The EU Biocidal Products Regulation (BPR) requires a biocidal active substance in the product to be approved for a specific product type.

Manufacturers must document efficacy and safety of the biocides. Thus, placing a biocidal product on the EU market requires extensive knowledge of the harmonized BPR requirements. 

The areas in which we can make a difference include:

• Providing strategic advice on authorization procedures (National Authorisation, Union Authorisation (UA), Mutual Recognition (MR), Simplified Authorisation etc.) as well as to identify the required studies and timeline
• Compiling the product dossiers that document safety and efficacy
• Compiling of technical documentations. Physical-chemical properties, toxicology, ecotoxicology and fate and behavior in the environment 
• Writing study summaries via IUCLID software, for all parts of a dossier
• Preparation and submission of applications for the inclusion in the “Article 95” list of authorized suppliers of active substances
• Preparation of technical equivalence dossiers for new sources of active substances
• Submission of the dossiers via the R4BP platform
• Preparation of draft of the PAR (Product Assessment Report & the Summary of Product Characteristics with SPC format
• Preparation and updating of SDS according to the CLP requirements
• Post submission monitoring and follow up with competent authorities.