ECHA Officially Removes Titanium Dioxide’s Carcinogen Classification

On September 11, 2025, the European Chemicals Agency (ECHA) announced that, in accordance with the Court of Justice of the European Union’s June 2025 ruling to revoke the carcinogenic classification of titanium dioxide, the harmonized classification has now been removed from the C&L Inventory, and the related Registration Intentions have been updated accordingly. Meanwhile, the guidance document on the classification and labeling of titanium dioxide has also been withdrawn.

Ruling Recap: What You Need to Know

In 2016, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) submitted a proposal to ECHA requesting that powdered titanium dioxide be classified as an "inhalation carcinogen." In 2017, ECHA’s Committee for Risk Assessment (RAC) adopted the opinion, supporting its classification as a "Category 2 suspected carcinogen." In October 2019, the European Commission passed Delegated Regulation (EU) 2020/217, officially listing "powdered titanium dioxide (with ≥1% particles ≤10 microns)" as a "Category 2 suspected carcinogen" and mandating the inclusion of the warning label "H351: Suspected of causing cancer when inhaled."

Subsequently, multiple titanium dioxide manufacturers, importers, and downstream users filed a lawsuit with the General Court of the European Union. In November 2022, the General Court ruled that the European Commission had committed a "manifest error" in adopting key scientific studies and failed to sufficiently demonstrate that titanium dioxide has intrinsic carcinogenic properties, thereby annulling the classification. France and the European Commission appealed the decision to the Court of Justice of the European Union. In June 2025, the Court of Justice issued a final ruling, dismissing the appeals from France and the European Commission and upholding the General Court’s November 2022 decision, officially revoking the carcinogenic classification of titanium dioxide.

Adjustments on ECHA’s Official Website

• The original entry "Carc. 2; H351 (inh)" for titanium dioxide has been removed from the C&L Inventory.
• The Registry of Intentions has been simultaneously updated, indicating "no further plans for harmonized classification."
• The previous version of the "Guidance on Classification and Labeling of Titanium Dioxide" PDF has been deleted.

Currently, titanium dioxide is no longer required to carry a "carcinogenic" warning within the EU. Corresponding requirements for export packaging, safety data sheets (SDS), and occupational exposure limits have been relaxed. CIRS will continue to monitor developments regarding the classification of titanium dioxide in the EU to assist companies in maintaining compliance.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

ECHA