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更多關(guān)于美國 FDA 21 CFR 第 73 部分的內(nèi)容，請?jiān)斠?a href="http://www.delmunsoft.com/law/usa/172305.html">美國FDA 21 CFR 第73部分關(guān)于免除產(chǎn)品證書的食品用著色劑種類匯總
§ 73.585 Tomato lycopene extract; tomato lycopene concentrate.
?。╝） 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.
?。?） 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
?。?） 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.
?。╠） 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 番茄紅素提取液和濃縮劑
?。╝）特性：
?。?）著色劑番茄紅素提取液是一種從紅色到暗褐色的粘稠油性樹脂。它是由乙酸乙酯從番茄漿中提取，然后蒸發(fā)掉溶劑而得到的。番茄漿是通過擠壓去除新鮮可食的各種番茄內(nèi)的液體而得到的，其主要的著色成分是番茄紅素。
?。?）著色劑番茄紅素濃縮劑呈粉狀。它是通過乙酸乙酯萃取，然后蒸發(fā)，從而除掉番茄紅素提取液中的大量液體而得到的。
?。?）用番茄紅素提取液或番茄紅素濃縮劑制備的著色劑混合物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。
?。╞）質(zhì)量規(guī)格：
（1）番茄紅素提取液應(yīng)符合下列規(guī)格：番茄紅素要不少于油性樹脂的5.5%。測定方法可參考由LycoRed Natural Products Industries公司于2001年5月30日出版的"番茄紅素的定量分析：高效液相色譜（HPLC）分析番茄漿和不同濃度的番茄油性樹脂 （Lyc-Omatov）中番茄紅素的異構(gòu)體及其他類胡蘿卜素"（S.O.P.number ：Lab/119/01）。此方法已被列為參考文獻(xiàn)并用。聯(lián)邦注冊辦公室的主任按照5U.S.C.552（a）和1CFR中51部分的要求來審批此項(xiàng)參考文獻(xiàn)的并用。你可以從下列地址得到此項(xiàng)參考文獻(xiàn)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閱此項(xiàng)參考文獻(xiàn)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）. 咨詢此項(xiàng)參考文獻(xiàn)在NARA的可獲得信息，可以打電話202-741-6030，或者登錄下列的網(wǎng)頁：
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html。也可以用其它類似的方法來測定番茄紅素。
?。?）番茄紅素濃縮劑應(yīng)符合下列規(guī)格：番茄紅素要不少于油性樹脂的60%，可用本節(jié)（b）（1）的方法來測定。
?。╟）使用與限制：一般情況下，符合GMP標(biāo)準(zhǔn)量的番茄紅素提取液和濃縮劑可以安全用于為食品著色。本著色劑不能用來對法規(guī)401部分中已確定標(biāo)準(zhǔn)的食品著色，除非所加入的色素是這類標(biāo)準(zhǔn)所允許的。
（d）標(biāo)簽標(biāo)注方式：本著色劑的標(biāo)簽應(yīng)符合本章§72.25中的規(guī)定。
?。╡）免除產(chǎn)品證書：本著色劑免除為保護(hù)公眾健康而設(shè)的產(chǎn)品證書，所生產(chǎn)的每批產(chǎn)品也免除按法規(guī)§721（c）中規(guī)定的產(chǎn)品證書需求。
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編輯：foodfagui