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184.1583 Pancreatin.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1583 Pancreatin.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1583]

[Page 550]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1583  Pancreatin.

    (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.html.
    (c) In accordance with Sec.  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 Sec.  
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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1583


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