The EN 1650 standard is one of the key European references for assessing the fungicidal and yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas.
Adopted in Spain as UNE-EN 1650:2020, this method is part of the harmonized framework developed by the European Committee for Standardization (CEN/TC 216 – Chemical Disinfectants and Antiseptics). Its objective is to ensure comparable and reliable results between laboratories when evaluating the performance of disinfectant products.
In this article, we examine the scope, methodology, reference microorganisms, efficacy criteria, and relevance of this standard for the chemical and cosmetic sectors, along with the role of SHAPYPRO in supporting laboratories through interlaboratory proficiency testing programs based on EN 1650.
Scope Of EN 1650
The EN 1650 standard applies to chemical disinfectant and antiseptic products used in non-medical areas, meaning it focuses on disinfectants intended for:
- Food and beverage processing facilities.
- Domestic and institutional environments such as schools, kitchens, nursing homes, laundries, and sports centers.
- Industrial settings, including the chemical and pharmaceutical industries, where hygiene control is essential.
It does not cover products applied directly to humans or animals, as those are regulated under other standards such as EN 1500 (hand hygiene) or EN 1656 / EN 1657 (veterinary area).
EN 1650: Purpose and Principles
1- The purpose of EN 1650 is to determine whether a disinfectant or antiseptic demonstrates sufficient fungicidal and yeasticidal activity under laboratory conditions simulating its practical use.
2- The method is a quantitative suspension test, where a microbial suspension is exposed to the product for a defined contact time, temperature, and concentration.
3- The outcome is expressed as a logarithmic reduction in viable microorganisms, allowing comparison between products under standardized and reproducible conditions.
EN 1650: Reference Microorganisms
EN 1650 specifies the use of two reference microorganisms, representative of the most common types of fungal contamination in relevant environments:
- Candida albicans – a yeast species commonly found in humid environments and often associated with environmental or product contamination.
- Aspergillus brasiliensis (formerly Aspergillus niger) – a mold known for its resistance and frequent occurrence on surfaces and in processing equipment.
These strains were selected for their relative resistance to disinfectants, ensuring that if a product is effective against them, it will also be active against a broad range of yeasts and molds.
Test Conditions in EN 1650
The EN 1650 test is carried out under controlled laboratory conditions that reflect real-life usage:
- Contact time: from 15 seconds up to 60 minutes, depending on the product’s intended use.
- Temperature: typically between 20 °C and 40 °C, though it can be adjusted (e.g., 4 °C for food industry applications).
- Clean and dirty conditions: simulated using proteins such as bovine albumin or other organic materials to represent soil load or food residues.
- Neutralization: a suitable neutralizing agent is applied to stop the disinfectant’s activity precisely at the defined time.
- Recovery method: surviving microorganisms are counted using plate count methods, either by dilution-neutralization or membrane filtration depending on the formulation.
These parameters ensure that the test reproduces realistic product performance and provides comparable data across laboratories.
Efficacy Criteria
To be considered fungicidal or yeasticidal according to EN 1650, a product must achieve a minimum reduction of 4 log₁₀, equivalent to 99.99% inactivation of the test organisms.
This threshold confirms that the product can significantly reduce fungal and yeast contamination under defined test conditions.
Depending on its application area, the product must meet these requirements under clean conditions (low organic load) or dirty conditions (high organic load).
Relationship With Other European Standards
EN 1650 is part of a coordinated family of European disinfectant standards, each focusing on a specific type of antimicrobial activity or area of application:
| Standard | Activity | Primary scope |
| EN 1276 | Bactericidal | Food, industrial, domestic, and institutional areas. |
| EN 1650 | Fungicidal / Yeasticidal | Non-medical areas (food, domestic, and industrial). |
| EN 13697 | Bactericidal and fungicidal (surface test without mechanical action) | Practical surface disinfection. |
| EN 1656 | Bactericidal | Veterinary field. |
| EN 1657 | Fungicidal / Yeasticidal | Veterinary field. |
| EN 14885 | Framework standard | Defines relationships and applicability of all disinfectant test methods. |
Together, EN 1276 + EN 1650 + EN 13697 form the foundation for evaluating disinfectants in non-medical applications across Europe.
Updates Introduced In The 2019 / 2020 Revision
The most recent revision, EN 1650:2019 (UNE-EN 1650:2020), introduced several important updates to align with other CEN/TC 216 standards:
- Updated terminology and definitions.
- Clarified neutralization procedure and validation requirements.
- Refined test conditions (contact time, temperature, concentration) for greater realism.
- Harmonization with EN 14885, ensuring consistent interpretation of disinfectant performance claims.
- Simplified test report format, improving usability in audits and regulatory submissions.
These changes enhance reproducibility, improve interlaboratory consistency, and make EN 1650 a more robust reference for both industry and regulators.
Relevance For The Chemical And Food Industries
The application of EN 1650 has a direct impact on chemical, food, and hygiene industries, ensuring microbial safety in processes where fungal contamination can affect product quality or consumer safety.
Key benefits include:
- Demonstrated efficacy: ensures products meet harmonized European standards for fungal and yeast control.
- Regulatory compliance: provides recognized proof of efficacy for audits and certifications (e.g., BRC, IFS, ISO 22000).
- Consumer protection: verifies that disinfectants eliminate not only bacteria but also resistant molds and yeasts.
- Support for innovation: provides an objective benchmark for developing and comparing new biocidal formulations.
For industries where fungi can cause product spoilage or health risks—such as cosmetics, detergents, and food manufacturing—EN 1650 serves as a fundamental technical and safety tool.
Application In The Cosmetics Sector
Although EN 1650 was not developed specifically for cosmetics, its principles are highly applicable to microbial control in cosmetic production.
It supports good manufacturing practices (GMP) by verifying that disinfectants used in formulation areas, packaging zones, or laboratory surfaces are effective against yeast and mold contaminants.
It is particularly relevant for:
- Creams, lotions, and emulsions with high water content.
- Shampoos, gels, and personal care products prone to microbial growth.
- Natural and organic formulations with minimal preservatives.
By adopting EN 1650 methodologies, cosmetic laboratories can strengthen their microbiological quality assurance and reinforce product safety before market release.
The Role Of SHAPYPRO In Applying EN 1650
At SHAPYPRO, we implement EN 1650 as part of our international proficiency testing programs, designed for laboratories aiming to demonstrate competence in accordance with ISO/IEC 17043.
Through these interlaboratory comparisons, participants can:
- Benchmark their results against peer laboratories.
- Evaluate the accuracy of their counting and neutralization procedures.
- Detect analytical deviations and improve method performance.
- Provide objective evidence of technical competence to clients and accreditation bodies.
Beyond proficiency testing, SHAPYPRO supports laboratories with technical training, regulatory consultancy, and analytical innovation, helping ensure compliance with EN 1650 and related disinfectant standards.
Conclusions
The EN 1650 standard is a cornerstone for evaluating the fungicidal and yeasticidal activity of chemical disinfectants in food, industrial, and domestic areas.
By establishing clear procedures, defined reference organisms, and harmonized performance criteria, EN 1650 guarantees reliable and comparable data for manufacturers and testing laboratories across Europe.
For manufacturers, it is a critical benchmark to demonstrate product efficacy and regulatory compliance. For laboratories, it serves as a robust methodological guide to ensure accuracy, reproducibility, and traceability in microbiological testing.
At SHAPYPRO, we actively promote the application of EN 1650 through proficiency testing, technical assistance, and training, contributing to the advancement of analytical quality and hygiene assurance in the chemical and cosmetic industries.
To learn more about suspension test methods and their differences across European standards, visit:
👉 Comparison of Suspension Test for Disinfectant.