As the deadline for the UK exiting the EU (‘Brexit’) draws closer, the uncertainty over whether we will leave with or without a deal remains. Having spent most of my career in the UK Government before joining the commercial sector, I understand the immense challenges that ex-colleagues at the UK’s Chemical Regulation Division (CRD) of the Health and Safety Executive (HSE) are now facing.
I hope that this article will help a little to cut through some of the ‘fog’ that currently exists regarding what will happen in the event of a deal or no deal Brexit. As the exact details are still unclear, this can only be an overview until more is announced. The key elements to note are as follows:
In the event of a deal:
• The UK will agree an ‘implementation period’ (IP) during which existing arrangements will continue to apply.
• Existing EU active substance approvals and Maximum Residue Levels (MRLs) will continue to be valid, whilst product authorisations continue in the UK.
• Any new decisions on active substance authorisations and MRLs, in addition to any new EU pesticide regulations or guidanceintroduced during the IP, will also apply in the UK.
• HSE would remain as the UK’s national regulator, acting on behalf of the UK Government and devolved administrations.
• HSE would continue to process applications for the UK market. Applications would continue to be considered against the current rules and standards.
• However, the UK will no longer be able to:
o Act as a rapporteur Member State on active substances.
o Act as lead evaluating Member State on MRLs.
o Act as lead Member State on zonal product applications.
o Play a formal role in EU decision making processes.
In the event of no deal:
• New national regulations will be implemented.
• All decision-making will be repatriated from the EU to the UK.
• Whilst the technical requirements of the national system will remain very similar to the existing EU system, there may be some differences to fix deficiencies arising from leaving the EU (e.g. such as processes that would no longer be operable nor required outside an EU context),to allow the system to operate on a UK-wide basis.
• There will be no substantive policy changes between the EU and UK regimes, but it is expected that there may be some divergence over time.
• Future applications for products, actives and MRLs will be determined under a national system with HSE remaining as national regulator on behalf of Defra and the Devolved Administrations.
• Applicants would need to make separate applications to the UK, as well asto the EU, if businesses decide to market products in both territories. The format of applications and basic data requirements would remain the same to make it as straightforward as possible for businesses to make applications in both EU and UK.
• The national regime may mean that decisions on applications could be made more quickly. HSE may be able to consider applications for actives, MRLs, and PPPs simultaneously, rather than sequentially. This could speed up the overall process of bringing new products to the UK market.
• Although EU decisionswill not be ‘rubber-stamped’, the new independent systemwould enable the HSE to take account of other regulators assessments when reaching UK decisions.
• Existing active substance approvals, PPP authorisations, and MRLs would remain valid from Day 1 following Brexit, to ensure that there will be no ‘cliff edge’ for businesses from leaving the EU. A minimum 3-year period for renewals will be granted in line with the existing EU rulesafter the point when new UK rules comes into force.
• There will be a new national statutory database of approved active substances and MRLs.
• EFSA’s role in providing independent scientific advice and coordinating public consultation would be fulfilled by the UK’s Expert Committee on Pesticides.
• For treated seeds, the UK would provide a transitional period of three years for seeds which have been treated with a pesticide authorised for that use in another Member State. After that transitional period, the pesticide must be authorised for that use under the UK regime.
• The parallel trading system would not be able to operate in the UK in a ‘no deal’ scenario as the EU system is reliant on inputs from other Member States. To ease the transition to the new system, all existing permits would remain valid for two years after exit day, or their current expiry date (whichever is the sooner). After this period, all products would need to be authorised in the UK, by means of an application to the UK-wide regime. HSE would also no longer be able to grant any new parallel trading permits after exit day.
Those of us in the regulatory affairs consultancy business, we will continue to maintain our close links with the UK regulators so that we are aware of any emerging decisions regarding Brexit and the future for the regulation of chemicals across all sectors in both the EU and UK.
Early indications are that a UK specific PPP system, whilst appearing to add to the administrative burden and cost for those companies wanting to sell products in the UK, could also bring valuable benefits in terms of:
● Faster decisions on active substances.
● The sound and pragmatic approach for which UK’s CRD has been well regarded.
Whilst we must currently wait to see how this might work in reality, it is important to be prepared and to have a clear plan of which products and actives are important to maintain in the UK.
If you need help in developing your strategy or undertaking any regulatory actions needed, please do get in touch.
This article was initially published in AgroPages '2019 CRO & CRAO Manual' magazine. Download the PDF version of the magazine to read more articles.