In a world where hygiene is more crucial than ever, disinfectants and antiseptic products play a fundamental role in preventing infections, both in medical settings and in everyday life. However, not all of these disinfectants offer the same protection or guarantee the same level of effectiveness. That is why specific European standards, such as EN 14885, define exactly how these products should be evaluated before being marketed.
This article explores the key aspects of the effectiveness of antiseptics and disinfectants, based on the requirements of the EN 14885:2023 standard, and how to identify products that truly meet quality and safety standards.
EN 14885: The Key Standard for Disinfectants and Antiseptics
The EN 14885:2023 standard sets out the general requirements for the tests used in evaluating the efficacy of antiseptic and disinfectant products in Europe. It is an essential reference for manufacturers, laboratories, and regulatory authorities, as it summarizes and organizes the specific European standards according to the product’s area of use (hospital, industrial, domestic, etc.).
It is structured around several types of tests:
- Phase 1: verifies basic antimicrobial activity.
- Phase 2/Step 1: tests efficacy under representative laboratory conditions.
- Phase 2/Step 2: tests efficacy under real-world conditions.
This structure allows for a progressive and rigorous evaluation, ensuring that only truly effective products reach the market.
Standards to be Applied in Product Evaluation
SHAPYPRO plans to evaluate a wide range of European biocide standards through 2029. Some of the most relevant include:
- EN 1500 – Hand hygiene (bactericidal)
- EN 14476 – Virucidal activity
- EN 13624 – Yeasticidal and fungicidal activity
- EN 13727 – Bactericidal activity in the medical field
- EN 1276 – Bactericidal activity in food environments
- EN 1650 – Yeasticidal and fungicidal activity
- EN 1656 – Bactericidal activity in veterinary applications
- EN 13697 – Activity on non-porous surfaces
- EN 14675 – Virucidal activity in veterinary settings
- EN 16615 – Activity on surfaces with mechanical action
These standards cover a broad spectrum of target microorganisms: bacteria, fungi, viruses, and spores.
Below is a table grouping the European standards by type of antimicrobial activity and application area. This classification helps identify the appropriate standard depending on the product’s intended use:
5-Year Outlook: Expanding Standards
SHAPYPRO has a roadmap for progressively implementing new antimicrobial efficacy standards between 2024 and 2029. The following timeline illustrates this strategic evolution:
Why Validating Disinfectants Is Essential for Public Health
In settings such as hospitals, clinics, or even the food industry, using products without verified efficacy can pose a serious health risk. Validating efficacy according to standards helps:
- Reduce the transmission of healthcare-associated infections.
- Ensure the elimination of pathogenic microorganisms.
- Enable proper selection of products for each specific application.
Additionally, poor disinfection practices may promote microbial resistance, an increasing concern in public health.
Application Areas According to EN 14885
The standard classifies products into five main areas:
- Medical area: hospitals, clinics, dentistry.
- Food, industrial, domestic, and institutional areas.
- Veterinary area.
- Hand hygiene.
- Treatment of inanimate surfaces.
Each of these areas has specific efficacy standards that must be met. For example, a disinfectant for surgical instruments is not evaluated in the same way as a household cleaner.
Product Example: Alcohol-Based Hand Gel
A hand gel must comply with, at minimum:
- EN 1500: bactericidal hand hygiene
- EN 14476: virucidal efficacy
- EN 13624: yeasticidal and fungicidal efficacy
These tests are carried out under controlled conditions (with or without soiling, depending on use) and in accredited laboratories.
How to Interpret the Results?
A product that has successfully passed the required tests should indicate the following on its label or technical data sheet:
- The standards under which it was evaluated
- The conditions of use to achieve efficacy (e.g., 60-second contact time)
- The antimicrobial activity (bactericidal, fungicidal, virucidal, etc.)
This allows end users—professionals or consumers—to use the product safely and effectively.
Laboratory Accreditation: A Key Step
It is not enough for the product to be tested—it must be tested in ISO/IEC 17025 accredited laboratories, which ensure impartiality, traceability, and valid results.
In this regard, SHAPYPRO is the only accredited provider of proficiency testing in the world. Our experience guarantees the reliability of every result issued and helps manufacturers meet European regulatory requirements.
Recommendations for Manufacturers
- Identify the intended use of the product
- Select the appropriate standards (refer to EN 14885)
- Conduct tests in accredited laboratories
- Maintain technical documentation for regulatory purposes
You can contact our team for personalized guidance.
How to Choose Effective Disinfectants as a Consumer
Not all products marketed as “disinfectants” actually comply with European criteria. As a user, you can check:
- That the product references standards such as EN 14476 or EN 13727
- That it specifies the types of microorganisms it eliminates
- That it clearly indicates how to use it (dilution, time, surface)
To learn more about how this affects your daily life, consult this technical report from ECHA on biocides, safety, and regulation in the European Union.
Disinfectants and Standards: Final Thoughts on Safety and Effectiveness
The effectiveness of disinfectant products is no minor detail—it directly impacts people’s safety. Complying with the EN 14885 standard is a mark of responsibility and trust.
At SHAPYPRO, we support you at every stage of the validation and accreditation process.