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WITH THE FIRST DEADLINE set for this week, companies have been rushing to com-plete the registration of chemicals under the European Union regulation for the Registra-tion, Evaluation, Authorization & Restric-tion of Chemical substances, known as REACH. But as they complete the long and tedious preparation, companies share some concern that their efforts may be diluted by inconsistent enforcement of the regulation and its uncertain utility in other regions.

Weekly statistics captured by the Euro-pean Chemicals Agency (ECHA), which was established in 2007 to implement REACH, show that registration through its website has ramped up rapidly in recent weeks, with more than 2,300 chemical registrations entered in one mid-November week. ECHA responded to the high demand by making the primary registration tool, known as REACH-IT, available during the weekend for the second half of the month.

“We anticipated this last rush in activ-ity,” reports Geert Dancet, executive direc-tor of ECHA, “although I must confess that we are a little behind in publishing data of incoming registrants.” ECHA has worked diligently to prepare guidance documents and information technology tools for registrants, but users report that frequent

revisions and updates have created extra challenges in the filing process.

Indeed, it seems that for all parties in-volved in meeting REACH deadlines, the process has proven to be more complex and costly than they anticipated.

By Nov. 30, companies must complete registrations for all chemicals made in or imported to Europe in quantities of more than 1,000 metric tons per year and for those considered particularly hazardous. As of Nov. 22, companies had submitted reg-istration dossiers for 19,237 chemicals and intermediates, and 13,747 of those registra-tions were confirmed as complete by ECHA. The deadline is June 2013 for chemicals with sales between 100 and 1,000 metric tons and June 2018 for those between 1 and 100 metric tons.

MOST MAJOR CHEMICAL companies have been focused on the deadline for months. “We are really close to the end,” says Markus Frank, REACH implementa-tion leader at Dow Chemical. “At this time, we are only double-checking to make sure we have not missed anything.”

As is typical for big firms, Dow is the so-called lead registrant for most of the prod-ucts that it has submitted for registration.

The lead registrant is the company that files the data pack-age for a particular chemical; the other companies that produce or import it then follow, linking their submission on

manufacturing process and customer end-uses to the primary filing.

In most cases, the major companies have much of the data, so it makes sense that they lead the registration process, Frank says. Dow is the lead registrant for 60 chemicals that exceed the 1,000-metric-ton volume threshold, and more than 100 employees are involved in the data compi-lation and reporting effort.

The lead registrant has a critical role, consolidating all data on the chemical, including physical properties, toxicology data, and exposure testing results. Addi-tionally, the lead company is charged with facilitating information exchange between registering companies, using an online dis-cussion tool called the Substance Informa-tion Exchange Forum (SIEF) to ensure that all available data are considered. Although ECHA provides the software support for the forum, discussions are run entirely by the companies, and it is their responsibility to organize and plan their data collection to prepare the chemical registration.

Managing SIEFs has been a daunting task, according to Michael P. Walls, vice president of regulatory and technical affairs at the American Chemistry Council (ACC), a U.S. trade association. “There are thousands of SIEFs, and there are some SIEFs that have thousands of members. Those members have to understand what data have been de-veloped and then come to some agreement about what should be reflected in the regis-tration dossier,” he says.

The German giant Bayer has taken the lead for about 60% of the chemicals it has registered, reports Andrea Paetz, the com-pany’s director of regulatory policy. Compa-ny representatives do use the SIEF tool, she says, but in some cases they have found that e-mail is more efficient. “We have moved to direct e-mail discussion in cases where industry association consortia already exist and we know the people involved and can share the workload,” Paetz adds, citing iso-cyanate derivatives as an example.

Registration is tougher for smaller com-panies, particularly those in newer Europe-an Union member states, observes Erwin

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ENGAGEMENT The European Chemicals Agency used stakeholder meetings to prepare companies for the complexities of REACH.

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Annys, director of REACH and chemicals policy at the European Chemical Industry Council (CEFIC). “The 12 newest states in the EU do not have the 40 years of history of chemical legislation in Europe.” He adds that language differences are also more of a problem in these countries because fewer employees know English and only a por-tion of REACH documentation is available in local languages.

To address filing challenges, ECHA has offered stakeholder meetings on how to use the filing tools and holds a pe-riodic dialogue with industry associa-tions through the Directors’ Contact Group, of which Annys is a member. The group has worked through a list of user problems, offering practical solutions for exceptional cases, such as when the lead registrant exits the market at a late stage or data will not be available by a filing deadline.

Complementing the tools from ECHA, CEFIC provides REACH compliance resources, including legal guidance on sharing product informa-tion with competitors and sample agreements for SIEF discussions. All of CEFIC’s tools are available to members and nonmembers alike. “We decided two-and-a-half years ago that documents on REACH would have more benefit if not limited to CEFIC member-ship,” Annys notes. “This is an industry service because it helps our member com-panies if everyone in the supply chain is well informed on REACH.”

ONE IMPORTANT target audience of the CEFIC and ECHA support documents is downstream chemical users. This group is less familiar with the regulation and has been concerned about what it could mean for the supply of key raw materials. “End users are really panicking at this point,” ECHA’s Dancet acknowledges. “We have been providing them with weekly updates on what chemicals have been registered, but that has not eased their concern.” Dancet adds that most requests for deadline exten-sions, none of which have been granted, have come from worried end-user groups.

End users need to be engaged in the process because REACH specifies that every end use be included in a chemical registration. Full disclosure on the use of a chemical is not typical between producers and customers, so registration is forcing a new level of dialogue, Bayer’s Paetz says. Additionally, some companies report that

the time needed to gather the information from customers has delayed registrations.

Luckily for companies, REACH does offer a grace period if an end use is missed. Joanne Lloyd, director of the U.K.-based consulting firm REACHReady, explains that if end users learn that a use was not listed, they have six months to report their application and a year to complete the safety assessment. “The timing is triggered once you hear from your supplier that your

use was not registered, which would be sometime next year probably,” she says.

Many of REACHReady’s clients are smaller companies that don’t have the in-house resources to support the registration process. This group is often overwhelmed by the volume of information that must be re-viewed and the online ECHA tools that must be mastered to complete the registration process. “A lot of problems that we are see-ing stem from the lack of confidence in the process and the tools, rather than the techni-cal content of the registration,” Lloyd says.

Smaller U.S. companies are another large user of REACHReady services, partic-ularly for training. “U.S. exporters have had difficulty understanding the obligations they have and how to best support their customers in the EU,” Lloyd observes.

A dominant issue for all companies is the high cost associated with registration. ECHA assesses a registration fee, although it is modest compared with the cost of compiling the documentation. Data-shar-ing costs can be in the range of $40,000 for each SIEF participant. Moreover, addi-tional charges can result if more testing is needed to complete a chemical registration (C&EN, Aug. 31, 2009, page 7).

“There is no rule-of-thumb cost because there are so many variables,” CEFIC’s An-nys acknowledges, citing overall costs per chemical that can range from $2 million to $14 million. “After the deadline, we will try to get a better estimate of the real costs for a registration dossier.”

These up-front costs have forced some companies to reevaluate their position in the market. “Many are deciding not to reg-ister,” Lloyd says, “because when they look

at the fees and the profit margins on that product over the next couple of years, it is not viable.” Lloyd and oth-ers expect that the smaller volume thresholds of future REACH dead-lines will drive even more suppliers from the market.

Certainly, REACH costs at major companies are high. Lanxess, for ex-ample, estimates it has spent $40 mil-lion and expects to need an addition-al $60 million through 2018. Annual costs of REACH implementation at Wacker Chemie are about $4 million. At a recent industry meeting, CEFIC Director General Hubert Mandery, a former BASF executive, estimated one member company’s overall cost at more than $1 billion (C&EN, Oct. 25, page 29).

And considering the significant invest-ment, companies are eager to ensure that their efforts do not damage their com-petitive position in the global chemicals market. Early in the process, many Euro-pean chemical producers were fearful that REACH implementation would hinder re-gional growth, although that view has soft-ened some in recent months. Companies remain concerned about costs and con-tinue to press for reduced bureaucracy in the filing process, but they seem resigned to the requirements.

A few managers even see a silver lining. Bayer’s Paetz suggests that the REACH re-quirements may boost business by encour-aging European companies to buy from each other instead of from importers that may choose to exit the region.

“We have seen many manufacturers and importers rationalize their product port-folio, which is probably something they should have done anyway for business rea-sons, not just health and safety reasons,” REACHReady’s Lloyd says.

One substantial issue that remains unre-solved on the eve of the registration dead-line is enforcement of the new regulation. At this point, REACH enforcement remains

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with member states and their national legal structures. Budget constraints in some countries may reduce the number of inspec-tions and, therefore, infractions captured.

“We must be sure that REACH will be enforced uniformly,” Dow’s Frank warns, “and not only for manufacturers but also traders, importers, and representatives of products.”

ECHA IS FACILITATING a discussion on harmonizing member-country enforce-ment, but the group has not reached a resolution. “This could become an issue,” Paetz cautions, “because countries such as Germany, the Netherlands, and France have very strict regulations, and we are not sure it will be that way in every country.”

As Europe works through REACH imple-mentation, other regions are assessing its utility. The most obvious output of REACH is a huge database of chemical information that can be shared globally. Beyond that, the implementation tools may have limited applicability outside Europe.

“REACH will result in a tidal wave of information,” ACC’s Walls notes. ACC has been engaged in REACH discussions for several years to provide input and track im-plementation for U.S. exporters. “Because of the relative size of the European chemical industry, it was clear that what they would do had the potential to set a precedent for how the U.S. revised its own laws,” he says.

But Walls argues that REACH is not a good fit for the U.S. “There is informa-tion available under the REACH program

that is relevant to our industry interaction with our own Environmental Protection Agency, but I don’t believe that REACH is a model for Toxic Substances Control Act modifications.” Walls cites legal structure, risk assessment, and handling of confiden-tial information as key issues that do not translate well from REACH.

Dancet says ECHA is willing to work with U.S. agencies on chemical regulation reform, but he cautions that the process is not quick. “It takes a long time to imple-ment a new legislation,” he states. “We prepared for three years for REACH imple-mentation in Europe. If the U.S. is clever, maybe they can save half that time.” ■

COMMUNICATION

Do You Speak My Language? Native language commu-nication has complicated implementation of the European Union regula-tion on the Registration, Evaluation, Authorization & Restriction of Chemical substances (REACH). Al-though English is rapidly becoming the primary language of business at major companies, English fluency is much less com-mon in Eastern European countries and in smaller firms throughout Europe. The European Chemicals Agency (EHCA), the group charged with enforcing REACH, has responded by preparing much of the required documenta-

tion in 22 languages. Currently more than

4,000 pages are available in print and online in all of the 22 languages to as-sist users in interpreting the regulation and filing registrations. Available multilingual documents include user manuals, guidance documents, news alerts, and webinar slides for user training.

Additionally, chemical associations in each EU country interpret user questions and help small-er companies understand, and then comply with, the regulation.

One challenge is that the primary interaction

and discussion platform for REACH, the Substance Information Exchange Forum (SIEF), exists only in English. These discus-sion forums are run by the companies involved in the registration of each chemi-cal, not ECHA, although ECHA provides the online network for the dialogue.

“The SIEF tool is only in English because compa-nies use it to communicate and agree on many com-plicated scientific steps,” notes Geert Dancet, execu-tive director of ECHA. “If they do not have a com-mon language between them, it creates more confusion.”