GroundRules
21 CFR 184.1560: Ox bile extract.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
- Subpart B—Listing of Specific Substances Affirmed as GRAS
(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. 1
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON