The General Court of the European Union has annulled the Regulation (2020/217) classifying titanium dioxide – a chemical substance used as a white pigment in products such as paint, medicines or toys – as a suspected human carcinogen in a judgment that was handed down on Wednesday 23 November (cases T-279&283&288/20).
The General Court, hearing an action brought by the manufacturers of the substance in question, held that, in this case, the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies had not been met.
In their opinion, by deeming the results of the scientific study by the French competent authority to be reliable and adequate, the Committee for Risk Assessment of the European Chemicals Agency (ECHA) had committed a manifest error of assessment. They did not take all the relevant elements into consideration when calculating the pulmonary overload of titanium dioxide particles, the General Court said, finding these conclusions to be completely implausible.
Consequently, the European Commission, by basing the contested regulation on the opinion of the ERC, had committed the same manifest error of assessment.
Taking into account the Regulation (1272/2008) on the classification and labelling of a substance as a carcinogen, the General Court interprets the notion of the ‘intrinsic properties’ of a substance being potentially harmful to human health in a literal way, insofar as it refers to the properties that are inherent to a substance.
However, in the opinion of the Committee for Risk Assessment, the carcinogenic hazard posed by titanium dioxide is described as ‘not intrinsic in the classical sense’. Therefore, by accepting the committee’s opinion that the mode of action of the carcinogenicity of titanium dioxide should still be taken into account for the classification of the substance in question under Regulation (EC) No 1272/2008, the General Court found that the European Commission had committed a further assessment error.
See the EU General Court judgment: https://aeur.eu/f/47c (Original version in French by Mathieu Bion)