Brexit has complicated product registration for agrochemical companies. But with the right dossier support, companies can ensure that pesticides can be sold and used across both the European Union and the United Kingdom. Battelle is here to help our customers navigate the new rules for product registration in the UK and ensure smooth global registration of vital plant protection products.
What’s the current state of agrochemical product registration in the UK?
While Brexit Day was January 31, 2020, plant protection products continued to be governed by the EU regulatory framework through a transition period. That period officially ended on December 31, 2020, but in practice, immediately after this date, little changed in the UK. Both the Chemical Regulations Directive (CRD), responsible for approval of pesticides, and the Health and Safety Executive (HSE), responsible for approval of biocides and industrial chemicals, brought over the existing EU regulations and product approvals largely unchanged—even retaining the same nomenclature and numbering of the regulations. However, as CRD and HSE start making their own regulatory decisions that are independent of the European Food Safety Authority (EFSA) and the European Chemicals Agency (EChA), we can expect to see divergences start to develop in product classifications, maximum residue limits (MRLs) and product approvals between the UK and the EU.
Moving forward, new plant protection products will have to go through a separate registration process for Great Britain (composed of England, Scotland and Wales) to that in the EU Member States. Although Northern Ireland is part of the UK, under the Northern Ireland Protocol (NIP), plant protection products sold in Northern Ireland are still subject to EU regulation. (The NIP was agreed between the UK and the EU to avoid creating a “Hard Border” between Ireland and Northern Ireland.)
We are already seeing some examples of divergences between EU and UK regulations for pesticides and other agrochemicals. For example, methylene dithiocyanate—used as a microbiocide, fungicide and disinfectant—was not approved for renewal by the EU Commission in 2022, meaning it can no longer be sold in EU member states or in Northern Ireland. However, it remains approved for use in Great Britain. Similarly, the pesticide mancozeb has been banned for use in the EU and Northern Ireland but remains available in England, Scotland and Wales. These situations have the potential to create confusion for chemical manufacturers, retailers and farmers—especially in Northern Ireland.
How can companies navigate UK and EU product registration?
The good news for agrochemical companies is that the application process for product registration remains largely the same for the UK and the EU. That means, for the moment, the same dossier information can typically be used for applications to both the EU and UK regulatory agencies. CRD and HSE do not currently require UK-specific field trials, meaning the same data can be used for applications in both the EU and the UK. However, while the information remains the same, the format of the dossiers and submission processes are now quite different.
For UK regulators, Brexit was meant to allow them more leeway to streamline the regulatory process and make independent decisions based on the needs of UK farmers and citizens. In the future, that may mean that processes and timelines across the two jurisdictions will start to look very different.
Whatever the future holds, Battelle is here to help our customers navigate the regulatory process for product registration in both the UK and the EU—and anywhere else in the world they wish to sell. We are already working with agrochemical companies to develop dual registration strategies that will ensure smooth approval across both jurisdictions. As the situation in the UK evolves, we will continue to work with our clients to help them move through the dual product registration processes efficiently and cost-effectively.
The Battelle Crop Protection Solutions team provides comprehensive regulatory support for plant protection products (both chemical and biological) and biocides to help companies move their products to market quickly and efficiently. From risk assessment and modeling, to study design and implementation, and finally, to dossier preparation and submission, we are helping companies bring innovative new crop protection products to market—in the UK, EU, US and beyond.