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.
Highlights
Millions of young children predominantly in developing and emerging countries may not reach their full physical and intellectual potential because of micronutrient deficiencies in their diet (Horton 2008)
It is generally accepted that the ethylenediaminetetraacetic acid (EDTA) molecules in iron EDTA fulfil a unique, positive role in delivering the iron ions from phytate-rich diets to the human body (Hurrell et al 2010)
Not justified by observations in highdosage animal experiments, this concern may have been aggravated by the emphasis on the maximum acceptable daily intake (ADI) of EDTA in regulatory documents on iron EDTA (Whittaker et al 1993; Heimbach et al 2000)
Summary
Millions of young children predominantly in developing and emerging countries may not reach their full physical and intellectual potential because of micronutrient deficiencies in their diet (Horton 2008). For a 5-kg infant, this intake of 5 mg day−1 iron as iron EDTA is equivalent to 17.9 μmol day−1 kgbw−1 of EDTA molecules, which is 2.8 times higher than the current maximum ADI of EDTA. This revised JECFA statement has greatly supported the acceptance of iron EDTA for nutritional purposes by decision makers and Health Authorities in the EU (EFSA 2010; EU 2010; EU 2011) and in India (Gazette of India 2011) In their safety evaluation report, JECFA rounded the figure of 1.95 mg day−1 kgbw−1 for the maximum ADI of EDTA expressed as H4EDTA (corresponding with 2.5 mg day−1 kgbw−1 of CaNa2EDTA) downwards to 1.9 rather than upwards to 2.0 (JECFA 2007).
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