Food and Drug Administration, HHS § 184.1763
product occurs as colorless crystals or codeloflfederallregulations/ a white crystalline powder. It may be ibrllocations.html. prepared in an anhydrous state or may (c) The ingredient is used as an anti- contain two moles of water per mole of microbial agent as defined in sodium citrate. § 170.3(o)(2) of this chapter; flavoring (b) The ingredient meets the speci- agent and adjuvant as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter; and pH 3d ed. (1981), pp. 283–284, which is incor- control agent as defined in § 170.3(o)(23) porated by reference in accordance of this chapter. with 5 U.S.C. 552(a) and 1 CFR part 51. (d) The ingredient is used in food at Copies are available from the National levels not to exceed current good man- Academy Press, 2101 Constitution Ave. ufacturing practice in accordance with NW., Washington, DC 20418, and the § 184.1(b)(1). Current good manufac- Center for Food Safety and Applied Nu- turing practice results in a maximum trition (HFS–200), 5100 Paint Branch level, as served, 0.4 percent for baked Pkwy., College Park, MD 20740, or may goods as defined in § 170.3(n)(1) of this be examined at the National Archives chapter; 0.1 percent for fats and oils as and Records Administration (NARA). defined in § 170.3(n)(12) of this chapter, For information on the availability of meat products as defined in this material at NARA, call 202–741– § 170.3(n)(29) of this chapter and soft 6030, or go to: http://www.archives.gov/ candy as defined in § 170.3(n)(38) of this federallregister/ chapter; 0.25 percent for gravies and codeloflfederallregulations/ sauces as defined in § 170.3(n)(24) of this ibrllocations.html. chapter; and 0.05 percent for snack (c) In accordance with § 184.1(b)(1), foods as defined in § 170.3(n)(37) of this the ingredient is used in food with no chapter and soups and soup mixes as defined in § 170.3(n)(40) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section, or different from those set forth in part 181 of this chapter, do not [47 FR 27815, June 25, 1982] exist or have been waived. § 184.1763 Sodium hydroxide. [59 FR 63896, Dec. 12, 1994] (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310–73–2) is also known as so- § 184.1754 Sodium diacetate. dium hydrate, soda lye, caustic soda, (a) Sodium diacetate (C4H7O4Na·xH2O, white caustic, and lye. The empirical CAS Reg. No. 126–96–5) is a molecular formula is NaOH. Sodium hydroxide is compound of acetic acid, sodium ace- prepared commercially by the elec- tate, and water of hydration. The tech- trolysis of sodium chloride solution nical grade is prepared synthetically and also by reacting calcium hydroxide by reacting sodium carbonate with ace- with sodium carbonate. tic acid. Special grades are produced by (b) The ingredient meets the speci- reacting anhydrous sodium acetate and fications of the Food Chemicals Codex, acetic acid. 3d Ed. (1981), which is incorporated by (b) The ingredient meets the speci- reference. Copies are available from fications of the Food Chemicals Codex, the National Academy Press, 2101 Con- 3d Ed. (1981), p. 284, which is incor- stitution Ave. NW., Washington, DC porated by reference. Copies are avail- 20418, or available for inspection at the able from the National Academy Press, National Archives and Records Admin- 2101 Constitution Ave. NW., Wash- istration (NARA). For information on ington, DC 20418, or available for in- the availability of this material at spection at the National Archives and NARA, call 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no
569
VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00579 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR § 184.1764 21 CFR Ch. I (4–1–12 Edition)
limitation other than current good § 184.1768 Sodium lactate. manufacturing practice. The affirma- (a) Sodium lactate (C3H5O3Na, CAS tion of this ingredient as generally rec- Reg. No. 72–17–3) is the sodium salt of ognized as safe (GRAS) as a direct lactic acid. It is prepared commercially human food ingredient is based upon by the neutralization of lactic acid the following current good manufac- with sodium hydroxide. turing practice conditions of use: (b) The ingredient must be of a pu- (1) The ingredient is used as a pH rity suitable for its intended use. control agent as defined in § 170.3(o)(23) (c) In accordance with § 184.1(b)(1), of this chapter and as a processing aid the ingredient is used in food with no as defined in § 170.3(o)(24) of this chap- limitation other than current good ter. manufacturing practice. This regula- (2) The ingredient is used in foods at tion does not authorize its use in in- levels not to exceed current good man- fant foods and infant formulas. The af- ufacturing practice. firmation of this ingredient as gen- (d) Prior sanctions for this ingredient erally recognized as safe (GRAS) as a different from the uses established in direct human food ingredient is based this section do not exist or have been upon the following current good manu- waived. facturing practice conditions of use: (1) The ingredient is used as an emul- [48 FR 52444, Nov. 18, 1983] sifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 184.1764 Sodium hypophosphite. § 170.3(o)(11) of this chapter; a flavoring (a) Sodium hypophosphite (NaH2PO2, agent or adjuvant as defined in CAS Reg. No. 7681–53–0) is a white, § 170.3(o)(12) of this chapter; a humec- odorless, deliquescent granular powder tant as defined in § 170.3(o)(16) of this with a saline taste. It is also prepared chapter; and a pH control agent as de- as colorless, pearly crystalline plates. fined in § 170.3(o)(23) of this chapter. It is soluble in water, alcohol, and (2) The ingredient is used in food at glycerol. It is prepared by neutraliza- levels not to exceed current good man- tion of hypophosphorous acid or by di- ufacturing practice. rect aqueous alkaline hydrolysis of (d) Prior sanctions for this ingredient white phosphorus. different from the uses established in (b) The ingredient must be of a pu- this section do not exist or have been rity suitable for its intended use. waived. (c) In accordance with § 184.1(b)(1), [52 FR 10886, Apr. 6, 1987, as amended at 73 the ingredient is used in food with no FR 8608, Feb. 14, 2008] limitations other than current good manufacturing practice. The affirma- § 184.1769a Sodium metasilicate. tion of this ingredient as generally rec- (a) Sodium metasilicate (CAS Reg. ognized as safe (GRAS) as a direct No. 6834–92–0) is a strongly alkaline human food ingredient is based upon white powder. It does not occur natu- the following current good manufac- rally but rather is synthesized by melt- turing practice conditions of use: ing sand with sodium carbonate at 1400 (1) The ingredient is used as an emul- °C. The commercially available forms sifier or stabilizer, as defined in of sodium metasilicate are the anhy- §§ 170.3(o)(8) and 170.3(o)(28) of this drous form (Na2SiO3), the pentahydrate chapter. (Na2SiO3·5H2O), and the nonahydrate (2) The ingredient is used in cod-liver (Na2SiO3·9H2O). oil emulsions at levels not to exceed (b) The ingredient must be of a pu- current good manufacturing practice. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the use established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [47 FR 38277, Aug. 31, 1982, as amended at 73 ognized as safe (GRAS) as a direct FR 8608, Feb. 14, 2008] human food ingredient is based upon
570
VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00580 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR