GroundRules
21 CFR 184.1329: Glyceryl palmitostearate.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
- Subpart B—Listing of Specific Substances Affirmed as GRAS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON