Requirements, procedures, guidance

An applicant who intends to place a new active biocidal substance on the market has to submit an application for inclusion of the active substance in Annex I/IA to the national competent authority in an EEA country optional together with an application for the (provisional) authorisation or registration of a biocidal product containing the new active substance. Furthermore, a dossier containing all data required has to be submitted. The procedure for new (as well as existing) substances is specified under Article 11 of the Biocidal Products Directive 98/8/EC.

For the time being, applications for 10 new active substances have been submitted within the EU (as of September 2009). Two active substances have been already listed in Annex I of the Biocidal Products Directive.

Formats and comments on the requirements, specifying the corresponding provisions of the Biocidal Products Directive (e.g. Annex II and III) can be found in the Technical Notes for Guidance (in particular the Technical Notes for Guidance (TNsG) on Data Requirements, TNsG on Technical Equivalence, TNsG on Dossier Preparation and the Technical Guidance Document (TGD) for chemical substances). The TGD and the TNsG also describe the methods for risk assessment as well as requirements for efficacy studies (TGD, TNsG on Annex I Inclusion, TNsG on Product Evaluation).
After the competent authority (CA) accepted the dossier as complete the CA starts the detailed evaluation. After the evaluation (draft CA report) and the technical discussions among the applicant, the Commission and the EU Member States have been finalised, a vote concerning the inclusion of the active substances in Annex I/IA of the Biocidal Products Directive is taken according to Article 28 (3) of the Directive.

In Austria, the dossier on an new active substance has to be submitted, together with the application form, to the Federal Ministry of Agriculture, Environment and Water Management, c/o Umweltbundesamt (Spittelauer Lände 5, 1090 Vienna). Detailed information on formats, evaluations and charges can be obtained on request under "Contact".