The April 30 2021 deadline for UK based companies to grandfather their EU REACH registrations is fast approaching. Companies who have not yet started the grandfathering process should do so immediately or they will not be able to rely on existing EU REACH registrations after May 1 2021. New registrations will be subject to fees equivalent to the registration fees under EU REACH, which can range from GBP 1,138 to GBP 29,419 per chemical substance.
We summarize the immediate next steps companies should take to benefit from the UK REACH transitional provisions, and provide further information on how HSE implements UK REACH as well as exploring the impact of Brexit on EU REACH obligations.
The UK Health and Safety Executive (HSE) has published detailed guidance on how to complete the grandfathering process. It is important to note that grandfathering may take over a day to complete as companies will need to:
create a Government Gateway ID to log into “Comply with UK REACH”;
request to download the substances’ IUCLID dossier from REACH IT (ECHA’s guidance on how to download IUCLID dossiers following a legal entity change can be found here);
migrate the IUCLID dossiers to version 6; and
upload the dossier and provide certain basic information about the substances on “Comply with UK REACH IT”.
Once grandfathering is complete, companies will receive a registration number and will be able to view the names and contact details of all other grandfathering registrants, as well as any new registrants for the substances (i.e. they will become part of a Substance Group).
Companies who run out of time for grandfathering should seek legal advice and contact HSE as matter of urgency.
Downstream Users Import Notifications
UK downstream users who imported chemical substances from the European Union prior to Brexit have until October 27 2021 to submit a Downstream User Import Notification (DUIN). HSE’s guidance on how to submit DUINs can be found here.
Downstream users should also inquire about their suppliers’ plans for compliance with UK REACH and consider registering themselves if the chemical substances will not be covered by a UK REACH registration further up the supply chain.
Please note, DUIN submissions will not entitle companies to become part of a Substance Group and participate in Lead Registrant and data sharing discussions with new and grandfathering registrants.
Article 26 Inquiries
Companies unable to grandfather and currently relying on their or their UK customers’ DUINs to continue importing into the United Kingdom should consider submitting an Article 26 inquiry (the first step in the UK REACH registration process) in order to be able to participate in Substance Group discussions.
HSE recently confirmed that all new registrants of existing chemical substances under EU REACH will benefit from the deferred submission deadlines for the full information requirements. This means that new UK REACH registrants will not be required to submit full registration dossiers until October 27 2023, 2025 or 2027 (depending on tonnage band and/or hazard profile of the substance) even where there are no other grandfathering registrants. However, HSE’s registrations fees will have to be paid following the submission of the registration dossier, even if submission of the full registration information is deferred.
The registration process under UK REACH begins by submitting an Article 26 inquiry through “Comply with UK REACH IT”. Provided the inquiry is successful, new registrants will then need to submit a registration dossier which, instead of the full information requirements, may include a waiver statement explaining why the registrant is not currently able to provide full registration information.
HSE has not provided further guidance on the wording of the waiver nor a list of accepted justifications allowing companies to defer submission of the full information requirements. It is likely HSE will consider the fact that the Lead Registrants have not yet been identified, or have not submitted a full registration dossier as an acceptable justification, however this may be subject to change in the long term.
Once the dossier containing the waiver is processed by HSE and the required registration fee has been paid, the new registrant will receive a registration number and will be considered compliant with UK REACH, pending full submission of data.
It is important to note that the text of UK REACH has not been updated to reflect these additional transitional provisions. HSE indicated DEFRA is currently considering how and whether to formalize these arrangements.
All grandfathered registrants and new UK REACH registrants for a substance will become part of the same Substance Group. Substance Groups fulfil a similar role to the Substance Information Exchange Forum (SIEF) under EU REACH. The main purpose of Substance Groups is to allow co-registrants to discuss data sharing and identify a Lead Registrant for the substance. Identification of Lead Registrants can commence on May 1 2021, once the grandfathering process is completed.
As mentioned above, companies who submitted DUINs in respect of a substance will not become part of the relevant Substance Group and will not be able to participate in discussions regarding the appointment of a Lead Registrant and data sharing unless they also submit an Article 26 inquiry.
UK Only Representatives (ORs) can grandfather EU REACH registrations, submit DUINs and Article 26 inquiries in the same way as other registrants. Grandfathering, DUINs and Article 26 inquiries will need to be submitted per each company they act as an OR for rather than once per substance (similar to the current system under EU REACH).
ORs will need to create a “Comply with UK REACH IT” account for themselves, and then a “child” account for each company they represent, as indicated by HSE. It is important to note that each “Comply with UK REACH IT” account will be linked to a Government Gateway ID and to the company’s registration number on Companies House.
Authorisations, Restrictions and Evaluations
Regarding other regulatory processes under UK REACH and UK CLP, HSE have confirmed they are currently working on two restrictions for lead shots and tattoo inks, analogous to restrictions adopted in the EU recently but not forming part of retained UK law.
Authorisations granted before January 1 2021 have been retained in UK law. Transitional provisions will apply for authorisation applications submitted to ECHA before the end of the transition period but not fully granted (as indicated in HSE’s guidance here). All new authorisations will need to be submitted directly to HSE.
HSE are currently reviewing RAC opinions on CLP proposals that have been published since Brexit in order to determine whether analogous provisions will be adopted in the United Kingdom.
HSE’s evaluation process will start once the transitional phases for UK registration have at least partially been completed. It is unclear from HSE’s guidance whether this will be in October 2023 or sooner, if sufficient data is available.
Transferred EU REACH Registrations
UK based companies who transferred their REACH registrations from the United Kingdom to an EU based entity should review and update their EU REACH safety and administrative information, such as the company’s role in the supply chain. If an update is required, registrants have up to three months to update administrative information or up to six, nine or 12 months for more complex updates.
Ensuring information is correct and up to date is part of a company’s duties under EU REACH and the REACH Implementing Regulations. ECHA will also review the completeness and correctness of EU REACH registrations and chemical safety reports on an ongoing basis.
Additionally, companies who transferred their REACH registrations to an EU entity should also review and update their contractual arrangements, both with their customers/suppliers and with the relevant consortia (i.e. LOA, consortium agreements) to ensure that legitimate access to data is not compromised.
For a full overview of the UK REACH regulatory system, please see our previous alert here.