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Code of Federal Regulations Title 21. Food and Drugs § 21.184.1329 Glyceryl palmitostearate

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

(a) Glyceryl palmitostearate is a mixture of mono-, di-, and triglyceryl esters of palmitic and stearic acids made from glycerin, palmitic acid, and stearic acid.

(b) The ingredient meets the following specifications:

(1) The substance is a mixture of mono-, di-, and triglycerides of palmitic acid and stearic acid.

(2) Heavy metals (as lead):  Not more than 10 parts per million.

(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 a formulation aid, as defined in § 170.3(o)(14) of this chapter.

(2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.184.1329 Glyceryl palmitostearate - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-184-1329/

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