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184.1148 Bacterially-derived carbohydrase enzyme preparation.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1148 Bacterially-derived carbohydrase 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: 21CFR184.1148]

[Page 499-500]
                        TITLE 21--FOOD AND DRUGS
                          SERVICES (CONTINUED)
SAFE--Table of Contents
        Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec.  184.1148  Bacterially-derived carbohydrase enzyme preparation.

    (a) Bacterially-derived carbohydrase 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 [alpha]-amylase (EC and [beta]-glucanase (EC, which catalyze the hydrolysis of O-glycosyl bonds in 
    (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:
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 
Copies may be examined

[[Page 500]]

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 polysaccharides (e.g., starch).
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[64 FR 19894, Apr. 23, 1999]

Additives that reference this regulation:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1148

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