Safety assessment of iron EDTA [sodium iron (Fe3+) ethylenediaminetetraacetic acid]: Summary of toxicological, fortification and exposure data

Iron EDTA [sodium iron (Fe3+) ethylenediaminetetraacetic acid (EDTA)], show n to have a significant beneficial effect on iron status by increasing iron bioavailability in human diets, has been proposed for use as a fortificant in certain grain-based products including breakfast cereals and cereal bar s. This paper presents an assessment of the safety of iron EDTA for its int ended uses in these products, Iron EDTA, like other EDTA-metal complexes, d issociates in the gastrointestinal tract to form iron, which is bioavailabl e, and an EDTA salt; absorption of the metal ion and EDTA are independent. Because of this dissociation, consideration of information on EDTA compound s other than iron EDTA is relevant to this safety assessment, EDTA compound s are poorly absorbed in the gastrointestinal tract and do not undergo sign ificant metabolic conversion. They have a low degree of acute oral toxicity . EDTA compounds are not reproductive or developmental toxicants when fed w ith a nutrient-sufficient diet or minimal diets supplemented with zinc. In chronic toxicity studies, diets containing as much as 5% EDTA were without adverse effects. EDTA compounds were not carcinogenic in experimental anima l bioassays and are not directly genotoxic, This lack of significant toxici ty is consistent with a history of safe use of other EDTA compounds (CaNa(2 )EDTA and Na(2)EDTA) approved by the FDA for use as direct food additives. An upper-bound estimated daily intake (EDI) of EDTA from iron EDTA (1.15 mg /kg bw/day for the US population) is less than half the acceptable daily in take (ADI) for EDTA of 2.5 mg/kg bw/day established by JECFA. The data coll ected and published over the past 20 to 30 Sears demonstrate that iron EDTA is safe and effective for iron fortification of food products and meets th e standard of "reasonable certainty of no harm". Based on the published rec ord, iron EDTA may be regarded as generally recognized as safe (GRAS) for t he intended food uses and maximum use levels. (C) 2000 Elsevier Science Ltd . All rights reserved.