Biocidal Product Testing: Analyses Required During the Authorization Process

Biocidal Product Authorization: Efficacy, Physicochemical Properties, and Toxicology

Biocidal Product Testing: Analyses Required During the Authorization Process

Biocidal products are formulations used to control harmful organisms, ranging from disinfectants to insecticides, rodenticides, and wood preservatives. These products must be authorized by the Ministry of Health before they can be placed on the market, and the successful completion of this process depends on accurate and reliable laboratory testing.

What Is a Biocidal Product?

Biocidal products are preparations that, thanks to their active ingredients, render target organisms—such as bacteria, viruses, fungi, algae, insects, and rodents—inactive or eliminate them. Classified under 22 main product types, biocides are widely used in many fields such as public health, food hygiene, industrial cleaning, agriculture, and veterinary medicine.

Critical Tests Required During the Registration Process

While the tests required for a registration application vary depending on the product type and formulation structure, they are essentially grouped into three main categories:

1. Efficacy Tests

This is the most critical group of analyses that demonstrates the product’s biocidal effect on target organisms. Efficacy tests are conducted in accordance with international EN standards.

Bactericidal and Fungicidal Activity Tests:

EN 1276: Bactericidal efficacy of chemical disinfectants used in food, domestic, and institutional settings
EN 13697: Surface disinfection efficacy of chemical disinfectants used in food, household, and institutional settings
EN 1650: Fungicidal activity of chemical disinfectants
EN 13727: Bactericidal efficacy of chemical disinfectants used in the medical field

Virucidal Activity Tests:
EN 14476: Virucidal efficacy of chemical disinfectants used in the medical field (against enveloped and non-enveloped viruses such as adenovirus, norovirus, and influenza)

Other Efficacy Tests:

EN 14348: Mycobactericidal efficacy of chemical disinfectants used in the medical field
Laboratory and field efficacy tests for target species of insecticide and rodenticide products

2. Physicochemical Analyses

These analyses are conducted to determine the product’s structural properties, quality, and stability throughout its shelf life:

Determination of appearance, color, odor, and physical state
pH and density measurement
Determination of viscosity and surface tension
Determination of active ingredient content (using HPLC, GC-MS, and titrimetric methods)
Accelerated shelf-life (stability) tests
Long-term storage stability
Low-temperature stability and transport tests
Packaging compatibility and corrosion tests

3. Toxicological and Ecotoxicological Assessments

These are tests designed to evaluate the product’s potential adverse effects on human health, non-target organisms, and the environment:

Acute oral, dermal, and inhalation toxicity studies
Skin and eye irritation tests
Skin sensitization assessment
Mutagenicity and genotoxicity screening tests
Acute ecotoxicity tests on aquatic organisms
Biodegradability assessment

Common Mistakes in Authorization Applications

The most common issues companies face during the biocidal product authorization process and the mistakes to avoid are as follows:

Submission of incomplete test reports or reports that do not comply with standards
Use of unvalidated analytical methods for active ingredient determination
Stability tests limited solely to accelerated data, with a lack of real-time data
Selecting the wrong standard, incorrect contact time, or inappropriate contaminant conditions in efficacy tests
Toxicological data not being compliant with current regulations and guidelines

Such deficiencies can lead to the rejection of the application or cause the authorization process to be delayed by months.

Successful Authorization Application with Nanolab

As the Nanolab Laboratories Group, we provide all critical tests required for the biocidal product authorization process in accordance with TÜRKAK accreditation and international standards.

Advantages provided by Nanolab:

All efficacy, physicochemical, and toxicological tests under one roof
Reporting fully compliant with the Ministry of Health and the EU Biocidal Products Regulation (BPR)
High accuracy and reproducibility with validated methods
Technical consulting support from a team of expert academics
Monitoring of current regulations and proactive updates
Fast turnaround times to help meet your application deadlines

For detailed information on biocidal product testing and the authorization process, please contact the Nanolab expert team.

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