The European Chemicals Agency (ECHA)’s 2018 evaluation report on the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation found important information was missing from approximately 75 percent of all evaluated registrations. More recently, a study by the German Environment Agency (UBA) and German Federal Institute for Risk Assessment (BfR) analyzed registration and found 24 percent did not meet REACH compliance requirements or were otherwise noncompliant, with companies omitting vital data.

While the ECHA had announced it would be increasing scrutiny of REACH registrations over 100 metric tons by 2023, the release of the joint UBA-BfR study saw non-governmental organizations (NGOs) ramp up pressure on the regulatory authority to increase its enforcement activities.

As a result, it is more important than ever that companies submit valid registrations to ensure a successful REACH declaration and maintain EU market access.

To learn how your organization can ensure it submits complete REACH registrations, download The REACH Handbook: Your Guide to SVHC Compliance today.

Data Gaps & Issues With Submitted Data

The ECHA is required to check five percent of dossiers at various tonnages under Article 54 of the EU REACH Regulation; in 2018, the agency addressed 484 registrations and conducted 286 dossier evaluations. The ECHA asked registrants for further information on 211 of those evaluations.

Following the revelation that 75 percent of these registrations were lacking important data, the ECHA announced it would increase its evaluation to include compliance checks on approximately 30 percent of all registered substances until 2027.

The UBA-BfR study found equally concerning results; despite their conclusion that 24 percent of the dossiers they analyzed at random were non-compliant, the study notes this is an average, and that “in at least 46% of the evaluated dossiers the information requirements under REACh are insufficiently fulfilled for at least one endpoint.” The study also concluded that such data gaps are the result of a lack of standard information or insufficiently established data waiving or adaptation processes.

Industry Response

Three major trade groups — the European Chemical Industry Council (CEFIC), Eurometaux (the European non-ferrous metals association) and Concawe (an oil trade group) — have announced their cooperation with the ECHA in encouraging companies to check their dossiers and voluntarily submit all necessary information ahead of a formal request.

This proactive approach poses a significant burden for industry members; for example, 170 CEFIC members have agreed to review their registration documents, which represents thousands of dossiers alone. According to CEFIC, these documents will be improved wherever necessary to bring them up to date with the latest developments.

The pressure to provide accurate information is not just coming from within the industry, however. The pending launch of the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database will further add to the obligations facing companies doing business in the EU, and its information will be fully accessible by the public.

As regulatory requirements continue to expand in line with public pressure, companies are turning to platform technology to automate their data requirements for a variety of regulations, including the EU REACH Regulation. Assent provides companies with a supply chain data management solution that supports complex compliance programs through automation, centralized risk identification and analysis. Leveraging a centralized database supported by industry-standard templates for data collection and export enables businesses to efficiently survey supply chains for more efficient access to key markets. To learn more, contact our experts.

Dr. Raj Takhar
Regulatory & Sustainability Expert, Product Sustainability

Raj helps companies meet their product compliance challenges in an ever-changing regulatory landscape. He specializes in product compliance, chemical reporting, and program implementation in Europe.

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