The EU Commission and ECHA are taking action to make sure that REACH registration dossiers are compliant with EU legal requirements. The increased level of compliance will result in improved industry data on chemicals and safer chemicals use in the EU.
The chemical products market is constantly changing. Product market shares, production volumes and manufacturing processes can change, as well as the uses or the availability of new scientific knowledge about a substance. For all these reasons, is important to keep updated information about the registered substances.
According to Article 22 of REACH, a registration should be updated without undue delay if there is any change in: the status of the registrant, the composition of the substance, the annual or total quantities manufactured or imported or its classification and labelling. Updating the registration dossier and the Chemical Safety Report (CSR) is required if new risks to human health or the environment all are identified. The introduction of new uses and uses advised against also requires an update to the registration dossier. Furthermore, even if there have been no changes, companies should review their registrations, and it is also recommended to make a bibliographic search of new information regularly.
At ECHA’s Safer Chemicals Conference in Helsinki on 22 May, the authorities pointed out that the compliance of REACH dossiers has to improve. An implementation regulation that requests registrants to update a dossier is being prepared. This regulation will also clarify some terms like ‘undue delay’.
On the other hand, it is also important the compliance with the legal requirements for substance registration. According to the first report from a recently REACH compliance project, a third of REACH registration dossiers do not fully comply with EU standard information requirements. For the rest of the dossiers, data were considered to be missing. The Authorities perform a technical completeness check for every registration. A registration number cannot be granted unless there is some information available for each required data endpoint.
Many intrinsic substance properties didn’t have the study data required by REACH. Registrants often deviated from standard data requirements towards the optional use of alternative approaches like read-across or quantitative structure-activity relationships (QSARs), but the justification for using these alternatives is not considered sufficient. Robust study summaries lack a sufficient level of detail and hinder an independent assessment in some cases.
To address this gap, the Commission requested ECHA to identify the main reasons of non-compliance and develop solutions.
The new Action Plan launched on the 24th of June, envisages a significant increase in the number of compliance checks carried out on registration dossiers. The Commission is proposing an amendment to REACH to increase the minimum required number of compliance checks from present 5% to 20% of registration dossiers in each tonnage band. The proposal is planned to be adopted before the end of this year.
ECHA will screen all registration dossiers submitted before the 2018 deadline and launch compliance check for at least 30% of substances. These include substances with hazardous properties, or where more information is needed to clarify a concern. The agency aims to reach this target for substances registered in very high volumes (over 100 tonnes per year) by 2023, and for substances in the lower tonnage bands (1-100 tonnes per year) by 2027.