21 CFR 184.1329
§ 184.1329 Glyceryl palmitostearate.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 184.1329, § 184.1329 Glyceryl palmitostearate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85562
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.