Following a request from the European Commission, 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 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 the specifications for maltitol syrup which is already authorised in the EU as a food additive.
Higher-order polyols of hydrogenated starch hydrolysates can be hydrolysed in the gastrointestinal tract in mammals to glucose and maltitol. Maltitol is mainly digested in the small intestine, being fermented by the intestinal flora to glucose and sorbitol, the latter being absorbed and converted to fructose and partially to glucose.
In a 13-week feeding study conducted in male and female Charles River CD rats, upon exposure to polyglycitol syrup in the diet, the following effects were observed: a decrease in the average testis to body weight ratio of male rats, which upon microscopic examination of both testes (including epididymides) did not reveal any treatment-related effect; an increase in the empty caecum to body weight ratio in both sexes; an increase in urinary excretion of calcium in the absence of elevated serum calcium in both sexes (observed in the 4700 and 9700 mg/kg bw/day male groups and in the 2400 and 5000 mg/kg bw/day female groups); and an increase in blood glucose concentration in male animals only (observed in the 4700 and 9700 mg/kg bw/day groups). NOAELs of approximately 15 400 mg/kg bw/day in males and 7600 mg/kg bw/day in females, the highest doses levels tested, were identified by the Panel for this study. The Panel considered these effects as non–adverse, being commonly observed also with other authorised indigestible polysaccharides.
No further toxicity data were provided on polyglycitol syrup, however in light of the absence of reported carcinogenicity potential of authorised higher-order polyols such as the maltitol syrups, and taking into consideration that the metabolism of polyglycitol syrup leads to the production of normal dietary constituents such as glucose, the Panel considers that no further toxicity testing is needed.
In a human study, the principal reported adverse effect specifically associated with polyglycitol syrup exposure was gastric disturbance which occurred at bolus doses equivalent to 1 g polyglycitol syrup/kg bw administered during 3 days.
The Panel noted that the highest daily exposure to polyglycitol syrup from all proposed food-uses was estimated on a per body weight basis, to be for pre-school children (1.5–4.5 years old) 3.67 g/kg bw/day at the 95th percentile and children (4 – 10 years old) 2.79 g/kg bw/day at the 95th percentile. The adult population group consumed the lowest amount of polyglycitol syrup on a per body weight basis with mean and 95th percentile all-user intakes around 0.35 and 0.85 g/kg bw/day, respectively.
Breakfast cereals, biscuits, cakes and pastries, were found to be the most important potential sources of polyglycitol syrup (>10%) in all age groups.
The Panel notes that the highest dietary exposure to polyglycitol syrup arising from the proposed use levels (3.67 g/kg bw/day) does not exceed the NOAELs identified by the Panel in the 13-week rat study, which were the highest doses tested (7.6 g polyglycitol syrup/kg bw/day in females and 15.4 g polyglycitol syrup/kg bw/day in males).
The Panel noted that these exposure estimates are based on the assumption that polyglycitol syrup would be present in all food for which its use is proposed. For individual food categories this might be realistic since consumer loyalty and individual preferences might cause a person to always choose particular brands containing this particular food additive. The Panel therefore considers that exposure to polyglycitol syrup from the proposed food uses and use-levels is close to the doses associated with gastric disturbances when administered as bolus doses in human trials and as reported in case reports. Therefore, laxative effects should be taken into account as with other polyols authorised as food additives.
The Panel considers that the toxicological data available on polyglycitol syrup are insufficient to establish an Acceptable Daily Intake (ADI), but based on the available data concludes that there is no indication of a safety concern for the proposed uses of polyglycitol syrup.