The Court of Justice of the European Union (CJEU) has dismissed the appeals brought by France and the European Commission (EC) against a 2022 judgment by the General Court annulling the EU classification of titanium dioxide (TiO₂) in certain powder forms as an inhalation carcinogen. The classification, introduced by Commission Delegated Regulation (EU) 2020/217, is thereby definitively annulled.
Background and Nature of the Dispute
In 2016, the French national agency ANSES (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) submitted to the European Chemicals Agency (ECHA) a proposal for classifying TiO₂ as a carcinogen by inhalation under the Classification, Labeling and Packaging (CLP) Regulation (EC No. 1272/2008). In 2017, ECHA’s Committee for Risk Assessment (RAC) issued an Opinion supporting the classification. Based on this, the EC adopted Delegated Regulation (EU) 2020/217 in 2019. This regulation classified TiO₂ in powder form, containing ≥1% of particles with an aerodynamic diameter ≤10 μm, as a category 2 carcinogen, suspected of causing cancer in humans via inhalation.
Multiple companies involved in the production and use of titanium dioxide challenged the regulation before the General Court on several grounds, including that the classification lacked a sound scientific basis and that the RAC misapplied the legal criteria of the CLP Regulation.
In a November 23, 2022 decision, the General Court annulled the classification, finding that the EC and the RAC had committed a manifest error of assessment by relying on a key scientific study (Heinrich et al. 1991) without sufficiently verifying its acceptability and reliability. The Court also stated, in the alternative, that the identified carcinogenicity did not result from an intrinsic property of the substance, which is a prerequisite under EU law for classification.
France and the EC appealed the judgment, arguing that the General Court had wrongly imposed a higher evidentiary standard (a “decisiveness” threshold) and distorted the scientific role of the RAC, that the General Court had exceeded its powers by engaging in an in-depth re-evaluation of scientific data, and that the conclusion regarding the absence of an intrinsic property was unfounded.
Judgment of the Court of Justice in Joined Cases C-71/23 P and C-82/23 P
On August 1, 2025, the CJEU dismissed both appeals in their entirety, deviating greatly as well from the conclusions provided in the Opinion of the Advocate General (AG) Ćapeta.
The CJEU acknowledged that the General Court may have exceeded the usual limits of judicial review by engaging closely with scientific matters. However, this did not affect the validity of the judgment. The CJEU held that the General Court was entitled to find that the RAC had failed to take into account all relevant factors when assessing the reliability of the scientific study in question.
CJEU Ruling on TiO₂ Classification Does Not Affect EU Food Additive Ban
The CJEU Judgment is entirely separate from the EC’s earlier decision to withdraw titanium dioxide (E171) from the EU list of approved food additives set forth in Regulation (EC) No. 1333/2008. That regulatory action, adopted in 2022, followed a scientific opinion by the European Food Safety Authority (EFSA) which concluded—on the basis of the precautionary principle—that a concern for genotoxicity could not be ruled out. The current judgment of the CJEU, by contrast, relates solely to the classification of titanium dioxide under the CLP Regulation (Regulation (EC) No 1272/2008) as a suspected carcinogen by inhalation. These are two distinct legal and scientific frameworks: one addressing food safety, the other chemical hazard classification. As such, the Court’s ruling does not affect the existing ban on the use of titanium dioxide as a food additive in the European Union.