Following the CARACAL meeting (Competent authorities Meeting for REACH and CLP regulations) on 18 September, the European Commission will move forward with its controversial proposal to classify titanium dioxide (TiO2) as a ‘Carcinogen category 2’ for its inhalation hazard, with classification code H351 (inhalation).

The classification is to be applicable to liquids as well as powders of mixtures containing 1% or more of titanium dioxide in the form of or incorporated in particles with aerodynamic diameter ≤ 10 µm

The controversial proposal originates from the ECHA RAC (Committee for Risk Assessment) opinion of 14 September 2017 where ECHA proposed to classify TiO2 as carcinogen category 2 by inhalation. This opinion was to a large extent based on a rat study from 1995, with questionable reliability as rats were exposed to an overload of TiO2 and the results can not be extrapolated to humans. 

In addition, large criticism to the EC proposal for classification is that it lacks an impact assessment, as many industries and users fear that the hazard from TiO2 is not related to the substance itself, but rather to its particulate form. A concern therefore arises as similar hazards and thus classifications may be use for other poorly soluble low toxicity particles that have the potential to form respirable dusts. There is also criticism as when TiO2 is incorporataed in a matrix, the possible human exposure is not significant. 

The classification will also have unclear effects on downstream users and use as it may hamper recycling as additional waste management will be required to deal with waste containing 1% or more TiO2, such as plastics, wallpaper and paint residues, porcelain or furniture, as such materials would be classified as hazardous waste, even if there were no potential for inhalation. 

The next steps is for the EC to submit its adopted act to the European Parliament and Council of Ministers who will have two months to formulate any objections to the act. If no objections are raised, the delegated act enters into force.