Use of titanium dioxide in medicinal products – Swissmedic announcement January 1, 2022
The pharmaceutical excipient titanium dioxide remains permissible in Switzerland until further notice
In October 2021, the EU Member States approved the proposal of the European Commission to ban titanium dioxide in all food products in the European Union (EU) (European Commission’s FAQ on titanium dioxide). This ban is expected to enter into force in the EU in early 2022, with a transitional period of six months. Similarly, a ban on titanium dioxide in food products is also envisaged in Switzerland (see Q&A of the Federal Food Safety and Veterinary Office: What measures is the FSVO now taking?).
In contrast to the rule on food products, titanium dioxide is still permitted as an excipient in medicinal products in the EU; this is based on the analysis published in September 2021 European Medicines Agency (EMA) on the use of titanium dioxide in medicinal products. However, the European Commission intends to re-evaluate the situation concerning the use of titanium dioxide in medicinal products in three years’ time.
Swissmedic has noted the EMA’s analysis and considers a coordinated international approach to be appropriate. The use of titanium dioxide in medicinal products will therefore also continue to be permitted in Switzerland. Swissmedic will closely monitor international evaluations and reassess the situation on an ongoing basis.
Source: Swissmedic
The topic of the further use of the excipient titanium dioxide in pharmaceutical formulation is very much discussed in the pharmaceutical community. Therefore we organised several talks and a dedicated panel on our virtual event ExciPerience.
