This in situ system consists of a plurality of precursors. However, they are firmly connected together (e.g. multi-component tabs) or blended together (e.g. in powdered form).
The precursors are marketed (advertised) as the precursors of an in situ system. This in situ system does not require a device for the in situ production of the active substance.
Application dossier
An RPC form must be completed for the firmly connected precursors (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 the precursors:
- 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)
- 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 for an in situ system of Category 2
Here tetra-acetylethylenediamine (TAED) and sodium percarbonate, blended together in powder form, are marketed as the precursor. (Peracetic acid generated from tetra-acetylethylenediamine (TAED) and sodium percarbonate [Redefined from Peracetic acid]).
