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§184.1315 食品添加剂硫酸亚铁(Ferrous sulfate)

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放大字体  缩小字体 2011-07-22 09:29:59  来源:GPO  浏览次数:3588
核心提示:按照§184.1(b)(1)规定,食品添加剂硫酸亚铁可用做§170.3(o)(20)中的营养增补剂,§170.3(o)(24)中的加工助剂,除现行良好生产操作规程外,无限制性规定。按照联邦食品、药品和化妆品法案,硫酸亚铁还可用于婴儿配方食品。
发布单位
FDA
FDA
发布文号 53 FR 16866
发布日期 1988-05-11 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,食品添加剂硫酸亚铁可用做§170.3(o)(20)中的营养增补剂,§170.3(o)(24)中的加工助剂,除现行良好生产操作规程外,无限制性规定。按照联邦食品、药品和化妆品法案,硫酸亚铁还可用于婴儿配方食品。

    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

  § 184.1315   Ferrous sulfate.

  (a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, FeSO4·7H2O, CAS Reg. No. 7782–63–0) is prepared by the action of sulfuric acid on iron. It occurs as pale, bluish-green crystals or granules. Progressive heating of ferrous sulfate heptahydrate produces ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of ferrous sulfate monohydrate (CAS Reg. No. 17375–41–6) with varying amounts of ferrous sulfate tetrahydrate (CAS Reg. No. 20908–72–9) and occurs as a grayish-white to buff-colored powder.

  (b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124 (ferrous sulfate, dried), 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 ingredients are used in food as nutrient supplements as defined in §170.3(o)(20) of this chapter and as a processing aid as defined in §170.3(o)(24) of this chapter, with no limitation other than current good manufacturing practice. The ingredients may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).

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

  [53 FR 16866, May 12, 1988]

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