Expert regulatory support for Plant Protection Products

We guide you through every step, from active substance strategy to product authorization.

Bringing your Plant Protection Products safely to market

At CEHTRA, we understand the challenges you face in navigating complex regulatory landscapes for plant protection products. Our experts provide end-to-end support from identifying data gaps to dossier submission and defense ensuring compliance with European and national requirements. With a tailored strategy and strong scientific expertise, we help you achieve successful approvals and accelerate your market access.

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Key regulatory services

for Plant Protection Products

Regulatory strategy & Dossier preparation

Data gap analysis (DGA, DMT) and study design
Dossier preparation (CADDY, IUCLID formats)
Submission to European and national authorities
Scientific argumentation and post-submission defense

Risk assessment & Scientific expertise

Human health (toxicology, operator, consumer exposure)
Environmental fate and behaviour
Ecotoxicology and ecosystem impact
Modelling and refinement for tailored risk assessments

Task Force & Project management

Coordination of multi-company dossiers at EU level
Strategic partnerships for active substance approval
Study monitoring and follow-up with laboratories
Regulatory support in Europe and worldwide

Added-Value Services

Endocrine Disruptor
Biocontrol, fertilizers, and biostimulants expertise
Customized field and operator studies
Preliminary risk assessments (PRA)

Looking for guidance on plant protection compliance?

Find it here.

The active substance contained in your PPP must first be approved at EU level. Once it is approved, you can apply for product authorization in the Member States, following zonal application or mutual recognition. CEHTRA supports manufacturers, formulators and distributors throughout the EU approval and national authorization processes of Regulation (EC) No 1107/2009. We guide you from initial regulatory strategy to dossier preparation, submission, and post-submission defense. Our experts ensure your products meet EU regulations efficiently, helping you bring them to market with confidence.

Biostimulants can enhance crop growth, improve nutrient efficiency, and increase tolerance to abiotic stress, and they may be put on the market at European level with Regulation (EU) 2019/1009 or at national level following Member States’ specific requirements. Our experts support you from safety assessment to dossier preparation and submission, ensuring your biostimulant comply with regulations and reach the market successfully.

Preliminary Risk Assessment (PRA) includes environmental screening, identifying in advance the potential risks to groundwater and to the ecosystem, that are associated with the use of Plant Protection Products (PPPs). This PRA is based on conditions of uses and effects on non-target organisms (NTO), and allows manufacturers and distributors optimising their field efficacy testing strategy, as well as adjusting ahead the Good Agricultural Practices so as to secure the environmental safety of their products’ uses.

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