ECHA will charge a fee for applications such as the below mentioned:
- Approval of an active substance;
- Renewal of an approval;
- Inclusion in Annex I of an active substance;
- EU authorisation, single product;
- Annual fee for EU authorised biocidal products
Fees charged by the Danish EPA
The Danish EPA will charge a fee for the processing of applications for authorisation of biocidal products under the BPR and the Danish transitional scheme.
The fee must be paid by any party applying for an authorisation or amendment to an authorisation of a biocidal product or approval of an active substance. The fee for authorisations is divided into a basic fee, which must always be paid for the service provided, and an additional fee which is taken out only when the conditions given are applying.
What does the fee cover?
The fees are set to cover the costs for the Danish Environmental Protection Agency for handling and evaluating applications. The Danish Environmental Protection Agency will always send an invoice to the applicant after receiving the application.
Danish fees may be adjusted annually using the latest published price and wages index in the Danish Ministry of Finance's guidelines on economic administration, see below for the current tariff sheet.
Administrative Changes under the Biocidal Regulation
All applications for administrative changes must follow the Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013.
According to the Regulations of describing the changes, some of the changes must be applied for before implementation. Other changes may simply be announced following implementation of these changes.
The Danish EPA will charge a fee in accordance with appendix 4 of the Statutory Order on Pesticides, cf. Part I.G, articles 1-3. Normally, they follow the Regulation of Changes, but there might be some differences.
Below are examples of some fees for different changes:
1. Administrative changes of products requiring prior notification before implementation
- Change of classification from DPD to CLP
- Changes that require a revised SPC
- Transfer of an authorisation to another authorisation holder (another company)
2. Administrative changes of products which can be announced after implementation
- Some conditions of use such as more precise instructions for use, the removal of a particular claim or additional modifications which are not relevant for the risk mitigation measure.
3. Minor administrative changes
- All changes regarding the authorisation holder: name and addresses for the holder and for the production site, changes in product and active substance manufacture(s) where the manufacturing procedure stays the same.
- Additional trade name or change of the existing product name.
A list of all fees levied with effect from 1 January 2023 can be found here. In addition to the fees listed for work on applications an annual fee of DKK 500 is levied on authorised products.