EUROPE – The European Food Safety Authority (EFSA) has established new safe daily intake levels for iron, superseding the previous attempt to set a tolerable upper intake level (UL) due to insufficient data.

These guidelines are intended to assist risk managers involved in producing iron supplements and iron-fortified food products.

Iron is essential for human health, yet excessive intake can result in negative health effects, particularly on the liver. High-dose iron supplements may also cause gastrointestinal issues.

Based on current scientific evidence, EFSA has determined safe levels of total iron intake.

The safe intake level for adults, including pregnant and lactating women, is set at 40 milligrams (mg) per day. For children aged 1 to 17, the recommended intake ranges from 10 to 35 mg per day, increasing with age.

Infants aged 4 to 11 months are advised to have an intake of 5 mg per day, which includes iron from fortified foods and supplements but excludes iron from infant or follow-on formula.

EFSA’s approach to nutrient safety is based on identifying a threshold intake above which adverse effects occur. However, despite thorough reviews, data were insufficient to establish a definitive UL for iron.

In 2004, EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens could not define a UL due to limited data.

Responding to a European Commission request, EFSA re-evaluated the 2004 opinion and, finding the data still insufficient, advised on a safe level of intake instead.

Unlike ULs, safe levels are not based on a specific threshold and do not imply risk above the set levels. Safe levels indicate the maximum amount that poses no risk to the general population.

Literature review and findings

EFSA commissioned the University of Copenhagen, the University of Oslo, and the Karolinska Institutet to review literature on the health impacts of high iron intake.

The review revealed that most toxicity data were individual case reports, highlighting toxicity from iron overload rather than normal dietary intake. Observed liver toxicity occurred even in individuals without underlying conditions affecting iron absorption, emphasizing the risks of excessive iron intake.

The new intake guidelines are partly based on the occurrence of black stool, indicating high unabsorbed iron levels in the gastrointestinal tract. Although not harmful by itself, black stool suggests potential gastrointestinal distress from excessive iron.

Expanded consumer protection in food supplements

In a related effort to enhance consumer protection, the EU Heads of Food Safety Agencies (HoA) have identified 117 substances to be prohibited or restricted in food supplements.

The oversight of these “other substances” is harmonized only for specific ingredients under EU regulations on fortified foods (EC No 1925/2006) and novel foods (EU 2017/2470).

To extend protection, HoA established a Food Supplements Working Group, comprising experts from 26 Member States, to reach a consensus on managing and assessing these substances. The group’s recommendations aim to integrate the list of risky substances into EU food law through amendments to EC No 1925/2006.

Priority substances for restriction

Of the 117 substances identified for restriction, 13 were flagged as priorities due to potential health risks when consumed as supplements.

These priority substances include coumarin in plant preparations, curcumin in Curcuma preparations, Hypericum perforatum, Melaleuca essential oils, melatonin, piperine, P-synephrine in Citrus preparations, tryptophan, Actaea racemose, Lepidium meyenii, Ocimum tenuiflorum, Tribulus terrestris, and Withania somnifera.

Additionally, 65 substances were classified as novel, 49 as not novel, and three are already regulated under EU laws.

The recommendations from the HoA report are intended to guide the European Commission and EU/EEA Member States in establishing appropriate legislative measures to protect public health.

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