The replacement of the TiO2 (E171) excipient

Titanium dioxide is a frequently used excipient used as a pigment or protective coating in oral solid or semi-solid dosage forms.

However, in 2021 EFSA published its opinion on the safety of TiO2 that currently available evidence along with all uncertainties. As genotoxicity could not be ruled out, TiO2 can no longer be considered as safe when used as a food additive.

To date, no single material has been identified that provides the same combination of properties that are unique to TiO2. Therefore, EMA, EC, and HMA are asking the pharmaceutical industry to make all possible efforts to accelerate the research and development of alternatives to titanium dioxide and to replace titanium dioxide in both new and already authorised products following the publication of Commission Regulation (EU) 2022/63. Currently, a Q&A document is being prepared by the Quality working party to clarify this issue.

More information can be found in EMA evaluation: 2021-09-08-Report on pharmaceutical aspects on impact of removal of TiO2 on medicines + Executive summary - Final (word version) (europa.eu)