September 01, 2025

Household cleaning products with claims such as kills 99.9% of bacteria or effective against viruses are classified as biocidal products in the European Union. Before these disinfectants, antibacterial sprays, or surface cleaners can be placed on the EU market, they must comply with the Biocidal Products Regulation (BPR, Regulation (EU) No. 528/2012).

The BPR ensures that biocidal products are safe for human health, effective in use, and environmentally sustainable. For businesses planning to launch or expand cleaning products in the EU, understanding the biocidal product registration process is critical.

 

What is the EU Biocidal Products Regulation (BPR)?

The Biocidal Products Regulation (BPR) sets the rules for placing biocidal products on the EU market. Its primary objective is to ensure that only products with proven safety, efficacy, and environmental compatibility are made available.

BPR applies to a wide range of disinfectants and cleaners used in:

  • Households (surface disinfectants, antibacterial sprays)
  • Healthcare facilities (hospital-grade cleaners)
  • Industrial environments (sanitizers, specialized cleaning agents)

 

Step-by-Step Process for Biocidal Product Registration in the EU

Businesses looking to achieve BPR compliance for their cleaning or disinfectant products must follow a structured regulatory pathway:

1. Active Substance Approval

  • The first step is ensuring that the active ingredient in the product is approved under BPR.
  • Approved substances are listed in the Union list of active substances.
  • If the substance is not listed, companies must submit a comprehensive dossier including:
    • Toxicological and ecotoxicological data
    • Efficacy assessments
    • Human and environmental safety studies

2. Biocidal Product Authorization

After active substance approval, the product itself must be authorized.

  • Applications are submitted through the R4BP 3 (Register for Biocidal Products) platform.
  • The dossier should cover:
    • Product efficacy studies (proof of disinfectant performance)
    • Human health risk assessment
    • Environmental risk assessment
    • Physicochemical properties and stability data
  • Compliance with BPR labeling and packaging rules is mandatory to ensure safe consumer use.

3. Choosing the Authorization Route

Companies can apply through two authorization types depending on their market strategy:

  • National Authorization – for marketing in a single EU member state.
  • Union Authorization – for marketing across all EU countries under one approval.

Choosing the right authorization pathway is key to aligning with business expansion goals.

 

Challenges in EU BPR Compliance

The EU disinfectant regulation framework is among the most stringent in the world. Key challenges businesses face include:

  • Extensive scientific testing and analytical studies
  • Complex dossier preparation and data submission
  • Long timelines and detailed regulatory reviews
  • Need for strategic planning to avoid delays in market entry

For many companies, especially those new to the EU market, navigating biocidal product authorization can be overwhelming without expert support.

 

How Maven Supports BPR Compliance

Maven helps businesses streamline their BPR registration process with:

  • End-to-end dossier preparation for both active substances and products
  • Regulatory strategy consulting tailored to EU disinfectant markets
  • Ongoing compliance support post-authorization
  • Guidance on Union vs. National authorization to optimize market entry

Whether you’re registering a new antibacterial cleaning spray or expanding an existing disinfectant range, Maven’s experts ensure compliance with all EU BPR requirements.

 

Conclusion

For any household cleaning product with biocidal claims, BPR compliance is mandatory to access the EU market. From active substance approval to product authorization and strategic route selection, each stage demands robust documentation and regulatory expertise.

With the right partner, the journey doesn’t have to be complicated. Maven’s regulatory team helps companies navigate BPR with confidence—simplifying approvals, ensuring compliance, and accelerating time-to-market.