--- kind: "section" citation: "21 C.F.R. § 184.1387" title: "21" number: "184.1387" heading: "Lactase enzyme preparation from Candida pseudotropicalis." url: "https://uscodex.org/cfr/21/184.1387" --- # §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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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)](/cfr/21/184.1.md?p=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)](/cfr/21/170.3.md?p=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. ## Notes ### Amendments [61 FR 7704, Feb. 29, 1996, as amended at 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] ### Authority Authority: 21 U.S.C. 321, 342, 348, 371. ### Source Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted. ### Amendments [61 FR 7704, Feb. 29, 1996, as amended at 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023]