Biocidal products containing a new active substance cannot be placed on the market in Denmark until the EU has evaluated the active substance concerned. This means that the enterprise must apply to have the active substance approved within the EU with the aim of inclusion in Annex I.
New active substances are substances that were not available on the EU market prior to 14 May 2000 and active substances that are not included in Annex I to Commission Regulation (EC) No 1451/2007, i.e. not covered by the EU's review programme.
In order for an active substance to be evaluated, the authorities must prepare an assessment report which refers to, summarises and evaluates the collective documentation for the substance concerned. The substances are distributed so that each Member State is responsible for evaluating a number of substances. The assessment reports form the basis for the decision concerning EU authorisation.
Application for authorisation of a product containing a new active substance
Product applications can be submitted from the date of inclusion in Annex I. The product may not normally be placed on the market in Denmark until it has been authorised by the Danish Environmental Protection Agency in accordance with the principles of the Biocidal Products Directive.
It is possible, however, to apply for provisional authorisation of a product containing an active substance that is new to the EU. Information on provisional authorisation can be obtained from the Danish Environmental Protection Agency.
Application for inclusion of a new active substance in Annex I
More information on the documentation (test data) required in connection with an application for approval of an active substance can be found in Annex 2.2 to the Danish Statutory Order on pesticides if the active substance is chemical, or Annex 2.3 if the active substance is microbiological.
An application for the evaluation of a new active substance in the EU costs DKK 1,436,000 if Denmark is chosen to prepare the evaluation report. Read more about the fees here.
Please contact the Danish Environmental Protection Agency if you wish to have a new active substance evaluated within the EU.