EN 1275 is a fundamental European standard for the evaluation of the fungicidal and yeasticidal activity of chemical antiseptics and disinfectants. It is a quantitative suspension test designed to demonstrate the efficacy of a product against yeasts and filamentous fungi under controlled and reproducible test conditions.
Although it is widely used during the development and validation of disinfectant formulations, EN 1275 remains a key reference within the European regulatory framework, as it provides the scientific basis required to substantiate efficacy claims against fungi and yeasts across different areas of application.
This article explains in detail the scope of the standard, its methodological principle, reference microorganisms, test conditions, efficacy criteria, and its role within the regulatory system for biocidal products.
General Framework And Scope Of Application Of EN 1275
The EN 1275 standard forms part of the set of European standards developed by CEN/TC 216, which focus on the evaluation of chemical antiseptics and disinfectants. It is integrated into the hierarchical system defined by EN 14885, which establishes which standards must be used to support different types of microbiological efficacy claims.
EN 1275 applies to products intended for:
- General disinfection
- Human hygiene
- Institutional hygiene
- Professional and industrial use
Its objective is to evaluate the fungicidal and/or yeasticidal activity of a product using a standardised method, prior to performing more complex or application-specific surface tests.
EN 1275 And Regulation (EU) No 528/2012
In the European Union, the placing of disinfectants on the market is regulated by Regulation (EU) No 528/2012 on biocidal products. This regulation requires that products:
- Are effective for their intended use
- Are supported by robust scientific data
- Use recognised and harmonised methods
EN 1275 provides the technical reference framework for demonstrating efficacy against fungi and yeasts when tests are performed in the liquid phase.
Without results obtained in accordance with this standard, claims of fungicidal or yeasticidal activity cannot be adequately justified to competent authorities or clients.
Principle Of The EN 1275 Test
EN 1275 is based on a quantitative suspension test, the objective of which is to measure a product’s ability to reduce the viability of fungi and yeasts under defined conditions.
Basic Methodological Concept
- A standard suspension of the test microorganism is prepared.
- The disinfectant product is brought into contact with the suspension for a defined contact time.
- The action of the product is neutralised at the end of the contact time.
- Surviving microorganisms are recovered and quantified.
- The logarithmic reduction achieved is calculated.
Results are expressed as a log₁₀ reduction of the initial microbial population.
Reference Microorganisms In EN 1275
The standard specifies particular microorganisms that represent the main groups of fungi and yeasts of sanitary and environmental relevance.
Yeasts
- Candida albicans
This yeast is widely used as a reference microorganism due to its clinical relevance and its frequent presence in humid environments and on surfaces.
Filamentous Fungi
- Aspergillus brasiliensis
This filamentous fungus represents a greater challenge for disinfectants because of its structure and relative resistance.
The combination of both microorganisms allows a balanced evaluation of efficacy against yeasts and moulds.
Test Conditions Defined In EN 1275
EN 1275 strictly defines experimental parameters to ensure the reproducibility of results.
Clean Conditions
The test is performed under clean conditions, using a low organic load as an interfering substance. This allows assessment of the intrinsic efficacy of the product without excessive organic interference.
Temperature And Contact Time
- Test temperature: 20 °C ± 1 °C
- Contact time: defined by the manufacturer and consistent with the intended use
Extrapolation without experimental support is not permitted.
Neutralisation
Neutralisation is a critical step in the method. The neutraliser must:
- Completely stop the action of the product
- Not be toxic to the test microorganisms
Validation of the neutraliser is mandatory before results can be accepted.
EN 1275 Efficacy Criteria
To comply with EN 1275, the product must demonstrate:
- ≥ 4 log₁₀ reduction of the test population
This criterion applies to both fungicidal and yeasticidal activity, depending on the microorganism evaluated.
Claims Supported By EN 1275
Correct interpretation of results is essential to avoid regulatory errors.
Examples of claims supported by EN 1275
- “Fungicidal activity”
- “Yeasticidal activity”
However, results obtained in suspension cannot be automatically extrapolated to surfaces or practical conditions without additional testing.
Differences Between EN 1275 And Related Standards
The EN 1275 should be understood as an initial-phase test, complemented by other, more application-specific standards:
- 1- EN 13624 → fungicidal/yeasticidal activity in the medical area
- 2- EN 1650 → fungicidal/yeasticidal activity in institutional and food areas
- 3- EN 13704 → sporicidal activity
Each standard corresponds to a different level of stringency and practical application.
Importance Of EN 1275 For Manufacturers And Laboratories
For manufacturers, EN 1275 is a key tool for:
- Early formulation development
- Selection of effective concentrations
- Comparative evaluation of products
For laboratories, it involves:
- Rigorous application of the method
- Strict microbiological control
- Qualified personnel
- Thorough validation of neutralisers
EN 1275 And Proficiency Testing
Given the technical complexity of the method, Proficiency Testing (PT) is essential to ensure the competence of laboratories performing EN 1275.
These programmes allow laboratories to:
- Compare results with other laboratories
- Detect methodological deviations
- Ensure the reliability of generated data
SHAPYPRO develops Proficiency Testing programmes aligned with microbiological standards such as EN 1275, contributing to continuous improvement and confidence in analytical results.
Evolution And Current Validity Of The Standard
Although the reference version of EN 1275 predates some more recent standards, it remains fully valid as a basic and comparative evaluation method.
Its use continues to be common in:
- R&D studies
- Quality control
- Technical and regulatory support
Conclusion: Relevance Of EN 1275
EN 1275 remains an essential standard for the evaluation of the fungicidal and yeasticidal activity of chemical antiseptics and disinfectants. Its standardised, reproducible, and scientifically robust approach enables the generation of reliable data that support the development of effective products compliant with European legislation.
In a demanding regulatory environment, correct application of EN 1275 helps ensure the safety, efficacy, and quality of disinfectant products from the earliest stages of development.