UK REACH registration and Only Representation, what businesses supplying Great Britain need to know
Businesses supplying chemicals into Great Britain need to consider their obligations under UK REACH separately from those that apply under EU REACH.
UK REACH has applied in Great Britain since 1 January 2021. Although it retains many of the principles of EU REACH, the two systems operate independently. An EU REACH registration does not, by itself, provide UK REACH registration coverage for imports into Great Britain.
For businesses based outside Great Britain, this raises an important question: who is responsible for meeting UK REACH registration requirements?
In many cases, responsibility will sit with the GB importer. However, manufacturers, formulators and article producers established outside Great Britain can appoint a GB based Only Representative, or OR, to take on the relevant UK REACH importer obligations. HSE confirms that an OR must be established in Great Britain and assumes the relevant legal requirements that would otherwise apply to the GB importer.
RPA supports businesses through UK REACH registration and can act as Only Representative for overseas suppliers. The starting point is not the registration dossier itself. It is understanding the substances, volumes and supply chains involved, and establishing which regulatory requirements apply.
When is UK REACH registration required?
A GB based legal entity intending to manufacture or import a substance into Great Britain at or above 1 tonne per year is generally required to register that substance with HSE, unless an exemption or other relevant provision applies.
Importantly, registration applies to substances, rather than mixtures themselves.
Where a company imports a formulated product containing several substances, it is the aggregated annual quantity of each individual substance that needs to be considered when assessing whether the 1 tonne registration threshold has been reached. Registration is also per substance, per legal entity.
Registration can also apply in certain limited circumstances to substances contained in articles, including where substances are intended to be released during use.
The position can therefore become more complicated where the same substance is present in several products, or where an overseas supplier has several GB customers.
When RPA’s Chemicals team considers a new enquiry, the initial assessment will typically establish:
- what substances are being supplied into Great Britain
- whether they are supplied on their own, in mixtures or, where relevant, in articles
- which legal entity is importing them
- the expected annual quantity of each substance
- whether valid UK REACH registration coverage already exists
- whether any exemptions or transitional arrangements may be relevant.
Sometimes this confirms that a registration is required. Just as importantly, it can establish that registration is not currently required.
Getting this assessment right at the outset can avoid unnecessary work and provide a clear basis for anything that does need to be done.
Who is responsible for UK REACH registration?
Where a substance is imported into Great Britain, the registration obligation would normally sit with the GB importer.
This is particularly important for supply chains involving the EU. A GB business that was previously a downstream user under EU REACH may now be an importer under UK REACH when it sources substances directly from the EU or EEA.
For an overseas supplier with multiple GB customers, this can leave individual importers responsible for ensuring that their imports have the necessary UK REACH registration coverage.
There is, however, another option.
What is a UK REACH Only Representative?
Under Article 8 of UK REACH, a manufacturer, formulator or producer of articles established outside Great Britain can appoint a natural or legal person established in Great Britain as its Only Representative.
The Only Representative takes responsibility for complying with the relevant legal requirements that would otherwise apply to the GB importers covered by the appointment.
An OR must be established in Great Britain, have sufficient background in the practical handling of substances and the information relating to them, and be appointed by mutual agreement with the overseas manufacturer, formulator or article producer.
For an overseas supplier, this can provide a more centralised way of managing UK REACH obligations across its GB supply chain.
It can also reduce the UK REACH responsibilities placed on the GB importers covered by the arrangement. HSE specifically identifies Only Representation as a mechanism that may help maintain access to the GB market by reducing responsibilities for importers.
What does an Only Representative actually do?
Only Representation can sometimes be seen primarily as a mechanism for obtaining a UK REACH registration number.
In practice, the responsibility is broader and ongoing.
When RPA acts as an Only Representative, it needs to maintain a clear understanding of the substances and supply chains covered by its appointment.
This includes understanding the substances and quantities being imported, maintaining appropriate records of the GB importers covered by the appointment, ensuring relevant UK REACH requirements are met, and communicating with both the overseas supplier and its GB supply chain.
Changes also need to be monitored.
A client may introduce a new product. A new GB customer may begin importing. Annual volumes may increase. A substance may move into a different tonnage band. Regulatory requirements themselves may also change.
Any of these developments can affect the UK REACH position.
RPA therefore approaches Only Representation as an ongoing regulatory compliance responsibility, rather than simply an administrative mechanism for obtaining a registration number.
Why might an overseas supplier appoint an Only Representative?
An OR arrangement will not necessarily be the right solution for every supply chain.
However, there can be both regulatory and commercial benefits.
Without an OR, individual GB importers may have their own UK REACH responsibilities. For an overseas manufacturer supplying several customers, regulatory responsibility can therefore sit across a number of different businesses.
An OR arrangement can instead allow the relevant importer obligations for the covered supplies to be managed centrally.
This can reduce the UK REACH responsibilities placed on GB customers and give the overseas supplier greater oversight of the arrangements supporting its access to the GB market.
It can also provide continuity as the customer base develops. New customers and changes to supply arrangements still need to be assessed and appropriately managed, but the regulatory arrangements are not necessarily dependent upon each individual customer establishing its own registration coverage.
A UK REACH registration is a process, not just a submission
For a new UK REACH registration, the route depends on the substance and its existing registration history.
The first stage is to establish the substance identity, the legal entity requiring coverage and the expected tonnage.
The first formal step of any new registration is then an Article 26 inquiry. The inquiry dossier is prepared using IUCLID and submitted to HSE through Comply with UK REACH.
Once an inquiry is successful, the prospective registrant’s contact details are shared with existing registrants, grandfathered registrants and other successful inquirers for the substance. This enables engagement in the data sharing process.
From there, the registration can broadly follow one of two routes.
New Registration of an Existing Substance, NRES
Where a substance was previously registered under EU REACH, a new UK registrant may be able to defer submission of the full information requirements. HSE confirms whether this is available when the Article 26 inquiry becomes successful.
Where this applies, an initial New Registration of an Existing Substance, NRES, dossier can be submitted.
This initial registration dossier contains the information needed for that stage of the registration but does not normally contain the full hazard and test data package that will ultimately be required.
Once the NRES dossier has passed the relevant checks, a UK REACH registration number can be assigned. HSE reporting confirms that NRES registrations undergo regulatory checks before a registration number and registration date are issued.
However, obtaining the registration number is not necessarily the end of the process.
The registrant subsequently needs to engage with the other registrants for the substance to address data sharing and the information that needs to be submitted jointly.
UK REACH retains the principle of one substance, one registration. Where there is more than one registrant for a substance, co registrants should agree who will act as lead registrant, while each legal entity must still submit its own registration dossier.
The full information requirements then need to be addressed by the applicable deadline.
This later stage is where the required information concerning the properties, hazards and uses of the substance becomes particularly important. UK REACH requires registrants to collect information on the properties and uses of substances and assess their hazards and potential risks.
Where the NRES route is not available
The position is different where the NRES route, including deferral of the full information requirements, is not available.
For substances that had not previously been registered with ECHA under EU REACH, HSE requires the information requirements for the relevant tonnage band to be fulfilled in their entirety before registration is granted, taking account of appropriate data waivers.
Where other registrants for the substance exist, this may involve working with them on data sharing and the joint elements of the registration.
Where there are no other registrants, the business may need to progress as the sole registrant and assemble the information necessary to satisfy the applicable registration requirements.
The distinction between these routes is important.
Where NRES deferral is available, a UK REACH registration number may be obtained before the full information requirements are subsequently addressed. Where deferral is not available, the applicable information requirements need to be fulfilled before registration can be granted.
Establishing which route applies at an early stage therefore provides more time to address substance identity, existing registrants, data access and the hazard and safety information that may ultimately be required.
What about the UK REACH transitional registration deadlines?
Separate transitional provisions exist for certain businesses that were previously downstream users or distributors under EU REACH and continued importing into Great Britain following the end of the transition period.
The current deadlines for submitting the relevant full registration information are 27 October 2029, 27 October 2030 and 27 October 2031, depending on tonnage and hazard profile.
The earliest deadline applies to substances at 1,000 tonnes or more per year and certain substances meeting specified hazard criteria. The subsequent deadlines extend to lower tonnage bands, with 27 October 2031 covering substances at 1 tonne or more per year that do not fall within an earlier deadline.
These transitional arrangements should not be confused with the position for a business introducing a substance into Great Britain for the first time today.
If a new registration is required and the downstream user import notification provisions do not apply, HSE states that a complete registration is required before manufacture or import into Great Britain reaches 1 tonne per year. No transitional provisions apply in those circumstances.
The policy position is also continuing to develop. Defra has committed to exploring alternative arrangements for transitional registrations, and the current deadlines were extended to facilitate this work.
Businesses should therefore establish which route applies to their particular circumstances rather than assuming that a transitional deadline is available.
How RPA supports UK REACH registration and Only Representation
RPA supports overseas manufacturers, formulators and other businesses seeking to establish or maintain compliant access to the Great Britain market.
Support can begin with establishing the regulatory position.
RPA can review substances, products, expected tonnages and supply chains to understand which UK REACH requirements apply and where registration may be required.
Where an Only Representative arrangement is appropriate, RPA can act as the UK REACH Only Representative and take on the relevant importer obligations for the supplies covered by its appointment.
Registration support can include substance identification, preparation and submission of Article 26 inquiries, establishing the appropriate registration route, engagement with other registrants, consideration of information and data requirements, preparation of registration dossiers and submission through Comply with UK REACH.
Importantly, where an initial NRES registration is possible, support does not need to end when the UK REACH registration number is issued. RPA can continue to support subsequent engagement with other registrants, data sharing and the work required to meet the applicable full information requirements.
Where RPA acts as OR, its involvement can also continue through the ongoing Only Representative appointment, maintaining the appropriate records and regulatory oversight and working with clients as products, volumes and GB customer bases change.
UK and EU REACH sit at the centre of RPA’s Chemicals & Product Regulation work. This enables RPA to combine the responsibilities associated with Only Representation with the wider technical and regulatory expertise required to understand and manage a client’s compliance position.
UK REACH may only be one part of the regulatory picture
Achieving UK REACH registration coverage does not necessarily mean that a chemical product is ready to be placed on the GB market.
Depending on the product, its composition and intended use, other regulatory requirements may also need to be considered.
These can include GB CLP, including classification, labelling and packaging requirements, together with requirements relating to safety data sheets.
There may also be sector or product specific legislation governing how particular products can be placed on the market in Great Britain. Depending on the product, this could introduce additional requirements concerning areas such as composition, labelling, claims, testing, technical information or import controls.
The substances present in a product may introduce further considerations. Depending on the circumstances, these could include controls relating to explosives precursors or requirements concerning the transport of dangerous goods.
The precise combination of legislation will be different for every product.
The important point is that UK REACH registration should not be considered in isolation.
When RPA’s Chemicals team considers a new substance or product entering the GB market, the aim is to understand the wider regulatory picture and identify what else the client may need to consider.
Planning to supply chemicals into Great Britain?
Businesses already supplying, or planning to supply, chemicals into Great Britain should establish their UK REACH position as early as possible.
The starting questions are often relatively straightforward:
What is being supplied? Which substances are involved? Who will import them? At what volumes? What registration coverage already exists?
From there, RPA can help establish whether UK REACH registration is required, whether an Only Representative arrangement would be appropriate, which registration route applies and what other regulatory requirements may need to be considered.
To discuss UK REACH registration, Only Representation or the wider regulatory requirements associated with supplying chemical products into Great Britain, please contact RPA’s Chemicals & Product Regulation team.