EU and UK Regulation
In 2020 the European Commission confirmed a new regulation changing the hazard classification of Titanium Dioxide from non-hazardous to suspected carcinogen category 2 (CLP: Regulation (EC) no. 1272/2008). This update to CLP was written into the legislation before the UK left the European Union and has also been adopted into the GB equivalent of CLP.
This change was based on evidence from an historical toxicology study on rats, submitted to the European Commission by France. Preceding its entry into force, industry leaders from around the world have disputed the relevance of the study supporting the legislation. Disputing the methodology and the accuracy of its extrapolation to human, supporting their argument with an independent study involving over 24,000 employees who regularly handled Titanium Dioxide without reports of elevated cancer rates.
However, despite industry objections and lobbying from trade associations like CEPE, the European Commission upheld their decision to classify Titanium Dioxide as a suspected carcinogen. This regulation became effective from the 1st October 2021.
The classification is driven by the mechanical effects of an overload of dust in lungs and not specific to the chemical properties of Titanium Dioxide, therefore the carcinogenic classification only concerns Titanium Dioxide of a respirable size i.e. powder with a diameter of ≤ 10 μm.
The classification and labelling is purely hazard-based and does not reflect the actual risks related to the use of our products. For example, classification does not consider if there is an actual risk of exposure to Titanium Dioxide particles from paint. The Titanium Dioxide in paint are combined in a polymer or oil and not free dust particles. Once dry the Titanium Dioxide particles are bound in a solid matrix and not freely respirable as a dust. Titanium Dioxide has been assessed and is permitted for use in cosmetics, medical products, food and food contact materials.