Transitional provisions

When the European Commission takes a decision to approve the last notified active substance of a biocidal product (included in the Lists of Annex 1 or 2), then the authorisation holder of an AN authorisation, in order to be able to seamlessly market its biocidal product, must submit, by at the latest the date of inclusion of this active substance, an application to the Notification Authority Chemicals following the European harmonised procedure.

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, 133 kB, 07.10.2021) or Annex 2 (XLSX, 152 kB, 01.10.2023) 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 A_N or A_C 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. 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 A_N/A_C or the same product in conjunction with an authorisation A_N/A_C) the applicant must state the authorisation number (CHZN or CHZB 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 A_L authorisation, for a simplified authorisation or for a parallel recognition, the A_N or A_C authorisation will be valid for three years after inclusion of the last active substance. After an A_L 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.