§ 184.1201 21 CFR Ch. I (4–1–14 Edition)

in § 170.3(o)(14) of this chapter; the following current good manufac- sequestrant as defined in § 170.3(o)(26) of turing practice conditions of use: this chapter; stabilizer or thickener as (1) The ingredient is used as a nutri- defined in § 170.3(o)(28) of this chapter; ent supplement as defined in and texturizer as defined in § 170.3(o)(32) § 170.3(o)(20) of this chapter. of this chapter. (2) The ingredient is used in gelatins, (d) The ingredient is used in foods at puddings, and fillings as defined in levels not to exceed current good man- § 170.3(n)(22) of this chapter. ufacturing practices in accordance (d) Prior sanctions for this ingredient with § 184.1(b)(1). Current good manu- different from the uses established in facturing practices result in a max- this section or different from that as imum level, as served, of 1.75 percent set forth in part 181 of this chapter, do for baked goods as defined in not exist or have been waived. § 170.3(n)(1) of this chapter; 0.4 percent for dairy product analogs as defined in [57 FR 10813, Mar. 31, 1992] § 170.3(n)(10) of this chapter; 4.5 percent § 184.1205 hydroxide. for gelatins and puddings as defined in § 170.3(n)(22) of this chapter; and 0.01 (a) Calcium hydroxide (Ca(OH)2, CAS percent for sugar substitutes as defined Reg. No. 1305–62–0) is also known as in § 170.3(n)(42) of this chapter. slaked lime or calcium hydrate. It is (e) Prior sanctions for this ingredient produced by the hydration of lime. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the Food Chemicals Codex, waived. 3d Ed. (1981), p. 52, which is incor- porated by reference. Copies are avail- [47 FR 27808, June 25, 1982] able from the National Academy Press, 2101 Constitution Ave. NW., Wash- § 184.1201 Calcium glycerophosphate. ington, DC 20418, or available for in- (a) Calcium glycerophosphate spection at the National Archives and (C3H7CaO6P, CAS Reg. No. 27214–00–2) is Records Administration (NARA). For a fine, white, odorless, almost taste- information on the availability of this less, slightly hygroscopic powder. It is material at NARA, call 202–741–6030, or prepared by neutralizing glycero- go to: http://www.archives.gov/ phosphoric acid with calcium hydrox- federallregister/ ide or calcium carbonate. The commer- codeloflfederallregulations/ cial product is a mixture of calcium b- ibrllocations.html. , and D-, and L-a-glycerophosphate. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the ‘‘Food Chemicals limitation other than current good Codex,’’ 3d Ed. (1981), pp. 51–52, which is manufacturing practice. incorporated by reference in accord- (d) Prior sanctions for this ingredient ance with 5 U.S.C. 552(a) and 1 CFR different from the uses established in part 51. Copies may be obtained from this section do not exist or have been the National Academy Press, 2101 Con- waived. stitution Ave. NW., Washington, DC 20418, or may be examined at the Na- [49 FR 26714, June 29, 1984] tional Archives and Records Adminis- tration (NARA). For information on § 184.1206 . the availability of this material at (a) Calcium iodate [Ca(IO3)2·H2O, CAS NARA, call 202–741–6030, or go to: http:// Reg. No. 7789–80–2], also referred to as www.archives.gov/federallregister/ lautarite, does not occur naturally but codeloflfederallregulations/ can be prepared by passing ibrllocations.html. into a hot solution of lime (CaCO3) in (c) In accordance with § 184.1(b)(1), which has been dissolved. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the ‘‘Food Chemicals manufacturing practice. The affirma- Codex,’’ 3d Ed. (1981), p. 53, which is in- tion of this ingredient as generally rec- corporated by reference. Copies may be ognized as safe (GRAS) as a direct obtained from the National Academy human food ingredient is based upon Press, 2101 Constitution Ave. NW.,

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Washington, DC 20418, or may be exam- flavoring agent or adjuvant as defined ined at the National Archives and in § 170.3(o)(12) of this chapter; a leav- Records Administration (NARA). For ening agent as defined in § 170.3(o)(17) of information on the availability of this this chapter; a nutrient supplement as material at NARA, call 202–741–6030, or defined in § 170.3(o)(20) of this chapter; go to: http://www.archives.gov/ and a stabilizer and thickener as de- federallregister/ fined in § 170.3(o)(28) of this chapter. codeloflfederallregulations/ (2) The ingredient is used in food, ex- ibrllocations.html. cept in infant foods and infant for- (c) The ingredient is used as a dough mulas, at levels not to exceed current strengthener as defined in § 170.3(o)(6) good manufacturing practice. of this chapter. (d) Prior sanctions for this ingredient (d) The ingredient is used in the man- different from the uses established in ufacture of bread in accordance with this section do not exist or have been § 184.1(b)(2) of this chapter in an waived. amount not to exceed 0.0075 percent based on the weight of the flour. [49 FR 35367, Sept. 7, 1984] (e) Prior sanctions for this ingredient different from the uses established in § 184.1210 . this section do not exist or have been (a) Calcium oxide (CaO, CAS Reg. No. waived. 1305–78–8) is also known as lime, quick [43 FR 11699, Mar. 21, 1978, as amended at 49 lime, burnt lime, or calx. It is produced FR 5611, Feb. 14, 1984] from calcium carbonate, limestone, or oyster shells by calcination at tem- § 184.1207 Calcium lactate. peratures of 1,700–2,450 °F.

(a) Calcium lactate (C6H10CaO6.xH2O, (b) The ingredient meets the speci- where x is any integer up to 5, CAS fications of the Food Chemicals Codex, Reg. No. 814–80–2) is prepared commer- 3d Ed. (1981), p. 55, which is incor- cially by the neutralization of lactic porated by reference. Copies are avail- acid with calcium carbonate or cal- able from the National Academy Press, cium hydroxide. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), p. 53, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Avenue NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. The affirma- [49 FR 26714, June 29, 1984] tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct § 184.1212 Calcium pantothenate. human food ingredient is based upon (a) Calcium pantothenate the following current good manufac- ((C9H16NO5)2Ca, CAS Reg. No. of the D- turing practice conditions of use: isomer, 137–08–6) is a salt of panto- (1) The ingredient is used as a firm- thenic acid, one of the vitamins of the ing agent as defined in § 170.3(o)(10) of B complex. Only the D-isomer of panto- this chapter; a flavor enhancer as de- thenic acid has vitamin activity, al- fined in § 170.3(o)(11) of this chapter; a though both the D-isomer and the DL-

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