Since the REACH regulation first entered into force, there has been little clarity on the deadlines for submitting dossier updates. For example, where new information becomes available, or where a tonnage band is exceeded, registrants were previously required to update dossiers “without undue delay” (Article 22.1 – REACH Regulation). But this is about to change, following the entry into force of Commission Implementing Regulation (EU) 2020/1435. The new regulation clarifies the meaning of ‘without undue delay’ by applying specific deadlines for different types of dossier update.
Deadlines for when dossier updates must be completed by include the following:
- Within three months for administrative updates (e.g. change in a registrant’s status or identity), and for changes in substance composition;
- Within three months of the date at which the higher tonnage band is reached. If new test data is required to support the tonnage band upgrade, then the three month deadline applies from the point at which the final test report becomes available;
- Within 6 months where the classification of a substance without a harmonised classification changes;
- Within 6 months, where a need to submit testing proposals (prior to conducting REACH Annex IX or X testing) is identified; and
- Within 12 months, for changes to the chemical safety report or guidance on safe use.
For members of a joint submission, where updates are dependent on the lead registrant making first updating the registration, alternate deadlines apply in some circumstances. When there are several reasons for updating a dossier, the longest of the relevant deadline would apply, so there would be no requirement to submit multiple updates.
The new implementing regulation will enter in to force in December.
If you need help updating your REACH dossiers in accordance with the new requirements, don’t hesitate to contact our experts. firstname.lastname@example.org