Following the revision of the Ordinance on Biocidal Products (OBP; SR 813.12) of 20 June 2014 (in force since 15 July 2014), active substances generated in situ and their precursor substances are now considered to be biocidal products and therefore subject to authorisation (Categories 1, 2 and 3).
However, electrolysers that are used to produce an active solution generated in situ (e.g. active chlorine1 generated at the site of use and used for disinfection, are not biocidal products as defined in Art. 2, para. 1 a OBP, and the devices themselves cannot therefore be authorised as biocidal products.
Users of electrolysers may only use precursor substances intended and marketed for this specific purpose and authorised accordingly by the provisions of the OBP. According to the transitional provisions of Art. 62b OBP, an application for authorisation of the precursor substances must be submitted by 31 August 2017.
If the precursor substance is not specifically marketed for the production of an active solution (e.g. of active chlorine) generated in situ, and/or the manufacturer/distributor of the precursor has no interest in applying for the authorisation of the precursor as a biocidal product as defined in the OBP, the following options are available:
the device manufacturer/distributor submits, by 31 August 2017 at the latest, an application for the authorisation of the active solution generated by the electrolyser and used on site.
the user submits, by 31 August 2017 at the latest, an application for the authorisation of the active solution generated by the electrolyser and used on site.
For cases (Category 4) in which the precursor substances cannot be authorised as biocidal products (e.g. active chlorine produced by electrolysis from sea water, air for the in situ production of ozone), either the device manufacturer or distributor or the user can apply for authorisation of the active solution generated in situ with the electrolyser.
If a solution is produced by electrolysis for the purposes of disinfection and then bottled and marketed, this is not considered to be in-situ production (since the solution is not generated at the site of use and used directly), and the produced and bottled solution must be authorised in accordance with the provisions of the OBP before it is placed on the market as a biocidal product.
At this point, we would like to state that the FOPH is guided by the current practice in the EU in respect of the authorisation of in-situ systems. In view of the complexity of the situation, further changes are certainly possible in the future.
1) The generic expression "active chlorine" is understood here to refer to an active substance consisting of a mixture of chlorine, hypochlorous acid and hypochlorite anions in equilibrium, in which the dominant species depends on the pH of the solution.