The EU CLH process is a regulatory regime that seeks to harmonise the classification of substances on the basis of their hazard properties and provide labels that allow the safe handling and use of the substances by workers. Over 200 substances have already undergone this process.
In June 2017 the Risk Assessment Committee (RAC) of the European Chemicals Agency has suggested that titanium dioxide (TiO2) should be classified as a suspected carcinogen (cat. 2), following a proposal from France that was based on inhalation exposure studies in rats. This is despite the fact that there is a vast body of scientific evidence that does not support a classification of TiO2 for humans, which is supported by over 50 years of epidemiological data on more than 24,000 workers and demonstrates there is no link between cancer in humans and exposure to titanium dioxide.
Classification could lead to further assessment processes under REACH, and could potentially lead to safety assessments of the substance in a range of applications such as cosmetics, pharmaceuticals and food.
The EU classification and labelling process is by its nature a long one with both a scientific and a regulatory phase. The scientific opinion and any comments received will now be forwarded to the European Commission, who will evaluate it and decide what, if any, regulatory measures are relevant.
The industry believes that TiO2 should not be classified as a suspected carcinogen (cat.2) by inhalation. The data on which the French proposal relies shows effects in rats, which are not reproducible in other species such as mice or hamsters. Most importantly, there is no evidence of effects in humans – where the industry has large amounts of data. We believe that the effect that is seen in this small number of studies referred to in the ANSES proposal is due to the biology of the rat, which is different from other species, including humans. In essence the rat cannot physically absorb the amount of the substance it is exposed to and this causes the effect. This reaction is not unique to TiO2 but common to many other substances that are also poorly soluble. The amount of TiO2 that the rats were exposed to in the studies referred in the proposal is far in excess of that to which human workers would ever be exposed. Moreover, the exposure conditions in the rat study used to support the proposal would invalidate the results as compared to current EU testing guidelines for an acceptable study. Learn more on the opinion of industry.