Code of Federal Regulations Title 21. Food and Drugs § 21.184.1388 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: