REACH Dossier Update - Obligations

REACH Dossier Update Obligations

REACH registration obligations do not cease upon dossier submission - REACH Article 22 places a responsibility on registrants to keep registrations up-to-date. It requires registrants to “update without undue delay with relevant new information and submitting it to the Agency” in a number of specified cases. Amid ECHA and EU member state concerns over high levels of non-compliance in REACH dossiers, the Commission has drafted an Implementing Regulation, which can be expected to be finalised soon. It aims to boost the frequency at which registration dossiers are updated and clarify what needs to be updated in dossiers and when.

Concerns Over Dossier Quality

Following a review of 10 years of evaluation, ECHA concluded there remains major incompliance in registration dossiers. ECHA are prioritising actions to ensure increased compliance with the regulation, with focus on improving dossier quality. This will be done through increased compliance checks (from 5% to 20%), together with a mandate for screening all registration dossiers.

Action Plan for Review/ 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 prioritisation criteria, and critical issues, in order to achieve a better alignment between submitted data and ECHA's current expectations on the content of dossiers.

How Exponent Can Help

Exponent provides a complete service to assist companies wishing to improve the quality of their registrations as a means of preparing for increased regulation (upon enactment of an Implementing Regulation) or to help mitigate risk of ECHA requests for additional test data. Exponent’s large REACH team comprises regulatory affairs professionals and project managers together with experts in chemistry, toxicology, ecotoxicology, environmental fate, exposure assessment, risk assessment, and socio-economic analysis. These scientists have varying backgrounds as regulators (including with ECHA, making them ideally placed to understand what is acceptable to the Authorities), as well as in industry, government and contract research giving us unparalleled expertise in solving complex regulatory problems and helping companies meet the new requirements.

Examples of assistance we can provide 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. Services include preparation of robust study summaries, end point summaries, testing proposals, classification and labelling, toxicokinetic assessment and SCC justifications

  • 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 prioritise cases requiring update (based on timelines, roles and responsibilities, substance prioritisation criteria, and critical issues)

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

Additionally, Exponent can provide assistance in post-submission work, including: preparing and supporting applications for authorisation; representing interests on proposed REACH and POPs restrictions and CLH submissions; preparing and submitting article notifications for SCIP; and project management. With dedicated offices in the EU, UK and Switzerland Exponent remains well placed to help companies meet their European regulatory requirements.

With offices and experts in the UK, EU, US, and Asia, we offer a comprehensive range of technical and regulatory expertise to help companies meet their REACH obligations.