Cosmetics and therapeutic goods
On this page:
- What is a therapeutic good?
- What is a cosmetic?
- What laws apply to cosmetics in Australia?
- Information about skin whitening products
In Australia, chemicals are regulated according to their use.
NICNAS regulates the importation and manufacture of chemicals for 'industrial' use, which includes cosmetics and soaps. Chemicals for human therapeutic use, such as medicines, are regulated by the Therapeutic Goods Administration (TGA).
Some products are used in a similar way to cosmetics but are actually regulated as therapeutic goods. Primary sunscreens are a common example. Other examples are commercial, household-grade and hospital-grade disinfectants, which are currently regulated, to varying degrees, by the TGA.
Several factors influence whether a product is a cosmetic or therapeutic good, including:
- the primary use or purpose of the product
- the ingredients in the product and their effects on the body
- how the product is applied and/or administered and
- how the product is promoted, represented, presented or labelled.
To help you determine whether your product is a cosmetic or therapeutic good complete the questionnaire: Is my product a cosmetic?
What is a therapeutic good?
Therapeutic goods are products that prevent, diagnose or treat diseases, or that affect the structure or functions of the human body.
View the TGA's definition of therapeutic goods and therapeutic use.
If your product is for therapeutic use read the TGA's regulation basics for more information.
What is a cosmetic?
A cosmetic is a substance that is designed to be used on any external part of the human body—or inside the mouth—to change its odours, change its appearance, cleanse it, keep it in good condition, perfume it or protect it.
Examples of cosmetics
These examples are not exhaustive. Omission from the list does not necessarily mean that a product is not classified as a cosmetic. Click the arrows to see all the product types.Expand All
Face and nail
- Nail care products including nail hardeners and products to deter nail biting
- Make up (mascara, eyeshadow, primer, bronzer etc)
- Nail polish and varnish
- Tinted bases and foundation (liquids, pastes, powders) without SPF sunscreen
- Make up removers
- Lipstick and lip balms without SPF sunscreen
- Face masks and scrubs
Hair care and hairdressing products
- Hair tints, hair dyes and bleaches
- Products for waving, straightening, and fixing hair
- Hair setting products (e.g. gels, sprays, lotions)
- Shampoo and hair cleansing products including lotions and powders
- Hair conditioner (e.g. lotions, creams, oils)
- Hairdressing products (e.g. lotions, lacquers, brilliantines)
Oral and dental hygiene
Products for care of the teeth and mouth:
- Toothpaste and gel.
- Some dental bleaches/whiteners. Read the Australian Dental Industry Association advice on teeth whitening product regulation.
- Denture cleansers and adhesives.
Desensitising toothpastes/gels are NOT cosmetics. These are therapeutics and regulated by the Therapeutic Goods Administration.
- Perfumes and colognes
- Eau de toilette
- Eau de colognes
- Eau de parfum
- Feminine hygiene products — intimate cleaners, deodorants, wash, powder, moisturise and gels. We do not regulate pads, tampons and panty liners as these are articles.
- Cleansers such as soap (e.g. toilet, deodorant, astringent, skin washes)
- Shaving products (e.g. creams, foams, lotions)
- Bath and shower preparations (e.g. salts, foams, oils, gels, etc.)
- After-bath powders
- Hygienic powders
- Skin moisturisers without SPF sunscreen such as creams, lotions, gels, foams
- Sunbathing products without SPF sunscreen or with SPF sunscreen <4
- Emollients eg creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc)
- Products for tanning without sun (without SPF sunscreen)
- Some skin-whitening products (without SPF sunscreen)
- Anti-wrinkle products (without SPF sunscreen)
- Anti-ageing products (without SPF sunscreen)
Skin-whitening products — cosmetic or therapeutic good?
Products that produce a skin-whitening effect by colouring the skin may be regulated as cosmetics.
If the following applies to your product, the product is not a cosmetic and it may be regulated as a therapeutic good:
- The product influences, inhibits or modifies a physiological process to produce the skin-whitening effect. This sort of product does not meet the definition of a cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989.
- An example of a skin-whitening product that does not meet the definition of a cosmetic is one that contains hydroquinone (arbutin), which inhibits the physiological process of melanin production.
What laws apply to cosmetics in Australia?
Cosmetics are made from a range of ingredients, which are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act).
Commercial importers and/or manufacturers of cosmetics, including packaged products and chemicals used in the formulation of cosmetic products, must comply with the ICNA Act as well as other legislation.
If you are producing cosmetics by blending ingredients that are purchased from an Australian supplier, you do not need to register your business with NICNAS. Read more about blending and manufacturing chemicals.
- All importers of cosmetics or cosmetic ingredients and/or manufacturers of cosmetic ingredients must be registered with NICNAS.
- All ingredients in a cosmetic product must be listed on the Australian Inventory of Chemical Substances (the Inventory) or notified to NICNAS for pre-market assessment unless an exemption applies.
- All ingredients not on the Inventory and notified to NICNAS will be subject to public health, work health and safety (WHS), and environmental risk assessment.
- All ingredients not on the Inventory and introduced under an exemption from notification and some permit categories are subject to annual reporting and record keeping requirements.
- All cosmetic products must be labelled in accordance with the mandatory standard for labelling of cosmetic products.
- Product liability is governed by the Competition and Consumer Act 2010, which allows for legal action against the supplier of a defective product that results in injury or loss.
- The Therapeutic Goods Administration's Poisons Standard (SUSMP) pertains to the use of chemicals in consumer products.
- Safe Work Australia's Hazardous Substances Information System (HSIS) pertains to chemicals used in the workplace.
- Cosmetic products must be used, advertised and presented in a particular way to be considered cosmetics rather than therapeutics. For more information contact the Therapeutic Goods Administration.
- Other regulations that may apply to cosmetic products include related State/Territory legislation, Trade Measurement, trade practices regulation, transport of dangerous goods regulation, customs, quarantine and others.
Last update 26 February 2019