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French Agency for Food, Environmental and Occupational Health & Safety

ANSES's proposal for titanium dioxide to be classified as carcinogenic by inhalation submitted for public consultation

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News of 09/06/2016

ANSES has submitted a proposal to the European Chemicals Agency (ECHA) for titanium dioxide to be classified as a Category 1B carcinogen by inhalation. Since 31 May 2016, this proposal has been the subject of a public consultation on the ECHA website to enable interested stakeholders to present their points of view, scientific arguments or any additional information they have at their disposal. After this public consultation, which will run for 45 days, the process of examining the classification proposal will follow the steps laid down by Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation, until the adoption of a final opinion by ECHA's Committee for Risk Assessment. On the basis of this opinion, the European Commission will decide whether to include the classification proposed by ANSES in the CLP Regulation.

 

There are several varieties of titanium dioxide (TiO2). They differ according to their crystalline phase and particle size distribution. For many years, titanium dioxide has been used at the micron scale for the production of pigments. It has also been used in nanoscale powder form since the 1990s, mainly for its ultraviolet-ray absorption properties. Thus, titanium dioxide is found in many types of products (cosmetics, food products, etc.) and in the construction sector (building and public works).

In 2006, the International Agency for Research on Cancer (IARC) classified titanium dioxide in group 2B, as a substance that is "possibly carcinogenic to humans". To date, titanium dioxide has not been assigned any harmonised European classification, under Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation.

The data currently available, as analysed by ANSES, demonstrate that titanium dioxide can cause malignant tumours in rats following exposure by inhalation. A sufficient level of evidence means that titanium dioxide can be considered as a proven carcinogen in animals in light of the experimental data. In humans, the carcinogenic nature continues to be discussed due to the methodological limitations of the available epidemiological studies.

Because of its physico-chemical properties, exposure to titanium dioxide by the respiratory route, at a certain level of concentration, may cause lung overload and lead to an inflammatory reaction, responsible for proliferative lesions.

These points led ANSES, on 20 May 2015, to submit a proposal to ECHA to classify titanium dioxide as a Category 1B carcinogen by inhalation (a substance that is presumed to have carcinogenic potential for humans), in the framework of the CLP Regulation, for all its crystalline phases and combinations of phases, sizes and shapes of particles. This proposal was submitted for public consultation on the ECHA website on 31 May 2016, to enable interested stakeholders to present their points of view, scientific arguments or any additional information they have at their disposal. This public consultation will be open for 45 days.

Comments can be sent via a dedicated form on the ECHA website.

After the public consultation, ANSES will respond to the comments received. The initial proposal, along with the comments and their responses, will be sent to ECHA's Committee for Risk Assessment (RAC), which will produce an opinion for the European Commission within 18 months.

On the basis of this opinion, the European Commission will decide whether to include the harmonised classification proposed by ANSES in the CLP Regulation.