Fast entry to the European market with a regulatory-compliant hand disinfectant
With the novel coronavirus (COVID-19) outbreak officially a pandemic, worldwide demand for handwashes, hand sanitizers and hydro-alcoholic gels continues to outstrip supply. Frequent hand washing and/or the use of a hand sanitizer is the most recommended method for preventing COVID-19 from spreading.
To help minimize spread, and meet the increased demand, can industry enter the European market quickly with a compliant disinfectant product? The answer is yes, there are several routes a company can take.
Compliance under transitional measures
During the transitional period, the making available on the market of biocidal products is regulated by the national regulations in force, pending EU approval of all the active substances they contain. There are still 16 active substances under review for Product Type 1 (PT1 human hygiene) including quaternary ammonium compounds, alcohols and chlorine. Combining one or more of the 11 already-approved active substances with a substance under review, allows companies to enter the market under transitional measures.
Countries with simplified procedures
Placing a hand sanitizer on the market under the transitional period can be fast in European countries where no in-depth evaluation of the application is required (about ten countries) or where the process takes less than a couple of weeks.
A number of countries in Europe have published temporary legislation to allow alcohol-based disinfecting products to be placed on the market under specific rules.
Changing the status of a cosmetic handwash into a biocide
Companies manufacturing ‘cosmetic’ hand gels, which provide a secondary antimicrobial effect on top of cleaning and/or moisturising hands, might be able to adapt the composition and/or label to allow primary claims for ‘disinfectant’, ‘antibacterial’ or ‘sanitizer’, enabling the product to be marketed as a biocide.
Whatever option a company selects, certain requirements must still be met to ensure regulatory compliance of hand sanitization products; these include Article 95 listing of the active substance supplier, CLP and biocidal product labelling, and transitional registration/notification.
How TSG can help
TSG Consulting can help identify the best route to market for your company. In addition to strategic guidance, we can assist with national transitional registrations, as well as review the labels of your hand sanitizers, enabling fast entry on to the European market.