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THE BRIEF FBRUARY 2019

This article appears in the January 209 edition of Valemus Law's THE BRIEF, a monthly email newsletter containing the latest legal news and opinion from our lawyers. To download your copy, please click on the button above. To subscribe to our monthly news round-ups, please email info@valemuslaw.com with 'Subscribe to The Brief' in the subject line.

European Commission publishes notice to stakeholders on chemicals regulation after Brexit

Reproduced by kind permission from Practical Law

On 26 February 2019, the European Commission published a notice to stakeholders on chemicals regulation after Brexit. The notice clarifies the following points on registration and authorisation:

  • Subject to any transition period agreed if a withdrawal agreement is concluded, the UK will be a third country (that is, not a member of the EU) from the withdrawal date (30 March 2019, 00:00 hours Central European Time). REACH registrations held by manufacturers, producers, importers or only-representatives (ORs) based in the UK will not be valid from the withdrawal date. To continue to access the EU market, UK registrants will need to either transfer their registration to manufacturers or importers in an EU-27 member state or appoint an OR in an EU-27 country as the registrant for the substance. European Chemicals Agency (ECHA) have produced guidance on how to transfer registrations.
  • Manufacturers or importers in a third country currently using a UK-based OR will need to transfer their registration to an OR in an EU-27 member state.
  • Importers based in the UK supplying substances in EU-27 member states must ensure that the manufacturer or producer in the third country from which they are importing appoints an OR in an EU-27 member state as a registrant for the substance.
  • Downstream users will need to check if the substances they use are registered by a registrant based in the UK or an EU-27 member state. If the registrant is based in the UK, the downstream user will need to identify an alternative supplier based in an EU-27 member state, check with the UK-based registrant that it intends to appoint an OR based in an EU-27 member state or register the substance themselves as an importer or OR appointed by the UK-based registrant. ECHA has published a list of substances that are only registered by UK-based registrants.
  • Where the joint registration of a substance is by a lead registrant based in the UK, it will become invalid so that either one of the other members of the joint submission that is based in an EU-27 member state will need to take over as lead registrant or the UK-based lead registrant will need to transfer the registration to a manufacturer or importer in the EU-27 or appoint an EU-27 OR.
  • From the withdrawal date, applications for authorisation made by, or authorisations held by UK-based entities will not be valid. This means that downstream actors in the applicant’s or authorisation holder’s supply chain will also no longer be authorised to use these substances. There are no adopted authorisation decisions that come within this scenario. Where pending authorisation applications fall within this scenario, the UK-based applicant must either transfer the application to an EU-27 OR or to an EU-27 entity. In the latter situation, the transfer must be the result of a change of legal entity (for example, as the result of a merger, a demerger or an asset sale), and the person to whom the application is transferred qualifies as manufacturer, importer or downstream user of the substances within the scope of the application for authorisation. ECHA must be notified of the changes.
  • Downstream users subject to authorisation will need to check if the applicant for authorisation that they rely on to cover their use is UK-based. Where they are, the downstream user needs to ensure that the application will be transferred to an EU-27 entity or EU-27 OR as described in the bullet point above.

The notice complements the guidance issued by ECHA in February 2019.

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