Polyglycerol fatty acid esters

Category

Nonionic Emulsifier

Grade

Pharmceutical Excipients

UNII

NA

Chemical Name

/

CAS Number

67784-82-1

Synonyms

PGE; Polyglycerol Esters of Fatty Acids

Administration route

Oral

Commonly used amount and the maximum amount

FAO/WHO(1984, g/kg) : Margarine 5; Cold drink 10. GB 2760-2001: Lactic acid bacteria drinks, vegetable protein drinks, ice cream, ice cream bars, popsicles, potato chips, fried snacks and starch and seasonings used for fried snacks, all 10g/kg.

Source and Preparation

The synthesis is divided into two steps. The first step is to add 5kg sodium hydroxide into 500kg refined glycerin at 200-300 ℃ and in the presence of a small amount of alkaline catalysts (such as NaOH, KOH, LiOH, etc.), steam away the water, condense at 260℃ for 24h, and then add CO2 gas to stir and remove the generated water. Inert gas is then injected at 220 ~ 225℃ and 267kPa to steam off the unreacted glycerol, and finally cooled under nitrogen protection. In the second step, 450kg stearic acid and 485kg glycerin were mixed and stirred, esterified for 2h at 220-230 ℃, and then cooled in CO2 airflow to separate a small amount of unreacted glycerin to obtain the product.

Safety

Polyglycerol fatty acid esters are almost completely hydrolyzed to polyglycerol and fatty acid in the gastrointestinal tract. No adverse effects of polyglycerol and fatty acid on human body have been found in existing studies. No adverse effects of polyglycerol fatty acid esters were observed in short-term subchronic or chronic toxicity studies, where the highest doses tested were 9000mg/ kg and 2500mg/ kg body mass, respectively. Based on the results of existing studies, polyglycerol fatty acid esters have not been found to have genotoxicity and reproductive toxicity. Therefore, the expert group considers that polyglycerol fatty acid esters as food additives do not pose safety problems in the current usage and range of use, and there is no need to specify ADI values.