INSIGHT: Industry, ECHA need to get to grips with Reach forums

12 August 2009 17:43  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS news)--Recent news from the European Chemicals Agency (ECHA) shows the Reach process (the registration, evaluation and authorisation of chemicals) at work.

The deadline for the first batch of substance dossiers that have to be submitted to fully register chemicals under Reach is not that far away. The first high-volume products, whether produced in the EU or imported into the region, have to be registered by 1 December 2010.

The data show that the agency had accepted 2,293 dossiers for processing by 5 August out of a total of 3,749, with the difference being those that are in one way or another incomplete. By 12 August, the ECHA had received the contact details of 1,190 lead registrants. Most of them, it said, intended to register by the 2010 deadline.

A lead registrant makes the first submission of a dossier for a substance and usually represents a group of companies, importers or other parties interested in that substance. It needs to register early to give co-registrants time to act.

It is widely felt that the first submissions of substance dossiers from lead registrants in particular need to be made by around mid-2010 to ensure eventual consensus among multiple registrants and to give co-registrants time to act.

So is the Reach registration process working effectively yet? And can the ECHA be expected to cope with a rush of registrations as the deadline nears? The Reach systems could be inundated later this year or earlier next.

Pre-registration caused so many headaches that the ECHA and, it must be said, most players in the chemicals industry, want to see this stage of Reach proceed effectively.

The full registration deadline will be a major event for the ECHA and for the chemical industry. It should further demonstrate that the ECHA systems work. But, more importantly, it should also show that sellers of chemicals in Europe, and their customers, have the systems in place to bring together interested parties in a substance and gather toxicity data on that substance effectively.

Given the number of pre-registrations, there could be close to 2.7m full registrations. However, the number is expected to be much lower than that. There were anomalies in the pre-registration process. At least one organisation pre-registered the entire EU chemicals directory, helping put considerable strain on the pre-registration process. Eventually 150,000 substances were pre-registered.

But registration itself is expensive: €31,000 ($44,000) for high-tonnage substances and less for low tonnage products sold by small to medium-sized enterprises (SMEs). The effort and costs required to put together a full registration dossier are likely to limit registrations only to those that are essential.

It cannot be forgotten, however, that the onus of Reach falls squarely on the shoulders of producers and other sellers of chemicals. It has taken time to get that message across and, for those that pre-registered a substance or substances, to come to terms with establishing the substance information exchange forums (SIEFs) and the consortia deemed necessary to streamline the Reach registration process.

Creating and managing the SIEFS and consortia has been far from easy, and practical advice has often been difficult to find. The agencies set up by national and regional trade groups and others have reported slow progress on SIEF formation, even though SIEFS will be the driving force behind the Reach registration process.

Reasonable progress is being made, some believe. And it seems as if the best SIEFS are getting there. But there are numerous issues around SIEF formation and operation that need to be addressed and, perhaps, publicised more widely.

The European Commission is concerned enough to be organising with the ECHA a workshop for lead registrants in Brussels on 11 September. The workshop will, among other subjects, cover best practices in the establishment and management of SIEFs and the preparation of registration dossiers.

The lead registrant’s role in leading the SIEF, gathering data and information on end-uses and submitting the initial registration is vitally important. It is they who submit the initial joint dossier and chemical safety report.

Talking about and disseminating best practice at this stage is vitally important, but it is an aspect of the Reach process that appears to be lacking. At an ECHA stakeholder day at the end of May of this year, the frustration felt by so many about the SIEF process was widely apparent.

The September meeting will either expose further frustration in the sector and downstream, or show that progress is being made.

A renewed sense of urgency on SIEF formation and operation on the part of the agency is, however, likely to be apparent as it launches a series of webinars, a helpdesk service and an electronic discussion platform for signed-up lead registrants.

To discuss issues facing the chemical industry go to ICIS connect

By: Nigel Davis
+44 20 8652 3214

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