Medicinal Products: EC Reaffirms Titanium Dioxide Use
On August 6th, 2025, the European Commission published a Staff Working Document reaffirming its position: Titanium dioxide remains approved for use as a colorant in medicinal products under Regulation (EU) 2022/63. This decision follows the European Medicines Agency’s (EMA) April 2024 review.
Background
In 2021, the European Food Safety Authority (EFSA) concluded that titanium dioxide (TiO₂) could no longer be considered safe as a food additive, prompting its removal from all food categories, including dietary supplements. This decision raised concerns about its continued use in medicinal products, leading the European Commission to request the European Medicines Agency (EMA) to assess the potential impact of eliminating TiO₂ from pharmaceuticals.
TiO₂ is Approved for Use in Medicinal Products
On August 6, 2025, the European Commission published a Staff Working Document reaffirming its position: TiO₂ remains approved for use as a colorant in medicinal products under Regulation (EU) 2022/63. This decision follows the European Medicines Agency’s (EMA) April 2024 review, which concluded:
- TiO₂ is essential for the safety, quality and efficacy of medicines.
- No feasible alternatives currently exist.
- Removal could risk serious shortages across 91,000 human and 1,600 veterinary products.
One aspect not addressed in the EC statement was safety. Since the 2021 EFSA report that led to the ban on TiO₂ in EU foods, regulatory authorities in Australia, Brazil, Canada, Japan, New Zealand, the UK, the US, and the WHO have all reviewed TiO₂ and concluded that it remains safe for continued use.
What About Dietary Supplements?
Despite this update for medicines, TiO₂ (E171) remains banned in EU food products, including dietary supplements. Although E171 is listed as an approved colourant, it is not permitted in any food category. This restriction is expected to continue, as the European Food Safety authority (EFSA) maintains its precautionary stance. By contrast, regulators outside of the EU continue to allow TiO₂ (E/INS 171) in food products, reporting no safety concerns in recent reviews carried out in many countries.
Carcinogen Classification Revoked
On August 1st, 2025, the EU Court of Justice also officially confirmed that TiO₂, in specific powder forms, is no longer classified as a suspected carcinogen by inhalation under EU law. This ruling will remove the need for additional product labelling and documentation going forward.
Connect with Colorcon
For more information on TiO₂ visit our Answer Centre via MyColorcon or contact us. Customers can also benefit from HyperStart C2C™, a digital self-service tool within My Colorcon that provides interactive formulation development tools. The platform offers instant access to formulation insights including film coating recommendations, color selection for branding and patient adherence, process guidance, troubleshooting support and regulatory insights for smooth submissions.
