INSIGHT: Reach will open market for safety data

16 April 2007 17:42  [Source: ICIS news]

LONDON (ICIS news)--The European Union’s new chemicals legislation Reach is opening up dialogue between suppliers and customers in the chemicals sector as never before.

The exchanges by necessity are widespread and can extend far down chemical product chains.

Discussions are complex, probably sometimes tiresome. At their heart, however, is a new currency – vitally important health and safety data.

The new legislation comes into force on 1 June this year and companies have until December 2008 to pre-register up to around 30,000 compounds.

That gives companies some time to get organised but all should be aware that Reach implementation is moving fast.

Website-driven Reach support and guidance from the EU’s executive arm, the European Commission, will be made available soon.

It will not be long before companies have to decide just how they will begin to share their own chemical safety and hazard information.

Registration under Reach – the legislation that covers the registration, evaluation and authorisation of all chemicals sold on the European Union (EU) – will follow first for high production volume (HPV) substances and substances of high concern, and then for compounds produced or imported in lower volumes.

By no means a simple task, the pre-registration/registration process will require companies to talk to suppliers and customers in ways few have done before.

All involved in the registration process will need significant amounts of safety, exposure and, where appropriate, protection data at their fingertips.

Putting the pieces of this vast legislative requirement into play will take considerable cross-industry effort.

“It is just so complicated”, warns Fiona Smith, regulatory and registration manager of polymethylmethacrylate (PMMA) maker Lucite International a company which has been preparing for Reach for years.

“Reach will come into force before technical guidance documents are available. The details of how the Reach dossier will look has not been worked out yet,” she says.

Lucite is not alone in having to draw its customers and supply chain intimately into the Reach pre-registration and registration process.

New publications, industry presentations, and even a Reach blog, are helping spread the message.

Reach places responsibility on manufacturers and importers to ensure that the substances, in quantities greater than 1 tonne per year, do not adversely affect human health or the environment.

A core part of this responsibility requires industry to provide comprehensive documented information for all qualifying substances, Smith notes in the Lucite Reach blog.

"Registration is for use,” she notes, “so you have to specify that use and demonstrate that it is safe”.

“This is why this [Reach registration] is really a commitment issue. You have to be able to assess the use scenario right down to the consumer level.”

Numerous Reach implementation projects (RIPs) set up among stakeholders in the Reach process are drawing fast to a close and give some indication of the heightened level of activity on the Reach front.

At their core, however, is the European Commission’s own RIP3.01 which will provide navigator tools linked to guidance documents due for release by June this year.

Currently, industry expects the EC’s IUCLID5 IT tool, the key piece of software for Reach registrations, to be available by May 2007.

Having passed into law Reach implementation is moving to strict deadlines that ultimately will extend to 2018.

The first years, however, will see the most activity and will be when the new legislation’s registration element is really tested.

Pre-registration is important as Smith says and will help companies understand what industry data are available and what can be shared in consortia.

“One of the issues is around the value of data for each substance,” Smith notes.

An issue of Reach not widely discussed outside chemical industry health and safety circles, the data debate is about to be broadened – significantly.

It has taken one of the most complex and hotly contested pieces of EU legislation to do it but the sector finally is about to demonstrate the value of its health and safety information.

By: Nigel Davis
+44 20 8652 3214

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