TiO2 has been assessed for safety by a large number of regulatory authorities and has consistently been found safe for all applications. Most recently, in September 2016, the European Food Safety Authority’s (EFSA) Scientific Panel on Food Additives and Nutrient Sources published an Opinion confirming TiO2 is considered safe for use in food. For further information see the industry response to the Agency’s Opinion.
On 9 June 2017, the Risk Assessment Committee (RAC) of the European Chemicals Agency suggested that TiO2 should be classified as a suspected carcinogen (cat. 2), based on inhalation exposure studies in rats. This opinion from the RAC goes against 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. The European Commission will now evaluate the opinion and decide what, if any, regulatory measures will be taken. Our scientific assessment, as outlined in the REACH dossier and further supported by the comments submitted in the public consultation, leads to a “no classification” for the substance, in all its forms. To read more about the reaction of TDMA to the RAC opinion, please follow this link.
Association of TiO2 with cancer
A link between TiO2 and cancer has never been established. The effect in rats relied upon by the French proposal are not reproducible in other species such as mice or hamsters. Most importantly, extensive studies conducted by both industry and independent institutions have found no evidence of effects in humans. While a small number of studies have associated TiO2 with cancer, these studies are based on exposing rats to quantities of TiO2 far above what humans, even workers, would ever be exposed to. We believe this triggers a unique biological effect in the lungs of rats which is not found in any other species, including humans. Essentially, exposing rats to a greater volume of a substance than they can physically absorb causes the effect. This reaction is not unique to TiO2 but common to many other substances that are also poorly soluble. Furthermore, the conditions under which the studies were performed do not comply with current EU testing guidelines for an acceptable study, and therefore cannot be considered valid. Learn more on the opinion of industry.
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) by inhalation, following a proposal from France that was based on inhalation exposure studies in rats. (for more, see Regulations covering TiO2)
The RAC opinion is non-binding. 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. TDMA is confident that European regulators will confirm the continued safe use of TiO2 in all applications. For more information on TDMA’s reaction to the RAC opinion, please see our press release.