EU biopesticide market: Pioneering innovative plant protection technologies such as RNAi in a changing regulatory environment

Agricultural producers around the world are facing increasing pressure to switch to green practices and processes. In the European Union, sustainable use regulations that proposed a 50% reduction in pesticide use were recently withdrawn. However, high-profile studies and polls continue to push the industry toward biopesticides.

In this environment, pesticide manufacturers and agricultural producers have an opportunity to consider the role that advances in biotechnology - including biopesticides such as microbiota, peptides, bacteriophages, and RNA interference (RNAi) - can play in their overall product strategies. Europe currently holds a sizable 30% share of the $6 billion global biopesticide market, which is expected to more than double in the next five years due to growing awareness of the harmful effects of chemical pesticides in the region and growing demand for organic foods.

However, demonstrating the viability of a new product without existing guidelines, historical data, or standardized protocols for establishing safety and efficacy poses significant hurdles to regulatory approval - requiring in-depth familiarity with existing regulatory requirements, broad research strategies, and literature and data reviews to validate the use of a new biotech product.

Biological pesticide technology innovation 

Biopesticides in Europe generally include four main categories: microorganisms (bacteria, fungi, protozoa, viruses), plant extracts (phytodrugs), chemical pheromones (pheromones), and novel alternatives such as RNAi and peptides. While existing biopesticides fall into the top three categories, solutions based on RNAi molecules and peptides are still being developed.

RNAi, a naturally occurring cellular process that regulates protein synthesis, works by blocking mRNA translation, thereby hindering protein production in target pests. Peptides are short chain amino acids that can also target crop pests and weeds. These technologies have high specificity, rapid decomposition and efficacy potential in plant protection. Using phage mixtures and microbial communities can also improve efficacy and prevent pathogens from developing drug resistance.

Despite the potential of these new plant protection technologies, the EU lacks solutions (such as regulatory guidance) for RNAi molecules and peptides. In addition, as of this year, there are no active substances based on phages or microbiota approved in the EU or the UK.

Regulatory challenge

A changing regulatory framework 

The current regulatory framework in the EU is designed for chemical pesticides and does not take into account the specific characteristics and modes of action of innovative biotechnologies. For example, although RNAi and peptide products are biomolecules, they act in different ways, but they must comply with existing registration standards for conventional chemical pesticides.

In addition, until 2022, the EU followed a strain-centric microbial approval system that required individual registration of each component in a phage mixture or microbial consortium. In addition to being laborious and expensive, this approach does not accurately represent how these techniques are used in biopesticides.

The recent changes to the EU Regulation (Part B of Regulation (EC) No. 283/2013) mark a positive shift in regulatory trends, allowing for potential approval by the Microbiological Union and recognising the need to adapt and accept advances in formulations containing microorganisms within the regulatory framework. This could mean that agrochemical manufacturers may soon use active substances based on microbiota in biopesticide products.

Adjust data generation and risk assessment strategies 

Despite some progress, the innovative nature of biopesticide technology means that the European guidelines and standardised protocols needed to generate the right data and demonstrate the safety and effectiveness of biopesticides are currently limited. Therefore, in order to obtain regulatory approval, the applicant needs to adapt the existing protocols and risk assessment methods historically developed for chemical pesticides in the context of the Microbiological Consortium. For example, the applicant has identified the need to adapt the current guidance to suit the testing and assessment of the risk of microbiological pesticides to bees.

Determine the direction of the law 

Collaborative approaches between agrochemical manufacturers and experts 

Technical and regulatory coordination

Manufacturers of plant protection products and agricultural producers will benefit from an in-depth understanding of modern complex technologies such as molecular biology, genetics, bioinformatics and regulatory frameworks to successfully register these innovative biopesticides.

For example, the clear identification and characterization of microbial strains is a regulatory requirement to demonstrate that microorganisms used in biopesticides lack pathogenicity and robust risk assessment methods. This requires a good understanding of microbial physiology as well as molecular and genomic technologies, such as marker gene-based phylogenetic assessment or whole genome sequencing.

In addition, ensuring the specificity of double-stranded RNAi (dsRNAi) is key to demonstrating that RNAi molecules lack non-targeted effects. This can be helped by using bioinformatics tools to optimize dsRNA sequences and eliminate homology to similar sequences in close relatives of target pests.

Engage with regulators early 

There is a growing willingness to simplify procedures for new plant protection technologies while maintaining safety standards. For example, recent changes to the EU's microbial pesticide registration requirements illustrate this trend, and the EU-funded Low-risk Pesticide Risk Assessment Project (RATION), scheduled for completion in 2026, aims to develop risk assessment programmes and tools for low-risk pesticides.

Some EU member states have also begun to consider how existing standards can be applied to new biopesticides. The Dutch Authority (Ctgb) recently addressed the lack of specific guidance on new technologies for plant protection products in its biopesticide Evaluation Manual, which emphasizes the importance of leveraging insights from other regulatory frameworks and initiating discussions early in the application process. Proactive conversations like these can help ensure that a given approach meets regulatory needs, reduce delays, facilitate smoother evaluations, and potentially help pioneer innovative plant protection solutions in the European market.

Future of biopesticides 

Biopesticides are expected to play a key role in the plant protection products market, providing opportunities for growth and differentiation in the agricultural sector, driven by advances in biotechnology and more favorable policies. However, obtaining approval from European regulators remains a regulatory challenge. Overcoming these barriers requires working with experts, engaging early with regulators, adapting approaches, and leveraging insights from other regulatory jurisdictions.