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Technical report on the technical assistance for the evaluation of additional information on ferric sodium EDTA as a novel food



Following a request from the European Commission, EFSA was asked to review the additional information submitted by an applicant for ferric sodium ethylenediaminetetraacetic acid (EDTA) as a novel food ingredient used as a source of iron. The additional information aimed at demonstrating the absence of particles in the nanometer size range in a product consisting of ferric sodium EDTA, commercialized as Ferrazone XF®, and previously assessed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). The additional information was generated through helium pycnometry, nitrogen absorption, dynamic light scattering, scanning electron microscopy and visual solubility. The specific surface area by volume obtained in the analyses indicates that the product is unlikely to consist of small particles (including nanoparticles). The solubility data indicate that the product is readily soluble, removing concerns over the presence of insoluble/persistent particles. Based on the additional information received, EFSA considers that exposure to small, insoluble and potentially biopersistent particlesof ferric sodium EDTA, including nanoparticles,resulting from the consumption of Ferrazone XF® is unlikely.