Unique products – bespoke solutions

Plant Biopesticides and Biostimulants are playing an increasingly vital role in sustainable food production and pest management.

As environmental concerns grow, conventional plant protection products and fertilisers face greater scrutiny. Biopesticides and biostimulants, while still holding a small market share (8% and 2%, respectively), are experiencing consistent growth as eco-friendly alternatives.

Enviresearch technical experts are renowned for new and innovative solutions to Plant Protection Product regulation and registration. Using our collective expertise we build robust evidence-based risk assessments and reasoned cases, taking time to engage with our clients to understand their needs.

For biopesticides, we understand that each new plant protection product and biostimulant can be unique. As such we approach these products with open-mindedness to new approaches and dedication to understanding the needs of our clients.

Helping you navigate the current regulatory landscape

Under EU and GB law (Regulation No. 1107/2009), biopesticides are regulated alongside synthetic agrochemicals under a system designed to ensure only safe and effective plant protection products reach the market. This system requires extensive data and rigorous testing.

Biopesticides differ from synthetic pesticides, including potentially having different data requirements under 283/2013 and 284/2013, making regulatory compliance challenging due to guidelines primarily designed for traditional chemicals. However, these challenges can be addressed through careful study design and open dialogue with authorities.

Biostimulants fall under the Fertilising Products Regulation (EU) 2019/1009, effective since July 2022. This regulation defines them as products enhancing plant nutrition independently of nutrients and sets harmonized rules for safety, efficacy, and labeling. CE-marked biostimulants comply with EU standards, but national rules apply to non-CE-marked products.

Industry leading knowledge and expertise

Our technical and regulatory experts have a wide range of experience in various fields applicable to the registration of biopesticides in the EU and UK, these include (but are not limited to):

• Soil microorganisms and fungal diseases of plants
• Pathophysiology of entomopathogenic fungi.
• Entomology
• Population-level effects
• Crop production systems – focussed on horticultural crop production
• Testing methods and study monitoring

In addition to the above technical areas, we also have regulatory experience of:

• Preliminary risk assessments
• Dossier writing and submission
• Liaison with Rapporteur Member States during pre-submission, evaluation and post-registration support
• Classification and labelling
• Endocrine disruption
• Weight of evidence approaches
• Efficacy requirements for Biopesticides (BAD authoring)
• Scope of Plant Protection Product Regulations and other routes to registration

What are biopesticides and biostimulants?

Biopesticides comprise of a range of different substances that are derived from nature, but may be refined or adapted to improve their crop-protection capabilities. There are three main groups of biopesticides:

• Microorganisms – these include a range of bacteria, fungi, viruses and bacteriophages that have symbiotic, antagonistic or competitive modes of action against the target host. 
• Plant extracts – these chemicals are derived from natural plant defence mechanisms or metabolites that provide active or passive deterrents against predation, parasitisation and infection in the wild. They are extracted, refined and stabilised to allow application in plant protection products. 
• Semiochemicals – these are complex chemicals that primarily act on the olfactory senses (like pheromones) of potential pests, creating attractant and deterrent effects or providing mating disruption to reduce overall populations or push pests out of a crop.

Biostimulants work like natural fertilisers, improving the nutrient availability or promoting the uptake of naturally occurring nutrients by the plant. These products have the advantage of fewer restrictions that plant protection products and are applied at various stages of the crop lifecycle.