At Blue Frog Scientific, we provide expert scientific and regulatory support for the preparation of active substance and plant protection product (PPP) dossiers under both the EU Plant Protection Products Regulation (EC) No 1107/2009 and the UK’s post-Brexit PPP regulatory framework.
With first-class experience in regulatory agencies, industry, and testing, our expert team delivers high-quality dossiers aligned with EFSA, HSE, and Member State Competent Authority (MSCA) requirements, helping you secure faster approvals and seamless market access.
Strategic Data Gathering and Gap Analysis
Ensuring regulatory success starts with a comprehensive data review. We assess your existing studies against EU and UK requirements, identifying gaps and developing strategies to optimise your dossier submission. Our service covers:
- Identity & Composition:
- Substance identity, purity, impurities, and formulation details
- Physicochemical Properties:
- Stability, analytical methods, and physical-chemical characterisation
- Toxicology & Human Health Risk Assessment:
- Acute, sub-chronic, and chronic toxicity, dermal absorption, reproductive toxicity, and operator exposure modelling
- Residues & Metabolism Studies:
- Plant and animal metabolism, residue trials, and consumer risk assessments for MRL compliance
- Ecotoxicology & Environmental Risk Assessment:
- Impact on birds, bees, aquatic organisms, and soil organisms
- Environmental Fate & Behaviour:
- Soil degradation, groundwater modelling, leaching potential, and persistence and bioaccumulation assessments
- Efficacy Testing:
- Demonstration of effectiveness against target pests under agricultural conditions
- Data Matching:
- Ensuring that the data used in a plant protection product dossier aligns with existing approved data for the active substance
- Endocrine Disruption (ED) Assessment:
- Comprehensive evaluation using EFSA/ECHA and OECD guidance
- New Approach Methodologies (NAMs):
- Application of in silico, in vitro, and alternative testing strategies where applicable
- Analysis of Alternatives:
- Required for active substances that are candidates for substitution or through comparative assessment if safer alternatives are available
Where data gaps exist, we provide cost-effective solutions, including:
- Data waivers: Scientific justifications to reduce unnecessary studies
- Read-across approaches: Leveraging existing data to fulfil requirements
- New study proposals: When additional data generation is required for compliance
Integrated Testing Strategies & Study Monitoring
We develop cost-effective, scientifically sound testing strategies to generate the necessary data for a successful active substance and plant protection product registration. Our approach prioritises the use of new approach methodologies (NAMs) to reduce cost and reliance on animal testing.
- New Approach Methodologies (NAMs):
- Incorporation of in silico models, in vitro assays, and read-across approaches to support hazard assessments where applicable
- Testing Strategy Development:
- Designing tiered testing approaches that align with regulatory and scientific best practices in both EU and UK
- Study Monitoring & Data Generation:
- Overseeing Good Laboratory Practice (GLP) studies, ensuring reliable and relevant results
Active Substance Dossier Preparation (IUCLID Format)
We develop scientifically robust active substance dossiers in IUCLID format, ensuring compliance with EFSA and HSE submission requirements. Our expert team prepares:
- Identity & Composition:
- Full chemical characterisation and impurities assessment
- Manufacturing & Quality Control:
- Batch consistency and analytical methods
- Toxicology & Human Health Risk Assessment:
- In-depth evaluation of safety and exposure
- Residues & Metabolism:
- Supporting Maximum Residue Level (MRL) compliance
- Ecotoxicology & Environmental Risk:
- Addressing risks to non-target species and ecosystems
- Environmental Fate & Behaviour:
- Modelling soil degradation, groundwater leaching, and environmental persistence
- Efficacy & Mode of Action:
- Demonstrating product effectiveness and resistance risk assessment
- Classification & Risk Management:
- CLP classification, risk mitigation measures, and regulatory labelling
- Comparative Assessment:
- If required, evaluating safer alternatives to meet regulatory expectations
Plant Protection Product Dossier Preparation (dRR Format)
For PPP product authorisations, we prepare comprehensive dRR dossiers to meet both EU and UK regulatory requirements.
- Part A – Risk Management
- Part B – Risk Assessments (human health, environmental fate, ecotoxicology)
- Part C – Efficacy Data
We ensure that your dRR meets EFSA, HSE, and MSCA expectations, supporting faster approvals in both zonal (EU) and national (e.g. UK) authorisation processes.
Submission and Regulatory Engagement
We manage the entire submission process, handling interactions with regulatory authorities and ensuring compliance at every stage.
EU Submissions:
- Active substance dossiers submitted via IUCLID/R4BP 3 to EFSA and a rapporteur MSCA
- PPP product dossiers submitted via the zonal authorisation process or directly to national competent authorities
UK Submissions:
- HSE evaluation of active substances and PPP products under the post-Brexit regulatory framework
- Applications submitted via the UK Submission Platform, adhering to UK-specific risk assessments
We proactively address regulatory queries, provide technical justifications, and respond to data requests, reducing delays and streamlining approvals.
Regulatory Review and Market Approval
We manage the peer review process, ensuring your active substance or product dossier meets all scientific and regulatory requirements:
- Scientific Peer Review – Coordination with EFSA (EU) or HSE (UK).
- Public Consultation – Responding to stakeholder comments
- Regulatory Decision & Market Authorisation – Supporting final approval and registration
Upon approval:
- EFSA or HSE lists the active substance on the EU Approved Active Substance List or the UK Active Substance Register
- National regulatory bodies issue product authorisations, granting market access
Decision and Market Authorisation
- For active substances, EFSA or HSE issues an approval decision, adding the substance to the EU Approved Active Substance List or the UK Active Substance Register.
- For plant protection products, national regulatory bodies issue product authorisations based on zonal or national review outcomes.
Ongoing Compliance and Renewal Support
We provide long-term regulatory support, helping you maintain compliance and market approval:
- Compliance Monitoring – Ensuring adherence to risk mitigation measures and labelling requirements
- Renewal Applications (EU AIR Process & UK Re-Evaluation) – Managing periodic re-assessments, including new risk assessments and data updates
Blue Frog Scientific brings together a team of expert consultants with first-class experience in regulatory agencies, industry, and regulatory testing, providing unmatched insight into EU and GB plant protection product registration. Our scientific expertise, regulatory knowledge, and strategic approach ensure smooth approvals for active substances and plant protection products.
From IUCLID and dRR dossier preparation to strategic regulatory planning and ongoing compliance, our tailored solutions ensure efficient approvals in the EU and GB.
Contact us today to discuss how we can support your EU and UK active substance registration and product authorisation.
