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Posted: June 16, 2009
Nanomaterials cause classification headache for Europe's REACH
(Nanowerk News) Confusion over classification of nanomaterials under the Reach chemicals legislation has led to two groups of companies using different criteria to submit data on carbon nanotubes to the European Chemicals Agency (ECHA).
Currently there is so much uncertainty about dealing with nanomaterials under the Reach regulations (which came into force in 2008) that different groups of companies are forming separate data-gathering bodies, called substance information exchange forums (SIEFs), to deal with carbon nanotubes (CNTs).
One group is setting up its own SIEF for carbon nanotubes to register them as distinct chemicals with their own safety profile. Another much larger collection of CNT producers and importers, including the multinationals Bayer MaterialScience and Arkema, are planning to register the nanomaterials as a form of bulk graphite so that they will not require their own registration dossier.
The European Commission has set up a Reach working group on nanomaterials to provide clearer guidance on identification of substances like CNTs. But publication of its report may be delayed as long as 2012.
Furthermore, under the present Reach rules, nanomaterials like CNTs may not be registered with safety data until 2018 or possibly not even be registered at all because they do not exceed the Reach registration threshold of 1 tonne or more of annual output or imports.
The Commission is now making it clear that this threshold will not necessarily allow companies to avoid providing safety data on nanomaterials under Reach or related legislation.
Speaking at a recent nanotechnologies conference hosted by Transatlantic Consumer Dialogue (TACD), Henrik Laursen, chemicals policy officer at the Commission's environment directorate, said that safety information on nanomaterials - whatever their tonnage - will still have to be assessed under the Classification and Labelling process for chemicals. This is being carried out in parallel with Reach by the ECHA.
Classification and labelling safety data on nanomaterials may have to be supplied to the ECHA as early as January next year, Mr Laursen said. The information would then have to be included in Safety Data Sheets (SDS) for dissemination to all downstream users of the material.
Any nanomaterial whose safety data categorises it as a substance of very high concern (SVHC) would have to be authorised and possibly be restricted under Reach no matter what volume is used, Mr Lausen warned.
'Safety has to be ensured for the substance in whatever size and form and for manufacturing and all identified uses,' said Mr Laursen.
Nonetheless nanomaterial producers point out the difficulty of providing safety data when there are still no agreed methodologies for conducting tests on nano substances.
'The authorities have not yet come up with a reasonable set of test protocols for CNTs,' says Des McGrathan, HSE manager at Thomas Swan & Co., a UK-based CNT producer involved in setting up a separate SIEF for carbon nanotubes. 'As a result, no-one yet has any data which can claim to be representative of the hazards associated with CNTs.'