TDMA/TDIC Statement

"RAC supports classification of titanium dioxide (TiO2) as suspected of causing cancer, category 2, through the inhalation route"

KRONOS considers RAC opinion to be unsupported by prevailing science

The Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued an opinion to classify TiO2 as a category 2 suspected carcinogen based on a certain inhalation study of rats. KRONOS, as a member of the European Titanium Dioxide Manufacturers Association (TDMA), does not agree that TiO2 is a suspected carcinogen. Of the many TiO2 studies of animals and humans, very limited effects were observed, and were specific to the rat species. These limited effects were not observed in scientific studies of any other species, including humans. In addition, this effect in a single animal species was only observed via inhalation, and at an exposure level elevated many times higher than those levels encountered by workers or consumers. It is further important to note prevailing scientific standards do not support the methodology of the rat study used by the RAC to support its opinion. The RAC ruled out carcinogenicity for oral and dermal routes of exposure.

This proposed classification is based only on the inhalable form of TiO2; however, the structure of the EU regulatory framework may prevent limitation of the classification to end use applications with inhalation risks. Similar effects are seen with all poorly soluble dusts and are not specific to TiO2. Therefore, ultimate approval by the EU Commission could set a precedent for similar classification recommendations for many other similar substances and will be hotly debated by multiple industries.

Next Steps

Once the formal opinion is completed it will be forwarded to the EU Commission for evaluation and a determination of what, if any, regulatory measures will be imposed for TiO2. The opinion will face additional scrutiny and potential clarification as it moves through the formal consideration process. The TDMA and its members will continue to strongly oppose this opinion and vigorously defend the safety of TiO2 by seeking out every opportunity to provide important information to the EU Commission during its review and decision-making concerning TiO2. A final decision is not expected until 2018.

The scientific assessment made by the EU manufacturers of TiO2, as outlined in the REACH dossier, fully supports a “no classification” for the substance, in both pigmentary and nano forms. TDMA and its members will continue to explore regulatory pathways ensuring the continued safe use of TiO2 across all industries and applications, and look forward to a constructive dialogue with the EU Commission on this topic. We urge other stakeholders to work within their industry groups to do the same. For further information on titanium dioxide please also refer to the following websites: