21 C.F.R. § 184.1639 Potassium lactate.
Title 21 - Food and Drugs
(a) Potassium lactate (C3H5O3K, CAS Reg. No. 996–31–6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) FDA is developing food-grade specifications for potassium lactate in cooperation with the National Academy of Sciences. In the interim, this 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 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]
Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS
§ 184.1639 Potassium lactate.
