Documentation requirements - mutual recognition
Authorisation of a biocidal product is based on an applicant submitting all necessary documentation to demonstrate that the product concerned has no unacceptable effects on either human health or the environment and that it is effective. This documentation typically consists of test data. The Danish Environmental Protection Agency carries out its own evaluation of the risk to the environment and health, whilst the efficacy of the product is evaluated by external consultation partners such as The university of Aarhus.
Below are listed the document types that must be enclosed your application for mutual recognition in order for the Danish Environmental Protection Agency to accept the application. Form and content requirements for the documentation (the accompanying dossier) are given at the bottom of the page.
When the reference Member State is not Denmark, but an applicant wishes to apply for mutual recognition in Denmark, the following information must be submitted to the Danish Environmental Protection Agency for the initial stage, in other words upon inclusion of the active substance in Annex I:
- Notification that an application for authorisation has been filed in a specified Member State and that an application will be filed for mutual recognition in Denmark (by means of R4BP)
- A signed print-out from R4BP
- A copy of the “summary dossier” submitted to the country of initial application (reference Member State). The Danish Environmental Protection Agency may ask for this to be translated into English.
For the second stage, the following must be submitted to the Danish Environmental Protection Agency within two months of initial authorisation in the country of initial application:
- A copy of the authorisation granted by the reference Member State and a translation thereof into Danish or English.
- A product assessment report produced by the reference Member State.
- A copy of the applicant’s summary dossier with the evaluation of the studies by the reference Member State (completed evaluation forms for each study) – in English.
- Updated Danish user instructions and a proposed Danish label in accordance with the initial authorisation, plus safety datasheets for co-formulants
The Danish Environmental Protection Agency may furthermore request the full original documentation (i.e. document IV from the full dossier) as submitted to the country of initial application. This should be available in English.
Incomplete applications will not be accepted
Once the Danish Environmental Protection Agency has received an application for authorisation of a biocidal product, the application is reviewed in order to ascertain whether the necessary documentation has been provided. If this is the case, the Danish Environmental Protection Agency will accept the application.
If certain studies are lacking, the Danish Environmental Protection Agency will inform the applicant that this is the case. The application cannot be processed until the required studies have been submitted – in other words, if the application is incomplete, the Agency will either set a deadline for the applicant to submit the studies that are missing, or reject the application. Where an application is rejected due to a lack of studies, it is possible to apply again once the studies in question have been obtained.
Requirements concerning form and content of the documentation
Form and information requirements for the dossier for submission
Here, you will find information on the test requirements, stipulations on the scope of the dossier, and access to the guidelines prepared by the EU.
Other requirements for biocidal products
All biocidal products must meet a raft of requirements. There are for example requirements concerning the label, marketing, classification, registration requirement for the product register, etc.