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 a number of regulatory fees, with the final cost depending on the complexity of the product and the level of assessment required.

1. HSE Fees

Typical HSE assessment fees include:

Sift: £229
Validation: £100
Assessment Manager: £6,800
Chemistry: £2,200
Toxicology: £1,800
Exposure Assessment: £4,800
Ecotoxicology: £800
Environmental Fate: £3,800
Efficacy: £4,800

HSE currently gives an average initial estimate of around £25,000 for a national product authorisation, with actual costs typically falling within a range of approximately £15,000–£35,000, depending on the application.

2. Fees for Multiple Trade Names

Additional trade names may incur further fees depending on whether they are added during the initial application or after authorisation.

Where trade names are added as a post-authorisation administrative change, HSE currently gives an initial estimated fee of around £500, with higher fees potentially applying where technical assessment is required.

3. Post-Approval Changes

Changes made after authorisation can also result in further regulatory fees.

Administrative change: £500
Administrative change requiring technical assessment: £1,000
Minor change – single principal aspect: £1,500
Minor change – multiple aspects: £2,500
Major change – single principal aspect: £3,500
Major change – multiple aspects: £6,500

Other potential costs can include regulatory consultancy, laboratory testing and additional analytical or efficacy work.

4. Important Notes

Costs vary depending on product complexity and the level of assessment required.
HSE operates on a cost-recovery basis, so the final fee may differ from the initial estimate.
GB BPR applies to England, Scotland and Wales.
Products intended for the EU market require separate authorisation under EU BPR.

Cost of EU BPR – Single Product or Union Authorisation

Authorising a biocidal product in the European Union can be pursued through several routes, including National Authorisation within an individual Member State or, where eligible, Union Authorisation.

1. National Authorisation in Germany

To market a biocidal product initially in Germany, an application can be made through the German competent authority.

Current regulatory fees include:

Standard Biocidal Product: €77,800
Biocidal Product Family: €118,100

Additional fees may apply for further uses or specific assessments.

2. Union Authorisation

For eligible products intended for use across multiple EU Member States under similar conditions, Union Authorisation provides a single EU-wide authorisation.

Current regulatory fees include:

ECHA Union Authorisation fee for a single product: €95,600
Evaluating Competent Authority fee: varies by Member State
Germany, for example, currently charges approximately €97,300 to evaluate a single-product Union Authorisation application

This gives an estimated initial regulatory cost of approximately:

€95,600 + €97,300 = €192,900

This excludes testing, consultancy and other supporting development costs.

ECHA also charges an annual fee following approval, currently €11,950 for a single Union-authorised product.

Key Considerations

Costs vary depending on the Member State chosen as the evaluating Competent Authority and the complexity of the product.
Additional testing and consultancy costs are not included.
National Authorisation can later be expanded into other EU Member States through Mutual Recognition, although additional fees apply.
Union Authorisation carries a much higher upfront cost but can provide a single authorisation across EU markets for eligible products.

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

Bringing a biocidal product to market under BPR is a complex and multi-disciplinary process requiring scientific, regulatory and compliance expertise.

1. Product Development & Efficacy Testing

Formulation Development: Selecting appropriate active substances at effective but safe concentrations and ensuring the product performs consistently in its intended application.
Microbiological Efficacy Testing: Conducting testing at different concentrations and conditions to establish an effective dose and support claims such as bactericidal, fungicidal or virucidal performance.

2. Stability & Shelf-Life Testing

Stability studies are required to demonstrate that the active ingredient and formulation remain within specification throughout the intended shelf life.
Accelerated and real-time stability studies may be required.
Potential degradation or formation of unwanted by-products may also need to be investigated.

Key Objective: Ensure the product remains safe, effective and within specification throughout its shelf life.

3. Risk Assessment & Additional Testing

Potential Reactants & By-Products: Analytical testing may be required where there is a risk of chemical reactions or degradation over time.
Packaging Compatibility: The product must remain compatible with its packaging throughout its shelf life.
Preservation: Additional preservation testing may be required for certain formats, particularly products such as wipes.

4. Multi-Disciplinary Team Involvement

A successful BPR product may require input from:

Development Chemists
Regulatory Specialists
GLP Laboratory Experts
Microbiologists
Regulatory Consultants
Manufacturing and QA Teams

5. Final Considerations

Skipping key stages of development can result in delays or regulatory failure.

Robust data generation, efficacy testing, stability assessment and risk assessment are therefore critical to achieving successful authorisation.

Every product is different, meaning the development programme and final regulatory cost will depend on the formulation, claims, intended use and markets being targeted.

Disclaimer: Fees were correct at the time of writing and may have since increased. This article aims to highlight the range of fees involved rather than their current costs.