This in situ system consists of one precursor (e.g. NaBr) or a plurality of precursors that are marketed together (i.e. in the same packaging).
The precursors are marketed as the precursor of an in situ system (i.e. advertised for a biocidal purpose). 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
An RPC form must be completed for each precursor (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 (the active substance created in situ) 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 as zero. The box “declared” must be checked for the precursor substances.
Please note: documents with confidential content should have an access level “author & federal authorities”. The access level can only be assigned after the document has been uploaded.
Under the tab “documents” the following documents must be uploaded for all components:
- Label
- Safety data sheet
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). 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, and the trade names of the precursors with the relevant CPID number must be stated in the associated comment field.
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;
- Excel template (XLSM, 289 kB, 10.10.2017) with information on the active substance suppliers as listed in the Art. 95 –BPR list (see notification obligation pursuant to Art. 62d OBP)
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 3
Here sodium bromide is marketed as the precursor for the production of active bromine by electrolysis: (Active bromine generated from sodium bromide by electrolysis [Redefined from Sodium bromide]).
