The Court of Justice of the EU revokes the classification of titanium dioxide as a carcinogen by inhalation

1. Errors in the scientific assessment in a General Court Ruling (2022)

2. Impact of the annulment

3. Relief for industry

4. Regulatory consequences following the CJEU ruling

5. What happens to titanium dioxide in food?

The Court of Justice of the European Union revoked the decision that classified titanium dioxide as a carcinogenic substance by inhalation.

In 2019, through Commission Delegated Regulation (EU) 2020/217, the European Commission included titanium dioxide in powder form as a category 2 inhalation carcinogen under the CLP Regulation, in ATP 14. This decision was based on the recommendation of ECHA (European Chemicals Agency).

According to that assessment, certain forms of TiO₂ powder ([in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm]) could increase the risk of lung cancer after prolonged exposure.

The measure involved strict labelling obligations and higher regulatory costs across a wide variety of products, from paints, cosmetics and plastics to pharmaceuticals and food products.

Products containing TiO₂ [in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm] were required to carry a warning of a possible carcinogenic risk, which resulted in increased costs and considerable legal uncertainty for companies.

Errors in the scientific assessment in a General Court Ruling (2022)

In 2022, in Commission Regulation (EU) 2022/63, the EU General Court concluded that the Commission had made errors in interpreting toxicological data.

The judges stated that the physical form of the compound (TiO₂ [in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm]) and its behaviour under real exposure conditions were not properly assessed. In addition, the available studies did not justify such a severe classification attributing intrinsic carcinogenic properties to TiO₂ in the defined powder form.

The applicants, in their capacity as manufacturers, importers, downstream users or suppliers of titanium dioxide, lodged appeals before the General Court requesting the partial annulment of Commission Delegated Regulation (EU) 2020/217 (ATP 14).

As a consequence, on 1 August 2025, the Court of Justice of the EU (CJEU) dismissed the appeals brought by France and the European Commission, upholding the annulment of the classification.

This entailed the removal of the classification of titanium dioxide (TiO₂) [in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm] as a carcinogenic substance by inhalation according to the CMR (Carcinogenic, Mutagenic, Reprotoxic) Category 2 classification.

Impact of the annulment

The annulment of the classification of titanium dioxide [in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm] as a carcinogen by inhalation in the European Union represents a significant shift in the regulation of this widely used substance.

Relief for industry

The European chemical industry has welcomed the ruling as a victory, considering that it restores legal certainty and confidence in regulatory processes.

Affected companies argued that the previous classification generated uncertainty and increased regulatory compliance costs. Following the annulment, products containing TiO₂ [in powder form containing 1% or more of particles with an aerodynamic diameter ≤ 10 µm] may now be sold without being labelled as carcinogenic by inhalation. In addition, workplace safety measures applicable to substances classified as carcinogens will no longer be required.

However, general obligations for dust exposure prevention and control in the workplace remain in force.

Regulatory consequences following the CJEU ruling

Although the European Commission could appeal the ruling, the decision sets an important precedent on how scientific data should be interpreted in EU chemical substance regulation.

The future regulatory status of titanium dioxide is not yet entirely clear. For now, the ruling provides significant regulatory relief for industries using this substance.

What happens to titanium dioxide in food?

The ruling does not modify the ban on titanium dioxide in food products, as it remains prohibited as an additive (E171) following the 2021 EFSA assessment, which indicated potential genotoxicity risks.

In other words, the General Court’s decision is limited to the industrial sphere, specifically to the classification of titanium dioxide powder as a carcinogen by inhalation, and does not affect its use in food or other regulated applications.

Conclusion

The regulatory reassessment of TiO₂ shows that standards must be based on updated science and solid evidence. It also reflects how the relationship between science, policy and regulation directly affects companies and consumers.

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