Years of dithering, discussion and debate have come to an abrupt end with the recent classification of titanium dioxide published in EU Official Journal. On 18 February 2020, the European Union published a delegated regulation classifying titanium dioxide (TiO2) as a category 2 suspected carcinogen by inhalation under EU Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.
Following a proposal based on an opinion of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) for the TiO2 classification in September 2017 and an expert hearing in September 2019, a draft regulation was adopted on 4 October, which included the proposal to classify TiO2 as a suspected carcinogen by inhalation.
The Committee gave the opinion that the substance is carcinogenic when inhaled in powders with a concentration greater than 1% and a particle size of titanium dioxide ≤ 10 μm.
Titanium dioxide is a white, naturally occurring mineral that is used in a great many industrial sectors, from the adhesives industry to personal care products, and more. It is a commonly used pigment in plastics: TiO2 demand in the plastics industry is around 1.5m tonnes per year, around 25% of global consumption.
The Titanium Dioxide Manufacturers Association lobbied hard against the decision, stating that theoretical dust hazard is not new and critically it is not specific to TiO2 but applies to more than 300 substances. The RAC stated clearly that there are no robust carcinogenicity studies but based its opinion a study performed in rats. According to the association, the available data of more than 24,000 workers demonstrates no link between cancer in humans and exposure to TiO2.
The American Chemistry Council's (ACC) Titanium Dioxide Stewardship Council (TDSC) said the decision is "unwarranted" and it is "considering all options" for challenging it. The FDA generally recognises titanium dioxide as safe (GRAS).
The regulation will enter into force after 20 days, and harmonised classifications will apply from September 9, 2021.