This in situ system consists of one or more precursor(s). The precursors as such are not marketed (advertised).
This, for example, is the case for oxygen from ambient air or from an oxygen bottle which is not marketed as a precursor for biocidal purposes. This in situ system requires a device (e.g. an electrolysis device) in order to generate the technical active substance generated in situ.
Application dossier
For the technical active substance generated in situ an RPC form must also be completed (see the guide to the digital application for an authorisation AN (PDF, 4 MB, 30.08.2023)). For the composition information, the in situ system must always be selected (e.g. chlorine dioxide, generated from sodium chlorite by oxidation), and the concentration of the active substance created in situ must be indicated. The manufacturer of the active substance must be specified as “in situ”.
N.B. The approximate composition of the technical active substance generated in situ must be stated.
Under the tab “documents” the following documents must be uploaded:
- Label (if the technical active substance generated in situ is stored temporarily before use)
- Claims
- Proof of efficacy (only for product types 1-5 and 8)
- Safety data sheet
- Instructions for use (production and use of the technical active substance generated in situ)
- Description of the device and procedure (e.g. electrolysis procedure)
- Instructions for use for the device
- additional document "additional information (RTF, 68 kB, 30.08.2023)", filled out.
After the digital application in the Chemicals Register (RPC) has been dispatched, the following information must be transmitted by email to the Notification Authority Chemicals (cheminfo@bag.admin.ch):
a. Trade name and CPID number of all components and of the technical active substance generated in situ
b. Indication that it concerns a first application for an in situ system with the description of the in situ system
Example of an in situ system of Category 4
Here ozone is generated from ambient air: (Ozone generated from Oxygen).
