TY - JOUR
T1 - Scientific opinion on the tolerable upper intake level for iron
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - de Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Knutsen, Helle Katrine
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Aggett, Peter
AU - Fairweather-Tait, Susan
AU - de Sesmaisons Lecarré, Agnès
AU - Fabiani, Lucia
AU - Karavasiloglou, Nena
AU - Saad, Roanne Marie
AU - Sofroniou, Angeliki
AU - Titz, Ariane
AU - Naska, Androniki
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2024/6/12
Y1 - 2024/6/12
N2 - 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 weight0.75), 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.
AB - 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 weight0.75), 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.
KW - adverse effects
KW - iron homeostasis
KW - iron overload
KW - safe level of intake
UR - http://www.scopus.com/inward/record.url?scp=85196145680&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/38868106
U2 - 10.2903/j.efsa.2024.8819
DO - 10.2903/j.efsa.2024.8819
M3 - Article
C2 - 38868106
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 6
M1 - e8819
ER -