§ 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

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