27 February 2014

The European Chemicals Agency (ECHA) has published its sixth annual evaluation report in which it sets out recommendations to all registrants on how to improve the quality of their dossiers.

The report notes that in 2013, 928 compliance checks were concluded, during which it was found that 61% did not comply with one or more REACH information requirements. The majority of the ECHA's information requests were related to substance identity, physicochemical properties, sub-chronic toxicity studies, pre-natal developmental toxicity studies and exposure assessment.

Regarding testing proposals, the ECHA focused on decision-making for sets of dossiers relying on read-across and category approaches. The Agency concluded 157 examinations and took 111 decisions. In 71 cases, the ECHA accepted the tests proposed by the registrants and in 37 cases, it modified at least one of the proposed tests. There were three decisions rejecting testing proposals.

The report gives specific recommendations for both future registrants ahead of the upcoming 2018 deadline and for existing registrants who may need to update their dossiers. The recommendations cover the following.

  • Improving the chemical safety report to reflect actual uses and risks.

  • Knowing how to react to (draft) decisions.

  • Keeping the dossier up to date.

  • Substantiating the reasoning when adapting the standard testing regime.