Biocidal products play a critical role in safeguarding public health and hygiene. However, their potential risks to humans and the environment require stringent regulation. In the European Union, this responsibility is governed by Regulation (EU) No 528/2012, commonly known as the Biocidal Products Regulation (BPR). EU Regulation for biocidal products sets the rules for approving biocides, authorising biocidal products, and selling biocide treated products, ensuring smooth market approval and a high level of protection for human health, animal health and the environment.
Why the BPR Matters
The goal of EU Biocidal Products Regulation is
- Single Market Efficiency: Streamline rules to avoid duplication and foster innovation.
- High Protection Standard: Ensure all biocidal products are demonstrated safe and effective before they reach users or the environment.
- Animal Welfare: Compulsory dataโsharing of vertebrate studies to reduce repeat testing and protect animal lives.
It introduces a two-step process:
- First, active substances must be evaluated and approved.
- Second, each biocidal product using those substances must be authorized.
Without going through these steps, products cannot be legally sold in the EU.
What is a Biocidal Product?
A biocidal product is any substance or mixture that contains or generates one or more active substances intended to destroy, deter, render harmless, or prevent the action of harmful organisms through chemical or biological means.
This includes surface disinfectants, Hand gels, Presaturated wipes, Insecticides, Bleaches and algaecides etc.
Biocidal Product Categories
Biocidal products are organised into 22 product types, grouped into four main areas
Disinfectants
- Human hygiene, veterinary, food/feed area, drinking water, and surface disinfection
Preservatives
- Film, wood, fibre/leather/rubber, construction materials, cooling fluids, slimicides, cutting fluids
Pest Control
- Rodenticides, avicides, molluscicides, piscicides, insecticides/acaricides, repellents, vertebrate control
Other Biocidal Products
- Antifouling agents and embalming/taxidermy fluids
Authorisation Process and Competent Authorities
National Authorisation
- Companies submit a dossier to a single Member State authority. Once granted, mutual recognition procedures can extend that authorisation to other Member States.
Union Authorisation
- For products of wide market interest, dossiers can be submitted directly to the European Commission, with opinions provided by ECHAโs Biocidal Products Committee (BPC).
Role of ECHA
- Provides scientific and technical assessments via the BPC
- Maintains the Register for Biocidal Products (R4BP) for dossier submission, information exchange and publication of approvals
- Manages the Article 95 list of suppliers of active substances.
Tips to Comply with EU Biocidal Products Regulation
1. Map Your Product Portfolio: Identify all microbialโcontrol products (including those without explicit efficacy claims, e.g., IPA wipes). Review Safety Data Sheets for active substances.
2. Verify Active Substance Suppliers: Ensure suppliers of active substances are listed on Article 95 of the BPR; request proof of inclusion from your supplier.
3. Check Authorisation Status: Confirm each productโs BPR authorisation number and relevant productโtype on ECHAโs information portal. Note there may be a lag between grant and online listing.
4. Handle Unauthorised Products:
- If active substances arenโt yet approved, supply under national rules and plan for future EU Biocidal Products Regulation submission.
- If dossiers are pending (e.g., delays due to COVID or Brexit), obtain R4BP Case Numbers as evidence of submission.
- If substances are approved but no dossier was submitted on time, switch suppliers or start revalidation to avoid market withdrawal.
5. DataโSharing and Letters of Access: Coordinate with other dossier holders to share vertebrateโanimal study data and obtain letters of access, minimising redundant testing.
The Role of Testing Laboratories
To comply with EU Biocidal Products Regulation, manufacturers must submit reliable and standardized test results. This is where accredited labs play a key role by providing:
- Efficacy testing against bacteria, fungi, and viruses
- Toxicity and safety testing
- Environmental impact assessments
- Support for dossier preparation and documentation
Efficacy Standards
To demonstrate efficacy and safety, biocidal products must comply with European or international standards, often under CEN frameworks:
- EN 1276 (Phase 2, Step 1): Quantitative suspension test for bactericidal activity.
- EN 13697 (Phase 2, Step 2): Quantitative surface test on nonโporous surfaces.
- EN 1650 (Phase 2 step 1): Quantitative suspension test for fungicidal activity.
- EN 14476 (Phase 2 step 1): Quantitative suspension test for virucidal activity.
Navigating the EU Biocidal Products Regulation can be complex, but with careful planning, early engagement and adherence to guidance, manufacturers can secure market access across the By understanding its objectives, product classifications, authorization routes and compliance strategies including robust testing under recognised standards, manufacturers and distributors can secure and maintain market access while upholding the highest protection standards for people and the environment.
At MIS , we offer full biocidal product testing under all key international standards and dedicated R&D services to help you develop, optimize and comply.
Contact us today to see how we can support your next project.
