[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]
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