Decoding the BPR cost puzzle: Maximizing your value through collaboration with Arxada

The EU Biocidal Products Regulation (BPR) ensures that biocidal products are efficacious and comply with strict requirements related to human, animal and environmental protection.

Unfortunately, every euro, every hour spent preparing for the Biocidal Products Regulation (BPR) drain your resource, leads to market access slowdown, and a business distraction.

AArxada supports its customers through the EU Biocidal Products Regulation (BPR)

What if there was a way to navigate this complex landscape with confidence and efficiency, freeing you to focus on what you do best: bringing exceptional products to the market?

See how Arxada leverages its extensive product and regulatory knowledge to assist customers like you.

The BPR Price Tag: A Breakdown

The BPR's two-step process—active substance approval and product authorisation—drives significant costs.

Active substance approval: This involves extensive data generation on substance properties. New active substances can take up to 10 years and substantial investment to approve. Even existing substances face ongoing review programs and associated costs.
Product authorisation: Demonstrating product efficacy and safety requires costly testing and risk assessments.

Hidden costs: The real BPR challenge

Beyond direct costs, several hidden expenses impact your budget:

Data generation (up to €250,000 per product): Extensive testing, including physical-chemical properties, efficacy, human health, and environmental impact studies, drives significant lab costs, potentially reaching €150,000 for external labs alone.
Registration fees (up to €150,000): Fees vary by Member State and route to market (e.g., Union authorisation), adding another substantial expense. ECHA annual fees for Union dossiers can reach €40,000.
Maintaining compliance: BPR guidance changes frequently, potentially invalidating existing data and requiring costly re-testing. This can easily add another €150,000 or more to the cost.
Internal resources: Your team's time (chemists, microbiologists, formulators) dedicated to BPR compliance represents a significant investment.

So, why does this matter for YOU? Because every euro spent wrestling with BPR is a euro not spent on innovation, marketing, or growing your sales. It drains your resources, slows your market access, and frankly, it's a massive distraction.

Here’s where Arxada steps in – and why it's a game-changer for you:

We've done the heavy lifting: We've been involved in about 30% of the entire EU BPR program's active substance reviews. That’s not a boast; that's experience you can leverage. We know the rules, the nuances, and the pitfalls because we've lived them.
Your problem solved, collaboratively: Arxada offers NUGEN® disinfectant formulations ready for immediate market introduction in EU Member States under your own brand. We ensure all formulations meet national notification requirements and adhere to safety/efficacy standards.
We simplify the regulatory process, supporting your applications to the MSCA with 'How-To' guides, Letters of Access (LoA), and Letters of Supply (LoS). This ensures your products can be nationally notified before Active Substance approval, allowing continuous supply under transitional arrangements until full BPR authorization.
We're fully committed to supporting NUGEN® formulations' BPR authorization. This comprehensive support ensures regulatory compliance and accelerates your market entry.

In essence, while the BPR presents a complex regulatory landscape, customers adopting NUGEN® benefit from our specialized support for their notification journey. Arxada is committed to facilitating a more efficient path through intricate processes so you can focus on bringing exceptional products to market.