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§184.1530 食品添加剂烟酸(Niacin)

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放大字体  缩小字体 2011-07-26 11:19:46  来源:GPO  浏览次数:2936
核心提示:按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂烟酸用于食品中无限制性规定。可用做§170.3(o)(20)中的营养增补剂,按照联邦食品、药品和化妆品法案,烟酸还可用于婴儿配方食品,用量以不超过现行良好生产操作规程为限。
发布单位
FDA
FDA
发布文号 64 FR 1760
发布日期 1999-01-12 生效日期 暂无
有效性状态 废止日期 暂无
备注 按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂烟酸用于食品中无限制性规定。可用做§170.3(o)(20)中的营养增补剂,按照联邦食品、药品和化妆品法案,烟酸还可用于婴儿配方食品,用量以不超过现行良好生产操作规程为限。

    更多关于已证实属于一般公认为安全(GRAS)的可直接加入食品中的物质种类,请点击美国FDA 21 CFR 第184部分已证实属于一般公认为安全(GRAS)的可直接加入食品中的物质种类汇总

  § 184.1530   Niacin.

  (a) Niacin (C6H5NO2, CAS Reg. No. 59–67–6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It is a non-hygroscopic, stable, white, crystalline solid that sublimes without decomposition at about 230 °C. It is soluble in water and alcohol. It is insoluble in ether.

  (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), p. 264, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), 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) In accordance with §184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

  (1) The ingredient is used as a nutrient supplement as defined in §170.3(o)(20) of this chapter.

  (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act.

  (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

  [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983, as amended at 64 FR 1760, Jan. 12, 1999]

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