GB BPR fees

HSE charges fees for processing and evaluating applications for biocidal active substance approval and product authorisation under the GB Biocidal Products Regulation (GB BPR). The fees charged by HSE are based on daily rates which are set out in law - access the law that provides the daily rates.

When you submit your application, we estimate how much it may cost to process your application based on the information provided - this is the initial estimated fee.

When we have completed the evaluation of your application, we will calculate the actual cost of the work that we have carried out. If the actual cost is more than the initial estimated fee, we will charge you a top-up fee for the difference. If the actual cost is less than the initial estimated fee, we will refund the difference. Please note: For active substance applications top-up fees may be charged part-way through the process.

Actual fees can vary significantly between applications depending on the quality of the application, the issues that arise during the evaluation, the number of products included in the application, how the product(s) is used, who uses it and where it is used. Assessment managers can provide updates on the fees throughout the assessment of an application to help keep you informed.

Failure to pay the fees charged may result in your:

The full details of the available payment methods will be outlined in your invoice.

Biocidal product fees

The initial estimates for biocidal products provided below reflect the final fees for applications completed by HSE during 2018-2020. Please note the daily rate has not changed.

The initial estimated fees for applications for biocidal product authorisation or changes to an authorisation are made up of modules. The modules are used to break down the processing and evaluation of an application into its different parts and are intended to provide greater transparency on the work involved.

An invoice value is usually made up of several different modules depending on:

The initial estimated fees for various modules that may be associated with a product application are shown below.

Administration

Module Initial estimated fee Comments
Sift £229 The process of estimating how much it may cost to process the application based on the information provided.
Addition of Trade name £50 A charge for each additional trade name associated with the lead product application prior to authorisation (or for each additional trade name after the first three requested as part of a change (see below).
Validation £100 A check to ensure that all required information has been submitted and is in the correct format.
Withdrawal £104 If an application has been sifted and then it is withdrawn, a withdrawal fee is charged.

National Product Authorisation

Module Initial estimated fee Comments
Assessment manager £6,800 Primary point of contact in HSE.
Management of the application through the process.
Production of final documentation.
Chemistry £2,200 Evaluation of chemistry data / study reports, including physical and chemical properties.
Toxicology £1,800 Evaluation of toxicology data / study reports, including human and animal health.
Operator exposure £4,800 Evaluation of data / study reports and risk assessments relating to human and animal (companion animals and livestock) health.
Ecotoxicology £800 Evaluation of ecotoxicology data / study reports, relating to the environment and non-target animals and other organisms.
Environmental fate and behaviour £3,800 Evaluation of data / study reports and risk assessments relating to the environment.
Efficacy £4,800 Evaluation of data / study reports, relating to the efficacy of the product.
Average initial estimate for product authorisation £25,000 Actual costs have ranged from £15,000 to £35,000.

Changes to authorised products

Application type Initial estimated fee Comments
Administrative change - 1 £500 Estimate for processing an administrative change that does not require technical assessment - eg change of name, transfer of ownership of an authorisation, or addition of up to three trade names* (*additional fee applies to each additional trade name).
Administrative change - 2 £1,000 Estimate for processing an administrative change that does require technical assessment - eg change to product classification and labelling.
Minor change - 1 £1,500 Estimate for processing a minor change that typically requires a change to one aspect of the technical terms and conditions of authorisation - eg change to shelf-life (except bait products) or pack size.
Minor change - 2 £2,500 Estimate for processing a minor change that typically requires a change to more than one aspect of the technical terms and conditions of the authorisation.
Major change - 1 £3,500 Estimate for processing a major change that may affect compliance with Article 19 or 25 of GB BPR - eg addition of a target organism or assessment of endocrine-disrupting properties as part of a post-authorisation condition.
Major change - 2 £6,500 Estimate for processing a major change that may affect compliance with Article 19 or 25 of GB BPR and requires multiple changes to the product risk assessment - eg additional use(s) or changes relating to the active substance(s).

Find out more about the types of changes you can make to your authorisation and how they are categorised.

Other product application types

Application type Initial estimated fee Comments
Simplified Product Authorisation £8,000 Estimate for processing a simplified product authorisation. This type of application requires the same technical expertise as a national product authorisation but typically includes less data. Actual costs have ranged from £7.000 to £16 000.
Same Biocidal Product £1,000 Estimate for processing a national authorisation via the same biocidal product route.
Product Authorisation Renewal £4,500 Estimate for processing a product authorisation renewal application.
Pre-submission meeting £5,000 A full-day meeting to discuss the data requirements for product authorisation.
Pre-submission meeting £500 A 2-hour meeting to discuss the data requirements for product authorisation.
Draft study protocols £400 Evaluation and commenting on draft study protocols for product authorisation prior to beginning the studies.

Active substance fees

The initial estimated fees for applications for biocidal active substance approval cover validation, the evaluation of data, drafting of a Competent Authority Report (CAR) and the development of the 'opinion' or regulatory decision. The evaluation fee is dependent on the amount of data that are contained in the dossier. The example given in the table represents a full data package for a single product type.

Application type Initial estimated fee Comments
Active Substance Approval
Validation £5,000 A check to ensure that all required information has been submitted and is in the correct format.
Evaluation £130,000 Technical assessment of data and technical consultation.
Opinion Development £25,000 Regulatory decision-making process including engagement with other organisations.
Active Substance Renewal
Full evaluation £50,000 Technical assessment of data and technical consultation.
Partial evaluation £25,000 Technical assessment of data and technical consultation.
Simplified Active Substance Approval
Validation £5,000 A check to ensure that all required information has been submitted and is in the correct format.
Evaluation £100,000 Technical assessment of data and technical consultation.
Opinion Development £25,000 Regulatory decision-making process including engagement with other organisations.

Other active substance application types

Application type Initial estimated fee Comments
Technical Equivalence £5000 Tier 1 technical assessment of data. Additional fee payable if Tier 2 assessment is required.
Inclusion on the GB Article 95 List as a product or substance supplier £500 or £5000 The £500 fee is the estimated cost for processing an application solely based on a Letter of Access to a GB active substance dossier. The fee of £5000 is the estimated cost for processing an application that relies on the submission of new data.
Pre-submission meeting £5,000 A full-day meeting to discuss the data requirements for active substance approval / product authorisation.
Draft study protocols £400 Evaluation and commenting on draft study protocols for active substance approval prior to beginning the studies.
 
Updated 2021-07-19