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184.1415 Animal lipase.
(a Animal lipase (CAS Reg. No. 9001C62C1 is an enzyme preparation obtained from edible forestomach tissue of calves, kids, or lambs, or from animal pancreatic tissue. The enzyme preparation may be produced as a tissue preparation or as an aqueous extract. Its characterizing enzyme activity is that of a triacylglycerol hydrolase (EC 3.1.1.3?
(b The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. ?981? 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 (HFSC200? 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 202C741C6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c In accordance with184.1(b)(1? the ingredient is used in food with no limitation other thancurrent 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:
? The ingredient is used as an enzyme as defined in170.3(o)(9 of this chapter to hydrolyze fatty acid glycerides.
? The ingredient is used in food at levels not to exceed current good manufacturing practice.
[60 FR 32911, June 26, 1995]