Achieving regulatory compliance if you missed the REACH registration deadline
Missed the REACH registration deadline? Unsure what to do next to ensure you remain REACH compliant? In many cases, it should still be possible to complete registration if you pre-registered and if the substance has a lead registrant who has successfully submitted a dossier. In these circumstances, there are two steps you can take to minimise the potential business impacts of missing the registration deadline.
STEP ONE: Pause your import/manufacture of in-scope substances
The first and most important step for any unregistered and in scope substance (i.e. where volumes determine that registration is required) is to halt manufacture/import with immediate effect. You may be non-compliant if you do not do so. Unregistered substances cannot be legally manufactured/imported into the EU without a valid REACH registration as of June 1, 2018.
STEP TWO: Submit dossier directly to ECHA – act quickly
Assuming the lead registrant has already successfully submitted their dossier, then for pre-registered phase-in substances, you will still be able to submit a non-lead dossier to ECHA directly without having to negotiate the ‘inquiry’ process. This approach offers time savings compared to the ‘inquiry’ process, although ECHA state that this opportunity is only available ‘until further notice’, so consider acting quickly. To take advantage of this opportunity, in addition to your valid pre-registration, you will need supporting information to accompany your non-lead submission. This includes: analytical data; volume data; a clear understanding of the uses for that substance; and the appropriate letter/s of access to support entry to the joint submission.
TSG can help
If you already have this information, then you can complete your registration very quickly. TSG can assist with dossier preparation and submission. Alternatively, we can advise on next steps, and support with dossier preparation and submission when the supporting data becomes available.
Remember that as with pre-registered phase-in substances, you also cannot legally manufacture or import substances which were not pre-registered until registration is complete. If you did not pre-register, then you will still be required to submit an inquiry dossier first, before being able to complete registration via a non-lead dossier.
Once you have successfully completed registration, imports/manufacture can be resumed.
To have an informal chat about dossier preparation and submission or next steps, please contact us.