Since the first registration deadlines were met by industry ECHA, through its screening and evaluation work has been reporting that for many of the submitted dossiers the quality of the information has not been of a high enough standard. The issue of dossier quality was highlighted earlier this year in the European Commission’s REACH Review report.
In response to quality shortcomings the Agency has launched a number of campaigns including the development of a dossier quality tool and continues to emphasise the importance of submitting complete and accurate information in the dossiers.
What happens if your dossier does contain quality issues?
While ‘quality issues’ are currently not part of the Technical Completeness Check (TCC), a dossier may be targeted for compliance check by ECHA after submission where quality issues have been detected. Where such inconsistences or non-compliances are found, ECHA will contact the registrant and request or invite them to update their dossier in the areas highlighted. In parallel ECHA informs Member States about these letters and on the response of the registrants. If the registrant does not clarify the issue, the Member State of the registrant may initiate some enforcement actions against the registrant directly.
Registrants are reminded that where they have received quality observation letters or other communications from ECHA relating to their submitted dossiers, that the enforcement authorities of their Member State could follow up directly with the registrant and could initiate enforcement proceedings, recent reports suggest that this is already happening in some of the member states. ECHA thereby encourages registrants to proactively improve the quality of their dossiers before submitting their 2013 registrations and for any previously submitted dossiers in order to avoid any prioritisation for follow up by ECHA and/or the enforcement authorities.
Should you have any questions about dossier quality issues, please contact us and avail of our free 30 minute consultation