Hand sanitisers

Product definition

Hand sanitisers can be divided into two broad categories – those which offer some form of biocidal action and those which do not and are merely used to ‘clean’ the hands and perfume or moisturise them.

Products which offer or claim a biocidal action are those which have an intended function to sanitise and kill germs or viruses are considered a biocide. If it is intended just to clean, perfume or moisturise, but with a secondary action of killing germs then it will generally be considered to be a cosmetic. Products which are considered biocides are the subject of this factsheet.

Common risks of hand sanitisers

This is a list of examples of common risks. However, the manufacturer has to carry out an assessment of the hand sanitiser that covers all relevant risks that may be associated with the product and actions taken to mitigate these risks where possible. A general definition of risk and its relationship to hazards can be found in the factsheet on Risk management. 

Since these products are intended to perform a sanitisation function, the formulations used may present a number of different risks:

1. Chemical risks:

• Dangerous chemicals can cause short- and long- term adverse health effects if they exceed allowed limits.
• Certain formulation which can be harmful to the user when applied to the skin, for example those which contain methanol rather than ethanol. Methanol is toxic to the central nervous system when applied to the skin.

2. Flammability risks:

• Can be caused in the case of ethanol-based formulation. In many cases this particular hazard cannot be eliminated, and therefore correct precautionary labelling is necessary to draw the attention of users to the risk and ensure that they manage it for themselves.

3. Other risks

• The product formulation is not effective, leading to users to assume that their hands are adequately sanitised, when in fact they are not. This leads to behaviours which may increase the risk of infection by viruses or other microbes.

Examples of dangerous products

Specific examples of measures taken against dangerous hand sanitisers offered for sale in the European Union are available on the Safety Gate website. Type ‘hand sanitiser’ into the free text search box (but without the quotation marks). A better understanding of mistakes made in the safety assessment of hand sanitiser, or their manufacture can help avoid their repetition.

Main applicable legislation

The Biocidal Products Regulations (EU) 528/2012 lays down criteria for authorisation of biocidal products, along with their composition, labelling and other rules for placing them on the EU market. The regulatory requirements are relatively complex, but detailed guidance on the regulations is available from the European Chemicals Agency (ECHA) here.
Further guidance is available from the European Commission here.

The Cosmetics Products Regulation makes cosmetics products sold in the European Union (EU) safer by providing tight safety requirements for protecting human health; it simplifies procedures for companies and regulatory authorities in the sector and ensures that cosmetic products can freely circulate in the single market; it updates the rules to take account of the latest technical and scientific developments, including the possible use of nanomaterials; and it bans animal testing.

Borderline or ‘grey’ products

Sometimes it is difficult to determine whether a product is a biocide or a cosmetic, as some products can fulfil a dual function, and determining the applicable regulatory framework will depend on the form of words used to describe the product or indicate it’s intended use. Some products which appear to be biocides may in fact be regulated as cosmetics or medicinal products, and vice versa. The European Commission has therefore developed guidance for manufacturers and market surveillance authorities to assist with the correct classification of products. This can be found here.

Applicable standards

There are no harmonised standards as such for biocides, as formulations are subject to pre-market approval by the ECHA, and therefore there is no need for a presumption of conformity. There are performance standards for manufacturers to assess the efficacy of their products however, and also agreed formulations specifically for hand sanitisers, which were permitted during the Covid 19 pandemic.

Further guidance on the applicable process for authorised formulations are available here.

However, a standard which is quite often used by manufacturers is:

EN 14476:2013+A2:2019

This standard provides certification criteria for chemical disinfectants and antiseptics, which can be used to determine the efficacy of hand sanitisation products.

Other legislation of relevance:

While manufacturer’s need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) – restricts chemical substances in goods. REACH places responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database.
• CLP Regulation (Classification, labelling and packaging of substances and mixtures) – This Regulation requires manufacturers to classify, label and package their hazardous chemicals appropriately before placing them on the market. This is particularly important for hand sanitisers, which are usually highly flammable and require warnings and precautionary statements to ensure users are aware of the actions they need to take to manage the risk of fire.
• Please note that every product must be safe for the consumers, according to the General Product Safety Directive (GPSD) of the EU.

Mandatory labelling & warnings

Since biocidal hand sanitisers require authorisation before they can be placed on the EU market, much of the product specific labelling requirements will be determined during this process.

There are specific labelling requirements, based on formulation in respect of the Classification, Labelling and Packaging of Substances and Mixtures Regulation (CLP) and these will be determined by the classification for the specific authorised formulation.

The Biocides Regulations require that the product is not labelled in any way which could mislead the user (for example ‘harmless’ or ‘natural’), not be packaged so as to be attractive to children and also include the following additional information:

• The identity of every natural substance and its concentration is metric units
• The nanomaterials contained in the product, if any, and any specific related risks, and following each reference to nanomaterials, the word ‘nano’ in brackets
• The authorisation number allocated to the biocidal product by the competent authority or the Commission
• The name and address of the authorisation holder
• The type of formulation
• The uses for which the biocidal product is authorised
• Directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided under the terms of the authorisation
• Particulars of likely direct or indirect adverse side effects and any directions for first aid
• If accompanied by a leaflet Read attached instructions before use’ and, where applicable, warnings for vulnerable groups
• Directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging
• The formulation batch number or designation and the expiry date relevant to normal conditions of storage
• Where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport
• Where applicable, the categories of users to which the biocidal product is restricted
• Where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water
• For biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.

General safety requirements

To ensure safety of hand sanitisers, there is also a range of general requirements to be fulfilled. These are explained in the following factsheets and need to be read in conjunction with this factsheet:

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate/RAPEX
• Selling online
• Technical file
• Testing
• Using a third party