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§184.1388 食品添加剂乳酸克鲁维酵母产生的乳糖酶制剂(Lactase enzyme preparation from Kluyveromyces lactis)

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放大字体  缩小字体 2011-07-23 09:05:52  来源:GPO  浏览次数:2976
核心提示:   按照§184.1(b)(1)规定,除现行良好生产操作规程外,食品添加剂乳酸克鲁维酵母产生的乳糖酶制剂用于食品中无限制性规定。可用做§170.3(o)(9)中转化乳糖为葡萄糖和半乳糖,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 49 FR 47387
发布日期 1984-12-04 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,食品添加剂乳酸克鲁维酵母产生的乳糖酶制剂用于食品中无限制性规定。可用做§170.3(o)(9)中转化乳糖为葡萄糖和半乳糖,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

  § 184.1388   Lactase enzyme preparation from Kluyveromyces lactis.

  (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast Kluyveromyces lactis (previously named Saccharomyces lactis). It contains the enzyme Β-galactoside galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose and galactose. It is prepared from yeast that has been grown in a pure culture fermentation and by using materials that are generally recognized as safe or are food additives that have been approved for this use by the Food and Drug Administration.

  (b) The ingredient meets the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107–110, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection 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 as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

  (1) The ingredient is used as an enzyme as defined in §170.3(o)(9) of this chapter to convert lactose to glucose and galactose.

  (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is to use this ingredient in milk to produce lactase-treated milk, which contains less lactose than regular milk, or lactose-reduced milk, which contains at least 70 percent less lactose than regular milk.

  [49 FR 47387, Dec. 4, 1984]

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