CJEU upholds annulment of titanium dioxide powder carcinogen classification

History

Titanium dioxide is one of the most widely used white pigments in paints, coatings, plastics, cosmetics, pharmaceuticals and other industrial applications. In 2016, France’s ANSES proposed to classify TiO₂ as a carcinogen by inhalation. The European Chemicals Agency’s Risk Assessment Committee (RAC) supported the classification in 2017. In 2019, the European Commission adopted a delegated regulation introducing the Category 2 classification (H351: “suspected of causing cancer by inhalation”) for powder forms containing 1% or more particles ≤10 μm.

This regulation was challenged by various manufacturers, importers and downstream users, arguing that the scientific basis was flawed. In November 2022, the General Court annulled the classification, citing manifest errors in the assessment of the scientific study underpinning the regulation.

Decision

By its ruling of 1 August 2025, the CJEU dismissed the appeals by France and the Commission. While it found that the General Court had exceeded the limits of its judicial review in parts, it confirmed that the RAC failed to take all relevant factors into account when evaluating the key scientific evidence.

Industry impact

This judgement removes the obligation to classify and label certain powder forms of TiO₂ as suspected carcinogens. The decision avoids potentially far-reaching regulatory consequences for coatings formulations and other downstream applications.

https://curia.europa.eu/jcms/upload/docs/application/pdf/2025-08/cp250099en.pdf