REACH Dossier Update Obligation

How does Exponent provide extensive, experienced REACH registration and dossier support?

The EU REACH Regulation requires registrants to update their REACH registrations "without undue delay" when information on their substance, the supply level of the substance, or company information changes. Implementing Regulation (EU) 2020/1435 sets out the timelines by which all registrants are obligated to update their registration dossiers.

Action plan for review and improvement of registration dossiers

Cefic, a major EU chemical industry association, has devised a "REACH Dossier Improvement Action Plan," which provides a voluntary framework for registrants to evaluate information that has been submitted as part of a registration, in a stepwise manner. The Action Plan outlines the timeline, roles and responsibilities, substance prioritization criteria, and critical issues to achieve a better alignment between submitted data and ECHA's current expectations on the content of dossiers.

How Exponent can help

Exponent supports companies wanting to improve the quality of their REACH registration dossiers prepare for increased regulations or mitigate the risk of ECHA requests for additional test data. Exponent's REACH team, composed of regulatory affairs professionals, understands what is acceptable to the regulatory authorities, providing unparalleled experience and expertise. With offices and experts in the U.K., EU, U.S., and Asia, we offer an extensive range of technical and regulatory services to help companies meet their REACH obligations.

services

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Provision of technical and scientific support on post-registration issues, such as evaluations and compliance checks

• Assessment of submitted data and provision of recommendations for improvement

• Full dossier update services: preparation and update of study summaries, end point summaries, testing proposals, classification, labelling, toxicokinetic assessment, Chemical Safety Report and Strictly Controlled Conditions justifications, and more

• Preparation of robust justifications for data waiving, weight-of-evidence, QSAR and read-across, in line with ECHA requirements

• Preparation and maintenance of a tracking system to identify and prioritize cases requiring updates (based on timelines, roles and responsibilities, substance prioritization criteria, and critical issues)

• Horizon-scanning to help identify future compliance issues and mitigate supply risk

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.