With just six months to go before the first deadline for registering substances under Europe's Reach legislation, companies are accelerating their efforts to gather the necessary data. But there are still concerns that some of the substance information exchange forums (SIEFs), which bring together companies registering the same substance, have ground to a halt.
Some companies and SIEFs will have problems meeting the deadline on November 30, 2010, warns Jytte Syska, president of Ariel Operations, part of 3E, a US-based company that provides information systems and services for regulatory compliance.
Through the SIEFs, both manufacturers and importers are expected to share the data required for a designated lead registrant to prepare a joint registration dossier.
'There are still SIEFs without a lead registrant, which means they haven't initiated the work yet,' Syska says. 'As a result, some companies will have big problems in the New Year.'
According to a survey by industry-backed consultancy ReachReady, one-third of the SIEFs working toward a 2010 deadline have still not appointed a lead registrant.
Significantly, some 30% of respondents have little confidence they will meet all their registration deadlines in time, even where a lead has been appointed.
'The most common complaint from SIEF members was a continued lack of communication on progress, coupled with real difficulties in identifying who has taken on the lead registrant role, even when one has been identified to ECHA [the European Chemicals Agency],' says Jo Lloyd, director of UK-based ReachReady.
DOSSIER SUBMISSIONS BEGIN
But many producers say they are on track to meet their Reach registration deadlines, and are starting to submit their registration dossiers to ECHA.
French specialty chemical producer Arkema says a few of its registration dossiers have already passed the ECHA completeness check. 'We are optimistic about complying with the deadline,' says Jean Morch, Arkema's vice president for safety and the environment.
'The flow of registrations is very slow at the moment, but I think at the end of the spring and during the summer, until November, the flow will increase.'
Arkema expects to register a total of 430 substances, of which 160 will need to be registered by the first Reach deadline of November 30, 2010, he says.
US-based Quaker Chemical, which intends to register five substances by the first Reach deadline, says it is on track to submit the registration dossiers in August or September. Quaker is the lead registrant for all five substances - four esters, plus monoethanolamine (MEA) polyborate, says Ton van der Kaaij, a Reach specialist at the US-based producer and blender.
Under Reach, substances have to be registered by November 30, 2010, May 31, 2013 or May 31, 2018, depending on the tonnage band and the hazardous properties of the substance. Substances that are manufactured or imported into the EU in quantities over 1,000 tonnes/year and substances of very high concern (SVHC) must be registered by the first deadline.
ECHA, which is responsible for implementing Reach, is urging lead registrants to submit their registration dossiers for high tonnage substances by at least October 1, when the time period ECHA has to accept or reject the dossier increases from three weeks to three months (see article on incomplete dossiers on page 17).
The Agency has responded to concerns that some SIEFs are making slow progress by giving companies extra time to update incomplete dossiers, says Geert Dancet, ECHA's executive director. Currently, companies have four months to add the missing information and resubmit their registration dossiers, but ECHA plans to extend this to six months from 1 October, he reveals.
Rules are also being developed to allow downstream users the right to appeal if a supplier fails to register. This will allow illegal suppliers to continue temporarily while a solution is found, and should prevent the collapse of supply chains, Dancet says.
News that there could be extensions to the deadline in specific circumstances will be welcomed by industry, but van der Kaaij warns that the new rules will prompt discussions about how they should be interpreted. 'It will not be easy to describe in a transparent and understandable way when an exemption will be valid,' he warns.
Connie Prostko-Bell, a solutions engineer with 3E, stresses that meeting the registration deadline remains the most pressing concern. 'It would not make sense to build business processes around the speculative possibility of enforcement delays or temporary exemptions,' she says.
FURTHER CLARITY NEEDED
Problems with the functioning of SIEFs have been compounded by delays in the provision of guidance on Reach rules and confusion about how the rules should be interpreted. For example, industry is requesting further clarity on how intermediates are defined under Reach.
'It's not simply a matter of determining whether the substance is converted into another chemical,' says Morch. 'The question mark is more about the strictly controlled conditions.'
The compilation of exposure scenarios for mixtures of substances is another area of concern, particularly for distributors and formulators. Customers would not find it helpful if distributors simply stapled together individual exposure scenarios for the substances contained in mixtures, says Patrice Rollet, chairman of the safety, health and the environment committee of the European Association of Chemical Distributors (FECC). A more appropriate route would be to develop a method for compiling one exposure scenario for the mixture, he suggests.
More details are also needed on the preparation of the safety data sheets, suggests Syska. Under Reach, safety data sheets are required for hazardous substances or preparations or when substances are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).
Safety data sheets must to be completed for pure substances by December 1, 2010 and for mixtures by June 1, 2015. ECHA is amending the requirements for safety data sheets under Annex II, which covers the introduction of classification, labeling and packaging (CLP) information into the safety data sheet.
'The first version of Annex II was very much in line with the old safety data sheet directive, but the changes that are coming now make it more stringent,' says Syska. 'The changes are causing confusion and a little bit of panic among companies because the clock is ticking.'
Van der Kaaij agrees that ECHA has been slow to produce some technical guidance. But Quaker's main concern, he says, is the impact of the Reach legislation on one of its key products, MEA polyborate. It is manufactured using boric acid, a reprotoxic substance that has been proposed for inclusion on the Reach candidate SVHC list.
'We know that boric acid will have a severe classification and we are hopeful that the classification for MEA polyborate will be less severe,' van der Kaaij adds.
In the meantime, ECHA is racing to provide updated guidance on a wide range of issues. New guidance on the definition of intermediates, for example, will be published shortly, according to Dancet.
Companies will have to monitor closely the changing rules. 'Although the deadline is so close, we are still on a learning curve because some tools and details of rules have been slow to arrive,' Morch concludes.