Regulatory Relief: EU Court Overturns Titanium Dioxide Cancer Warning

On August 1st, 2025 European Court of Justice published the judgment on Titanium Dioxide as a suspected carcinogen. 

The European Court of Justice has upheld a 2022 judgment annulling the classification of titanium dioxide in certain powder forms as a suspected carcinogen. The ruling invalidates the European Commission's labelling requirement under the CLP Regulation, impacting chemical manufacturers, importers, and downstream users across sectors. The decision removes a significant labelling burden. 

The French health agency ANSES initiated the reclassification of titanium dioxide as a Category 1B carcinogen by inhalation in 2016. The European Chemicals Agency (ECHA) Risk Assessment Committee supported a less severe Category 2 classification, which was adopted in Commission Delegated Regulation (EU) 2020/217. The regulation required substances containing 1% or more titanium dioxide particles with diameters ≤10 μm to be labeled with the hazard statement H351 (inhalation). However, the General Court ruled in 2022 that the Commission committed a "manifest error" in evaluating a key scientific study. 

A ruling annuls the classification of titanium dioxide as a hazardous chemical, reducing the need for companies to alter product labelling and Safety Data Sheets, but does not prevent future reclassification efforts. 

The Court upheld the General Court's findings, annulling titanium dioxide classification as a suspected inhalation carcinogen, advising regulatory teams to reassess compliance strategies and monitor scientific assessments.