It will depend on the active substance(s) in the biocidal product. If not all the actives are approved yet and at least one is still in the review programme under Product Type 1 (human hygiene), the hand sanitiser may be placed on the market under transitional measures. In some countries, the national regulations in place allow an almost ‘immediate’ placing on the market whereas others have recently published temporary derogations to place such products on the market. Fast track measures also apply in some countries to disinfectants under Product Type 2 (disinfectants and algaecides not intended for direct application to humans or animals) and Product Type 4 (food and feed). TSG’s regulatory specialists will be able to advise the most appropriate route for your company to take.

The European Chemicals Agency (ECHA) maintains a list of the approved active substances for biocidal products on its website here.

Depending on whether the biocidal product contains ethanol or propan-2-ol, different regulations apply in different countries. It is important to comply with the requirements and eventual derogations in place in the appropriate European country before placing your product on the market. TSG's specialists routinely assist companies in complying with the relevant regulations.

Products coming from outside the EU may not be compliant with the different European regulations in place. For example, the active substance may not be sourced from an approved supplier and the labelling may not be compliant with CLP. TSG's specialists will be able to advise on complying with the relevant regulations.

‘CE’ marking means that the product sold has been assessed to meet high safety, health, and environmental protection requirements. It does not mean the product is compliant with the BPR nor that it has been approved as safe.

A biocidal product is made available on the market when supplied for distribution or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge. In both cases, the hand sanitiser must comply with the regulations in place before it is placed on the market.