Form and data requirements for the accompanying dossier
The information requirements for biocidal active substances and biocidal products are set out in the Biocidal Products Regulation. More specifically, the requirements can be found in Part A: Guidance on information requirements, one guidance is available for each area of identity/phys-chemical/analytical methodology, efficacy, human health and environment.
The information requirements for active substances and products generally cover the following areas:
- Information on the applicant
- Information on identity
- Physical, chemical and technical properties
- Methods for identification and analysis
- Efficacy (included proposed user instructions in Danish)
- Toxicological studies and exposure
- Ecotoxicological studies and exposure
- Measures to protect people, animals and the environment
- Classification and labelling (incl. proposed label in Danish)
Structure of the dossier
The dossier must contain the documents I-IV, with documents I-III making up the so-called summary dossier. You can see a figure of the documents in the dossier here.
Documents I and II in the dossier must be in Word format, while document III may be in Word or IUCLID6 format. If the applicant purchases the rights to studies on the active substance, the part of the dossier on the active substance can be replaced by a Letter of Access (LOA).
The content of the dossier - information requirements
If an active substance is included in Annex I or IA, there is no need to submit data concerning the active substance, but access is required to the active substance data set in the form of a so-called “Letter of Access”, which is issued by the owner of the relevant data on the active substance.
Information on the product must comply with Annex 2.2 b and d of the Statutory Order if the active substance is chemical, or with Annex 2.2 b if it is not chemical.
The information requirements for both the active substance and associated product are divided into a common core data set and an additional data set. The common core data set is required for all active substances and for products, irrespective of product-type. The common core data set will usually be the minimum data that must be submitted. In addition, there are in some circumstances additional information requirements for the active substance and the product. This depends, for example, on the properties, use and exposure of the active substance and the product.
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.
Information requirements in connection with an application for authorisation of a biocidal product are described in the following sources
The more formal requirements for the additional documents that must be enclosed with an application for Danish authorisation, as well as information on the electronic application form via R4BP (Register for Biocidal Products), can be found under the menu items " Documentation requirements " and " Application forms and the R4BP-database ".