(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.

[60 FR 63621, Dec. 12, 1995]