BREXIT – Influence on EU procedures and national UK procedures

Date: 18 May 2020

The withdrawal of the United Kingdom from the European Union, based on the UK-wide referendum in June 2016, entered into force on 31 January 2020. During the subsequent transition period until 31 December 2020, negotiations about the future relationship between the UK and the EU Member States are taking place (this paragraph reflects the status at 5th May 2020).

With entry into force of the BREXIT and the beginning of the transition period UK became a “third country” (non-EU and non-EEA). This change of the status of UK influenced the procedures for active substances and plant protection products in the EU:

  • According to EU law, UK could no longer act as rapporteur Member State (RMS) for active substance evaluations, evaluating Member State (EMS) for MRL related procedures, or zonal rapporteur Member State (zRMS) for plant protection product registrations.
  • The European Commission published in 2018 a notice, encouraging business operators to take necessary actions to choose another Member State as evaluator for new applications. For on-going procedures, where it was already conceivable or it could not be ruled out that the evaluation conducted by UK would not be finalised before withdrawal, business operators were advised to change the Member State within the procedure.
  • For active substances where the UK was already in place (evaluation not finalised until withdrawal) or was foreseen as rapporteur or evaluating Member State the Commission has re-allocated the position to another Member State.
  • As of the withdrawal date, the United Kingdom cannot be a reference Member State in the mutual recognition procedure. Business operators need to apply for an authorisation based on an existing product authorisation in another Member State. However, where an authorisation has been granted under the mutual recognition procedure before the withdrawal date, this authorisation is not affected by the withdrawal.
  • With date of the withdrawal, parallel trade permits granted in the past for parallel trade from UK to another Member State are no longer valid. Plant protection products benefiting from such parallel trade permit can therefore no longer be placed on the market in the particular Member State.

For business operators intending registrations in UK, HSE released following information for procedures during the transition period (among others):

  • Existing active substance approvals and MRLs remain valid and new EU active substance approval and EU MRL decisions will apply to the UK.
  • The EU technical equivalence of any new source of active substance included in applications where authorisation will be completed during the transition period would need to have been approved in the EU.
  • Existing product authorisations remain valid. New “UK only application” will be considered against the current EU rules and standards. On-going applications (started before withdrawal) where the UK is concerned Member State will be completed to conclude a national UK decision. For this purpose, the applicant may need to provide HSE with the finalised EU registration report once available.
  • Applications under Article 40 (mutual recognition) for UK national authorisation are accepted.
  • Existing parallel trading permits for PPPs remain valid. HSE will continue to accept applications for parallel trading permits until the end of the transition period.

Information about future procedures in UK was not yet released. If and how far a future cooperation between UK and the EU with regard to plant protection related procedures will take place has to be decided within the negotiations during transition phase. Confronted with the Covid-19 pandemic and thus aggravated circumstances for negotiations a prolongation of the transition phase could be conceivable, but not yet requested.

Jasmin Philippi