Authorisation of biocidal products

Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.

Biocidal products must get an authorisation before they can be made available on the market. 

Types of authorisation
Companies can choose between several alternative processes, depending on product types and the number of countries where they wish to sell them.

Guidelines and requirements for applications
The requirements for documentation depend on the authorisation procedure chosen by the applicant.

Guidance documents
The objective of Guidance documents is to facilitate the implementation of the Biocidal Products Regulation (BPR) by describing good practice on how to fulfil the obligations.

Fees BRP
A fee must be paid for the work with approval of biocidal active substances and biocidal products. The fee will cover the costs for the Danish Environmental Protection Agency in connection with the administration and evaluation of the application.

Fees - old Danish autohrisation scheme
Authorisation or amendment of an authorisation of a biocidal product, where the active substance is still under evaluation pursuant to the BPR.

IT-tools for your application
After preparing an application for authorisation of a biocidal product, the applicant must submit the application via the Register for Biocidal Products (R4BP 3). The application must be composed using EU software called IUCLID 6. The applicant will also need to create a user account through REACH-IT.

Book a meeting with the Danish EPA
In the experience og the Danish EPA, a meeting between the applicant and authority in the planning phase of the application is a constructive way of addressing potential technical og practical problems. Hence the Danish EPA offers to meet with companies that are considering Denmark as rapporteur member state (a national application under the BPR), or plan to submit a dossier for a new active substance and are considering Denmark as evaluating authority. Contact Obfuscated Email to hear more about the possibility of a meeting.

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