From 2016 on titanium dioxide (TiO2) has been the focus of some Authorities and media due to a proposed classification as carcinogen by inhalation.

Because it is an inert dust with no known hazard our industry has been involved to advocate that it should not be classified for such effect. We are convinced that it is not hazardous and therefore that it does not deserve to be classified.

Titanium dioxide (TiO2) is the number 1 pigment purchased and used by our industry. We depend on the fine particle pigment grade to provide brightness and opacity. It is present in >90% of our products at >1% concentration. No alternative offers the equivalent brightness, whiteness, opacity and protection. Our industry is the major user worldwide of TiO2, but many other industries use it as well: plastic, rubber, paper, cosmetic, food additive etc. It has been used safely for over a century.

The issue at stake could be summarized as ‘Too much dust in your lungs is not good for you’. We think that the EU classification and labelling legislation (CLP) should not have been used to classify dust particles that have no intrinsic toxicity and do not present a realistic hazard.

In order to act as a pigment it is incorporated in paint and inks in the size of micrometers, the optimum size for light scattering. The nano form is not used as pigment since it is transparent.

It is toxicologically inert. Despite this, a classification as carcinogen by inhalation category 2 ‘suspected of causing cancer’ has been adopted under the EU Regulation on Classification, Labelling and Packaging (CLP 1272/2008).

The basis for this is the observation in studies on rats that by overloading the lungs of these animals with huge quantities of dust during their entire lifetime the lungs are not able to naturally excrete that quantity and the cells get inflamed, and chronic inflammation develops tumors in rats. This has never been observed in Human, despite many studies, and will never be seen because that situation of living an entire life in a forced environment of extreme dust level is not a realistic condition.

We think that such dust effect should not have been in scope of CLP as it is not relevant to warn of an unrealistic hazard. We also think that titanium dioxide should not have been classified as the effect observed in rat is not due to an intrinsic property of TiO2 but of any other similar solid particle of poor solubility. There is only one group of people that must be aware of the risk from too much dust, it is the group of industrial workers. And all Member States in Europe had already existing occupational safety limits in place for dust (all dusts), which is the most appropriate measure to address this concern.

The use of CLP to warn of an unrealistic hazard will lead to misunderstanding and stigmatization.