In a European Food and Safety Authority (EFSA) technical report, additional data confirms the product Ferrazone XF 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 particles of ferric sodium ethylenediaminetetraacetic acid (EDTA) including nanoparticles, resulting from its consumption is unlikely.
“Therefore, the additional information provided by the applicant satisfactorily addresses the uncertainties identified in the previous opinion by the EFSA Panel, with regard to the particle size and the potential presence of nanoparticles.
The decision comes as EFSA adopted the scientific opinion on the evaluation of authorised ferric sodium EDTA as a Novel Food (NF) ingredient back in June 2018.
At the time, EFSA confirmed that ferric sodium EDTA was a source from which iron is bioavailable.
In this latest report, the Authority noted the previous decision made for ferric sodium EDTA (marketed as Ferrazone) would have no bearing on its judgement of AkzoNobel’s latest product Ferrazone XF.
This product is judged to be of a finer consistency, produced by adding an extra grinding step to the manufacturing process.
EFSA notes that particle size was not one of the proposed parameters for the revised specifications.
They also note that it was not possible to determine whether particles of ferric sodium EDTA in the nano range were present in solid Ferrazone XF.
What is Ferrazone?
Ferrazone is an iron compound used to fortify foods that are stored in dry form such as powdered beverages, candy bars and flour.
Its powdered format has proved to be much more effective than conventional forms of iron, many of which cannot be absorbed by the body.
Ferrazone is also a highly effective iron source in food fortification to combat iron deficiency anaemia and is recommended by the World Health Organization as the preferred iron fortificant for wheat and maize flour.
It has proved useful in functional foods like sport drinks as well as powdered drinks and ready-to-serve lemonades such as Cola and beer.
Ferrazone can also be used in iron containing food supplements under various forms (like syrups, sprays, tablets and powder sachets).
On October 9, 2018 AkzoNobel's Specialty Chemicals arm, which manufacturers Ferrazone, was rebranded as a new company, Nouryon.
In its summation, EFSA recommends that additional toxicological data be provided to address the shortcomings in the toxicity database prior to the re-evaluation of calcium disodium EDTA (E385) as a food additive.
“In order to address the shortcomings identified in the EFSA opinion and proceed with the NF authorisation procedure in accordance with Regulation (EU) 2015/2283, the applicant has carried out additional testing and analysis,” the report states.
“The applicant also provided the additional analytical information concerning particle size of Ferrazone XF, while additional toxicological data might be provided in the future.”