Use of titanium dioxide in medicinal products should be maintained, reaffirms European Commission

On 06 August 2025, the European Commission communicated its conclusions on the European Medicines Agency (EMA) assessment of titanium dioxide (TiO₂) in medicinal products.

The report highlights the importance of TiO₂ for the safety, quality and efficacy of medicinal products as well as the lack of feasible alternatives and the risk of shortages which could be detrimental to patients, given the number of medicinal products affected. It further details the unique photostability of TiO₂ which helps to protect medicines from degradation caused by light.

As a result, the European Commission concluded that the use of TiO₂ in medicinal products should be maintained. As TiO₂ remains listed under Regulation (EC) No 1333/2008, as amended by Regulation (EU) 2022/63, no further regulatory action is required to maintain the use of TiO₂ in medicines.

The TDMA welcomes the conclusion of the Commission. It is consistent with the latest scientific evidence regarding the safety of food grade TiO₂, the form used in medicines, assessed by a growing list of regulatory global bodies worldwide. These include, Health Canada, Food Standards Australia and New Zealand (FSANZ), the World Health Organisation (WHO), the United States Food and Drug Administration (FDA), the China National Centre for Food Safety Risk Assessment (CFSA), the Ministry of Health of Japan and the UK Committee of Toxicity.
Source: Use of titanium dioxide in medicinal products should be maintained, reaffirms European Commission - TDMA