Notification of new substances
Before a new substance is allowed to be placed on the market in Switzerland for the first time, it must be notified to the joint Swiss Notification Authority for Chemicals of the FOEN, FOPH and SECO in accordance with the provisions of the Chemicals Ordinance (ChemO). The obligation to notify is incumbent on the manufacturer or importer of the new substance, as applicable.
Since the beginning of 2022, a substance has been considered a 'new substance' if it meets one of the following criteria:
- the substance is not registered in accordance with Article 5 of Regulation (EC) No 1907/2006 (REACH Regulation) of the European Chemicals Agency (ECHA), or
- the substance is registered with ECHA exclusively as an intermediate under Article 17 or Article 18 of the REACH Regulation and the substance in question is not a monomer, or
- the substance is to be placed on the Swiss market in higher quantities than those registered with ECHA.
The notification requirement concerns not only a substance on its own, but also substances in a preparation or in an object from which the new substance may be released under normal or reasonably foreseeable conditions of use. If a new substance is contained in a polymer as a monomer or as another substance in the form of monomer units or chemically bound, the notification requirement applies for the substance on its own. Furthermore, the Notification Authority may require the notification of a substance contained in an object if it has reason to believe that the substance may be released when the object is used.
The Notification Authority and the federal offices involved in the notification procedure have a period of 60 days in which to review a notification. A substance subject to notification may only be placed on the Swiss market once the Notification Authority issues its acceptance of the notification or at the earliest 60 days after the submission of the notification dossier, if the Notification Authority has not issued any response within this period.
Further information and details on legal obligations within the notification procedure for new substances can be obtained on the webpage of the Swiss Notification Authority.
