On request from the European Commission, EFSA updated the UL for vitamin D for infants, i.e. 25 and 35 µg/day for the first and second half-year respectively. EFSA also characterised the risk of infants to have intakes above the UL, particularly when consuming formulae with the maximum vitamin D content (3 µg/100 kcal) under the future new European Regulation.
For younger infants up to 4 months, calculations used the maximal allowed vitamin D content in infant formulae (IF) and published default ‘high’ values for IF consumption. For infants 4 -< 12 months, using its Nutrient Composition and Comprehensive European Food Consumption Databases, EFSA defined intake scenarios, considering ranges of vitamin D amounts in current and future European legal frameworks for formulae, with or without additional intake from fortification.
Depending on reference body weight, age and energy content of IF, using the maximum vitamin D content of 3 µg/100 kcal may lead some younger infants to consume amounts above the UL from formulae alone without considering vitamin D supplemental intake. The precise percentage of infants could not be determined from the data used. In older infants, the 95th percentile of intake, estimated from scenarios comprising formulae and foods fortified or not with vitamin D, does not exceed the ULs, without considering vitamin D supplemental intake.
This intake assessment, considering possible voluntarily and mandatorily fortiﬁed foods on the European market and different food patterns, will support decision-making by risk managers. Further national consumption surveys in infants would help improve the intake assessment.

ASSESSMENT BY THE EUROPEAN FOOD SAFETY AUTHORITY (EFSA) OF THE RISK OF INFANTS TO HAVE VITAMIN D INTAKES ABOVE THE TOLERABLE UPPER INTAKE LEVEL (UL)