Extensive requirements apply concerning documentation, both when you apply for approval of an active substance within the EU and when you apply for authorisation of a product through the Danish Environmental Protection Agency (Danish EPA). The Danish EPA therefore recommends companies to start preparing their applications early.
To authorise a biocidal product a company must submit sufficient documentation on a number of topics including the product's risks to human health, animal llhealth and the environment, and its efficacy. The documentation typically consists of experimental data. In Denmark the risks to health and the environment will be assessed by the Danish EPA, whereas the efficacy will often be assessed by external parties.
The requirements for documentation depend on the authorisation procedure chosen by the applicant.
Below is a review of the types of documents which must accompany the two types of applications to ensure that the Danish EPA will be able to validate the application.
The form and content requirements for the documentation are described at the bottom of the page.
- You wish to apply for a parallel trade permit
- You wish to apply for authorisation under the simplified authorisation procedure
- You wish to apply for national authorisation of your product in Denmark
- You wish to apply for mutual recognition in parallel in Denmark
- You wish to apply for mutual recognition in sequence in Denmark
- You wish to apply for Union authorisation of your biocidal product
- You wish to apply for authorisation under the old Danish authorisation scheme
Form and data requirements for the dossier to be submitted
The data requirements for biocidal active substances and biocidal products are specified in the BPR. Data must be submitted via the R4BP database.
For applicants wishing to apply for authorisation under the BPR, the data requirements for biocidal active substances and biocidal products are specified in the Regulation, Annex II, and Annex III
ECHA has prepared a guidance document on information requirements to the dossier. The guidance document is available here
See Guide to efficiency for:
Requirements that must be met in order to have a product assessed for efficacy with a positive result.