21 CFR § 184.1631 - Potassium hydroxide.
(a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known as caustic potash, potash lye, and potassa. The empirical formula is KOH. It is a white, highly deliquescent caustic solid, which is marketed in several forms, including pellets, flakes, sticks, lumps, and powders. Potassium hydroxide is obtained commercially from the electrolysis of potassium chloride solution in the presence of a porous diaphragm.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available from 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 § 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 formulation aid as defined in § 170.3(o)(14) of this chapter; a pH control agent as defined in § 170.3(o)(23) of the chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; and a stabilizer and thickener as defined in § 170.3(o)(28) 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.