26 May 2010 10:18 [Source: ICB]
The executive director of the European Chemicals Agency insists his organization will cope as the global chemical industry sends thousands of Reach registration dossiers his way
You might expect Geert Dancet, head of theEuropean Chemicals Agency (ECHA), to be in a state of extreme stress as the impending November 2010 deadline fast approaches and with the industry still clamoring over the excesses of compliance.
If history is anything to go by, he should be worried. Prior to the first, preregistration, deadline in December 2008, ECHA's IT infrastructure seemed to be in a state of collapse. There were tales of frustration as those responsible for Reach compliance in companies across the EU and globally toiled all night to input data as the creaking website froze or crashed their browsers.
The statistics still look pretty frightening. In May, only 700 detailed dossiers have been submitted and accepted with 100 more currently being processed. ECHA expects 4,415 substances to be registered by November 30, based on the number of active SIEFs (Substance Information Exchange Forums) (see below). It expects 38,000 registrations in total.
More worryingly, ECHA only knows the identity of the lead registrant for 2,509 of those 4,415 SIEFs. This means there probably is no lead registrant, meaning the group may not be functioning effectively.
But Dancet seems unruffled. If there is panic beneath that measured, Belgian exterior, it does not show. The original estimate for the number of substances to be registered was 6,000-9,000, but Dancet says: "We thought the figure of 9,000 was exaggerated and now this is confirmed."
His main aim in communicating with the industry is to underscore the sense of urgency as the deadline approaches: "We are seven months away and there are still a vast number of dossiers to be submitted. The top priority should be for lead registrants to register early. Time will be short at the end to check if the dossier has been completed properly and passes the business rules."
Although time will be short, it may not be quite as short as many believe. Dancet points out that provided the dossier is submitted and passes the quick, initial "business rules" check by November 30, ECHA then has three months to decide if the dossier has been completed correctly and passed the technical completeness check. If it fails, SIEFs will have another six months from October to provide the missing information.
This takes us to the end of June 2011 which may be reassuring for some in the industry.
Dancet reveals that in 2009 there were only around 10 dossier rejections by ECHA after the second chance to get it right. Of course that number may rise steeply as the trickle of entries becomes a flood.
"Sometimes the registration fee never arrived or arrived late. Other times the information is not complete. If there is no justification for missing data we have to reject. As 70-80% failed the initial check we've introduced a technical completeness tool which has cut that to around a 10-15% failure rate."
Teams of experts at ECHA aim to make a further, more detailed compliance check of at least 5% of dossiers. "If they judge that a substance has been declared safe without scientific justification, we can demand further tests be carried out. We may choose to make further checks because we're suspicious about a product or it may be a random selection," Dancet adds.
Once registered, a substance registration number is given to the SIEF lead registrant which can be passed on to all members when they register.
By the end of May, ECHA was due to launch a system update to allow all members of a SIEF to submit their own, more basic, dossiers simultaneously with the lead registrant. At present the rest of a SIEF must wait for the registration number to be given to the lead before submitting.
Dancet expects 25,000-45,000 dossiers to be submitted in total. But he remains unruffled by the prospect: "We think we'll be able to cope and have a plan to deal with difficult levels of up to 75,000 dossiers. IT-wise, we could deal with more, but we would need more human resources to deal with it. We can bring in up to 120 extra people."
He adds: "We also have IT contingency: we will have another system to capture dossiers."
The next stage of Reach - "substance evaluation" - will be undertaken at national level. "By the end of 2011 ECHA must develop a plan to divide the work between EU member states. From 2012 they will examine all dossiers to assess whether the information is complete and the substance is adequately controlled."
"There are still a vast number of dossiers to be submitted"
Geert Dancet, executive director, European Chemicals Agency
He adds: "The combination of "authorization" and "restriction" will ultimately give us a feeling for how many substances require very vigorous measures to protect workers and the public. I expect hundreds to be restricted or authorised over the next 10 years."
Dancet expects restrictions on use rather than total bans to be commonplace, though: "Sometimes it may be better to be cautious."
SUPPLY CHAIN WORRIES
There has been a lot of worry about the impact of Reach on the supply chain if a manufacturer fails to register in time for Reach and has to halt supplies before it breaks the law.
Dancet says ECHA is working with the authorities responsible for the enforcement of Reach to formulate guidance to prevent supply chains collapsing if a manufacturer or importer fails to register a substance.
New guidance being developed by the EU's forum of enforcement authorities should give downstream users of chemicals the right to appeal for a temporary exception to allow an illegal supplier to continue operating while alternative arrangements are put in place.
"If there is no justification for missing data, we have to reject"
Geert Dancet, executive director, European Chemicals Agency
Dancet said the group was due to meet later in May to discuss how to protect supply chains which become vulnerable due to a noncompliant feedstock supplier.
"We are looking for these types of exceptions. Such an exception could not be granted under Reach," Dancet said.
"It would be up to the enforcement authorities to grant an exception. We hope to conclude these discussions by the end of the month - to have some advice for industry on those types of exceptional situations," he added.
All producers and importers of chemicals into Europe have until the 30 November to submit to, and have accepted by ECHA, chemical safety dossiers. Any producer or importer of chemicals over 1,000 tonnes/year or of a Substance of Very High Concern which fails to meet this deadline would risk breaking the law.
Dancet also revealed that new guidance was due to be published in May on the definition of intermediates. The industry is worried about a lack of clarity on what counts as an intermediate. There has also been concern about what will happen to companies which make their own interpretation of the rules and then submit a dossier which later turns out to be incomplete when new guidance is published.
"The clarification will give examples of what counts as an intermediate. If a dossier was complete, it remains complete. If new guidance comes afterwards companies will have a chance to update the dossier and there is no deadline for that," he declared.
"Registration" - Once dossiers of safety data supplied by SIEFs are accepted as technically complete, ECHA will issue a registration number to be used by all SIEF members when they submit their own, more limited dossiers. Registration does not imply approval of the substance, but allows manufacture and sale to continue
"Evaluation" - ECHA will initially do a more detailed check to evaluate the quality of at least 5% dossiers. Next, ECHA and EU member states draw up a plan for more-detailed evaluation of substances they judge to require further analysis
"Authorization" - Substances of Very High Concern (SVHC) will be evaluated, authorised and restricted on a rolling program by EU member states allowing for a EU-wide decision on their continued use/restriction
"Restriction" - ECHA and EU states will prepare dossiers on proposed restrictions in use to be presented to the European Commission
SVHC - Substances that may have very serious and often irreversible effects on humans and the environment are placed on a list of SVHC.
SIEF - Substance Information Exchange Forum - groups set up by manufacturers of the same substance. Allows for sharing of testing data and coordinated submission of dossier by Lead Registrant
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