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§172.803 糖精(Advantame)

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放大字体  缩小字体 2014-05-28 08:31:29  来源:GPO  浏览次数:3604
核心提示:食品添加剂糖精(advantame)在符合现行GMP条件下,可作为甜味剂和增味剂安全地用于一般食品(肉类和家禽除外),用量应不超过达到预期工艺效果所需的适宜需用量。本添加剂可用于联邦食品、药品和化妆品法401制定的标准所允许使用的食品中。若含有本添加剂的食品作为特殊膳食用食品声称,需依据本章105部分的规定予以标示。
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备注 食品添加剂糖精(advantame)在符合现行GMP条件下,可作为甜味剂和增味剂安全地用于一般食品(肉类和家禽除外),用量应不超过达到预期工艺效果所需的适宜需用量。本添加剂可用于联邦食品、药品和化妆品法401制定的标准所允许使用的食品中。若含有本添加剂的食品作为特殊膳食用食品声称,需依据本章105部分的规定予以标示。

  §172.803   Advantame.

  (a) Advantame is the chemical N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (CAS Reg. No. 714229-20-6).

  (b) Advantame meets the following specifications when it is tested according to the methods described or referenced in the document entitled “Specifications and Analytical Methods for Advantame” dated April 1, 2009, by the Ajinomoto Co. Inc., Sweetener Department 15-1, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315, Japan. 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. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.

  (1) Assay for advantame, not less than 97.0 percent and not more than 102.0 percent on a dry basis.

  (2) Free N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-α-aspartyl]-L-phenylalanine, not more than 1.0 percent.

  (3) Total other related substances, not more than 1.5 percent.

  (4) Lead, not more than 1.0 milligram per kilogram.

  (5) Water, not more than 5.0 percent.

  (6) Residue on ignition, not more than 0.2 percent.

  (7) Specific rotation, determined at20 °C [α]D: ?45.0 to ?38.0° calculated on a dry basis.

  (c) The food additive advantame may be safely used as a sweetening agent and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice, in an amount not to exceed that reasonably required to achieve the intended technical effect, in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

  (d) If the food containing the additive purports to be or is represented to be for special dietary use, it must be labeled in compliance with part 105 of this chapter.

  [79 FR 29085, May 21, 2014]

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