Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a ‘no deal’ scenario. The DEFRA have therefore continued to work on the issues that would arise when leaving EU REACH.
One question was the status of authorisation applications still in progress at the time of exit. The effect of a recent European Court of Justice judgement against the European Commission which overturned some existing authorisations, combined with the extension of Article 50 to the end of October, means that there is an increasing backlog of EU decisions which will be undecided at the time of exit. Further to extensive discussions with stakeholders, the Government has developed a solution striking a balance between enabling business continuity and maintaining rigorous regulation of chemicals.
Under a ‘no-deal’ scenario, there will be a number of applications for authorisation for Substances of Very High Concern (SVHCs) which will not have been processed by ECHA and the EU Commission before the day that UK leaves the EU. The sunset date for some of those substances has already passed, or will pass before exit day. Where the latest application date (LAD) or sunset date for a substance passes before exit day, use of the substance in the UK would have to cease from exit day until such time as a UK authorisation is granted following a fresh application under UK REACH. This would have a significant impact on businesses which rely on being able to use substances while awaiting authorisation decisions.
The extension of Article 50 to 31 October has also meant that there will be more UK applicants submitting their applications to ECHA (rather than the UK authorities) to be able to continue to use those substances. After exit, they will need to redirect their applications to the UK authorities but they will not be covered by the provision that enables continued use after the sunset date where a decision is still pending. This is because they will not have been able to make their UK applications before the LAD.
To prevent supply chains being interrupted and businesses becoming non-compliant due to EU Exit, the Government has laid a Statutory Instrument (SI), which amends the REACH SI laid on 9 January 2019. This SI will set new LAD and sunset dates for those SVHCs which are listed in Annex XIV of UK REACH with current LAD or sunset dates after 29 March 2017. The SI moves the LAD and sunset dates to 18 months after exit day. The amending instrument therefore provides industry with greater business certainty that the substances for which they have applied for authorisation will be attended to by the UK regulatory authorities.
There are two categories of businesses that will benefit from the extension of the LADs and sunset dates. The first is the applicant if they were a UK entity. The second is a UK downstream user that uses the substance on the basis of an application by a UK entity or an EU-27 company. If the application was made by a UK entity, the new transitional provision will not apply if Article 127G applies to the application (i.e. if ECHA’s opinion is with the Commission to make a decision), as that already allows for continued use until such time as the UK application is determined. If the application was made by anyone else, the new transitional provision will not apply if the application was determined before exit day.
UK businesses wishing to continue their manufacture or use of the substance beyond the new sunset date will need to apply to the HSE for a UK REACH authorisation within 18 months of the UK leaving the EU. This will ensure a clear process and timescale for transitioning the authorisation procedure into UK REACH and contribute to the effective management of chemicals in the UK.
The extension of Article 50 has also impacted on timeframes set in the REACH SI. The amending SI has made the necessary corrections to reflect the original intention of the SI. As a result, where ‘grandfathering’ was specified to apply to any substance registered by a UK legal entity within 2 years prior to the UK leaving the EU, grandfathering will now apply to all substances registered by a UK entity at any point on or after 29 March 2017.
This SI also makes some minor amendments to reflect changes being made by another exit SI. Those amendments are to the Medical Devices Regulations 2002, which are cross-referred to in the UK REACH legislation. Furthermore, the SI makes some technical amendments to the REACH SI relating to recent amendments to the EU REACH Regulation in order to make them operable in the domestic context.
The amending SI and explanatory notes are available here. The SI will now make its way through the parliamentary processes, with the intention that it will come into force before the UK leaves the EU. Guidance on the HSE website will be updated to reflect these provisions.