REACH Dossier Improvement Action Plan

Cefic launches Action Plan to help REACH registrants review chemical safety data

In June 2019 the European chemical industry launched an unprecedented action to help its members proactively and systematically review and update data in previously submitted REACH registration dossiers. This initiative comes in response to the recent conclusion by the European Chemicals Agency (ECHA) that many REACH registration dossiers require additional information.

To this end Cefic has developed a multi-annual Action Plan, which provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. The Action Plan outlines the timeline, roles and responsibilities, substance prioritisation criteria, critical issues, and explains how progress will be reported.

The goal of the Action Plan is to achieve a better alignment between the data that have been submitted in good faith by registrants and ECHA’s current expectations on the content of dossiers. Since there is no ‘perfect REACH dossier’ template and every case is different, the Action Plan will be implemented in cooperation with ECHA.

The Action Plan Package consists of the following elements:

  • Declaration of Intent: signed by individual companies,whereby companies express their intent to re-evaluate dossiers and to provide further information, where appropriate, in line with the Action Plan. Companies also commit to report to Cefic on KPIs so that Cefic can report on progress on an annual basis. To that effect, a reporting template has been developed.
  • Cooperation Agreement between Cefic and ECHA: outlines a series of specific activities to support the implementation of this Action Plan and guide registrants to a better understanding of how to meet ECHA’s expectations under Article 41 of REACH (‘Compliance Check’).

The Action Plan will run between 2019-2026, allowing for one year of planning and setting-up and seven years of actual updates.

All Cefic Board members have already committed to this Action Plan. All Cefic member companies and national association (Member / Partner federations) members are also encouraged to sign the Declaration of Intent.

Cefic does not have access to registration dossiers, and all updates will be done by individual companies. However, Cefic will facilitate the support and development of tools and solutions for cross-cutting, unresolved key issues related to registration dossiers.

The Action Plan is not a static document, it will be adapted to developments when and if needed.

On 29 November 2019 Cefic and ECHA held a kick-off workshop to discuss some concrete aspects of the REACH dossier review process and exchange knowledge and best practices on overcoming scientific and technical challenges related to registration dossiers. A summary of this workshop is available here.

On 31 March 2020 Cefic published the 1st progress report on the implementation of the Action Plan. On 7 April 2021 Cefic published the 2nd progress report.


Supporting Documents

Cefic 2020 progress report on REACH Dossier Improvement Action Plan

REACH Registration Dossier Action Plan

Dossier Quality Action Plan Reporting Template

Cooperation agreement Cefic – ECHA

REACH Dossier Improvement Declaration of Intent

Results of the ECHA-Cefic pilot project to explore different read-across approaches and respective testing strategies

List of signatories to the REACH Dossier Improvement Action Plan

Action Plan Review and Improvement of REACH registration dossiers – Q&A

Factsheet: What is takes to prepare and maintain a REACH registration dossier

Cefic Action Plan on REACH Dossier Improvement – presentation

Cefic 2019 progress report on REACH Dossier Improvement Action Plan