The Court of Justice of The European Union Finally Ruled To Revoke The Classification of TiO2 As Carcinogenic

一、Is Titanium Dioxide Carcinogenic?

  Titanium dioxide is an inorganic compound that is often used in the form of white pigments in coatings, cosmetics, pharmaceuticals, food, and toys. Due to its widespread use and potential health risks, it has been embroiled in regulatory and legal disputes at EU level since 2016.

  In 2016:

    The French National Agency for Food, Environment and Occupational Health Safety (ANSES) submitted a proposal to the European Chemicals Agency (ECHA) to list titanium dioxide as a carcinogen by the route of inhalation, based on data from rat inhalation experiments (Heinrich study).

  In 2017:

    The Risk Assessment Committee (RAC) of ECHA supports this classification opinion.

  In 2019:

    The European Commission passed Regulation (EU) 2020/217 to classify certain powder forms (containing 1% and more ≤ 10 μm particles) as "suspected carcinogenic to humans" (Category 2, inhalation route) and mandatory labeling of warning information.

  This classification instantly affected the hundreds of billions of industrial chains such as coatings, cosmetics, and food contact materials, triggering a strong backlash.

二、The Industry Fought Back

  In 2022:

    Several manufacturers, importers, and downstream users, including CWS Powder Coatings, Venator, and Billions Europe, have joined forces to sue the European Commission on two main arguments:

  1:"Data falsification": Serious methodological errors in the calculation of lung particle load in questionable key studies (Heinrich study). The plaintiff pointed out that RAC knew that nanoscale P25 titanium dioxide particles would agglomerate in the lungs, and the actual aggregate density was only about 1.6 g/cm³, but still used a "standard particle density" of 4.3 g/cm³, resulting in distorted results and exaggerated risks.

  2:"Attribute defense": It is believed that the potential harm of titanium dioxide mainly comes from physical lung overload caused by high-dose inhalation, not its chemical properties, and does not meet the classification standard of "must have intrinsic carcinogenic properties" under the same regulation. In November 2022, the General Court of the European Union sided with the plaintiffs, finding that the Commission had clearly erred in its scientific assessment and ruled to revoke the carcinogenic classification.

三、The End: The Three Consecutive Strikes of The Court of Justice of the European Union

  In 2025:

    In the face of appeals from France and the European Commission, the Court of Justice of the European Union issued a historic ruling in August 2025:

  Regarding the grounds of appeal on whether titanium dioxide carcinogenicity is an intrinsic property, the court held that this part was only an "incidental" opinion of the ordinary court, so no substantive ruling was made, leaving room for possible legal disputes in the future.