Biocidal product registration (BPR)
2012
Finland
Frescon Oy is a Finnish company founded in 2004, producing high-quality health and well-being products. Frescon, located in Lempäälä, Pirkanmaa, offers a range of products, including medical devices such as cold and heat therapy products, along with natural cosmetics and wellness products for animals. The company’s philosophy is rooted in safety, environmental responsibility, and quality. Certified according to EN ISO 13485:2016, Frescon places strong emphasis on product reliability, regulatory compliance, and ethical principles such as non-animal testing.
When Frescon decided to develop and market a repellent product within the European Union, it recognized the importance of meeting all legal and scientific requirements set by the EU’s Biocidal Products Regulation (BPR, EU Regulation 528/2012). To ensure a smooth and compliant authorization process, Frescon chose Chementors as its regulatory partner.
Companies registering biocidal products in the EU must carefully consider several regulatory and technical aspects to ensure full compliance.
Chementors provided Frescon with a complete and structured approach to biocidal product registration. It began with an initial regulatory assessment to determine the appropriate product type, evaluate the status of the active substance, and ensure Article 95 compliance. This early-stage work was essential to set the regulatory strategy and avoid unnecessary delays later in the process.
The next step involved planning, organizing and supervising the necessary testing with laboratories. Qualitative and quantitative results on the product’s composition, analytical methods, physical-chemical properties, and product stability were among the key data required to obtain. Chementors worked closely with lab experts to monitor the testing progress and assessed the results to ensure that the outcome is qualified and sufficient for the registration. In addition, Chementors’ team planned, set up and conducted a tailored efficacy test at a local horse farm within its network.
During the process, Chementors also maintained active communication with the suppliers of active substances for the Letter of Access and other required information.
With the test results in place, Chementors prepared the full biocidal product dossier in accordance with all the requirements stipulated by the regulation. The dossier was submitted to the Finnish Safety and Chemicals Agency (TUKES), ensuring that all technical and regulatory standards were met.
Throughout the process, Chementors communicated directly with TUKES. Experts at Chementors managed pre-submission discussions, responded to questions during the evaluation phase, and handled any requests or further clarifications required. This proactive approach ensured the process moved forward efficiently and with minimal uncertainty.
The collaboration with Chementors provided Frescon with a smooth and structured path for the registration efforts for its biocidal products. With regulatory strategy and dossier preparation managed by Chementors, Frescon was able to concentrate on its core strengths: developing quality products and serving its customers.
The company gained the assurance that all the requirements placed on them and the biocidal products are met, reducing regulatory risks and ensuring smooth access to the European market. This process also strengthened Frescon’s internal understanding of biocidal product legislation, testing requirements, and compliance strategy—knowledge that will support future product development.
Working with an experienced regulatory partner gave Frescon confidence in both the technical quality and legal robustness of its biocidal registration, ensuring a strong foundation for growth in the EU market.
Working with Chementors provided us with clarity and confidence: from testing through submission to post-registration follow-up, they handled the complex steps so we could keep our focus where it counts.
— Frescon Oy – Harri Vaismaa, CEO