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Commission rejects idea of EU nano register

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The European Commission has told member state officials that its preferred option on improving transparency on nanomaterials is a public website listing existing information, rather than an EU register.

At a meeting last week of the CASG-Nano group of national competent authorities, Commission officials also confirmed what has looked inevitable for some months – that the introduction of new REACH information requirements for nanomaterials will not happen in time to affect the final raft of substance registrations.

David Azoulay of the Centre for International Environmental Law (Ciel), who is an official observer at the meetings, said he and other stakeholders are furious that the Commission “manipulated the process, effectively ensuring that we would not get any information about nanomaterials coming onto the market for years”.

Back in 2006, when the final negotiations on the drafting of the REACH Regulation were being conducted, said Mr Azoulay, the Commission promised that REACH would provide robust requirements for information on nanomaterials. But when the first registration deadline in 2010 approached, it said it needed to wait for the necessary guidance to be written.

Then, when the second registration in 2013 drew near, it said the information could not be produced, unless the REACH Regulation’s annexes on information requirements were updated. Since then, he said, the Commission has dragged its heels on finalising the impact assessment of the proposed annex changes, which was announced back in 2013.

One member state asked the Commission at the CASG-Nano meeting for a “clear explanation” of why it “repeatedly delayed its work, failing to adhere to defined and promised delivery dates”. Another told Chemical Watch there was a “shared feeling at the meeting of frustration at the lack of progress – particularly that the annexes won’t be ready for 2018”.

There are rumours that Sweden will hold a workshop to resurrect the idea of a separate “nano patch” Regulation, which would set information requirements for nanomaterials. Several member states have suggested they may support this idea.

New option on annex changes

The Commission revealed, at the meeting, that it has come up with a new option for amending the annexes, which is based on elements of options two, four and six in the original consultation. But instead of an official document setting this out, it presented a non-paper, which some member states said was confusing and difficult to follow.

Several participants criticised the Commission’s draft impact on all the options on the grounds that it contained no information on the benefits, only on the costs, and that these seemed “extremely high and based on industry numbers”.

Mr Azoulay said the new option raises two major problems for Ciel and other stakeholders: one is that it would allow some level of grouping (although it goes under a different name) to be done for different nanoforms of a substance, even though “we still lack the knowledge to group nanomaterials for hazard assessment”.

The other is that it’s unclear whether the requirements would apply to all nanomaterials – although a bulk form of the substance was on the EU market before 2008 – or only to substances which did not have any form (bulk or nano) on the market, prior to that date. If it is the latter, then most nanomaterials on the market today would escape the requirements.

Nano observatory

Echa will develop the website or “observatory”, providing existing information on nanomaterials. The agency and Commission will also hold a workshop in Brussels on 25 April.

Echa says the observatory will be developed under its 2015-2018 nanomaterials workplan. Much of the information contained in national nanomaterial registers is confidential but the agency says different sections of the website “may have different key audiences”.  It also faces a “special challenge” to present information in a way that can be easily understood by consumers.

The draft impact assessment, for both the annex changes and the transparency options, was rejected by the Commission’s Regulatory Scrutiny board on 3 February but the Commission is understood to be confident that they will get board approval soon.

The draft legal proposal on changing the annexes will then be prepared and discussed in the REACH Committee, probably in the second half of this year.

Meanwhile, the Commission hopes to launch a public consultation on the review of the EU nanomaterial definition this “spring” and agree on the new definition by “mid-2016”.  This is unlikely to address the issue of what is a “nanoform” – something that, instead, will be addressed by Echa guidance.

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