The European Court of Justice (ECJ) has ruled that titanium dioxide in paints and varnishes was unlawfully classified as a carcinogenic substance. It thus confirms the ruling of the General Court from 2022, which had declared the relevant EU regulation null and void. The judges found that the European Commission had made “manifest errors” in its assessment of the scientific data.  

Back in 2016, the French health authority ANSES had submitted an application to the ECHA to classify certain powder forms of titanium dioxide as a carcinogenic substance. In 2017, the Risk Assessment Committee (RAC) recommended classification in category 2 (“suspected carcinogenic effect when inhaled”). On this basis, the European Commission issued Delegated Regulation (EU) 2020/217 in 2019. For the industry, this meant that powdery products containing titanium dioxide had to be labelled with the warning “H351 (inhalation)” from then on. 

Numerous companies, led by CWS Powder Coatings, filed a lawsuit against this classification. They received support from the German Paint and Coatings Industry Association, among others. In 2022, the General Court ruled in favour of the plaintiffs, stating that titanium dioxide does not have any intrinsic, i.e. substance-specific, carcinogenic properties. The risk arises solely from particle overload in the lungs – an effect that cannot be attributed to the chemical substance itself. 

The ruling of the ECJ

In its ruling of 1 August 2025, the ECJ confirmed this assessment. The appeals lodged by France and the European Commission were dismissed. Although the General Court had partially exceeded the limits of its powers of review, the regulation remained null and void. 

The Luxembourg judges made clear: 

• Classification as carcinogenic requires an intrinsic property of the substance, which is not present in titanium dioxide.
• The European Commission and the RAC had not sufficiently taken into account key scientific factors such as particle density and agglomeration behaviour.
• Uncertainties in the data do not justify classification as long as the reasoning is not transparent and comprehensible.

Significance for industry

For manufacturers, suppliers and users, the ruling is a relief above all. Safety data sheets and product labels will no longer have to indicate a blanket suspicion of cancer. This will also make communication with customers much easier, especially in the construction sector, the automotive industry and for consumer goods. 

However, the ban on titanium dioxide as a food additive (E171), which came into force in 2022, remains unaffected. The EU continues to view this as an unacceptable risk. 

The ruling is likely to send a signal far beyond the titanium dioxide case. Future classifications of chemical substances are under pressure to be scientifically substantiated to an even greater extent. For the industry, this means greater legal certainty – but also an obligation to contribute more of its own data and studies to regulatory procedures.