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Titanium Dioxide "Carcinogenic" Label Removed, European Union Court Upholds Original Ruling

Buy Plastics and Chemicals 2025-08-06 15:44:18

The latest news shows that the EU court has rejected the appeals of France and the European Commission, confirming the cancellation of the classification of certain powdered forms of titanium dioxide (TiO₂).2Classification of substances suspected to be carcinogenic by inhalation.

The European Union Court ultimately ruled to remove specific powder form TiO.2Classification of carcinogenic substances—this ruling will have a profound impact on coating formulations and regulatory compliance in the EU region.

As the most widely used white pigment in industries such as coatings, plastics, cosmetics, and pharmaceuticals, titanium dioxide has experienced a tumultuous fate. In 2016, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) first proposed classifying it as a carcinogen by inhalation. In 2017, the Risk Assessment Committee (RAC) of the European Chemicals Agency supported this classification. In 2019, the European Commission adopted an authorization regulation classifying powder forms containing 1% or more particles ≤10 micrometers as a Category 2 carcinogen (H351: "Suspected of causing cancer by inhalation").

The regulation was jointly challenged by multiple manufacturers, importers, and downstream users, accusing it of having flawed scientific basis. In November 2022, the General Court of the European Union annulled the classification on the grounds that there were manifest errors in the evaluation of the key scientific studies supporting the regulation. On August 1, 2025, the Court of Justice of the European Union dismissed the appeals filed by France and the European Commission. Although it noted that the General Court had partially exceeded its judicial competence in its review, it confirmed that the RAC had indeed failed to fully consider all relevant factors in assessing the core scientific evidence.

Industry Impact

This judgment exempts the company from liability regarding the specific powder form of TiO.2The obligation to classify and label carcinogens avoids far-reaching regulatory impacts that coating formulations and other downstream applications may face.

Industry response

Hans-Helmut Schmidt, the main initiator of the lawsuit and former owner of CWS company, stated: "It's nothing short of a miracle; I had almost lost hope. People sometimes lose faith in the judicial system. However, the procedures of the first and second trials were professional and meticulous, demonstrating perfect legal logic. Although the second trial's verdict was incomprehensibly overturned, fortunately, the final appeal was successful."

"This ruling is of decisive significance—if the use of or mandatory labeling of the carcinogenic properties of this key raw material is enforced, it will trigger a 'tsunami effect' across numerous raw material sectors. Its impact concerns not only the field of chemical raw materials, but will also reshape the entire judicial system of the EU."

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