subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"
part_code: "184"
part_subject: "DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE"
subpart_code: "B"
subpart_subject: "Listing of Specific Substances Affirmed as GRAS"
section_number: "184.1560"
section_subject: "Ox bile extract."
cfr_reference: "21 CFR 184.1560"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 170 to 199"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.