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184.1386 Isopropyl citrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1386 Isopropyl citrate.



[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: 21CFR184.1386]

[Page 531]
 
                        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.  184.1386  Isopropyl citrate.

    (a) Isopropyl citrate is a mixture of the mono-, di-, and 
triisopropyl esters of citric acid. It is prepared by esterifying citric 
acid with isopropanol.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for isopropyl citrate. In the interim, this ingredient must be of a 
purity suitable for its intended use.
    (c) In accordance with Sec.  184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antioxidant as defined in Sec.  
170.3(o)(3) of this chapter; a sequestrant as defined in Sec.  
170.3(o)(26) of this chapter; and a solvent and vehicle as defined in 
Sec.  170.3(o)(27) of this chapter.
    (2) The ingredient is used in margarine in accordance with Sec.  
166.110 of this chapter; in nonalcoholic beverages as defined in Sec.  
170.3(n)(3) of this chapter; and in fats and oils as defined in Sec.  
170.3(n)(12) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1386


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