Regulating pesticides during a potential implementation period
Leaving the EU with a deal remains the UK Government’s top priority.
Subject to ratification of an agreement, there would be an implementation period (IP) of a set duration, during which EU law would continue to apply to the UK)..
This is guidance on arrangements for regulation of plant protection products (PPPs), which are often referred to as ‘pesticides’, during the IP. We have also produced guidance to help you prepare in the event the UK leaves the EU without a deal (and therefore without an implementation period). It is meant for guidance only, and you should consider whether you need separate professional advice before making specific preparations.
Preparations for an implementation period
The UK will no longer be a Member State of the European Union during an implementation period, but market access will continue on current terms. This means that UK-EU trade will be able to continue on the same terms as now until the end of an implementation period.
During an implementation period the EU PPP regulatory regime, including new decisions taken under the EU regime, will continue to apply, providing continuity and stability. There will be some changes to the way that the regulations work during the IP which businesses need to understand.
What businesses need to know
During an IP, all active substance approvals, PPP authorisations and Maximum Residue Levels (MRLs) in place before exit day will continue to be valid in the UK as they are now.
Any new EU decisions taken during the IP will also apply to the UK. This includes active substance and MRL decisions and any new EU PPP legislation or guidance which is put in place during the IP.
HSE will remain as the UK’s national regulator, on behalf of the UK Government (Defra) and the devolved administrations.
The key difference for businesses is that, during the IP, the UK will not be able to act as a ‘leading authority’ under the EU regime. This means that HSE will not be able to conduct active substance evaluations under Regulation (EC) No 1107/2009 or MRL evaluations under Regulation (EC) No 396/2005. Businesses wishing to submit an active substance or MRL application during the IP will need to apply to another EU member state’s regulatory authority. Similarly, HSE will not be able to act as the lead for zonal product authorisation applications, which must be made to another EU member state. Also, as the UK will not be a member state, it will not play a formal role in EU decision making processes during the IP.
There is no requirement under the EU PPP and MRL Regulations for applicants to be based in the UK or the EU. Applicants, authorisation holders and approval holders can be based anywhere in the world, as is the case now.
More about how things will change if the UK leaves the EU with a deal.
Applications for active substance approvals
During an IP, applications for active substance approvals in the EU and UK will need to be made to an EU member state, not to HSE.
Existing active substance approvals remain valid and new EU active substance approval decisions during the IP will also apply to the UK.
Maximum Residue Levels (MRLs)
During the IP, applications relating to setting MRLs in the EU and UK will need to be made to an EU member state, not to HSE.
Existing MRLs remain valid and new EU MRL decisions during the IP will also apply to the UK.
Applications for product authorisations
During the IP, HSE will continue to process PPP applications for the UK market, as now. Any applications will continue to be considered against the current rules and standards.
Existing product authorisations remain valid.
HSE will not be able to act as a zonal Rapporteur Member State (zRMS) but will continue to be able to recognise ‘Central Zone’ PPP authorisations by EU member states, as now.
We will continue to be able to review or withdraw a product authorisation in the UK during the IP if that is deemed necessary to protect human health and the environment.
Applications which have started before exit day
HSE will continue to accept applications. Applicants should be aware that any active substance approval applications which are likely to still be under consideration on exit day will be transferred to another EU member state by the European Commission.
For PPP applications currently being evaluated by HSE with the UK as a zRMS, HSE is aiming to complete these types of applications before exit day where possible. If a decision is not taken before exit day, the application will be transferred to an EU member state to lead.
For zonal applications, led by other EU member states, the UK will continue to act as concerned Member State (cMS) between now and exit day. Any applications in the system on exit day where the UK is a cMS will be completed by the zRMS in the usual way. The decision of the zRMS will be able to be recognised in the UK as now.
Trading in plant protection products
The statutory requirements for authorisation of products to be marketed will remain unchanged during the IP.
The statutory requirements for record keeping by producers, suppliers, distributors, importers, exporters and users will remain unchanged during the IP.
Existing parallel trading permits for PPPs remain valid after exit day. HSE will continue to accept new applications for parallel trading permits until the end of the IP.
Seeds treated with a product authorised for that use in any EU member state can continue to be traded in the UK and the EU during the IP, as now.
Information for pesticides users
Existing product authorisations remain valid, so the same products will continue to be permitted to be marketed and used after exit day.
If there is ‘no-deal’
We have produced guidance to help you prepare in the event the UK leaves the EU without a deal (and therefore without an implementation period).
This guidance notice was produced jointly by Defra and the Health and Safety Executive, in consultation with the devolved administrations.