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Home , Potassium hydroxide

Food and Drug Administration, HHS § 184.1631

manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. (1) The ingredient is used as a flavor (d) Prior sanctions for this ingredient enhancer as defined in § 170.3(o)(11) of different from the uses established in this chapter; as a flavoring agent as de- this section, or different from those set fined in § 170.3(o)(12) of this chapter; as forth in part 181 of this chapter, do not a nutrient supplement as defined in exist or have been waived. § 170.3(o)(20) of this chapter; as a pH control agent as defined in § 170.3(o)(23) [59 FR 63896, Dec. 12, 1994] of this chapter; and as a stabilizer or thickener as defined in § 170.3(o)(28) of § 184.1631 . this chapter. (a) Potassium hydroxide (KOH, CAS (2) The ingredient is used in food at Reg. No. 1310–58–3) is also known as levels not to exceed current good man- caustic , potash , and potassa. ufacturing practice. Potassium chlo- The empirical formula is KOH. It is a ride may be used in infant formula in white, highly deliquescent caustic accordance with section 412(g) of the solid, which is marketed in several Federal Food, Drug, and Cosmetic Act forms, including pellets, flakes, sticks, (the Act) or with regulations promul- lumps, and powders. Potassium hydrox- gated under section 412(a)(2) of the Act. ide is obtained commercially from the (d) Prior sanctions for this ingredient electrolysis of potassium solu- different from the uses established in tion in the presence of a porous dia- this section do not exist or have been phragm. waived. (b) The ingredient meets the speci- [48 FR 51614, Nov. 10, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by § 184.1625 . reference. Copies are available from the National Academy Press, 2101 Con- (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- stitution Ave. NW., Washington, DC tassium of citric . It is pre- 20418, or available from inspection at pared by neutralizing citric acid with the National Archives and Records Ad- potassium hydroxide or potassium car- ministration (NARA). For information bonate. It occurs as transparent crys- on the availability of this material at tals or a white granular powder, is NARA, call 202–741–6030, or go to: http:// odorless and deliquescent, and contains www.archives.gov/federallregister/ one mole of water per mole of potas- codeloflfederallregulations/ sium citrate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d ed. (1981), p. 242, which is incor- limitation other than current good porated by reference in accordance manufacturing practice. The affirma- with 5 U.S.C. 552(a) and 1 CFR part 51. tion of this ingredient as generally rec- Copies are available from the National ognized as safe (GRAS) as a direct Academy Press, 2101 Constitution Ave. human food ingredient is based upon NW., Washington, DC 20418, and the the following current good manufac- Center for Food Safety and Applied Nu- turing practice conditions of use: trition (HFS–200), 5100 Paint Branch (1) The ingredient is used as a formu- Pkwy., College Park, MD 20740, or may lation aid as defined in § 170.3(o)(14) of be examined at the National Archives this chapter; a pH control agent as de- and Records Administration (NARA). fined in § 170.3(o)(23) of the chapter; a For information on the availability of processing aid as defined in § 170.3(o)(24) this material at NARA, call 202–741– of this chapter; and a stabilizer and 6030, or go to: http://www.archives.gov/ thickener as defined in § 170.3(o)(28) of federallregister/ this chapter.

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(2) The ingredient is used in food at Academy Press, 2101 Constitution Ave. levels not to exceed current good man- NW., Washington, DC 20418, or may be ufacturing practice. examined at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this this section do not exist or have been material at NARA, call 202–741–6030, or waived. go to: http://www.archives.gov/ federallregister/ [48 FR 52444, Nov. 18, 1983] codeloflfederallregulations/ § 184.1634 . ibrllocations.html. (c) The ingredient is used as a dough (a) Potassium iodide (KI, CAS Reg. strengthener as defined in § 170.3(o)(6) No. 7681–11–0) is the potassium salt of of this chapter. hydriodic acid. It occurs naturally in (d) The ingredient is used in the man- sea water and in salt deposits, but can ufacture of bread in accordance with be prepared by reacting hydriodic acid § 184.1(b)(2) of this chapter in an (HI) with amount not to exceed 0.0075 percent (KHCO ). 3 based on the weight of the flour. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 246–247, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National Academy Press, 2101 Constitution Ave. [43 FR 11699, Mar. 21, 1978, as amended at 49 NW., Washington, DC 20418, or may be FR 5613, Feb. 14, 1984] examined at the National Archives and Records Administration (NARA). For § 184.1639 Potassium lactate.

information on the availability of this (a) Potassium lactate (C3H5O3K, CAS material at NARA, call 202–741–6030, or Reg. No. 996–31–6) is the potassium salt go to: http://www.archives.gov/ of lactic acid. It is a hydroscopic, federallregister/ white, odorless solid and is prepared codeloflfederallregulations/ commercially by the neutralization of ibrllocations.html. lactic acid with potassium hydroxide. (c) The ingredient is used as a nutri- (b) The ingredient must be of a pu- ent supplement as defined in rity suitable for its intended use. § 170.3(o)(20) of this chapter. (c) In accordance with § 184.1(b)(1), (d) The ingredient is used in table the ingredient is used in food with no salt in accordance with § 184.1(b)(2) of limitation other than current good this chapter as a source of dietary io- manufacturing practice. This regula- dine at a maximum level of 0.01 per- tion does not authorize its use in in- cent. fant foods and infant formulas. The af- (e) Prior sanctions for this ingredient firmation of this ingredient as gen- different from the uses established in erally recognized as safe (GRAS) as a this section do not exist or have been direct human food ingredient is based waived. upon the following current good manu- [43 FR 11699, Mar. 21, 1978, as amended at 49 facturing practice conditions of use: FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, (1) The ingredient is used as a flavor 1996] enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adju- § 184.1635 . vant as defined in § 170.3(o)(12) of this

(a) Potassium iodate (KIO3, CAS Reg. chapter; a humectant as defined in No. 7758–05–6) does not occur naturally § 170.3(o)(16) of this chapter; and a pH but can be prepared by reacting iodine control agent as defined in § 170.3(o)(23) with potassium hydroxide. of this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the ‘‘Food Chemicals levels not to exceed current good man- Codex,’’ 3d Ed. (1981), pp. 245–246, which ufacturing practice. is incorporated by reference. Copies (d) Prior sanctions for this ingredient may be obtained from the National different from the uses established in

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