Ingredients

Iron

EFSA has not set an upper level for iron. In 2024 it set a safe level of intake instead, 40 mg a day for adults from all sources. Iron is also a recognised poisoning risk for young children.

At a glance

Forms permitted in food supplements

Nineteen, listed in Directive 2002/46/EC Annex II, including ferrous bisglycinate, fumarate, gluconate and sulphate

Nutrient reference value (labelling)

14 mg per day (Regulation (EU) No 1169/2011, Annex XIII)

EFSA safe level of intake

40 mg/day for adults, including during pregnancy and lactation (NDA Panel, 2024). This is not a UL

Children

1–3 y 10 mg; 4–6 y 15 mg; 7–10 y 20 mg; 11–14 y 30 mg; 15–17 y 35 mg. Under 1 year, 5 mg of supplemental iron, excluding infant and follow-on formula

Forms and labelling

Annex II lists iron compounds such as ferrous carbonate, citrate, gluconate, fumarate, lactate, sulphate, bisglycinate and phosphate; ferric diphosphate and ferric sodium EDTA; elemental iron; and newer forms such as iron hydroxide adipate tartrate, iron milk caseinate and iron (II) taurate. Labels declare the iron itself per daily portion, together with the percentage of the 14 mg reference value.

The safe level of intake

EFSA found that systemic iron overload leads to organ toxicity but that no UL could be established. It concluded instead that "a total intake of iron of 40 mg/day, from diet and supplements, is not expected to lead to adverse effects in the general adult population." The value is based on black stools, which EFSA describes as not adverse in themselves. A safe level has more limited use than a UL because the intake at which risk starts to rise is not defined. It does not apply to people receiving iron under medical supervision.

There is no harmonised EU maximum for a product. National figures for a daily dose differ: 14 mg in France, 45 mg in Belgium, and a non-binding 6 mg recommended in Germany, where men, post-menopausal women and pregnant women are advised to consult a doctor first. See EFSA upper levels.

Authorised health claims

Regulation (EU) No 432/2012 authorises claims that iron contributes to normal cognitive function, energy-yielding metabolism, formation of red blood cells and haemoglobin, and oxygen transport in the body; to the normal function of the immune system; and to the reduction of tiredness and fatigue. It also has a role in the process of cell division. A separate children's claim, that iron contributes to normal cognitive development of children, is authorised under Article 14. A claim may be used only for food that is at least a source of iron as defined in the Annex to Regulation (EC) No 1924/2006.

Safety considerations

Iron poses an acute risk to young children. EFSA's 2004 opinion records numerous reports of accidental poisoning with medicinal iron, especially in young children, and states that an acute oral dose of 60 mg of iron per kilogram of body weight can be lethal. Every food supplement label must say that the product should be stored out of the reach of young children. If a child may have swallowed iron tablets, seek urgent medical help.

Over time, overload leads to iron accumulating in organs, especially the liver, with possible cirrhosis, liver failure and hepatocellular carcinoma. EFSA notes that people with haemochromatosis are particularly sensitive and are not the target of its reference value. This page does not give dosing advice; whether iron is needed is a question for a physician or pharmacist.

Frequently asked questions

What is the upper limit for iron supplements?

EFSA has not set a tolerable upper intake level for iron. In 2024 it set a safe level of intake of 40 mg per day from diet and supplements for adults, with lower figures for children.

Is iron dangerous for children?

It can be. EFSA records numerous accidental poisonings with medicinal iron in young children, and supplement labels must say the product should be stored out of their reach. Seek urgent medical help after a suspected overdose.

Which forms of iron are allowed in EU food supplements?

The nineteen forms in Annex II of Directive 2002/46/EC, including ferrous bisglycinate, fumarate, gluconate and sulphate.

Last reviewed: November 2026.