Meeting requirements to manufacture, supply or advertise hand sanitisers

The COVID-19 pandemic has seen a marked increase in the production of hand sanitisers and the promotion of these products. Claims about hand sanitisers such as 'for use in clinics and hospitals', 'effective against viruses' or 'helps to reduce the transmission of COVID-19' are all therapeutic use claims. 

Products that make therapeutic use claims are therapeutic goods and are required to be included in the Australian Register of Therapeutic Goods (ARTG), unless subject to an exemption that excludes them from regulation.

Hand sanitisers may be excluded from regulation either because:

• they meet specified formulation, manufacturing, labelling and advertising requirements
• they are 'general consumer products' (cosmetics).

Hand sanitisers that are excluded from TGA regulation because they meet specified formulation, manufacturing, labelling and advertising requirements

In response to the COVID-19 pandemic, on 28 March 2020, the TGA excluded specified hand sanitisers from TGA regulation, provided they only contain particular ingredients in particular quantities in the final formulation and comply with certain manufacturing, advertising and labelling conditions.

Under the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 (the Exclusion Determination), hand sanitiser products that meet the requirements specified in the Exclusion Determination are not subject to therapeutic goods legislation and do not need to be included in the ARTG. However, these products will continue to be regulated as consumer goods under Australian Consumer Law.

For more information about Australian Consumer Law, you may wish to contact the Australian Competition and Consumer Commission (ACCC).

Manufacturing of these products is not considered compounding.

In response to feedback and concerns raised with the TGA by members of the public, businesses and industry representatives, the Exclusion Determination was amended to clarify ingredient, labelling and presentation requirements. The amended Exclusion Determination took effect on 6 May 2020.

Under transition arrangements, the Exclusion Determination continues to apply until 30 June 2020. Products that comply with the previous Exclusion Determination can continue to be manufactured and supplied until this time.

Provided the exact formulation and all other requirements are complied with, the following products are covered by the Exclusion Determination and permitted for use in both health care settings and for personal consumer use:

• ethanol hand sanitisers
• isopropyl alcohol hand sanitisers.

The specified formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration.

The requirements for ethanol and isopropyl alcohol hand sanitizers are outlined below.

Required formula

The final formulation of the hand sanitiser contains only the following ingredients:

• ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution, the ethanol may be denatured with a suitable denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v)
• purified water
• glycerol 1.45% v/v (pharmacopoeial or food standard grade)
• hydrogen peroxide 0.125% v/v (pharmacopoeial grade).

The final formulation must not contain any other active or inactive ingredients, including colours, fragrances or emollients.

The purified water is water derived from potable water that has been rendered sterile or purified by:

• boiling or distillation; or
• other purification process, such as reverse osmosis, that is validated to produce and distribute water that is of both acceptable chemical and microbiological quality (see below under Required manufacturing criteria).

The purified water must be used as quickly as possible following such processes.

The hydrogen peroxide used can be either hydrogen peroxide concentrate USP, hydrogen peroxide topical solution USP, hydrogen peroxide solution (30%) BP, hydrogen peroxide solution (6%) BP or hydrogen peroxide solution (3%) BP provided the concentration of hydrogen peroxide in the final formulation is 0.125%v/v.

Required manufacturing criteria

The hand sanitiser must meet the following manufacturing criteria:

• For purified water that is produced by purification processes other than boiling or distillation, regular microbiological testing of the water must be undertaken to ensure acceptable microbiological quality (microbial count that is less than 100 CFU per mL), including the sampling of water at the point of use, by one of the following methods:
  • filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating at 30-35°C for not less than 5 days as per the method described in the current monograph relating to purified water in the British Pharmacopoeia or European Pharmacopoeia; or
  • filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating separate plates at 35-37°C and 20-22°C, with the incubation periods extended to not less than 5 days as per the method described in AS/NZS Standard 4276.3.2:2003 Water microbiology - Method 3: Heterotrophic colony count methods - Method 3.2: Plate count of water containing biocides.
• The concentration of ethanol must be verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy
• The hand sanitiser must be manufactured under sanitary conditions using equipment that is well maintained and fit for purpose
• Records relating to the manufacture of the hand sanitiser must be kept by the manufacturer in relation to the required formula and manufacturing criteria.

Required front label

Ethanol hand sanitiser 80%

Hand rub [optional text: suitable for use in medical and health services]

DO NOT DRINK

[Insert volume of the product in mLs]

[Insert name of the manufacturer or supplier]

[Insert contact details of the manufacturer or supplier]

Required back label

Contains:

Ethanol 80% v/v, water, glycerol and hydrogen peroxide.

[insert name of denaturant used, if applicable]

Use:

Antiseptic hand rub when soap and water are not available.

Directions for use:

Apply sufficient amount of product on hands to cover all surfaces. Rub hands together until dry.

Warnings:

For external use only. Flammable. Keep away from heat or flame.

Keep out of eyes, ears and mouth.

Discontinue use if skin irritation or rash occurs.

Keep out of reach of children.

Poisons Information - 13 11 26

Store below 30 °C.

Date of manufacture: dd mm yyyy

Required formula

The final formulation of the hand sanitiser contains only the following ingredients:

• isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution
• purified water
• glycerol 1.45% v/v (pharmacopoeial grade)
• hydrogen peroxide 0.125% v/v (pharmacopoeial grade).

The final formulation must not contain any other active or inactive ingredients, including colours, fragrances or emollients.

The purified water is water derived from potable water that has been rendered sterile or purified by:

• boiling or distillation; or
• other purification process, such as reverse osmosis, that is validated to produce and distribute water that is of both acceptable chemical and microbiological quality (see below under Required manufacturing criteria).).

The purified water must be used as quickly as possible following such processes.

Required manufacturing criteria

The hand sanitiser must meet the following manufacturing criteria:

• For purified water that is produced by purification processes other than boiling or distillation, regular microbiological testing of the water must be undertaken to ensure acceptable microbiological quality (microbial count that is less than 100 CFU per mL), including the sampling of water at the point of use, by one of the following methods:
  • filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating at 30-35°C for not less than 5 days as per the method described in the current monograph relating to purified water in the British Pharmacopoeia or European Pharmacopoeia; or
  • filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating separate plates at 35-37°C and 20-22°C, with the incubation periods extended to not less than 5 days as per the method described in AS/NZS Standard 4276.3.2:2003 Water microbiology - Method 3: Heterotrophic colony count methods - Method 3.2: Plate count of water containing biocides.
• The concentration of isopropyl alcohol must be verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy.
• The hand sanitiser must be manufactured under sanitary conditions using equipment that is well maintained and fit for purpose.
• Records relating to the manufacture of the hand sanitiser must be kept by the manufacturer in relation to each of the matters specified in the required formula and manufacturing criteria.

Required front label

Isopropyl alcohol hand sanitiser 75%

Hand rub [optional text: suitable for use in medical and health services]

DO NOT DRINK

[Insert volume of the product in mLs]

[Insert name of the manufacturer or supplier]

[Insert contact details of the manufacturer or supplier]

Required back label

Contains:

Isopropyl alcohol 75% v/v, water, glycerol and hydrogen peroxide.

Use:

Antiseptic hand rub when soap and water are not available.

Directions for use:

Apply sufficient amount of product on hands to cover all surfaces. Rub hands together until dry.

Warnings:

For external use only. Flammable. Keep away from heat or flame.

icon meaning flammable
Keep out of eyes, ears and mouth.

Discontinue use if skin irritation or rash occurs.

Keep out of reach of children.

Poisons Information - 13 11 26

Store below 30 °C.

Date of manufacture: dd mm yyyy

The front and back labels for both ethanol and isopropyl alcohol hand sanitisers can be combined into a single label, or co-located, and can be printed in colour.

The labels can also include the following:

• a business name or logo of the manufacturer or supplier, and/or a trade name for the product provided that neither suggest the product has been approved or recommended by a government or government authority
• a batch number and expiry date (no more than 3 years from the date of manufacture)
• a statement that the product is 'based on the handrub formulation of the WHO'
• any other caution, warning or other marking that relates to the safe use, transportation or storage of the goods.

Products should not be presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages. This is to address concerns raised with the TGA about children potentially mistaking hand sanitisers supplied in inappropriate containers as food or drink. Examples of inappropriate containers include foil sachets, pouches with a spout or containers with a pop-top lid.

Safe Work Australia also provides a summary of the work health and safety (WHS) requirements when manufacturing, importing, supplying, handling or storing hand sanitisers in response to COVID-19 (see Manufacture or supply of alcohol-based hand sanitisers).

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

• they 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 therapeutic claims about the product are limited to general low level activity against bacteria (for example, kills 99.9% of bacteria).

The Australian Industrial Chemicals Introduction Scheme regulates the ingredients in cosmetics - you can read their information on hand sanitisers. The Australian Competition and Consumer Commission (ACCC) regulates labelling of cosmetics.

However, if these products make any therapeutic claims beyond being active against bacteria, they are not excluded from regulation by the TGA. The Therapeutic Goods (Excluded Goods) Determination 2018 (the Excluded Goods Order) sets out the circumstances in which antibacterial skin care products will be regulated as therapeutic goods. These include therapeutic claims made about the products in relation to:

• being active against viruses, fungi or other microbial organisms (other than bacteria)
• for use in connection with disease, disorders or medical conditions
• being for use in a health care setting (this includes aged care facilities).

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

• products that are claimed to kill specific organisms (e.g. E. coli or viruses)
• 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.

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 more critical than in domestic use.

They must also be included in the 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.

For further information about hand sanitisers that are regulated as therapeutic goods, contact nonprescriptionmedicines@health.gov.au or telephone 1800 020 653.

Your obligations as an advertiser

If you are unsure about your obligations under therapeutic goods legislation, seek guidance from the TGA website, consult with your industry body or representative on the Therapeutic Goods Advertising Consultative Committee, seek advice from a regulatory affairs consultant or obtain independent legal advice.

Remember that the label or packaging of a product is a form of advertising.

Advertisements about certain hand sanitisers are excluded from regulation by the TGA

As outlined above, the Exclusion Determination means that if the hand sanitiser product you want to advertise meets the requirements specified in the Exclusion Determination, the product is not subject to therapeutic goods legislation.

The Exclusion Determination covers:

• ethanol hand sanitisers
• isopropyl alcohol hand sanitisers.

However, the product must still meet the advertising requirements of the Exclusion Determination.

Legal advertising of hand sanitisers covered by the Exclusion Determination

If your advertisement relates to a hand sanitiser that is covered by the Exclusion Determination, any promotional material about that hand sanitiser must be limited to:

• information required on the label including the permitted claims
• the business logo or name, and/or trade name
• a statement that the product is 'based on the handrub formulation of the WHO'
• the wording: 'suitable for use in medical and health services'.

Advertisements may also include details about where the product may be purchased and price information.

Illegal advertising about hand sanitisers

Advertising hand sanitisers for coronavirus claims is illegal

An advertisement for a hand sanitiser of any kind (therapeutic good, cosmetic or a hand sanitiser under the Exclusion Determination) cannot:

• make a virucidal claim about the product (e.g. 'kills the coronavirus')
• expressly or by implication promote the product as preventing or treating 'COVID-19'.

For a product that would otherwise be captured by the Exclusion Determination or Excluded Goods Order, the use of these types of claims will void the exclusion of the product and it will be subject to the therapeutic goods requirements, including the need for it to be included in the ARTG.

For products regulated as therapeutic goods, these sorts of claims are unauthorised prohibited or restricted representations. The advertising of therapeutic goods must also comply with all other applicable requirements in the Act and the Therapeutic Goods Advertising Code.

Not all hand sanitisers can be promoted for healthcare use or specific organism claims

The only types of hand sanitisers that can be legally promoted as being suitable for use in medical or health services (such as clinics and hospitals) are those hand sanitisers that are:

• included in the ARTG
• captured by the Exclusion Determination.

For a hand sanitiser to be advertised as being able to kill a specific organism (e.g. E.coli) or as being virucidal, it must be included in the ARTG. In addition, the TGA must have approved the use of this type of claim in relation to the hand sanitiser being advertised.