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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
§ 73.35 Astaxanthin.
（a） Identity. （1） The color additive astaxanthin is 3, 3′-dihydroxy-β， β-carotene-4, 4′-dione.
（2） Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
（b） Specifications. Astaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
Physical state, solid.
0.05 percent solution in chloroform, complete and clear.
Absorption maximum wavelength 484–493 nanometers （in chloroform）.
Residue on ignition, not more than 0.1 percent.
Total carotenoids other than astaxanthin, not more than 4 percent.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals, not more than 10 parts per million.
Assay, minimum 96 percent.
（c） Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
（1） The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
（2） The quantity of color additive in feed is such that the color additive 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 premixes prepared therefrom shall bear expiration dates for the sealed and open container （established through generally accepted stability testing methods）, 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） of this section.
（2） The presence of the color additive in finished fish feed prepared according to paragraph （c） of this section shall be declared in accordance with §501.4 of this chapter.
（3） The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with §§101.22（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.
[60 FR 18738, Apr. 13, 1995]
§73.35 虾青素
（a）特性：
（1）着色剂虾青素的化学名为3，3'-二羟基-β，β-胡萝卜素-4，4'-二酮。
（2）虾青素仅作为一种稳定的着色剂混合料的组成之一用于鱼饲料中。供鱼饲料用的加有虾青素的着色剂混合料，只能选用适当的和符合本分部中所列可安全地用于食品着色的稀释剂。
（b）质量规格：虾青素应符合下列质量规格，除了指名的杂质在规定范围内以外，不得含有在现行GMP条件下可以避免的杂质：
物理状态为固体。
0. 05%的氯仿溶液应全部溶解并澄清。
最大吸收波长为484～493nm（于氯仿中）。
灼烧残渣，不超过0.1%。
虾青素以外的总类胡萝卜素，不超过4%。
铅，不超过5mg/kg。
砷，不超过2mg/kg。
汞，不超过1mg/kg。
重金属，不超过10mg/kg。
含量，不低于96%。
（c）使用和限制条件：虾青素在符合下列条件下，可安全地用于鲑鱼类的饲料。
（1）本着色剂是用于加深鲑鱼类的肉色由粉红至橙红色。
（2）本着色剂在饲料中的用量，不得超过成品饲料量的80mg/kg（72g/t）。
（d）标签标注方式：
（1）本着色剂和任何由本着色剂配成的混合料，无论是密封包装的或是用敞口容器盛装的，均须标明失效期（须由一般公认的稳定性试验法确定），此外，其标签尚应符合本章§70.25中的要求，对本节（c）中所述的限制条件也应做充分说明，以使最终成品符合条件。
（2）根据本节（c）中要求生产的含有虾青素的成品鱼饲料，应按本章§501.4要求标明含有虾青素。
（3）含有虾青素的喂饲鲑鱼类的饲料，应按照本章§101.22（k）（2）和§101.100（a）（2）中的要求标明含有虾青素。
（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）中规定的需要产品证书。
