Positive Opinion for new iron source
22 January 2010
EFSA has published a positive Scientific Opinion on ferric sodium EDTA as source of iron to be used in foods for the general population (including food supplements) and foods for particular nutritional uses. In its opinion, the Panel on Food Additives and Nutrient Sources added to Food (ANS) in particular addressed the safety of ferric sodium EDTA as a source of iron and the bioavailability of iron from this source.
Studies provided in support of the bioavailability include iron fortification studies in humans. From these studies the Panel deduced that iron is liberated from the complex and that it is bioavailable. The studies further show that iron in the form of ferric sodium EDTA is two to three times more bioavailable than iron in the form of ferrous sulfate and that it is efficiently incorporated into haemoglobin.
The Panel also concludes that the use of ferric sodium EDTA as a source of iron in food is of no safety concern as long as it does not lead to an exposure to EDTA above 1.9 mg EDTA/kg bw/day. In addition, the Panel concludes that ferric sodium EDTA as a source of iron at the proposed use level in fortified food for the general population would not be of safety concern.
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