At the “59th meeting of representatives of Member States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products” (59th CA Meeting) it was established that from 1 September 2015 in-situ biocidal chlorine dioxide can only be made available on the market if the supplier of the precursors is on the Article 95 list.
The supplier of the precursors referred to in Article 95 is also the representative of the active substance dossier. Moreover, the entire in-situ system (precursor – active substance) is part of the active substance dossier.
The existing active substance chlorine dioxide, which is still listed under No. 491 of REGULATION (EU) No. 1062/2014, is now considered an in-situ generation system. As at the 59th CA Meeting, chlorine dioxide has now been defined and distinguished as follows:
- Chlorine dioxide generated from sodium chlorite by electrolysis
- Chlorine dioxide generated from sodium chlorite by acidification
- Chlorine dioxide generated from sodium chlorite by oxidation
These in-situ systems are currently being evaluated.
DK-DOX® comes under the generation system “Chlorine dioxide generated from sodium chlorite by oxidation”. The active ingredient dossier covers not only the precursor sodium chlorite but also the oxidising agents as precursors.
Dr. Küke GmbH ensures that the starting material for the production of DK-DOX products, sodium chlorite, as defined in the 59th CA Meeting, is only purchased in the supply chain from the dossier representative for the generation system. This is listed in the Article 95 list.