EU Court Affirms Reversal of Titanium Dioxide’s Carcinogen Status in Powder Form

Key Takeaways

The CJEU has upheld the annulment of titanium dioxide powder’s classification as a suspected inhalation carcinogen.
Industry groups argued that the original assessment relied too heavily on flawed studies and calculations.
The ruling emphasizes the need for thorough scientific evaluation in chemical hazard classifications.

European Court Dismisses Titanium Dioxide Carcinogen Classification

The Court of Justice of the European Union (CJEU) has rejected appeals from both the French government and the European Commission, affirming the annulment of the EU’s classification of titanium dioxide powder as a suspected inhalation carcinogen. This decision revolves around the assessment methods used in the 2020 ruling, which classified titanium dioxide in powder form (with ≥1% of particles ≤10μm in diameter) as a Category 2 carcinogen under the CLP Regulation due to concerns regarding its inhalation effects.

Industry stakeholders contested the classification, claiming the basis for the decision heavily relied on a single inhalation study conducted in 1995 by Heinrich et al. They highlighted significant flaws, particularly regarding the parameters employed in calculations related to “lung overload.” In 2022, the General Court ruled in favor of the industry, identifying errors in the original assessment and a lack of analysis regarding particle agglomeration effects.

In the recent appeal, the CJEU supported the General Court’s conclusions, affirming that the European Chemicals Agency’s Risk Assessment Committee (RAC) had neglected to consider all relevant scientific factors in its assessment. The CJEU maintained that the General Court did not exceed its judicial review powers, further reinforcing the decision to annul the classification of titanium dioxide as a carcinogen.

This ruling effectively nullifies the current classification of titanium dioxide unless a new regulatory assessment is undertaken. It highlights a significant trend in the EU legal landscape, demonstrating a rigorous approach to evaluating the scientific validity of chemical hazard classifications. The decision serves as a reminder to regulators that comprehensive, transparent, and evidence-based evaluations are crucial, particularly given the far-reaching implications such classifications may have on several industries, including coatings, plastics, and cosmetics.

The outcome not only impacts the regulatory framework surrounding titanium dioxide but also illustrates the courts’ readiness to challenge existing scientific assessments, pushing for higher standards of accountability in how chemical risks are classified. This ruling may set a precedent, encouraging more detailed scrutiny in future evaluations of chemical substances, thereby influencing the regulatory approach within the European Union and beyond.

The content above is a summary. For more details, see the source article.