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銆€銆€§ 184.1150 Bacterially-derived protease enzyme preparation.
銆€銆€锛坅锛� Bacterially-derived protease enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes subtilisin 锛圗C 3.4.21.62锛� and neutral proteinase 锛圗C 3.4.24.28锛�, which catalyze the hydrolysis of peptide bonds in proteins.
銆€銆€锛坆锛� The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. 锛�1996锛�, pp. 128–135, which is incorporated by reference in accordance with 5 U.S.C. 552锛坅锛� 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 锛圢ARA锛�. 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. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives 锛圝ECFA锛�, Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611–F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
銆€銆€锛坈锛� In accordance with §184.1锛坆锛夛紙1锛�, the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:
銆€銆€锛�1锛� The ingredient is used as an enzyme as defined in §170.3锛坥锛夛紙9锛� of this chapter to hydrolyze proteins or polypeptides.
銆€銆€锛�2锛� The ingredient is used in food at levels not to exceed current good manufacturing practice.
銆€銆€[64 FR 19895, Apr. 23, 1999]