§73.30 食品着色剂胭脂树橙提取物(Annatto extract)

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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

　　§ 73.30   Annatto extract.

　　（a） Identity. （1） The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in paragraph （a）（1） （i） and （ii） of this section:

　　（i） Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph （a）（1）（ii） of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity.

　　（ii） Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene.

　　（2） Color additive mixtures for food use made with annatto extract 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. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications:

　　（1） Arsenic （as As）, not more than 3 parts per million; lead as Pb, not more than 10 parts per million.

　　（2） When solvents listed under paragraph （a）（1）（ii） of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter.

　　（c） Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that 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.

　　（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. Labels shall bear information showing that the color is derived from annatto seed. The requirements of §70.25（a） of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph （a）（1）（ii） of this section.

　　（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.

　　§73.30　胭脂树橙提取物

　　（a）特性：

　　（1）着色剂胭脂树橙提取物，系由胭脂树橙的种子（Bixa orellana L.）用本节中（a）（1）（Ⅰ）和（Ⅱ）栏中所列食用级萃取剂中的任何一种或适当配合后提取而得：

　　（i）碱性水溶液，碱性丙二醇，乙醇或碱性乙醇液，食用植物油或脂肪，食用植物油或脂肪制得的甘油酯化产物单和双甘油酯。由碱性水溶液或醇溶液所得的提取液，可用食用级酸进行处理，使胭脂树橙色素沉淀，然后从液体中分离后干燥。其中间体可用本节（a）（1）（ii）中所列溶剂进行重结晶。也可不进行重结晶。碱度可用食用级碱或碳酸盐进行调节。

　　（ii）丙酮、二氯乙烷、己烷、异丙醇、甲醇、二氯甲烷、三氯乙烯。

　　（2）由胭脂树橙提取物所制成的食品用着色剂混合料，只能选用合适的本分部所列可安全地用于食品着色的食品着色剂混合料稀释剂。

　　（b）质量规格：胭脂树橙提取物，包括其色淀，应符合下列质量指标：

　　（1）砷（以As计）不超过3mg/kg；铅（以Pb计）不超过10mg/kg。

　　（2）如用本节（a）（1）（ii）中所列的溶剂处理过的胭脂树橙提取物，则其中溶剂的残存量应不超过本章170～189部分中相应食品添加剂规定中有关香辛料油树脂中相应溶剂的允许残留量。

　　（c）使用和限制条件：胭脂树橙在符合GMP用量条件下可安全用做一般食品的着色，但不能用于本法规401节中公布的已认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制成的混合料，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。标签上必须标明本色素由胭脂树橙种子制得。按本章§70.25（a）的要求，所有的组分必须列出名称，但并不必按本章（a）（1）（ii）中规定列出溶剂残留量的说明。

　　（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。