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§184.1296 食品添加剂柠檬酸铁铵(Ferric ammonium citrate)

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放大字体  缩小字体 2011-07-21 15:50:18  来源:GPO  浏览次数:3198
核心提示:按照§184.1(b)(1),食品添加剂柠檬酸铁铵可用做§170.3(o)(20)中的营养增补剂,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,柠檬酸铁铵还可用于婴儿配方食品。
发布单位
FDA
FDA
发布文号 53 FR 16864
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),食品添加剂柠檬酸铁铵可用做§170.3(o)(20)中的营养增补剂,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,柠檬酸铁铵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

  § 184.1296   Ferric ammonium citrate.

  (a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by the reaction of ferric hydroxide with citric acid, followed by treatment with ammonium hydroxide, evaporating, and drying. The resulting product occurs in two forms depending on the stoichiometry of the initial reactants.

  (1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1332–98–5) is a complex salt of undetermined structure composed of 16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65 percent citric acid and occurs as reddish brown or garnet red scales or granules or as a brownish-yellowish powder.

  (2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1333–00–2) is a complex salt of undetermined structure composed of 14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75 percent citric acid and occurs as thin transparent green scales, as granules, as a powder, or as transparent green crystals.

  (b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 116–117 (Ferric ammonium citrate, brown) and p. 117 (Ferric ammonium citrate, green), 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, 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 16864, May 12, 1988]

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