What is foreseen for medicines containing Titanium dioxide (E171)?
The European Medicines Agency (EMA) published on 8 October 2021 analysis on the use of titanium dioxide in medicines. The findings were that E171 is used very frequently in oral solid dosage forms, in oral semi-solid dosage forms and is also present in dosage forms administered via other routes e.g., products for cutaneous, inhalation, oromucosal, sublingual, transdermal and vaginal use. It is present in many essential medicines for human and several veterinary medicinal products. Considering the scale of the E171 use, the time and costs involved in the reformulation and the volume of impacted products, it is judged that replacing titanium dioxide in medicine will probably cause significant medicines shortages and discontinuations of medicines from the EU/EEA market.
In EC Regulation (EU) 2022/63, as of 18 January 2022, it is foreseen that titanium dioxide remains on the list of authorised additives in medicinal products as a colour. However, the revision of the regulation is planned by 3 years from entering into force. This means re-evaluation of the impact should be done by 1 April 2024.
The future European Commission review should be based on an updated EMA assessment and considering the progress made in development of alternatives to titanium dioxide in both, new and already authorised products, with possible impacts on quality, safety and efficacy, as well as on the availability of medicinal products.
The replacement of titanium dioxide will require pharma industry to investigate and test of suitable alternatives to ensure that quality, safety and efficacy of medicines remains. Consequently, where replacement of titanium dioxide in medicinal products has not taken place until 1 April 2024, only objective verifiable reasons related to the lack of feasibility of its replacement is going to be discussed.
In summary, one of the reasons for transition period is to avoid shortages of medicinal products containing titanium dioxide as this could impact public health, animal health and welfare.