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21 U.S.C. 321, 342, 348, 371.
42 FR 14653, Mar 15, 1977, unless otherwise noted.
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Subscribe to: 21 CFR 184.1560
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Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.
(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.
[43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985]