Scientific Opinion on the use of Polyglycitol Syrup as a food additive.

Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of polyglycitol syrup when used as a food additive. Polyglycitol syrup belongs to the hydrogenated starch hydrolysate syrups composed of maltitol, sorbitol and higher molecular weight polyols. In contrast to maltitol syrup EU specifications, the polyglycitol syrup has a defined concentration of sorbitol, a lower concentration of maltitol and a defined concentration of higher molecular weight polyols. Consequently, it is not covered by specifications for maltitol syrup which is an EU authorised food additive. In humans, the main reported adverse effect specifically associated with polyglycitol syrup exposure was gastric disturbance. The Panel considers that conservative estimates of the exposure to polyglycitol syrup, for consumer-only and the general population, arising from the proposed uses and use-levels, are close to, and for children even higher than, doses associated with gastric disturbances when administered as bolus doses in human trials and as reported in recent case reports.