News Markets & Companies

CJEU upholds annulment of titanium dioxide powder carcinogen classification

The Court of Justice of the European Union (CJEU) has dismissed appeals by France and the European Commission, confirming the annulment of the classification of titanium dioxide in certain powder forms as a suspected carcinogen by inhalation.

The CJEU has confirmed the annulment of the carcinogen classification for certain TiO₂ powder forms – a ruling with significant implications for coatings formulations and regulatory compliance across the EU. Source: Anastasiia - stock.adobe.com

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. 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.

Industry reaction

Hans-Helmuth Schmidt, former owner of CWS and key initiator of the lawsuit against the EU, expressed his relief:
“It’s phenomenal, I almost didn’t think it was possible anymore. You sometimes lose hope and faith in our legal system. The proceedings in the first and second instances were very professional and followed a wonderful, legally professional and straightforward path. Unfortunately, the judgement of the second instance was then revised again in an absolutely incomprehensible manner. Thank God the appeal has now worked.

The judgement is also so decisive because a ban or mandatory labelling as a carcinogenic substance of this important raw material would have had a tsunami effect or triggered a domino effect on many other raw material groups. The effects of this judgement are of course not only of great importance for the world of chemical raw materials, but also for the entire jurisdiction in the EU.”