Biocidal Product Authorisation:

Registration / authorisation procedure for biocidal products:

Following review and evaluation of dossiers by Rapporteur Member States, the European Commission decides upon inclusion of an active substance in Annex I of the Biocides Directive (from 2006 onwards for substance of the first priority list). Subsequently, any formulated biocidal product to be placed on the market will be subject to national regulatory approval.

EBRC offers comprehensive assistance in the preparation of dossiers in support of product registration:

• Data gap analysis and data package development for the
  respective biocidal product
  
  
• Planning, coordination and monitoring of experimental studies
  
  
• Preparation of application dossiers for national registration / authorisation of biocidal products (i.e. Annex II-B / III-B dossier, post Annex I inclusion)
  
  
• Performance of product-type specific risk assessments (product safety, human health, environment, efficacy assessment), including highly qualified data management
  
  
• Submission and defence of dossiers in the authorisation process
  
  
• General services in the maintenance of regulatory approvals for products already on the market