Gaining authorisation for a biocidal product, product family, or approval of an active substance under the EU BPR (Regulation 528/2012) or GB BPR is a complex, multi-stage process. Success depends on a clear regulatory strategy and input from multiple scientific disciplines, including toxicology, ecotoxicology, efficacy and chemistry.
With deep expertise across these areas, Sagentia Regulatory helps companies meet compliance requirements effectively, supporting smooth progression through the authorisation process and sustained access to the European market.
Expert regulatory support across all biocidal product types
Biocidal products cover a broad spectrum of applications. Whether you’re developing a disinfectant, preservative, pest control product, or another type of biocidal solution, achieving regulatory compliance under the Biocidal Products Regulation (EU BPR 528/2012 and GB BPR) requires a clear understanding of the specific obligations tied to each product type.
We offer targeted support across all product types to help you navigate these complex regulatory landscapes with confidence.
Disinfectants – Support for disinfectant products used in human hygiene, veterinary hygiene, food and feed areas, drinking water, and algaecides, ensuring safety, efficacy, and regulatory compliance across all applications.
Preservatives – Guidance on preservatives used during storage and in materials including film, wood, fibre, leather, rubber, polymers, construction materials, liquid cooling and processing systems, slimicides, and cutting fluids, aligned with current regulatory expectations.
Pest control – Expert support for insecticide products used as rodenticides, avicides, molluscicides / vermicides, piscicides, insecticides / acaricides, and repellents / attractants, ensuring your pest control products meet safety and performance standards.
Other biocidal products – Regulatory expertise for antifouling products used on boats aquaculture equipment and other structures used in water, as well as embalming and taxidermist fluids.
Strategic regulatory solutions for biocides
Is your company looking to gain access to the EU and GB market? Or are you navigating the challenges of maintaining existing access through the renewal programme, while keeping pace with evolving regulations and guidance?
Whether you need to appoint an EU- or UK-based Article 95 representative, or submit a new active substance application to ECHA or HSE, Sagentia Regulatory can support you with clear, strategic guidance at every step.
Active substance approval
- Product registration – Complete dossier preparation and submission (R4BP) and post-authorisation support, we manage the full process. Starting with determining the must have portfolio and claims, structuring of families, test strategies and planning, choice of evaluating authorities and market areas. Combined with comprehensive and complete administrative package including label development, SPC, IUCLID and SDS preparation, expert waivers, and Poison Centre Notifications (Article 45 of the CLP)
- Risk assessment – Robust risk assessments are essential for demonstrating product safety and efficacy. Our multidisciplinary team delivers high-quality evaluations aligned with current regulatory expectations
- Technical support – Focused technical input strengthens your regulatory position. Services include data gap analysis, study design and monitoring
- Endocrine disruption assessment – Demonstrating endocrine-disrupting properties is critical for approval. We deliver assessments aligned with ECHA/EFSA guidance of June 2018, including data searches, collation of published studies and regulatory information, and expert monitoring of in vitro and in vivo ED studies. We also provide scientifically robust waiver justifications for technically challenging substances or where study requests lack justification. For biocidal products, we offer targeted screening-level assessments to identify potential endocrine-disrupting properties efficiently and aligned with regulatory expectations, helping you build a scientifically sound and defensible submission
- Analysis of alternatives and comparative assessment – Active substances that meet BPR exclusion criteria will face non-approval unless a robust analysis of alternatives (AoA) and socio-economic impact assessment (SEIA) demonstrate the substance is irreplaceable. Products based on substances meeting exclusion criteria require a detailed comparative assessment of similar products. We guide you through the AoA, SEIA, and Comparative Assessment processes – evaluating technical and socio-economic feasibility, supporting derogation justifications, and helping you build a scientifically sound and defensible case
- Regulatory strategy and compliance – A clear regulatory strategy helps you stay ahead of evolving requirements. From Union Authorisation to national submissions, Sagentia Regulatory provides tailored guidance, including support for non-EU markets such as Switzerland and Norway. Our team helps structure biocidal product families, prepare robust justifications, and tackle Biocidal Product Committee (BCP) reviews with confidence
- Consortium management – Expertly managing consortia and task forces for biocides, agrochemicals, and general chemicals under REACH, we ensure collaboration is both strategic and compliant. Services include member identification, drafting consortium agreements, data collation and analysis, study monitoring, regular meetings, and full dossier preparation and submission support—delivered with transparency at every stage
- Training and workshops – Customised training programmes and workshops keep your team up to date with the latest regulatory developments and best practices in the biocides industry, empowering informed, confident decision-making
- Representatives – Acting as a trusted regulatory representative, we support GB companies on the EU and EU companies on the GB Article 95 lists, ensuring continued market access and compliance on both sides of the Channel
Why choose us for biocidal product support?
With years of experience in the biocides sector, our team has the expertise to guide you through every stage of the regulatory process. We take a client-centric approach, working closely with you to develop solutions that align with your business goals. Our proven track record in securing product authorisations and ensuring compliance reflects the quality and reliability of our support.
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