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

K. Pentieva, Dominique Turck, Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Grazyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjodin, Martin Stern, Daniel Tome, Henk Van Loveren, Marco Vinceti, Peter WillattsMary Fewtrell, Christel Lamberg-Allardt, Hildegard Przyrembel, Davide Arcella, Celine Dumas, Lucia Fabiani, Laura Martino, Daniela Tomcikova, Monika Neuhauser-Berthold

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31 Citations (Scopus)


Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to revise the tolerable upper intake level (UL) for vitamin D for infants (≤ 1 year) set in 2012. From its literature review, the Panel concluded 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 Panel conducted 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 200 nmol/L or below is unlikely to pose a risk of adverse health outcomes in infants, the Panel estimated the percentage of infants reaching a concentration above this value at different intakes of vitamin D. Based on the overall evidence, the Panel kept the UL of 25 μg/day for infants aged up to 6 months and set a UL of 35 μg/day for infants 6–12 months. The Panel was also asked to advise on the safety of the consumption of infant formulae with an increased maximum vitamin D content of 3 μg/100 kcal (Commission Delegated Regulation (EU) 2016/127 repealing Directive 2006/141/EC in 2020). For infants aged up to 4 months, the intake assessment showed that the use of infant formulae containing vitamin D at 3 μg/100 kcal may lead some infants to receive an intake above the UL of 25 μg/day from formulae alone without considering vitamin D supplemental intake. For infants aged 4–12 months, the 95th percentile of vitamin D intake (high consumers) estimated from formulae and foods fortified or not with vitamin D does not exceed the ULs, without considering vitamin D supplemental intake.
Original languageEnglish
Number of pages118
JournalEFSA Journal
Issue number8
Publication statusPublished (in print/issue) - 7 Aug 2018


  • vitamin D
  • infants
  • adverse health outcome
  • 25(OH)D
  • UL
  • Intake


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