REACH is like the proverbial swan, says Peter Newport, director of the Chemical Business Association (CBA). The EU’s chemical safety regime, which came into force three years ago, appears to be sailing serenely towards its next big deadline on 30 November while the European Chemicals Agency (ECHA), the European Commission and the main EU trade associations paddle furiously beneath the surface.
Campaigners hope REACH will stop harmful substances appearing in consumer goods and making their way into people’s bodies and the environment. But the most recent upset to the system is a series of legal challenges by chemical companies over the categorisation of particular chemicals as substances of very high concern (SVHCs).
The list of SVHCs and the authorisation process, which would bring in controls on them, was already developing more slowly than NGOs were expecting. This could be a further setback.
But the CBA – representing many of the UK’s smaller chemical makers, distributors and traders – fears on the other hand that REACH might be driving chemicals from the EU market unnecessarily.
The new regime comes at a particularly bad time for a chemical industry hit by the recession and competition from Asia and the Middle East. REACH also overlaps with new rules on the classification, labelling and packaging of chemicals which will bring the EU in line with a globally harmonised system developed by the UN (see pp 27-28).
So how is the REACH regime going? Is it worth all the effort and are there risks to fragile businesses?
At its heart, REACH is a simple concept. The problem of the risks to human health and the environment posed by thousands of unassessed chemicals on the market solved by forcing the companies to do the risk assessment work themselves.
Outcomes should include a market for chemicals that have been proved safe, controls for risky substances, information transfer through the supply chain and bans on anything too hazardous to justify its use.
Is it simple to implement? Well, of course not. First there is the pre-registration process for ‘phase-in’ substances initially placed on the market before 1981 (after that date substances had to undergo tests before they were sold). This is a transition measure allowing these pre-1981 substances to be used while the full registration dossiers eventually required by REACH are prepared. But the pre-registration process, which ran throughout the second half of 2008, threw up 2.75 million submissions, more than 20 times the expected number.
They covered 146,000 substances and most submissions came in just before the November 2008 deadline, overwhelming ECHA’s IT system and forcing it to switch to a back-up.
Some of the problems were due to chemical users, as well as makers and importers, pre-registering substances to ensure they stayed on the market. There were also repeat registrations of the same substance under different names.
But there were also multiple pre-registrations from consultancies hoping to cash in on the subsequent registration process. To keep animal testing to a minimum, companies registering the same substance have to share data through a substance information exchange forum (SIEF). Consultants hoped that being listed among the firms interested in forming a particular SIEF would bring opportunities for work.
The next stage of the REACH process for these pre-1981 substances is full registration. This is being done over the next eight years in three batches.
The first batch covers high-volume and potentially hazardous substances (see timeline), with the deadline set for the end of November this year.
ECHA spent last year insisting the number of registrations expected at this first deadline would be about 9,000. But updates on its website showing the number of lead registrants from SIEFs to have made contact has ticked up only slowly and is still below 2,500. Now, the agency suggests the total number of substances registered by November will only be about 4,400.
In April, it put a list of the chemicals it expects to be registered on its website so users can check that those they need will still be legally available in December.
Geert Dancet, ECHA’s executive director, admits there may still be substances missing from ECHA’s list, but says it has no way of knowing how many.
A recent survey by the UK Chemical Industries Association’s REACHReady service, suggested a third of the SIEFs working towards this year’s deadline have not appointed a lead registrant. About 30% of respondents thought that most SIEFs they were involved in would miss their registration deadlines.
SIEFs are curious beasts. They have to establish themselves from lists of pre-registrants pooled by ECHA, share data and work out how to apportion costs all without breaching competition rules designed to stop competing companies collaborating improperly. Often the participants that volunteered to act as ‘SIEF formation facilitators’ have vanished and swathes of pre-SIEF contacts fail to respond to emails (ENDS Report 413, pp 23-24). Some participants also complain about a lack of information and control over progress.
However, the situation has improved as more organised companies or consortia formed of the major players in particular markets have taken charge. Larger firms can have dozens of substances to register this year and are tending to move ahead on their own, keeping dormant members updated regularly.
“We see a lot of activity in those SIEFs that are active. Many of our companies are working extremely hard,” says Erwin Annys, director of REACH and chemicals policy at the European Chemical Industry Council (CEFIC). But he admits some smaller makers and importers without the personnel or finances to devote to REACH are struggling.
Although the 2010 deadline is the end of November, each SIEF’s lead registrant must submit its dossier and have it accepted by ECHA’s IT system before other members can register. At the moment, many lead registrants are hoping to submit in June or July. If this does not happen, it will be awkward for ECHA which is meant to earn its keep from registration and other fees. The agency currently has a rather hand-to-mouth existence and too many late registrants could force it to ask the European Commission for a sub to tide it over.
The registration dossiers submitted by SIEFs undergo three checks. The first two are carried out by ECHA’s IT system when registrants submit their dossier online. These had failure rates close to 50% last year.
ECHA now offers an IT tool that registrants can run their dossiers through to see if they will pass the total completeness check (TCC) – the second of these tests – before submission.
But the first check covering administrative issues such as previous registrations of the same substance, confidentiality and production locations is still proving problematic and ECHA is trying to extend the TCC tool to cover these issues too. The third compliance check is done manually by ECHA staff to a small sample of submitted dossiers.
The agency is also putting in place a back-up IT system that will accept dossiers and issue invoices and registration numbers if the main system is overwhelmed. ECHA’s Mr Dancet hopes it will be ready by September.
But Matt Townsend, a partner at law firm Allen & Overy, says registrants are still nervous about having dossiers rejected with little time to correct them. Other experts have spotted continuing problems with the IT system that could deter early registration. One is that names of companies registering through third-party representatives are revealed to other SIEF members, removing the anonymity the third party is meant to provide.
Mr Townsend worries that the contracts being used by consortia and SIEFs to underpin their collaboration and to create dossiers have not been stress-tested. “They were put together very quickly in order to get the process under way,” he says.
He says the sheer number of participants in SIEFs made it unrealistic in many cases to have normal negotiations over the terms. “What will be interesting around December and subsequent deadlines is how far these agreements stand up to real scrutiny and handle any disputes that emerge.
“The lead registrant will be the first in line to be challenged if there is a failure in submitting a dossier or if it is rejected by ECHA. I’m concerned a number of agreements don’t properly address liability and dispute resolution.”
There are other difficulties too. ECHA caused a furore in February when it presented what appeared to be a new interpretation of an ‘intermediate’ –a chemical used to make other substances. Intermediates can get by with simpler registration dossiers if their use is strictly controlled.
Mr Dancet insists ECHA’s stance has not changed but industry representatives were angered by what they saw as a tightening of the definition to exclude catalysts and substances used to treat products.
“It would be a disaster if you were working on the assumption that a substance due for registration this year was an intermediate and it isn’t,” says Ruxandra Cana, a partner and REACH expert at law firm Field Fisher Waterhouse.
More long-awaited guidance on read-across rules which allow a chemical’s characteristics and potential hazards to be inferred from those of similar substances was only published recently. Other documents are still outstanding.
Drawing up guidance is a vital collaborative process between ECHA and industry. But CEFIC says it is distracting company experts from working up their own registrations. For ECHA, waiting for industry to respond is often the delaying factor. “If you want to involve industry you have to wait until they come up with examples [in problem areas],” Mr Dancet says.
The delays have prompted industry groups to ask ECHA not to issue new guidance for at least a few months before each deadline. It has since agreed.
ECHA’s response to the various SIEF concerns has been to form a director’s contact group with six industry representatives and the commission. It met for the first time in February and has already produced some initial guidance, but there are concerns from some quarters about the lack of representatives of chemical users.
CEFIC and the CBA are unsure of the eventual impacts of the registration process on their sectors. Firms are not going to admit to customers that they plan to drop particular chemicals come December, says the CBA’s Mr Newport.
But several of his members are worried they will have to stop using some substances because suppliers have told them their type of use will not be covered by an exposure scenario in the registration dossier.
The lack of information on listed uses, or even whether substances will be registered as intermediates, in the expected registration list published by ECHA makes it next to useless for downstream users, says Mr Newport. It could even lull some into a false sense of security.
The CBA is unusual in its outspoken criticism of ECHA and the REACH process. Mr Newport believes this is because national trade associations’ voices become diluted as they are translated through their EU umbrella organisations, with dissenting views frozen out of the debate.
But he seems to have a point when he questions the huge burden being placed on ECHA which was only created three years ago. Already it has had responsibility for overseeing the new rules on classification, labelling and packaging of chemicals added to its duties before it has had the chance to prove itself. More duties on biocides may follow.
Helsinki-based ECHA says it has achieved a great deal since 2007. “Never has an agency had to be set up as fast,” says Mr Dancet. “We already have about 400 staff. I believe we’re on-track to deliver what we need to for this year and in building this agency.”
“Everyone now understands it is more complex than we ever thought, more difficult than we could ever imagine,” says CEFIC’s Mr Annys. “People are saying this is progressing slowly, I can only say this is progressing at a high speed. There are large amounts of guidance that have been produced and there have been changes in the IT software.
“Yes, some changes are late but they are needed in order to integrate comments and requests from industry.”
Struggling through the hurdles of registration, it is easy to lose sight of the end game. But registration is not the only part of REACH.
Registering a chemical under the regime allows for its continued legal use within the EU. But any potential hazards flagged up in the dossier can be further evaluated by member states and they can suggest it as a possible SVHC. The commission can also propose its own additions via ECHA.
Confirmed SVHCs are put on the candidate list which brings information disclosure requirements for any firm in the supply chain selling the substance or products containing it.
The gradual lengthening of the list of SVHCs – it is now 30 substances long – is forcing manufacturers, importers and retailers to start thinking more seriously about the systems they use to track substances in the products they buy. Until now, many have relied on ad hoc solutions, including blanket letters from suppliers promising their goods do not contain SVHCs.
However, there are concerns about impurities, by-products and the extent to which suppliers outside the EU keep up to date with changes to the candidate list. Buyers may have to put in place more thorough due diligence systems and consider doing their own tests on goods they buy, says Cándido García Molyneux, a REACH lawyer at Covington & Burling.
ECHA must also recommend a subset of the candidate list of SVHCs to the commission for authorisation at least once a year. Once a substance is put on the final authorisation list, also known as Annex XIV, it is given a ‘sunset date’. Beyond that point, it can only be sold or used by authorised firms. Applicants will have to show that the substance’s risks will be controlled adequately, or that the socioeconomic benefits from its use outweigh the risks and no suitable alternatives exist.
There are some substances for which there is already data to show they meet the SVHC criteria. These can be added to the candidate list directly but this process has been slower than expected.
NGOs, trade unions and the European Parliament’s environment committee have all expressed concern about this (ENDS Report 411, pp 17-18). The NGOs and trade unions have highlighted hundreds of chemicals they think should be added.
Furthermore, nothing has been added to the authorisation list because of a long-running debate between the European Commission’s industry and environment departments on the exact conditions applicants would have to meet.
This was settled in March, which should allow the first substances to be added to the authorisation list by the end of the year (ENDS Report 423, pp 55-56). The commission also promised in March that about 100 more substances would be added to the candidate list by 2012. But Ninja Reineke, senior policy officer at WWF Europe, was disappointed that the commission’s announcement lacked detail on how many and which chemicals it will ask ECHA to put on the list directly. The promise still seems to leave most of the work to member states, she says.
It would have been better to have automatically transferred the hundreds of substances already identified as carcinogenic or toxic to reproduction during the previous chemicals regime directly onto the REACH candidate list, she believes.
“Instead, now a lot of work and a long bureaucratic process is needed to nominate substances… It’s over three years since REACH was adopted and still not a single chemical has been tackled in authorisation.”
One of the things that seems to have been deterring member states from proposing SVHCs is the volume of evidence they think is needed – as much as for full authorisation in some cases. The commission is yet to propose any SVHCs.
The progress in March was followed by a step back for the authorisation process in May when nine firms filed legal challenges against the inclusion of four substances on the candidate list. One of the substances is defined as “pitch, coal tar, high temperature”, the other three are types of anthracene.
The companies say the classifications of these substances as persistent, bioaccumulative and toxic (PBT) are wrong because they were only based on properties of constituent substances. They also say procedural errors were made in the supporting dossiers.
Another SVHC, acrylamide, is already under review because it is used mainly as an intermediate, so might not be eligible for authorisation. Opinions are mixed on the case’s chance of success but it is seen as a test of the European Court of Justice’s power in these situations.
“We have quite a litigious way of life and the fact industry is taking action on acrylamide will frighten member states,” says Gwynne Lyons of chemicals NGO CHEM Trust. She fears the authorisation procedure, which had seemed like a good way to implement the precautionary principle, will prove just as much a slow “drip torture process” as the previous regime for existing substances (ENDS Report 405, p 28).
Mr Dancet is more optimistic. He is pleased that a call for interim measures which kept acrylamide from the candidate list for a few months was overruled. This allows the process to continue as normal while the court considers the case, which will take some years. Member states should not be put off proposing potential SVHCs because it is ECHA that has to defend the cases in court, he says.
The real test for the candidate list will come once registrations and evaluations begin in earnest. This should generate more SVHCs but the process depends on member states’ resources, which are likely be reduced over the next few years.
Picking SVHCs from industry data alone might also miss some substances, says Ms Lyons. The decade-long battle over plastics intermediate bisphenol A is a case in point, she argues (ENDS Report 422, pp 27-28).
There is also a disparity between dossiers, which have to indicate whether a substance is PBT, carcinogenic, mutagenic or toxic to reproduction (CMR) or very persistent and very bioaccumulative (vPvB), and the conditions for the candidate list, which also allow substances “of equivalent concern”. This term could cover fire retardants that are found in pristine polar environments and wildlife but are not thought to meet the classic bioaccumulation criteria, for example, or endocrine disruptors (ENDS Reports 421, pp 24-25 and 396, p 50).
Some NGOs would like the registration requirements changed to force firms to flag up equivalent concerns in their dossiers too.
On top of this questions remain as to how REACH should account for nanoparticles and mixtures of chemicals. Nanoparticles measure less than 100 nanometres in at least one dimension and can have very different properties, and hazards, from bulk versions of the same substance (ENDS Report 418, p 30). The question of how to include them in REACH is still under review (ENDS Report 413, pp 45-47).
The mixture issue relates to endocrine disruptors which can act together to create a greater cumulative effect than any one substance on its own (ENDS Report 414, pp 55-56). Three phthalate plasticisers prioritised for authorisation are known to work together like this but REACH does not have a formal way of accounting for the effect and it could be difficult to add at this stage.
There is a danger that while everyone focuses on SIEFs, issues such as these slip by, says Ms Lyons. “Do I want to trash REACH totally? No, but I think there are real concerns here. Everyone has to work together.”
So when, and how, will we know if REACH is working? The European Commission has attempted to settle the question by developing a set of metrics and doing a benchmark study ahead of the start of the regime. But this has been roundly criticised for its complex and opaque scoring system based on the hazards and risks of 237 randomly selected chemicals (ENDS Report 414, p 56).
Really the answer depends on the viewer’s standpoint. For Ms Lyons, it will be when the use of hazardous substances in everyday goods is limited and managed. For CEFIC, the crucial factor is whether the extra burden of REACH puts EU firms at a disadvantage on the global chemicals market and whether their access to raw materials is affected.
“We’ve been saying for the last three years that it’s still early days, but it’s getting more difficult to say that as time goes by,” says Dr Reineke. Despite her concerns, she thinks industry attitudes are changing. And when asked by people in other countries how chemicals should be managed, she would describe some of the basic principles REACH is trying to implement such as ‘no data, no market’, and mechanisms to replace chemicals of high concern.
But these are distant and theoretical concerns for companies worrying about putting together dossiers for the three registration deadlines. Or, as the CBA’s Mr Newport describes it, to eat the REACH elephant in just three sittings. Their minds are fixed firmly on November.
WHAT IS REACH?
REACH is the EU’s chemical regulatory regime, introduced in 2007. The acronym stands for the Registration, Evaluation, Authorisation and restriction of CHemical substances.
REACH applies across the EU and is coordinated by the European Chemicals Agency (ECHA) in Helsinki. Member states are responsible for enforcing the regulation in their own countries.
Chemicals produced in the EU or imported in quantities greater than one tonne a year must be registered under REACH before they can be put on the market.
The detail required for a substance’s registration depends on the volumes produced and imported. But the central aim is to place responsibility for a chemical’s safety on its producer. There are interim measures for substances already on the market.
The data provided by companies is scrutinised – or evaluated – by ECHA and member states and they can ask for extra safety tests.
The most hazardous substances can be removed from the market entirely by restricting them. The authorisation process is a more nuanced system which allows use of risky substances to continue under specific controls or circumstances. If a substance is placed on REACH’s authorisation list, companies wanting to make or use it must seek permission from the European Commission.
REACH also requires the communication of information up and down the chemicals supply chain. Suppliers must tell buyers which hazardous substances are in their products and how to manage them, and consumers can ask retailers if their products contain potentially hazardous chemicals. In return, firms using chemicals must tell suppliers how they use them.