The European standard “EN 13704 Chemical disinfectants - Quantitative suspension test for evaluation of spore-killing activity of chemical disinfectants used in food, industrial, domestic and institutional settings - Test method and requirements (phase 2, step 1)” describes a test method (phase 2, step 1) and minimum requirements for the spore-killing activity of chemical disinfectant products used in food, industrial, domestic and institutional settings that form a homogeneous, physically stable preparation in hard water. Products used on living tissues are excluded from the scope of this standard, except for areas and situations where medical disinfection is required and those used for hand hygiene in the aforementioned areas.
This standard applies to at least the following:
Using this standard, it is not possible to determine the spore-killing activity of the undiluted product because some dilution always occurs with the addition of the vaccine and intervention agent. Products can only be tested at a concentration of 80 percent or lower.
The described method is designed to determine the activity of commercial formulations or active substances on spores under the conditions in which they are used.
Laboratory testing closely simulates application conditions. The chosen conditions (contact time, temperature, suspension status, etc.) reflect parameters found in practical situations, including conditions that may affect the effectiveness of disinfectants. Each usage concentration obtained from this test corresponds to defined experimental conditions. The conditions are designed to cover general purposes and provide a reference between laboratories and product types. However, the recommended usage conditions for a product may differ for some applications, and therefore additional test conditions may be required.
The basic requirement is this: When tested according to the table titled "Minimum and additional test conditions" given in the standard, the product must show a decrease of at least 3 decimal logarithmic units (lg).
The test principle involves adding a test suspension of bacterial spores in an inhibitor solution, simulating clean or contaminated conditions, to the sample of the product to be tested, diluted in hard water (or water for ready-to-use products). The mixture is maintained at a specific test temperature of ±1 degrees Celsius for a specified contact time (±10 seconds). If the contact time is 1 minute, the allowable tolerance should be ±5 seconds.
During this contact time, a sample is taken, and the spore-killing effect in this sample is immediately neutralized or suppressed using a validated method. The preferred method is dilution-neutralization. If a suitable neutralizer is unavailable, membrane filtration is used. The number of surviving bacterial spores in each sample is determined, and the reduction in viable counts is calculated.
In short, the EN 13704 standard contains a standardized method for evaluating the spore-killing activity of chemical disinfectants. The latest update to this standard has introduced stricter requirements.
Bacterial spores, such as those of Bacillus and Clostridium species, are among the most resistant forms of microorganisms. They can survive extreme conditions, including heat, desiccation, and many chemicals, making them a significant concern in environments where contamination can lead to outbreaks, such as food processing plants (e.g., Bacillus subtilis is common in soil and food). While standard disinfectants can kill vegetative bacteria, they may be ineffective against spores, so specific spore-killing claims require rigorous evidence.
The EN 13704 standard provides a consistent, repeatable method for testing whether a disinfectant can effectively inactivate spores under controlled conditions. It is particularly important for non-medical settings, excluding medical disinfection or products applied to live tissues (except for hand hygiene in these areas).
This standard applies to disinfectants used in the following areas:
The method described is a phase 2, step 1 test. It is a laboratory suspension test simulating baseline efficacy (not surface or real-world use, this is a phase 2, step 2 test).
For products to be tested under this standard, they must form a homogeneous and stable preparation in hard water.
The method is a quantitative suspension test:
Test conditions include the following:
To claim spore-killing activity, the disinfectant must provide at least a 3 log10 reduction (99,9 percent kill) in live spores under the tested conditions. This must be demonstrated at multiple concentrations, including active and inactive ranges.
The verification steps ensure that the neutralization does not harm the spores and that the survivors are properly recovered.
For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting them in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services in accordance with the EN 13704 standard.
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