European Court Upholds Ruling on Classification of Titanium Dioxide

A recent ruling of the Court of Justice of the European Union affirms a lower court’s decision that the EU’s classification of titanium dioxide as a suspected carcinogen was wrongly determined. Titanium dioxide is a white, odorless powder used as a pigment in various products, including paint and toys.

The case stemmed from a 2016 proposal by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) to the European Chemicals Agency (ECHA) advocating for classification of titanium dioxide as a suspected carcinogen by inhalation. The ECHA Committee for Risk Assessment supported the proposed classification, and in October 2019 the European Commission adopted a regulation requiring the labels of mixtures containing one percent or more of titanium dioxide powder to carry the H351 hazard statement, which indicates a substance suspected of being carcinogenic.

Several companies challenged the regulation, and, in November 2022, the General Court of the European Union found in the companies’ favor. 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.”

France and the Commission appealed to the Court of Justice, but their appeals were dismissed Aug. 1. A statement from the Court of Justice indicates that “the General Court was fully entitled to hold that the RAC had failed to take into account all the relevant factors for the purposes of assessing the scientific study in question.”

For more information on the decision, read the press release from the Court of Justice (PDF). Documents related to the case are available online.

NIOSH considers titanium dioxide to be a potential occupational carcinogen, and the International Agency for Research on Cancer (IARC) classifies titanium dioxide as Group 2B, possibly carcinogenic to humans.