21 CFR § 184.1560 - Ox bile extract.

---
identifier: "/us/cfr/t21/s184.1560"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 184.1560 - Ox bile extract."
title_number: 21
title_name: "Food and Drugs"
section_number: "184.1560"
section_name: "Ox bile extract."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "184"
part_name: "DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 348, 371."
regulatory_source: "42 FR 14653, Mar 15, 1977, unless otherwise noted."
cfr_part: "184"
---


# 184.1560 Ox bile extract.

(a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified oxgall or sodium choleate, is a yellowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. It is the purified portion of the bile of an ox obtained by evaporating the alcohol extract of concentrated bile.

(b) Food-grade ox bile extract shall meet the specifications of the U.S. Pharmacopeia (USP), XIV, 1950, p. 410. 
<sup>1</sup>
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<sup>1</sup> Copies may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.

(c) The ingredient is used as a surfactant as defined in § 170.3 (o)(29) of this chapter.

(d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.002 percent for cheese as defined in § 170.3(n)(5) of this chapter.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985]