ANSES's recommendations to ensure the effectiveness of hand sanitisers
Alcohol-based gels and solutions used as hand sanitisers are disinfectants designed to remove bacteria or viruses from healthy skin. They are biocidal products, and as such are subject to the European Regulation on these products. ANSES is responsible for assessing and issuing marketing authorisations for these types of products. Following their massive use in response to the COVID-19 pandemic, the Agency issued an opinion on the effectiveness criteria for hand sanitisers. What properties make them effective against viruses or bacteria? Can they replace hand washing? How should they be stored?
Useful information to ensure the effectiveness of a hand sanitiser
Solution or gel?
Alcohol-based solutions and gels differ according to the composition of the products, in addition to the active substance. Gels contain thickeners, making them less fluid than solutions, which do not contain them. This difference has no impact on their effectiveness.
Biocide, cosmetic or medicinal product?
Some hand hygiene products do not mention "biocide" or "disinfectant" on the label. Products presented solely as "cleansers" do not guarantee the eradication of bacteria or viruses. They are covered by the regulations on cosmetics and not biocides, because they have no disinfectant effect. The alcohol-based gels and solutions used to disinfect healthy hands are biocidal products. They are distinct from disinfectants used on wounds, which are medicinal products.
Bactericide or virucide?
To be able to claim an effect against a category of micro-organisms such as viruses, bacteria or fungi, products have to pass standard tests on model strains. A bactericidal product is not intended to be effective against viruses. The effectiveness of virucidal products is governed by the European standard EN 14476. In an opinion published on 8 June 2020, ANSES considered that hand sanitisers containing at least 65% alcohol are effective against enveloped viruses, including coronaviruses. Any product labelled with the words "virucidal activity" in accordance with standard EN 14476, or alcohol-based solution recommended by the World Health Organization for hand antisepsis or alcohol-based gel for hand antisepsis - exemption order is in principle effective against coronavirus.
Which should you choose between hand washing with soap and water or use of hand sanitiser?
Soap has a cleansing role and removes all organic matter, living or dead, including bacteria and viruses. A hand sanitiser does not wash, it only disinfects. Disinfecting a dirty surface or hands is more difficult because dirt can "hide" bacteria and viruses. Whenever possible, it is therefore recommended that you wash your hands with soap and water rather than using a hand sanitiser solution or gel.
How should it be stored?
Once the bottle of hand sanitiser is opened, the alcohol contained in the product may evaporate, making it less effective. Certain precautions should therefore be taken:
- comply with the storage and use instructions given on the packaging;
- store the product away from heat and sunlight;
- use the product fairly quickly after opening;
- when transferring it from one container to another, do this in a place with a temperature below 20°C.
Ethanol, the main alcohol used in hand sanitisers, is not effective against all bacteria, so there is a risk of contamination. To avoid this:
- keep the product in a clean place and do not exceed the recommended expiry date;
- use the product fairly quickly after opening;
- if reusing a container, clean it before refilling, at least with soap and water, and limit the number of times it is reused.
ANSES assesses and authorises disinfection products intended for human hygiene
According to the European Biocides Regulation, alcohol-based gels and solutions are disinfectant products intended for human hygiene (product type 1). Active substances first have to be approved at European level, then the products containing them must be authorised in the countries where they are placed on the market. In France, this role of assessing active substances and biocidal products has been assigned to ANSES, which decides whether or not to issue marketing authorisations (MAs) for these products for the French market.
The hand sanitisers on the market contain mainly ethanol, isopropanol (propan-2-ol) or propan-1-ol.
Not all of these biocidal substances have been assessed and approved to date, which has an impact on the regulatory framework for the products. It means that alcohol-based gels and solutions are currently marketed according to two different regimes:
- ethanol is still currently being assessed for product type 1: the marketing and use of ethanol-based products are therefore regulated at national level (provisions of the transitional period).
- the other two substances have been approved for product type 1: the marketing and use of isopropanol and propan-1-ol products are therefore covered by the authorisation regime provided for in the European Biocides Regulation (regular regime).
The list of biocidal active substances and their status can be found on the ECHA website.