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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
§ 73.125 Sodium copper chlorophyllin.
(a) Identity. (1) The color additive sodium copper chlorophyllin is a green to black powder prepared from chlorophyll by saponification and replacement of magnesium by copper. Chlorophyll is extracted from alfalfa ( Medicago sativa ) using any one or a combination of the solvents acetone, ethanol, and hexane.
(2) Color additive mixtures made with sodium copper chlorophyllin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) Specifications. Sodium copper chlorophyllin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
(1) Moisture, not more than 5.0 percent.
(2) Solvent residues (acetone, ethanol, and hexane), not more than 50 parts per million, singly or, in combination.
(3) Total copper, not less than 4 percent and not more than 6 percent.
(4) Free copper, not more than 200 parts per million.
(5) Lead (as Pb), not more than 10 parts per million.
(6) Arsenic (as As), not more than 3 parts per million.
(7) Mercury (as Hg), not more than 0.5 part per million.
(8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, not less than 3.4 and not more than 3.9.
(9) Total copper chlorophyllins, not less than 95 percent of the sample dried at 100 °C for 1 hour.
(c) Uses and restrictions. Sodium copper chlorophyllin may be safely used to color citrus-based dry beverage mixes in an amount not exceeding 0.2 percent in the dry mix.
(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom 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.
[67 FR 35431, May 20, 2002]
§73.125 葉綠酸銅鈉
(a)特性:
(1)著色劑葉綠酸銅鈉是一種綠色至黑色的粉末,通過將葉綠素皂化并把鎂離子置換成銅離子而制得。所用葉綠素是用丙酮、乙醇和己烷中的任一種或其組合溶劑從紫花苜蓿中提取出來的。
(2)由葉綠酸銅鈉制得的著色劑只能選用本分部中所列的合適的、能安全用于食品著色的著色劑混合物稀釋劑。
(b)質量規格:葉綠酸銅鈉應符合下列規格,除了指明的雜質在規定范圍內之外,不得含有在現行GMP條件下可以避免的其它雜質。
(1)水分,不超過5%;
(2)溶劑殘留(丙酮、乙醇和己烷),單一或組合時不超過50mg/kg;
(3)銅離子總量,不少于4%且不超過6%;
(4)自由銅離子,不超過200mg/kg;
(5)鉛(以Pb計),不超過10mg/kg;
(6)砷(以As計),不超過3mg/kg;
(7)汞(以Hg計),不超過0.5mg/kg;
(8)405nm吸光度與630nm吸光度比值A405/A630,不低于3.4且不超過3.9;
(9)葉綠酸銅總量,100℃干燥1h后,不低于95%。
(c)使用和限制條件:葉綠酸銅鈉可安全地用于柑橘類干飲料混合物的著色,在干混合物中的量不能超過0.2%。
(d)標簽標注方式:本著色劑和任何由本著色劑制備的混合物的標簽應遵循本章§70.25的要求。
(e)免除產品證書:本著色劑免除為保護公眾健康而設的產品證書,所生產的每批產品也免除按法規§721(c)中規定的產品證書需求。