INSIGHT: Data-sharing SIEFs are real Reach challenge

05 May 2009 17:28  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS news)--The EU expected 180,000 pre-registrations of 30,000 substances under its Reach, registration, evaluation and authorisation of chemicals scheme. Yet its new chemicals agency was all but overwhelmed by 2.7m pre-registrations of some 143,000 substances said to be manufactured or imported into the EU in quantities of more than one tonne.

Now the prospect of possibly 15 times more than initially planned full-blown substance registrations is hardly relished, by the agency or anyone else.

It is not surprising that so many chemical manufacturers and importers, including companies in sectors other than chemicals, are concerned about this critical next stage of Reach.

If a substance is not pre-registered or eventually registered under Reach there can be no market for it in the EU.

Most national European authorities have already started to police this pre-registration and registration process.

But the next Reach deadline looms large. It is 1 December 2010 for the submission of full Reach registration dossiers. These are the documents that contain most of the safety and toxicity data on a substance and a classification of that substance into an acceptable category.

But not everyone understands what Reach registration is and, particularly, what substance data, it requires.

The European Chemicals Agency (ECHA) has promoted the formation of substance information exchange forums, or SIEFs, and substance consortia.

Through the SIEFs, producers, distributors and importers – the substance pre-registrants – are expected to share substance toxicity and other data; decide on a classification for the substance- whether a skin irritant or a carcinogen, for example; and through a lead company submit a Reach registration dossier.

Yet no-one has taken anything but the first steps along the path to successful SIEF formation and operation.

Already arguments are surfacing about possible SIEF fees – initial registration fees of between €30,000 and €40,000 ($40-$53,000) have been mentioned for some of the larger SIEFS with additional running costs expected.

There are no SIEF guidelines; best practice is non-existent – indeed it hasn’t been achieved yet – and the SIEF’s have no legal standing.

These private groups of chemicals manufacturers and others are expected to gather data and submit registration dossiers for most of the chemicals used throughout European industry.

The SIEF process is a minefield that will test supply chain cooperation to the full.

And the trouble is; all this is new. SIEF participants can make up the rules as they go along. Some have the picture in their minds eye of flying the plane while it is being built.

SIEFS range in size, also, from the very small to the very big. The ethanol SIEF with 5,000 or so members is the largest. Imagine trying to organise a single reach registration from that number of potentially active participants.

Finding a lead registrant and achieving consensus among some of the larger SIEFs will be a tough job. But the regulators expect industry – and not just chemicals makers – to step up to the mark.

This phase of Reach presents the first real test of the chemicals control regulation.

Producers are expected to be in contact with distributors; importers with downstream customers keen to know the origin of the substances they use in preparations and other goods. The mammoth task is an unprecedented chemicals data sharing exercise.

Pitfalls will be exposed along the way. Currently there is a great deal of confusion and little activity. It is almost as if everyone is waiting for everyone else to make the first definitive moves.

However, the SIEFs need to gain momentum. December 2010 may seem a long way off but some in the industry believe that registration dossiers need to be ready by June next year.

Reach is a complex and contentious process. But the wheels have begun to grind faster.

The first stages of Reach are being enforced; it pays to understand as fully as is possible and to be well prepared for the next steps.

($1 = €0.75)

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By: Nigel Davis
+44 20 8652 3214



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