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更多关于美国 FDA 21 CFR 73 部分的内容,请详?a href="//www.sqrdapp.com/law/show-172305.html">美国FDA 21 CFR ?3部分关于免除产品证书的食品用着色剂种类汇怺/font>
73.125 Sodium copper chlorophyllin.
(a Identity. ? 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.
? 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:
? Moisture, not more than 5.0 percent.
? Solvent residues (acetone, ethanol, and hexane? not more than 50 parts per million, singly or, in combination.
? Total copper, not less than 4 percent and not more than 6 percent.
? Free copper, not more than 200 parts per million.
? Lead (as Pb? not more than 10 parts per million.
? Arsenic (as As? not more than 3 parts per million.
? Mercury (as Hg? not more than 0.5 part per million.
? Ratio of absorbance at 405 nanometers (nm to absorbance at 630 nm, not less than 3.4 and not more than 3.9.
? 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 叶绿酸铜钟/p>
(a)特性:
?)着色剂叶绿酸铜钠是一种绿色至黑色的粉末,通过将叶绿素皂化并把镁离子置换成铜离子而制得。所用叶绿素是用丙酮、乙醇和己烷中的任一种或其组合溶剂从紫花苜蓿中提取出来的、/p>
?)由叶绿酸铜钠制得的着色剂只能选用本分部中所列的合适的、能安全用于食品着色的着色剂混合物稀释剂、/p>
(b)质量规格:叶绿酸铜钠应符合下列规格,除了指明的杂质在规定范围内之外,不得含有在现行GMP条件下可以避免的其它杂质、/p>
?)水分,不超?%:/p>
?)溶剂残留(丙酮、乙醇和己烷),单一或组合时不超?0mg/kg:/p>
?)铜离子总量,不少于4%且不超过6%:/p>
?)自由铜离子,不超过200mg/kg:/p>
?)铅(以Pb计),不超过10mg/kg:/p>
?)砷(以As计),不超过3mg/kg:/p>
?)汞(以Hg计),不超过0.5mg/kg:/p>
??05nm吸光度与630nm吸光度比值A405/A630,不低于3.4且不超过3.9:/p>
?)叶绿酸铜总量?00℃干?h后,不低?5%、/p>
(c)使用和限制条件:叶绿酸铜钠可安全地用于柑橘类干饮料混合物的着色,在干混合物中的量不能超过0.2%、/p>
(d)标签标注方式:本着色剂和任何由本着色剂制备的混合物的标签应遵循本章70.25的要求、/p>
(e)免除产品证书:本着色剂免除为保护公众健康而设的产品证书,所生产的每批产品也免除按法?sect;721(c)中规定的产品证书需求、br />