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§74.303 红色三号(赤藓红)(FD&C Red No. 3.)
2011-09-25 19:43  点击:4647
发布单位:FDA
发布文号:暂无
发布日期:暂无
生效日期:暂无
有效性状态:
废止日期:暂无
备注:用赤藓红制成的食用着色剂混合物中只能含有本章第73部分所列适用的和可安全地用于制品着色的着色剂混合物稀释剂。赤藓红挥发物、氯化物和硫酸盐的总量不超过13.0%。水不溶物不超过0.2%。碘化钠不超过0.4%。并规定了铅、砷等金属的含量。赤藓红在符合现行GMP条件下,可安全的用于食品着色,但除非有标准规定,否则不得用于本法规得401节中颁布的已确定标准的食品。每一批赤藓红,均应按本章第80部分的规定需要产品证书。

    §74.303 FD&C Red No. 3.

      (a) Identity. (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o- carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated fluoresceins.

  (2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.

  (b) Specifications. FD&C Red No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

  Volatile matter (at 135 °C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent.

  Water-insoluble matter, not more than 0.2 percent.

  Unhalogenated intermediates, total not more than 0.1 percent.

  Sodium iodide, not more than 0.4 percent.

  Triiodoresorcinol, not more than 0.2 percent.

  2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2 percent.

  Monoiodofluoresceins not more than 1.0 percent.

  Other lower iodinated fluoresceins, not more than 9.0 percent.

  Lead (as Pb), not more than 10 parts per million.

  Arsenic (as As), not more than 3 parts per million.

  Total color, not less than 87.0 percent.

  (c) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring foods generally (including dietary supplements) in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

  (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

  (e) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter.

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下一篇:§74.340 红色40号(诱惑红)(FD&C Red No. 40.)
上一篇:§74.302 橙红2号(Citrus Red No. 2)
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