CJEU Upholds TiO₂ Label Reversal

1 August 2025, the Court of Justice of the European Union (CJEU) upheld the annulment of the EU’s classification of titanium dioxide (TiO₂) in certain powder forms as a suspected carcinogen. The decision rejects appeals brought by France and the European Commission, solidifying the earlier 2022 General Court ruling.

Background of the Classification

• 2016: France’s ANSES proposed that titanium dioxide in powder form (≥1% of particles ≤10 µm) be classified as carcinogenic by inhalation.
• The European Chemicals Agency’s Risk Assessment Committee (RAC) supported the proposal.
• 2019: The European Commission adopted the classification, requiring hazard labeling under CLP Regulation.

2022 Annulment by General Court

The General Court of the EU annulled the classification in November 2022, citing a "manifest error of assessment". It ruled that the RAC and Commission relied on flawed scientific interpretation when classifying the substance.

Final Ruling by CJEU in 2025

The CJEU's 2025 ruling dismissed both appeals, stating that while the General Court may have exceeded its judicial review bounds, the annulment still stands due to insufficient scientific justification in the RAC’s assessment.

📌 Key Point: The court found that the RAC did not fully consider alternative scientific interpretations, rendering the classification invalid.

Regulatory & Industry Impact

🚫 Labeling Requirement Removed: Titanium dioxide in powdered form is no longer classified as a suspected carcinogen in the EU.
🏭 Widespread Industrial Use:

TiO₂ is found in:

• Paints & coatings
• Plastics
• Pharmaceuticals
• Food & cosmetics

📊 Affected Sectors must now reassess hazard communication and product compliance strategies.

Recommended Business Actions

✅ Update Safety Data Sheets (SDS): Remove outdated carcinogen labels and harmonize hazard communication.
✅ Revise REACH Dossiers: Adjust classification data and chemical safety reports accordingly.
✅ Monitor Scientific Developments: Future reclassification may still be possible as new evidence emerges.

Significance of the Ruling

This case sets a precedent for how scientific evidence is assessed in chemical classification decisions. It also reaffirms judicial oversight of EU regulatory agencies, emphasizing the need for robust, transparent science in chemical hazard regulation.

Reference: CJEU Press Release – 1 August 2025 (PDF)