Chemical industry organizations including those representing producers of titanium dioxide, have criticized the decision by the Risk Assessment Committee (RAC) of the European Chemicals Agency, ECHA, to classify the chemical used to whiten coatings and plastics as a category 2 (1A) carcinogen when inhaled.

ECHA, the agency that implements the EU chemicals legislation REACh, reviewed the chemical at the request of France, which had pressed to have TiO₂ placed in the 1b category. This would have meant that it was assumed to cause cancer and made it a candidate for listing as substance of very high concern (SVHC) under REACh.

The risk assessment committee said it had concluded that the available scientific evidence met the criteria in the Classification, Labelling and Packaging (CLP) regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route. At the same time it said there was insufficient evidence to classify TiO₂ as a category 1B carcinogen as advocated by the French Agency for Food, Environmental and Occupational Health & Safety, ANSES.

The full text of the decision will be published on ECHA’s website at the same time it is sent to the European Commission for a final decision. The opinion is to be formally adopted later by written procedure or at the committee’s September meeting.

In the view of Germany’s Titanium Dioxide Manufacturers Association (TDMA), which belongs to the European Chemistry Council (CEFIC), the “vast body of scientific evidence based on over 50 years of epidemiological data on more than 24,000 workers does not support a classification of TiO₂ for humans. There is “no link between cancer in humans and exposure to titanium dioxide,” it added.

The association noted that the studies considered by the risk assessment committee were specific to rats and have not been seen in scientific studies on any other species, including humans. TDMA said the classification “would do nothing to increase the level of protection of human health and the environment, which is the whole point of the labelling and classification system.”

In their own comments, Germany’s chemical industry association Verband der Chemischen Industrie, VCI, and its sub-association Verband der Mineralfarbenindustrie said ECHA’s planned classification would have repercussions across the spectrum of TiO₂ applications, including those in which the chemical cannot be inhaled because it is bound into a matrix such as plastic and thus produces no dust.