[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. 184.1012 [b.alpha]-Amylase enzyme preparation from Bacillus
(a) [alpha]-Amylase enzyme preparation is obtained from the culture
filtrate that results from a pure culture fermentation of a
nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus.
Its characterizing enzyme activity is [alpha]-amylase (1,4 [alpha]-D
glucan glucanohydrolase (E.C. 220.127.116.11)).
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the ``Food Chemicals Codex,'' 3d ed. (1981), pp.
107-110, 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), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont
Ave. NW., suite 1200, Washington, DC, 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://
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practices.
The affirmation of this ingredient as GRAS as a direct human 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, in the hydrolysis of edible starch to
produce maltodextrins and nutritive carbohydrate sweeteners.
(2) The ingredient is used at levels not to exceed current good
[60 FR 55789, Nov. 3, 1995]
Additives that reference this regulation: