Case study: regulation and effectiveness of hydroalcoholic gels
Le 7 January 2025
Regulation of hydroalcoholic gels and biocidal effectiveness
Hydroalcoholic gels are biocidal products of type PT1, used for human hygiene. They play a key role in hand disinfection, particularly in medical environments or during epidemic periods. Their marketing and effectiveness are governed by strict regulations.
Active substance
Ethanol (CAS No. 64-17-5) is the most commonly used active substance in hydroalcoholic gels.
Regulatory framework
Hydroalcoholic gels containing ethanol as an active substance currently fall under a transitional framework. This means that national regulations in each country apply until ethanol is officially evaluated by the European Union under the Biocidal Products Regulation (BPR).
Effectiveness
Hydroalcoholic gels must demonstrate at least bactericidal and fungicidal efficacy and are often also virucidal.
These efficacies must be proven through standardized phase 2 tests, and the minimum required action time must be specified and validated.
Risk of reclassification
The biocidal status of hydroalcoholic gels is clearly established, and there is no regulatory ambiguity regarding their classification.
Conclusion
Hydroalcoholic gel is an essential product for human hygiene. However, it remains under a transitional framework due to ethanol as an active substance, meaning its regulatory status could evolve based on decisions made by the European Union.
Mastering biocide regulations
Why are hydroalcoholic gels considered PT1 biocides?
Hydroalcoholic gels are classified as PT1 because they are intended for human hygiene and contain biocidal active substances like ethanol to eliminate microorganisms.
What is the regulatory framework for hydroalcoholic gels in Europe?
They fall under a transitional framework due to ethanol as an active substance, meaning national regulations apply until the active substance (ethanol) is approved under the Biocidal Products Regulation (BPR).
What tests must be conducted to prove the effectiveness of a hydroalcoholic gel?
It must demonstrate bactericidal, fungicidal, and often virucidal efficacy through standardized phase 2 tests, which assess its performance under real-world conditions.