Revised ECHA Completeness Check to Include Chemical Safety


The European Chemicals Agency (ECHA) plans to extend the completeness check to the chemical safety report.

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 revised completeness check will be launched with the release of a new version of IUCLID, an online scientific database for chemicals in a regulatory context, 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.

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 prioritization of substances for regulatory action by authorities, enhance the dissemination of use information and improve the starting point for appropriate supply chain communication.

ECHA will also strengthen computerized completeness checks on use information. 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.

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.

For more information about this revision, contact ECHA.

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