Scientific Opinion on the use of ferric sodium EDTA as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on ferric sodium EDTA added for nutritional purposes to foods for the general population (including food supplements) and to PARNUTS. Iron from ferric sodium EDTA is 2 to 3 times more bioavailable than from other mineral sources. In PARNUTS and food supplements ferric sodium EDTA would provide up to 22.3 mg iron/day (children) and 11.1 mg/day (adults). In fortified foods the proposed uses would result in an additional intake of iron of 2.2 mg/day (children) and 4.8 mg/day (male adults) on average and of 4.8 mg/day and 11.3/day respectively at the 95th percentile. The combined exposure to EDTA in the proposed applications amounts to 8.6 mg/kg bw/day (children) and 4.2 mg/kg bw/day (adults) on average and to 9.5 mg/kg bw/day and 4.8 mg/kg bw/day respectively at the 95th percentile. From two 90-day rat studies the Panel derives a NOAEL of 250 mg ferric sodium EDTA/kg bw/day. The Panel considers that from the information available there is no safety concern with respect to genotoxicity of ferric sodium EDTA as a source of iron added for nutritional purposes to foodstuffs. Chronic toxicity or carcinogenicity studies have not been provided. However, from relevant studies with other EDTA salts the Panel concludes that ferric sodium EDTA does not raise concern with respect to carcinogenicity. There is no concern on a carcinogenic potential of EDTA. No ADI for EDTA has been established. However, from the ADI of 2.5 mg/kg bw/day established for calcium disodium EDTA a value of 1.9 mg EDTA/kg bw/day can be calculated. The Panel concludes 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.