Biocidal Products Regulation
European Regulation (EU) No. 528/2012 governs the placing on the market of biocidal products. Any product with a biocidal function or making a biocidal claim is classified as a biocidal product. Regulatory compliance therefore becomes a mandatory requirement for manufacturers.
A biocidal product is a substance or mixture intended to destroy, repel, or neutralize harmful organisms, prevent their action, or otherwise control them by means other than purely physical or mechanical action.
Biocidal products contain one or more active substances. Different regulatory requirements apply depending on the regulatory status of those active substances.
Naturakem Consulting supports you in achieving compliance for your biocidal products. We provide all the regulatory services necessary to ensure that your products meet applicable requirements.
Our european Regulatory Compliance Services for Biocidal Products
- Regulatory Strategy – We provide strategic guidance to facilitate the commercialization of your biocidal products.
- Formula Audit – Analysis of your product composition to ensure regulatory compliance.
- Transitional Period Support – Assistance with submissions and procedures before the competent authorities for products containing active substances under transitional arrangements.
- Safety Data Sheets (SDSs) – Preparation and translation of Safety Data Sheets in accordance with current regulations.
- Marketing Authorization Applications – Guidance in preparing and submitting authorization dossiers.
- Labeling Compliance – Support in drafting labeling statements that comply with regulatory requirements.
- Poison Centre Notifications – Where required, we carry out poison centre notifications, which are mandatory to help ensure end-user safety.
- Electronic Notification of Biocidal Products – Assistance with online regulatory declarations.
- Environmental and Marketing Claims – We help identify appropriate claims for your product in accordance with current regulations and explain how such claims may affect the legal status of your products.
why work with naturakem consulting ?
Bringing products to the European market requires more than regulatory knowledge, it requires a multidisciplinary approach. Our team of chemists, legal advisors, and technical operators works together to ensure your products meet all applicable European requirements efficiently and accurately.
As pioneers in the practical application of the REACH Regulation across Europe, we have developed extensive expertise in substance classification and regulatory compliance. By combining specialist knowledge with advanced software tools, we deliver highly accurate classifications and compliance assessments that help our clients reduce risk and accelerate market access.
Our expertise extends beyond specialized chemical regulations. We also support companies with broader product compliance requirements, including the General Product Safety Regulation (GSPR), product claims, labeling requirements, and other horizontal legislation applicable to products placed on the European market.
We don’t simply interpret regulations, we provide practical, business-focused solutions that help you achieve compliance while supporting your commercial objectives.