The UK has withdrawn from the EU. The transitional period has ended on the 31st December 2020. The UK has confirmed that from 1st January 2021, Great Britain (GB)-only chemical regulations separate to those already in force in the rest of the EU will be implemented. Northern Ireland will remain within the EU Regulations for at least 5 years. The GB and EU systems run in parallel.

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European Union

 

ECHA have answered multiple questions concerning existing chemical registrations by UK companies with a clear statement. In order to continue supplying EU-27-based customers on the basis of your own REACH registration or biocide product authorisation, it will be necessary to either relocate to the EU-27 or to appoint a REACH Only Representative, or BPR Representative, within the EU-27/EEA.

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Arrow Regulatory offers an EU Representative service for both REACH and biocides from either our Irish or Austrian office  - contact us.

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United Kingdom

The UK government have confirmed that for EU companies wanting to continue to supply in Great Britain it will be necessary to open a UK office or appoint a REACH Only Representative, or BPR Representative.

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Arrow Regulatory offers a GB Representative service for both REACH and biocides from our Nottingham office - contact us.

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UK REACH

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The UK Government has updated its information on UK REACH and how that will operate after the transition period ends on 31st December 2020. The information can be found here.

 

In summary:

 

UK REACH starts on 1st January 2021. Anyone making, selling or distributing chemicals in the UK and the EU needs to follow UK REACH and EU REACH rules respectively.

 

Under UK REACH, manufacturers and importers have a duty to register chemicals that access the UK market. GB-based companies currently registered with EU REACH will no longer be able to sell into the EEA market without transferring their registrations to an EU/EEA-based organisation.

 

Under the Northern Ireland Protocol, the process for NI businesses moving to and from the EU under EU REACH will not change from 1st January 2021.  Further guidance will be published for NI businesses moving goods into the GB market.

 

EU REACH registrations held by UK-based companies will carry across directly into UK REACH (‘grandfathering’). The grandfathering process may be continued by providing basic information to the HSE by 30th April 2021. The information is submitted using the UK REACH IT system, ‘Comply with UK REACH’. The grandfathering process must be completed within 2, 4, or 6 years of 28th October 2021, depending on the Tonnage Band Deadline.

 

UK downstream users (i.e. companies not holding an EU REACH registration) currently importing chemicals from an EU/EEA country need to ensure the substances are covered by a valid UK REACH registration. These UK downstream users must notify the HSE using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU/EEA by 27th October 2021. A new registration must then be submitted within 2, 4, or 6 years of 28th October 2021.  Alternatively, the EU/EEA supply can appoint a UK-based Only representative (OR) to undertake the submission of the DUIN and subsequent registration, thereby relieving the UK importer of the responsibility.

 

As the UK will be operating an independent regulatory system, UK downstream users will no longer be able to rely on EU REACH authorisation decisions addressed to companies in the EU/EEA as of the 1st January 2021. All existing authorisations which have gone through the full authorisation process (and have a review date) will be recognised by UK REACH. This means that chemicals can continue to be used by UK companies who rely on these authorisations. New authorisation applications, and authorisations waiting for EU/ECHA approval, must be submitted to UK REACH.

 

Businesses can use the 'Comply with UK REACH' service to:

 

• validate existing UK-held EU registrations (‘Grandfathering’)

• submit downstream user import notifications (DUIN)

• submit new substance registrations

• submit new product and process orientated research and development (PPORD) notifications

 

Businesses will need to contact the HSE to ensure that they:

 

• validate existing UK-held product and process orientated research and development (PPORDs), known as ‘grandfathering’

• provide information on any authorisation matter, including new authorisation application, grandfathering of existing authorisations, and downstream user notifications of authorised uses

 

 

GB Biocidal Products Regulation (GB BPR)

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For EU active substance approvals and biocidal product authorisations still on-going at the end of the transitional period, it will be necessary for those companies wishing to continue marketing their products in Great Britain, to resubmit the application dossiers with UK HSE. In order to maintain marketing in the UK, the submission must be made within 90 days of the implementation date of 1st January 2021, if the UK was the original Rapporteur or Evaluating Member State under EU BPR and 180 days for any other EU Member State.

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Approved suppliers already listed in the EU Article 95 list will be automatically listed on the GB list but must transfer to a UK based Legal Entity by January 2023.

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