Biocides regulatory strategy and authorisation
Navigating the EU Biocidal Products Regulation (BPR) requires robust regulatory strategy, structured dossier preparation, and effective interaction with ECHA and national competent authorities. Companies face challenges such as data gaps, product family structuring, transitional regime management, and evolving active substance decisions. Our biocides regulatory consulting services support product authorisation, mutual recognition, risk assessment, and lifecycle compliance.
We help manufacturers accelerate market access, reduce regulatory risk, and ensure long-term compliance across EU and international markets.
Customised regulatory consulting for biocidal product registration under BPR, including strategy definition, dossier coordination, and submission management.
Data gap analysis & waiving strategy
Structured identification of missing data and development of scientifically justified waiving approaches to optimise testing requirements.
Biocidal product family structuring
Support in defining Biocidal Product Family (BPF) scope and regulatory positioning to maximise flexibility and reduce redundant studies.
Transitional & national regime support
Consulting for transitional measures, national authorisations, and alignment with country-specific regulatory frameworks all over Europe.
Dossier preparation & submission
Preparation, review, and submission support for regulatory dossiers in compliance with BPR and ECHA guidance.
Regulatory liaison with competent authorities
Manage communication with ECHA and Competent Authorities during evaluation, requests for information, and lifecycle updates.
Endocrine disruptor screening & risk assessment
Screening of biocidal products formulation for potential endocrine disrupting properties of co-formulants.
Ethanol regulatory strategy (PT1, PT2, PT4)
Regulatory support following the BPC positive opinion on ethanol for human hygiene, surface disinfection, and food/feed applications. We assist manufacturers in updating dossiers, adapting risk assessments, and aligning authorisation strategies with evolving ethanol regulatory decisions.