By Aineias Spiliotis, January 2023
On 23 November 2022, press release No. 190/2022 was published on the website of the Court of Justice of the European Union announcing that the General Court annulled the Commission’s 2019 Delegated Regulation on the classification and labelling of titanium dioxide as a carcinogen when inhaled in the form of certain types of powder.
It should be noted that titanium dioxide is an inorganic chemical substance used in the form of a white pigment, for its colorant and covering properties in various products, ranging from paints to medicinal products and toys.
In particular, in 2016, a proposal submitted to the European Chemicals Agency (ECHA) to classify titanium dioxide as a carcinogenic substance. The following year, ECHA’s Committee for Risk Assessment (‘the RAC’) adopted an opinion classifying titanium dioxide as a category 2 carcinogen, including the hazard statement ‘H 351 (inhalation)’.
The European Commission adopted Regulation 2020/217 which went ahead with the harmonised classification and labelling of titanium dioxide, recognising that this substance was suspected to be carcinogenic to humans by inhalation in the form of powder containing 1% or more of particles with a diameter equal to or less than 10 μm.
Against this Regulation companies 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 adjudicated that, in the present case, the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. In so far as, for the purposes of the harmonised classification and labelling of titanium dioxide, the Commission based the contested regulation on the RAC Opinion and thus followed the RAC’s conclusion as to the reliability and acceptability of the results of the scientific study at issue, which constituted a decisive study for the classification proposal for titanium dioxide, it made the same manifest error of assessment as the RAC.
In this respect, the General Court found that the contested classification and labelling 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. 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 therefore concluded that, the conclusion contained in the RAC Opinion as for the mode of action of carcinogenicity on which that committee relied could not be regarded as intrinsic toxicity in the classical sense. In fact, the cancer risk is exclusively associated with certain inhaled titanium dioxide particles, which are in a specific physical state, form, size and quantity, is only apparent under conditions of pulmonary overconcentration of particles and is related to the toxicity of the particles.
