Titanium dioxide (TiO2) is by far the highest volume and most versatile globally-used white pigment which is also widely used as a brightener for colours other than white. No other pigment comes close to matching its exceptionally high opacity (a result of TiO2 having the highest refractive index among all known white pigments), bright whiteness and UV absorbing, protective properties. It is manufactured in 18 plants in the European Economic Area (EEA) with an annual production volume of ca. 1,100 k tonnes and an estimated market value of ca. €3 billion.
The French authorities submitted a proposal for a new harmonised classification (CLH) for TiO2. The proposal was to classify the substance as a Carcinogen Category 1B by inhalation and it was made available for public consultation on the ECHA website on 31 May 2016 with a deadline of 15 July 2016 for submission of comments. During this period, the Titanium Dioxide Manufacturers Association (TDMA) submitted extensive comments as did numerous other stakeholders, the vast majority of whom expressed severe reservations over the validity of the scientific arguments made in the French proposal but also highlighted the potential adverse effects from the proposed classification across the TiO2 supply chains. Indeed, a harmonised classification of Carc Cat 1B would clearly have significant repercussions on the manufacture and use of the substance in the EEA. Furthermore, the presence of TiO2 in several minerals placed on the market at discernible concentrations and the commonality of the key principles on which carcinogenicity is claimed in the French proposal between TiO2 and other poorly soluble powders could mean that the proposed harmonised classification might have significant direct and indirect adverse impacts on other supply chains too.
ECHA’s Risk Assessment Committee (RAC) adopted an opinion on 14 September 2017 in which the proposal for a Carc Cat 1B harmonised classification was rejected. Nevertheless, the RAC believed that the available scientific evidence meets the criteria in the CLP Regulation to classify TiO2 as a substance suspected of causing cancer (Carc Cat 2) via the inhalation route.
The report produced by RPA reviews the regulatory impacts and analysis of socio-economic impacts from the proposed harmonised classification and takes into account the RAC’s conclusion by assessing what the socio-economic impacts of a Carc Cat 2 (as opposed to a Carc Cat 1B) classification would be.
This report demonstrated that the Carc Cat 2 harmonised classification for TiO2 proposed by the RAC, similar to the original French proposal for a more severe Carc Cat 1B classification, would result in severe social and economic cost impacts, firstly for the manufacturers of the substance, secondly for the multitude of downstream users of TiO2 in a diverse range of industry sectors, thirdly on the marketing and use of a vast array of industrial, professional and consumer products and finally on the employment of a very significant number of workers. This report gave particular emphasis on impacts arising from the labelling of mixtures that contain TiO2, potential restrictions arising for the marketing and use of the substance in products such as toys, cosmetics, food contact materials, foodstuff and pharmaceuticals as well as products that are currently awarded an ecolabel. It also highlighted the waste management impacts of a Carc Cat 2 classification of TiO2.
The report concluded that the classification of the substance as a suspected carcinogen fails to meet the requirement for proportionality; harmonised classification as a Carc Cat 2 is not necessary to achieve the objective of protecting the health of workers and consumers while it leads to highly disproportionate costs for society and stigmatisation of the substance irrespective of its form or route of potential exposure.