Guidance for new registrants under UK REACH
Any GB-based legal entity intending to manufacture or import a substance into Great Britain (England, Scotland and Wales) at or above 1 tonne per year is required to submit a registration to HSE for that substance.
Though registration is not required for mixtures (formulations), the substances that comprise a mixture must be registered if the aggregated import volumes for any of those substances reach 1 tonne or more per year.
Registration is per substance, per legal entity.
If you have previously placed chemicals on the GB market as a downstream user or distributor under an EU REACH registration, for those substances downstream user import notification provisions may apply to you.
Who is this guidance for?
- GB-based companies that manufacture in or import substances into GB in quantities of 1 tonne or more per year.
- GB-based companies that had submitted a registration dossier to ECHA via REACH-IT but did not receive a registration number prior to the date of Exit.
- Manufacturers, formulators or article producers based outside of GB intending to appoint a GB-based Only Representative (OR) to take on the registration responsibilities of their GB-based importers.
If you have determined that a new registration is required, and the provisions for downstream user import notifications do not apply to you, a complete registration will be required prior to the manufacture or import into GB reaching 1 tonne per year. In such circumstances, no transitional provisions will apply.
If, prior to 1 January 2021 when the transition period ended, you imported substances or mixtures from the EU or imported from outside of the EU under an Only Representative agreement, you will have been regarded as a downstream user or distributor. Therefore, you may be able to take advantage of transitional provisions allowing you to effectively defer your registration obligation. Find out more about downstream user import notifications.
Article 26 Inquiry
The first step of any new registration is to submit 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There are no provisions for pre-registration under UK REACH and pre-registrations previously submitted to ECHA are no longer valid in GB.
An inquiry dossier is compiled using the freely-available IUCLID software package and contains information about your company and the specific substance you intend to manufacture/import in GB.
The process for compiling an inquiry dossier is analogous to the process under EU REACH and the requirements are the same. Therefore, ECHA's manual How to prepare an inquiry dossier remains a valid guide. There is also a helpful video to guide you through the process of creating an inquiry dossier.
Inquiry dossiers can be submitted to HSE via the Comply with UK REACH service on GOV.UK.
Once you have successfully inquired about a substance and received your inquiry number, your contact details (as input during the 'account creation' process), or the contact details of your appointed Third Party Representative (TPR) will be shared with existing registrants, grandfathered registrants and other successful inquirers regarding that substance. This will enable you to engage in the data sharing process.
Registration
Under UK REACH, as under EU REACH, registrations are to be submitted jointly, the concept of 'one substance, one registration' has been retained. Each legal entity must still submit their own registration dossier. New registrations must be accompanied by the appropriate registration fee.
If there is more than one registrant for a substance, co-registrants should agree between themselves who the "lead registrant" will be.
Lead registrant responsibilities.
For substances that have not previously been registered with ECHA under EU REACH, the information requirements for your tonnage band must be fulfilled in their entirety before your registration is granted, taking into account appropriate data waivers.
For substances that were previously registered under EU REACH, which you are intending to manufacture or import into the UK for the first time, you will still be required to submit a registration. However, it may be that you are able to defer the submission of the full information requirement such that you are able to share data with other registrants and grandfathered registrants. If this applies to you, you will be informed at the point your Article 26 inquiry dossier becomes successful.
In all cases, once you have received your inquiry number you will be able to submit your registration dossier via the Comply with UK REACH service on GOV.UK.
Registration dossiers are compiled using the IUCLID software package. As with inquiry dossiers, the process and requirements for registration dossiers are the same as under EU REACH, therefore ECHA's manual How to prepare registration and PPORD dossiers can be used to help create your registration dossier.