May 28, 2020
REACH dossier update obligations
Registration, Evaluation, Authorization of Chemicals (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 [submit] it to the Agency" in a number of specified cases. However, the ambiguity in this requirement has resulted in many companies failing to update their registrations.
As the European Chemicals Agency (ECHA) is working through previously submitted dossiers to assess their REACH compliance, they are finding that, in most cases, existing registrations are non-compliant and requesting additional information from registrants, which can include requests for a battery of expensive studies. Amid ECHA and EU member state concerns over high levels of non-compliance in REACH dossiers, the European Commission has drafted an Implementing Regulation, which is expected to be finalized soon. It aims to boost the frequency at which registration dossiers are updated and clarify what needs to be updated in dossiers and when.
Industry groups, such as Cefic, have said they would welcome a draft Implementing Regulation on Article 22. Cefic has devised a "REACH Dossier Improvement Action Plan," which provides a voluntary framework for REACH registrants to evaluate the data that has been submitted against ECHA's current expectations on the content of dossiers in a stepwise manner. Exponent is already actively engaged in assisting clients wishing to better position themselves by following the Cefic Action Plan ahead of an Implementing Regulation. Many companies also see benefit in improving the quality of their dossiers as a means of mitigating the risk of the Agency requesting additional test information.
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.
ECHA affirms that many of the registration dossiers it has received do not include all required information. The Agency's concern is that this lack of information could mean that potential risks posed by the substances are not being managed properly. The Joint Action Plan of ECHA and the European Commission aims to address the lack of compliance in registration dossiers. Under the Joint Action Plan, ECHA compliance checks will increase from 5 to 20% in each tonnage band (corresponding to 30% of all registered substances). Additionally, by 2023 for all registrations in the tonnage bands over 100 tonnes/year and by 2027 for the tonnage bands 1 — 100 tonnes/year, ECHA will have screened all registration dossiers submitted by the 2018 deadline, independent of their tonnage band. It will also have performed a compliance check for all substances where data gaps prevent a conclusion on whether there is a concern or where the substance is of low priority for further regulatory action.
How Exponent Can Help
Exponent provides a complete service to help companies improve the quality of their registrations in preparation for increased regulation (upon enactment of an Implementing Regulation) or mitigate the 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, as well as in industry, government, and contract research, giving us unparalleled expertise in solving complex regulatory problems.
More specifically, the services offered by Exponent include, but are not limited, to:
- Preparation and maintenance of a dedicated tracking system to identify and prioritize cases requiring update (based on timelines, roles and responsibilities, substance prioritization criteria, and critical issues);
- Technical and scientific support on post-registration issues, such as evaluations and compliance checks;
- Assessment of submitted data and recommendations for improvement;
- Full dossier update services, including 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; and
- Horizon-scanning to help identify future compliance issues and mitigate supply risk.
Additionally, Exponent can provide assistance in post-submission work, including preparing and supporting applications for authorization; 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 is well placed to help companies meet their European regulatory requirements.
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