The European Commission is ready to adopt ‘Carcinogenic Category 2’ hazard classification for titanium dioxide present on the market in inhalable powder forms, with particle aerodynamic diameter of < 10 µm.

Titanium dioxide (TiO2) is a very commonly used white pigment that characteristically adds whiteness and opacity to chemical products. It is widely used in paints, printing inks, coatings. It is also used in cosmetics, textiles, food and feedstuff and pharmaceuticals and many other economic sectors.

In early September 2019, the Commission held its final consultation with the Competent Authorities for REACH and CLP (Caracal) and is now progressing to adopt the draft regulation amendment, which will then be passed to the European Parliament and Council of Ministers.

The decision follows multiple attempts by industry and stakeholders who argue that the carcinogen hazard is not an intrinsic characteristic of TiO2 but arises from particle toxicity – a dust effect(1). Conversely, NGOs have also raised concerns over deviation from the Risk Assessment Committee (RAC) Opinion, which calls for all forms of TiO2 to be classed as carcinogenic via the inhalation route. Industry’s request for a comprehensive impact assessment have been unsuccessful, with the Commission maintaining that normal procedure to implement harmonised classification have been undertaken, which included a public consultation of the RAC opinion.

All parties involved are now awaiting the two-month period where the European Parliament and Council inspect the draft regulation amendment, and a decision should be reached by the end of 2019 or early 2020. There is a possibility for the draft regulation amendment to be rejected should either institute object.

In the event of the European Parliament and Council passing the amendment, the industry will face the complex and multifaceted task of reviewing products containing TiO2, for reformulation or reclassification. The impact of TiO2’s suspected hazards is already visible in France, which requires banning of TiO2 (also known as E171) as a food additive from 2020.

Authors:

Madhuri Sugand and Dr Neil Hunt

References
(1) https://tdma.info/what-you-should-know-about-eu-titanium-dioxide-regulations/