EFSA prohibits titanium dioxide in food- should pharmaceuticals be next?

Titanium dioxide (TiO₂) is a natural, inorganic compound widely used across various industries due to its multiple properties. Recently, the European Food Safety Authority (EFSA) raised safety concerns regarding the use of TiO₂ in foods, specifically its potential for genotoxicity, accumulation in the body, and associated health risks when used as a food additive. As a result, its use in food has been banned in the food industry in the European Union (EU) since 2022. Furthermore, the safety of TiO₂ is currently being evaluated as a pharmaceutical excipient, and its use is likely to be banned in EU by 2025. The food industry is significantly impacted by the ban, and a subsequent pharmaceutical ban can lead to issues such as the lack of a single replacement for its multiple applications, product redevelopment/revalidation and regulatory submissions. Other regulatory authorities from other countries conducted independent reviews and concluded that there is insufficient evidence to justify a ban on TiO₂ in foods, thereby allowing its continued use. Various substitutes, both natural and synthetic, are being explored, however none can fully replicate all the properties provided by TiO₂ alone. In this review, we discuss the safety concerns associated with TiO₂, which have led to its ban on food products, as well as the challenges that may arise if a similar ban is imposed on its use in pharmaceuticals.