原文后附带中文翻译，由食品伙伴网食品论坛网友gaoketian提供，食品伙伴网在此表示感谢！
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
§ 73.95 β-Carotene.
（a） Identity. （1） The color additive is β-carotene prepared synthetically or obtained from natural sources.
（2） Color additive mixtures for food use made with β-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
（b） Specifications. β-carotene shall conform to the following specifications:
Physical state, solid.
1 percent solution in chloroform, clear.
Loss of weight on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Lead （as Pb）, not more than 10 parts per million.
Arsenic （as As）, not more than 3 parts per million.
Assay （spectrophotometric）, 96–101 percent.
（c） Uses and restrictions. The color additive β-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color those 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 and intended solely or in part for coloring purposes shall conform to the requirements of §70.25 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.
§73.95 β-胡萝卜素
（a）着色剂：
（1）本着色剂为β-胡萝卜素，由合成方法制得或由天然原料提取而得。
（2）用β-胡萝卜素配制成的食用着色剂混合料，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物稀释剂。
（b）质量规格：β-胡萝卜素应符合下列质量指标：
物理状态，固体。
1%氯仿溶液，应澄清。
干燥失重，不超过0.2%。
灼烧残渣，不超过0.2%。
铅（以Pb计），不超过10mg/kg。
砷（以As计），不超过3mg/kg。
含量（分光光度法），96%～101%。
（c）使用和限制条件：着色剂β-胡萝卜素在符合现行GMP用量条件下可安全地用于一般食品的着色，但不能用于法规401节中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。
（d）标签标注方式：本着色剂和任何由本着色剂所配成的混合物，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中的要求。
（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。
