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.