原文后附帶中文翻譯，由食品伙伴網(wǎng)食品論壇網(wǎng)友gaoketian提供，食品伙伴網(wǎng)在此表示感謝！
更多關(guān)于美國 FDA 21 CFR 第 73 部分的內(nèi)容，請(qǐng)?jiān)斠?a href="http://delmunsoft.com/law/usa/172305.html">美國FDA 21 CFR 第73部分關(guān)于免除產(chǎn)品證書的食品用著色劑種類匯總
§ 73.75 Canthaxanthin.
?。╝） 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.
?。╞） 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:
?。╥） The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and
?。╥i） 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.
?。?） Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
?。╥） 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
?。╥ii） The quantity of color additive in feed shall not exceed 80 milligrams per kilogram （72 grams per ton） of finished feed.
?。╠） 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.
?。?） 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.
?。?） 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.
?。╡） 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 斑蝥黃
?。╝）特性：
?。?）著色劑斑蝥黃為β-胡蘿卜素-4，4'-二酮。
?。?）用斑蝥黃配制成的食品著色劑混合料，只能選用合適的、本分部所列的、可安全地用于食品著色的著色劑混合料稀釋劑。
?。╞）質(zhì)量規(guī)格：斑蝥黃應(yīng)符合下列質(zhì)量指標(biāo)，不得含有下述以外的雜質(zhì)，和在良好生產(chǎn)操作規(guī)程（GMP）條件下可以避免的其它雜質(zhì)：
物理性狀，固體。
1%的氯仿溶液應(yīng)全部溶解并澄清。
熔程（分解），207℃至212℃（校正過）。
干燥失重，不超過0.2%。
灼燒殘?jiān)?，不超過0.2%。
除反式斑蝥黃之外的總類胡蘿卜素，不超過5%。
鉛，不超過10mg/kg。
砷，不超過3mg/kg。
汞，不超過1mg/kg。
含量，96%～101%。
（c）使用和限制條件：
?。?）著色劑斑蝥黃可安全地用于一般食品的著色，但應(yīng)符合下列限制條件：
?。╥）固體或半固體食品中斑蝥黃的用量不得超過66.08mg/kg，液體食品中不超過52.82mg/L。
（ii）不得用于法規(guī)401節(jié)頒布的已確定標(biāo)準(zhǔn)的食品的著色，除非所加入的色素是這類標(biāo)準(zhǔn)所允許的。
（2）在符合下列條件下，斑蝥黃可安全地用于燒烤用雞的飼料，以增強(qiáng)雞皮的黃色（為了補(bǔ)充其它已知葉黃素和有關(guān)的類胡蘿卜素源來達(dá)到所需效果），摻入飼料中的斑蝥黃量不得超過4.41mg/kg（4g/t）飼料。
?。?）在符合下列限制條件下，斑蝥黃可安全地用于鮭魚飼料中：
?。╥）斑蝥黃僅以一種穩(wěn)定的著色劑混合物形式用于魚飼料；
?。╥i）斑蝥黃是用于使鮭魚肉色由粉紅色增色至橘紅色。
?。╥ii）斑蝥黃的用量應(yīng)不超過80mg/kg（72g/t）飼料。
?。╠）標(biāo)簽標(biāo)注方式：本著色劑和任何由本著色劑配成的混合物，擬單獨(dú)使用或起部分著色效果時(shí)，其標(biāo)簽必須符合本章§70.25中的規(guī)定。
?。╡）免除產(chǎn)品證書：本著色劑免除產(chǎn)品證書以保護(hù)公眾健康。所生產(chǎn)的每批產(chǎn)品也免除按法規(guī)721（c）中所規(guī)定的需要產(chǎn)品證書。
更多國外法規(guī)翻譯，請(qǐng)聯(lián)系食品翻譯中心
編輯：foodfagui