Authorisations according to the European harmonized system
Biocidal products that contain only approved active substances (active substances that have been incorporated into the lists in Annex 1 (XLS, 133 kB, 07.10.2021) or Annex 2 (XLS, 828 kB, 01.09.2022) OBP), can be placed on the Swiss market only with an authorisation from the European harmonised procedure.
Please consult the relevant Internet page for the specific requirements of the various types of authorisation.
A biocidal product that comprises only approved active substances of the lists of Annex 1 or/and 2 of the OBP, can be authorised by a first authorisation in Switzerland (Authorisation AL) or another EU or EFTA Member State.
A biocidal product, for which a first authorisation has been submitted in an EU or EFTA Member State, can be simultaneously recognised in parallel in Switzerland.
A biocidal product that contains only approved active substances of the list of Annex I of the OBP and fulfils the conditions of Art. 11h OBP may be authorised under the simplified procedure.
With the new procedure for the Union authorisation the European Biocidal Products Regulation (BPR)1 makes it possible for a biocidal product to be authorised for the entire EEA Market (plus Switzerland)2, thereby obviating the need for an application in the individual states for national authorisations or recognition.
A licence for parallel trade can be granted for a biocidal product that is authorised in an EU Member State1 and is identical to a biocidal product that is already authorised in Switzerland.
Biocidal products that are identical to an already authorised product or product family can be authorised as a same biocidal product (Art. 15 para. 1 OBP).
The concept of the biocidal product family represents a further development of the concept of frame formulations. Under certain conditions, an authorisation as a biocidal product family is more flexible and enables a plurality of products to be brought to the market by means of a single authorisation.
The administrative procedure that has to be used for each modification of existing authorisations depends on the type of change. There are administrative changes, minor and major changes.
The application for extension must be submitted via R4BP at least 550 days prior to the expiration of the first authorisation to the national authority that assessed the first application.
