Calcium phosphoryl oligosaccharides (POs-Ca®) as a source of calcium added for nutritional purposes to food, food supplements and foods for special medical purposes

POs-Ca^® is a calcium salt of phosphoryl oligosaccharides (POs) obtained from potato starch. POs-Ca^® is stable at the temperature and pH values encountered for its intended use in chewing gum, hard confectionary, sugar-free soft candy and apple juice. POs-Ca^® is highly soluble in water and readily dissociates into phosphorylated oligosaccharides and calcium in the gastrointestinal tract. POs-Ca^® is expected to be absorbed, distributed and eliminated in a manner similar to other dietary sources of calcium and oligosaccharides. Calcium was bioavailable as revealed by the increase in plasma calcium concentrations after intra-gastric administration in rats. POs are not acutely toxic and a no observed adverse effect level of 1,000 mg/kg body weight (bw) per day, the highest dose tested, was established from a 90-day oral toxicity study in rats. No evidence of genotoxicity was observed in a reverse bacterial mutation assay and an in vitro mammalian chromosome aberration test. Overall, the Panel considered that the toxicity data provided in support of the current application were in line with the Tier 1 requirement of the Guidance for submission for food additive evaluations issued by the ANS Panel in 2012 and, in the absence of an indication for a toxic potential of POs-Ca^®, there was no need for additional data. Overall, the Panel concluded that calcium is bioavailable from POs-Ca^® and although the toxicity database was too limited to derive an acceptable daily intake, there is no safety concern for its use as a source of calcium added for nutritional purposes to food, food supplements and foods for special medical purposes at the proposed use and use levels. The Panel noted that POs-Ca^® would be a major contributor to the daily intake of calcium with respect to the overall average daily intake of calcium.