Food and Drug Administration, HHS § 184.1613

(d) Prior sanctions for these ingredi- sium alginate is prepared by the neu- ents different from the uses established tralization of purified alginic acid with in this section do not exist or have appropriate pH control agents. been waived. (b) The ingredient meets the speci- [48 FR 51149, Nov. 7, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incor- § 184.1595 Pepsin. porated by reference. Copies are available from the National Academy Press, (a) Pepsin (CAS Reg. No. 9001–75–6) is 2101 Constitution Ave. NW., Wash- an enzyme preparation obtained from ington, DC 20418, or available for in- the glandular layer of hog stomach. It spection at the National Archives and is a white to light tan powder, amber Records Administration (NARA). For paste, or clear amber to brown liquid. information on the availability of this Its characterizing enzyme activity is material at NARA, call 202–741–6030, or that of a peptide hydrolase (EC go to: http://www.archives.gov/ 3.4.23.1). federal register/ (b) The ingredient meets the general l code of federal regulations/ requirements and additional require- l l l ibr locations.html. ments for enzyme preparations in the l Food Chemicals Codex, 3d ed. (1981), p. (c) In accordance with § 184.1(b)(2), 110, which is incorporated by reference the ingredient is used in food only in accordance with 5 U.S.C. 552(a) and 1 within the following specific limita- CFR part 51. Copies are available from tions: the National Academy Press, 2101 Con- Maximum stitution Ave. NW., Washington, DC level of use in 20418, or may be examined at the Office Category of food food (as Functional use of Premarket Approval (HFS–200), Food served) and Drug Administration, 5100 Paint (percent) Branch Pkwy., College Park, MD 20740, Confections and 0.1 Stabilizer, thickener, and at the National Archives and frostings, § 170.3(o)(28) of this Records Administration (NARA). For § 170.3(n)(9) of this chapter chapter. information on the availability of this Gelatins and puddings, 0.7 Do. material at NARA, call 202–741–6030, or § 170.3(n)(22) of this go to: http://www.archives.gov/ chapter. federallregister/ Processed fruits and 0.25 Do. fruit juices, codeloflfederallregulations/ § 170.3(n)(35) of this ibrllocations.html. chapter. (c) In accordance with § 184.1(b)(1), All other food cat- 0.01 Do. the ingredient is used in food with no egories. limitation other than current good manufacturing practice. The affirma- (d) Prior sanctions for potassium al- tion of this ingredient as GRAS as a di- ginate different from the uses estab- rect food ingredient is based upon the lished in this section do not exist or following current good manufacturing have been waived. practice conditions of use: [47 FR 29951, July 9, 1982] (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this § 184.1613 Potassium bicarbonate. chapter to hydrolyze proteins or (a) Potassium bicarbonate (KHCO3, polypeptides. CAS Reg. No. 298–14–6) is made by the (2) The ingredient is used in food at following processes: levels not to exceed current good man- (1) By treating a solution of potas- ufacturing practice. sium hydroxide with carbon dioxide; [60 FR 32911, June 26, 1995] (2) By treating a solution of potassium carbonate with carbon dioxide. § 184.1610 Potassium alginate. (b) The ingredient meets the speci- (a) Potassium alginate (CAS Reg. No. fications of the Food Chemicals Codex, 9005–36–1) is the potassium salt of al- 3d Ed. (1981), p. 239, which is incor- ginic acid, a natural polyuronide con- porated by reference. Copies are avail- stituent of certain brown algae. Potas- able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- Records Administration (NARA). For ington, DC 20418, or available for in- information on the availability of this spection at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. the affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used in food as a the following current good manufac- flavoring agent and adjuvant as defined turing practice conditions of use: in § 170.3(o)(12) of this chapter; nutrient (1) The ingredient is used as a formu- supplement as defined in § 170.3(o)(20) of lation aid as defined in § 170.3(o)(14) of this chapter; pH control agent as de- this chapter; nutrient supplemlent as fined in § 170.3(o)(23) of this chapter; defined in § 170.3(o)(20) of this chapter; and processing aid as defined in pH control agent as defined in § 170.3(o)(24) of this chapter. § 170.3(o)(23) of this chapter; and proc- (2) The ingredient is used in food at essing aid as defined in § 170.3(o)(24) of levels not to exceed current good man- this chapter. ufacturing practice. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [48 FR 52442, Nov. 18, 1983] this section do not exist or have been waived. § 184.1622 Potassium chloride. [48 FR 52442, Nov. 18, 1983] (a) Potassium chloride (KCl, CAS Reg. No. 7447–40–7) is a white, odorless § 184.1619 Potassium carbonate. solid prepared from source minerals by (a) Potassium carbonate (K2CO3, CAS fractional crystallization or flotation. Reg. No. 584–08–7) is produced by the It is soluble in water and glycerol and following methods of manufacture: has a saline taste at low concentration (1) By electrolysis of potassium chlo- levels. ride followed by exposing the resultant (b) The ingredient meets the speci- potassium to carbon dioxide; fications of the Food Chemicals Codex, (2) By treating a solution of potas- 3d Ed. (1981), p. 241, which is incor- sium hydroxide with excess carbon di- porated by reference. Copies are avail- oxide to produce potassium carbonate; able from the National Academy Press, (3) By treating a solution of potas- 2101 Constitution Ave. NW., Wash- sium hydroxide with carbon dioxide to ington, DC 20418, or available for in- produce potassium bicarbonate, which spection at the National Archives and is then heated to yield potassium car- Records Administration (NARA). For bonate. information on the availability of this (b) The ingredient meets the speci- material at NARA, call 202–741–6030, or fications of the Food Chemicals Codex, go to: http://www.archives.gov/ 3d Ed. (1981), p. 240, which is incor- federallregister/ porated by reference. Copies are avail- codeloflfederallregulations/ able from the National Academy Press, ibrllocations.html. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, D.C. 20418, or available for in- the ingredient is used in food with no spection at the National Archives and limitation other than current good

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