Processing of an application requires that the applicant provides documentation and pays a fee. In addition, the applicant will typically have to pay for access to data to the company which has been granted approval of the active substance.
When Denmark is the initial country of application (the reference Member State), the application must include the following:
- Use of R4BP-3 to process your application
- A dossier in IUCLID 6 format (the software used in the EU for exchange and sharing of data on active substances and biocidal products). The dossier must meet the requirements laid out in Article 20(1)(a) of the BPR
- The applicant must fill in all information within the PAR (Product Assessment Report). The template is available at ECHAs homepage.
- The application submitted must include the original studies of efficacy and the so-called maximum residue limits (MRL) as well as safety data sheets for co-formulants. See Guide to efficacy studies
- A letter of access if the applicant himself is unable to provide all the information required in the dossier.
- A summary of the biocidal product characteristics (SPC). This document plays a major role in the processing of the application.
- A statement that the applicant has not applied to any other authority for a national authorisation for the same biocidal product.
ECHA has published a manual in which you will be guided through the application process. Read the manual here
Furthermore, ECHA has prepared a guidance document on information requirements to be met by the applicant. Read the guidance document
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.