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!
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:
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...
Gain a comprehensive overview on UK REACH. Join our free web-Seminar on 24 September 2020.
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,
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.
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.|
To date, the following major changes are known for the Veterinary Medicines market:
|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.|