The Technical Completeness Check (TCC) done by ECHA for each REACH registration dossier now includes manual checks on the content of chemical safety reports. The extended completeness check will apply to both new registrations and updates of existing ones. Implementation of the revised completeness check was originally planned for November 2020 but was postponed until 2021. This TCC improvement aims to enable better prioritisation of substances for regulatory action by authorities and to improve supply chain communication. Companies are responsible for registering substances that are manufactured or imported above one tonne a year.
What is completeness checking?
ECHA carries out a TCC on each incoming registration dossier to ensure that all required information is provided. The completeness check includes a manual verification which means that ECHA checks certain elements of the registration dossier that cannot be checked automatically. The TCC process, applied to all registration dossiers submitted to ECHA, previously included only the following elements:
- Substance identification
- Data-waiving justifications
- Testing proposals on vertebrate animals
- Justification for opting-out
- Specific requirements for nanoforms
As of 1 March 2021, manual completeness checks performed by ECHA staff will be extended to chemical safety reports to ensure they contain all the elements required under REACH. A chemical safety report is required for all substances subject to registration in quantities of 10 tonne a year or more per registrant. Exposure assessment and risk characterisation are checked from chemical safety reports. Since the chemical safety report is submitted as a text document attached to the IUCLID dossier, the information cannot be verified by the Validation assistant. This makes verifying the completeness of a dossier before submitting more difficult. Registration dossiers sent before 1 March 2021 are not checked for the new TCC rules.
Registrants should, therefore, prepare for the changes, as their update registrations may no longer pass the revised technical completeness check. If your first submission fails the TCC, you will get four months to correct the information. If your second submission is also incomplete, your submission will be rejected, and the data will not be included in ECHA’s database. ECHA will not refund or otherwise credit any fees before the rejection.
More information
Technical Completeness Check: https://echa.europa.eu/technical-completeness-check
ECHA’s webinar on the revised completeness check: https://echa.europa.eu/-/revised-completeness-check-what-changes-and-how-you-can-prepa-1
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Text: Mikael Hirn
Picture: Shutterstock
Source: ECHA