Documentation requirements - Denmark as Reference Member State
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 Danish Pest Infestation Laboratory.
Below are listed the document types that must be enclosed the application, when Denmark has been selected as the Reference Member State. Form and content requirements for the documentation (the accompanying dossier) are given at the bottom of the page.
When Denmark is the Reference Member State, a full application must be submitted to the Danish Environmental Protection Agency:
- a signed print-out of the R4BP application, and
- two electronic copies of the full application (two CDs). This includes a copy of a signed print-out of the R4BP application, the full dossier, checklists for active substance and product data, safety datasheets for all co-formulants, and Danish user instructions and a proposed Danish label.
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 data requirements for the accompanying 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.