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Code of Federal Regulations Title 21. Food and Drugs § 21.184.1386 Isopropyl citrate

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.184.1386 Isopropyl citrate - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-184-1386/

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