Brexit update: two months to UK-REACH

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It is likely that there will be two entirely separate regulatory regimes: UK-REACH and EU-REACH.

This post updates you on the UK REACH Regulation, the Government’s main instrument for gathering hazard information for forming UK chemical policy post Brexit.

Alchemy Compliance services for REACH compliance can be found here, or contact us.

Where we are

UK chemical companies will have to comply with UK REACH, which will become effective in January 2021.

As of 31st January 2020, the UK is no longer a Member State of the EU. A transition period is currently in place, until 31 December 2020, so that important EU regulations on the safe use of chemicals, such as REACH (Regulation 1907/2006) and CLP (1272/2008) will remain in force in the UK until then. The UK Government has ruled out an extension to the deadline.

The regulatory landscape after the end of this transition depends on the results of trade negotiations between the UK and EU. The UK Chemicals Industry [1] has called for:

  • Tariff-free trading terms
  • Partnership of UK authorities in ECHA, preventing the need for re-registration under a new UK REACH regulation
  • If there is no partnership, then regulatory alignment between EU REACH and UK REACH, to ease compliance with both systems.

None of these aspirations look likely to be fulfilled, because the UK Government’s preference for a trade deal based on Canadian or Australian models, with increasing regulatory divergence. The EU negotiating team have stated that regulatory alignment is necessary for frictionless, tariff-free trade.

It is therefore likely that there will be two entirely separate regulatory regimes: UK-REACH and EU-REACH. The UK will be seen as a ‘third party’ for purposes for complying with EU-REACH, so that UK companies will not be responsible for EU-REACH compliance when exporting to remaining EU countries. That responsibility will fall on the EU-based importer.

UK companies will have to comply with UK REACH, and will be responsible for any UK-REACH registrations if they manufacture substances or import substances from outside the UK.

Northern Ireland is currently still problematic from a regulatory viewpoint, and trading terms are being negotiated at UK–EU level in the ‘Northern Ireland Protocol’ (part of the UK draft Withdrawal Agreement) [2].

It is expected that the additional regulatory burdens will lead to short-term supply chain disruption. In the longer term, costs of chemical product in the UK will increase owing to costs of dual regulatory compliance, and some chemical substances will be withdrawn from the UK market.

Compliance with UK REACH

UK companies importing from the EU will be importers for the purposes of UK-REACH, and newly responsible for UK-REACH registrations

UK chemical companies will have to comply with UK REACH [3], which will become effective in January 2021. This requires manufacturers or importers to compile registration dossiers to demonstrate to the UK authority that they have data on the hazards of the substances under a ‘no data, no market’ principle.

UK companies holding EU REACH Registrations

UK companies currently holding EU registrations will have to transfer these registrations to a company in a remaining EU country, or see the registration lapse. A non-EU country cannot hold an EU-REACH registration.

For UK-REACH compliance, companies holding EU REACH registrations can benefit from a transition period of up to 6 years before providing full registration dossier to UK authorities, in a process called ‘grandfathering’. This extension of the transition period is a recent concession to the chemical industry, and will allow companies to spread costs over a longer period. Previous recommendations allowed only two years for the submission of the full dossier.

The grandfathering process has two stages:

  • By 30 April 2021, enter basic information into the new UK REACH IT system.
  • Within two to six years, supply a full registration dossier, depending on the tonnage and hazards of the substance (see Table).

The UK authorities plan to grandfather 12 000 EU registrations held by UK companies into the UK system.

UK companies, previously downstream users, newly requiring a registration

Before Brexit, UK companies importing chemical products from the EU would not require an EU-REACH registration, because registration was an obligation only for manufacturers, or importers sourcing from outside the EU.

UK companies importing from the EU would be regarded as downstream users (DUs) in EU-REACH. After the transition period ends on 1 January 2021, UK companies importing from the EU will be importers for the purposes of UK-REACH, and newly responsible for UK-REACH registrations.

Many smaller UK companies importing products from the EU will be faced for the first time with the responsibility of REACH-like registration procedures. If they lack the capacity or expertise that registration requires, they may have to rely on consultants for UK-REACH compliance, or on their EU suppliers appointing a ‘UK-only representative’ (UK-OR) to take over the burden (see only-representative route below).

There is a similar two stage process for UK-REACH registration in such cases.

  • Notification of intention to continue importing substances from the EU by 27 October 2021 (so-called DU Import Notification, DUIN)
  • Within two to six years, supply a full registration dossier, depending on the tonnage and hazards of the substance (see Table).

Potential registrants who have submitted a DUIN must then submit an enquiry dossier and are assigned a substance group (the equivalent of the EU SIEF). The substance group will then self-organise to produce a lead-dossier for the lead registrant and joint dossiers for other members of the group, the same as was required during the EU-REACH transition period (see Data gathering below).

DeadlineCriteria
28 October 20231000 tonnes/year
1 tonnes/year for CMR substances
1000 tonnes/year for substances with following classifications: Aquatic Acute 1, H400; Aquatic Chronic 1, H410.
Any substance on the EU Candidate List on 31 December 2020.
28 October 2025100 tonnes/year
Additional substances on UK Candidate List on 27 October 2023.
28 October 20271 tonne/year
Table: Deadlines for submission of full dossier for UK REACH

The Only Representative route to compliance

[back to Downstream user registration]

The regulatory burden of compliance with UK-REACH rests with the UK importer or the manufacturer, as these activities constitute ‘placing on the market’ in the UK.

As mentioned above, some UK companies that were downstream users in EU-REACH, will become responsible for UK-REACH registrations if they continue to import from the EU.

An alternative is for the EU supplier to appoint a UK-based Only Representative (OR) to undertake registrations on behalf of one or more UK importers. Only a non-UK company can appoint a UK-OR, and only a UK-based company can act as UK-OR.

The OR system can simplify access to the UK market for the non-UK supplier, and reduce the responsibilities for UK importers (who are then regarded as DUs).

Non-UK companies cannot set up a UK OR until after Brexit transition period has ended.

Similarly, UK-based exporters to the EU will be able to appoint EU Only Representatives from 1 January 2021 to facilitate trade with EU-based customers.

See our REACH services or contact us if you would like to know more about using Alchemy Compliance as your UK only representative.

Data gathering

[back to Downstream user registration]

For most substances, the way to fulfil data requirements for the UK REACH dossier is to purchase a ‘Letter of Access’ from data holders

UK-REACH has the same data requirements for registration as EU-REACH. The exact testing requirements depend on the tonnage, the physical properties of the substance, and sometimes the uses.

For the EU-REACH transition period, which ended in May 2018, industry had to self-organise into ‘Substance Information Exchange Fora’ (SIEFs) in order that each substance had only one registration (one-substance, one registration principle). The Registration comprised a lead-registration, and joint registrations based on the same dataset, with each joint registrant adding company-specific data.

SIEFs no longer have official status, although many operate informally to support updates to the EU dossier.

For most substances, the way to fulfil data requirements for the UK REACH dossier is to purchase a ‘Letter of Access’ (LoA) from data holders, likely to be the lead-registrant in the EU-REACH Registration.

If the data cannot be purchased, the UK-REACH registrant may need to fulfil through read–across to similar substances, structure–activity relationships, or testing. Animal testing is considered a last resort due to animal welfare concerns. The UK Authorities believe there should be no additional testing for substances already registered under EU-REACH.

UK-REACH IT system and fees

The UK has developed its own UK-REACH IT system to handle the notifications and registrations. The system is based on the EU REACH IT portal, which handles all notifications and registrations. The UK portal is not yet available.

Registrations for REACH are prepared in an electronic format called IUCLID.

The UK Authority will charge fees for new UK REACH registrations, depending on tonnage band and company size. The grandfathering process will not incur fees.

How to prepare for UK REACH

The UK chemical company needs to be confident that their supply chains will continue to function after the transition period finishes.

There is much preparation required for companies involved in EU–UK trade, particularly around customs arrangements, transport, VAT, and import and export documentation. Companies trading across the new border need to decide who will fulfil each duty.

Chemical companies face significant additional regulatory burden, in preparing for UK-REACH.

The most important task for UK manufacturers and importers (from the EU and beyond) is check the identity and tonnages of substances in their products. Imported mixtures need to be broken down into component substances, as REACH Registration applies only to substances.

Once the company understands the identity and amounts for each substance, they can establish what registrations will be required, estimate the costs for compliance, and decide whether products are commercially viable.

For each substance, the company should should check the supply chain to establish the stakeholders and assign responsibilities. The UK chemical company needs to be confident that their supply chains will continue to function after the transition period finishes.

UK importers newly responsible for UK REACH should decide their capacity for the extra regulatory work and whether to engage a consultancy service to help out. They may wish to petition their non-UK manufacturers or formulators to appoint an OR in the UK.

UK companies currently holding EU registrations will have to transfer these registrations to a company in a remaining EU country, or see the registration lapse. A non-EU country such as the UK cannot hold an EU-REACH registration.

Summary

The UK will have a new chemical regulatory scheme from 1 January 2021, entirely separate from that of the EU. EU and UK REACH are likely to diverge in the coming years, as Europe implements its Green Deal and new chemicals strategy and the UK Government ‘takes back control’ of its regulations.

UK divergance from the regulatory framework of the EU has an inherent cost to the UK chemicals industry, and a duplication of much effort that has particularly gone into EU REACH.

The UK will not have access to the EU chemicals database, making UK chemical policy less robust and safe for human health and the environment than that of the EU.

References

[back to Where we are]

[1] Britain at work; Chemical Industries Association; November 2019.

[2] Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community; 19 October 2019.

[3] Exiting the European Union Consumer Protection, Environmental Protection, Health and Safety; The REACH etc. (Amendment etc.) (EU Exit) Regulations, 2019.

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