(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

1 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]