The FDA has not updated its general guidance on safety assessments since 2007. Within that time, there has been a significant increase in research on the confluence of toxicology, nanotechnology and human health. The EU updates its guidance regularly with new science available to offer proper safety assessments, with its most recent update published in 2021.

Because of health risks, France banned titanium dioxide as a food additive in 2020. Two years later the European Union also banned titanium dioxide as a food additive. 

In a 2016 study published in Scientifica (Cairo), Egyptian researchers examined the effects of titanium dioxide nanoparticles on the organs of mice by orally administering the food additive daily, for five days. The results showed that the exposure produced “mild to moderate changes in the cytoarchitecture of brain tissue in a time dependent manner.” Furthermore, “Comet assay revealed the apoptotic DNA fragmentation, while PCR-SSCP pattern and direct sequencing showed point mutation of Presenilin 1 gene at exon 5, gene linked to inherited forms of Alzheimer’s disease.” The researchers wrote: “From these findings, “the present study concluded that TiO2NPs is genotoxic and mutagenic to brain tissue which in turn might lead to Alzheimer’s disease incidence.”