April 27, 2026

How will EN 14476:2025 affect your antiviral claims?

A major update to the European virucidal efficacy standard, EN 14476:2025, came into force in October 2025. Replacing the 2013 and 2019 editions, this revised version introducessignificant technical changes that directly influence how antiviral and hygienerelated claims must now be generated, evidenced, and defended.

Key changes include:

De-harmonization of the standard: Annex ZA and references to MDR/MDD have been deleted.
Vaccinia virus testing expanded: now required for enveloped viruses across textile and instrument disinfection.
New requirements for hand hygiene products: Vaccinia virus testing has also been added for handrub and handwash claims, with defined logreduction criteria now mandatory for handwash formulations.
Updated reference substances: Glutaraldehyde has been introduced as an alternative to formaldehyde.

Peracetic acid added for chemothermal disinfection: Strengthening reference conditions for textile disinfection and related applications.

What this means for brands and manufacturers

If your product carries antiviral or hygienerelated claims, your existing data may not fully align with the new requirements. The updated test organisms, reference substances, and performance thresholds may mean some products need retesting or simply a review of current evidence to ensure claims remain accurate and compliant.

Our microbiology team is already helping manufacturers interpret the new requirements and assess the impact on their product portfolios. If you’d like support reviewing your claims or understanding the impact of EN 14476:2025 on your products, please contact us.

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