UK post Brexit

 

Now that the UK has left the EU, there will be consequences for companies manufacturing in or importing into the UK. However, to what extent your products might be affected depends on the regulatory framework that applies.

The implementation or transition period during which the UK still follows EU rules and regulations ends on 31st December 2020. If the UK and EU are unable to agree on regulatory alignment or another form of cooperation which would allow the UK to remain within the EU regulatory frameworks, we will see the UK regulatory landscape going separate ways. Currently, it very much looks as if there will be no such agreement!

 

Chemicals

End of May 2020 Rebecca Pow, MP and Parliamentary Undersecretary of State at the Department for Environment, Food and Rural Affairs (Defra) announced that the UK's independent REACH regime will be activated from 1st January 2021. It was reiterated that the UK are not seeking associate membership of the European Chemicals Agency (ECHA) and participation in (EU) REACH. Instead, the UK’s Health & Safety Executive (HSE) will take the role of ECHA in administering new UK regulations commonly called UK REACH. UK REACH will be based on (EU) REACH but will be an entirely separate regulatory regime.

Consequences of this include:

  • Substances which are manufactured in or imported into both the UK and EU-27 would require two registrations, under both UK REACH and (EU) REACH.
  • UK companies purchasing substances from the EU-27, even though these substances are registered under (EU) REACH, will become importers under UK REACH with obligations to register the substances in the UK. These obligations could be alleviated if the EU-27 supplier were to appoint an Only Representative (OR) based in the UK to act according to UK REACH.
  • Companies based outside the EEA using an OR who is based in the UK to cover imports into the EU-27 will need a new OR based in the EU-27. Conversely, companies based outside the EEA using an OR based in the EU-27 to cover imports into the UK will need a new OR based in the UK. In short, non-EEA/non-UK companies may need two ORs: one for the UK and one for the EU-27!

With affiliates based in the UK and EU-27, as well as many years of experience acting as OR for non-EEA companies selling into the EEA, knoell is well placed to support clients in maintaining their business and fulfilling their regulatory duties once UK REACH comes into force.

We can act as OR...

  • for UK manufacturers or non-EEA suppliers selling into the EU-27 via knoell NL and knoell Germany.
  • for EU-27 or non-EEA suppliers selling into the UK, including submitting notifications and registrations to the relevant UK authority and preparing registration dossiers as appropriate via knoell UK.

Gain a comprehensive overview on UK REACH. Join our free web-Seminar on 24 September 2020.

 

Biocides

From 1st January 2021, the EU chemicals legislation (REACH, CLP, BPR and PIC) will no longer apply if your chemical substances, mixtures or articles, biocidal products or active substances are placed on the UK market (ECHA, www.echa.europa.eu/withdrawal-from-the-eu).

Similar to the consequences outlined for Chemicals above,

  • UK based companies will have to apply to the UK HSE to continue selling in the UK, i.e. they need to re-register their active ingredients and products
  • UK based manufacturers or suppliers of biocides/biocidal products wishing to market within the EU have to either be located in the EU or have an appointed EU-based representative to be listed in Article 95 list of substances and suppliers. A UK version of the EU list of approved active substance suppliers will be created and operate in parallel to the EU Article 95 list from 1st January 2021.
  • EU-27 or non-EEA manufacturers and suppliers selling into the UK will require either a company located in the UK or a representative to obtain authorisation via UK HSE.

Plan ahead:

We can help you make appropriate contingency plans based on your individual circumstances and then be ready to support you when the UK switches to a separate regulatory regime.

Plant Protection Products

Most recent information available state that, following 1st January 2021, the current EU regulatory regime for Plant Protection Products (PPPs) will be converted into UK-wide regulations which will remain very similar to the existing EU regime. After this point, EU decisions on active substances and Maximum Residue Levels (MRLs) will no longer apply to the UK. HSE will continue to act as the national regulator UK-wide and will make its own decisions on active substance approvals, PPP authorisations and set MRLs based on its own assessments. Applicants will need to make separate applications under the UK and EU regimes to obtain access to both markets. There will be a UK list of approved active substances and MRLs.

In contrast to other regulatory frameworks (eg. Chemicals and Biocides), companies will not need local representation to obtain authorisation for their active substances and products in the UK or EU-27. Also, the current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) will remain valid in the UK and EU after exit day and therefore immediate action is not required.

Veterinary Medicines

To date, the following major changes are known for the Veterinary Medicines market:

  • Following the UK’s exit from the EU, UK-based companies can no longer hold Marketing Authorisations for Veterinary Medicinal Products marketed in EU Member States. These include nationally authorised products but also so-called ‘Community authorisations’ licensed via the Centralised, Decentralised or Mutual Recognition procedures. 
  • The Veterinary Medicines Directorate (the VMD – the UK agency) can no longer act as RMS for European Marketing Authorisation Application procedures, and for Veterinary Medicine Products (VMPs) already marketed in the EU where the UK acted as RMS, this responsibility will need to be transferred to the authority of another Member State.
  • Since the incentives available for Minor Use, Minor Species (MUMS) products are a European Union initiative, it will be necessary for UK-based licence holders to transfer MUMS products to European companies in order to continue to avail of the incentives.
  • It has not yet been clarified how the exact requirements for Qualified Persons will change.  However, as is the case for holding EU Marketing Authorisations, batch release for the EU market will no longer be possible from a UK address and this function will need to be transferred. 
With headquarters in Bristol, UK and a new office in Mannheim, Germany, knoell's affiliate Cyton can continue to offer all services in regulatory affairs and product development, in both regions, regardless of the final outcome of the Brexit negotiations. For further information visit Cyton's website and also check their separate Brexit news page.

 

Dr. Iain A. MacKinnon Managing Director
+44 29 2034 9880 +44 29 2034 9889 send mail