The Impact of a ‘no-deal’ Brexit on your REACH Responsibilities
With the United Kingdom due to leave the European Union in less than 2 months, chemical manufacturers and businesses concerned with chemical supply chains must now be undertaking contingency planning to ensure continued regulatory compliance in the UK and EU, and minimise disruption to their business activities.
As the UK prepares to withdraw from the EU on 29th March 2019 much uncertainty remains over the terms of departure. With the UK parliament voting against the initially agreed withdrawal agreement, and the UK Prime Minister, Theresa May, now wishing to reopen negotiations with Brussels, there is an increasing likelihood of the UK exiting the EU with no deal agreed.
In the event of a ‘no-deal’ Brexit, EU legislation – including the REACH regulation – will cease to apply in the UK. This scenario will have a number of implications for chemical manufacturers and companies involved in chemical supply chains in the UK and EU, including:
- EU REACH registrations held by UK-based companies will no longer be valid in the EU.
- Companies will need to ensure compliance with the new regulatory framework for chemicals that will be established in the UK in order to maintain access to the UK market.
In recent months, the UK Government has released advice on the actions that UK-based companies which manufacture, import or export chemicals under REACH will need to take to ensure continued regulatory compliance in the EU and the UK following Brexit.[1,2]
The European Chemicals Agency (ECHA) has also published advice online outlining the actions UK businesses will need to take to ensure continued REACH compliance and maintain access to the EU market.[3, 4]
Maintaining continued access to the UK market under a ‘no-deal’ Brexit
The UK Government has confirmed that in event of a ‘no-deal’ Brexit, the EU REACH regulation will be transferred into UK law with any necessary amendments made to enable its implementation as a UK national regulatory system. This new UK framework will be referred to as ‘UK REACH’, with the Health and Safety Executive (HSE) taking over ECHA’s role as the lead regulatory authority for chemicals in the UK.
UK REACH will operate as an entirely independent regulatory framework from EU REACH, meaning companies which manufacture, import, or exporting substances to and from the EU and UK will need to ensure that substances (including those in mixtures and articles) are registered with the ECHA and HSE separately in order to maintain/gain access to both markets.
Upon UK REACH coming into force, UK chemical manufacturers and importers/distributors would need to take the following actions to ensure regulatory compliance in the UK:
- Existing EU REACH registrations held by UK businesses will be moved directly into UK REACH. However, companies will need to validate their registrations via opening an account with the new UK REACH IT system, and providing some basic information within 60 days of the UK leaving the EU. A complete technical data package for the relevant tonnage band will then be required to be submitted to the HSE within 2 years of the UK leaving the EU. The information requirements for UK REACH will be identical to those currently laid down in the EU REACH regulation.
- Downstream users or distributors of EU-imported substances will need to submit ‘notifications’ for those substances via the new UK REACH IT system within 180 days of the UK leaving the EU. A complete technical dossier for notified substances will again need to be submitted to the HSE within 2 years of the UK leaving the EU.
- Existing EU REACH authorisations held by UK-based companies will be moved directly into UK REACH. Businesses will need to provide the HSE with technical information relating to the authorisation within 60 days of the UK leaving the EU.
- UK downstream users of an EU REACH authorisation held by an EU company will need to confirm to the HSE that they are an existing authorised downstream user under EU law. Companies will also be required to notify the HSE of the existing EU authorisation, any conditions set out in the authorisation, and the identity of the substance supplier within 60 days of the UK leaving the EU.
A tabulated summary of actions that will be required to be taken under different scenarios for chemical manufacturers, or those involved with chemical supply chains, has also been made available by the HSE at http://www.hse.gov.uk/brexit/ag-scenario-table.pdf.
Maintaining continued access to the EU market under a ‘no-deal’ Brexit
In the event of a ‘no-deal’ Brexit, UK-based companies will no longer be able to act as registrants for chemicals under REACH - all existing UK-held REACH registrations will cease to be valid from the day the UK’s withdrawal. UK businesses will therefore need to take the following actions in advance of the UK leaving the EU in order to maintain access to the EU market:
- UK chemical manufacturers will need to transfer their existing REACH registrations to an EU-based legal entity – e.g. an affiliate or an ‘Only Representative’’ – or seek agreement with their EU-based customers to register the chemicals themselves.
- UK-based companies who currently import chemicals from non-EU countries into the EU will need to transfer their importing activities to an EU-based legal entity.
- UK-based companies will no longer be able to act as Only Representatives for non-EU companies unless they relocate to an EU-27 (or EEA) country. Otherwise, the non-EU manufacturer must assign a new Only Representative based in one of the EU-27 (or EEA) countries.
- REACH authorisations granted to UK-based companies will no longer be valid in the EU. UK authorisation holders will need to transfer authorisations to an Only Representative in the EU in order to maintain the authorisation under EU REACH.
Contingency planning for a ‘no-deal’ Brexit
UK-based chemical manufactures and companies involved in chemical supply chains should now be making contingency plans for a ‘no-deal’ Brexit to ensure continued regulatory compliance and maintained marker access in both the EU and UK. Such planning includes:
- Exploring options and making arrangements for the transfer of REACH registrations to EU-based affiliates or ‘Only Representatives’.
- Importers of chemicals from non-EU countries should consider arrangements for establishing themselves in the EU.
- Chemical manufacturers should identify their existing REACH registrations and begin considering preparations for validating them under the new UK REACH framework when it enters into force.
- Chemical manufacturers should review data packages for their existing REACH registrations and identify any data sharing issues in preparation for submitting a full registration data package within 2 years of UK REACH coming into force.
- Companies should identify all chemicals they currently import from the EU and begin preparations for making notifications for these substances under UK REACH.