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Biocidal product fee examples

This page provides examples of how HSE’s module fee structure maybe used to calculate the initial estimated fee for application for product authorisation submitted to the UK under the EU Biocides Regulation 528/2012 (EU BPR).

The examples below are made up from administrative, co-ordination and specialist fee modules for biocidal products. The co-ordination fee covers the co-ordination of the evaluation, production of authorisation documents and update of R4BP3. If data/study reports and risk assessments have been provided for a technical area then this is charged 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 technical area, then this is charged as a 'case module'. These examples are for illustrative purposes only and should not be taken as the actual fee charged by HSE. Please note these examples are for HSE fees only and are charged under the Biocidal Fees & Charges Regulations 2013.Additional fees may be payable to the European Chemicals Agency (ECHA).

Example 1 – Product authorisation application with case modules for human health toxicology and ecotoxicology and data modules for other specialist areas

Module type Module Description Fee (GBP £)
Administrative Sift 229
Validation 100
Technical sift 1000
Co-ordination Co-ordination 1 (data plus) 1800
Specialist Physicochemical studies: data module 750
Efficacy studies: data module 1200
Human health toxicology: case module (read-across/reliance on active substance dossier/MSDS) 500
Human health risk assessment: data module 1200
Ecotoxicology: case module (read-across/reliance on active substance dossier/MSDS) 500
Environmental fate and behaviour risk assessment: data module 2500
TOTAL INITIAL ESTIMATED FEE (GBP £) 9779

Example 2 – A major change involving assessment of new chemistry and efficacy data

Module type Module Description Fee (GBP £)
Administrative Sift 229
Validation 100
Co-ordination Co-ordination 2 (data plus) 1200
Specialist Physicochemical studies: data module 750
Efficacy studies: data module 1200
TOTAL INITIAL ESTIMATED FEE (GBP £) 3479

Example 3 – A same biocidal product application where the original product was authorised after September 2013 and the new product has the same authorisation holder

Module type Module Description Fee (GBP £)
Administrative Sift 229
Admin approval 150
TOTAL INITIAL ESTIMATED FEE (GBP £)* 379

* Note: a validation fee of £100 would be included if reduced label claims were requested under Article 3 of Regulation 414/2013

Updated 2016-03-29