Following appeals against this decision (we have reported ECJ annuls harmonised classification and labelling of titanium dioxide in powder form) by France and the European Commission, the European Court of Justice (ECJ) today announced its final judgment. The ECJ dismissed the appeals and thereby confirmed the judgment of the General Court. The classification of titanium dioxide as carcinogenic therefore remains annulled.
The ECJ found that the General Court had exceeded the limits of its review when assessing and reviewing the classification. Nevertheless, the annulment of the decision on the harmonised classification and labelling was justified on other grounds. In the opinion of the ECJ, the General Court had correctly ruled that the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) had not taken into account all aspects relevant to the assessment of the scientific study in question.
Opinion of the Advocate General
The decision comes as a surprise in light of the opinion of Advocate General Tamara Ćapeta 06.02.2025. She had proposed that the underlying judgment be set aside and the case be referred back to the General Court. The Advocate General had taken the view that the General Court had exceeded its powers of review by substituting its own scientific assessment for that of the Commission and ECHA’s Risk Assessment Committee (RAC), which had acted in the preliminary stage. The specific point of reference was the assessment of the phenomenon of agglomeration and the consideration of the maximum tolerable dose to be taken into account in studies (according to the so-called Morrow overload calculation).
In addition, the Advocate General stated that the General Court had misinterpreted and misapplied the concept of “intrinsic properties.” In this respect, the Court had assumed a “circular” definition insofar as the term was understood as “properties which a substance has in and of itself”. The Advocate General was of the opinion that the Commission and the RAC had concluded, on the basis of the form, size, and poor solubility of titanium dioxide, that toxic effects leading to the development of tumors could be observed in the lungs when certain quantities were inhaled, and that these aspects, when correctly interpreted, fell within the concept of a “substance with the intrinsic property of causing cancer.”
Contrary to the appellants’ submissions, the Advocate General did not agree with the argument that the General Court had exceeded the limits of a reasonable assessment of the evidence available.
Request for reopening of the oral proceedings
Since the ECJ follows the opinion of the Advocate General in the vast majority of cases, the appellants initially sought to have the oral proceedings reopened before the ECJ. However, the ECJ rejected this request quite clearly, emphasizing that such a possibility is not provided for in either the ECJ Statute or the Rules of Procedure. Furthermore, no further aspects needed to be discussed in order for the ECJ to rule on the appeal.
Decision on the grounds of appeal
With regard to the grounds of appeal raised, the ECJ first found that the decision of the General Court was not based on a distortion of the evidence or an assessment of the evidence available which proved to be incorrect without the need to gather new evidence. In this context, the ECJ emphasized, among other things, that the RAC may, in principle, attach greater weight to some data than to others in its assessment, provided that this is based on an assessment of reliability, acceptability, and weight of evidence. The ECJ also rejected the appellants’ further arguments concerning the “relevance” of certain studies in the overall assessment and did not find any error of assessment on the part of the General Court in this respect.
The ECJ also ultimately rejected the ground of appeal concerning the exceeding of the limits of judicial review. In this respect, the ECJ, as a starting point, followed the reasoning of the Advocate General and ultimately confirmed that the General Court erred in referring to its own scientific assessment on the application of the Morrow overload calculation. However, the ECJ emphasizes that the decision of the General Court is correct on other legal grounds. The ECJ finds that the RAC itself made errors in the relevant calculation insofar as relevant aspects such as the phenomenon of agglomeration were not sufficiently taken into account or further clarified.
Although the interpretation of the term “intrinsic properties” according to the judgment of the General Court has probably received the most attention in the public debate, the ECJ avoids further clarification in its decision. This is because the relevant statements were only dealt with by the General Court in its judgment “in the interests of the sound administration of justice” and did not constitute a relevant reason for the contested judgment.
Consequences of the decision
With the dismissal of the appeal, the initial decision of the General Court becomes effective (see Art. 60 para. 2 of the Statute of the ECJ). Delegated Regulation (EU) 2020/2017 is therefore void insofar as it concerns the harmonized classification and labeling of titanium dioxide in powder form with at least 1% of particles with an aerodynamic diameter of not more than 10 μm. The corresponding harmonized classification is therefore no longer binding under Art. 4 para. 3 CLP.
Affected manufacturers and suppliers of titanium dioxide must therefore carry out the classification in accordance with the general requirements of CLP. On this basis, the labeling and safety data sheets must be amended. In this respect, it is not necessary or required to wait for the amendment of the information on the classification of titanium dioxide on the ECHA website. The decision of the ECJ and the associated effects of the judgment of the General Court are not subject to implementation by the ECHA. However, affected market players should bear in mind that, in the event of any new findings, a new proposal for harmonized classification and labeling of titanium dioxide may be considered. In this respect, the ECJ’s decision is likely to be only another intermediate step. Further discussions and proceedings on the classification of titanium dioxide are to be expected, as are further proceedings on the understanding of the term “intrinsic properties.”
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