A chemical regulation comes of age

The man on the street may not have felt it, but last year there was a seismic shift in the way chemicals are regulated in Europe. The first registration deadline for arguably the most ambitious piece of chemical legislation - the registration, evaluation, authorisation and restriction of chemicals (Reach) regulation - came and went, and those close to the matter were in no doubt about the significance. ’Today was perhaps the most important date in this year’s calendar for the many thousands of companies supplying chemicals in the EU,’ declared the UK Chemical Industries Association on 1 December 2010.

The 2010 deadline 

The Reach regulation has many elements to it. But registration is perhaps the one that has generated the most discussion. In general, the regulation requires companies to submit registration dossiers for the chemicals they make or import. After the relevant deadline, companies are only allowed to carry on supplying their chemicals if they are covered by registration dossiers. The 2010 deadline applied to bulk chemicals, those supplied in quantities of over 1000 tonnes per year, and very hazardous chemicals. Deadlines in 2013 and 2018 will apply to chemicals supplied in smaller quantities. 

In the run-up to the deadline, many expressed concern over how the European Chemicals Agency (ECHA), the administrative centre for the Reach regulation, would stand up to the deluge of dossiers. The agency was hampered by embarrassing technical difficulties in 2008 during the pre-registration process, in which companies had to signal to the ECHA their intention to register chemicals (see Chemistry World, July 2008, p8). 

The ECHA website was then unavailable for several days in September this year due to damage to a broadband cable in Sweden. But in general the registration deadline seemed to pass without incident. Certainly, the industry view was positive. Jo Lloyd runs ReachReady, a consultancy that helps companies comply with Reach. She says that those companies she works with that had to register did make the deadline. 

ECHA boss Geert Dancet says that his team learned important lessons from the pre-registration deadline. For pre-registration, there was no way of knowing how many submissions to expect. In the end, the 3 million received vastly exceeded the prediction of 200 000 made at the start of the pre-registration period. But the ECHA was better prepared this time around, Dancet says, and was expecting that a large proportion of submissions would not be made until the last few months before the deadline.  

The post-registration world 

There is also evidence that the underlying legislation is functioning well. The chemical industry has always said that Reach places an unprecedented burden on companies. But the statistics from the first registration deadline suggest that the groups considered most poorly equipped to shoulder it faired better than expected. For example, medium, small and micro companies together represented 14 per cent of submissions. Another group that some thought would struggle were non-EU companies that - despite their main activities taking place elsewhere - have to comply due to the spread of their supply chains. But registrations from such companies, which came through separate legal entities, accounted for 19 per cent, evidence, Dancet says, that the process was accessible to all. Perhaps most tellingly, the option that in ’exceptional circumstances’ companies would be allowed to dodge certain aspects of registration was little used. Only 17 companies identified themselves as affected by relevant issues. 

But was everything registered that needed to be registered? Earlier this year, downstream manufacturers in the UK voiced concern that they could suffer disproportionately if their suppliers failed to register the chemicals they used. They should be given a period of grace, they argued, because they might have to adjust to problems that someone else created for them. Reach advocates dismissed such concern as hyperbole. But the number of registrations did fall short of expectations. The ECHA received 25,000 registration dossiers covering 3400 ’phase-in’ substances - chemicals that were on the market before the regulation came into force. This represented 28 per cent fewer chemicals than the 4700 it had expected. Kevin Considine, senior policy adviser at UK manufacturers’ organisation EEF says that the difference is worrying. But he adds that it will take several more months before manufacturers will know for sure whether the chemicals they need have been covered. 

’We don’t know whether it’s a cause for concern,’ says Dancet. The list of substances used for the estimate was put together from several different industry sources. ’There may be some exaggeration there,’ he adds. 

Lloyd has some suggestions that could explain the discrepancy. In some cases, several substances may have contributed to the estimate but been merged together into a single registration due to essential similarities between them. In other cases, it may have been decided that a substance that contributed to the estimate was actually exempt due to its composition, the quantities in which it is supplied or its removal from the market. 

But it could be that some companies simply missed the deadline. ’We want to get to the bottom of this clearly,’ Dancet says. ’We promised that to the downstream industry.’ The ECHA now needs to finish checking the dossiers for completeness. As the first deadline passed, 15,000 of the 25,000 dossiers submitted for the first deadline had been processed. Companies responsible for incomplete dossiers will get four months to submit additional information. 

Meanwhile, national authorities charged with enforcing the Reach regulation are likely to see a spike in the number of complaints, says Mike Potts from the UK Health and Safety Executive. This is what happened after the pre-registration deadline. ’We’ve had a lot of carpet-bombing complaints from people trying to "shop" their competitors,’ he says. But most of the accusations investigated so far have been groundless. Potts says that, to date, only three prosecutions based on the Reach regulation have been initiated by authorities in the UK. The HSE itself has served notices to 30 companies, all of which are working towards compliance. ’There’s a lot of self-policing in the supply chain,’ he says. ’We get a lot of people confessing to their non-compliance as well.’ 

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