The European Commission organised a major stakeholder conference on REACH last Friday (23 September) to draw lessons learned to date and "ease the way" for the second registration deadline in 2013.
In the meantime, however, the Commission will initiate a review of REACH in 2012. But rather than lobbying to get the rules changed, the EU executive urged chemical firms to focus their efforts on submitting clearer and more truthful dossiers in the future.
Environment Commissioner Janez Potočnik said he knows many are worried about whether the review "will change the rules of the game" but stressed that the review was a legal requirement and that the Commission would "only put forward a legislative revision if it were really needed and necessary".
Potočnik suggested that time was probably not ripe yet for major changes as it has only recently started being applied. "[This] legislation is just starting to function and we have still much to learn," he underlined, playing down expectations for deeper changes.
Improving the 'quality' of dossiers for 2013
Officials from the Commission and the European Chemicals Agency (ECHA) in Finland urged companies to start work as soon as possible for the 2013 registration deadline, in order to ensure better quality dossiers are submitted.
Leena Ylä-Mononen, ECHA director of evaluation, stressed that companies "need to provide detailed reasoning and supporting data" to support their submissions. ECHA wants "no vague sentences" in the dossiers and companies need to clearly state the identity of chemical substances they submit for approval, she added.
Summing up the 2010 registration experience, ECHA executive director Geert Dancet noted that 25% of the 25,000 registrations were submitted as "intermediates," thereby benefiting from reduced information requirements and reduced fees.
However, he said that initial sampling shows that these substances may actually not qualify as intermediates and that the agency would follow up on the matter. "Companies must not erroneously benefit from the reduced requirements of REACH. A substance that is not intermediate should be fully registered and not unduly benefit from exemption from eventual authorisation obligation," Dancet said.
He said some companies have also sought to deceive regulators by declaring themselves small businesses, which benefit from simplified procedures under REACH.
"We have evidence that a proportion of companies have mistakenly claimed to be small or medium," said Dancet, promising a follow-up of these dossiers to make the companies pay the full cost, plus a surplus charge to cover the administrative expenses.
The agency is also tracing some 1,500 "missing" substances it expected to be submitted by the 2010 deadline following company's declared intentions. In addition, ECHA is checking whether all confidentiality claims made by companies are legitimate, Dancet added, suggesting deceptive applications may have been filed there too.
Company cooperation, SME worries
Dancet produced further statistics on the 2010 registration experience, which he said raised suspicions at ECHA.
For example, while REACH encourages companies to submit a joint registration – mainly to reduce costs and avoid unnecessary testing on animals – 6% of the 2010 registrations were still made by individual registrants. According to Dancet it was not evident in some cases why the registrant did not join with other manufacturers of the same substance. As a consequence, he indicated that those individual registrants would be investigated.
Erwin Annys, from the European Chemical Industry Council (CEFIC), noted that open communication in these registration groups was "not always working fantastically" and that "how to share data and costs” remains the most challenging exercise for many companies - wary of protecting their trade secrets.
As the second REACH deadline of 31 May 2013 extends the registration to a wider circle of substances, 30%-80% more SMEs are expected to be concerned, said Thomas Fischer, chemical policy advisor for UEAPME, the EU's small business organisation.
Meanwhile, small companies have no time to cope with hundreds of pages of guidance and elaborate registration dossiers, Fischer said. And if the registrants groups only consist of SMEs, it means the leader of the group is an SME as well, which might have no scientific or legal expertise to do so, he said.
Small companies need a lot of external help and that's why REACH is so costly for small companies, he summarised.
‘REACH ignores downstream users’
At the conference, several participants raised concern over how the REACH registration process ignores the downstream users of chemicals.
"This is very unfortunate because even though our core business is not chemicals our business depends completely on chemicals," said Cristian Samoilovich from the Aerospace and Defence Industries (ADS).
He told the conference that the complexity of downstream industries' supply chains, as well as communication and other requirements, are not given due consideration. "Efforts to understand our issues are not made or we are not consulted in the first place," he complained.
Jacqueline Henshaw from the Aerospace Defence & Security Trade Association added that in the run up to the 2010 registration "we were in a position where our supply chain completely dried up of two chemicals used in flight critical situations".
"We need significant help in order to manage this process and have the recognition that downstream users are not to be forgotten," she added.
Aerospace and Defence Industries also told EurActiv that from the beginning REACH has been considered more as a relation between regulators and manufactures or importers. "People at ECHA and elsewhere are not really familiar with the industrial world" as they work more on the policy side of things, she said.
Meanwhile, small companies relying on small niche chemicals for their operations might go out of business once the manufactures or importers of those substances find REACH compliance requirements too costly compared to the amounts sold and stop dealing them, ADS noted.
ADS also regretted that REACH's compliance burden is costing much more than it should to downstream users, who are investing millions in IT systems and consultancy to track substances just "to please ECHA and tell them what's in a product". Instead, he said the money could be spent on R&D for new substances that are more environmentally-friendly.