The European Food Safety Authority accepts that the risks from titanium dioxide are negligible
On 6 August 2025, the European Commission published a report confirming that the European Medicines Agency (EMA) considers the risk from titanium dioxide (TiO2) in medicines to be negligible. These conclusions were based on a safety assessment conducted by the EMA applying its standard practice for evaluating any newly authorised substances. The report was subsequently reviewed by both the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) and endorsed by the EMA’s Committee for Medicinal Products for Human Use.
Since the EFSA’s opinion in 2021, multiple high-quality studies to the latest guidelines have been carried out, including research from independent government laboratories in Japan and China. All of which concluded that no adverse effect is caused by the ingestion of TiO2.
The form of TiO2 used in medicines, E 171, is the same as the one used as a food additive and must comply with the food additive specifications laid down under EU Regulation 231/2012. This aligns EFSA’s position with that of other authorities worldwide, which have assessed the safety of TiO2 and found no cause for concern.
It is useful to note that the use of TiO2 as a food additive represents much less than 1% of the volume of TiO2 placed on the market with the vast majority of TiO2 used in industrial applications where it plays a crucial role in protecting structures against damage from the elements, making them more sustainable.
Food additives are often linked to broader concerns around healthy diet and the preference for natural foods. Food grade TiO2 is industrially manufactured to meet strict regulatory safety and purity standards. The TDMA would like to emphasise that these are two distinct concepts: a preference for natural foods should not be conflated with unsupported claims about the safety of a regulated ingredient.
Source: The European Food Safety Authority accepts that the risks from titanium dioxide are negligible - TDMA