U.S. chemical companies preparing for the May 31, 2018 REACH chemical registration deadline should prepare for more thorough dossier checks by the European Chemicals Agency than have previously been carried out, according to a Keller and Heckman attorney.
“It will be more difficult to pass the completeness check then it was in 2010 and 2013,” said Herb Estreicher, who commutes between the Washington, D.C., and Brussels offices of the Keller and Heckman LLP. He spoke during a recent webinar held by the law firm.
Keller and Heckman’s webinar, “What U.S. Companies Need to Know in Preparation for the 2018 REACH Registration Deadline,” offered detailed information about the process companies will need to use, pitfalls they may face and responsibilities they’ll still have after the deadline passes.
Christopher Bell, a Houston-based attorney working for Greenberg Traurig, LLP, had a slightly different take on the upcoming registration deadline.
“The rules haven’t changed for 2018,” Bell told Bloomberg BNA.
What has changed is that many more small companies with limited resources will be subject to those rules, he said.
Both attorneys discussed the EU’s registration, evaluation, authorization and restriction of chemicals, or REACH, regulation (EC) No 1907/2006, REACH requires that chemicals made in or imported into the European Economic Area in volumes ranging from one to 100 metric tons annually be registered with the European Chemicals Agency by May 31, 2018.
Higher volume chemicals already were registered under the 2010 and 2013 deadlines. The European Economic Area consists of the 28 EU member states along with Iceland, Liechtenstein and Norway.
Unregistered chemicals can’t be made or sold in the European Economic Area unless their production or importation volume is less than one metric ton (2,204 pounds).
Rethinking the Business Model
Large chemical manufacturers will already have registered many of their chemicals, Bell said. Their specialty chemicals may need to be registered for REACH 2018, but the process will be familiar to them, he said.The companies that will be dealing with REACH for the first time are the many small and medium-sized businesses that have to register their chemicals, Bell said. Due to limited resources, “some will rethink how they do business in Europe,” Bell said.
A U.S. chemical manufacturer that exports a low-volume chemical to Europe may conclude it’s better for the importing company to register the substance, Bell said.
Evolving Registration Process
The registration process has evolved as the European Chemicals Agency has gained more experience with dossiers. B
The agency basically used a check-the-box approach to determine if dossiers were completed during the first 2010 and 2013 registration deadlines. In 2018, however, the agency is expected to closely analyze waiver requests, he said.
Companies submit waivers when they ask to be allowed not to submit certain mandated toxicity, physicochemistry or other data. Reasons for seeking waivers include that the characteristics of the chemical being registered—its lack of solubility for example—would make it impossible to do an acute aquatic toxicity test.
Substance Information Exchange Forums
Under REACH, manufacturers of the same chemical form substance information exchange forums, or SIEFs, to share information, agree upon the classification of the chemical and make other joint decisions. The forums are managed by a lead registrant.
The regulation envisioned that company officials would sit around a room and make decisions together, Estreicher said.
The reality is that companies don’t sit down and work through issues; the lead registrant makes the decision, he said. The lead registrant will run its decisions past other forum members, but unless they reply by a certain date, their agreement is presumed, Estreicher said.
Some REACH 2018 forums will have a different characteristic than previous forums for larger volume chemicals did, Bell said.
For previous deadlines, a few large companies with a lot of resources gathered the information they needed from their supply chains, he said. “That takes a lot of horse power.”
Small companies will have a harder time identifying all the planned uses customers for the chemical the manufacturer makes, Bell said.
Chemical manufacturers’ REACH obligations will continue beyond 2018.
That means U.S.-based companies, which like all non-European companies must use entities called Only Representatives (ORs) to register their chemicals, will have to maintain their contractual obligation with that representative.
Ongoing REACH responsibilities include notifying the European Chemicals Agency to update registration dossiers if companies are bought out or merge or if a chemical’s production volume changes.
Compliance is an ongoing obligation that should be built into day-to-day business practices, Bell said.
The essential obligation is the same whether a company does business in the U.S., Europe or Korea, he said. “You have to know what chemicals you make, export and import. Know where they end up, and know where your markets are.”