21 CFR § 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 ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 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 § 170.3(o)(3) of this chapter; a sequestrant as defined in § 170.3(o)(26) of this chapter; and a solvent and vehicle as defined in § 170.3(o)(27) of this chapter.
(2) The ingredient is used in margarine in accordance with § 166.110 of this chapter; in nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; and in fats and oils as defined in § 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice.
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