§184.1595 食品添加剂胃蛋白酶(Pepsin)

    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

　　§ 184.1595   Pepsin.

　　（a） Pepsin （CAS Reg. No. 9001–75–6） is an enzyme preparation obtained from the glandular layer of hog stomach. It is a white to light tan powder, amber paste, or clear amber to brown liquid. Its characterizing enzyme activity is that of a peptide hydrolase （EC 3.4.23.1）.

　　（b） The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. （1981）, p. 110, which is 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 Office of Premarket Approval （HFS–200）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and 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 GRAS as a direct 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 hydrolyze proteins or polypeptides.

　　（2） The ingredient is used in food at levels not to exceed current good manufacturing practice.

　　[60 FR 32911, June 26, 1995]