On 1 August 2025, the Court of Justice of the European Union (CJEU) ruled at final instance to annul the classification of titanium dioxide (TiO2) as a substance with carcinogenic effects. The judgment upheld the General Court’s ruling of November 2022 and found an erroneous assessment and a breach of the criteria laid down by Regulation (EC) No 1272/2008 (CLP) for the classification of chemical substances.

Link to the ruling: https://curia.europa.eu/juris/documents.jsf?num=C-71/23%20P

The position of the Czech Republic and the Czech Nanotechnology Industries Association

The Czech Nanotechnology Industries Association was actively involved from the outset in shaping the Czech Republic’s position on this matter. The Ministry of the Environment took a pragmatic approach based on assessing risks before initiating classification, rather than the other way round. The Czech Republic proposed addressing the issue through dust limits, but the European Commission rejected this.

Limits in force in the Czech Republic:

• Workplace environment: 10 mg/m³
• Indoor living environment (Decree No 6/2003 Coll.):
  • PM10 (non-respirable dust): 150 μg/m³
  • PM2.5 (respirable dust): 80 μg/m³

Problematic aspects of the original process

The Czech Nanotechnology Industries Association, together with its international partners, drew attention to several fundamental shortcomings in the classification process:

• Insufficient transparency of the procedure
• Duplication with existing legislation
• A testing methodology based on extreme overloading of the lungs of laboratory animals under unrealistic conditions
• A political decision taken under an expedited procedure by means of delegated powers

The proposed test conditions involved an 18-month exposure equivalent to inhaling 17.5 g of TiO2 daily – roughly 3,000 times more than current safety standards permit.

Current protection

The current legislative framework of both the EU and the Czech Republic ensures adequate protection of the population and the environment against the risks associated with chemical substances. The CJEU ruling confirms this and closes the chapter on a legal dispute that lasted several years.

Illustrative photograph:
Titanium dioxide (TiO2) – white powder
Source: Titanweiß.JPG, Wikimedia Commons