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e-CFR data is current as of November 24, 2020

Title 21Chapter ISubchapter BPart 184Subpart B → §184.1386


Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS


§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.

(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]

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