In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) has issued a determination that hand sanitisers manufactured in accordance with specified formulations will be exempt from TGA regulation, as long as they contain particular ingredients, comply with advertising and meet labelling conditions.
The specified formulation contains very high percentages of either ethanol or isopropyl alcohol, both of which are dangerous goods:
- 80 per cent (by volume) ethyl alcohol (ethanol), or
- 75 per cent (by volume) isopropyl alcohol (isopropanol)
Both these types of alcohol are classified as flammable liquids, as they present a fire hazard. Because they are flammable, alcohol-based sanitisers and some of their ingredients have the potential to harm persons and property.
Hand sanitisers may also contain other ingredients that are dangerous goods.
Dangerous goods classifications – Ethanol solution and isopropanol
|Ethanol solution (95%)||Isopropanol (Isopropyl alcohol)|
New importers or manufacturers may not be aware of the risks associated with the highly flammable ingredients they are working with, or of the precautions they need to take for the safe storage and handling of materials prior to, during and after the manufacturing process.
Under the Occupational Health and Safety Act 2004:
- Manufacturers and suppliers of substances have duties to provide certain information.
- Employers must provide and maintain a working environment that is safe and without risks to health, so far as is reasonably practicable.
- Employers must provide necessary information, instruction and training to ensure employees can perform their work safely.
Under the Dangerous Goods Act 1985, an occupier or person in charge of premises where dangerous goods are manufactured or stored must take all reasonable precautions against any fire, explosion or leakages involving dangerous goods. This obligation also applies to persons who use, handle or transfer dangerous goods.
Other duties apply under the Occupational Health and Safety Regulations 2017 and the Dangerous Goods (Storage and Handling) Regulations 2012 in relation to controlling risks associated with using, manufacturing, storing and transporting these chemicals.
Recommended ways to control risks
Manufacturers and importers should undertake a dangerous goods risk assessment and put appropriate risk controls in place before storage and manufacturing commences.
The control measures listed below should be considered for reducing risks associated with flammable materials.
AS1940 The storage and handling of flammable and combustible liquids also provides guidance in relation to controlling risks of fire and explosion.
Note: If you are not currently equipped to manufacture, store or handle flammable liquids and oxidising chemicals, WorkSafe strongly recommends that you seek expert advice from a suitably qualified and experienced person (for example an industry consultant) before you start working with these chemicals.
Storing raw materials and finished products
- Storage areas need to be adequately separated from on-site and off-site protected places (eg dwellings, public buildings, offices, workshops, warehouses).
- Incompatible dangerous goods need to be kept apart so they do not react and cause an incident.
- Hazardous areas in and around the location need to be correctly classified beforehand, with explosion and fire risks controlled before commencing storage.
- Control of ignition sources – do not smoke near or bring mobile phones into a storage area for flammable liquid. Staff should wear garments made entirely from natural fibres (eg cotton) to reduce the risk of static ignition.
- Spill containment – storage areas need to be provided with spill containment to capture and contain spills. Any spills should be cleaned up as soon as possible, using appropriate equipment and materials for dangerous goods.
- Ventilation – flammable liquid storage areas need to be ventilated adequately.
- Electrical equipment in hazardous areas, such as lights, light switches, electrical wiring, forklifts and ventilation fans, need to be suitable for use in hazardous areas.
- Fire protection – adequate fire protection needs to be provided.
- Operational safety – staff working in flammable liquids storage or handling areas need to be trained to work in those areas safely. Ensure staff are provided with appropriate personal protective equipment (PPE), including training on how to safely use, maintain and clean or dispose of PPE.
- Placarding – storage areas must have placards if storing more than 250 litres of UN Class 3 packing group II dangerous goods, or more than 1000 litres of UN Class 3 packing group III dangerous goods.
- Labelling and packaging – hand sanitiser packaging and labelling must comply with the Australian Dangerous Goods Code (ADG Code) and the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) or Approved Criteria for Classifying Hazardous Substances, as required by relevant state legislation.
- Safety data sheets (SDS) – manufacturers, suppliers and importers have duties under OHS and dangerous goods legislation to provide certain information about products in SDSs and labelling.
- The manufacturing area needs to be adequately separated from on-site and off-site protected places. The storage and manufacturing areas should also be separated.
- Pumps and valves need to be suitable for handling flammable liquids.
- Control of ignition sources – do not smoke near or bring mobile phones (unless hazardous area rated) into the manufacturing areas. Staff should wear garments made entirely from natural fibres (eg cotton) to reduce the risk of static ignition.
- Spill containment – mixing and blending vats or vessels need to be provided with spill containment to capture and contain spills. Any spills should be cleaned up as soon as possible, using appropriate equipment and materials for dangerous goods.
- Ventilation – the manufacturing areas need to be adequately ventilated.
- Hazardous areas around the manufacturing facility must be correctly classified beforehand with explosion and fire risks controlled before commencing operations. More guidance is provided in AS/NZS 60079.10.1 Explosive atmospheres Classification of areas - Explosive gas atmospheres.
- Electrical equipment in hazardous areas, such as electrically operated pumps, switches, general power outlets and fans, need to be suitable for use in hazardous areas. This may also include the use of hazardous area rated forklifts for moving or removing raw materials and finished products to and from manufacturing areas.
- Additional safety controls may be required as a result of the risk assessment. For example, a large-scale production site with a risk of off-site impacts may require a flammable vapour detector interlocked with an automatic shutdown system for manufacturing plant.
- Ensure safe transfer of raw materials and finished products by confirming that correct hoses are used and that mixing vessels and associated equipment are suitably bonded and earthed to minimise electrostatic discharge hazards.
- Fire protection – adequate fire protection needs to be provided.
- Operational safety – staff working in the sanitiser mixing area must be consulted on matters related to their health or safety (such as risk controls) and trained adequately so that they can do their work safely. Ensure staff members are provided with appropriate PPE to handle the sanitiser mixes and raw materials.
- Placarding – manufacturing areas need to be adequately placarded.
- If a site is storing or handling more than 2500 litres of flammable liquids of packing group II, including raw materials (alcohols), finished product and mixing or process tanks, the occupier must notify WorkSafe Victoria, and have regard to written advice from emergency services in developing an emergency management plan.
- The occupier of any site where dangerous goods are stored and handled must ensure the site has a fire protection system. If a site is storing or handling more than 10,000 litres of flammable liquids of packing group II, the occupier must, in addition to notifying WorkSafe, have regard to written advice from emergency services in establishing any fire protection system.
For information on controlling the risks associated with dangerous goods email [email protected]
Code of practice: The storage and handling of dangerous goods
Compliance code: Hazardous substances
TGA - Hand sanitisers and COVID-19External link
SafeWork Australia - Manufacture or supply of alcohol-based hand sanitisersExternal link
ACCORD Australasia – Alcohol-based hand sanitiser manufacturing and transportExternal link
WHO - Recommended handrub formulationsExternal link
NTC - Road and rail transport checklist for alcohol-based hand sanitiserExternal link