In the context of health emergencies and increasing concern over infection control, the standard EN 16777:2019 has gained significant relevance. This European norm specifies the virucidal efficacy requirements of chemical disinfectants and antiseptics intended for use on non-porous surfaces in the medical, veterinary, food, industrial, domestic, and institutional sectors.
This article aims to clarify the key aspects of EN 16777, its methodology, and how it differs from suspension tests such as EN 14476. We also highlight its importance in product development, regulatory compliance, and participation in proficiency testing.
What is EN 16777:2019?
EN 16777:2019 is a quantitative non-porous surface test designed to evaluate whether a disinfectant has virucidal activity when applied to a contaminated surface. It simulates real-world conditions by requiring the product to act on viruses dried onto a stainless-steel surface.
It complements EN 14476, which is a suspension test (i.e., tests activity in a liquid environment). While EN 14476 is suitable for hand and surface disinfectants under clean conditions, EN 16777 is essential for products designed for surface disinfection under dirty conditions, such as in clinical or food environments.
Where EN 16777 Applies: Scope and Use Cases
EN 16777 applies to:
- Surface disinfectants used in human and veterinary medical areas
- Disinfectants in food industry, agriculture, and domestic use
- Products used in schools, offices, and public transport
The test is suitable for:
- Ready-to-use liquids
- Disinfecting wipes
- Concentrates that require dilution
This makes EN 16777 a versatile benchmark for evaluating a wide range of products under real application scenarios.
Key Definitions
The standard defines “virucidal activity” as the product’s capacity to reduce viral infectivity by ≥ 4 log10, equivalent to 99.99% reduction of the viral load.
Test viruses must be enveloped, such as:
- Modified vaccinia virus Ankara (MVA): a safe surrogate virus for enveloped viruses
This choice reflects the standard’s intention to validate products for general virucidal action against enveloped viruses (e.g., coronaviruses, influenza).
EN 16777 Testing Methodology Overview
EN 16777 follows a precise and reproducible laboratory procedure:
- Preparation of a stainless-steel carrier inoculated with the virus
- Drying the virus under controlled conditions
- Application of the disinfectant (ready-to-use or diluted)
- Defined contact time and temperature
- Recovery and titration of the residual virus
- Calculation of the log10 reduction
Two test conditions are applied:
- Clean conditions (low organic load)
- Dirty conditions (high organic load)
A product must demonstrate virucidal efficacy in the presence of organic matter to be considered compliant.
Acceptance criteria
To pass EN 16777, a product must:
- Reduce the viral titer by ≥ 4 log10
- Achieve this in both clean and dirty conditions
- Maintain efficacy at the lowest recommended concentration and shortest claimed contact time
This stringent requirement ensures real-world relevance and consumer safety.
Comparison with EN 14476
| Feature | EN 14476 | EN 16777 |
| Test Type | Suspension | Surface (carrier-based) |
| Application | Hands, surfaces (clean) | Surfaces (dirty) |
| Environment | Homogeneous liquid | Dried virus on surfaces |
| Contact with Product | Full immersion | Surface contact |
| Viral Reduction Required | ≥ 4 log10 | ≥ 4 log10 |
Thus, EN 16777 complements rather than replaces EN 14476, and both may be required depending on the product claims.
Why is EN 16777 important?
EN 16777 is critical because:
- 1- It simulates real-life contamination conditions
- 2- It is often required by regulatory bodies for virucidal claims
- 3- It boosts consumer confidence in disinfection efficacy
- 4- It is referenced in BPR (Biocidal Products Regulation) dossiers
- 5- It is used in proficiency testing schemes to assess lab performance
For companies looking to market their products in the EU, passing this test is often mandatory.
SHAPYPRO and EN 16777 testing
At SHAPYPRO, we offer EN 16777 testing within our accredited scope, ensuring:
- Use of validated protocols under ISO/IEC 17025
- High reliability and reproducibility
- Full traceability and compliance with EU regulations
Additionally, SHAPYPRO organizes proficiency testing schemes based on EN 16777. These interlaboratory comparisons help laboratories:
- Benchmark performance
- Demonstrate technical competence
- Improve internal processes
Contact us to join upcoming interlaboratory studies or learn more about our testing services.
Regulatory framework
EN 16777 is often cited under:
- Regulation (EU) No 528/2012 (BPR) for biocidal product authorization
- National health authority guidelines for disinfection protocols
- ISO 21702 and EN 14476 for complementary evaluations
Good laboratory practices and tips
When conducting EN 16777:
- Calibrate carriers and viral titration tools
- Maintain consistent environmental conditions
- Validate each step for robustness
- Ensure internal audits and peer review of data
Documentation should be clear, traceable, and reviewed prior to submission.
Conclusion
EN 16777:2019 sets the gold standard for evaluating virucidal activity of surface disinfectants under realistic conditions. Unlike suspension tests, it captures the complexity of surface contamination and organic load interference.
At SHAPYPRO, we are committed to helping manufacturers and laboratories meet this standard with precision, speed, and regulatory confidence.