Case study: regulation and effectiveness of anti-lice sprays
Le 7 January 2025
Case study: regulation and effectiveness of biocidal anti-lice sprays
Anti-lice sprays are biocidal products that can be classified as either PT18 (Insecticide) or PT19 (Repellent). Their mode of action and composition determine their regulatory classification.
Active substances
The most common active substances in these sprays are:
- Hydrated/cyclized eucalyptus citriodora essential oil (CAS No. 1245629-80-4)
- Geraniol (CAS No. 106-24-1)
These substances can be used individually or in combination.
Regulatory framework
Anti-lice sprays currently fall under a transitional framework if they contain the above-mentioned active substances. This means that the national laws of each country apply while awaiting an official evaluation of these substances by the EU.
Effectiveness
The assessment of effectiveness depends on the product type:
- PT19 (Repellent): The duration of protection must be specified and demonstrated.
- PT18 (Insecticide): The biocidal effect must be demonstrated through testing that specifies the minimum required action time.
Risk of reclassification
Anti-lice sprays can be reclassified as medical devices depending on their composition and mode of action. For example, a product that acts mechanically (by suffocating lice or preventing their attachment to hair) could be classified as a medical device.
Conclusion
Anti-lice sprays must be appropriately positioned in the market based on their regulatory classification. Their effectiveness, composition, and mode of action require close attention to avoid potential reclassification as medical devices. Furthermore, these products remain under a transitional framework due to their active substances, meaning their regulatory status could evolve depending on decisions made by the European Union.
Mastering biocide regulations
What is the current regulation for anti-lice sprays in Europe?
They fall under a transitional framework if they contain one or both of the active substances mentioned above. Each country applies its own regulations while awaiting European-level approval of these substances.
What is the difference between a PT18 and a PT19 anti-lice spray?
A PT18 (Insecticide) eliminates lice by killing them, whereas a PT19 (Repellent) prevents their attachment without lethal action.
Why can some anti-lice sprays be reclassified as medical devices?
If the product acts mechanically, for example by suffocating lice without using a biocidal active substance, it can be classified as a medical device instead of a biocide.