Biocide registration

Biocidal products are subject to product registration requirements under the EU’s Biocidal Products Regulation (EU) No 528/2012. This legislation is considered worldwide as one of the most demanding applicable to biocidal products. Based on product application, Eurofins BioPharma Product Testing Italy has established a solid reputation in supporting registration of a wide range of products including disinfectants, sterilizers, preservatives, and unique antimicrobial applications. We are carefully guiding our clients to successfully bring their new products to market and to develop cost-effective strategies.

In addition to the preparation of dossiers for biocidal products, we constantly monitor the developments of the regulatory aspects assuring an exhaustive fulfillment of your designated obligations as a producer. In borderline cases our strong experience with active substances and related products from different categories enables us to advise you which regulatory framework is applicable and how regulatory compliance can be achieved.

We understand that navigating the world of Biocidal Products can be very complex, with a high demand for information and many deadlines, so it is important to be supported by experts who can help optimize time and investment and successfully bring a product to market by foreseeing the challenges that the Regulation can bring.

Our consulting team is able to understand regulatory requirements, identify constraints and risks and develop the project together with the Sponsor, from formulations screening, to Dossier submission and follow-up with the Authorities.

• Project management of biocide registration projects
• Data gap analysis (completeness check)
• Waiving strategy
• Biocidal Product Family feasibility, structure and testing optimization
• Endocrine Disruptors (ED) screening
• Substances of Concern (SoC) screening
• Risk assessments (human health and environmental)
• Preparation of the Product Assessment Report (PAR)
• Preparation of the IUCLID 6 dossier
• Preparation of the Summary of Product Characteristic (SPC)
• Submission of applications using the R4BP3 platform
• Liaison with regulatory authorities