EU court upholds annulment of titanium dioxide carcinogen classification in major regulatory ruling
The Court of Justice of the European Union (CJEU) has upheld the annulment of the European Commission’s classification of titanium dioxide (TiO₂) in certain powdered forms as a suspected carcinogen by inhalation. This ruling represents a significant legal victory for the Titanium Dioxide Industry Association (TDMA) and its legal team at Mayer Brown.
The case dates back to November 2022, when the General Court of the EU annulled the harmonised classification of TiO₂ as a Category 2 suspected carcinogen under the EU’s Classification and Labelling (CLP) Regulation. The General Court found the Commission’s decision was not supported by sufficient scientific evidence.
Following this, the European Commission and the French Government appealed the ruling, prompting Mayer Brown to defend the annulment on behalf of TDMA before the CJEU.
The Court’s judgment confirms that courts have full jurisdiction to review administrative decisions based on complex scientific and technical assessments. It notably rejects the Advocate General’s earlier opinion, which suggested limiting judicial oversight in such cases on the basis that judges are not scientists and cannot assess conflicting or inconclusive scientific data.
By upholding the annulment, the court has emphasised the importance of accountability in regulatory decisions, ensuring that scientific assessments must meet rigorous standards and can be challenged in court.
Titanium dioxide is a widely used white pigment found in a broad range of products including paints, coatings, cosmetics, medicinal products, and toys. The classification as a suspected carcinogen had required extensive labelling and documentation, potentially impacting many downstream applications and industries.
The court’s decision removes the obligation to classify and label certain powder forms of TiO₂ as carcinogenic, alleviating regulatory burdens for manufacturers and formulators.
Beyond titanium dioxide, this ruling sets an important precedent for how courts in the EU review scientific evidence underpinning regulatory classifications and could influence the interpretation of undefined concepts within the CLP Regulation.
The Mayer Brown legal team in Brussels was led by Litigation Regulatory Enforcement partners Jean-Philippe Montfort and Pavlina Chopova-Leprêtre, supported by Antitrust & Competition partner Aymeric de Moncuit.
This outcome is closely watched across chemical, pharmaceutical, and regulatory sectors as it reinforces the role of judicial oversight in safeguarding scientific integrity in EU regulatory frameworks.




