This in situ system consists of one precursor or a plurality of precursors.
If the in situ system consists of a plurality of precursors, these are marketed together (i.e. in the same packaging). The auxiliary is not subject to authorisation. The precursors are marketed as the precursors of an in situ system (i.e. advertised for a biocidal purpose). This in situ system does not require a device to produce the active substance 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)
- additional document "additional information (RTF, 68 kB, 30.08.2023)", filled out;
- Form Declaration Art. 95 BPR 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 1 with two precursors
Performic acid generated from formic acid and hydrogen peroxide (Redefined from Formic acid).
