General information on the authorization procedure AN
This type of authorisation applies to biocidal products containing at least one notified active substance whose inclusion in the lists of Annex 1 or 2 of the Ordinance on Biocidal Products (OBP; RS 813.12) has not yet been decided.
The other active substances in the product may already be listed in Annex 1 or 2.
Important:
When the last notified active substance of a biocidal product is approved (Annex 1, OBP or Annex 2, OBP), holders of an Authorisation AN have various options outlined under the transitional regulation.
The authorisation procedure AN includes different types of authorisations based on a simplified assessment.
The authority examines, within the framework of this temporary transitional authorisation through a summary risk assessment, whether:
- the documentation is complete;
- the active substances are permitted for the intended use of the biocidal product. Authorities specifically check whether the active substances contained in the biocidal product comply with legal requirements for the requested product type;
- biocidal products intended for the general public do not have characteristics outlined in Article 11d OBP;
- no clearly inappropriate uses are authorised, e.g., dermal application of a type 19 product classified as skin-irritating or sensitising by the applicant;
- biocidal products for drinking water disinfection (product type 5) additionally meet the requirements of the Ordinance of the FDHA on Drinking Water and Water in Publicly Accessible Baths and Showers (RS 817.022.11);
- no prohibited uses are authorised, e.g., algae and moss control products;
- the correct efficacy evidence for disinfectants (product types 1-4) has been submitted;
- the efficacy of wood preservatives has been demonstrated;
- the use of insecticides (product type 18) does not have harmful effects on aquatic organisms, bees/pollinators, and livestock.
In the sections on the left, you will find further explanations of the various types of authorisations and their respective guidelines.