§73.315 食品着色剂玉米胚乳油(Corn endosperm oil)

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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

　　§ 73.315   Corn endosperm oil.

　　（a） Identity. （1） The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained by isopropyl alcohol and hexane extraction from the gluten fraction of yellow corn grain. The definition of corn endosperm oil in this paragraph is for the purpose of definition as a color additive only and shall not be construed as a food standard of identity under section 401 of the act.

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

　　（b） Specifications. Corn endosperm oil conforms to the following specifications:

　　Total fatty acids, not less than 85 percent.

　　Iodine value, 118 to 134.

　　Saponification value, 165 to 185.

　　Unsaponifiable matter, not more than 14 percent.

　　Hexane, not more than 25 narts per millimn.

　　Isopropyl alcohol, not more than 100 parts per million.

　　（c） Uses and restrictions. The color additive corn endosperm oil may be safely used in chicken feed in accordance with the following prescribed conditions:

　　（1） The color additive is used to enhance the yellow color of chicken skin and eggs.

　　（2） The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph （c）（1） of this section.

　　（d） Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by §70.25 of this chapter, a statement of the concentration of xanthophyll contained therein.

　　（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.

　　§73.315　玉米胚乳油

　　（a）特性：

　　（1）玉米胚乳油系红棕色液体，其主要组成为各种甘油酯、脂肪酸、谷甾醇和类胡萝卜素色素，它是由黄玉米粒的谷蛋白部分用异丙醇和己烷提取而得。本栏所指的玉米胚乳油仅供着色剂使用，不同于法规第401节中所指的。

　　（2）用玉米胚乳油配制成的食用着色剂混合物，只能选用本分部所列的可安全和适用于食品着色的着色剂混合物稀释剂。

　　（b）质量规格：玉米胚乳油应符合下列质量指标：

　　总脂肪酸，不低于85%。

　　碘值，118～134。

　　皂化值，165～185。

　　不皂化物，不超过14%。

　　己烷，不超过25mg/kg。

　　异丙醇，不超过100mg/kg。

　　（c）使用和限制条件：着色剂玉米胚乳油可安全地用于鸡饲料，但应符合下列规定条件：

　　（1）本着色剂用做加深鸡皮和鸡蛋的黄色。

　　（2）这种着色剂在饲料中的用量，是作为叶黄素和类胡萝卜素的增补料，使饲料成品能达到本节（c）（1）规定的效果。

　　（d）标签标注方式：本着色剂和任何混有本着色剂的预混合物，其标签除本章§70.25中所需标明的资料外，还应标明其中所含叶黄素的浓度。

　　（e）免除产品证书：本着色剂免除产品证书以保护公众健康。所生产的每一批产品也免除按法规§721（c）中所规定需要产品证书。