---
kind: "section"
citation: "21 C.F.R. § 184.1012"
title: "21"
number: "184.1012"
heading: "α-Amylase enzyme preparation from Bacillus stearothermophilus."
url: "https://uscodex.org/cfr/21/184.1012"
---

# §184.1012. α-Amylase enzyme preparation from Bacillus stearothermophilus.

- (a) α-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 α-amylase (1,4 α-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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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 [§ 184.1(b)(1)](/cfr/21/184.1.md?p=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 [§ 170.3(o)(9)](/cfr/21/170.3.md?p=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.**

## Notes

### Amendments

[60 FR 55789, Nov. 3, 1995, as amended at 78 FR 14666, Mar. 7, 2013]

### Authority

Authority: 21 U.S.C. 321, 342, 348, 371.

### Source

Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.

### Amendments

[60 FR 55789, Nov. 3, 1995, as amended at 78 FR 14666, Mar. 7, 2013]