September 16, 2016 / Andrew Brown

No Data, No Market: Start Your REACH Registration Now

Companies should be in compliance with GHS labeling requirements by now. That said, For many companies, registering chemicals before the REACH deadline will not be easy process, given the technical, legal and financial considerations. Additionally, a larger number of registrants and an increase in the number of specialty chemicals registered will present challenges. “For a large portfolio you need a lot of time. That’s why you need to start now with your activities,” said Sandra Meijer, director of business development at The REACH Centre.

The deadline is May 31, 2018. It can take up to 30 weeks to complete a registration, even if everything goes smoothly. “There’s only a certain number of labs who can do some of these tests,” said Meijer, and some are already at capacity.

Technical Considerations

Data gathering is a huge part of REACH. Competitors are expected to collaborate to develop one hazard data set for the chemicals. Though some hazard data may be compiled already, there are always gaps, said Meijer. You can potentially fill those gaps with read-across, waiving arguments and QSAR. If confidentiality is an issue, you can submit your uses separately from the lead dossier, but then you have to conduct your own safety assessment.

Legal Considerations

Every Substance Information Exchange Forum (SIEF), should have an agreement outlining how you’ll work together. It should express the obligations for each member and how you’ll share costs. It should also address potential refund mechanisms, in case more companies join the registration than anticipated. An ECHA regulation now stipulates that the agreement address whether or not there’s a refund mechanism. Meijer also cautioned attendees not to run afoul of EU competition law. She referenced a list of Dos and Don’ts available at www.cefic.org.

Financial Considerations

Registration costs include the data sharing and ECHA fees. There can be ongoing cost and unforeseen costs as well. Depending on the testing required, the costs add up, especially if you are the only registrant. Ultimately whether to register or not is a business decision. If chemicals in your inventory haven’t been registered yet, you may need to take the lead and incur a large upfront cost. If the costs outweigh the benefits of being in the market, some companies may reduce their exports to less than one tonne or replace the substance with something else.

The Wider Impact of REACH

“REACH registration is only the start of the process,” said Meijer. Registrants must update dossiers when new hazard data or new uses become available (if new members join, for example). Similarly, updates are required if your company changes names or size as a result of M&A activity.

Also, ECHA uses the data it gathers to see which chemicals need better controls. The agency may check the dossier to ensure that it’s scientifically sound. It may conduct an evaluation if it’s concerned about the substance, or it can ask registrants for more information. Depending on the results, ECHA could restrict a chemical, impose a ban or propose a reclassification, which could lead to other impacts. “Know your substances. Communicate with your fellow registrants in your supply chain,” Meijer advised.

Andrew Brown

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