Under EN 14885, the efficacy of a disinfectant or antiseptic cannot be demonstrated through a single, generically selected test. The evaluation programme must be related to the product’s intended use, its area of application, the microorganisms against which activity is claimed and the actual conditions of use.
EN 14885 provides the framework required to select and interpret the European standards applicable to chemical disinfectants and antiseptics. It is therefore an essential reference for manufacturers, laboratories, consultants and authorities that need to develop or assess an efficacy testing strategy.
The current European edition is EN 14885:2022, supplemented by the corrigendum AC:2023.
What is EN 14885?
EN 14885 is a framework standard that establishes how the different European standards developed to evaluate the activity of chemical disinfectants and antiseptics should be applied.
It does not describe a single test procedure. Its purpose is to establish the relationship between:
- The product’s area of use.
- The type of application.
- The claimed microbiological activity.
- The conditions of use.
- The phases and steps of evaluation.
- The specific standards that should be used.
- The information that may be used to support efficacy claims.
EN 14885 therefore makes it possible to move from a commercial claim, such as “bactericidal surface disinfectant”, to a testing programme that is technically consistent with that claim.
The standard does not in itself constitute a marketing authorisation, replace the regulatory assessment of the product or automatically imply CE marking. Its purpose is to guide the selection of the European tests required to support claims of microbiological activity.
Areas of application covered by EN 14885
The standard applies to products intended for three main areas:
Medical area
This includes disinfectants and antiseptics used in situations where disinfection or antisepsis is medically indicated, such as:
- Hospitals and healthcare facilities.
- Clinics and medical practices.
- Dental facilities.
- Care homes and other care facilities.
- Medical laboratories.
- Hand hygiene.
- Disinfection of surfaces, instruments and textiles.
Veterinary area
This includes products used in:
- Animal breeding and housing.
- Livestock facilities.
- Veterinary clinics.
- Animal transport.
- Equipment and materials used in veterinary settings.
- Veterinary laboratories.
- Facilities related to animal production and disposal.
The standard does not apply to disinfectants used within the food chain after slaughter and after the product has entered the processing industry.
Food, industrial, domestic and institutional areas
This includes products used in the production, processing, distribution and sale of food of animal or plant origin, as well as in:
- The food industry.
- Professional kitchens.
- Industrial facilities.
- Public spaces.
- Educational facilities.
- Homes.
- Institutional facilities.
- Surfaces, equipment, pipework and other systems associated with these areas.
The selection of the test standard depends on the specific area of application. A result obtained using a method designed for the medical area cannot automatically be transferred to a veterinary, food or domestic use, as the test conditions and requirements may differ.
From the intended use to the testing programme
Before selecting a standard, it is necessary to define precisely how the product will be used. This step is essential because small differences in the instructions for use may change the required testing programme.
The following questions should be considered:
- In which area will the product be used?
- Will it be applied to hands, surfaces, instruments, textiles or other materials?
- Is it a ready-to-use product or must it be diluted?
- Will it be applied by spraying, immersion, wiping or circulation?
- Will mechanical action be involved during application?
- What concentration will be used?
- What contact time will be stated?
- At what temperature will it be used?
- Will it be applied under clean or dirty conditions?
- Which microorganisms or microbial groups will be included in the claim?
Within the possibilities of the standardised method, the testing strategy should reproduce the conditions that will subsequently appear on the label, in the technical data sheet or in the regulatory documentation.
Microbiological activities covered
EN 14885 organises the applicable standards according to the activity to be demonstrated. The main claims include:
- Bactericidal activity.
- Yeasticidal activity.
- Fungicidal activity.
- Mycobactericidal activity.
- Tuberculocidal activity.
- Virucidal activity.
- Activity against enveloped viruses.
- Sporicidal activity.
- Activity against specific microorganisms, where applicable.
Not all these activities are required for every product. The required activity will depend on the intended use, the area of application and the claim to be made.
Furthermore, passing a test against certain reference microorganisms does not mean that the product can be presented as effective against any microorganism, at any concentration or under any conditions of use. Claims must remain within the scope actually demonstrated by the tests.
Phase 1 and Phase 2 tests under EN 14885
The European evaluation of disinfectants and antiseptics is structured into different phases and steps.
Phase 1: basic antimicrobial activity
Phase 1 tests are quantitative suspension tests used to determine whether an active substance or formulation demonstrates activity against certain microorganisms.
These tests may be useful during product development or for an initial characterisation of its activity. However, they do not sufficiently reproduce the conditions of application and, on their own, are generally not suitable for supporting an efficacy claim associated with a specific use.
Phase 2, step 1: quantitative suspension tests
Phase 2, step 1 tests evaluate the product under conditions that are closer to its intended use.
They allow variables such as the following to be incorporated:
- Product concentration.
- Contact time.
- Temperature.
- Interfering substances.
- Clean or dirty conditions.
- Reference microorganisms.
- Type of diluent or water used.
These tests determine whether the product achieves the required microbial reduction under laboratory conditions.
Phase 2, step 2: tests simulating practical conditions
Phase 2, step 2 tests reproduce more directly the way in which the product will be used.
They may include tests on:
- Non-porous surfaces.
- Instruments.
- Hands.
- Textiles.
- Washing systems.
- Applications with or without mechanical action.
These tests determine whether the product achieves the required microbial reduction under real-use conditions.
Examples of standards related to EN 14885
EN 14885 brings together and establishes the relationship between numerous specific standards. The selection depends on the area, the type of product, the claimed activity and the method of application.
Some examples include:
Medical area
- EN 13727: bactericidal activity using a quantitative suspension test.
- EN 13624: fungicidal or yeasticidal activity using a quantitative suspension test.
- EN 14476: virucidal activity using a quantitative suspension test.
- EN 1500: hygienic handrub.
- EN 12791: surgical hand disinfection.
- EN 16615: disinfection of non-porous surfaces with mechanical action.
Veterinary area
- EN 1656: bactericidal activity using a quantitative suspension test.
- EN 1657: fungicidal or yeasticidal activity using a quantitative suspension test.
- EN 16437: bactericidal activity on non-porous surfaces without mechanical action.
- EN 16438: fungicidal or yeasticidal activity on non-porous surfaces without mechanical action.
Food, industrial, domestic and institutional areas
- EN 1276: bactericidal activity using a quantitative suspension test.
- EN 1650: fungicidal or yeasticidal activity using a quantitative suspension test.
- EN 13697: bactericidal, yeasticidal or fungicidal activity on non-porous surfaces without mechanical action.
- EN 13704: sporicidal activity using a quantitative suspension test.
This list is not exhaustive. Nor does it mean that all standards must be applied to every product. EN 14885 should be used to identify the appropriate combination of tests for each particular case.
The importance of test conditions under EN 14885
An efficacy claim does not depend solely on passing a particular standard. It also depends on the specific conditions under which the result was obtained.
Concentration
The test must be performed at a concentration compatible with the instructions for use. When the product is tested in diluted form, any additional dilution that may occur during the test procedure itself must be considered.
Contact time
The time evaluated must correspond to the time that will be claimed for the product. A result obtained after 15 minutes cannot automatically support an application time of 5 minutes.
Temperature
Efficacy may vary depending on temperature. Test conditions should therefore be representative of the intended use and comply with the limits established by the applicable standard.
Interfering substances
Interfering substances simulate the presence of organic matter or other residues that may reduce the activity of the product.
Clean and dirty conditions are not interchangeable. When a product is intended for use on surfaces where organic matter may be present, the strategy should include conditions that are consistent with that scenario.
Test microorganisms
Each standard specifies the reference microorganisms required to demonstrate a particular activity. In some cases, additional microorganisms associated with a specific claim may be included, but these do not necessarily replace the mandatory organisms established by the method.
Basic claims and additional claims
EN 14885 helps distinguish between the activities required to support the product’s main intended use and any additional claims that the manufacturer may wish to include.
For example, a product may need to demonstrate basic bactericidal and yeasticidal activity for a particular use, while fungicidal, virucidal or sporicidal activity may constitute an additional claim.
This distinction helps prevent insufficient testing programmes, but also avoids unnecessarily extensive evaluations. The objective is not to accumulate standards for the sake of it, but to generate the evidence required for the product and the claims that will actually be used.
EN 14885 and the Biocidal Products Regulation
Biocidal products marketed in the European Union are subject to Regulation (EU) No 528/2012, known as the BPR.
One of the conditions for authorisation is that the product must be sufficiently effective for its claimed uses. The documentation must demonstrate that the proposed conditions of use, such as concentration, contact time, application method and target organisms, are supported by appropriate data.
The efficacy guidance issued by the European Chemicals Agency states that EN 14885 provides information for applying and interpreting the European standards used in the evaluation of disinfectants corresponding to product types 1, 2, 3 and 4 under the BPR.
EN 14885 and the BPR therefore perform related but different functions:
- The BPR establishes the legal framework for the authorisation and marketing of biocidal products.
- EN 14885 helps select the standardised methods through which their microbiological efficacy can be demonstrated.
Passing the relevant tests is an important part of the dossier, but it does not replace risk assessment, physicochemical characterisation, labelling requirements or the remaining regulatory documentation.
Main changes introduced by EN 14885
The current version of EN 14885 updates and expands the previous framework. Its main changes include:
- Updated normative references and specific standards.
- Revision of the tables covering the medical, veterinary, food, industrial, domestic and institutional areas.
- Addition of new definitions and revision of terminology.
- Greater precision regarding the concentrations that should be selected during testing.
- Guidance on distinguishing between active and non-active substances within a formulation.
- Information on standards under preparation or revision.
- Integration of content relating to the differentiation between active and non-active substances.
- Clarification of certain chemical-thermal disinfection processes.
The AC:2023 corrigendum also introduced a clarification regarding how logarithmic reductions should be expressed and rounded.
Common mistakes when designing an efficacy strategy
Incorrect planning may result in repeated tests, regulatory delays or claims that are not sufficiently supported.
The most common mistakes include:
- Selecting the standard based only on the microorganism.
- Failing to consider the area of application.
- Testing contact times that differ from those stated on the label.
- Using clean conditions when the intended use requires dirty conditions.
- Confusing a suspension test with a practical application test.
- Transferring results between medical, veterinary or food uses without justification.
- Assuming that a single test demonstrates universal efficacy.
- Conducting studies before defining the commercial and regulatory claims.
- Failing to check whether the standard being used is still current or has been amended.
Defining the strategy before testing begins helps reduce these risks and produces more coherent documentation.
How to plan tests correctly using EN 14885
A well-structured evaluation programme can be developed through the following steps:
- Define the product and its final formulation.
- Identify the area and type of use.
- Determine the intended microbiological claims.
- Establish the concentration, contact time, temperature and application method.
- Select the applicable standards using EN 14885.
- Identify the required Phase 2, step 1 and Phase 2, step 2 tests.
- Check whether additional regulatory requirements apply.
- Document the technical justification for the strategy.
- Verify that the standards are current before beginning the study.
- Ensure consistency between the results and the final instructions for use.
This planning should be completed before commissioning or beginning the tests. Subsequent changes to the concentration, contact time or method of application may mean that the results obtained no longer support the intended claim.
The role of SHAPYPRO
At SHAPYPRO, we help laboratories and companies interpret the technical and regulatory requirements associated with chemical disinfectants and antiseptics.
We also organise proficiency testing programmes associated with different standards included within the EN 14885 framework. These programmes allow biocidal efficacy testing laboratories to:
- Compare their performance with that of other participants.
- Evaluate the correct application of the methods.
- Detect technical deviations.
- Strengthen the reliability of their results.
- Obtain evidence for their quality systems.
- Support compliance with requirements for participation in interlaboratory comparisons.
SHAPYPRO is accredited in accordance with ISO/IEC 17043:2023 for the provision of proficiency testing, supporting the competence, impartiality and consistency of the programmes included within its scope of accreditation.
Conclusion
EN 14885 is an essential tool for converting the intended use of a disinfectant or antiseptic into a technically justified evaluation strategy.
Its correct application requires an analysis of the area of use, the application method, practical conditions, target microorganisms and the claims to be supported. It is not simply a matter of selecting a familiar standard, but of building a body of evidence that is consistent with the product that will ultimately be placed on the market.
Planning tests from the earliest stages of the project helps prevent repetition, reduce delays and ensure that the efficacy documentation is compatible with both the instructions for use and the applicable regulatory requirements.
In a sector where small differences in concentration, contact time or application may change the result, efficacy should not be assumed: it must be demonstrated under clearly defined conditions.