Biocides | Services

Biocidal products

Following inclusion of an active substance in Annex I of the Biocides Directive, any formulated biocidal product to be placed on the market will be subject to national regulatory approval.

EBRC provides extensive and qualified support in preparation and submission of applications (dossiers) for national registration/authorisation of biocidal products (i.e., Annex-II-B/III-B dossier, post Annex I inclusion):

  • Initial completeness check of data sets on biocidal products
  • Identification of data gaps
  • Evaluation of the validity of existing studies
  • Strategy for closing data gaps, e.g. through comprehensive literature searches or conduct of new experimental studies
  • Planning, coordination and monitoring of experimental studies
  • Development of concepts for data waiving
  • Evaluation of physicochemical hazards of biocidal products
  • Assessment of the efficacy of biocidal products
  • Evaluation of the toxicological profile of biocidal products
  • Assessment of combined effects in case of several active substances/substances of concern
  • Assessment of the exposure of humans (users, bystanders, general public) using EU standard models (TNsG on human exposure, BEAT, ConsExpo, …)
  • Development and coordination of occupational exposure measurements, if required
  • Risk characterisation for human health
  • Evaluation of the environmental profile of biocidal products
  • Modelling of releases to the environment using EU standard models (EUBEES-ESDs, EUSES, …), estimation of PECs (predicted environmental concentrations)
  • Coordination of environmental monitoring, if required
  • Risk characterisation for relevant environmental compartments
  • Proposals for classification & labelling of biocidal products
  • Submission and defence of dossiers in the authorisation process
  • General services in the maintenance of regulatory approvals for products already on the market