[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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
(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:
(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: