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Food and Drug Administration, HHS § 184.1207

the National Academy Press, 2101 Con- this section do not exist or have been stitution Ave. NW., Washington, DC waived. 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 iodate. the availability of this material at (a) [Ca(IO ) ·H O, CAS NARA, call 202–741–6030, or go to: http:// 3 2 2 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 (CaCO ) in (c) In accordance with § 184.1(b)(1), 3 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., the following current good manufac- Washington, DC 20418, or may be exam- turing practice conditions of use: ined at the National Archives and (1) The ingredient is used as a nutri- Records Administration (NARA). For ent supplement as defined in information on the availability of this § 170.3(o)(20) of this chapter. material at NARA, call 202–741–6030, or (2) The ingredient is used in gelatins, go to: http://www.archives.gov/ puddings, and fillings as defined in federallregister/ § 170.3(n)(22) of this chapter. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) The ingredient is used as a dough this section or different from that as strengthener as defined in § 170.3(o)(6) set forth in part 181 of this chapter, do of this chapter. not exist or have been waived. (d) The ingredient is used in the man- [57 FR 10813, Mar. 31, 1992] ufacture of bread in accordance with § 184.1(b)(2) of this chapter in an § 184.1205 Calcium hydroxide. amount not to exceed 0.0075 percent based on the weight of the flour. (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305–62–0) is also known as (e) Prior sanctions for this ingredient slaked lime or calcium hydrate. It is different from the uses established in produced by the hydration of lime. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, [43 FR 11699, Mar. 21, 1978, as amended at 49 3d Ed. (1981), p. 52, which is incor- FR 5611, Feb. 14, 1984] porated by reference. Copies are avail- able from the National Academy Press, § 184.1207 Calcium lactate.

2101 Constitution Ave. NW., Wash- (a) Calcium lactate (C6H10CaO6.xH2O, ington, DC 20418, or available for in- where x is any integer up to 5, CAS spection at the National Archives and Reg. No. 814–80–2) is prepared commer- Records Administration (NARA). For cially by the neutralization of lactic information on the availability of this acid with calcium carbonate or cal- material at NARA, call 202–741–6030, or cium hydroxide. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), p. 53, which is incor- ibrllocations.html. porated by reference. Copies are avail- (c) In accordance with § 184.1(b)(1), able from the National Academy Press, the ingredient is used in food with no 2101 Constitution Avenue NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. spection 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

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material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no limitation other than current good [49 FR 26714, June 29, 1984] manufacturing practice. The affirma- § 184.1212 Calcium pantothenate. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct (a) Calcium pantothenate human food ingredient is based upon ((C9H16NO5)2Ca, CAS Reg. No. of the D- the following current good manufac- isomer, 137–08–6) is a salt of panto- turing practice conditions of use: thenic acid, one of the vitamins of the (1) The ingredient is used as a firm- B complex. Only the D-isomer of panto- ing agent as defined in § 170.3(o)(10) of thenic acid has vitamin activity, al- this chapter; a flavor enhancer as de- though both the D-isomer and the DL- fined in § 170.3(o)(11) of this chapter; a racemic mixture of calcium panto- flavoring agent or adjuvant as defined thenate are used in food. Commercial in § 170.3(o)(12) of this chapter; a leav- calcium pantothenate is prepared syn- ening agent as defined in § 170.3(o)(17) of thetically from isobutyraldehyde and this chapter; a nutrient supplement as formaldehyde via 1,1-dimethyl-2-hy- defined in § 170.3(o)(20) of this chapter; droxy-propionaldehyde and and a stabilizer and thickener as de- pantolactone. fined in § 170.3(o)(28) of this chapter. (b) Calcium pantothenate meets the (2) The ingredient is used in food, ex- specifications of the Food Chemicals cept in infant foods and infant for- Codex, 3d Ed. (1981), p. 56, which is in- mulas, at levels not to exceed current corporated by reference. Copies are good manufacturing practice. available from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or available for this section do not exist or have been inspection at the National Archives waived. and Records Administration (NARA). [49 FR 35367, Sept. 7, 1984] For information on the availability of this material at NARA, call 202–741– § 184.1210 . 6030, or go to: http://www.archives.gov/ (a) Calcium oxide (CaO, CAS Reg. No. federallregister/ 1305–78–8) is also known as lime, quick codeloflfederallregulations/ lime, burnt lime, or calx. It is produced ibrllocations.html. from calcium carbonate, limestone, or (c) In accordance with § 184.1(b)(1), oyster shells by calcination at tem- the ingredient is used in food with no peratures of 1,700–2,450 °F. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 55, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter. information on the availability of this (2) The ingredient is used in foods at material at NARA, call 202–741–6030, or levels not to exceed current good man- go to: http://www.archives.gov/ ufacturing practice. Calcium panto- federallregister/ thenate may be used in infant formula codeloflfederallregulations/ in accordance with section 412(g) of the ibrllocations.html. Federal Food, Drug, and Cosmetic Act (c) In accordance with § 184.1(b)(1), (the act) or with regulations promul- the ingredient is used in food with no gated under section 412(a)(2) of the Act.

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