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Updated: Jun 24, 2025

The Caco-2 Cell Bioassay for Measurement of Food Iron Bioavailability
Published on: April 28, 2022
Scientific opinion on the tolerable upper intake level for iron
Establishing safe iron intake levels is crucial for public health. This study determined safe iron intake levels for adults and children, noting that a tolerable upper intake level (UL) could not be established due to limited evidence.
Area of Science:
- Nutrition science
- Dietary guidelines
- Public health
Background:
- Systemic iron overload can cause organ toxicity.
- Previous research has not established a tolerable upper intake level (UL) for iron.
- The European Commission requested an opinion on safe iron intake levels.
Purpose of the Study:
- To establish a scientific opinion on the tolerable upper intake level (UL) for iron.
- To review evidence on high iron intake risks, including chronic diseases and gastrointestinal effects.
- To assess adverse effects of iron supplementation in infants, children, and pregnant women.
Main Methods:
- Conducted systematic reviews to identify relevant scientific evidence.
- Utilized dose-response analysis, identifying black stools as a key indicator.
- Applied allometric scaling (body weight^0.75) to extrapolate safe intake levels across age groups.
Main Results:
- No tolerable upper intake level (UL) for iron could be established.
- A safe iron intake level of 40 mg/day was determined for adults.
- Safe intake levels for children and adolescents ranged from 10 mg/day (1-3 years) to 35 mg/day (15-17 years).
- A safe supplemental iron intake of 5 mg/day was derived for infants (4-11 months).
Conclusions:
- Safe iron intake levels have been established for various age groups.
- The established safe levels are derived from conservative endpoints like black stools.
- These safe intake levels apply to iron from fortified foods and supplements, excluding infant formulas.
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