/>iOn August 1, 2025, the European Court of Justice (ECJ) issued a judgment upholding the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the European Commission’s (EC) decision to classify titanium dioxide as a suspected human carcinogen. The French government and the EC appealed the decision, arguing that the court exceeded the limits of permissible judicial review of an EC decision and that the court incorrectly interpreted the concept of “intrinsic properties” as it appears in the Classification, Labeling, and Packaging (CLP) Regulation.
Background
In 2016, the competent French authority submitted a proposal to the European Chemicals Agency (ECHA) to classify titanium dioxide as a category 1B carcinogenic substance (carcinogenic to humans). In 2017, ECHA’s Committee for Risk Assessment (RAC) adopted an opinion classifying titanium dioxide as a category 2 carcinogen (suspected human carcinogen), including the hazard statement “H 351 (inhalation).” On the basis of RAC’s Opinion, the EC adopted Regulation 2020/217, implementing the harmonized classification and labeling of titanium dioxide, recognizing that the substance was suspected of being carcinogenic to humans, by inhalation, in powder form containing one percent or more of particles of a diameter equal to or less than ten micrometers (µm). The transition period for adoption of these changes ended October 1, 2021. The applicants, in their capacity as manufacturers, importers, downstream users, or suppliers of titanium dioxide, brought actions before the General Court for the partial annulment of Regulation 2020/217.
The General Court held that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. According to the press release, in recognizing that the results of a scientific study on which it based its opinion on the classification and labeling of titanium dioxide were sufficiently reliable, relevant, and adequate for assessing the carcinogenic potential of that substance, RAC committed “a manifest error of assessment.”
ECJ Judgment
According to ECJ’s August 1, 2025, press release, the ECJ “upholds the judgment of the General Court and the annulment of the contested classification of titanium dioxide as a carcinogen.” In its judgment, the ECJ notes that although the lower court erred in finding that “it was for it to assess the appropriateness of the choice of the standard density value of titanium dioxide particles used by the RAC for the purposes of applying the Morrow calculation, it did not err in law in holding that the RAC had failed to take into account all the relevant factors in order to calculate the lung overload for the purposes of the assessment of the Heinrich study by means of that calculation.” The press release states that according to the ECJ, “even though the General Court exceeded the limits of its judicial review, the annulment of the contested classification and labelling is nevertheless justified.” The lower court “was fully entitled to hold that the RAC had failed to take into account all the relevant factors for the purposes of assessing the scientific study in question.”
As reported in our March 11, 2025, blog item, the European Union (EU) Advocate General (EU AG) recommended in February 2025 that the ECJ overturn the lower court’s decision. EU AGs are responsible for presenting, with complete impartiality and independence, opinions in assigned cases, and their opinions are non-binding.
