Autorisation AN for In-situ Systems
In-situ generated active substances, as well as their precursors, are considered biocidal products and are subject to authorisation requirements.
Devices used for the technical generation of an in-situ active substance (e.g., active chlorine1, produced at the point of application and used for disinfection) are not considered biocidal products under Article 2, paragraph 1, letter a OBP. As a result, such devices themselves cannot be authorised as biocidal products. Instead, the entire system is described and authorised.
Due to the diversity of in-situ systems, the requirements for application documents and the evaluation methodology vary. To account for these differences, in-situ systems have been classified into four case types. This classification is not exhaustive and may be expanded or adjusted in the future if necessary.
Classification of In-situ Systems:
- Type 1: In-situ system consisting of at least one precursor without a device.
- Type 2: In-situ system consisting of at least one precursor with a device.
- Type 3: In-situ system based on a catalyst and subsequent activation (Free Radicals).
- Type 4: In-situ system consisting of at least one precursor and/or a device to generate in-situ active substances. The precursor is not marketed for biocidal purposes. The in-situ generated active substance is the biocidal product subject to authorisation.
Note: Type 4 also includes Free Radicals systems, where the catalyst is incorporated into a solid object (e.g., ceramic or polymer).
1Under the generic term “active chlorine”, the active substance is understood to be a mixture of chlorine, hypochlorous acid, and hypochlorite anions in equilibrium, where the dominant species depends on the pH of the solution.