GB-based applicants awaiting an ECHA opinion on an EU REACH authorisation when the transition period ends

If you are based in Great Britain and have submitted an authorisation application under EU REACH but ECHA has not finalised its compiled RAC/SEAC opinions under Article 64(5) by the end of the transition period, you'll need to resubmit your dossier to HSE to continue placing a substance on the GB market or using it in Great Britain after the sunset date. See the transitional arrangements below.

This will incur the fee applicable to a new UK REACH application for authorisation.

GB-based Downstream users of EU-27/EEA applications without a decision at the end of the transition period

Any GB-based downstream users relying on an upstream application made by an EU-27/EEA applicant, where the EU Commission has not granted the authorisation by the end of the transition period, will have to make a new application to HSE to continue to use the substance. This also applies for those applications where there is a RAC/SEAC opinion.

This will incur the fee applicable to a new UK REACH application for authorisation.

Transitional arrangements (Article 127GA)

The following transitional arrangements will apply for GB based companies in the two situations described above.

Article 127GA states, if ALL THREE of these conditions are met:

then the LAD and sunset date will be moved to 18 months after the end of the transition period for those specific applicants/downstream users this provision applies to. This will allow both GB applicants and GB downstream users of non-GB applications to make an application to HSE and continue to use the substance subject to authorisation, up to the extended Latest Application Date and, if they make an application by that LAD, while their application is determined under UK REACH.

If all three conditions cannot be met then the use(s) must cease until a new application has been granted under UK REACH.

Please note that these provisions only apply in cases where the user can demonstrate that they were operating under an existing authorisation application made before the UK left the EU.

You want to You need to By when
Maintain your use or supply for a use in Great Britain (Re)submit your application to the Agency (the HSE) The end of the transition period + 18 months

In the first instance you should notify the Agency of your intention to submit an application by e-mailing [email protected] using the subject "notification of intention to submit an application for authorisation".

The following information should be provided:

GB-based downstream user of a resubmitted GB-based authorisation application (as described above)

If you are a GB-based downstream user of an application made by a GB-based company to ECHA before the relevant EU latest application date (LAD), but ECHA has not adopted a final opinion (ie there is not a compiled RAC and SEAC opinion) you can continue to use the substance beyond the sunset date, pending the Authorisation decision, provided the GB- based applicant resubmits their application to the Agency (HSE) by the given deadline (the end of the Transition Period + 18 months) as described above.

You have to notify the Agency within three months of the first time the substance was delivered to you. This obligation applies after the authorisation decision has been published by the Secretary of State.

The information you need to submit consists of;

You may also submit information about the typical annual volume and the number of staff using the substance. Furthermore, you may provide a brief additional description about your use and any involvement in potential substitution activities.

If the authorisation decision requires you to submit specific data to the Agency, eg on exposure, you will need to provide this by the deadline set in the decision.

This information should be submitted by e-mail in IUCLID 6 format to [email protected] using the subject 'UK Authorisation – Article 66 DU notification'.

 
Updated 2021-08-10