About
Iron is an essential mineral nutrient required for the synthesis of hemoglobin, myoglobin, and numerous enzymes involved in oxygen transport and cellular metabolism. It is added to foods such as cereals, flour, infant formula, and salt as a fortification ingredient, and is sold as a dietary supplement primarily to prevent or treat iron-deficiency anemia.
Safety summary
The US Institute of Medicine established a Tolerable Upper Intake Level (UL) of 45 mg/day for adults; JECFA set a provisional maximum tolerable daily intake (PMTDI) of 0.8 mg/kg bw/day (~56 mg/day for a 70 kg adult). EFSA (2024) found that adverse gastrointestinal effects, liver dysfunction, and renal failure can occur at chronic intakes well above 50 mg/day, and noted insufficient data to establish a formal UL. Individuals with hereditary hemochromatosis, thalassemia, or sickle cell anemia face elevated risk from excess iron intake and require medical supervision.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Iron is permitted as an added nutrient in foods under FSANZ Food Standards Code Standard 1.1.1 and 1.3.2. UL of 45 mg/day for adults is consistent with NHMRC/IOM guidance referenced by EFSA's 2024 UL overview.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Numerous iron forms (ferrous ammonium phosphate, ferrous phosphate, iron(II) taurate, iron l-pidolate, ferrous bisglycinate, ferric sodium EDTA, iron hydroxide adipate tartrate, iron milk proteinate/caseinate) approved for addition to foods and food supplements under Regulation (EC) No 1925/2006. EFSA 2024 NDA Panel opinion found insufficient data to set a formal UL; safe intake levels were established instead. Adverse GI effects, liver dysfunction, and renal failure noted at chronic intakes well above 50 mg/day.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Iron is a mandated fortification nutrient under FSS (Fortification of Foods) Regulations, 2016/2018, for staple foods including wheat flour, rice, and double-fortified salt. Mandatory label warning: 'People with Thalassemia may take under medical supervision and persons with Sickle Cell Anaemia are advised not to consume iron-fortified foods.' Nutraceutical/health supplement quantities must not exceed the ICMR-recommended daily allowance per FSS (Health Supplements, Nutraceuticals) Regulations, 2016.source |
Who should approach with care
Research citations
- 1FDA. GRAS Determination of the Complexation Products of Iron with Sodium Citrate. fda.gov
- 2EFSA. Scientific opinion on the tolerable upper intake level for iron, 2024. efsa.europa.eu
- 3FSSAI. Food Safety and Standards (Fortification of Foods) Regulations, 2016 – Compendium 2021, 2021. fssai.gov.in
- 4PubMed. Reasons for raising the maximum acceptable daily intake of EDTA and the benefits for iron fortification of foods for children 6–24 months of age, 2015. pmc.ncbi.nlm.nih.gov
- 5EFSA. Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA] related to the Tolerable Upper Intake Level of Iron, 2004. efsa.europa.eu
