Success for Kapellmann-team before the Court of Justice: judges confirm annulment of classification of titanium dioxide as ‘suspected to be carcinogenic’

In its judgment of 23 November 2022, the General Court of the European Union annuled a 2019 delegated regulation of the European Commission insofar as it concerns the harmonised classification and labelling of titanium dioxide in certain powder forms as a substance suspected of being carcinogenic if inhaled (T-279/20, T-283/20 and T-288/20). 

Several companies had brought applications for annulment against the delegated regulation: on the one hand, German and Austrian manufacturers of paints and varnishes (cases T-279/20 and T-288/20) and, on the other hand, manufacturers of titanium dioxide (T-283/20). Other affected companies and industry associations joined the proceedings as interveners on the side of the applicants. The European Parliament, the Council, the European Chemicals Agency (ECHA) and Denmark, France, the Netherlands, Sweden and Slovenia intervened on behalf of the European Commission.

The General Court found that the European Commission had committed a manifest error in assessment of the reliability and acceptance of a study on which the classification as ‘suspected to be carcinogenic’ was based. Furthermore, the General Court found that the European Commission had infringed the criterion that the classification must relate only to a substance with the intrinsic property of causing cancer.

The European Commission and France had appealed the judgment of the General Court. Since appeals are limited to questions of law, they objected in particular that the General Court had exceeded the limits of judicial review and had substituted its own assessment for that of the European Commission and the ECHA's Risk Assessment Committee (RAC).

In its judgment of 1 August 2025, however, the Court of Justice essentially upheld the findings of the General Court and dismissed the appeals. The General Court did not err in law when it held that the RAC had not taken into account all the studies relevant for the classification of titanium dioxide. The Court of Justice considered the appeals lodged in relation to the requirement of ‘intrinsic property’ to be irrelevant to the decision. 

This means that the ruling by the General Court that the classification of titanium dioxide is invalid is now legally binding.

The ‘titanium dioxide’ case, which was concluded today with the ECJ ruling, is widely seen as a precedent because, beyond the specific case of titanium dioxide, the findings of the General Court and the Court of Justice are highly relevant for the chemical industry (and beyond that for the delegated legislative power of the European Commission in other areas). The judicial review powers have been strengthened, which also means that the EU administration and legislature must prepare and justify their decisions (even) more carefully. Therefore, the judgment has significance beyond the individual case, as it deals with the fundamental question of the extent of judicial review in complex administrative decisions under EU law.

Kapellmann advises companies, associations and public institutions on all issues of EU law, in particular on regulatory issues of the European internal market such as product safety. The lawyers in the Brussels office regularly represent their clients before the European Commission and the Union Courts in Luxembourg.

See also:

• Lemonnier, Interview des Verbändereports zum Thema „Interessenvertretung in der EU über das Gesetzgebungsverfahren hinaus?“, Verbändereport Ausgabe 3/2023
• van der Hout/Lemonnier, EuG erklärt Einstufung von Titandioxid als vermutlich krebserregend unter die CLP-Verordnung für nichtig – Besprechung des Urteils EuG, 23.11.2022 in den verb. Rs. T-279/20, T-283/20 und T-288/20, StoffR 1| 2023, S. 37-41