Ensuring compliance with biocides regulations in the EU and UK requires expert knowledge of complex regulatory frameworks and adaptation to EU & GB/NI regulatory divergence. Blue Frog Scientific provides specialist consultancy services to support businesses in meeting their obligations under the EU Biocidal Products Regulation (BPR) (Regulation (EU) No 528/2012) and the UK Biocidal Products Regulation (GB BPR).
Our team of regulatory experts assists clients across the biocides supply chain, from manufacturers and formulators to importers and downstream users. We deliver tailored regulatory strategies, helping businesses secure product approvals and maintain compliance with evolving legislative requirements.
How We Help You Overcome Critical Regulatory Challenges
Streamlining the Active Substance Approval and Product Authorisation Process
Both EU BPR and UK BPR require separate regulatory approval for active substances and biocidal products, involving multiple review stages by authorities such as ECHA (EU) and HSE (UK). We develop a clear regulatory strategy that ensures your active substance dossier and biocidal product applications meet all data requirements and comply with both EU and UK frameworks. We manage interactions with Competent Authorities (MSCA for EU, HSE for UK) to keep the approval process on track and avoid unnecessary delays.
Managing Complex Data Requirements
Authorities require extensive toxicology, ecotoxicology, environmental fate, and efficacy data to assess both active substances and biocidal products. In recent years, the introduction of endocrine disruption assessments and new efficacy testing requirements has increased the complexity of compliance under both EU and UK BPR.
We conduct a full data gap analysis for both active substance and product dossiers, ensuring all required studies are identified. We support data waivers, read-across justifications, and the use of new approach methodologies (NAMs) to minimise unnecessary testing while ensuring regulatory acceptance in both jurisdictions.
Reducing Costs and Resource Burden
Preparing BPR active substance and product authorisation dossiers is costly and time-consuming, particularly when applying for parallel approvals in the EU and UK. Study costs, regulatory fees, and consultancy expenses can quickly add up, making cost-effective strategies essential.
We help you optimise your regulatory spending, offering cost-effective dossier preparation and data-sharing strategies. Our expertise in task force coordination and letter of access negotiations ensures you avoid unnecessary costs while securing regulatory compliance in both markets.
Liaison with Competent Authorities
While EU BPR approvals are overseen by ECHA and a Member State Competent Authority (MSCA), UK BPR approvals are managed separately by the Health and Safety Executive (HSE). Companies must submit active substance dossiers and product applications via R4BP 3 (EU) or the HSE submission system (UK), which follow similar but distinct evaluation processes.
We can act as your regulatory representatives, handling all communication with ECHA, MSCAs, and HSE. Our deep understanding of regulatory precedents and technical requirements ensures proactive resolution of regulatory concerns, avoiding delays and rejections in both jurisdictions.
Ensuring Market Access and Product Compliance
Even after an active substance is approved, businesses must obtain product authorisation before placing biocidal products on the market. Companies must decide between national authorisation, mutual recognition, or Union authorisation (EU), while in the UK, a separate national authorisation process applies.
We provide strategic product authorisation services, supporting you through the optimal authorisation route for both EU and UK markets based on your commercial objectives.
Adapting to Regulatory Change
Both EU and UK BPR requirements continue to evolve, impacting active substance approvals, product authorisations, and ongoing compliance obligations. Companies operating in both regions must track regulatory updates and ensure dual compliance.
We monitor regulatory developments, upcoming restrictions, and new scientific guidance in both the EU and UK. Our early warning and regulatory impact assessment services help businesses stay ahead of compliance changes and avoid unexpected regulatory hurdles.
Minimising the Risk of Rejection
Non-compliant dossiers can lead to delays, additional testing requirements, or even rejection of both active substance approvals and product authorisations under EU and UK BPR.
We conduct pre-submission reviews and risk assessments to identify potential obstacles early. Our expert scientists and regulatory experts provide robust justifications to support your application and reduce regulatory risk in both markets.
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.
