[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1316]
[Page 522]
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
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 184.1316 Ficin.
(a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained
from the latex of species of the genus Ficus, which include a variety of
tropical fig trees. It is a white to off-white powder. Its
characterizing enzyme activity is that of a peptide hydrolase (EC
3.4.22.3).
(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 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 32910, June 26, 1995]
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