Back in 2003, EFSA’s predecessor, the Scientific Committee on Food (SCF), established a tolerable upper intake level (UL) of 25 µg vitamin D/day for infants aged 0 to 24 months. The value was based on the absence of hypercalcaemia in two intervention studies on infants, and a lack of data meant that it could not be refined by EFSA in 2012. In the current (2018) draft update, the available data on daily vitamin D intake and potential adverse health outcomes are still not considered to be a sufficient basis for a UL on their own. However, a dose-response relationship between daily supplemental intake of vitamin D and mean achieved serum 25-hydroxy-vitamin D [25(OH)D] concentrations was established. A serum concentration of 200 nmol 25(OH)D/L or less is considered unlikely to pose a risk of adverse health outcomes in infants, so EFSA estimated the percentage of infants likely to exceed this value, given their vitamin D intakes. Based on these findings, EFSA retained the UL of 25 µg/day for infants aged up to 6 months, and set a new UL of 35 µg/day for those aged between 6 and 12 months. The safety of infant formulae containing vitamin D at a maximum content of 3 μg/100 kcal was also evaluated.

European Food Safety Authority (2018). Panel on Dietetic Products, Nutrition and Allergies (NDA). Update of the tolerable upper intake level for vitamin D for infants. Draft.

Supporting documents are available at


The above items were taken from the July 2018 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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