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In Situ Generated Active Substances and Products

Historical Background and Current Situation under the Biocidal Product Regulation

Tatjana Röder

DOI https://doi.org/10.21552/icrl/2018/2/4



When the Biocidal Product Directive was repealed by the Biocidal Product Regulation in 2013, the biocide world expected more clarity and guidance as well as harmonisation within the European Union. Since one of its major amendments concerned the regulation of in situ activated substances and products, manufacturers of in situ devices waited in eager anticipation. Today, almost five years later, guidance documents are still under review or being amended and Member States are still ploughing their own furrow. SMEs, which supposedly account for the majority of the biocidal market, are overstrained by the mere quantity of published guidance documents and notes by Competent Authorities. Due to this and in order to submit a suitable dossier they are facing an enormous financial burden despite possibilities of data sharing and consortia.

Tatjana Röder, M.A., Business Development & Regulatory Issues, aquagroup AG, Weiden (Germany). Tatjana Röder studied at the University of Regensburg (Germany) and the University of Boulder, CO (USA) and completed her studies with a Master degree. For correspondence: <mailto:t.roeder@aquagroup.com>.

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