The much-anticipated date of 31 December 2020 is fast approaching. The well-known “transition period” will come to an end, and from 1 January 2021, Great Britain will adopt its own independent regulatory regime for plant protection products.
This means that any new decisions made at the EU level, including those related to active substances and Maximum Residue Limits (MRLs), will no longer apply in Great Britain (England, Scotland, and Wales).
In Northern Ireland, however, EU legislation on plant protection products will continue to apply.
Let’s take a closer look at what changes 2021 will bring in the UK.
Existing approvals, authorisations, and MRLs
Existing PPP authorisations will remain valid until their expiry date.
Approvals of active substances expiring by December 2023 will be extended by 3 years to allow proper planning and implementation of the UK Review Programme.
Existing Maximum Residue Limits will remain valid until further notice.
New applications
Applicants for new active substance approvals, PPP authorisations, and MRLs will continue to submit their applications to the HSE (Health and Safety Executive), using the same format as before. HSE will remain the sole Regulatory Authority for plant protection products in the UK, acting on behalf of the British government.
Active substances
A national approval process for active substances is expected to be introduced: this means that plant protection products marketed in Great Britain must contain active substances approved in Great Britain. A list of approved substances will be available in a dedicated register that HSE will compile and publish on its website from 1 January 2021.
HSE reserves the right to review all approvals at any time if new data emerges that raises concerns for human health or the environment.
Mutual Recognition
New Mutual Recognition applications will no longer be accepted. Those currently under evaluation will be completed, and where there are no discrepancies with EU authorisation conditions, an authorisation (valid in both Great Britain and Northern Ireland) may still be granted.
In Northern Ireland, it will still be possible to submit new mutual recognition applications.
Zonal applications and renewal requests
Any zonal authorisation or renewal applications that are still pending with HSE as of 1 January 2021 (because the zonal Rapporteur Member State has not completed the evaluation) will be converted into Article 33 applications. At that point, the applicant will have three options:
- submit the registration dossier once it is finalised by the zRMS. HSE may proceed with the application, acknowledging the absence of Part C as a data gap.
- request that the UK carry out a full evaluation under Article 33, submitting supporting data and paying additional evaluation fees.
- submit a completely new application under Article 3, in accordance with HSE’s forthcoming requirements.
Parallel trade permits
Existing parallel trade permits will remain valid until their expiry date or until 31 December 2022, whichever comes first. However, it will no longer be possible to submit new parallel trade permit applications.
Use of plant protection products
Existing authorisations for plant protection products remain valid, and there will be no changes to the distribution and/or use of authorised products.
From 1 January 2021, however, it will be essential to closely monitor any updates to MRLs in Great Britain, as any changes—especially if they diverge from EU MRLs—may impact products intended for export.