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Biocides
→ Biocidal Active
Substances & Products
Turning Active Substances and Biocidal
Products into Compliant Market Access.
Biocidal products are subject to complex regulatory requirements under the Biocidal Products Regulation (EU) No 528/2012 (BPR) and, during the transitional period, national frameworks. We help companies define and implement the right regulatory pathway, from active substance approvals and renewals to product authorisations, Article 95 compliance, mutual recognition and Union Authorisations. Our multidisciplinary teams assess data requirements, identify waiving opportunities, develop regulatory strategies and prepare robust dossiers, while managing interactions with ECHA, the European Commission and national authorities.
We bring together scientific and regulatory expertise to simplify complex requirements and support efficient, sustainable market access across Europe.
What We Deliver
- Regulatory strategy under the EU and GB BPR, including national transitional schemes
- Active substance and product authorisations, including approvals, renewals, technical equivalence, Article 95 compliance, Union Authorisations, national authorisations and mutual recognition
- Biocidal Product Family (BPF) strategy, development and lifecycle management
- Data gap analysis, testing strategies and data waiving assessments
- Human, animal and environmental risk assessment, including exposure and dietary risk assessment, efficacy strategy and claims substantiation
- Technical dossier preparation, submission and defence, including authority interactions, consortium and project management, portfolio and country management
Why It Matters
The right strategy/
The right data/
Reliable authorisations/
We turn complex BPR requirements and transitional challenges into clear regulatory pathways, helping companies secure authorisations, optimise portfolios and build sustainable market access strategies across Europe, the UK and beyond.
