As part of the TISK – Things I Should Know – sessions at Rothamsted, which are organized by Dr Dana MacGregor, plant molecular geneticist at Rothamsted Research, we were fortunate to host Dr Tony Wilson, Senior Policy Officer from the Health and Safety Executive, for an insightful overview around pesticide regulations for getting crop protection products on the market.
One of the standout insights that might surprise a lot of organizations war thar registration alone can account for up to 14% of total development costs—and that’s before a product even reaches the market.
What’s more surprising is where that cost really sits. The application fee itself is relatively small. The real investment lies in the years of data generation, field trials, and dossier preparation required to demonstrate that a product is safe, effective, and fit for purpose.
For startups, researchers and innovators in the crop protection space, this is a critical reality to understand early.
Regulation Is Part of the Innovation Journey
The regulatory pathway for crop protection products is well-defined, both in the UK and EU. The expectations are clear—but meeting them takes time.
Three years is a minimum, and in practice it’s often longer. This isn’t just a form-filling exercise. It requires a comprehensive scientific case covering everything from how your product works to how it behaves in the environment and what it means for human health. Therefore timelines depend heavily on access to trials, the quality of data, and the complexity of the product itself.
This isn’t bureaucracy for its own sake. It reflects the breadth of what needs to be assessed before a product can be approved.
What Gets Assessed—and Why It Matters
A crop protection product isn’t evaluated on a single dimension. It is assessed as a whole system, across multiple specialist areas, including:
- Chemistry – what the product is and how it behaves
- Efficacy – whether it actually works in real-world conditions
- Toxicology – potential impacts on human health
- Operator and public safety – risks to users, workers, and nearby communities
- Ecotoxicology – impacts on non-target organisms like bees, birds, and soil life
- Environmental fate and behaviour – how the product moves and persists in soil, water, and air
- Residues – what remains in food and how that affects consumers
Each of these areas contributes to a single, overarching question: is this product safe, effective, and acceptable for use? Crop protection products, by their nature, are designed to affect biological systems. Without proper oversight, there is a real risk of unintended consequences — from environmental damage to human health impacts.
Therefore, there is an inherent tension at the core of crop protection regulation. On one hand, there is a collective responsibility—as global citizens—to protect human health, biodiversity, and the environment. On the other, there is a need to support agricultural productivity, economic growth, and food security.
The goal is not zero risk—that’s rarely achievable—but acceptable risk, based on robust scientific evidence.
But for individual startups, researchers or even larger corporations bringing new products to market, it can be tempting to feel like regulation is a barrier to progress.
Planning Ahead: What Startups Should Know
One of the biggest pitfalls for early-stage companies is underestimating regulatory requirements until late in development.
A few practical lessons stand out:
- Plan for regulation from day one
It is not a final hurdle—it shapes your entire development pathway. - Budget realistically
Data generation, trials, and expert input require significant investment. - Keep your data organised and accessible
Clear, traceable data packages and supporting evidence can save months in the review process. - Understand your use case in detail
How and where your product is used will influence the data required and will inform any advice received from the regulator. - Value your assessment manager
Your regulatory contact plays a key role in guiding your application through the system—they are an important advocate in the process.
A Post-Brexit Landscape: Similar, But Not Identical
While UK regulation is largely derived from EU frameworks, Brexit has introduced divergence over time.
For companies targeting both markets, this means:
- Requirements may not always align perfectly
- Additional checks and adaptations may be needed
- Parallel strategies for UK and EU approval may be necessary
The good news is that there is still scope to use international data, provided it is relevant. For example, trial data from other regions can be accepted where climates are comparable – supported by guidance such as the EPPO PP1 standards.
Final Thought
Innovation in agriculture has never been more important. From climate pressures to food security, the need for new solutions is urgent and the demand is growing.
However, taking a crop protection product to market is not just a scientific challenge—it’s a regulatory one. The process is in place to ensure that when your product does reach the market, it contributes positively—not just to productivity, but to the wider system we all depend on.
Understanding that early, and planning for it properly, can significantly improve your chances of success and sharing experiences, knowledge and lessons learned with others going through the same process can be helpful to make the journey easier.
