What is Biocidal Product Analysis?
Biocidal product analysis involves a series of tests and evaluations aimed at assessing the efficacy, safety, and potential risks of biocidal products to human health and the environment. These analyses play a critical role in demonstrating regulatory compliance and ensuring that products meet safety standards before being placed on the market.
Chemleg’s Biocidal Product Analysis Support help clients to meet the strict requirements of the EU Biocidal Products Regulation (BPR) by providing expert guidance in product testing, analysis, and dossier preparation.
Is Biocidal Product Analysis Mandatory?
In the European Union, biocidal products must undergo analysis as required by the Biocidal Products Regulation.
The authorisation process for biocidal products in the EU involves two stages: the approval of the active substance and the authorisation of the biocidal product. Comprehensive analyses must be conducted at both stages.
Who Needs Biocidal Product Analysis?
Manufacturers and formulators intending to place their biocidal products on the EU market, as well as importers, and companies using treated articles, are required to conduct biocidal product analyses.
This is essential to comply with the Biocidal Products Regulation (BPR), fulfill dossier submission requirements, ensure product quality and safety, and mitigate the risk of legal penalties.
Take Advantage of Chemleg’s Biocidal Product Analysis Support
Chemleg’s biocidal product analysis evaluation service includes the interpretation of test results in line with BPR requirements. Evaluated tests include:
- Active Substance Identification & Quantification – Verifying the concentration of the active ingredient to ensure compliance with product claims and regulatory thresholds.
- Efficacy Testing – Assessing biocidal performance through laboratory and field studies to demonstrate effectiveness against target organisms (e.g., bacteria, fungi, viruses).
- Physico-Chemical Properties Testing – Evaluating stability, solubility, pH, and other key characteristics essential for product safety and performance.
- Toxicological & Ecotoxicological Assessments – Conducting studies to determine potential risks to human health and the environment.
- Microbiological Analysis – Checking for microbial contamination and verifying antimicrobial activity.
- Residue & Exposure Testing – Measuring residue levels on treated surfaces and assessing user exposure risks.
- Compatibility & Packaging Stability Studies – Ensuring the product remains stable and effective throughout its shelf life.
Why Choose Us?
Chemleg shares expert insights on testing requirements, provides tailored recommendations for your product category, and supports you throughout the entire process—from study design to dossier preparation.
Collaborate with our experts by filling out the form.
Frequently Asked Questions
What is BPR analysis?
BPR analysis involves evaluating biocidal products to determine their effects on human health and the environment, as well as testing their efficacy and safety.
Which laboratories can perform these analyses?
In the EU, biocidal product analyses must be carried out in laboratories that meet certain criteria:
- Accreditation according to ISO/IEC 17025, which defines the general requirements for the competence of testing and calibration laboratories.
- Compliance with Good Laboratory Practice (GLP) standards.
- Execution of studies by qualified personnel with relevant expertise and experience.
Analyses can be performed by private accredited and GLP-certified laboratories, universities, research institutes, or laboratories of national competent authorities that meet these criteria.
What happens if the analysis results are negative?
In such cases, the authorisation or registration process may be suspended or rejected. This can result in delays and financial loss. The company will need to identify the reasons behind the negative results, improve the formulation or manufacturing processes, and then reapply with updated analyses.
Which biocidal products must be analysed?
All products that fall under the definition of a biocidal product must undergo analysis.
How long does the analysis process take?
Unfortunately, it is not possible to give a precise duration. The time required varies significantly depending on the type of tests, product complexity, and specific regulatory requirements.
