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21 U.S.C. 321, 342, 348, 371.
42 FR 14653, Mar 15, 1977, unless otherwise noted.
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Subscribe to: 21 CFR 184.1768
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Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.
(a) Sodium lactate (C3H5O3Na, CAS Reg. No. 72-17-3) is the sodium salt of lactic acid. It is prepared commercially by the neutralization of lactic acid with sodium hydroxide.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. This regulation does not authorize its use in infant foods and infant formulas. 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 an emulsifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
[52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008]