Biocidal product regulation Approval and market access for disinfectants and other biocidal products in Great Britain are regulated by the UK Biocidal Products Regulation (UK BPR). There are several challenges that Companies face while placing disinfectants and other biocidal products on the UK market, including regulatory complexities, data requirements, and administrative delays
Key Challenges in Securing UK BPR Approval
1. Regulatory Divergence from EU BPR
While UK BPR is based on the EU Biocidal Products Regulation (EU BPR), there are differences in data submission, deadlines, and approval processes. Let’s understand EU BPR vs UK BPR:
- Separate applications are required for UK BPR approval, even if the product is already authorized under the EU BPR.
- Active substances approved in the EU are not automatically accepted in the UK and must undergo separate UK BPR evaluation followed by UK BPR active substance approval.
2. UK BPR Data Requirements and Testing Costs
UK BPR demands comprehensive data on product efficacy, toxicology, and environmental impact:
- New studies may be needed to align with UK-specific data expectations, increasing the overall cost of compliance.
- Access to essential data, such as Letters of Access (LoAs) from active substance suppliers, may involve additional fees or negotiation challenges.
3. Administrative and Resource Burdens
The UK’s Health and Safety Executive (HSE) is responsible for reviewing UK BPR submissions:
- Staffing limitations and application backlogs contribute to extended approval timelines, ranging from several months to years.
- Companies must allocate significant internal resources for UK HSE regulatory submissions, compliance management, and ongoing updates as UK disinfectant regulations keep evolving.
Companies must obtain UK HSE biocides approval for Biocidal product registration UK.
4. Supply Chain and Market Access Hurdles
To market biocidal products in the UK:
- Companies importing biocidal products or active substances into Great Britain must appoint a UK-based entity for UK BPR compliance.
- If suppliers do not seek UK BPR approval for active substances, companies must find alternative sources or face product withdrawal from the UK market
5. Labelling and Packaging Compliance
Biocidal product labelling UK rules must be followed:
- Product labels must conform to GB CLP (Classification, Labelling and Packaging) standards or UK CLP Labelling Standards, including UK hazard statements and supplier contact information.
- Products authorized under EU BPR may require separate packaging for UK distribution to meet these criteria.
6. Transitional Measures and Critical Deadlines
- EU BPR approvals are not recognized under UK BPR, so companies must reapply under the UK framework.
- Biocidal products with EU BPR authorization may need transitional authorizations until UK approvals are granted.
- Businesses must track critical deadlines to avoid non-compliance or market disruptions.
Conclusion
Achieving UK BPR approval for disinfectants and biocidal products is a multi-layered and resource-intensive process. Businesses must establish a UK-specific regulatory strategy, ensure timely access to data, and closely monitor updates to the UK BPR framework to maintain uninterrupted market presence.
Freyr supports companies with end-to-end UK BPR compliance - from dossier preparation and data gap analysis to submission and post-approval maintenance - helping ensure smooth regulatory pathways and sustained market access.
