(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 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, as amended at 73 FR 8607, Feb. 14, 2008]