[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: 21CFR184.1150]
[Page 501]
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. 184.1150 Bacterially-derived protease enzyme preparation.
(a) Bacterially-derived protease enzyme preparation is obtained from
the culture filtrate resulting from a pure culture fermentation of a
nonpathogenic and nontoxigenic strain of Bacillus subtilis or B.
amyloliquefaciens. The preparation is characterized by the presence of
the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC
3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.
(b) The ingredient meets the general requirements and additional
requirements in the monograph on enzyme preparations in the Food
Chemicals Codex, 4th ed. (1996), pp. 128.135, 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 Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or 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. In addition,
antibiotic activity is absent in the enzyme preparation when determined
by an appropriate validated method such as the method ``Determination of
antibiotic activity'' in the Compendium of Food Additive Specifications,
vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food
and Agriculture Organization of the United Nations, Rome, 1992. Copies
are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD
20706, or from The United Nations Bookshop, General Assembly Bldg., rm.
32, New York, NY 10017, or by inquiries sent to http://www.fao.org.
Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
(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.
[64 FR 19895, Apr. 23, 1999]
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