The Risk Assessment Committee (RAO 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.
In the studies considered by the RAC, the effects observed were specific to the rat and have not been seen in scientific studies on any other species, including humans, as they relate to a mode of action that only occurs in rats. These effects in rats are only observed via inhalation at an exposure level many times higher than those encountered by workers on a daily basis. Most importantly, these effects are seen with all poorly soluble dusts and are not specific to TiO2. This means many other poorly soluble particulate substances will become liable for classification too.
Robert Bird, chairman of the Titanium Dioxide Manufacturers Association (TDMA) expressed disappointment about ECHA's RAC committee opinion to classify TiO2 as a cat. 2 carcinogen. Dr. Bird said: "The scientific evidence is clear: there are no grounds for classifying TiO2 as carcinogenic for humans by inhalation. Also, 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."
As part of the classification procedure, 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. Dr. Bird said "We are confident that European regulators will confirm the continued safe use of TiO2 in all applications."