Iron | whatsinit

About

What it is and where it shows up.

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 regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Other — Individuals with hereditary hemochromatosis should avoid supplemental and fortified-food iron, as their inability to regulate iron absorption leads to organ-damaging iron overload in the liver, heart, and pancreas.

Other — FSSAI mandates that persons with Sickle Cell Anaemia are advised not to consume iron-fortified foods, as excess iron can exacerbate iron loading common in this condition.

Other — FSSAI mandates that persons with Thalassemia take iron-fortified foods only under medical supervision, as chronic transfusion therapy in thalassemia already causes significant iron overload.

Infants — EFSA (2024) notes potential adverse effects of iron supplementation in infants; IOM sets a lower UL of 40 mg/day for children aged 1–13 years, and iron supplement doses for infants require medical guidance.

Pregnancy — Iron requirements increase substantially during pregnancy and iron supplementation is commonly recommended, but dose should be determined by a healthcare professional to avoid both deficiency and excessive intake.

Research citations

The sources behind this verdict.

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

Independently researched5 citations