Biocidal Products Regulation

Biocides regulation:

Dossiers for biocidal product authorisation

EU Directive 98/8/EC on biocidal products and its transposition in national legislation has resulted in far-reaching changes and new requirements not only for the manufacturer and those placing a product on the market, but also for the competent authorities. The new Regulation (EC) No 528/2012 (effective from 1 September 2013) represents yet another milestone in the biocides regulation and defines new requirements for the biocidal product authorisation.

After dossiers have been elaborated for many active substances, with the active substances successively becoming included in Annex I, the task now is to draft applications for authorisation of biocidal products and to bring the authorisation procedures to a successful end. The starting point will be an analysis of the data requirements for the products and to efficiently use the data from the active substance dossiers.


FoBiG is a partner with the service provider network RegisGate. Together with our partners

Battelle, Geneva, Switzerland

Hydrotox GmbH, Freiburg, Germany

ECT Ökotoxikologie GmbH, Flörsheim, Germany

FoBiG offers a comprehensive service for the drafting of active substance dossiers and the authorisation of biocidal products. 

FoBiG's focus within RegisGate and in relation to biocides in general are:

  • Estimation of human exposure
  • Toxikological assessment of active substances and additives


Your contact for biocidal product authorisation:

Dr. Klaus Schneider