On 23 November 2022, the European Court of Justice annulled Commission Delegated Regulation 2020/217 (18th ATP to CLP) with regard to the harmonised classification and labelling of titanium dioxide as an inhalation carcinogen in certain powder forms. A rare event, which the European Commission must now examine.
According to the court, the Commission 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.
Court of Justice of the Euopean Union’s press release
Titanium dioxide is an inorganic chemical substance used, in particular in the form of a white pigment, for its colourant and covering properties in various products, ranging from paints to medicinal products and toys.
In 2016, the competent French authority submitted to the European Chemicals Agency (ECHA) a proposal to classify titanium dioxide as a carcinogenic substance. The following year, ECHA’s Committee for Risk Assessment (RAC) adopted an opinion classifying titanium dioxide as a category 2 carcinogen, including the hazard statement “H 351 (inhalation)”.
On the basis of the RAC Opinion, the European Commission adopted Regulation 2020/217, by which it proceeded with the harmonised classification and labelling of titanium dioxide, recognising that that substance was suspected of being carcinogenic to humans, by inhalation, in powder form containing 1% or more of particles of a diameter equal to or …