You are required to follow certain general procedures for making biocidal products available on the market.
Information for pharmacists
The Royal Decree of 18 March 2020 on the preparation and placement on the market of alcohol-based hand sanitisers for human hygiene to control the spread of COVID-19 is no longer applicable since 20 September 2020.
Therefore, hydroalcoholic solutions prepared by pharmacies for the general public and hospital pharmacies may no longer be made available on the Belgian market without prior authorisation from the FPS Public Health.
Excise duty on alcohol
If you want to produce hydroalcoholic gels, hand sanitisers or other alcohol-based disinfectants in Belgium, you must comply with the Belgian regulations on excise duties and, more specifically, the denaturing methods to be applied.
Only the methods listed below are acceptable for the denaturing of alcohol in biocidal products (of Product Type 1 or 2):
- Either 3 l ether per hl absolute alcohol
- Or 3 l isopropyl alcohol + 1 g denatonium benzoate per hl absolute alcohol
- Or 78 g tert-butanol + 1 g denatonium benzoate per hl absolute alcohol
- Or 2 l isopropyl alcohol + 2 l butanone per hl absolute alcohol
- Or the addition of euro-denaturant, which is equivalent to 1 l isopropyl alcohol + 1 l butanone + 1 g denatonium benzoate per hl absolute alcohol