After almost a decade of discussion, the European Commission has signed sealed and delivered its decision to reclassify the inhalable powder form of titanium dioxide TiO₂) as a category 2 suspected carcinogen under the EU’s labeling and packaging (CLP) regulation.

The decision was published in the Official Journal of the European Union on Feb. 18, following its formal adoption by the Commission’s formal adoption in October 2019, based on a proposal initially introduced by France and backed by the risk assessment committee (RAC) of the European Chemicals Agency (ECHA).

While the EU governing body initially named Sept. 9, 2021 as the date for the legislation to take effect, it has now corrected it to Oct. 1, 2021, when TiO2 producers will be required to attach warning labels to the powdered form of TiO2 as well as mixtures containing 1% or more of the whitening pigment.

The Brussels-based Titanium Dioxide Manufacturers Association (TDMA) said its member companies are weighing a challenge to the new classification, which could include legal action against the Commission. For now, however, they will proceed with implementation of amended regulation, as legal proceedings could conceivably stretch beyond the 2021 date.

In response to last week’s publication, the producers repeated earlier concerns that the decision was “not based on any new scientific evidence or new understandings about potential harm.” They also pointed out that the theoretic dust hazard is “critically not specific to TiO2,” but could also apply to around 300 other powdered substances. 

TDMA additionally criticized the text of the entry, which it said introduces several new concepts and terms without providing any meaningful definitions or interpretative guidelines and thus opens the door to various interpretations.

The association said, moreover, that there is no precedent upon which stakeholders can rely in implementing the requirements and that the classification also introduces uncertainties in the treatment of waste containing TiO2 that will need to be addressed and clarified.

 As there is no direct substitute for titanium dioxide, the TiO2 producers believe the new regulations could have a "catastrophic" impact on many downstream industries, and that warning labels on the mixtures could confuse buyers.

During the long review process, the coatings industry in both Germany and the UK spoke out against mandatory warning labels, and the German waste disposal and recycling federation BDE said it feared that labeling TiO2 a possible carcinogen would erect barriers to waste collection.

To ensure consistency in implementation, TDMA has urged clarification of the labeling requirements for liquids and mixtures, which it said is crucial for the waste disposal and construction sectors in particular. The European Council of the Paint, Printing Ink and Artists' Colours Industry (CEPE) has also asked for clarity on the waste regulation, well before the regulations go into effect

Whether companies in post-Brexit Britain will be subject to the rules will depend on the specifics of a not yet negotiated bilateral trade agreement. Most UK industries, however, have urged their government to accept the EU rules so as not to be cut off from the European market.