PPP Dossier Support & EU Registration

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Introduction

From study design to market authorization with full scientific support

Registering a plant protection product under Regulation (EC) No 1107/2009 requires a full data package and a strategic approach. Whether you are applying for a new authorization, seeking renewal or submitting a zonal application, your dossier must be complete, justified and ready for evaluation. Triskelion helps you design the studies, interpret the results and build a dossier that supports your product both scientifically and strategically.

What is PPP registration, and why does it matter?

To place a plant protection product on the EU market, you need authorization from at least one Member State. This requires submission of a detailed dossier containing information on the active substance, formulation, efficacy, residues, toxicology, environmental impact and more. The core dossier (dRR) must follow a strict format and be backed by validated studies.

The stakes are high. Incomplete or unclear dossiers can result in rejection or years of delay. Strong dossiers help you avoid additional questions, reduce evaluation time and improve your chances of success across multiple markets.

What does the legislation require?

Regulation 1107/2009 governs the placing of plant protection products on the market. It requires applicants to

submit a full data package in dRR format
• justify the use and risk profile of the product
• include GLP-compliant studies on efficacy, toxicology and residues
• assess environmental fate and ecotoxicological risk
• follow zonal or mutual recognition procedures where applicable

The regulation is harmonised at EU level, but national requirements and interpretations may vary. A tailored strategy is essential to manage both the scientific and procedural challenges.

What does this mean in practice?

Dossier support becomes critical when
• your formulation is new, changed or borderline in scope
• you need to bridge data gaps or rely on existing studies
• you face zonal complexities or diverging national expectations
• you lack the in-house resources to build or update the dRR

Without expert guidance, it is difficult to align study design, regulatory expectations and dossier quality. Many applicants rely on a partner who can connect the dots from lab results to regulatory approval.

How we support your PPP dossier and registration

Triskelion offers a complete service to support your PPP dossier strategy and submission.

Study design and coordination: we help define which studies are needed and ensure they are GLP-compliant
• Data interpretation: our experts turn raw data into regulatory justifications, risk assessments and exposure evaluations
• dRR compilation: we structure and write your dossier in line with zonal, national and EU requirements
• Submission and follow-up: we support you through the application process, authority feedback and renewals

Our strength lies in combining deep regulatory insight with laboratory expertise. We generate data, interpret results and build a compelling dossier that increases your chances of approval.

Frequently asked questions

Can I reuse data from previous dossiers?
In some cases, yes. You will need access rights or Letters of Access. We help assess data usability and negotiate agreements.

Do I need efficacy data for every crop or use?
Not always. We help determine where bridging, extrapolation or minor use justifications are acceptable.

What if the competent authority rejects part of my dossier?
We help analyse the response, adjust the dossier and manage resubmission or clarification.

Want to bring your PPP to market?

We help you align science, data and dossier for a successful authorization. Contact us for a dossier review or tailored intake.