On November 23, 2022, the Court of Justice of the European Union issued a press release announcing that it has annulled a previous decision classifying titanium dioxide (TiO2; CAS 13463-67-7) as carcinogenic in powder forms. The court has found that the scientific study used to determine its carcinogenic properties via inhalation exposure was not reliable and acceptable. It argues that the European Chemicals Agency’s Risk Assessment Committee (RAC) did not properly consider all factors related to the density of agglomerates of nano-sized TiO2 to justify a lung overload. It also argues that the previous decision incorrectly applied the criteria for carcinogenicity under the classification and labeling rules, which require the substance to exhibit an intrinsic hazard. It argues that the hazard considered was non-intrinsic due to the respirable particles having to be present in a certain form, physical state, size, and quantity. The full text of the court’s judgment is also available.
The judgment now reverses the classification and labeling requirements for TiO2, and institutions are responsible for responding to any legal vacuums created by the court’s decision. This is the latest update in a legal debate over TiO2 safety that began in 2016 with the European Food Safety Authority (EFSA) determining it unsafe as a food additive in 2021 due to the potential for genotoxicity (FPF reported). TiO2 remains authorized as an additive in plastic food contact materials (Regulation (EU) 10/2011). Furthermore, it is included in ten global FCM inventories indicating uses in, e.g., colorants, silicones, coatings, and adhesives. It is identified as a “substance of potential concern” in the Food Packaging Forum’s Food Contact Chemical database (FCCdb) due to its recognition by some authorities as a possible endocrine-disrupting chemical.
Reference
Court of Justice of the European Union (November 23, 2022). “The General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the harmonised classification and labelling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms.” (pdf)
