§73.75 食品着色剂斑蝥黄(Canthaxanthin)

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    更多关于美国 FDA 21 CFR 第 73 部分的内容，请详见美国FDA 21 CFR 第73部分关于免除产品证书的食品用着色剂种类汇总

　　§ 73.75   Canthaxanthin.

　　（a） Identity. （1） The color additive canthaxanthin is β-carotene-4,4′-dione.

　　（2） Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.

　　（b） Specifications. Canthaxanthin 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:

　　Physical state, solid.

　　1 percent solution in chloroform, complete and clear.

　　Melting range （decomposition）, 207 °C. to 212 °C. （corrected）.

　　Loss on drying, not more than 0.2 percent.

　　Residue on ignition, not more than 0.2 percent.

　　Total carotenoids other than trans-canthaxanthin, not more than 5 percent.

　　Lead, not more than 10 parts per million.

　　Arsenic, not more than 3 parts per million.

　　Mercury, not more than 1 part per million.

　　Assay, 96 to 101 percent.

　　（c） Use and restrictions. （1） The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions:

　　（i） The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and

　　（ii） 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.

　　（2） Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogam （4 grams per ton） of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect.

　　（3） Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

　　（i） Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture;

　　（ii） The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and

　　（iii） The quantity of color additive in feed shall not exceed 80 milligrams per kilogram （72 grams per ton） of finished feed.

　　（d） Labeling requirements. （1） The labeling of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.

　　（2） For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates （established through generally accepted stability testing methods） for the sealed and open container, other information required by §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph （c）（3） of this section.

　　（3） The presence of the color additive in finished fish feed prepared according to paragraph （c）（3） of this section shall be declared in accordance with §501.4 of this chapter.

　　（4） The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with §§101.22（b）, （c）, and （k）（2）, and 101.100（a）（2） of this chapter.

　　（e） Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721（c） of the act.

　　[42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998]

　　§73.75　斑蝥黄

　　（a）特性：

　　（1）着色剂斑蝥黄为β-胡萝卜素-4，4'-二酮。

　　（2）用斑蝥黄配制成的食品着色剂混合料，只能选用合适的、本分部所列的、可安全地用于食品着色的着色剂混合料稀释剂。

　　（b）质量规格：斑蝥黄应符合下列质量指标，不得含有下述以外的杂质，和在良好生产操作规程（GMP）条件下可以避免的其它杂质：

　　物理性状，固体。

　　1%的氯仿溶液应全部溶解并澄清。

　　熔程（分解），207℃至212℃（校正过）。

　　干燥失重，不超过0.2%。

　　灼烧残渣，不超过0.2%。

　　除反式斑蝥黄之外的总类胡萝卜素，不超过5%。

　　铅，不超过10mg/kg。

　　砷，不超过3mg/kg。

　　汞，不超过1mg/kg。

　　含量，96%～101%。

　　（c）使用和限制条件：

　　（1）着色剂斑蝥黄可安全地用于一般食品的着色，但应符合下列限制条件：

　　（i）固体或半固体食品中斑蝥黄的用量不得超过66.08mg/kg，液体食品中不超过52.82mg/L。

　　（ii）不得用于法规401节颁布的已确定标准的食品的着色，除非所加入的色素是这类标准所允许的。

　　（2）在符合下列条件下，斑蝥黄可安全地用于烧烤用鸡的饲料，以增强鸡皮的黄色（为了补充其它已知叶黄素和有关的类胡萝卜素源来达到所需效果），掺入饲料中的斑蝥黄量不得超过4.41mg/kg（4g/t）饲料。

　　（3）在符合下列限制条件下，斑蝥黄可安全地用于鲑鱼饲料中：

　　（i）斑蝥黄仅以一种稳定的着色剂混合物形式用于鱼饲料；

　　（ii）斑蝥黄是用于使鲑鱼肉色由粉红色增色至橘红色。

　　（iii）斑蝥黄的用量应不超过80mg/kg（72g/t）饲料。

　　（d）标签标注方式：本着色剂和任何由本着色剂配成的混合物，拟单独使用或起部分着色效果时，其标签必须符合本章§70.25中的规定。

　　（e）免除产品证书：本着色剂免除产品证书以保护公众健康。所生产的每批产品也免除按法规721（c）中所规定的需要产品证书。