ECHA’s RAC Finalizes Recommendation for Titanium Dioxide Dust Inhalation
October 9, 2017 •
On Sept. 27, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) announced that it finalized its recommendation to classify titanium dioxide (TiO2) as a Category 2 Carcinogen, or a substance suspected of causing cancer by inhalation. The RAC recommendation will go to the European Commission (EC) for further deliberation and possible adoption as a final classification. If finalized, the classification would trigger labelling requirements under the Classification, Labelling and Packaging (CLP) Regulation for both industrial and consumer products containing titanium dioxide, used in Europe. At this writing, RAC had not yet published its recommendation online.
The RAC opinion will face additional scrutiny and potential clarifications as it moves through the formal consideration process, culminating in a final decision by EC officials in the first quarter of 2018.
TiO2, a commonly used white pigment in paints and a variety of other products, is under review to establish a possible hazard classification under the European Union’s (EU) CLP Regulation. The CLP Regulation is an ongoing regulatory program to harmonize classifications of substances based on hazard properties (but does not consider risk of human exposure). Classifications have implications across the EU for product labels, formulation restrictions and worker protection.
In June, as part of this process, RAC announced it would issue an advisory opinion to the EC to classify TiO2 as a Category 2 (Animal Evidence) carcinogen via inhalation. The detailed rationale for this advisory opinion will be released soon, after which the EC will then consider and issue a final approved hazard classification. There is considerable industry concern that the basis for the opinion is flawed and does not inform on risk to humans. It is important to consider that the risks profiled are not attributable formulated products, like paint, where TiO2 dust is embedded in the mixture.
For the paint industry, it is imperative to stress that, in addition to the fact that the best scientific evidence does not indicate a carcinogenic hazard arising from TiO2 dust exposures, any form of TiO2 used in paint and other formulated products is embedded in a liquid matrix and not available for exposure. Accordingly, ACA believes the RAC-recommended hazard classification for TiO2, or any other similar form of chemical substance found in particulate (dust) form, is not appropriate for downstream mixtures in which the materials are stably embedded into a polymer matrix.
ACA and other paint industry trade associations have urged ECHA to consider the very real consequences associated with the current proposal, citing the many other national chemicals management schemes that acknowledge the lack of exposure and pursuant health risk for substances embedded in polymers. Paints, coatings, inks and other polymers have a long history of safe use, as do the organic and organo-metallic pigments and dyes that have been used in these and other applications.
ACA believes that any evaluation of TiO2 hazards should be based on sound science. ACA recently filed a brief with the World Trade Organization (WTO) stating that classification as a carcinogen is not warranted and could unnecessarily constrain or even eliminate certain products from international trade. ACA coordinated its filing with the WTO through the U.S. Trade Representative, filing in conjunction with other trade associations.
ACA also supports the position of the Titanium Dioxide Manufacturers Association, which is heading the effort to advance sound science on the classification issue, working in concert with many downstream industries to ensure responsible use.