Plant protection regulatory services
Expert guidance for EU and GB plant protection product compliance
Bringing plant protection products to market in Europe and the UK requires more than data – it calls for a clear understanding of Regulation (EC) No 1107/2009, evolving regulatory requirements, and a well-defined submission strategy. Whether planning a new approval/authorisation or managing renewals, early decisions can have a lasting impact on project timelines and outcomes.
Sagentia Regulatory supports companies at every stage of the regulatory journey, helping you anticipate challenges, reduce risk, and make informed, science-led decisions that facilitate your products’ progress through the decision-making process.
Plant protection product types
Under Regulation (EC) No 1107/2009, a wide range of plant protection products and active substance types require authorisation. These include:
- Pesticides – Control pests that threaten crop yield and quality
- Herbicides – Manage unwanted vegetation and invasive species
- Fungicides – Prevent and treat fungal infections in crops
- Insecticides – Target insect pests with precision and safety
- Rodenticides – Control rodent populations in agricultural settings
- Plant Growth Regulators – Influence plant development and productivity
Within these there is a broad range of active substance types, including conventional chemicals, low-risk compounds, natural substances, plant extracts, complex mixtures, semiochemicals and microbial agents.
Sagentia Regulatory supports your plant protection regulatory compliance journey
- PP dossier preparation – Accurate, well-structured dossiers are essential for successful authorisation. Whether you’re preparing a zonal application (Article 33), a reauthorisation (Article 43), or seeking mutual recognition, Sagentia Regulatory helps ensure your submissions meet EU and GB requirements – minimising delays and supporting a smooth review process
- Strategic advice and guidance – A well-informed regulatory strategy reduces uncertainty, shortens timelines, and increases the likelihood of a positive outcome. Our regulatory and scientific experts draw on decades of experience across industry, government, and research to deliver tailored, actionable guidance. With Sagentia Regulatory, you gain science-led insight to interpret and apply Regulation (EC) No 1107/2009 across the EU and GB – helping you navigate complexity and bring products to market effectively
- Data generation and study monitoring – Generating high-quality data is critical to regulatory success. Our team designs and oversees field trials, laboratory studies, and ongoing research in line with Good Laboratory Practice (GLP) standards – ensuring your data are robust, compliant, and fit for purpose
- Risk assessment – Thorough risk assessments are essential to demonstrate product safety. Our in-house toxicologists, ecotoxicologists, and environmental scientists evaluate human health and environmental risks – including operator and consumer exposure, environmental fate, and ecotoxicology – to support regulatory approval
- Regulatory liaison –Extensive experience with regulatory authorities allows us to anticipate expectations, communicate effectively, and resolve issues before they become obstacles. Acting as intermediaries, we streamline interactions and support well-aligned submissions. With offices in the UK, France, Germany, and Spain, we offer local insight and pan-European coordination, ensuring your approval and authorisation processes run smoothly across jurisdictions
- Data gap analysis – Identifying and addressing data gaps early helps avoid costly delays. Our experts assess your projects across multiple specialist disciplines, chemistry, residues, toxicology, and environmental fate and ecotoxicology , ensuring robust and compliant data packages
- Product registration –Timely registration and renewal are essential to keeping products on the market. Sagentia Regulatory supports active substance approvals across GB and EU Member States, with a strong track record in new approvals and renewals under the AIR programmes
- IUCLID and CADDY – Preparing electronic dossiers in the correct format is essential for successful submission. With extensive experience in IUCLID and CADDY-XML, Sagentia Regulatory ensures your dossiers are fully compliant with EU regulatory systems and meet the requirements of the Transparency Regulation (EU 2019/1381), streamlining the approval and renewal process
Why choose Sagentia Regulatory?
Partnering with Sagentia Regulatory means working with a team deeply embedded in the European regulatory landscape. Our scientific and regulatory experts combine practical experience with local insight to support the successful approval of plant protection active substances and authorisation of products across the EU and GB. With a client-focused approach and a strong track record in European procedures, we help you navigate complexity and achieve regulatory success.
