UK beyond Brexit
Now that the UK has left the EU there will be consequences for companies manufacturing or importing into the UK. However, to what extent your products might be affected depends on the regulatory framework that applies.
A standalone chemicals regulation, commonly referred to as UK REACH, will come into force from 1 January 2021 in Great Britain (GB: England, Scotland, Wales). Under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021: (EU) REACH will still apply. UK REACH will be administered by the UK’s Health & Safety Executive (HSE). UK REACH is closely based on (EU) REACH but will be an entirely separate regulatory regime so may diverge in future. Transitional arrangements to allow companies to comply with UK REACH will apply during 2021 and for some years thereafter.
Consequences of this include:
- Substances which are manufactured in or imported into both GB and EU would require two separate registrations, under both UK REACH and (EU) REACH.
- GB companies purchasing substances from the EU, even though these substances are registered under (EU) REACH, will become importers under UK REACH with obligations to register the substances in GB. These obligations could be alleviated if the EU supplier were to appoint an Only Representative (OR) based in GB.
- Companies based outside the EEA using an OR who is based in GB to cover imports into the EU will need a new OR based in the EU. Conversely, companies based outside the EEA using an OR based in the EU to cover imports into GB will need a new OR based in GB. In short, non-EEA/non-GB companies may need two ORs: one for GB and one for the EU!
- There will also be standalone GB regulations corresponding to CLP and PIC.
With affiliates based in GB and EU, 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...
From 1 January 2021, the EU biocides legislation (BPR) will no longer apply if your biocidal products or active substances are placed on the GB market. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021.
Similar to the consequences outlined for Chemicals above,
- GB based companies will have to apply to the UK HSE if they wish to apply for an active substance to be approved, or for a biocidal product to be authorised, in GB.
- GB 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 GB version of the EU list of approved active substance suppliers will be created and operate in parallel to the EU Article 95 list from 1 January 2021.
- EU or non-EEA manufacturers and suppliers selling into GB will require either a company located in GB or a representative to obtain authorisation via UK HSE.
We can help you make appropriate contingency plans based on your individual circumstances and then be ready to support you with the new separate regulatory regime.
Plant Protection Products
Most recent information available states that from 1st January 2021 the current EU regulatory regime for Plant Protection Products (PPPs) will be converted into GB-wide regulations which will remain very similar to the existing EU regime. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021 and EU PPP legislation will continue to apply. After this point, EU decisions on active substances and Maximum Residue Levels (MRLs) will no longer apply to GB. 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 GB and EU regimes to obtain access to both markets. There will be a GB list of approved active substances and MRLs.
Existing PPP authorisations remain valid in GB until their current expiry date.
|In contrast to other regulatory frameworks (e.g. Chemicals and Biocides), companies will not need local representation to obtain authorisation for their active substances and products in GB or EU. Also, the current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) will remain valid in GB and EU after exit day and therefore immediate action is not required.|
With animal health teams in both the EU and the UK, knoell can offer our clients a full range of services in product development and regulatory affairs to meet the requirements for both regions. For further information have a look at knoell's Animal Health page "UK beyond Brexit".