,Global Biocidal Product Regulations
Biocidal products are disinfectants/anti-microbial products that have gained new meaning and purpose after COVID-19. These products are identified and regulated differently across countries and regions, which makes it challenging for manufacturers to market them.
The different terms and Regulatory classifications applicable to these products include chemical disinfectants/HUHS/biocides/pesticides/OTC/quasi-drugs/anti-microbial pesticides, as well as consumer products, cosmetics, medical devices, and medicinal products..
While biocidal product regulations in some countries have a clear framework, with a well-defined registration process and timeline, many countries do not have well-defined structures and processes, resulting in uncertainties, data duplication, and delays in market access. Moreover, chemical regulations are dynamic and ever-evolving, considering new scientific data and pressure on sustainability..
Our End to End BPR Process and Global Market Support
The other key factors for market access and Biocidal Products Regulation Compliance are provided below:
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Regulatory Requirements for major Global Markets
Our BPR Compliance Services
To place a biocidal product on any market or a set of markets, companies first need to build robust strategies to achieve compliance with market-specific regulations(GB BPR Services, EU BPR services etc.) and exploit overlapping testing and certification requirements to minimize cost and time-to-market.
Freyr has extensive expertise in providing BPR services or Disinfectant Regulatory Services including biocidal product classification and Regulatory solutions across global markets.
Biocidal Classification
Understanding product classification based on the product descriptor & claims
Pre-Submission Assessment
Preliminary key check – Active substance related obligations/ Legal representation/ local entity presence etc. before starting dossier initiating dossier submission related work
Data Requirements
Develop Data matrix checklist as per regulatory requirements for Biocidal product registration/ notification).
Regulatory Gap-analysis
Data gap analysis (Tests/ SDS/ labels/ composition etc.) & preparation of declaration & Global Biocides Authorization letters as per regulatory specific format (Letter of supply etc.)
Dossier Compilation
Dossier compilation in required format and submission via desired mode (online/ manual)
Regulatory Authority Liason
Active post submission support & follow up with authority untill Disinfectant market approval
Regulatory Labeling Compliance
Final labelling recommendation as per approved content in Registration certificate
Frequently Asked Questions (FAQs) on Biocidal Product Regulation
We are here to provide you with the information you need quickly and efficiently.
01. What’s the difference between notification vs authorisation?
Notification is a simpler, faster process to inform authorities about a product, usually for lower risk uses. Authorisation is a detailed approval process requiring full dossier submission and risk assessment before marketing or use.
02. How do you support consortia or LOAs?
We support consortia by coordinating joint submissions, managing data-sharing, and ensuring compliance. For LOAs, we help identify data holders, negotiate access, and handle documentation for smooth and compliant registrations.
03. What are post submission services?
Post-submission services include responding to regulatory queries, addressing data gaps, updating documents, tracking approvals, and ensuring ongoing compliance with authority requirements after dossier submission.
04. What is the EU BPR, and why is it important?
The EU Biocidal Products Regulation (BPR, EU No. 528/2012) ensures only safe, effective, and environmentally sound biocidal products reach the market. It governs disinfectants and other biocides used in homes, industries, and healthcare settings.
05. What are the key steps for EU BPR compliance?
BPR compliance involves active substance approval, product authorization, and dossier submission via R4BP 3. Companies must meet efficacy, safety, and environmental data requirements before product launch in the EU market.
06. How does UK BPR differ from EU BPR?
Though based on EU BPR, the UK BPR operates separately post-Brexit. Products approved in the EU require independent UK submissions, active substance evaluation, and HSE authorization for sale in Great Britain.
07. What are the main challenges in securing UK BPR approval?
Key hurdles include regulatory divergence from EU rules, costly testing, limited HSE resources, and data access issues. Businesses must plan strategically to manage timelines, data gaps, and compliance costs.
08. Why is data access crucial under UK BPR?
UK BPR demands comprehensive efficacy, toxicology, and environmental data. Without access—often via Letters of Access—companies face delays, higher costs, or potential market withdrawal due to incomplete submissions.
09. What are Freyr’s support services for BPR compliance?
Freyr provides end-to-end regulatory support, including dossier preparation, active substance and product authorization, data gap analysis, and post-approval maintenance. Services also cover label review, local registration, safety assessments, SDS/e-SDS, and poison centre notification.
10. What regions does Freyr support for biocide registration?
Freyr provides end-to-end regulatory support across EU markets (Poland, Italy, Greece, France) and non-EU regions including the USA, Canada, Israel, Brazil, and South Africa.
