On August 1, 2025, the European Court of Justice (ECJ) dismissed appeals by France and the European Commission, confirming the 2022 EU General Court decision to revoke the classification of certain powdered titanium dioxide (TiO₂) as a carcinogenic substance. The ruling temporarily closes a years-long regulatory dispute over TiO₂’s alleged health risks.

Background Titanium dioxide, valued for its opacity and whiteness in applications such as coatings, pharmaceuticals, and food products, came under scrutiny in 2016 when France’s ANSES proposed to the European Chemicals Agency (ECHA) its classification as an inhalation carcinogen. ECHA’s Risk Assessment Committee (RAC) backed this in 2017, categorizing it as a Category 2 suspected carcinogen.

In October 2019, the European Commission adopted Delegated Regulation (EU) 2020/217, officially classifying “powdered titanium dioxide (≥1% particles ≤10 micrometers)” as a Category 2 carcinogen and requiring the H351 hazard warning: “Suspected of causing cancer when inhaled.”

ECJ Confirms Overturn of Titanium Dioxide Carcinogenic Classification

The European Court of Justice (ECJ) has upheld the 2022 EU General Court decision annulling the classification of certain powdered titanium dioxide (TiO₂) as a Category 2 inhalation carcinogen, rejecting appeals by France and the European Commission.

Background and Legal Challenge Following the EU’s 2019 regulation requiring TiO₂ products to carry the H351 warning label (“Suspected of causing cancer when inhaled”), several manufacturers, importers, and downstream users challenged the decision. In 2022, the General Court found the European Commission had made “manifest errors” in interpreting key scientific studies, failing to prove TiO₂’s inherent carcinogenicity.

Key Ruling The ECJ ruled that animal study data showing lung tumors in rats could not be directly applied to humans, as the observed effects were linked to particle overload—a non-specific response to excessive lung particle accumulation—rather than intrinsic carcinogenic properties. While noting the General Court slightly exceeded its scope of review, the ECJ confirmed the annulment was justified due to inadequate scientific evaluation by the Risk Assessment Committee (RAC).

Next Steps The European Commission may reassess TiO₂’s hazards, but any future classification must be based on “sufficient, reliable, and comprehensive scientific data.” For now, exporters of TiO₂-containing products to the EU are no longer required to carry the H351 warning label, marking a significant win for the industry.

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