Registration Is Over: Now What?

It is still unclear if many chemicals are vanishing from the EU market or how industry can collaborate on its continuing REACH duties

After a decade of work, the registration phase of REACH concluded on 31 May, with the third and final deadline, for substances manufactured in or imported into the EU and European Economic Area (EEA) market in quantities of 1-100 tonnes/year. The message that ‘REACH is not over’ should hopefully have got through to everyone by now.

"The ten-year journey stopped yesterday at midnight," Echa executive director Bjørn Hansen said on 1 June. "The next ten years start today." This begins with work on using the data available on chemicals on the market, so that industry can "handle and use chemicals safely in the supply chain to improve product quality and become more sustainable", he added.

Regulators’ and industry’s attention now shifts towards other REACH processes, such as evaluation, authorisation and restriction. Companies, said Echa director of registration Christel Musset, must continue to update their dossiers, including new information in safety data sheets (SDSs), which the agency will soon begin evaluating.

Close to the deadline, Echa said that it saw many indications of companies starting to prepare for registration very late. And it received a high number of enquiries about existing registrations, data sharing and solutions offered by the Directors’ Contact Group (DCG) for companies in ‘exceptional situations’. The agency’s own services remained open right until midnight to assist last-minute registrants.

The number of registrations was also well short of the estimated total of 30,000 cited in the 2001 European Commission white paper; Echa had later revised this figure to 25,000 and then again to 20,000. Industry and regulators are divided over what make of this. In all, Echa received 33,363 dossiers for 11,114 substances in the third phase, bringing the combined totals across all three phases to 88,319 and 21,551 respectively. There were 6,824 substances registered for the first time in 2018.

Ms Musset noted that final figures will not be available until after the completeness checks are finished. "We are convinced that the absolute majority of the substances currently used on the market have been successfully registered," she said.

Of the 2018 registrations, 29% were made by only representatives on behalf of non-EU companies and 48% by importers, some of which may also be manufacturers. The rest were submitted by EU and EEA producers. The proportion submitted by importers was much higher than in the first two rounds, Ms Musset said. The top five importing countries for this deadline were: US (27%), China (15%), Japan (14%), India (12%) and Switzerland 6%.

While the true number of substances that could potentially be registered under REACH was always unknowable, there hasbeen concern in some quarters that a large number of ‘missing’ substances will disappear from the market because no-one registered them. Where have they gone? What is the true extent of the problem, if there is one? Did these substances even exist in the first place?

Both Echa and Cefic have expressed confidence that the chemical industry can go on supplying its markets uninterrupted. Echa added that its initial expectations were based on information collected "before the rules on registering similar substances together were clarified" and that the market has changed considerably since 2001.

However, Ueapme, the trade body for European SMEs, has expressed concerns. Marko Sušnik, adviser to the association, said that the shortfall is not only significant, it may grow further still. Removing most non-phase-in substances and all on-site isolated intermediates might reduce the number to nearer 15,000, he said.

"It is hard to believe that the market has changed so drastically in the last ten to 15 years," Mr Sušnik said. He pointed to the 135,000 individual substances on the classification and labelling (C&L) inventory of 2011 and other lists as better reflecting what is actually on the EU market. More analysis must be done to determine where the ‘missing’ chemicals are ’, in his view.

Moreover, Mr Sušnik said, SMEs accounted for only 17% of the registrants this year. This is actually slightly less than their total contribution over all three deadlines, when a much higher proportion would be expected this time. Considering how accurate the forecast numbers of registrations were in 2010 and 2013, he said, something is wrong somewhere.

Ueapme had been warning industry about the large number of ‘missing’ registrations for over a year. This could lead to "serious and unforeseen impacts on many value chains", the association argued.

One issue to examine is the lead dossiers in Echa’s joint submissions list that have probably been abandoned. This is often because the lead registrant changed the substance identity and created another joint submission, or because companies lowered the production volumes or ceased production.

Echa has identified 855 dossiers that are now ‘missing’ from all three deadlines, although it expects most to be submitted at some point; 78 that pre-date the removal of ‘empty’ joint registrations in June 2016 have almost certainly been abandoned and the number may be much higher. The picture will become clearer by September, when dossier checks should be completed.

The substance information exchange fora (Siefs) that came together to register substances under REACH ceased to exist as of 1 June. It is generally agreed that this was a productive way of working that should continue but it is still unclear how to take this forward.

The European Commission said that Sief members should agree new `discussion platforms` to ensure continuing collaboration on such activities as dossier updates, new Echa information requests, data and cost sharing and the consolidation of single submissions into joint registration. They will need "a platform that will not be called a Sief and for which Sief rules do not apply," a spokesman said.

Meanwhile, just before the deadline the DCG published detailed recommendations urging Sief members to continue working together. Cefic sounded a note of caution about potential antitrust issues and said members should only share specific information for certain agreed tasks.

Brexit did not appear to have any impact on the deadline, though it will clearly be a long-term concern. Ahead of 31 May Mr Hansen revealed that UK companies were the second highest registrants after Germany, accounting for 2,020 substances. This was entirely in line with Echa’s expectations and there has not been "any major effect of any companies moving location".

However, he said, there has been "significant" use of Echa’s Brexit webpage which contains advice and Q&As on post-Brexit implementation of REACH in the EU27. "We’ve received a lot of questions via our help desks so I would say my feeling is UK companies are fully aware that something could happen and they are definitely informing themselves," he said.