UK BPR Approval: Challenges Compliance for Biocides

The approval and market entry for disinfectants and other biocidal products in Great Britain fall under the UK Biocidal Products Regulation (UK BPR). Companies encounter numerous challenges when introducing these products to the UK market, including complex regulations, specific data requirements, and potential administrative delays.

Primary Challenges in Attaining UK BPR Approval 

1. Regulatory Differences from EU BPR 

Although UK BPR is derived from the EU Biocidal Products Regulation (EU BPR), significant differences exist in terms of data submissions, deadlines, and approval methods. Here's a comparison of EU BPR and UK BPR: 

   - Companies must submit separate applications for UK BPR approval, even if their products are already approved under EU BPR. 

   - Active substances that have obtained EU approval do not automatically qualify for acceptance in the UK and must undergo a distinct evaluation process under UK BPR, followed by the necessary UK approval.

2. Data Requirements and Testing Costs Under UK BPR 

UK BPR entails stringent data obligations concerning product efficacy, toxicological effects, and environmental implications: 

   - New studies might be necessary to meet UK data standards, which can elevate compliance costs significantly. 

   - Obtaining essential data, such as Letters of Access (LoAs) from suppliers of active substances, might incur additional expenses or negotiation challenges.

3. Administrative Burdens and Resource Allocation 

The UK’s Health and Safety Executive (HSE) is charged with the review of UK BPR submissions: 

   - Limited staffing and application backlogs lead to prolonged approval durations, sometimes extending from several months to years. 

   - Companies need to dedicate considerable internal resources to manage UK HSE regulatory submissions, compliance, and ongoing regulatory updates as UK disinfectant standards adapt.

4. Supply Chain Challenges and Market Entry Issues 

When marketing biocidal products in the UK: 

   - Companies importing these products or their active ingredients must designate a UK-based representative to comply with UK BPR regulations. 

   - Should suppliers fail to pursue UK BPR approval for active substances, companies must seek alternative resources or risk product removal from the UK market.

5. Requirements for Labelling and Packaging 

Compliance with UK labelling regulations for biocidal products is vital: 

   - Labels must adhere to GB CLP (Classification, Labelling and Packaging) standards, incorporating UK hazard statements and supplier details. 

   - Products accepted under EU BPR may necessitate separate packaging to satisfy UK distribution criteria.

6. Transitional Provisions and Key Deadlines 

EU BPR approvals are not acknowledged by UK BPR, mandating companies to reapply within the UK framework. 

   - Biocidal products with existing EU BPR approvals may require temporary authorizations until UK approvals are secured. 

   - Organizations must monitor critical deadlines to prevent compliance issues or market interruptions.

Conclusion 

Securing UK BPR approval for disinfectants and biocidal products is a complex and resource-heavy endeavor. Businesses must formulate a regulation-specific strategy for the UK, ensure timely data access, and remain vigilant about updates to the UK BPR framework to uphold a consistent market presence.

Freyr assists companies in navigating end-to-end UK BPR compliance—from dossier preparation and identifying data gaps to submission and maintenance post-approval—ensuring smooth regulatory processes and ongoing market