Scientific opinion on the tolerable upper intake level for iron

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, K. Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Peter Aggett, Susan Fairweather-Tait, Agnès de Sesmaisons Lecarré, Lucia Fabiani, Nena Karavasiloglou, Roanne Marie SaadAngeliki Sofroniou, Ariane Titz, Androniki Naska

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)
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Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for iron. Systematic reviews were conducted to identify evidence regarding high iron intakes and risk of chronic diseases, adverse gastrointestinal effects and adverse effects of iron supplementation in infancy, young childhood and pregnancy. It is established that systemic iron overload leads to organ toxicity, but no UL could be established. The only indicator for which a dose–response could be established was black stools, which reflect the presence of large amounts of unabsorbed iron in the gut. This is a conservative endpoint among the chain of events that may lead to systemic iron overload but is not adverse per se. Based on interventions in which black stools did not occur at supplemental iron intakes of 20–25 mg/day (added to a background intake of 15 mg/day), a safe level of intake for iron of 40 mg/day for adults (including pregnant and lactating women) was established. Using allometric scaling (body weight 0.75), this value was scaled down to children and adolescents and safe levels of intakes between 10 mg/day (1–3 years) and 35 mg/day (15–17 years) were derived. For infants 7–11 months of age who have a higher iron requirement than young children, allometric scaling was applied to the supplemental iron intakes (i.e. 25 mg/day) and resulted in a safe level of supplemental iron intake of 5 mg/day. This value was extended to 4–6 month-old infants and refers to iron intakes from fortified foods and food supplements, not from infant and follow-on formulae. The application of the safe level of intake is more limited than a UL because the intake level at which the risk of adverse effects starts to increase is not defined.
Original languageEnglish
Article numbere8819
Pages (from-to)1-106
Number of pages106
JournalEFSA Journal
Volume22
Issue number6
Early online date12 Jun 2024
DOIs
Publication statusPublished online - 12 Jun 2024

Bibliographical note

Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

Keywords

  • adverse effects
  • iron homeostasis
  • iron overload
  • safe level of intake

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