On May 6, 2021 the European Food Safety Authority (EFSA) announced it is not possible to rule out genotoxicity from titanium dioxide (TiO2; CAS 13463-67-7) and therefore it “can no longer be considered as safe when used as a food additive.” This is a change in opinion from EFSA’s last assessment of titanium dioxide in 2016 and later statements in 2018 and 2019 (FPF reported here and here). Following the updated assessment, the European Commission will likely propose the additive’s removal from the list of authorized food additives in the European Union.

A chemical is genotoxic when it has the ability to damage DNA. According to Matthew Wright, chair of EFSA’s titanium dioxide working group, “although the evidence for general toxic effects was not conclusive…we could not rule out a concern for genotoxicity and consequently we could not establish a safe level for daily intake of the food additive.” With thousands of new studies since 2016 creating an increased understanding of titanium dioxide nanoparticles, this was the first time the 2018 EFSA Guidance on Nanotechnology was applied towards a food additive.

The announcement will only affect titanium dioxide used as an additive to foods, such as a whitening food colorant. But titanium dioxide is also authorized as an additive in food contact materials according to the European Union’s and EFSA’s authorized chemicals for use in plastic and non-plastic food contact materials, respectively. However, titanium dioxide is identified as a “substance of potential concern” in the Food Packaging Forum’s Food Contact Chemical database (FCCdb) due to its recognition by some authorities as a possible endocrine disrupting chemical.

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EFSA Panel on Food Additives and Flavoring (May 6, 2021). “Safety assessment of titanium dioxide (E171) as a food additive.” EFSA Journal

EFSA (May 6, 2021). “Titanium dioxide: E171 no longer considered safe when used as a food additive.” EFSA Newsroom

Natasha Foote (May 6, 2021). “EU U-turns on ‘unsafe’ common food additive linked with cancer risk.” Euractiv