European Union Biocides Regulation Services

Our multidisciplinary team of scientists and registration specialists can assess your biocidal products and treated articles to determine their current status and future compliance requirements.   Intertek provides full technical and regulatory support including:

• Product development and strategic advice
• Regulatory support and consulting 
  • Identification of compliance requirements under the BPR, including data requirements for active substances.
  • Completion of data gap analysis and preliminary risk assessments (including cost estimates for completing the data package)
  • Identification of authorization requirements of the BPR throughout the transitional periods.
  • Identification of requirements for listing on Art. 95 list of active substances and products suppliers
  • Classification and labelling support in compliance with CLP.
• Regulatory submissions and study support
  • Dossier writing, submission and monitoring.
  • Dossier preparation (IUCLID) and submission (R4BP3) according to BPR and National transitional rules (National applications prior to the approval of the active substance)
  • Post submission monitoring and liaison between competent authorities and clients
• Technical documentation support
  • Physical-chemical properties, efficacy, toxicology, ecotoxicology and fate and behavior in the environment 
  • Toxicological, Fate and behavior and Ecotoxicological Risk assessment
• Study placement, monitoring, and design (both in-house and through partner laboratories) 

Additionally, Intertek offers global support and customised solutions for clients wishing to gain authorisation of biocides (active substance and product formulations) on the Canadian and United States markets.

Related Services

Authorisation of Hand Sanitizers in the EU
Authorization of Sanitizers and Disinfectants in the United States
GB Biocidal Products Regulation (BPR) Services
In Silico Methods for Hazard Characterization
Microbiology Testing Services