European Commission Confirms Titanium Dioxide Use in Medicines Following EMA Review

In early August 2025, the European Commission released a working document¹ on the decision concerning the use of the excipient titanium dioxide (TiO₂) in pharmaceuticals. “In view of the EMA’s [European Medicines Agency] findings, the Commission takes the view that the use of titanium dioxide as a colour in medicinal products, as provided for in Regulation (EU) 2022/63 amending Regulation (EC) No 1333/2008, should be maintained,” the Commission concluded.

As the document explains, TiO₂ is used in 91,000 human medicinal products as a pigment to add whiteness and as an opacifier to ensure uniform color. It also serves as a protective coating for the active pharmaceutical ingredient.

On August 13, global pharmaceutical capsule supplier ACG released a statement supporting the European Commission’s decision. “This is a wise and pragmatic decision for the pharmaceutical sector,” stated Subhashis Chakraborty, PhD, general manager, head - global product management at ACG Capsules, in the press release. “We remain fully committed to supporting the nutraceutical industry in navigating the ongoing ban through innovative TiO₂-free capsule solutions.”

As ACG explains, the company has been working toward developing alternatives to TiO₂ as well as providing education to the pharmaceutical industry on the situation. It also worked with the IQ Consortium, which created the database on impacts a TiO₂ ban could have.

As summarized by the Commission, in 2022, the EU had banned TiO₂ as a food additive, but allowed its use as a color in medicinal products, based on earlier assessments from European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). In 2024, EMA released an analysis on the possibilities of alternatives to TiO₂ and how the quality, safety, and efficacy of medicines could be affected. EMA found the alternatives to be inferior, and that removing it would be impractical for most medicines and a risk of shortages could occur, based on the number of medicines that would be affected.

In March 2025, EMA also shared its safety assessment of TiO₂ and concluded that, based on its limited data set, the carcinogenicity risk from exposure in medicines was negligible.

Additionally, in an August 1 press release², the Court of Justice of the European Union stated it upheld the invalidation of TiO₂ categorized as a potential carcinogen by inhalation in powder forms. In 2019, the European Commission had adopted the classification, and in 2022, after manufacturers, suppliers, and others had contested the classification, the General Court annulled the classification and labelling. France and the Commission appealed the decision to the Court of Justice, which upheld the annulment, considering it justified.

“By today’s judgment, the Court of Justice dismisses those appeals and thus upholds the judgment of the General Court and the annulment of the contested classification of titanium dioxide as a carcinogen,” the Court stated.

References

1. European Commission. Commission staff working document on the use of titanium dioxide in medicinal products https://health.ec.europa.eu/document/download/34542b69-8507-4fc2-b106-bd15b481e40d_en?filename=mp_working-doc-titanium-dioxide_en.pdf (accessed 2025-08-15).
2. Court of Justice of the European Union. The Court of Justice upholds the annulment of the classification of titanium dioxide in certain powder forms as a carcinogenic substance https://curia.europa.eu/jcms/upload/docs/application/pdf/2025-08/cp250099en.pdf?ck_subscriber_id=829056957 (accessed 2025-08-15).