Biocontrol: building robust regulatory dossiers in an evolving environment
The development of biocontrol solutions comes with a wide range of regulatory and scientific challenges. From the characterisation of a new active substance to the preparation of a regulatory dossier, the assessment of available data and the anticipation of regulatory developments, each project requires a tailored strategy.
CEHTRA’s participation in ABIM 2026 in Basel gave Estelle Beltran, Head of Plant Protection at CEHTRA, the opportunity to exchange with industry stakeholders on current regulatory challenges and developments that may influence the future of biocontrol solutions.
Regulatory challenges start early in product development
Discussions at ABIM 2026 covered several issues faced by companies developing or marketing solutions for plant protection.
Key topics included:
requirements and timelines for the approval of new biocontrol active substances;
the use of QSARs and NAMs in Plant Protection regulatory dossiers;
knowledge and assessment of co-formulants;
requirements applicable to fertilisers and biostimulants in France;
regulatory developments that may affect development strategies.
Discussions around semiochemicals and Natural Substances also illustrated the importance of continuously monitoring changes in guidance and regulatory expectations.
In this context, a regulatory strategy should not begin only when a dossier is ready for submission. Integrating regulatory considerations early in development can help identify available data, potential data gaps and issues that may influence the next stages of the project.
From a biocontrol project to a regulatory dossier
Preparing a biocontrol regulatory dossier requires the collection and interpretation of data from several scientific disciplines. CEHTRA supports manufacturers of biocontrol solutions, excluding macro-organisms, from the early stages of product development.
Depending on the project, this support may include product characterisation, literature searches, assessment of available data and data gaps, definition of testing strategies, and preparation of the elements required for the regulatory dossier.
The objective is to develop an approach consistent with the product, its intended use and the applicable regulatory requirements. This work is supported by CEHTRA’s expertise in areas including toxicology, ecotoxicology, environmental fate and behaviour, exposure and risk assessment.
Birds & Mammals: anticipating the impact of evolving guidance
At ABIM 2026, CEHTRA also presented a poster focusing on the evolution of the Birds & Mammals guidance from EFSA 2009 to EFSA 2023.
This topic illustrates one of the challenges faced by companies developing Plant Protection Products: scientific methodologies, guidance documents and regulatory expectations continue to evolve, including while products are already under development.
Biocontrol solutions also need to be assessed according to the relevant exposure scenarios and applicable regulatory requirements. Identifying changes that may affect a dossier at an early stage can therefore help structure the assessment and adapt the regulatory strategy when required.
Combining regulatory expertise with digital tools
High-quality regulatory consultancy relies first and foremost on expert scientific and regulatory interpretation. However, with an increasing number of information sources and continuously evolving regulatory and toxicological data, digital tools can support the monitoring and identification of relevant information.
This is why CEHTRA combines scientific and regulatory expertise with digital solutions.
For example, CEHTRAWATCH supports automated monitoring of regulatory and toxicological developments relating to substances within a portfolio. It helps identify relevant changes so that experts can assess their potential implications for the substances, products and activities concerned.
In silico approaches and data analysis tools can also complement consultants’ expertise in specific assessments, while keeping scientific and regulatory interpretation at the centre of decision-making. The objective is not to replace human expertise, but to provide experts with structured and actionable information that can strengthen the regulatory advice provided to industry.
Building a regulatory strategy tailored to your biocontrol project
The discussions held during ABIM 2026 reinforced the importance of considering regulatory requirements as an integral part of product development.
A project may require answers to several questions: What data are already available? What information is missing? Which studies or assessments may be relevant? Which regulatory developments should be monitored? How should the different stages of the dossier be organised?
With its experience in Plant Protection, CEHTRA supports companies in preparing regulatory dossiers and defining strategies tailored to their products and objectives.
Our approach combines regulatory expertise, scientific knowledge and digital tools to help companies gain a clearer and more structured view of their regulatory challenges.
Developing a biocontrol solution?
Whether you need to assess your regulatory strategy, prepare a dossier or identify the data required for your project, CEHTRA can support you throughout the process.
Contact Estelle Beltran and CEHTRA’s Plant Protection experts to discuss your project and regulatory needs.
