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§172.804 天门冬酰苯丙氨酸甲酯(甜味素)(Aspartame)

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放大字体  缩小字体 2011-04-28 04:32:25  来源:GPO  浏览次数:529
核心提示:规定食品添加剂天门冬酰苯丙氨酸甲酯安全用做食品的甜味剂和风味增强剂需符合的条件。本添加剂用做甜味热饮料的代糖片时,L-亮氨酸可用做制造这种片剂时的润滑剂,但其用量不得超过片剂量的3.5%。当本添加剂用做焙烤食品和焙烤用预混合粉时,其总量不得超过即食焙烤制品或焙烤前最终制品组成量的0.5%。
发布单位
FDA
FDA
发布文号 39 FR 27319
发布日期 1974-07-26 生效日期 暂无
有效性状态 废止日期 暂无
备注 规定食品添加剂天门冬酰苯丙氨酸甲酯安全用做食品的甜味剂和风味增强剂需符合的条件。本添加剂用做甜味热饮料的代糖片时,L-亮氨酸可用做制造这种片剂时的润滑剂,但其用量不得超过片剂量的3.5%。当本添加剂用做焙烤食品和焙烤用预混合粉时,其总量不得超过即食焙烤制品或焙烤前最终制品组成量的0.5%。

  § 172.804   Aspartame.

  The food additive aspartame may be safely used in food in accordance with good manufacturing practice as a sweetening agent and a flavor enhancer in foods for which standards of identity established under section 401 of the act do not preclude such use under the following conditions:

  (a) Aspartame is the chemical 1-methyl N- l-α-aspartyl-l-phenylalanine (C14H18N2O5).

  (b) The additive meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981) pp. 28–29 and First Supplement p. 5, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food And Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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.

  (c)(1) When aspartame is used as a sugar substitute tablet for sweetening hot beverages, including coffee and tea, L-leucine may be used as a lubricant in the manufacture of such tablets at a level not to exceed 3.5 percent of the weight of the tablet.

  (2) When aspartame is used in baked goods and baking mixes, the amount of the additive is not to exceed 0.5 percent by weight of ready-to-bake products or of finished formulations prior to baking. Generally recognized as safe (GRAS) ingredients or food additives approved for use in baked goods shall be used in combination with aspartame to ensure its functionality as a sweetener in the final baked product. The level of aspartame used in these products is determined by an analytical method entitled “Analytical Method for the Determination of Aspartame and Diketopiperazine in Baked Goods and Baking Mixes,” October 8, 1992, which was developed by the Nutrasweet Co. Copies are available from the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or are available for inspection at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and 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.

  (d) To assure safe use of the additive, in addition to the other information required by the Act:

  (1) The principal display panel of any intermediate mix of the additive for manufacturing purposes shall bear a statement of the concentration of the additive contained therein;

  (2) The label of any food containing the additive shall bear, either on the principal display panel or on the information panel, the following statement:

  PHENYLKETONURICS: CONTAINS PHENYLALANINE

  The statement shall appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

  (3) When the additive is used in a sugar substitute for table use, its label shall bear instructions not to use in cooking or baking.

  (4) Packages of the dry, free-flowing additive shall prominently display the sweetening equivalence in teaspoons of sugar.

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

  [39 FR 27319, July 26, 1974]

  Editorial Note:   For  Federal Register  citations affecting §172.804, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

  更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规,请点击美国FDA 21 CFR 第172部分已批准的直接用于人类食品的添加剂种类汇总

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