[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1631]
[Page 554]
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
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 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 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 formulation aid as defined in Sec.
170.3(o)(14) of this chapter; a pH control agent as defined in Sec.
170.3(o)(23) of the chapter; a processing aid as defined in Sec.
170.3(o)(24) of this chapter; and a stabilizer and thickener as defined
in Sec. 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.
[48 FR 52444, Nov. 18, 1983]
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