Inclusion of active substances in the Lists of Annex 1 and/or 2
The inclusion of active substances in the Lists of Annex 1 (XLS, 110 kB, 01.03.2018) or Annex 2 (XLS, 712 kB, 25.06.2019) of the Ordinance on Biocidal Products (OBP; SR 813.12) is published approx. two years before the entry into force. Since the information is published later in Switzerland than in the EU, the Notification Authority informs each company individually at around the time the inclusion is published in the EU.
Authorisation holders can then decide how to proceed with their products. If they do nothing, the following periods of validity will apply: Authorisations of the type AN or AC are valid six months after the final active substance in the biocidal product is included in the Lists of Annex 1 or 2. In this case, product may still be placed on the market for up to 360 days and supplied to end consumers for additional 360 days (as of the date of inclusion). Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment. If the intention is to keep the products on the market for longer, they must be assessed using the harmonised EU criteria, i.e. one of the following dossiers must be submitted to the Notification Authority:
- Application for Authorisation AL
- Application for simplified authorisation
- Application for chronologically parallel recognition of an authorisation of an EU Member State
- Proof, that an application for Union Authorisation has been submitted (case number in R4BP)
The final date on which this dossier may be submitted is the date on which the last active substance in the biocidal product is included. This deadline has been harmonised throughout Europe.
If the biocidal product is already on the Swiss market under a transitional authorisation (authorisation AN/AC or the same product in conjunction with an authorisation AN/AC) the applicant must state the authorisation number (CHAN or CHAC number) and the proprietary name of this biocidal product when submitting the application to the Notification Authority for Chemicals using the harmonised European procedure (IMPORTANT: additional costs will be charged if queries arise).
If the applicant submits a full dossier for an AL authorisation, for a simplified authorisation or for a parallel recognition, the AN or AC authorisation will be valid for three years after inclusion of the last active substance. After an AL authorisation or a recognition has been issued, the biocidal product with the existing label can be placed on the market for up to 360 days and supplied to end consumers for additional 360 days.