.
(a Copper gluconate (cupric gluconate (CH2OH(CHOH?COO?Cu, CAS Reg. No. 527C09C3 is a substance that occurs as light blue to bluish-green, 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. ?981? 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 202C741C6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c In accordance with184.1(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:
? The ingredient is used as a nutrient supplement as defined in170.3(o)(20 of this chapter and as a synergist as defined in 170.3(o)(31 of this chapter.
? The ingredient is used in food at levels not to exceedcurrent good manufacturing practice. Copper gluconate may be used in infant formula in accordance with section 412(g of theFederal 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]