21 C.F.R. § 184.1583 Pancreatin.
Title 21 - Food and Drugs
(a) Pancreatin (CAS Reg. No. 8049–47–6) is an enzyme preparation obtained from porcine or bovine pancreatic tissue. It is a white to tan powder. Its characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36). (b) The ingredient meets the general requirements and additional requirements 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.php. (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]
Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS
§ 184.1583 Pancreatin.
