§73.585 食品着色剂番茄红素提取液和浓缩剂(Tomato lycopene extract; tomato lycopene concentrate)

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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

　　§ 73.585   Tomato lycopene extract; tomato lycopene concentrate.

　　（a） Identity . （1） The color additive tomato lycopene extract is a red to dark brown viscous oleoresin extracted with ethyl acetate from tomato pulp followed by removal of the solvent by evaporation. The pulp is produced from fresh, edible varieties of the tomato by removing the liquid. The main coloring component is lycopene.

　　（2） The color additive tomato lycopene concentrate is a powder prepared from tomato lycopene extract by removing most of the tomato lipids with ethyl acetate and then evaporating off the solvent.

　　（3） Color additive mixtures made with tomato lycopene extract or tomato lycopene concentrate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food.

　　（b） Specifications . （1） Tomato lycopene extract shall conform to the following specification: Lycopene, not less than 5.5 percent of oleoresin as determined by the method entitled “Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-O-Mato?（Tomato Oleoresin） and in Tomato Pulp by High Performance Liquid Chromatography （HPLC）,” S.O.P. number : Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural Products Industries, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552（a） and 1 CFR part 51. You may obtain a copy of the method from the Center for Food Safety and Applied Nutrition （HFS–200）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. You may inspect a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, or at the National Archives and Records Administration （NARA）. For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

　　（2） Tomato lycopene concentrate shall conform to the following specification: Lycopene, not less than 60 percent of oleoresin as determined by the method identified in paragraph （b）（1） of this section.

　　（c） Uses and restrictions . Tomato lycopene extract and tomato lycopene concentrate may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of added color is authorized by such standards.

　　（d） Labeling . The label of the color additive 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.

　　[70 FR 43045, July 26, 2005]

　　§73.585　番茄红素提取液和浓缩剂

　　（a）特性：

　　（1）着色剂番茄红素提取液是一种从红色到暗褐色的粘稠油性树脂。它是由乙酸乙酯从番茄浆中提取，然后蒸发掉溶剂而得到的。番茄浆是通过挤压去除新鲜可食的各种番茄内的液体而得到的，其主要的着色成分是番茄红素。

　　（2）着色剂番茄红素浓缩剂呈粉状。它是通过乙酸乙酯萃取，然后蒸发，从而除掉番茄红素提取液中的大量液体而得到的。

　　（3）用番茄红素提取液或番茄红素浓缩剂制备的着色剂混合物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。

　　（b）质量规格：

　　（1）番茄红素提取液应符合下列规格：番茄红素要不少于油性树脂的5.5%。测定方法可参考由LycoRed Natural Products Industries公司于2001年5月30日出版的"番茄红素的定量分析：高效液相色谱（HPLC）分析番茄浆和不同浓度的番茄油性树脂 （Lyc-Omatov）中番茄红素的异构体及其他类胡萝卜素"（S.O.P.number ：Lab/119/01）。此方法已被列为参考文献并用。联邦注册办公室的主任按照5U.S.C.552（a）和1CFR中51部分的要求来审批此项参考文献的并用。你可以从下列地址得到此项参考文献的副本： the Center for Food Safety and Applied Nutrition （HFS-200）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 你可以在下列地址查阅此项参考文献的副本：the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, 或者在the National Archives and Records Administration （NARA）. 咨询此项参考文献在NARA的可获得信息，可以打电话202-741-6030，或者登录下列的网页：

　　http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html。也可以用其它类似的方法来测定番茄红素。

　　（2）番茄红素浓缩剂应符合下列规格：番茄红素要不少于油性树脂的60%，可用本节（b）（1）的方法来测定。

　　（c）使用与限制：一般情况下，符合GMP标准量的番茄红素提取液和浓缩剂可以安全用于为食品着色。本着色剂不能用来对法规401部分中已确定标准的食品着色，除非所加入的色素是这类标准所允许的。

　　（d）标签标注方式：本着色剂的标签应符合本章§72.25中的规定。

　　（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规§721（c）中规定的产品证书需求。