Issue Date: December 8, 2008
Chemical Plan Limps To Its Next Phase
ON JAN. 1, 2009, the business of registration, authorization, and evaluation of chemicals in the European Union finally gets under way. Everyone involved in the new regulatory program, known as REACH, is hoping it won't be as difficult as the preregistration process, which just concluded last week.
By law, companies must have preregistered with the European Chemicals Agency (ECHA) by Dec. 1 those chemicals covered by the legislation that they will be marketing in the EU after Jan. 1, 2009. By the close of Dec. 1, ECHA had received more than 2.2 million preregistrations filings, with 109,260 filed on Nov. 27 alone. The total, ECHA said in a press release, was some 15 times more than expected.
REACH is not just for European chemical producers and their customers. The program, which went into effect on June 1, covers all chemicals used in the EU, no matter where they are made, or whether they are marketed on their own or are formulated into consumer products. If the chemicals are not preregistered by the deadline, anyone selling them, or products incorporating them, is breaking the law.
In theory, REACH is simple enough. It covers an estimated 30,000 chemicals introduced before 1981, when more modern, stringent regulations took effect. REACH aims to bring safety data on these chemicals up to current standards under a single program that supersedes the multiple regulatory regimes now in force across Europe.
Companies were given from June through November to preregister chemicals they were considering keeping on the market after this year. The process will allow ECHA to assign chemicals into groups called Substance Information Exchange Forums (SIEFs).
PREREGISTRATION, however, was only the starting point for full registration. During the more involved full registration process beginning on Jan. 1, 2009, manufacturers, marketers, importers, and customers will be assigned to SIEFs to cooperate on gathering and processing data to complete the safety dossiers that ECHA will demand for full registration. These SIEFs will minimize safety testing, particularly those involving animals. SIEFs will also agree on labeling, under United Nations guidelines, to prevent potentially conflicting safety labels on any given product.
ECHA set the timetable for registration according to volumes of chemicals produced and perceived hazards and risks. Large-volume chemicals must be fully registered before low-volume ones, and materials with perceived higher hazard or risk profiles must be registered earlier than those considered more benign.
Preregistration did not go smoothly. Reports indicate that it was troubled from the very beginning. For example, ECHA overcame early problems of preregistering several chemicals through a single filing only in mid-July. And as the summer rolled into fall and companies realized their filing obligations, the torrent of filings through its website meant that more and more firms had problems in accessing ECHA's preregistration portal, REACH-IT.
The process was set up to be relatively easy, "quicker than booking a train ticket online," says Mark Selby, consultant with Denehurst Chemical Safety. The only information needed, he points out, was the intended date of registration and the EU identification number or CAS Registry Number of the chemical.
But in practice, people trying to register chemicals could not access the ECHA website, or they could gain access, but the system would crash midway through a filing.
By October, the agency had backpedaled on its early advice that companies preregister any chemical they might want to market after Jan. 1, 2009. Instead, the agency pleaded for companies to preregister only those products they definitely intended to market. That shift was not enough to resolve the mounting website access problems.
ECHA was worried enough about last-minute heavy use overwhelming the REACH-IT system that it set up a contingency plan. Late last month, the agency said that it was poised to activate a back-up procedure on Dec.1 to allow companies to submit preregistration files if they could not access REACH-IT.
By the end of the day on Dec. 1, however, ECHA said that usage of REACH-IT on the last day of preregistration "had been lower than expected." The agency's monitoring indicated that all companies that wished to preregister should have been able to do so in REACH-IT, without need of the contingency back-up system.
In fact, preregistration was judged a success by the European Chemical Industry Council. Alain Perroy, CEFIC director general, says: "When we started, we knew there would be some delays and that some rules were still to be clarified. But over time, and thanks to the good cooperation with all stakeholders, we managed to overcome all the main problems."
The agency has been constrained in what it could actually do to solve preregistration problems, observers note. Although ECHA will enforce REACH throughout the EU, it is strictly an administrative agency charged with enforcing regulations made by the EU's Parliament and Council of Ministers. It does not set the fees it charges and it does not set its timeline. Any formal extension for preregistration, for instance, would have had to be approved by the EU's Commission, the Council of Ministers, and the Parliament, and the process would have taken weeks if not months to arrange.
Michael Bunegar, a consultant with HFL Risk Services, a Manchester, England-based consulting company specializing in regulatory affairs, notes that by the end of the preregistration period, companies "were working during nonoffice hours." His assessment of the program on the days leading up to the Dec. 1 deadline: "Extremely hectic."
Bunegar says his clients have several concerns for the next phase of REACH when full chemical registration begins. For example, he says, they worry that costs will escalate in unforeseen ways.
The concern has basis. Geert Dancet, ECHA's executive director, has already begun to fret that the agency's budget won't cover all its costs and that he might have to request a larger budget from the EU.
COMPANIES THEMSELVES will be spending heavily to gather basic data such as NMR and mass spectrometry analyses to establish whether their chemical has the same profile as all the others in the same SIEF. There are also questions, Bunegar says, about how SIEFs will work legally. For example, how will members of the SIEFs come to agreements on confidentiality while avoiding commercial entanglements that could arouse the concerns of antitrust authorities?
Making SIEFs work will be a complex task, emphasizes Denehurst's Selby. As just one example, he notes, companies will have to determine the value of data—the cost of toxicity studies needed—and how such costs will be shared. Selby adds, "The words 'fair' and 'REACH' do not always fit comfortably in the same sentence."
"There will be lots of money for analytical companies and lawyers," Bunegar predicts.
SIEFs also were the topic at the first of a series of one-day seminars held in late September by REACHReady, an arm of the U.K.'s Chemical Industries Association. For most company managers, SIEF formation "will be a new experience, and one that is daunting and potentially very difficult without support," CIA said in a press release.
Participants initially were skeptical about who would take the lead and how SIEFs would work together so that nobody loses out. More than one attendee likened these activities to "playing a game of chicken" and "signing a prenuptial agreement," CIA added.
Jo Lloyd, director of REACHReady, said afterward that the seminar "was truly enlightening. It's becoming clearer that those willing to work together will reach an agreement more quickly, efficiently, and cost-effectively than those who do not cooperate." Although company executives might be inclined to play hardball with their competitors in setting up SIEFs, they might do better in the long run to cooperate, Lloyd said. That could be especially important, she added, if a company is going to meet the other companies again on other SIEFs.
FOR MANUFACTURERS of only a few chemicals, large-volume monomers, for example, the prospect of joining SIEFS might not be too bad. For specialty chemical producers and distributors and their customers, however, the prospect is much more daunting. The preregistration experience described by Peter Fields, chief operating officer in the U.K. offices of European distributor Azelis, gives a taste of what the registration process may be like.
Azelis and several other European chemical distributors raised eyebrows when, in July, they preregistered all the chemicals in the European Inventory of Existing Commercial Substances (EINECS), which is composed of more than 100,000 chemicals. The dramatic action temporarily threw ECHA off stride, but it was necessary, Fields maintains.
"We are a specialty chemicals distributor," he says. "Most of our products are of multiple substances, containing more than one chemical. The way the registration is framed, if a substance has more than one chemical—21, say—and you know that 20 out of the 21 are preregistered, you still couldn't sell the product if you don't know that that last one is preregistered."
As Fields points out, ECHA will be particularly vigilant about formulated products that are designed to be "released" into the environment—shoe polish, for example—and products such as batteries that are prone to accidental releases.
Azelis was finding several basic problems in covering its range of chemicals, Fields says. "Often a supplier was telling us a product might contain between zero and 1%—a trace—of a chemical. But it either is there or it is not; we couldn't accept that imprecision. So where there was an uncertainty around a formulation, we had problems," he says.
Sometimes a supplier of a formulated product distributed by Azelis didn't want to divulge its complete contents. Or perhaps the supplier didn't know precisely what the components are.
Nor could Azelis rely on others to preregister. "Because we import a lot of substances, and customers were demanding guarantees that we have preregistered products, we couldn't wait for suppliers to give us guarantees," Fields says.
"We spent hours on this, way before the preregistration process actually started," Fields recalls. "Our end conclusion: We can't be sure what is in the products and can't be sure what is preregistered. So we finally decided, let's preregister them all. At first, that seemed like a crazy idea. But finally we decided to do it and did so back in July."
The action, he emphasizes, "was an insurance policy. Once we had the entire list preregistered, then we could go through and take out what we knew we wouldn't ever be selling—uranium, for example. We would err on the side of not breaking the law. That way, we don't have to worry about it."
Even as ECHA gears up to digest the preregistrations and sort out SIEFs, threats of legal action are rumbling. For example, one marketer who asked not to be named wonders about companies that could not preregister. " 'Best effort' doesn't count," he says. "A possible legal defense might be, 'I tried to log on and did everything possible.' But how would the court react? A company could countersue the agency on the grounds that it failed to provide what was needed from the immediate onset of the preregistration process."
And some countries maintain that REACH is a violation of free-trade rules and that it can be used to discriminate against chemicals produced outside the EU.
Looking ahead to the registration process, HFL's Bunegar is still not sure that REACH will work in practice. "The fact that it is an overall EU regulation, controlled by ECHA, gives a better, more level playing field than some legislation out of the EU, which is open to more interpretation at the individual country level," he says. "That is probably good. But there are concerns as to how it will actually work. That's what people are really worried about now."
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