A new questions and answers concerning titanium dioxide was published by the EMA. The Q&A, including five questions, gives guidance about the replacement or removal of titanium dioxide in medicines.
Titanium dioxide (E 171) is commonly used in the pharmaceutical industry for a variety of functions. A study, performed by the European Food Safety Authority (EFSA), concluded that the genotoxic potential cannot be excluded for titanium dioxide.
The Regulation foresees that TiO2 remains for the time being on the list of authorised additives to allow its use in medicinal products as a colourant, in order to avoid shortages of medicinal products containing TiO2.
Nevertheless, applicants are reminded to make all possible efforts to accelerate the research and development of alternatives and to replace TiO2.
Marketing authorisation holders and applicants can find the necessary guidance in “Quality of medicines questions and answers: Part 2 | European Medicines Agency (europa.eu)”.