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184.1012 &b.alpha;-Amylase enzyme preparation from Bacillus stearothermophilus.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1012 &b.alpha;-Amylase enzyme preparation from Bacillus stearothermophilus.



[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: 21CFR184.1012]

[Page 485]
 
                        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  [b.alpha]-Amylase enzyme preparation from Bacillus 
stearothermophilus.

    (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. 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 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.
    (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 
manufacturing practices.

[60 FR 55789, Nov. 3, 1995]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1012


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