Biocide Regulations, a Constraining Development

  • Biocidal products include disinfectants, insecticides, rodenticides, and other specialities that act by chemical or biological repulsion or neutralisation. They are classified in four main groups and 22 Product Types (TP). Surface disinfectants are classified TP2, TP3 or TP4.

    The release to the market and utilisation of biocides is governed at the Community level by European Regulation (EU) No. 528/2012 which has replaced and repealed European Directive 98/8/EC. This regulation limits release to the market solely to active substances and effective products that present risks acceptable for humans, animals and the environment. An assessment of the active biocidal substances (analysis of the effectiveness of finished products or formulations and of the risks they pose) can cost as much as €1.5 to 2 million.

    This study makes it possible to request Marketing Authorisation on a National Level or for the European Union. This costs about €250k and takes between 24 and 30 months to obtain. A company that proposes to dilute a product that is sold in concentrated form will be considered a manufacturer, and will therefore have to pay the costs of the Active Substance Marketing Authorisation dossier. This development has resulted in a drastic reduction in the number of manufacturers of disinfectants, and a grouping together of the companies working in this sector to allow them to pool these costs.

    Jean Marc EVANNO, President of DEVEA