European General Court Annuls Harmonized Classification and Labeling of Titanium Dioxide
On November 23, 2022, the Court of Justice of the European Union (EU) announced a decision of the General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. According to the press release, the European Commission (EC) “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.”
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 that 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.
Findings of the Court
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.” Specifically, to verify the degree of lung overload of titanium dioxide particles in that scientific study to assess carcinogenicity, RAC used a density value corresponding to the density of unagglomerated primary particles of titanium dioxide, “which is always higher than the density of the agglomerates of nano-sized particles of that substance.” The press release states that in so doing, RAC did not take into account all the relevant factors to calculate the lung overload during the scientific study at issue, namely the characteristics of the particles tested in that scientific study, the fact that those particles tend to agglomerate, and the fact that the density of the agglomerates of particles was lower than the particle density and that, for that reason, those agglomerates occupied more volume in the lungs. Thus, according to the General Court, RAC’s findings that the lung overload in the scientific study at issue was acceptable were implausible. Consequently, when the EC based the contested regulation and the harmonized classification and labeling of titanium dioxide on the RAC Opinion, thus following RAC’s conclusion as to the reliability and acceptability of the results of the scientific study at issue, “it made the same manifest error of assessment as the RAC.”
The General Court found that the contested classification and labeling “infringed the criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.” Under Regulation (EC) No 1272/2008, harmonized classification and labeling of a substance as carcinogenic may be based only on the intrinsic properties of the substance that determine its intrinsic capacity to cause cancer. The General Court interpreted the concept of “intrinsic properties,” stating that, although that concept does not appear in Regulation (EC) No 1272/2008, “it must be interpreted in its literal sense as referring to the ‘properties which a substance has in and of itself’, which is consistent, inter alia, with the objectives and purpose of harmonised classification and labelling under that regulation.” The General Court notes that the contested classification and labeling are intended to identify and notify a carcinogenic hazard of titanium dioxide, which, in the RAC Opinion, was classified as “non-intrinsic in a classical sense.” According to the press release, the General Court states that that “non-intrinsic in the classical sense” nature stems from several factors, referred to both in that opinion and in the contested regulation. The carcinogenicity hazard is linked solely to certain respirable titanium dioxide particles when they are present in a certain form, physical state, size, and quantity; it occurs only in lung overload conditions; and corresponds to particle toxicity.
The General Court concluded that, by upholding the conclusion contained in the RAC Opinion that the mode of action of carcinogenicity on which RAC relied could not be regarded as intrinsic toxicity in the classical sense, but which had to be taken into consideration in the context of harmonized classification and labeling under Regulation (EC) No 1272/2008, the EC committed a manifest error of assessment. According to the press release, the General Court states that the examples of classification and labeling of other substances, relied on to compare them with the classification and labeling of titanium dioxide, “illustrate only cases in which, even though the form and size of the particles were taken into account, certain properties specific to the substances were nevertheless decisive for their classification, which does not correspond to the case here.”
Bergeson & Campbell PC, 06-12-22