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

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), 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, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Henk Van Loveren, Marco VincetiPeter Willatts, Mary Fewtrell, Christel Lamberg-Allardt, Hildegard Przyrembel, Davide Arcella, Céline Dumas, Lucia Fabiani, Laura Martino, Daniela Tomcikova, Monika Neuhäuser-Berthold

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34 Citations (Scopus)
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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
Article numbere05365
Pages (from-to)1-118
Number of pages118
JournalEFSA Journal
Issue number8
Early online date7 Aug 2018
Publication statusPublished - Aug 2018


  • 25(OH)D
  • adverse health outcomes
  • infants
  • intake
  • UL
  • vitamin D

ASJC Scopus subject areas

  • Food Science
  • veterinary (miscalleneous)
  • Animal Science and Zoology
  • Microbiology
  • Parasitology
  • Plant Science


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