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184.1150 Bacterially-derived protease enzyme preparation.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1150 Bacterially-derived protease enzyme preparation.



[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: 21CFR184.1150]

[Page 500]
 
                        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.  184.1150  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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1150


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