SG 118/25
The Court of Justice of the European Union (CJEU) has upheld its decision to annul the classification of titanium dioxide in certain powder forms as a category 2 carcinogenic substance.
In 2020, the European Union (EU) published Commission Delegated Regulation (EU) 2020/217 of October 2019 to revise and correct Regulation (EC) No. 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to February 2025). This amendment, inter alia, classifies titanium dioxide (TiO2) in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10µm as a category 2 carcinogenic substance by inhalation.
TiO2 is widely used in the manufacture of consumer goods, including but not limited to adhesives, automotive products, ceramics, coated fabrics and textiles, cosmetics, floor coverings, food contact materials, paints and coatings, paper, plastics and rubber, printing inks, roofing materials, sunscreen products and toys.
The classification and labeling of TiO2 in the specified forms resulted in legal proceedings, a challenge which eventually led to the annulment of the contested classification and labeling. In its 2022 judgment, the CJEU ruled that the Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based, and incorrectly applied the classification criteria as laid down by the CLP Regulation.
In 2023, the European Commission and France appealed the General Court’s decision to annul the classification and labeling of TiO2 in the specified forms as carcinogenic (SafeGuardS 27/23 and references therein).
On August 1, 2025, the CJEU announced the dismissal of those appeals and upheld its judgment to annul the contested classification of TiO2 as a carcinogenic substance.
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