On 5 August 2025, the European Commission published the Staff Working Document on the use of titanium dioxide in medicinal products, which was drafted by the European Medicines Agency. In light of the EMA’s findings, the Commission concluded that the use of TiO2 as a colouring agent in medicinal products (according to Regulation (EU) 2022/63 amending Regulation (EC) 1333/2008) should be maintained.
TiO2 is a widely used white pigment, currently present in approx. 91,000 human medicines and 1,600 veterinary ones. This excipient is often critical for protecting the active ingredient from light and degradation, and for enabling tablet dissolution. According to the EMA report, the removal of TiO2 would likely be feasible for less than 5% of the medicines. All 20 of the investigated possible alternatives were found to be inferior to TiO2. The EMA also stated that the same challenges would apply also to new medicinal products under development, and that capacity issues could arise for both the industry and regulators. This could lead to product shortages and withdrawal, and delay access to new medicines.
Furthermore, medicines without TiO2 would only be commercialised in the European Union and the European Economic Area (EEA), thus requiring differentiated supply chains, processes and dossiers to be available. The reformulation of individual products is expected to take between 4 to 6 years; the report suggested a transition period of more than 12 years.