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

Abstract

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.

Iron Absorption in Iron-Deficient Women, Who Received 65 mg Fe with an Indonesian Breakfast, Is Much Better from NaFe(III)EDTA than from Fe(II)SO4, with an Acceptable Increase of Plasma NTBI. A Randomized Clinical Trial

“…Our conclusion is that humans, after being exposed for a longer time to NTBI values in plasma that can be reached after treatment with highly absorbable iron compounds with a rather moderate increase of serum NTBI, remained healthy. These considerations may contribute to the discussion on the maximum acceptable daily intake of EDTA for iron fortification and iron therapy [ 30 ].…”

Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial

“…First, the iron fortificant used, iron-EDTA, has proven bioavailability in phytate-rich meals like millet, with absorption levels 2 to 3 times higher than with other types of iron, while also increasing the absorption of iron present in other foods included in the diet [ 17 ]. It has been shown to be safe for everyday use, even at a higher dosage and at large scale [ 18 ]. The calcium present in yoghurt could reduce the bioavailability of iron, but the amount provided in one sachet of MNFY was 50 mg, much lower than the level (300 mg) estimated to cause maximal inhibitory effect on iron [ 19 ].…”

Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children

“…It has been argued, however, that this ADI may have been set too low [56], and a recent trial in Moroccan children has shown that daily oral intake of EDTA can reduce blood lead concentrations [57], which is important in view of the enormous public health burden due to lead exposure in developing countries.…”

“…Our data show that the fortification dose of 3 mg iron as NaFeEDTA cannot be increased without a substantial proportion of children in this age range exceeding the ADI for EDTA. It has been argued, however, that this ADI may have been set too low [ 56 ], and a recent trial in Moroccan children has shown that daily oral intake of EDTA can reduce blood lead concentrations [ 57 ], which is important in view of the enormous public health burden due to lead exposure in developing countries.…”