Fees and charges for biocidal products
The fees and charges for an application for authorisation of a biocidal product depend on the status of the active substances in Europe and the specific type of application. Applications under transitional legislation are subject to the Ctgb Tariffs Decree. For applications under the Regulation, fees and charges must often be paid to ECHA as well. Consequently, the fees and charges are subject to both the Ctgb Tariffs Decree and the Implementing Regulation of ECHA.
Small and medium-sized enterprises established in the European Union can benefit from reduced fees under Biocidal Products Regulation, depending on their size and provided that certain conditions are met. In order to do this, companies need to submit the documentary evidence proving their entitlement to such reduction in advance of the actual application. The conditions and the instructions on how to submit the documentation for the SME check are described in more detail on the ECHA website.
Tariffs based on an advance payment and subsequent calculation.
Applicants pay an advance fee for the assessment based on the standard costs. Then the risk assessment follows on various aspects, such as human toxicology, ecotoxicology, behavior and fate in the environment, physicochemical properties and efficacy. The costs depend on the required work and that differs considerably per type of application.
Active substance application:
See Tariffs Decree, page 12: Chapter 8 1a. Fees and charges for applications for approval of active substances (authorisation and renewal of active substances as well as inclusion in Annex I (of Regulation (EU) 528/2012))
Product authorisations under BPR
Ctgb does not charge an annual fee for union authorisations biocidal product. In case The Netherlands act as eCA (evaluating Competent Authority) for a union authorization, the assessment fees will be charged (see chapter 8 of the tariff decree of Ctgb).
See Tariffs Decree, page 12: Chapter 8 1b Fees and charges for applications for the authorisation of a product or for the amendment or renewal of a product authorisation, where the Ctgb is the evaluating authority (eCA).
Simplified authorisation under BPR
See Tariffs Decree, page 12: Chapter 8 1b Fees and charges for applications for the authorisation of a product or for the amendment or renewal of a product authorisation, where the Ctgb is the evaluating authority (eCA). Starting with code: B-ET – SA-APP
Mutual Recognition under BPR
See Tariffs Decree, page 13: Chapter 8 1c Fees and charges for applications for the authorisation of a product or for the amendment or renewal of a product authorisation, where the Netherlands is Concerned Member State (CMS).
Tariffs based on fixed costs
See Tariffs Decree, page 13: Chapter 8 1d Fees and charges for other applications or administrative requests biocidal products – Fixed fees and charges
Fixed tariffs for mutual recognition under the BPR and for Simplified authorisations, Same Biocidal Product applications and applications under transitional law.
Transitional law applications
See Tariffs Decree, page 14: Chapter 8 2 Fees and charges for product applications and other services and activities where one or more existing active substances for the requested PTs are not yet included in the Union list of approved substances or Annex I of Regulation (EU) 528/2012.