ECHA keeps focus on compliance check of REACH dossiers

A priority for ECHA in 2021 is dossier evaluation that includes compliance check and examination of testing proposals. Attention is on higher tonnage bands and substances of concern.

Since 2019, ECHA has put efforts into checking the quality of the registration dossiers, both by manual completeness check right after submission and by compliance check of critical endpoints in dossiers for substances of concern.

Critical higher-tier hazard endpoints
ECHA’s programme for 2021-2024 presents the detailed work plan for 2021. This includes dossier evaluation that entails compliance check and examination of testing proposals. Focus in the compliance check is on industry dossiers in the higher tonnage bands (>100 tonnes per year) and on higher-tier hazard endpoints, such as toxicity to reproduction for substances of potential concern or groups of such substances.

Closing the data gap
One output from a compliance check is a need for more information and closing of data gaps, which ECHA deems not to be fulfilled. Closing of data gaps often requires test data, as the building of robust non-testing scenarios like read-across is very burdensome in data requirement and justifications.

We have experienced a need for supplementing the registration dossiers with test data and have helped several clients to update their registrations, including:

  • new tests
  • update of the dossier in IUCLID
  • update of the chemical safety report

For this work we have established active collaboration with several test laboratories inside and outside the EU. We assist in monitoring tests, reviewing study protocols and study reports, as well as discussions and advice on test results.

For more information, please contact:

Anne Rathmann Pedersen
Tel +45 4516 9370