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更多關于美國 FDA 21 CFR 第 73 部分的內容，請詳見美國FDA 21 CFR 第73部分關于免除產品證書的食品用著色劑種類匯總
§ 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 胭脂樹橙提取物
（a）特性：
（1）著色劑胭脂樹橙提取物，系由胭脂樹橙的種子（Bixa orellana L.）用本節中（a）（1）（Ⅰ）和（Ⅱ）欄中所列食用級萃取劑中的任何一種或適當配合后提取而得：
（i）堿性水溶液，堿性丙二醇，乙醇或堿性乙醇液，食用植物油或脂肪，食用植物油或脂肪制得的甘油酯化產物單和雙甘油酯。由堿性水溶液或醇溶液所得的提取液，可用食用級酸進行處理，使胭脂樹橙色素沉淀，然后從液體中分離后干燥。其中間體可用本節（a）（1）（ii）中所列溶劑進行重結晶。也可不進行重結晶。堿度可用食用級堿或碳酸鹽進行調節。
（ii）丙酮、二氯乙烷、己烷、異丙醇、甲醇、二氯甲烷、三氯乙烯。
（2）由胭脂樹橙提取物所制成的食品用著色劑混合料，只能選用合適的本分部所列可安全地用于食品著色的食品著色劑混合料稀釋劑。
（b）質量規格：胭脂樹橙提取物，包括其色淀，應符合下列質量指標：
（1）砷（以As計）不超過3mg/kg；鉛（以Pb計）不超過10mg/kg。
（2）如用本節（a）（1）（ii）中所列的溶劑處理過的胭脂樹橙提取物，則其中溶劑的殘存量應不超過本章170～189部分中相應食品添加劑規定中有關香辛料油樹脂中相應溶劑的允許殘留量。
（c）使用和限制條件：胭脂樹橙在符合GMP用量條件下可安全用做一般食品的著色，但不能用于本法規401節中公布的已認定標準的食品的著色，除非所加入的色素是這類標準所允許的。
（d）標簽標注方式：本著色劑和任何由本著色劑制成的混合料，擬單獨使用或起部分著色效果時，其標簽必須符合本章§70.25中的要求。標簽上必須標明本色素由胭脂樹橙種子制得。按本章§70.25（a）的要求，所有的組分必須列出名稱，但并不必按本章（a）（1）（ii）中規定列出溶劑殘留量的說明。
（e）免除產品證書：本著色劑免除產品證書以保護公眾健康。所生產的每批產品也免除按法規721（c）中規定的需要產品證書。
