Unit 5.3 Biocide Procedure, Assessment of Active Substances and Efficacy

The Chemicals Act designates the Federal Agency for Chemicals (BfC) at the BAuA as the authorisation body for biocides. Regulation (EU) No. 528/2012 provides for a two-stage procedure for the authorisation of biocidal products: First, the active substances are evaluated and, if applicable, approved, then all biocidal products containing the approved active substances must undergo an authorisation procedure.

The tasks of Unit 5.3 in the biocide procedure consist in detail of:

  • Design and coordination of the approval procedure for biocidal active substances.
  • Processing applications for the inclusion of biocidal active substances in the Union list of approved active substances according to the Biocides Regulation
  • Design, coordination and implementation of efficacy evaluation of active substances and biocidal products for the intended uses; development of test strategies and evaluation standards, if appropriate with the participation of other technical authorities.
  • Commenting on risk and efficacy assessments for active substances from other Member States.
  • Dealing with general and fundamental questions on the approval procedure for active substances in the Union list of approved active substances.
  • Participation and representation of German interests within the framework of cooperation with the European Commission, the European Chemicals Agency, the other EU Member States as well as the OECD states.
  • Participation in national committees
  • Providing technical advice to the national authorities
  • Providing of information material for industry, authorities, ministries and the public
  • Organisation of conferences on specific topics
  • Participation in the REACH-CLP Biocide Helpdesk; cooperation with the other member states on issues of European importance.

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ChemD'in Dr Kornelia Macho

Head of
Unit 5.3 Biocide Procedure, Assessment of Active Substances and Efficacy

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