New UK-REACH regulation

Posted by

It was undoubtedly good news for the UK chemicals industry that the Trade and Cooperation Agreement was reached

This post updates you on the UK-REACH Regulation, now that the Brexit transition period is finished and the new Regulation has come into force.

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

UK–EU Trade and Cooperation Agreement

From 31st January 2020, the UK was no longer a Member State of the EU. A transition period ran until 31 December 2020, during which UK chemicals regulation remained aligned with the EU. During the transition period, the UK Government and the EU negotiated a new trade agreement to define their future relationship.

The Trade and Cooperation Agreement [1] was published on 24th December 2020, coming into force just a week later.

It was undoubtedly good news for the UK chemicals industry that the Trade and Cooperation Agreement was reached at the last minute, as it secured some important benefits, when having no trade deal appeared to be a likely outcome:

  • Tariff- and quota-free trading terms on the movement of goods;
  • A commitment to cooperation on chemicals, facilitating the exchange of non-confidential information between the EU and UK authorities, including cooperation on electronic formats and tools used to store data;
  • Commitment to implementing a version of the UN GHS [2] for hazard classification, safety data sheet preparation, and labelling.

However, the Agreement falls short of what the UK Chemicals Industry wanted [3] for chemical regulation, particularly:

  • Partnership of UK authorities in ECHA, preventing the need for re-registration under a new UK REACH regulation;
  • Alignment between the UK and EU chemicals regulations, to ease compliance with both the UK and EU systems.

This article examines the new UK regulatory landscape for chemicals under UK REACH.

UK REACH transitional measures for registration

UK chemical policy will be 8 years behind that of the EU, because the new data will not be available until 2026, the last registration deadline for UK REACH

UK chemical companies will have to comply with a new UK-REACH regulation, which became effective in January 2021 [4].

UK REACH is the term used by the UK authorities for the legislation, but it relates only to GB; Northern Ireland remains under the EU REACH. This causes some difficulties for GB companies who wish to market products in Northern Ireland, particularly regarding labelling of products with the Unique Formula Identification (UFI) code.

The UK authority no longer has access to the confidential parts of EU chemicals database. In order to reproduce the information, and inform UK chemicals policy, they will oblige UK chemical companies to compile new registration dossiers, duplicating the work they did between 2012 to 2018 in providing chemical data to the European Chemicals Agency (ECHA) .

This puts a tremendous burden on the UK chemical industry. The Chemical Industry Association has estimated the cost for UK REACH registration to be greater than £1 billion [5].

UK chemical policy will be 8 years behind that of the EU, because the new data will not be available until 2026, the last registration deadline for UK REACH.

UK REACH has some transitional arrangements to ease the burden a little by spreading the costs of registration over two to six years.

Grandfathering EU-REACH Registrations into UK REACH

Companies who held EU-REACH registrations for substances between 29 March 2017 (the date the UK notified the EU of its intention to leave) and the end of 2020 can benefit from a process called grandfathering, whereby the UK authorities adopt EU-REACH registrations.

Companies complete the grandfathering process in the following steps:

  • Open an account on the new UK REACH IT system called ‘Comply with UK REACH’;
  • By 30 April 2021 (120 d after end of transition period), upload a IUCLID 6 dossier, redacted for information which you do not have rights (eg because the EU SIEF contract only covered EU registration). The dossier should contain information at least as given in REACH Annex VI, but can be a full dossier if you have rights to all the data;
  • Include the EU registration number, the date of the EU registration, and whether there is an outstanding decision from ECHA concerning the registration;
  • On successful dossier submission, a UK REACH registration number is issued;
  • The potential registrants for a particular substance are put in a substance group (similar to the EU SIEF) to negotiate data access, and decide which company will be lead registrant (under the ‘one substance, one registration’ principle);
  • Supply a full registration dossier within two to six years, depending on the tonnage and hazards of the substance (see Table).

DUINs for UK companies importing from the EU

The OR system can simplify access to the UK market for the non-UK supplier, and reduce the responsibilities for UK importers

Before 1 January 2021, UK companies importing chemical products from the EU would not require an EU-REACH registration, because they would be downstream users (DUs).

After 1 January 2021, UK companies importing from the EU will change to being importers for UK REACH, and therefore be newly responsible for UK-REACH Registrations.

For these cases, the process for registration is as follows:

  • For all chemical imports from the EU, the company should compile a list of substances (including ingredients of mixtures) for which they act as importer at > 1 tonne per year;
  • On the ‘Comply with UK REACH’ website, register as a downstream user or distributor to obtain a DUIN number for your company;
  • By 27 October 2021: notification of intention to continue importing those substances from the EU (so-called DU Import Notification, DUIN). The data is supplied on a Microsoft Excel sheet. Only company details and substance identity are mandatory information requirements. Other information, such as analytical and spectral data, can be provided if available;
  • Potential registrants who have submitted a DUIN must then submit an enquiry dossier (so-called Article 26 enquiry) and proceed with a new registration;
  • Supply a full registration dossier within two to six years, depending on the tonnage and hazards of the substance (see Table).

Many smaller UK companies lack the capacity or expertise that registration requires, and may request that their EU suppliers appoint a ‘UK-only representative’ (UK-OR) to take over the burden.

Only a non-UK company can appoint a UK-OR, and only a UK-based company can act as UK-OR.

For UK only representative services see here, or contact us.

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).

Table: Deadlines for the submission of a full dossier for UK REACH

[Back to Grandfathering] [Back to DUINs]

DeadlineCriteria
28 October 2023 (2 years, plus 300 days from end of transition period)> 1000 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 2025 (4 years, plus 300 days from end of transition period)> 100 tonnes/year
Additional substances on UK Candidate List on 27 October 2023.
28 October 2027 (6 years, plus 300 days from end of transition period)> 1 tonne/year

Exporting to the EU

There are now two entirely separate regulatory regimes: UK REACH and EU REACH. The UK are a ‘third party’ for purposes for complying with EU REACH, and UK companies have no obligations for compliance with EU REACH. Those obligations, eg for EU-REACH registration, supply of compliant safety data sheets, and labelling, fall on the EU-based importer.

To relieve the burden on the EU-based importer, the UK-based supplier can now appoint an EU-based only representative (OR), in particular to take care of REACH Registrations.

They can provide safety data sheets, labelling and translations on a voluntary basis.

GB-based companies can no longer hold an EU-REACH Registration. These registrations should have been transferred before the end of 2020, but there are currently ca. 2900 registration dossiers currently held by UK companies at risk of annulment.

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.

Regulatory divergence has an inherent cost to the UK chemicals industry, and a duplication of much effort that has particularly gone into EU REACH. In particular, the cost of UK-REACH registrations will put the UK chemicals industry at a competitive disadvantage compared to EU companies.

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

In the longer term, costs of chemical product in the UK will inevitably increase owing to costs of dual regulatory compliance, and some chemical substances will be withdrawn from the UK market on economic grounds.

References

[Back to UK-EU Trade Agreement] [Back to UK REACH transition]

[1] Trade and Cooperation Agreement Between the European Union and the European Atomic Energy Community, of the One Part, and the United Kingdom of Great Britain and Northern Ireland, of the Other Part; 24 December 2020.

[2] Globally Harmonized System of Classification and Labelling (GHS); Eighth Revised Edition; United Nations; 2019.

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

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

[5] Peter Foster in the Financial Times: UK chemical industry warns of £1bn cost to duplicate EU regime; 3 August 2020.

One comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s