§184.1329. Glyceryl palmitostearate.
21 C.F.R. § 184.1329
Glyceryl palmitostearate is a mixture of mono-, di-, and triglyceryl esters of palmitic and stearic acids made from glycerin, palmitic acid, and stearic acid.
The ingredient meets the following specifications—
The substance is a mixture of mono-, di-, and triglycerides of palmitic acid and stearic acid.
Heavy metals (as lead)— Not more than 10 parts per million.
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:
The ingredient is used as a formulation aid, as defined in § 170.3(o)(14) of this chapter.
The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice.
Notes, amendments, and revision history
Amendments
[60 FR 63621, Dec. 12, 1995]
Authority
Authority: 21 U.S.C. 321, 342, 348, 371.
Source
Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.
Amendments
[60 FR 63621, Dec. 12, 1995]