Dossier evaluation

The dossier evaluation process, and in particular the check of compliance, contributes to the generation of relevant data on chemicals and to instil confidence of the general public that industry takes responsibility to ensure the safety of the substances they manufacture and import. ECHA and the European Commission published a REACH Evaluation Joint Action Plan to address the lack of compliance of the information in the registration dossiers.

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 and performed a compliance check for all substances where data gaps prevent from concluding whether the Substance is of concern or whether it is of low priority for further regulatory action. The Action Plan also requires commitment from authorities to make the process more efficient and from industry to review their dossiers and generate further information as needed.

REACH requires EU companies manufacturing and importing chemicals to assess their chemicals and propose risk management measures. This assessment needs to be documented in a registration dossier which companies need to prepare and submit to ECHA. Information on properties and uses must be provided on all chemicals manufactured or imported in quantities of one tonne or more per year.

Under dossier evaluation, ECHA checks that information outlined in the standard information requirements of REACH is available in the dossier or proposed in a testing proposal. This information is crucial for understanding whether a chemical may pose a risk to human health and the environment.

Dossier evaluation covers two processes: compliance check and examination of testing proposals.

Categories Display