Surfachem | Biocidal Product Regulation

Cost of GB BPR Authorisation for a Single Product – Including All Fees

Applying for biocidal product authorisation under GB BPR involves several fees, including HSE charges and additional costs for multiple trade names.

1. HSE Fees

Admin Fees: o Sift: £229 o Validation: £100
Assessment Fees: o Assessment Manager: £6,800 o Chemistry: £2,200 o Toxicology: £1,800 o Exposure Assessment: £4,800 o Ecotoxicology: £800 o Environmental Fate: £3,800 o Efficacy: £4,800
Typical total cost: £15,000 – £35,000 (varies by complexity).

2. Fees for Multiple Trade Names

Each additional trade name in dossier: o Admin Change Fee: £500 o With Technical Assessment: £1,000

Example: Base product authorisation: ~£25,000 • 5 trade names added: £500 × 5 = £2,500 • Total estimated cost: £27,500+

3. Post-Approval Changes

Minor Changes: o Single aspect (e.g., fragrance change): £1,500 o Multiple aspects: £2,500
Major Changes: o Single aspect (e.g., active substance adjustment): £3,500 o Multiple aspects: £6,500
Other potential costs include consultancy (£5,000–£20,000) and lab testing (varies).

4. Important Notes

Costs may vary based on product complexity.
Applies only to GB BPR (England, Scotland, Wales). • Ireland & EU require a separate EU BPR dossier.

Cost of EU BPR – Single Product or Union Authorisation

Authorising a biocidal product in the European Union (EU) can be pursued through two primary pathways: National Authorisation for individual Member States, such as Germany,

and Union Authorisation for EU-wide approval. Below is an overview of the estimated regulatory fees associated with each route.

1. National Authorisation in Germany

To market a biocidal product exclusively in Germany, you must apply for national authorisation through the Federal Institute for Occupational Safety and Health (BAuA).
Estimated Fees: • Standard Biocidal Product: €77,800 • Biocidal Product Family: €118,100
Note: Additional fees may apply for further uses or specific evaluations. Source: BAuA Fees

2. Union Authorisation (All EU Member States)

For products intended for use across multiple EU Member States under similar conditions, Union Authorisation provides a harmonised approval process.
Estimated Fees: • ECHA Fee for Union Authorisation: €80,000 • Evaluating Competent Authority (eCA) Fee: Varies by Member State. For example, Germany charges €97,300 to evaluate a Union Authorisation application. • Annual Fees: ECHA charges maintenance fees after approval.
Total Estimated Initial Cost: €177,300 (combining ECHA and eCA fees) Source: BAuA Union Authorisation Fees

Key Considerations:

Costs vary depending on the Member State chosen as the evaluating competent authority (eCA) and product complexity.
Additional testing and consultancy costs are not included.
National Authorisation allows later Mutual Recognition to expand to other EU countries, but each additional country incurs fees.
Union Authorisation is more expensive upfront but provides single approval for all EU markets under the same conditions.

More Information: ECHA Guide to Union Authorisation

Developing a BPR-Compliant Product – A Multi-Step Process

Bringing a biocidal product to market under the Biocidal Products Regulation (BPR) is a complex and multi-disciplinary process requiring scientific, regulatory, and compliance expertise. Ensuring that a product meets efficacy, stability, and safety standards involves extensive development, testing, and assessment.

1. Product Development & Efficacy Testing

Formulation Development: Selecting the right active substances at effective yet safe concentrations. Ensuring the product performs consistently across different applications.
Microbiological Efficacy Testing: Conducting repeated testing at various concentrations to determine the lowest effective dose. Establishing a clear efficacy breakpoint to support claims (e.g., bactericidal, fungicidal, virucidal).

2. Stability & Shelf-Life Testing (GLP Standards)

Regulatory-Approved Laboratory (GLP Testing): Stability studies ensure the active ingredient remains effective over time. Accelerated and real-time stability testing assesses how the formulation holds up under different storage conditions. Any risk of degradation or by-product formation must be investigated (e.g., aldehydes, peroxides).

Key Objective: Ensure the product remains within specification throughout its shelf life.

3. Risk Assessment & Additional Testing

Potential Reactants & By-Products: Some formulations may lead to undesirable chemical reactions over time. Analytical testing is required to confirm no harmful by-products are generated.
Packaging Compatibility & Preservation Testing: Compatibility testing ensures packaging materials do not degrade the product. Preservative efficacy testing may be needed to prevent microbial contamination, especially in wipes.

4. Multi-Disciplinary Team Involvement

A successful BPR product requires expertise from multiple fields:

Development Chemists – Formulate and optimise the product.
Regulatory Specialists – Ensure compliance with dossier requirements.
GLP Laboratory Experts – Conduct efficacy, stability, and safety testing. Consultants – Guide dossier preparation and risk assessments.
Manufacturing & QA Teams – Scale up production and maintain quality.

5. Final Considerations

Skipping key steps can lead to regulatory failure. Proper data generation and risk assessment are critical to gaining approval. Each product is unique and requires tailored development and validation.