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
§ 184.1387 Lactase enzyme preparation from Candida pseudotropicalis.
（a） This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase （β-D-galactoside galactohydrolase, EC 3.2.1.23）, which converts lactose to glucose and galactose. It is prepared from yeast that has been grown by a pure culture fermentation process.
（b） The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. （1981）, pp. 107–110, which are 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, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 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 limitations 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 limited to use of this ingredient to reduce the lactose content in milk and milk-derived food products where food standards do not preclude such use.
[61 FR 7704, Feb. 29, 1996]
