The French authorities have submitted an intention to propose a harmonised classification for titanium dioxide as a category IB carcinogen. The intention says the proposal was submitted recently, but details have yet to be published.
Classification as a category 1A or B carcinogen has significant implications under REACH as:
- it is a criterion for nominating substances of very high concern (SVHC) under Article 57a; and
- substances with such a classification should be restricted in consumer applications – of which titanium dioxide has many, including some using the substance in its nanoform.
The dossier proposing the classification was sent to Echa by the French Agency for Food, Environmental and Occupational Health and Safety (Anses).
In response to the proposal, the Titanium Dioxide Manufacturers Association (TDMA) said the industry assessed the substance's classification as part of the REACH registration dossier submission back in 2010.
This, it said, "involved an extensive review of all available scientific data and, since then, [the dossier] has been updated with new findings and subsequent studies.
“Based on assessment of the high quality studies, industry and consultant experts have concluded that titanium dioxide should not be classified in any of its forms for any end points. This is supported by the findings of epidemiology studies of 20,000 workers in 15 titanium dioxide manufacturing plants over several decades, which showed no adverse health effects from occupational exposure.”
The trade body will review the Anses’ proposal when it is published and provide a detailed response to the Echa public consultation.
Tony Jones, global technology fellow at Huntsman Pigments and Additives, and chair of the titanium dioxide industry consortium, said companies have known since last March that Anses was preparing a proposal because of the postponement of the substance’s evaluation under REACH.
Titanium dioxide was initially proposed for evaluation under the Community Rolling Action Plan (Corap) in 2014. But this was postponed when industry appealed against a decision by Echa on the dossier compliance check. This centred around substance identification (CW 4 November 2014).
The substance evaluation is now due to start in 2016 – with France as the evaluating member state. The Corap justification, which seeks clarification on data relating to nanoforms of the substance, notes that several classifications for the substance are included in the classification and labelling inventory.
Huntsman Pigments is the REACH lead registrant for titanium dioxide. Under its legal entity name of Tioxide Europe, the company has posted a message on the C&L platform. This advises companies that have notified titanium dioxide, in any of its forms, as hazardous to consider aligning them with the vast majority of companies.
David Azoulay, environmental health programme director with the Center for International Environmental Law (Ciel) said: "Industry might be paying the price for having systematically refused to acknowledge the specificities of nano titanium dioxide compared to the bulk form, as well as the differences between the various nanoforms."
If the CLH proposal is accepted, an opinion on its adoption takes 18 months.