At Blue Frog Scientific, we provide expert regulatory and scientific support for the preparation of active substance product dossiers under both the EU Biocidal Products Regulation (BPR) (Regulation (EU) No 528/2012) and the UK Biocidal Product Regulation (UK BPR).
Data Gathering & Gap Analysis
Before dossier preparation, Blue Frog Scientific conducts a comprehensive review of availabe data to assess compliance with BPR information requirements. This includes:
- Physicochemical Data:
- Substance identity, composition, stability, and analytical methods.
- Toxicology and Human Health Assessment:
- Fulfilment of endpoints such as acute, sub-chronic, chronic, and reproductive toxicity studies, dermal absorption, and toxicokinetics.
- Ecotoxicology and Environmental Health:
- Fulfilment of endpoints such as effects on aquatic and terrestrial organisms, persistence, bioaccumulation, and degradation.
- Environmental Fate and Behaviour:
- Fulfilment of endpoints such as biodegradation, leaching potential, hydrolysis, and phototransformation.
- Efficacy Testing:
- Demonstration that the biocidal product is effective for the intended use.
- Endocrine Disruption (ED) Assessment:
- Evaluation in accordance with ECHA and EFSA guidance.
- New Approach Methodologies (NAMs):
- Use of alternative testing strategies where applicable is now mandatory under BPR.
- Residues and Metabolism Studies:
- For relevant products, metabolism in crops, livestock, and food residues.
If data gaps are identified, waivers, read-across justifications, or new studies may be required.
Dossier Compilation in IUCLID
- IUCLID Dossier Compilation:
- The International Uniform Chemical Information Database (IUCLID) format is mandatory for both EU BPR and UK BPR active substance and product dossiers.
- Data Entry:
- All study summaries and reports are formatted and uploaded into IUCLID, ensuring compliance with the latest ECHA and HSE guidelines.
- Safety Assessments:
- Hazard classification, exposure assessment, and risk characterisation are conducted for human and environmental safety.
- Comparative Assessments:
- If the active substance is classified as a candidate for substitution, alternative substances must be evaluated.
Preparation of Risk Assessment Reports
For active substances, the Draft Assessment Report (DAR) is prepared for submission to the evaluating Competent Authority (eCA). This includes:
- Human Health Risk Assessment (HHRA)
- Environmental Risk Assessment (ERA)
- Classification and Labelling (CLP) Justifications
- Mode of Action and Efficacy Evaluations
For biocidal product dossiers, the risk assessment includes:
- Operator, worker, and bystander exposure models (e.g., ConsExpo, BEAT, EUROPOEM).
- Environmental exposure modelling using EUSES, or specific FOCUS models for environmental compartments according to relevant emission scenario methods.
Submission via R4BP 3 (EU) or HSE System (UK)
- EU Submission:
- Active substance and product dossiers are submitted via R4BP 3, where ECHA conducts a validation check before forwarding the application to the Competent Authority (eCA).
- UK Submission:
- Dossiers are submitted via the HSE online system, which follows a similar but separate evaluation process.
Evaluation & Follow-Up
- Competent Authority Review:
- The evaluating MSCA (EU) or HSE (UK) conducts a scientific assessment, often requiring additional data or clarifications.
- Public Consultation and Peer Review:
- Active substance dossiers undergo ECHA peer review, while product authorisation may involve Member State feedback.
- Final Decision:
- The European Commission (EU) or HSE (UK) issues approval decisions, granting market access.
Post-Approval Obligations
- Compliance Monitoring: Continued adherence to approved risk mitigation measures.
- Renewal and Review: Periodic re-evaluation of active substances and products based on updated regulatory requirements.
Blue Frog Scientific brings together a team of specialist consultants, with first-class experience in regulatory agencies, industry, and testing laboratories, provides strategic insight and technical expertise to ensure the successful approval of active substances and biocidal products in both the EU and UK.
