EU Court Confirms Annulment of Titanium Dioxide Carcinogen Classification

On 1August 2025, the Court of Justice of the European Union (CJEU) delivered its final judgment on the classification of titanium dioxide (TiO2), upholding the 2022 General Court decision that annulled the European Commission’s classification of the substance as a suspected carcinogen by inhalation.

The ruling definitively invalidates the European Commission's labelling requirement introduced under Commission Delegated Regulation (EU) 2020/217, which had amended the CLP Regulation (Regulation (EC) No 1272/2008). The decision has major implications for chemical manufacturers, importers, and downstream users, particularly those in the coatings, plastics and cosmetics sectors. The decision removes a significant labelling burden. 

Background

The classification of titanium dioxide was first proposed by the French health agency ANSES in 2016,  which recommended a Category 1B carcinogenic classification by inhalation. However, the European Chemicals Agency (ECHA) Risk Assessment Committee (RAC) endorsed a less severe Category 2 classification for certain powder forms of the substance.

This recommendation led to the adoption of Commission Delegated Regulation (EU) 2020/217, which classified titanium dioxide as suspected carcinogen (Category 2, inhalation) and required products containing 1% or more titanium dioxide particles with an aerodynamic diameter of ≤10 μm to be labelled with the hazard statement H351 (inhalation).

In November 2022, the General Court ruled annulled this classification, finding that the Commission had committed a "manifest error of assessment" in evaluating a key scientific study that served as basis for the classification. The Commission appealed the decision to the CJEU.

CJEU Judgment

In its 2025 ruling, the CJEU dismissed the Commission’s appeal, fully confirming the General Court’s conclusions.  The Court held that the classification was not supported by sufficient scientific evidence demonstrating that titanium dioxide, in powder form, posed a carcinogenic hazard to humans by inhalation under realistic exposure conditions.

As a result, the classification and corresponding labelling obligations for titanium dioxide under Delegated Regulation (EU) 2020/217 are definitively annulled. The decision also applies to downstream legal consequences, including product labelling, packaging, and Safety Data Sheet (SDS) requirements.

Impact and Next Steps

The judgment removes a significant regulatory burden for companies handling titanium dioxide, eliminating the need to label affected products with carcinogenic warnings. However, the ruling does not preclude future reclassification efforts if new scientific evidence emerges or if ECHA re-evaluates the substance in light of updated data.

Manufacturers and importers are advised to review their compliance strategies and ensure that existing documentation reflects the annulment of the classification while continuing to monitor ongoing scientific assessments and regulatory developments.

For further details, the full judgment is available on the CJEU website here.