EFSA Journal (Aug 2018)

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 Vinceti,
  • Peter Willatts,
  • Mary Fewtrell,
  • Christel Lamberg‐Allardt,
  • Hildegard Przyrembel,
  • Davide Arcella,
  • Céline Dumas,
  • Lucia Fabiani,
  • Laura Martino,
  • Daniela Tomcikova,
  • Monika Neuhäuser‐Berthold

DOI
https://doi.org/10.2903/j.efsa.2018.5365
Journal volume & issue
Vol. 16, no. 8
pp. n/a – n/a

Abstract

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Abstract 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.

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