On 11 December 2019, ECHA claimed that they expected to extend the completeness check to the chemical safety report. Up to now, the chemical safety report has remained outside the scope of the completeness check, which has focused on the other elements of the registration dossier.
With experience gained in performing manual completeness checks on certain dossier elements, ECHA is now ready to tackle the content of the chemical safety reports. With this improvement, ECHA can better fulfil its obligation to ensure that all the required elements are included in the registration.
The decision to cover the chemical safety report in the completeness check also supports ECHA’s regulatory strategy, which foresees requests under evaluation to mainly be used for obtaining hazard information. Extending the completeness check to the chemical safety report is expected to enable better prioritisation of substances for regulatory action by authorities, enhance the dissemination of use information and improve the starting point for appropriate supply chain communication.
In parallel, ECHA will also strengthen computerised completeness checks on use information. In particular, cases where the service life description of an article is expected but has been left out of the registration dossier will be detected. Improvements are also foreseen for the endpoints related to mutagenicity, reproductive toxicity and degradation. More information on these changes is available in the annex to this news release.
The revised completeness check will be launched with the release of a new version of IUCLID in April 2020 and will apply to both new registrations and updates of existing ones. Registrants should, therefore, prepare for the changes as registrations submitted before may no longer pass the revised completeness check rules.
ECHA aims to minimise unwanted impact for registrants and will provide support in addressing the areas of the completeness check revision and preparing to successfully submit their registrations. A webinar explaining the changes in the completeness check will be organised on 29 January 2020.
The IUCLID Validation assistant will be made available with the April IUCLID release and can be used to detect all computer-based incompleteness issues in the dossiers before submitting them to ECHA. Since chemical safety reports are submitted as text documents attached to the IUCLID dossier, the information cannot be verified by the Validation assistant.
ECHA is also making the Chesar software available, which guides users in carrying out a complete chemical safety assessment. In addition, written support material will be available on ECHA’s website. For case-specific advice, ECHA’s contact form should be used.