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184.1560 Ox bile extract.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1560 Ox bile extract.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1560]

[Page 549]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  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. \1\
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    \1\ Copies may be obtained from: U.S. Pharmacopeial Convention, 
Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
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    (c) The ingredient is used as a surfactant as defined in Sec.  170.3 
(o)(29) of this chapter.
    (d) The ingredient is used in food in accordance with Sec.  
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 Sec.  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]

[[Page 550]]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1560


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