# 21 C.F.R. § 184.1012 (2026): α-Amylase enzyme preparation from Bacillus stearothermophilus

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P184_S184_1012

## Section

- **Citation:** 21 C.F.R. § 184.1012 (2026)
- **Heading:** α-Amylase enzyme preparation from Bacillus stearothermophilus
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 184 / Subpart B / § 184.1012: § 184.1012   α-Amylase enzyme preparation from Bacillus stearothermophilus.

## Text

(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) 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 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), 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) 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, as amended at 78 FR 14666, Mar. 7, 2013]

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P184_S184_1012. Check the current official text before relying on it. Not legal advice.