BPR Compliance – Complex, Costly, but Manageable (The Consortium Approach)
As this series has shown, Biocidal Products Regulation (BPR) compliance is far more involved than simply formulating a product and putting it on the market. It’s a detailed, multi-phase journey that demands time, money, and regulatory expertise.
• Formulation Development & Testing: Products must demonstrate efficacy, stability, and safety, often requiring analytical testing and data on possible by-products.
• Data Collection & Risk Assessment: Micro-efficacy, toxicology, and environmental data all form part of a robust submission.
• Regulatory & Administrative Burden: High fees, complex documentation, and the need for consultants can make this a costly process.
Sodium Hypochlorite: An Ongoing Cost Example Sodium hypochlorite, a widely used disinfectant, has been subject to additional data requests even after its dossier was accepted under BPR. This resulted in unexpected costs for manufacturers, many of whom believed the regulatory process was complete. It’s a clear reminder that approval doesn’t always mark the end of the expense.
Collaboration Makes a Difference
One effective way to reduce both cost and complexity is through joining a consortium. This approach allows companies to share data, expenses, and regulatory workload—offering strength in numbers when facing evolving requirements.
Bottom line: BPR compliance can be unpredictable, but with careful planning and collaborative strategies, it’s a challenge that can be managed.
In the previous post, we looked at the consortium approach under BPR, where multiple companies collaborate to get an active or product authorised. This means shared investment, joint decisions on formulation and QC methods, and collective responsibility for getting the dossier over the line.
But what if you’re not part of a consortium?
There are other routes to BPR compliance, especially when working directly with a supplier or distributor.
Piggyback / Sub-Authorisation Route
In this model, a supplier agrees to add your trade name to their existing product authorisation. You’ll typically:
• Pay a yearly fee (anywhere from £10,000 to £50,000),
• Or commit to purchasing a minimum volume of material annually,
• Or both, depending on the terms.
You don’t hold the authorisation yourself – you’re effectively “piggybacking” on the supplier’s dossier and approval. The supplier’s details appear on the product label, and you must stick to the exact approved formulation. This is a straightforward way to stay on the market without managing your own dossier, though it comes with commercial strings attached.
