Bringing a biocidal product to market under the Biocidal Products Regulation (BPR) requires more than just test results. You need a complete, well-structured and scientifically sound dossier — one that holds up during evaluation and reflects your product strategy. Triskelion supports you throughout this critical phase. We help you interpret data, prepare robust documentation, and navigate the submission process with confidence. That way, your product is not just tested, but truly ready for the market.
Under the BPR, authorization of a biocidal product requires submission of a full regulatory dossier. This includes details on the active substance, product composition, intended uses, efficacy, toxicology and environmental impact. The dossier must be built in accordance with strict EU formats and expectations, including the Summary of Product Characteristics (SPC), assessment reports and a completed IUCLID file.
Preparing a dossier is not just administrative work. It demands strategic thinking, regulatory insight and scientific precision. Errors or omissions can delay approval, trigger questions from authorities or even result in rejection. A high-quality dossier can accelerate evaluation, reduce costs and strengthen your market position.
The BPR (Regulation (EU) No 528/2012) sets out detailed requirements for product authorization. Depending on your situation, you may be submitting via national authorization, mutual recognition or the Union authorization route. In all cases, the dossier must contain:
The legislation also requires applicants to demonstrate that their product complies with Article 95, and that all active substances are approved or under review. Failing to submit a compliant dossier can result in substantial delays, additional studies or loss of market access.
Dossier preparation becomes a strategic challenge when
• you work with complex formulations or multiple use classes
• your product combines active substances with different regulatory timelines
• your available data comes from multiple sources or legacy reports
• you are unsure how to structure the SPC or address data gaps
Without expert guidance, it is easy to overlook critical elements or misinterpret regulatory expectations. This not only affects your approval chances but can also impact your timelines, costs and product claims. That is why many companies choose to work with a partner who can translate complex requirements into clear, structured actions.
Triskelion offers an integrated, expert-led approach to dossier preparation and submission.
Our experience in both laboratory testing and regulatory consultancy allows us to bridge the gap between science and compliance. We deliver dossiers that are not only complete, but defensible and aligned with your commercial goals.
Do I need to prepare the dossier myself?
You are responsible for the submission, but you do not have to do it alone. Many companies outsource dossier work to avoid mistakes, save time and reduce risk.
Can I re-use data from other dossiers?
Yes, but only if you have valid data access. Triskelion can help assess reusability, negotiate Letters of Access and ensure compliance with Article 95.
What if authorities come back with questions?
We help you prepare clear responses, update your dossier if needed and manage the interaction. Our goal is to resolve issues without delays or escalation.
We help you translate data into a dossier that gets approved. Contact us for a dossier check, intake or tailored proposal for BPR submission support.
