Impacts of EU Exit on the Plant Protection Products Regulation and Biocidal Products Regulation
On 31 December 2020, the United Kingdom officially exited the European Union. As a result, all existing EU legislation, including that relating to chemicals, was adopted into UK law. These newly adopted laws are now applicable in Great Britain, with special arrangements made for Northern Ireland (NI), which remains subject to EU regulations. In this article, we focus on some of the impacts so far of the EU exit on the GB Plant Protection Products Regulation and the GB Biocidal Products Regulation and where we have started seeing divergence in these regulations.
The Plant Protection Products Regulation (Regulation (EC) No 1107/2009)
From January 1 2021, the EU and GB had identical active substance approvals, maximum residue levels (MRL), and assessment criteria for pesticides. While the registration requirements largely remain identical, there has been some divergence in relation to the application of new guidance and MRLs. One example is the non-dietary human exposure guidance. The updated guidelines for the non-dietary exposure assessment of PPPs was published by the European Food Safety Authority (EFSA) in January 2022. Starting from 1 January 2023, all applications for authorisation in the EU and NI must be conducted using the revised guidance and calculator. Meanwhile in GB, the non-dietary exposure assessment of PPPs authorised for professional use is currently based on the 2014 EFSA Exposure Guidance, which will continue to apply until further notice from the HSE. However, the HSE is currently considering whether it is appropriate to adopt the updated guidance for relevant assessments in GB. EFSA has also just last month published the revised guidance on the risk assessment for birds and mammals, which updates the guidance published in 2009. Once the guidance has been noted by SCoPAFF and comes into force, it will be implemented for applications to the EU and Northern Ireland. It remains to be seen if GB will adopt this new guidance.
When it comes to MRLs, the HSE has been conducting reviews for GB as needed. This has meant there have been instances of the HSE either raising or lowering MRLs compared to the EU. These divergences may affect the trade of pesticide products or treated goods. For instance, where an MRL is raised in GB but not yet in the EU, a new GB-only authorisation for the corresponding use may be granted, but goods approved under this authorisation may exceed the EU MRL, making it impossible to trade them in the EU or NI until the EU MRL is raised. Similarly, if an MRL is raised in the EU but remains the same in GB, it may not be possible to import treated goods into GB without an import tolerance application to raise the MRL. In the event that an active substance approval is renewed, not renewed or amended in the EU, any corresponding product authorisation for Northern Ireland may also be modified or revoked. However, it is possible that the existing pesticide may still be accessible for purchase and use in Great Britain.
The Biocidal Products Regulation (Regulation (EU) No 528/2012)
In January 2023, the Health and Safety Executive (HSE) opened a 2-month consultation period on proposed changes to active substance and product data requirements under the Great Britain Biocidal Products Regulation. The proposed revisions aim to reduce the need for animal testing and better align data requirements with current guidance, missed in GB as they were introduced to the EU after Brexit, and OECD test methods. While the proposals are similar to revisions made to EU BPR that came into effect last April (Regulation 2021/525), the changes would introduce some divergence between GB and EU BPR data requirements, such as additional developmental neurotoxicity studies on rats, requirements related to efficacy data on treated articles and revision of wording regarding 5-batch analysis of active substance technical material.
This divergence between the GB and EU BPR may have major implications for biocides businesses due to additional data requirements and testing in GB compared to requirements already in place under the EU BPR. This is further evidence of how the UK is willing for GB regulatory frameworks to diverge from equivalent EU law where it is deemed appropriate and necessary to meet specific needs and conditions within Great Britain.