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Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to re-evaluate the safety in use of vitamin D and to provide, if necessary, revised Tolerable Upper Intake Levels (ULs) of vitamin D for all relevant population groups. The ULs for adults including pregnant and lactating women, children and adolescents were revised. For adults, hypercalcaemia was selected as the indicator of toxicity. In two studies in men, intakes between 234 and 275 µg/day were not associated with hypercalcaemia, and a no observed adverse effect level (NOAEL) of 250 µg/day was established. Taking into account uncertainties associated with these studies, the UL for adults including pregnant and lactating women was set at 100 µg/day. Despite a continuing paucity of data for high vitamin D intakes in children and adolescents, the UL was adapted to 100 µg/day for ages 11-17 years, considering that owing to phases of rapid bone formation and growth this age group is unlikely to have a lower tolerance for vitamin D compared to adults. The same applies also to children aged 1-10 years, but taking into account their smaller body size, a UL of 50 µg/day is proposed. For infants, the UL of 25 µg/day based on previously available data relating high vitamin D intakes to impaired growth and hypercalcaemia was retained as limited additional evidence has emerged since the previous risk assessment. Data Hypercalciuria can be associated with hypercalcaemia, but it can also occur without.For the derivation of the UL, the occurrence of hypercalcaemia and hypercalciuria has been assessed in studies using daily or weekly supplementation of vitamin D for several weeks to months. The shorter-term studies were generally performed in seasons of low sun exposure. Study populations were not generally vitamin D-deficient, and two studies were conducted in subjects with a high vitamin D status at baseline. Study populations included whites, African Americans, young men, preand postmenopausal women, elderly nursing home residents, and overweight and obese adults. It was concluded that vitamin D at doses up to 275 µg/day does not lead to persisting hypercalcaemia or hypercalciuria in adults.Long-term health outcomes (all-cause mortality, cardiovascular disease, cancer, fractures and kidney stones) were also considered, but no studies reported an association between vitamin D intake and increased risk for adverse long-term health outcomes. Studies reporting on an association between 25(OH)D concentration and all-cause mortality or cancer were inconsistent. When 25(OH)D concentrations were associated with an increased risk for adverse long-term health outcomes in some studies, there was a wide variation in 25(OH)D concentrations associated with the adverse effect. It was considered that 25(OH)D concentrations cannot be used to characterise the risk for adverse long-term health outcomes.In adults, a daily vitamin D dose of 250 µg/day (range 234-275 µg/day) was considered to reflect a no observed adverse...