The Biocidal Products Regulation (BPR - Regulation (EU) 528/2012) presents a challenging series of regulatory hurdles that must be overcome prior to receiving approvals for the placing on the market of biocidal products in the European Union. Biocidal products are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.
Blue Frog Scientific provides a comprehensive range of services to the EU biocides sector, including:
- Strategic planning
- Execution of technical and regulatory strategies (e.g. data-gap analysis, study monitoring, pre-submission meetings)
- Hazard and risk assessment for relevant Product Types
- Technical Dossier compilation and Draft Risk Assessment Report compilation
- Project management
- Advocacy and product defence
Our technical and regulatory specialists can assist with any scope of project, from full planning and execution of active substance and/or product registrations, to discreet problem solving with hazard or risk assessments, and responding to eCA questions during the evaluation phase of submissions.
Our service provision to Clients is always designed on a case-by-case basis, to ensure that our Clients receive a service tailored to their needs ensuring accurate scoping and realistic budgeting.