Hand sanitiser regulations – Europe
Biocidal hand sanitisers and handwashes placed on the market in the EU are regulated under the Biocidal Products Regulation 528/2012 (BPR). This regulation concerns the making available and use of biocidal products on the market.
The continuing COVID-19 pandemic has seen a global surge in demand for such products, requiring industry to respond by supplying new hand sanitiser products under significant time-pressures. Whether sourced from EU or other countries, the appropriate rules and regulations must still be followed to ensure the safety of the product.
For active substances already approved at EU level, specific derogations have been granted by some Member States allowing companies to place hand sanitisers on the national market without a BPR authorisation. For biocidal products containing an active substance not yet approved, the process to place the product on the market is specific to each Member State according to the transitional rules. This means that there are differing requirements between countries making it more challenging to place biocidal products on the EU market.
TSG can help
TSG's consultants are available to help navigate the regulatory landscape for biocidal hand sanitiser and handwash products, including:
- Applying for transitional national registrations/notifications across Europe
- Compiling BPR dossiers for product authorization and active substance approval
- Reviewing of existing labels or drafting of compliant labels
- Expedited service available for time-sensitive submissions
- Strategic advice to assist with identification of the best route to market
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG's team of scientists and regulatory experts manage all aspects of biocidal active substance approval, biocidal product authorisation and strategic planning.
Frequently asked questions
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.