Update of the tolerable upper intake level for vitamin D for infants

Following a request from the European Commission, the Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to revise the tolerable upper intake level (UL) for vitamin D for infants (≤1year) set in 2012. From its literature review, the Panelconcluded that the available evidence on daily vitamin D intake and the risk of adverse health outcomes (hypercalciuria, hypercalcaemia, nephrocalcinosis and abnormal growth patterns) cannot be used alone for deriving the UL for infants. The Panelconducted a meta-regression analysis of collected data, to derive a dose–response relationship between daily supplemental intake of vitamin D and mean achieved serum 25(OH)D concentrations. Considering that a serum 25(OH)D concentration of 200nmol/L or below is unlikely to pose a risk of adverse health outcomes in infants, the Panelestimated the percentage of infants reaching a concentration above this value at different intakes of vitamin D. Based on the overall evidence, the Panelkept the UL of 25μg/day for infants aged up to 6 months and set a UL of 35μg/day for infants 6–12months. The Panelwas also asked to advise on the safety of the consumption of infant formulae with an increased maximum vitamin D content of 3μg/100kcal (Commission Delegated Regulation (EU) 2016/127 repealing Directive 2006/141/EC in 2020). For infants aged up to 4months, the intake assessment showed that the use of infant formulae containing vitamin D at 3μg/100kcal may lead some infants to receive an intake above the UL of 25μg/day from formulae alone without considering vitamin D supplemental intake. For infants aged 4–12months, the 95th percentile of vitamin D intake (high consumers) estimated from formulae and foods fortified or not with vitaminD does not exceed the ULs, without considering vitamin D supplemental intake.