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The Court of Justice of the European Union (CJEU) has delivered a significant blow to the European Commission's classification of titanium dioxide (TiO2) in certain powder forms as a suspected carcinogen. In a ruling issued on August 1, 2025, the CJEU dismissed appeals from France and the European Commission, thereby upholding a 2022 General Court judgment that annulled the controversial classification.
Background Titanium dioxide is an inorganic chemical substance composed of oxygen and titanium with the molecular formula ‘TiO2’ and which can be found in nature or produced industrially. It is used, in particular in the form of a white pigment, for its colourant and covering properties in various products, such as paints, coating materials, varnishes, plastics, laminated paper, cosmetics, including sunscreen, medicinal products, toys and foodstuffs. |
The Journey to Annulment
The reclassification saga of titanium dioxide began in 2016 when the French health agency ANSES submitted a dossier to the European Chemicals Agency (ECHA), proposing its classification as a Category 1B carcinogen by inhalation (Carc. 1b, H350i).
ECHA Risk Assessment Committee (RAC) subsequently issued an opinion in 2017, supporting a less severe Category 2 classification. This led to the adoption of Commission Delegated Regulation (EU) 2020/217, which mandated labeling for substances in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10μm with the hazard statement H351 (inhalation).
However, this classification faced immediate challenges from titanium dioxide producers, importers, downstream users and suppliers. In May 2020, three separate lawsuits were filed at the General Court seeking to annul the contested classification and labeling. The core complaint was that the scientific assessment underlying the regulation was flawed. Specifically, they alleged a "manifest error of assessment" in how the RAC evaluated the key scientific evidence, a 1995 study known as the "Heinrich study."
The argument surrounding the scientific flaws brought up to the court are explains as follows:
The RAC used a standard particle density of 4.3 g/cm³ when applying a calculation (the "Morrow calculation") to assess lung overload in the Heinrich study.
The companies argued that the RAC should have used a lower density value corresponding to the agglomerates (clusters) that titanium dioxide nanoparticles form.
This is a critical distinction because lower-density agglomerates take up more volume in the lungs, which significantly impacts the assessment of whether the study's conditions were acceptable and reliable.
In 2022, the General Court ruled that the European Commission had made a manifest error of assessment by failing to account for the agglomeration of particles and their lower density. This error rendered the RAC's conclusion—and by extension, the regulation based on those findings—implausible and unreliable. In addition, the ruling also concluded that the contested classification infringe on the criteria laid down in CLP Regulation, in that it did not relate to a substance that has the intrinsic property to cause cancer.
Despite appeals from France and the European Commission, the CJEU, in its August 1, 2025 ruling, upheld the General Court's judgment, effectively dismissing the appeals and confirming the annulment of the contested classification and labeling.
Impact on Supply Chains
The annuled classification of titanium dioxide as a carcinogen alleviated the immediate pressure on a wide array of industries to implement costly compliance measures. Companies are no longer required to revise product labeling, update Safety Data Sheets (SDS), and potentially reformulate products to comply with the new regulations. This would save substantial operational costs and potential changes in manufacturing processes.
Precedent for Future Challenges
The CJEU's ruling on titanium dioxide is a powerful reminder that regulatory decisions, even those based on scientific opinions, are subject to rigorous review.
For regulatory bodies, this could lead to increased scrutiny of other classifications, especially those based on complex toxicological data or where the relevance of animal studies to human exposure is debated.
For chemical companies, this ruling sets a significant precedent. It empowers industry stakeholders to challenge regulatory decisions if they can identify procedural irregularities or“manifest error of assessment” in the scientific basis.
Proactive engagement in regulatory process is also crucial. Under REACH and CLP, regulatory processes typically involve multiple public consultations, stakeholder dialogues, and scientific committee meetings. Submit well-reasoned scientific arguments and data at every stage of the regulatory process and do not wait for a final decision.
On the other hand, the declassification does not mean zero risks associated with titanium dioxide. Companies should always remain vigilant and closely monitor any new scientific assessments or reclassification proposals that may emerge from agencies like ANSES or ECHA.
