Regulating pesticides (PPP) if there’s no deal
This guidance outlines the arrangements that would come into force to regulate Plant Protection Products (PPPs), often referred to as ‘pesticides’, if the UK leaves the EU without a deal. It is meant for guidance only, and you should consider whether you need separate professional advice before making specific preparations.
What are PPPs?
Plant Protection Products (PPPs, more commonly known as ‘pesticides’) are treatments that protect valuable plants, such as crops, against pests and diseases or prevent the growth of unwanted plants such as weeds. They benefit society by helping UK farming to provide a supply of high quality, affordable food and aid in keeping transport infrastructure, public and amenity spaces and gardens clear of unwanted plants. However, pesticides can also pose risks to the environment and human health and therefore it is essential to have effective regulation in place.
Currently, PPPs are subject to EU regulations. The EU regime relies on centralised EU processes, EU institutions and the sharing of responsibilities between all EU countries. It comprises of three main measures:
- Regulation of the placing of PPPs on the market, including the approval of active substances, authorisation of products and the management of associated risks. (EU 1107/2009)
- Regulation of Maximum Residue Levels (MRLs) of an active substance contained in plant protection products permitted to remain in marketed foods, reflecting the residue arising from the authorised use of PPPs. (EU 396/2005)
- A framework of action to ensure the sustainable use of pesticides.
Further information on the EU regime.
Preparations for if there is no deal
If the UK exits the EU with no deal the current EU regulatory regime will be converted into UK-wide regulations.
This regime will enable UK-wide decision making and exercise of functions by the UK Government and the devolved administrations acting collectively, with HSE continuing to act as the regulator on behalf of all four administrations. After we leave the EU, we will maintain the current high standards of protection for people and the environment.
The new UK-wide PPP legislation will remain very similar to the existing EU regime.
We will only make corrections where needed to ensure the new laws work sensibly in a UK-wide context.
In the event of no deal the UK will make its own decisions on active substance approvals and plant protection product authorisations and set Maximum Residue Levels (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. You will need to apply for approval in the UK to HSE in the same way as now. HSE will remain as the national regulator, on behalf of the UK Government (Defra) and the devolved administrations.
There will be a UK list of approved active substances and MRLs. EU decisions on active substances and MRLs will no longer apply to the UK. We will be able to take into account work done by other regulators where it is relevant to the UK.
With or without a deal, after we leave the EU the UK Government and devolved administrations have assured stakeholders that we will maintain the current standards of environmental and health protection.
The precautionary principle will be retained in PPP legislation when it is converted into UK-wide law.
No immediate action is required in respect of current active substance approvals, PPP authorisations, and MRLs. These will all remain valid in the UK and EU after exit day as now.
General action for business
- No immediate action is required in respect of current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs). These will all remain valid in the UK and EU after exit day as now.
- Start to consider what new applications businesses might wish to make under both the UK and EU regimes in the period after EU exit, and to plan ahead for any applications under each regime relating to renewals of existing approvals and authorisations as they expire over time.
- Keep in touch with HSE as the regulator with respect to any current applications.
Further information - applications for active substances and products
All current active substance approvals, PPP authorisations and MRLs in place on the day we exit the EU would remain valid in the UK after we leave, so businesses could continue to trade and products would continue to be available.
An approval granted in the UK after we leave in a no-deal scenario would be UK specific. Documentation supporting an application will be the same as it is now. HSE will accept applications in the same way and will still require a registration / assessment report in the same format in support of an application for authorisation / approval.
There is no requirement to be based in the UK or EU under the new UK-wide regime or the EU regulatory regime. Applicants, authorisation holders and approval holders can be based anywhere in the world, as now.
After leaving the EU, we expect to be able to reach decisions more quickly. The statutory timings in the regulation will remain largely as they are now. However, the EU regime assesses active substance applications, MRLs and PPP authorisations sequentially, meaning that the time required to successfully take an active substance application through to authorisation of a product is typically around 5 years. Under an independent UK-wide regime we plan to take decisions on active substances, PPPs, and MRLs in parallel, which is likely to reduce the period outlined above to around 2 years.
Functions which are currently carried out at EU level will be repatriated to national bodies where they remain relevant in a national context. This includes making arrangements for providing independent scientific advice in the UK. Initial arrangements will be put in place at the point of leaving the EU, drawing on the expertise of the Expert Committee on Pesticides, to inform the longer-term approach to independent scientific advice. The requirement for public consultation on active substance applications, currently carried out by EFSA, will be retained and carried out by HSE. There will be a requirement to consider relevant information in coming to a decision, such as Environment Agency environmental monitoring data.
Elements of EFSA’s role which are designed for an EU context would no longer be required in a national regime, for example the additional layer of process to review EU countries’ risk assessment conclusions, to ensure harmonisation across all EU countries.
The UK Government and the devolved administrations will develop a UK-wide active substance renewals programme after exit. The expiry dates of any active substances and associated products due to expire within the first 3 years after exit day will be extended by three years to allow time for the necessary evaluation to be carried out under the national regime.
Divergence between EU and UK
Some degree of divergence from EU decisions is possible over time. This is because the UK-wide regime will be taking independent decisions on its evaluations, and potentially at different times to the EU regime.
For authorisation in the UK you will be required to submit a standalone UK application.
In a no-deal exit the EU will make its own decisions regarding active substance approvals and PPP approvals. There will be no formal arrangement for mutual recognition of substances or products between the EU and UK post-exit. However, HSE will be able to make use of other regulators’ work in informing a UK decision.
After exit, existing mutual recognition authorisations will remain valid until their current expiry date, unless amended as part of normal regulatory action.
Mutual recognition applications being processed by HSE at the point of exit will be completed by HSE to a decision under the UK-wide regime.
At this stage we are not able to confirm how the EU will view authorisations decided under the UK-wide regime. For future updates read the European Commission’s note to stakeholders.
Under an independent PPP regime the HSE will make its evaluations available to other regulatory authorities on request. Please note that where this includes information not routinely published, evaluations would be released only with the data owner’s prior agreement.
Applications which have started before exit day
Until the UK leaves the EU HSE is focusing its operational resource on:
- those applications already in the system
- any new applications with a completion deadline in 2018/19
- any new UK only applications
If this affects you, we encourage you to contact us to discuss your situation.
HSE will continue to accept applications. Applicants should be aware that any applications still under consideration at exit day will be progressed to a UK only conclusion, under the new UK-wide regime.
Please note that the UK will be unable to issue parallel trading permits after exit. More information on parallel trading permits in the technical notice.
For PPP applications currently being evaluated by HSE with the UK as a zonal Rapporteur Member State (zRMS), and unlikely to be complete at the point of exit, HSE is aiming to complete these types of applications before the UK exits the EU. If a decision is not taken before exit day, HSE will complete the application reaching a UK decision.
If businesses are interested in how other EU Member States might take account of UK decisions after exit day, then they should contact the Member State concerned.
The UK will continue to act as a concerned Member State (cMS) between now and exit day. For any applications in the system on exit day where the UK is a concerned Member State (cMS), please be aware that should the zonal Rapporteur Member State (zRMS) evaluation not be completed until after exit day, HSE may need to consider the application as a standalone UK application. As a result of this you may be asked to submit additional information in support of the UK’s evaluation.
Maximum Residue Levels (MRLs)
All MRLs in place on exit day will remain valid in the UK after we leave. MRLs in the UK and the EU will therefore be aligned at the point of exit.
Technical standards for setting MRLs will remain in place and will not be lowered. Moving forward, some degree of divergence from EU MRLs is possible (due to decisions taking place at different times or different data being available).
After exit, the UK will set its own MRLs which will be published on a statutory UK specific MRL database. You will be required to submit an application to HSE to set an MRL in the UK. Decisions leading to changes to UK MRLs will be made publicly available.
It is the responsibility of those putting treated produce on the market to ensure that it is compliant with the MRLs that are applicable in that market. UK MRLs will match EU MRLs at the point of exit but may diverge over time. In future, you will therefore need to consider what market you are intending to sell produce within, and make sure that it complies with the relevant MRLs. For example, if you intend to sell treated produce in the UK, the EU, and / or in other parts of the world, you should consider the MRL requirements in each market.
MRLs called import tolerances can be set for imported produce where they meet the regulatory requirements. After a no-deal exit, it would remain possible to make applications for import tolerances to seek adjustments to MRLs in receiving markets where necessary.
An import tolerance application to sell on the UK market would be made to HSE. An import tolerance application to sell on the EU market must be made to an EU member state.
Import tolerances themselves may change if new information indicates that a different level is justified.
After we exit the EU, the UK will become a third country with respect to EU regulations. At present the EU considers import tolerance applications from third countries, so we anticipate applications for import tolerances from the UK would be treated in the same way.
Trading in plant protection products
The major statutory requirements for authorisation of products to be marketed and for record keeping by producers, suppliers, distributors, importers, exporters and users will remain unchanged.
There will be changes relating to parallel trade permits and to seeds which have been treated with a PPP authorised for that use in another Member State.
Parallel trade permits
The parallel trade permit system operates within the EU’s PPP regime. After exit, therefore, HSE will be unable to accept applications for new parallel trade permits or grant any further parallel trade permits.
Existing permits will remain valid for up to a maximum of 2 years from exit, or until their current expiry date if that is sooner. After expiry, businesses would need to obtain authorisations for marketing and use of their products in the UK.
Seeds treated with a product authorised for that use in other EU countries can be traded in the UK for 3 years after exit. After this transitional period, only seed treated with a product authorised for that purpose in the UK may be traded.
After that 3-year period expires, you will need to ensure that any product used to treat the seed is authorised for that purpose under the new independent UK-wide regime. The transitional period should allow sufficient time for the necessary applications for product authorisations to be considered. It will also be possible to apply for extensions of authorisations for minor use (EAMUs) for UK authorised products under the new independent regime.
The HSE will continue to operate on a full cost recovery basis after exit.
There will be some minor changes to HSE fees and charges after EU Exit:
- the current fee ‘helping (EFSA) to evaluate Draft Assessment Report where the UK is Rapporteur Member State or co-Rapporteur Member State’ will be redefined as ‘coordinating scientific advice and public consultation and finalising Draft Assessment Report’
- zonal surcharges relating to applications for PPPs where the UK is acting as lead evaluating authority will be removed.
- there will be the addition of charging to support the requirement for a standalone UK system for setting MRLs
- there will be two new fees introduced for import tolerances (as other applications)
- Initial Consideration Fee £229.00
- Coordination Fee £1,872.00
Information for pesticides users
The same products will continue to be authorised for use in the UK immediately after point of exit. Users should not need to take any action as the current markets and levels of access to PPPs should be maintained, though PPP supply is reliant on imports.
Storing excess PPPs carries risks of product leakage and spoilage, which costs money and can cause serious environmental damage. If users do wish to store additional PPPs then care should be taken to ensure they are stored and disposed of appropriately.
If you wish to gain acceptance of alternative sources of active substances, you will need to submit a separate application to HSE following the same process as is currently in place to establish the equivalence of an alternative active substance source for the UK.
GLP is an Organisation for Economic Co-operation and Development (OECD) arrangement. UK laboratory data should be treated in a similar way to GLP laboratory data from other OECD countries, so we would expect it to still be accepted by the EU after the UK has left.
Official Recognition, (or GEP) for field trials is an EU-specific derogation for efficacy trials. The UK will continue to operate our Official Recognition scheme for all UK trials facilities and operators after EU exit, and will continue to accept officially recognised trials from elsewhere in the world where the trials are relevant to a UK application. It is a matter for the EU whether they continue to accept UK field trials.
The process for authorising adjuvants in the UK will remain as it is currently. Existing adjuvant authorisations will remain valid.
This guidance notice was produced jointly by Defra and the Health and Safety Executive, in consultation with the devolved administrations.
Please note that this guidance relates to the new independent UK pesticide regime that would come into effect in the event of a no deal Brexit. Businesses wishing to understand how the EU regime will operate after exit, particularly in relation to mutual recognitions and parallel trade permits based on UK authorisations, should check the Commission’s own guidance or contact the regulatory authority of the relevant EU Member State.