Active substance analyses in biocidal products: BPR compliance and Nano-Test solutions
Biocidal products are chemical or biological preparations used to kill, neutralize, or control harmful organisms. These products, which are divided into 22 different product types – from disinfectants to pest control agents, wood preservatives, and antifouling paints – exert their effect on the target organisms thanks to the active substances contained therein. The correct identification of the active substance, the precise determination of its quantity, and the proof of compliance with the specified specifications are of decisive importance for both the supervisory authorities and the safety of end users.
The regulation on biocidal products issued by the Turkish Ministry of Health stipulates that the tests to be submitted in the application files for active substances and biocidal products must be carried out in accordance with international standards and the principles of Good Laboratory Practice (GLP). In the European Union, the guidelines published by the ECHA within the framework of the Biocidal Products Regulation (BPR – 528/2012) set the framework for active substance analyses.
Significance and scope of active substance analysis
The main purpose of active substance analysis in biocidal products is to verify that the product complies with the stated composition. These analyses should provide answers to the following questions:
- Is the active substance stated in the product actually present?
- Does the concentration of the active substance correspond to the value stated on the label and in the approval documents?
- Does the product contain any other undeclared active substances or harmful impurities?
- Is the stability of the active substance maintained throughout the entire shelf life of the product?
Answering these questions with scientific methods forms the basis of the approval process and the basis for the product's evidence in market controls.
Selection of the analysis method according to the type of active substance
When classifying biocidal active substances according to their chemical functional groups, the choice of analysis method becomes clearer. Different groups such as phenolic compounds, iodine-containing compounds, quaternary ammonium compounds, amine-based compounds, organometallic compounds, and peroxides require different analytical approaches.
1. Non-volatile active substances: HPLC-DAD
For non-volatile active substances such as quaternary ammonium compounds (QACs), biguanides, and certain organic acids, high-performance liquid chromatography (HPLC) is the preferred method. In combination with a diode array detector (DAD), both quantitative analyses and impurity profiles can be created.
2. Volatile active substances: GC-FID/ECD
For alcohol-based disinfectants (isopropanol, ethanol) and certain volatile organic compounds, gas chromatography (GC) is used. While the flame ionization detector (FID) enables general quantification, the electron capture detector (ECD) offers high sensitivity for halogenated compounds.
3. Trace analyses: LC-MS/MS and ICP-MS
For the analysis of the impurity profile and residues in biocidal products, LC-MS/MS (organic impurities) and ICP-MS (metal-based active substances and heavy metals) are used. These techniques offer detection limits in the ppb range (parts per billion).
4. 5-Batch analysis (Five batches)
For the approval of an active substance within the framework of the BPR, samples from at least five different batches must be analyzed to prove the consistency of the manufacturing process. This analysis determines the purity of the active substance, its impurity profile, and batch variability.
Comparison of analysis methods for biocidal active substances
The following table summarizes the basic methods used in the analysis of active substances in biocidal products:
| Analysis method | Suitable active substance type | Limit of detection | Scope of application |
|---|---|---|---|
| HPLC dad | QACs, Biguanide, organic acids | ppm range | Routine active substance determination, impurity profile |
| GC-FID | Alcohols, volatile organic compounds | ppm range | Determination of active substances in disinfectants |
| GC-ECD | Halogenated compounds, pesticides | ppb range | Active substance analysis in the trace range |
| LC-MS/MS | Polar and thermally unstable compounds | ppb-ppt range | Identification of impurities, residue analysis |
| ICP-MS | Active substances based on metals (silver, copper, zinc) | ppb range | Determination of heavy metals and metallic active substances |
Active substance analyses within the framework of the BPR and national regulations
The authorization of biocidal products involves a two-stage process: first, the authorization of the active substance, then the authorization of the product containing this active substance. In both phases, active substance analyses play a crucial role.
Dossier for the authorization of an active substance (Active Substance Approval)
For an active substance to be authorized under the BPR, technical equivalence (technical equivalence) must be demonstrated. In this context:
- The chemical identity and structure of the active substance are shown.
- The purity and impurity profile are determined.
- A 5-batch analysis with samples from at least five batches is performed.
- The analytical methods are fully validated and presented.
Product authorization dossier (Product Authorisation)
For product authorization, it must be demonstrated that the active substance content in the finished product is in agreement with the specified value. In this context:
- The active substance quantity is determined in the finished product.
- Stability tests are carried out over the entire shelf life.
- Certificates of analysis (CoA) are issued.
GLP-compliant analysis of active substances in biocidal products with Nano-Test
Active substance analyses form the basis for manufacturers of biocidal products both for the approval process and for quality control. Nano-Test is a reliable solution partner for the biocidal industry with its GLP-compliant analysis services in this area.
Nano-Test – Performance Description
Nano-Test offers comprehensive services in the field of active substance analyses (Active Ingredient Analyses) for biocidal products. Analyses are carried out in our laboratories accredited according to GLP and ISO/IEC 17025, fully meeting the requirements of the BPR (528/2012) and national regulations.
Our service portfolio:
- Determination of the active substance quantity: Precise quantification using HPLC-DAD, GC-FID/ECD, LC-MS/MS, and ICP-MS.
- 5-Batch analysis: Technical equivalence studies for the active substance approval dossier.
- Impurity profile: Identification and quantification of relevant impurities.
- Stability tests: Monitoring of active substance stability throughout the entire shelf life.
- Method development and validation: Validation studies according to ICH Q2(R2) and Q14.
- Batch analysis certificates: Creation of CoA for each batch accepted by the approval authorities.
All our work is carried out ensuring data integrity (ALCOA+ principles) and submitted as GLP compliance reports with test approval.
Advantages of Nano-Test in the analysis of biocidal active substances:
- Wide range of active substances: Validated methods for QACs, alcohols, phenols, organometals, and more.
- BPR compliance: Full compliance with ECHA guidelines and BPR annexes.
- Fast reporting: Delivery of results within 5–10 working days for standard analyses.
- One-stop solution: Active substance determination, impurity profile, and stability testing – all under one roof.
- Expert team: A team with experience in biocidal legislation and analytical chemistry.
Active substance analyses in biocidal products are indispensable for the safety, efficacy, and regulatory compliance of the product. The performance of these analyses within the framework of the BPR and national regulations, in compliance with GLP principles, with validated methods and correct reporting, is a prerequisite for a smooth authorization procedure.
Nano-Test meets the requirements of biocidal product manufacturers for active substance analysis with its advanced analytical infrastructure, GLP-certified processes, and specialist staff. Have your active substance analyses carried out with the guarantee of Nano-Test to enable your products to have smooth access to global markets.