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Hand sanitisers and COVID-19

29 March 2020

While washing hands with soap is considered to be the most effective way to practice good hand hygiene during the COVID-19 pandemic, hand sanitisers can play an important role in keeping hands as free from harmful microorganisms as possible.

How hand sanitisers work

Hand sanitisers contain antiseptic ingredients. An antiseptic is a substance that is used on the skin to kill microorganisms or prevent the growth of microorganisms.

Hand sanitisers can be either hand washes for use with water or handrubs for use without water, and are regulated as either a cosmetic or therapeutic good (see below) depending on how they are used, what they contain and what they claim to do.

Appropriate use of hand sanitisers

You should always follow the directions for use located on the label of all hand sanitiser products. For those products regulated by the TGA, the directions for use have been approved based on test data. Homemade hand sanitisers for your own use are not regulated by us. The TGA is unable to endorse the use of homemade products since we cannot confirm their safety, quality and effectiveness.

The Department of Health recommends using soap and water wherever possible, but hand sanitiser where soap and water may not be available. Further tips on good hand hygiene during COVID-19 on the Department of Health website.

It is important to remember that handrubs that are used without water may not work well when hands are visibly dirty, Therefore, handrubs should be used only when hands are visibly clean or when soap and water is not available.

Hand sanitisers are regulated as either 'cosmetics' or 'therapeutic goods'

As a result of the high demand for hand sanitisers, there are now three classes of hand sanitisers – general consumer products ('cosmetics'), therapeutic goods and products with one of two specific formulations (excluded from TGA regulation for the duration of the COVID-19 pandemic).

General consumer products ('cosmetics') - not regulated by the TGA

Hand sanitisers, or antibacterial skin preparations, are considered to be 'general consumer products' (cosmetics) and are not regulated by the TGA if they:

  • are for personal or domestic use only and not for use in a health care setting (this includes aged care facilities), and
  • have claims that are limited to general low level activity against bacteria or germs (for example, kills 99.9% of germs), and
  • have no claims against viruses, and
  • that contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard).

The National Industrial Notification and Assessment Scheme (NICNAS) regulates the ingredients in cosmetics and the Australian Competition and Consumer Commission (ACCC) regulates labelling of cosmetics. Hand sanitisers regulated as cosmetics are only permitted to make low-level activity claims against bacteria or germs such as "kills 99.9% of germs".

The Therapeutic Goods (Excluded Goods) Determination 2018 sets out the circumstances when antibacterial skin preparations are not therapeutic goods.

Therapeutic goods (hand sanitisers regulated by the TGA)

Antibacterial hand hygiene products that require evaluation from the TGA and inclusion in the Australian Register of Therapeutic Goods (ARTG) are those that:

  • claim to kill specific organisms (e.g. E.coli or viruses), and/or
  • are to be used in clinics or hospitals.

These products are regulated as registered over-the-counter (OTC) medicines. The claims permitted on the labels of these products depends on the proposed use of the product and the data provided to support the safety and effectiveness. For example, typical claims include the following:

  • Antiseptic hand wash/rub
  • Hygienic hand wash/rub
  • Healthcare personnel antiseptic hand wash/rub

Specific formulations excluded from TGA regulation for the duration of the COVID-19 pandemic

On 28 March 2020, specified hand sanitiser formulations were excluded from TGA regulation, as long as they only contain particular ingredients in particular quantities in the final formulation, and comply with certain manufacturing practices, and advertisement and labelling conditions. Provided that the exact formulation and other requirements are followed, this formulation is permitted for use in both healthcare facilities and consumer use.

This exclusion will facilitate the urgent and continued supply of large volumes of hand sanitisers in Australia.

The formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration. The final formulation of the hand sanitiser must contain only the following ingredients:

  • EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
  • sterile distilled water or boiled cold water;
  • glycerol 1.45% v/v (pharmacopoeial grade);
  • hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
  • does not contain any other active or inactive ingredients, including colours, fragrances or emollients.

There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping. The legislation enabling production of these sanitisers is the Therapeutic Goods (Excluded Goods - Hand Sanitisers) Determination 2020.

The products will continue to be regulated as consumer goods under Australian Consumer Law. Manufacture of this product is not considered compounding.

Manufacturing and supplying therapeutic hand sanitisers

Hand sanitisers regulated by the TGA must be manufactured by TGA-licensed manufacturers in Australia in accordance with the principles of Good Manufacturing Practice (GMP), or be manufactured at an overseas site where the sponsor has been issued with a GMP clearance that confirms the site complies with these GMP principles. This is because they are used in higher risk situations (hospitals, aged care facilities) and/or make claims on killing specific organisms, and so their quality and performance is much more critical than for example in domestic use.

They must also be included in the Australian Register of Therapeutic Goods (ARTG) before being imported into, supplied in, or exported from Australia.

In order for a product to be included in the ARTG, a sponsor must submit an application to the TGA, together with relevant supporting data. The sponsor of a therapeutic good included in the ARTG must be an Australian resident and/or carrying on business in Australia.

For further information, contact otc.medicines@health.gov.au or telephone 1800 020 653.