Microbiological efficacy tests for biocidal products: the scientific basis for marketing approval
Biocidal products include a wide range of products - such as disinfectants, antiseptics, preservatives, pesticides and pesticides - intended to combat microorganisms or harmful organisms. In order for these products to be marketed, the alleged effectiveness must be scientifically proven. Microbiological Efficacy Tests Measure the killing or inhibitory effect of a biocidal product on target microorganisms under standardized conditions.
An efficacy test for biocidal products is not only an official requirement, but also forms the basis for the reliability of the marketing statements on a product. Without efficacy data, it is not possible to obtain approval for a biocidal product. Therefore, the proper design of the tests, their implementation in accordance with the applicable standards and the comprehensive reporting directly determine the approval process of your product.
The scientific basis of microbiological efficacy tests
Microbiological efficacy tests are based on the quantitative measurement of the effect of a biocidal product on target microorganisms at a given concentration, a specific exposure time and under certain conditions. The primary result of the test is the logarithmic reduction value (log reduction), which is calculated as the difference between the initial microorganism number and the number after the test. A 5 log reduction means, for example, that the initial microorganism number has decreased by a factor of 100,000 and represents a frequently required threshold for the effectiveness of disinfectants.
The test design depends on factors such as the target microorganism species, the scope of the product (body care, food contact surfaces, hospital environments, veterinary facilities), the exposure time, temperature and organic load. By adding an organic load (dirt, serum, proteins) to the test conditions, the performance of the product can be more accurately simulated under real conditions of use. For this reason, effectiveness tests are carried out according to different standards, depending on the product class and application scenario.
Biocide efficacy tests are divided into three main groups depending on the product's range of effects: bactericides (bacterial killings), fungicides (fungal killers) and virucidal (virus-killing) efficacy. In addition, sporicides (spore-killing), mycobactericides (mycobacterial killers) and tuberculocidal efficacy tests may also be required, depending on the information on the product. Different reference strains of microorganisms and different standards are used for each type of efficacy.
Efficacy Tests by Product Class
Biocidal products are subject to different requirements for efficacy tests, depending on the intended use. Disinfectant tests are carried out according to different standards, depending on the area of application (human health, veterinary medicine, food, household). Bactericidal and fungicidal efficacy under high organic stress are required for disinfectants used in hospital areas; Additional virucidal tests are required for virucidal information. Examinations for antiseptics are used to assess their effectiveness on the skin and mucous membranes. For preservatives (used in cosmetics, pharmaceuticals and industrial products), a preservative efficacy test - known as a challenge test - is carried out; This test assesses whether the product provides protection against microbial contamination throughout its shelf life.
Hand disinfectant tests are carried out according to specific standards such as EN 1500 (Hygienic Hand Disinfection) and EN 12791 (Surgical Hand Disinfection). Norms EN 1276 (bactericidal), EN 1650 (fungicide) and EN 14476 (virucidal) apply to surface disinfectants. For instrument disinfectants, the standards EN 13727, EN 14561 and EN 14476 apply. Each standard defines different requirements regarding test microorganisms, exposure time, organic stress and acceptance criteria.
The following table summarizes the effectiveness test standards used according to the main classes of biocidal products.
| Product class | Bactericidal | Fungicide | Virucidal |
|---|---|---|---|
| Hand sanitizer | EN 1500, EN 12791 | EN 1500 (additional fungicide efficacy test) | EN 14476 |
| Surface disinfectant | EN 1276, EN 13697 | EN 1650, EN 13697 | EN 14476, EN 16777 |
| Instrument disinfectant | EN 13727, EN 14561 | EN 13624, EN 14562 | EN 14476 |
| Antiseptics | EN 1040, EN 13727 | EN 1275, EN 13624 | EN 14476 |
| Preservative (Challenge Test) | ISO 11930, USP <51>, EP 5.1.3 | ISO 11930, USP <51>, EP 5.1.3 | — |
Test parameters
Test parameters include exposure time, temperature, organic load and product concentration. Each of these parameters must be kept within the ranges specified in the standard; Otherwise, the results are considered invalid. In order to ensure the reproducibility of the test, all steps must also be carried out according to the standard work instructions (SOPs) and properly documented. Our laboratory reports on all tests according to the GLP principles, traceable and with complete quality control data.
BPR and the regulatory framework
In the European Union, biocidal products are approved in accordance with BPR (Biocide Regulation - 528/2012). The BPR prescribes that efficacy tests that are suitable for the product's range of effects to demonstrate its effectiveness must be carried out. Efficacy data is an essential part of the product's application for approval, and the application will not be accepted without this data.
According to the BPR, effectiveness tests are assessed by the competent authority of the Member State in question on the basis of the intended use of the product. The tests must be performed in an accredited laboratory under GLP or GMP conditions, and the results must be fully documented. In addition, the specified spectrum of activity of the product must correspond to the application instructions given on the label; Inconsistencies between the efficacy data and the information on the etiquette can lead to serious problems during the admissions process.
Scope of our laboratory
Our GLP-certified laboratory carries out bactericides, fungicides and virucidal efficacy tests for biocidal products in accordance with the relevant EN standards and BPR requirements.
Our test method begins with an assessment of the product properties and the specified spectrum of effects; Subsequently, the appropriate standard, the test microorganisms and the test conditions are determined. The tests are carried out using validated methods and accompanied by quality control data.
Testing the biocidal efficacy is a crucial part of the approval process for your product.
The right standards, appropriate test design and comprehensive reporting prevent delays in the approval process and guarantee the reliability of your product information. Our laboratory provides the scientific infrastructure and regulatory expertise you need throughout this process.
Frequently Asked Questions
What efficacy tests are required for my product? The required tests depend on the intended use of the product and the specified spectrum of effects. In the case of disinfectants, bactericides, fungicides and virucidal tests are required, depending on the intended use; A challenge test is required for preservatives; And antiseptics require efficacy tests on the skin and mucous membranes. Our laboratory determines the required test list based on the properties of your product.
How long do the tests take? The duration of the test varies depending on the nature of the effectiveness and the norm. Bactericidal and fungicidal tests usually last 2-4 weeks; Virucidal tests can take 4-6 weeks due to cell culture phases.
Including reporting and quality assurance, the total duration is 4-8 weeks.
Can a permit application be submitted without efficacy data? No. According to the BPR and the Turkish Biocidal Ordinance, efficacy data are an obligatory part of the application for admission. Applications without efficacy data will not be accepted.
Contact our laboratory to scientifically demonstrate the effectiveness of your biocidal product and speed up your approval process. Our team of experts develops a test strategy tailored to your product and will provide you with all the necessary effectiveness data in full.