Last reviewed 5 September 2023

In this feature Caroline Raine talks us through what to do if you start to import a new substance into Great Britain over one tonne per annum; otherwise known as the NRES process under UK REACH.

Introduction

Withdrawal from the European Union meant that Great Britain needed its own Registration, evaluation, authorisation and restriction of chemicals (REACH) regulations.

UK REACH is made up of five regulations.

  1. The REACH etc. (Amendment) Regulations 2021 SI No.904 2021.

  2. The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 SI No.1577 2020.

  3. The REACH etc. (Amendment etc.) (EU Exit) (No. 3) Regulations 2019 SI No.1144 .2019

  4. The REACH etc. (Amendment etc.) (EU Exit) (No. 2) Regulations 2019 SI No.858 2012.

  5. The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 SI No.758 2019.

There is a consolidated version available here.

Key dates

The key dates relevant to UK REACH are as follows:

  • 1 Jan 2021 — UK REACH came into force

  • 30 April 2021 — Grandfathering deadline

  • 27 October 2021 — Downstream User Import Notifications (DUIN)/Only Representative Inquiry

  • 27 October 2026 — first registration deadline

  • 27 October 2028 — second registration deadline

  • 27 October 2030 — third registration deadline.

Please note that the DUIN window is still open despite the hard deadline. And note that the registration deadlines have been extended to October 2026, 2028 and 2030 (from October 2023, 2025 and 2027).

Grandfathering and DUINs

For GB legal entities that previously held EU REACH registrations they had the ability to grandfather in their registrations.

If under EU REACH you fell onto the role of a downstream user then companies had the option to submit a Downstream User Import Notification (DUIN). The Health and Safety Executive (HSE) has provided a spreadsheet that must be completed and sent to the HSE. To be eligible to submit a DUIN the company must have previously imported the substance in the two years prior to the end of December 2020. (ie 1 January 2019 to 31 December 2020).

The text on the HSE website states:

“If in the 2 years prior to 1 January 2021 you were a downstream user or distributor under EU REACH, or you were regarded as a downstream user by virtue of an Only Representative (OR) agreement, you were able to submit a downstream user import notification (DUIN) before 27 October 2021(300 days from January 2021). By submitting a DUIN you effectively defer your registration obligation for 2, 4 or 6 years, depending on the tonnage band and/or hazard profile, beginning after those 300 days.”

It is worth noting that a sample would be considered as a previous import.

The DUIN process is as follows.

  • Use the Comply with UK REACH service to indicate that you are an existing downstream user or distributor. At this point your UK REACH DUIN number will be issued to you. This only needs to be done once per legal entity and covers all substances that you wish to continue importing from the EU.

  • This fulfils the Article 10(a)(i) information requirement of Article 127E.

  • Populate the additional information additional information spreadsheet template with information about the substances that you wish to continue importing. Note, some information only has to be included if it is available to you. When available, the spreadsheet should list individually all of the substances that you wish to continue importing from the EU, one per line.

  • Where a substance is included in the spreadsheet, it must contain at least one of the following identifiers: substance name, CAS number, EC number.

  • Send the completed spreadsheet to the Agency at ukreach.dunotification@hse.gov.uk.

  • You should include your legal entity name and DUIN number in the subject line of the email.

  • It may be easier to fulfil some of the information requirements by attaching a Safety Data Sheet (SDS) to the email rather than including it in the spreadsheet, eg the Article 10(a)(iv) information pertaining to classification.

  • Where an SDS for a substance is attached to the email along with the spreadsheet, the spreadsheet must also list that substance.

New substances — NRES

If you are considering a new substance from a supplier that has not previously been registered under EU REACH or for a substance that you had not previously imported in the two years prior to the 31 December 2020 (ie 1 Jan 2019 to 31 December 2020). You cannot benefit from the delayed registration process. You will need to follow the NRES process. For anything new since 1 Jan 2021 you would need to complete a NRES.

If you are unable to Grandfather and you hadn’t previously imported the substance, then you cannot do a DUIN and must do a New Registration of an Existing Substance (NRES).

  • The system is not yet in place to allow purchase of letters of access to dossiers or data from lead registrants or substance groups

  • Nor is it easy to complete full data requirements for existing substances.

  • Not possible to purchase access to dossiers/data from substance groups.

  • So there are deferred deadlines for full registration data (similar to DUIN/grandfathering).

The steps include.

  • To submit an Inquiry dossier (including substance identity information).

  • After Inquiry, HSE will inform if any deferred registration applies.

  • To submit a registration dossier with data waivers.

  • To pay the registration fee to HSE.

  • Manufacture/importing may now commence.

Inquiry

The first step of any registration is to submit an Article 26 Inquiry. Anyone who has completed a DUIN and intends to register will also need to complete an Article 26 Inquiry. There are no provisions for pre-registration under UK REACH and pre-registrations previously submitted to ECHA are no longer valid in Great Britain.

An inquiry dossier is compiled using IUCLID, it should contain information about your company and the specific substance you intend to manufacture/import in Great Britain. The inquiry dossier is the same as the one required under EU REACH. The in-depth topic on Article 26 Inquiries gives more detail on the process.

The completed dossier should be uploaded on the Comply with UK REACH.

Conclusions

  • The next steps regarding UK REACH are unclear and in the large unknown.

  • Discussions are ongoing with key Government and industry stakeholders to ensure that a workable UK REACH regime is introduced.

  • This is an area to monitor and feed into as more information becomes available.

  • If you have not yet submitted your DUINs then do so as soon as possible and where you are importing new substances follow the NRES process.