35.

Heimbach J, Rieth S, Mohamedshah F, Slesinski R, Samuel-Fernando P, Sheehan T, Dickmann R, Borzelleca J. Safety assessment of iron EDTA (sodium iron (Fe3+) ethylenediaminetetraacetic acid): summary of toxicological, fortification and exposure data. Food Chem Toxicol. 2000; 38(1):99-111. (CA) [A review with many refs. Iron EDTA [sodium iron (Fe3+)EDTA(EDTA)], shown 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 bars. This paper presents an assessment of the safety of iron EDTA for its intended uses in these products. Iron EDTA, like other EDTA-metal complexes, dissocs. in the gastrointestinal tract to form iron, which is bioavailable, and an EDTA salt; absorption of the metal ion and EDTA are independent. Because of this dissocn., consideration of information on EDTA compds. other than iron EDTA is relevant to this safety assessment. EDTA compds. are poorly absorbed in the gastrointestinal tract and do not undergo significant metabolic conversion. They have a low degree of acute oral toxicity. EDTA compds. are not reproductive or developmental toxicants when fed with a nutrient-sufficient diet or minimal diets supplemented with zinc. In chronic toxicity studies, diets contg. as much as 5% EDTA were without adverse effects. EDTA compds. were not carcinogenic in exptl. animal bioassays and are not directly genotoxic. This lack of significant toxicity is consistent with a history of safe use of other EDTA compds. (CaNa2-EDTA and Na2-EDTA) approved by the FDA for use as direct food additives. An upper-bound estd. 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 intake (ADI) for EDTA of 2.5 mg/kg bw/day established by JECFA. The data collected and published over the past 20 to 30 yr demonstrate that iron EDTA is safe and effective for iron fortification of food products and meets the std. of "reasonable certainty of no harm." Based on the published record, iron EDTA may be regarded as generally recognized as safe (GRAS) for the intended food uses and max. use levels.]

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