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The Court of Justice of the EU confirms the annulment of the classification of titanium dioxide as a carcinogen in powder form

The highest European court supports the decision to remove the "possible carcinogen" label from titanium dioxide powder, alleging flaws in the scientific basis of the classification

12 of August of 2025
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European Union
European Union

The Court of Justice of the European Union (CJEU) has confirmed this August 1, 2025 the annulment of the classification of titanium dioxide (TiO₂) as a carcinogenic substance by inhalation when presented in powder form with at least 1% of particles with an aerodynamic diameter equal to or less than 10 µm.

Background

  • In 2016, the French agency ANSES proposed to ECHA to classify titanium dioxide as a carcinogen (category 1B) by inhalation FieldfisherCuria.

  • In 2017, the ECHA Committee for Risk Assessment (CER) considered the classification justifiable, compromising its danger to health CuriaFieldfisher.

  • Based on that opinion, the European Commission adopted in 2019 Delegated Regulation 2020/217, which labeled TiO₂ as suspected of being carcinogenic when inhaled in powder with small particles.

The General Court ruled in a judgment of November 23, 2022 and annulled said classification, arguing that:

  1. The Commission committed a manifest error in assessing the reliability of the scientific studies on which the classification was based.

  2. The applied classification was not limited to an intrinsic property of the substance, but to specific conditions (form, size, concentration, pulmonary overload), which does not comply with the CLP Regulation.

CJEU Confirmation (August 2025)

The Court of Justice dismissed the appeals filed by France and the Commission, thus validating the annulment. It recognized that, although the General Court exceeded its judicial review, the annulment of the classification is justified, since the CER did not consider all the relevant factors.

These are the implications of the ruling

  • The titanium dioxide industry celebrates this resolution as a significant victory, both legally and technically, as it establishes limits on the type of judicial review that courts can make against decisions based on complex scientific analyses.

  • On the other hand, various voices from the public sector and consumer associations consider that this ruling could weaken the EU's regulatory capacity against potentially dangerous substances.