[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. 184.1148 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 220.127.116.11) and [beta]-glucanase (EC
18.104.22.168), 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: 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 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: