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§184.1212 食品添加剂泛酸钙(Calcium pantothenate)

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放大字体  缩小字体 2011-07-20 16:15:31  来源:GPO  浏览次数:2847
核心提示:按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂泛酸钙用于食品中无限制性规定。可用做§170.3(o)(20)中的营养增补剂,用量以不超过现行良好生产操作规程为限。泛酸钙还可用于联邦食品、药品和化妆品法案中412(g)和412(a)(2)婴儿配方食品。
发布单位
FDA
FDA
发布文号 48 FR 51908
发布日期 1983-11-15 生效日期 暂无
有效性状态 废止日期 暂无
备注 按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂泛酸钙用于食品中无限制性规定。可用做§170.3(o)(20)中的营养增补剂,用量以不超过现行良好生产操作规程为限。泛酸钙还可用于联邦食品、药品和化妆品法案中412(g)和412(a)(2)婴儿配方食品。

    更多关于已证实属于一般公认为安全(GRAS)的可直接加入食品中的物质种类,请点击美国FDA 21 CFR 第184部分已证实属于一般公认为安全(GRAS)的可直接加入食品中的物质种类汇总

  § 184.1212   Calcium pantothenate.

  (a) Calcium pantothenate ((C9H16NO5)2Ca, CAS Reg. No. of the D- isomer, 137–08–6) is a salt of pantothenic acid, one of the vitamins of the B complex. Only the D- isomer of pantothenic acid has vitamin activity, although both the D- isomer and the DL- racemic mixture of calcium pantothenate are used in food. Commercial calcium pantothenate is prepared synthetically from isobutyraldehyde and formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and pantolactone.

  (b) Calcium pantothenate meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 56, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

  (c) In accordance with §184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

  (1) The ingredient is used as a nutrient supplement as defined in §170.3(o)(20) of this chapter.

  (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. Calcium pantothenate may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act.

  (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

  [48 FR 51908, Nov. 15, 1983]

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