This website uses non-intrusive cookies to improve your user experience. You can visit our cookie privacy page for more information.

Biocides fees

This page provides details of the fees charged by HSE as the UK Competent Authority (CA) to assess and evaluate product and active substance dossiers submitted to the UK under the EU Biocides Regulation 528/2012 (EU BPR). Fees are charged under the Biocidal Fees & Charges Regulations 2013.

HSE accepts payments by either cheque or bank transfer. The full payment details/methods will be outlined in your invoice.

Fees for the authorisation of a Biocidal Product Dossier

Work on biocidal products is charged out at a rate of £409 per day (the daily rate is adjusted pro rata for parts of a day). An initial estimated fee will be invoiced based on our assessment of the work involved.

A modular approach has been introduced which separates the evaluation into smaller modules and provides greater transparency on the extent of the work involved.

The table below details the modules and the associated initial estimated fee (this fee is based on our experience of the resource required to complete the module). The total invoice value may be made up of a number of modules depending on the application type and the data in the dossier. HSE has produced some examples of initial estimated product fees made up from the administrative, co-ordination and specialist modules listed below.

Administrative / Co-ordination Modules

Administrative/Co-ordination Modules Initial estimated fee Comments
Withdrawal £104
Sift (Preliminary Consideration) £229
Validation £100 As required under Article 29 of EU BPR
Technical Sift £1,000 Initial stage of evaluation intended to identify technical gaps early
Co-ordination 1 (data plus) £1,800 For applications with 3 or more specialist data modules
Co-ordination 2 (data) £1,200 For applications with 1 or 2 specialist data modules
Co-ordination 3 (no data) £700 For application with no specialist data modules (cases only or no specialist input)
Parallel Import Verification £200
Administrative approvals* £150
Admin Task* £50 For making an identical change to several products

*An ‘Administrative approvals’ fee is charged for the first product, an ‘Admin Task’ fee is then charged for each subsequent product

Specialist modules

The table below details the specialist modules and the associated initial estimated fee. If data/study reports and risk assessments have been provided for a specialist area then this will be sifted as a 'data module', whereas if there is a reliance on read-across to other information/data, or only waivers have been included for a specialist area, then this is sifted as a 'case module'.

Specialist Modules Estimates initial fee
Chemistry data £750
Chemistry case £500
Toxicology data £750
Toxicology case £500
Residues Data £750
Residues Case £500
Operator Hygiene data £1,200
Operator Hygiene case £500
Ecotoxicology data £1,200
Ecotoxicology case £500
Fate & behaviour data £2,500
Fate & behaviour case £500
Efficacy data £1,200
Efficacy case £500

On completion of the evaluation of your application, the actual cost will be calculated and, if it has gone beyond the initial estimated fee, a top-up fee will be requested which must be paid prior to you receiving your product authorisation number and associated UK legal documents. Alternatively, if the actual cost is less than the initial estimated fee a refund will be given.

Fees for the Evaluation of an Active Substance Dossier

Work on Active Substance evaluations is charged out at a rate of £465 per day (the daily rate will be adjusted pro rata for parts of a day).

An initial fee will be invoiced based on our assessment of the work involved.

All applications for active substance approval will be charged a validation check fee and the relevant data package fee. For example a full data pack will be charged the Full Data package fee and smaller or additional active substance data packages will be charged the relevant band depending on the resource requirements to evaluate the data package.

Application type Estimates initial fee
Validation Check £5,000
Full Data Package £130,000
Data Package Band 7 £130,000
Data Package Band 6 £110,000
Data Package Band 5 £80,000
Data Package Band 4 £60,000
Data Package Band 3 £35,000
Data Package Band 2 £20,000
Data Package Band 1 £10,000
EU Discussion & Committee Process £55,000
Renewal of Active Substance £12,000

The cost of the evaluation of your application will be monitored throughout and if the cost goes beyond the initial estimate a top up fee may be requested. On completion the actual costs will be calculated and if necessary a further top-up fee will be invoiced. Alternatively, if the actual costs are less than the fees already paid, a refund will be given.  Approvals will not be issued until all invoices have been paid.

Fees for the Evaluation of a Simplified Active Substance Dossier

An application for a ‘Simplified Active’ is for an active substance that the applicant wishes to be included onto Annex I of the EU Biocides Regulation, rather than ‘Approved’ through the conventional route. Annex I contains active substances that can be used in products that are expected to have a more favourable environmental and human health profile and there are specific restrictions on what substances can be included onto Annex I, further details are on our Simplified Actives page.

Work on Simplified Active Substance evaluations is charged out at a rate of £465 per day (the daily rate will be adjusted pro rata for parts of a day).

All applications will be charged a validation check fee and the relevant data package fee. For example a full data pack will be charged the Full Data package fee and smaller or additional active substance data packages will be charged the relevant band depending on the resource requirements to evaluate the data package.

Application type Estimates initial fees
Validation Check £5,000
Full Data Package £100,000
Data Package Band 7 £100,000
Data Package Band 6 £80,000
Data Package Band 5 £60,000
Data Package Band 4 £50,000
Data Package Band 3 £30,000
Data Package Band 2 £15,000
Data Package Band 1 £7,500
EU Discussion & Committee Process £40,000

The cost of the evaluation of your application will be monitored throughout and if the cost goes beyond the initial estimate a top up fee may be requested. On completion the actual costs will be calculated and if necessary a further top-up fee will be invoiced. Alternatively, if the actual costs are less than the fees already paid, a refund will be given.  Approvals will not be issued until all invoices have been paid.

Other Fees

Application type Estimates/Initial Fees
Pre Submission Meeting (initial estimated fee for full day meeting) £5,000
Pre-Submission Meeting (initial estimated fee for 2 hour meeting) £500
Evaluation & Commenting on draft study protocols £400
Updated 2016-03-30