[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1012]

[Page 468-469]
 
                        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. 184.1012  -Amylase enzyme preparation from Bacillus stearothermophilus.

    (a) -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 -amylase (1,4 -D 
glucan glucanohydrolase (E.C. 3.2.1.1)).
    (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 the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (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

[[Page 469]]

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 
manufacturing practices.

[60 FR 55789, Nov. 3, 1995]