How we are participating in the dossier evaluation in accordance with the REACH Regulation
The European Chemicals Agency (ECHA) evaluates testing proposals and registration dossiers for their fulfilment of the requirements (compliance check). We check the corresponding draft decisions and comment on them.
In accordance with the REACH Regulation, manufacturers, importers and downstream users must ensure that their substances do not adversely affect human health or the environment (Article 1 (3), REACH Regulation).
The appropriate proof is provided through a registration dossier which must be submitted by the registrant to the European Chemicals Agency (ECHA). Depending on the amounts of substance that is used annually, requirements, e.g. with regard to the required toxicology studies, differ. If studies are missing, the registrant must either justify the waiving or submit a testing proposal. The ECHA is obliged to evaluate all of the testing proposals submitted with regard to the meaningfulness of the proposal; so that superfluous animal studies are avoided.
In addition to the submitted testing proposals, at least 5% of all the registration dossiers submitted are subject to a quality check (“compliance check”) by the ECHA.
In both cases, the Assessment Unit OSH reviews the respective draft decisions of the ECHA. It considers the statements about the toxicological testing proposals and about deficiencies in the compliance check of the registration dossier. It comments on cases in which it reaches other conclusions than the ECHA.