Manufacture of hand sanitisers
Hand sanitisers are biocidal products whose manufacturing supervision is primarily the responsibility of the Finnish Safety and Chemicals Agency (Tukes). This page contains information on matters within Valvira’s powers, which the hand sanitiser manufacturer must take into account on the basis of the Food Act and the Alcohol Act.
Manufacture of hand sanitisers for consumer use
The ethanol content of hand sanitisers sold for consumer use may not exceed 80 per cent by volume. The ethanol in the product must be slightly denatured. More information on ethanol denaturation can be found on the Spirit denaturation page. In addition to denatured ethanol, hand sanitisers must also contain other substances, and simply adding water is not enough. Typically, the products include glycerol and various gel-forming agents.
Manufacture of hand sanitisers for healthcare
Valvira may grant a licence to use hand sanitisers for professional use in public and private healthcare. Products whose composition differs from that of products intended for consumer use may be sold to holders of such licences.
Slightly denatured ethanol is commonly used in the manufacture of hand sanitisers. A hand sanitiser company does not need a permit to purchase and use slightly denatured ethanol. Slightly denatured ethanol can be purchased from several wholesalers in the industry. Import without a licence is also permitted.
A company must obtain a licence to use industrial alcohol from Valvira if it wants to purchase undenatured ethanol, denature it and manufacture hand sanitisers from it. If a manufacturer of alcoholic beverages or another Valvira’s licence holder wants to start denaturing on their premises, they must apply for a change in their licence. The self-monitoring plan for the denaturing of ethanol (spirits) must include a description of how the denaturing is carried out to make the product unfit for consumption, and information on the denaturants used and their quantities.
Slightly denatured spirits may be sold through wholesale only to companies for the purposes of manufacture and cleaning. The wholesale of slightly denatured ethanol must be reported to Valvira. More information on reporting can be found on the Sales of slightly denatured spirits page.
The premises used for the production of alcoholic beverages are food premises. The premises must be properly separated from other premises or operations which may endanger or impair the hygienic quality of the food handled in the food premises. The area and equipment used for the production of hand sanitisers must be kept either completely separate from the rest of the operations at the food premises or at least separated time wise from the production of alcoholic beverages. It is a good idea to discuss the matter with Valvira before starting manufacture.
For the manufacture of hand sanitisers, the manufacturer of alcoholic beverages must record the following in its self-monitoring plan
- the manufacturing process of hand sanitisers
- the equipment to be used and the area defined for it
- how the manufacture of hand sanitisers is carried out separately from the rest of the production.
After manufacture, cleaning must be carried out to ensure that the manufacture of hand sanitisers does not endanger food safety. To avoid confusion, the product should not be packaged in bottles similar to those in which alcoholic beverages are sold.