EFSA’s Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) also commented on the bioavailability of iron from this source, stating that studies demonstrate that iron in the form of ferric sodium EDTA is 2 to 3 times more bioavailable than ferrous sulfate and that it is efficiently incorporated into haemoglobin.
Iron deficiency is estimated to affect half of all children in the developing world, and undermines the health of 500 million women of reproductive age, according to UNICEF.
The ANS concluded that, “ferric sodium EDTA as a source of iron in food supplements, PARNUTS and fortified foods is of no safety concern at the proposed use levels as long as it does not lead to an exposure to EDTA above 1.9 mg EDTA/kg bw/day.”
The ANS found that overall exposure from all food sources was in the range of 8.6 mg/kg
bw/day for children and 4.2 mg/kg bw/day for adults on average and to 9.5 mg/kg bw/day for children and 4.8 mg/kg bw/day for adults at the 95th percentile.
The Panel said that while this exceeded the value for EDTA of 1.9 mg/kg bw/day derived from the ADI established for calcium disodium EDTA, it could not estimate the probability that an individual is exposed to all products where ferric sodium EDTA is intended to be added as a source for iron although it considers this as rather unlikely.
According to the ANS, the petitioner, Dutch firm Akzo Nobel Functional Chemicals, did not indicate precise use levels but instead stated that these would be similar to that of other forms of iron currently approved for use in food supplements.
Akzo Nobel also said that it expected the iron intake from the use of ferric sodium EDTA not to exceed 22.3 mg/day for a 60 kg adult or 11.1 mg/day for a 30 kg child.
The Panel notes that the UK Expert Group on Vitamins and Minerals (EVM) has stated that for guidance purposes only, a supplemental intake of approximately 17 mg iron per day (equivalent to 0.28 mg/kg bw/day for a 60 kg adult) would not be expected to produce adverse effects in the majority of people.
A No-Observed-Adverse-Effect-Levels (NOAEL) of 250mg/kg, bw/day for ferric sodium EDTA, based on two rat studies, was derived by the Panel
The ANS also noted that, based on previous research, no influence has been observed of the effect of ferric sodium EDTA on the absorption and metabolism of other nutrients in food such as zinc, copper, calcium, manganese in animals or humans.
Moreover, while chronic toxicity or carcinogenicity studies were not provided in the dossier, the Panel concluded, from relevant studies with other EDTA salts that ferric sodium EDTA does not raise concern with respect to carcinogenicity.
The opinion can be found here.