EU Court Overturns Titanium Dioxide Carcinogen Label, Reshaping Chemicals Compliance

The Court confirmed that the European Commission had erred in basing its 2019 classification on insufficient scientific grounds, leading to legal challenges from titanium dioxide producers and industry stakeholders. The decision removes an important labelling burden affecting products in paints, foodstuffs, toys, pharmaceuticals, and cosmetics.

Scientific grounds and regulatory history

The reclassification of titanium dioxide was initiated by the French health agency ANSES, which in 2016 proposed its classification as a Category 1B carcinogen by inhalation. The following year, the European Chemicals Agency (ECHA) Risk Assessment Committee issued an opinion supporting a less severe Category 2 classification, which was ultimately adopted in Commission Delegated Regulation (EU) 2020/217.

This regulation required substances in powder form containing 1% or more of titanium dioxide particles with diameters ≤10 μm to be labelled with the hazard statement H351 (inhalation). However, the General Court ruled in 2022 that the Commission had committed a “manifest error” in evaluating a key scientific study. That judgment was appealed by France and the European Commission, but dismissed by the CJEU in this latest ruling.

Impact across supply chains and compliance regimes

The ruling has broad ramifications for businesses involved in the production and use of titanium dioxide. As a widely used white pigment, titanium dioxide is essential in coatings, plastics, paper, pharmaceuticals, and food packaging. Companies were previously obligated to alter product labelling and Safety Data Sheets (SDS), incurring operational and reputational costs.

The annulment lifts those obligations, at least for now. However, professionals should remain alert: while this ruling removes the existing classification, it does not prevent future reclassification efforts should stronger evidence emerge.

Regulatory clarity and next steps

Although the Court upheld the General Court’s findings, it also noted that the lower court had exceeded its judicial review boundaries. Nevertheless, the final outcome stands: the titanium dioxide classification as a suspected inhalation carcinogen is annulled.

Regulatory teams should reassess ongoing compliance strategies, update risk communications, and monitor any new scientific assessments or reclassification proposals from ANSES or ECHA.