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

The current maximum acceptable daily intake (ADI) of ethylenediaminetetraacetic acid (EDTA) of 1.9 mg day(-1) per kilogram bodyweight (mg day(-1)  kgbw(-1) ) limits the daily intake of iron as iron EDTA [ferric sodium EDTA; sodium iron(III) EDTA] to approximately 2-2.5 mg day(-1) for children 6-24 months of age. This limit was defined by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1973 based on data from an animal-feed study published in 1963. Other animal studies indicate that this limit can be raised to 4.4 or possibly up to 21.7 mg day(-1)  kgbw(-1) , which is 2.3-11.4 times higher than the current value. For nearly 50 years, iron EDTA has been used in France in medicinal syrup for infants 1-6 months of age. The maximum recommended dosage of this drug is 37 times higher than the maximum ADI of EDTA. No adverse health effects have been reported as a result of this medicinal consumption of iron EDTA. Raising the maximum ADI of EDTA to only 4.4 mg day(-1)  kgbw(-1) would enable iron EDTA, an iron fortificant with proven bioavailability in phytate-rich meals, to be added in adequate amounts to cereal-based meals for children 6-24 months of age, who are at risk of iron deficiency.