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更多關(guān)于美國(guó) FDA 21 CFR 第 73 部分的內(nèi)容，請(qǐng)?jiān)斠?jiàn)美國(guó)FDA 21 CFR 第73部分關(guān)于免除產(chǎn)品證書(shū)的食品用著色劑種類匯總
§ 73.95 β-Carotene.
（a） Identity. （1） The color additive is β-carotene prepared synthetically or obtained from natural sources.
?。?） 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.
?。╞） 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.
?。╟） 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.
?。╠） 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.
?。╡） 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-胡蘿卜素
（a）著色劑：
?。?）本著色劑為β-胡蘿卜素，由合成方法制得或由天然原料提取而得。
?。?）用β-胡蘿卜素配制成的食用著色劑混合料，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物稀釋劑。
?。╞）質(zhì)量規(guī)格：β-胡蘿卜素應(yīng)符合下列質(zhì)量指標(biāo)：
物理狀態(tài)，固體。
1%氯仿溶液，應(yīng)澄清。
干燥失重，不超過(guò)0.2%。
灼燒殘?jiān)?，不超過(guò)0.2%。
鉛（以Pb計(jì)），不超過(guò)10mg/kg。
砷（以As計(jì)），不超過(guò)3mg/kg。
含量（分光光度法），96%～101%。
?。╟）使用和限制條件：著色劑β-胡蘿卜素在符合現(xiàn)行GMP用量條件下可安全地用于一般食品的著色，但不能用于法規(guī)401節(jié)中頒布的已確定標(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。
?。╠）標(biāo)簽標(biāo)注方式：本著色劑和任何由本著色劑所配成的混合物，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中的要求。
?。╡）免除產(chǎn)品證書(shū)：本著色劑免除產(chǎn)品證書(shū)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(shū)。
