UK beyond Brexit
Now that the UK left the EU there are consequences for companies manufacturing or importing into this market. However, to what extent your products are affected depends on the regulatory framework that applies.
A standalone chemicals regulation, commonly referred to as UK REACH, entered into force 1 January 2021 in Great Britain (GB: England, Scotland, Wales). Under the Northern Ireland Protocol, the process for Northern Ireland businesses did not change after 1 January 2021: (EU) REACH still applies. UK REACH is administered by the UK’s Health & Safety Executive (HSE). UK REACH is closely based on (EU) REACH but must be considered 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 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, become importers under UK REACH with obligations to register the substances in GB. These obligations can 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 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 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 are 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) no longer applies 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 did not change after 1 January 2021.
Similar to the consequences outlined for Chemicals above,
- GB based companies 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 was created and operates in parallel to the EU Article 95 list from 1 January 2021.
- EU or non-EEA manufacturers and suppliers selling into GB 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) was converted into GB-wide regulations which is very similar to the existing EU regime. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses did not change after 1 January 2021 and EU PPP legislation continues to apply. EU decisions on active substances and Maximum Residue Levels (MRLs) no longer apply to GB. HSE continues to act as the national regulator UK-wide taking decisions on active substance approvals, PPP authorisations and setting MRLs based on own assessments. Applicants need to make separate applications under the GB and EU regimes to obtain access to both markets.
Existing PPP authorisations and MRLs remain valid in GB until their current expiry date.
|In contrast to other regulatory frameworks (e.g. Chemicals and Biocides), companies do 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) remain valid in GB and EU after exit day.|
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".