---
kind: "section"
citation: "21 C.F.R. § 184.1595"
title: "21"
number: "184.1595"
heading: "Pepsin."
url: "https://uscodex.org/cfr/21/184.1595"
---

# §184.1595. Pepsin.

- (a) **Pepsin (CAS Reg.** No. 9001-75-6) is an enzyme preparation obtained from the glandular layer of hog stomach. It is a white to light tan powder, amber paste, or clear amber to brown liquid. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.23.1).
- (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 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 of 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, and 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 practice. The affirmation of this ingredient as GRAS as a direct 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 to hydrolyze proteins or polypeptides.
  - (2) **The ingredient is used in food at levels not to exceed current good manufacturing practice.**

## Notes

### Amendments

[60 FR 32911, June 26, 1995, as amended at 78 FR 14667, 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 32911, June 26, 1995, as amended at 78 FR 14667, Mar. 7, 2013]