UK Pesticides Regulatory Regime
After the Brexit on 1st of January 2021, an independent pesticides regulatory regime is in operation in Great Britain (England, Scotland and Wales).
In Great Britain (GB) the European law was retained in GB law, whereas the European legislations continue to apply in Northern Ireland (NI). The UK authority (HSE) remains the national regulator for the whole of the United Kingdom (Great Britain and Northern Ireland).
Active Substance
To maintain an active substance in the GB, it is necessary to send the application three years before the expiry date and submit the renewal dossier 33 months before the expiry date. Currently the requirements follow the retained regulation (EU) No 844/2012 and a copy of the EU dossier is sufficient under specific circumstances. Once new GB renewal requirements are agreed, an update of the supplementary dossier may be required prior to the beginning of the assessment of an active substance renewal.
The MRLs are still regulated in GB under retained Regulation (EC) No 396/2005. Many existing MRLs resulted from EU legislations adopted before the Brexit. These transferred EU MRLs remain valid until they are amended. For some active substances, the MRL granted in the European Union and Great Britain are already different.
Plant Protection Products
Plant protection products are currently evaluated according to the relevant articles of regulation (EC) 1107/2009. However, some new GB guidance documents are already available and have to be considered when applying for registrations. Further changes can be expected in near future. The dossier preparation and risk assessments are by now to be carried out according to available GB requirements by using specific GB templates.
For the preparation of studies, the application for trial permits should be considered. Trials permits are usually issued for three years.
For Northern Ireland the EU rules and laws continues to apply under the terms of the Withdrawal Agreement and Northern Ireland Protocol. Therefore, it is possible to mutually recognise an EU PPP authorisation in Northern Ireland. For this application a specific UK dRR is to be prepared. Also, applications for parallel trade permits are possible from the EU to NI.
SCC regulatory services in the UK (GB and NI)
For the UK market, we provide you the following regulatory services:
- Developing individual registration and compliance strategies for Great Britain and Northen Ireland
- Data gap analysis and (preliminary) risk assessments for all sections
- Planning and monitoring studies, including trial permits
- Preparing and submitting registrations, including follow-up and defence
Please do not hesitate to contact our experts if you have questions or want to learn how we can help you ensure the regulatory compliance of your agrochemicals and biorationals, including adjuvants, fertilisers and biostimulants, on the UK market.