---
kind: "section"
citation: "21 C.F.R. § 173.115"
title: "21"
number: "173.115"
heading: "Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis."
url: "https://uscodex.org/cfr/21/173.115"
---

# §173.115. Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.


The food additive alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation, may be safely used in accordance with the following conditions:

- (a) The food additive is the enzyme preparation derived from a modified Bacillus subtilis strain that contains the gene coding for α-ALDC from Bacillus brevis.
- (b)
  - (1) The manufacturer produces the additive from a pure culture fermentation of a strain of Bacillus subtilis that is nonpathogenic and nontoxigenic in man or other animals.
  - (2) The manufacturer may stabilize the enzyme preparation with glutaraldehyde or with other suitable approved food additives or generally recognized as safe substances.
  - (3) The enzyme preparation must meet the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 4th ed., 1996, pp. 133-134, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation 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 may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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) The additive is used in an amount not in excess of the minimum required to produce its intended effect as a processing aid in the production of alcoholic malt beverages and distilled liquors.

## Notes

### Amendments

[66 FR 27022, May 16, 2001, as amended at 88 FR 17722, Mar. 24, 2023]

### Authority

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

### Source

Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.

### Amendments

[66 FR 27022, May 16, 2001, as amended at 88 FR 17722, Mar. 24, 2023]