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Completeness check of chemical safety reports postponed until October 2020

Corrigendum 21 October 2020: The extension of the manual completeness checks to include chemical safety reports has been further postponed due to the implications of the financial situation forcing us to review our work planned for 2021.

Corrigendum 30 September 2020: The extension of the manual completeness checks to include chemical safety reports will start on 2 November 2020 following an update of IUCLID. 

Corrigendum 8 April 2020: The headline and content of the news has been amended to reflect that the completeness checks of chemical safety reports will now only start in October 2020 to help companies facing difficulties due to the COVID-19 pandemic. The remaining changes to the completeness check will take effect on submissions as of 1 May 2020, as previously communicated.

ECHA/NR/19/46

The completeness check will be extended to chemical safety reports, to ensure they contain all the elements required under REACH. More explicit checks on key hazard endpoints will also be included in the revision.

Helsinki, 11 December 2019 – ECHA plans to extend the completeness check to the chemical safety report. So far, 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. The completeness checks of chemical safety reports was originally postponed until 2 November 2020 to help companies facing difficulties due to the COVID-19 pandemic and to align with an update of IUCLID. This date has been put back further due to the implications of the financial situation forcing us to review our work planned for 2021.

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.


Background

Under Article 20(2) of REACH, ECHA is obligated to check that all of the required elements are provided in a REACH registration dossier. Before registration numbers can be issued, each dossier has to pass a completeness check.


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