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§184.1261 食品添加剂硫酸铜(Copper sulfate)

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放大字体  缩小字体 2011-07-21 11:04:24  来源:GPO  浏览次数:2953
核心提示:按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂硫酸铜在食品中使用无限制性规定。可用做§170.3(o)(20)中的营养增补剂,§170.3(o)(24)中的加工助剂,用量不超过现行良好生产操作规程为限,按照联邦食品、药品和化妆品法案规定,硫酸铜还可用于婴儿配方食品。
发布单位
FDA
FDA
发布文号 73 FR 8607
发布日期 2008-02-14 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,食品添加剂硫酸铜在食品中使用无限制性规定。可用做§170.3(o)(20)中的营养增补剂,§170.3(o)(24)中的加工助剂,用量不超过现行良好生产操作规程为限,按照联邦食品、药品和化妆品法案规定,硫酸铜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

  § 184.1261   Copper sulfate.

  (a) Copper sulfate (cupric sulfate, CuSO4·5H2O, CAS Reg. No. 7758–98–7) usually is used in the pentahydrate form. This form occurs as large, deep blue or ultramarine, triclinic crystals; as blue granules, or as a light blue powder. The ingredient is prepared by the reaction of sulfuric acid with cupric oxide or with copper metal.

  (b) The ingredient must be of a purity suitable for its intended use.

  (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 and as a processing aid as defined in §170.3(o)(24) of this chapter.

  (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Copper sulfate 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.

  [49 FR 24119, June 12, 1984, as amended at 73 FR 8607, Feb. 14, 2008]

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