The Court of Justice of the European Union (CJEU) upheld a lower court’s ruling annulling the European Commission’s regulation that classifies certain powdered forms of titanium dioxide (TiO₂) as a suspected human carcinogen by inhalation. The CJEU agreed with the lower court’s determination that the European Commission made a “manifest error” in the scientific assessment on which the classification was based. In short, the science did not support the classification.
TiO2 has been used safely for decades in products like paint, plastic, food, cosmetics, and pharmaceuticals. But in 2020, the European Commission adopted a regulation classifying certain powdered forms of TiO₂ as a suspected human carcinogen by inhalation. The regulation was immediately challenged by TiO2 manufacturers and other industry stakeholders. In 2022, the General Court found that the classification regulation was not justified. France and the Commission appealed the General Court’s decision to the CJEU.
For manufacturers, importers, and users of TiO₂, the CJEU’s ruling helps to restore market confidence by removing the classification as a suspected human carcinogen. More importantly, the courts’ rulings validate the principle that regulation must be based on a robust consideration of scientific evidence.
TiO2 will be removed from the list of harmonized classifications in Annex VI of the Classification, Labelling and Packaging (CLP) Regulation once the Commission has completed a multi-step regulatory process in the coming months.
Read the press release from the European Court of Justice here.