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Are my Creations Cosmetics or Therapeutic Goods

Different rules are for cosmetic and therapeutic goods.  Ensure you know which category your product falls in to.

The Government have two branches of thought when it comes to body products.  This information is from their website

 

Cosmetics and therapeutic goods

Last update 30 November 2016

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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.

  • Face and nail

    • Products for nail care (including preparations that are applied to the nails to harden or to deter biting of the nails)

    • Products for make up

    • Products for colouring or varnishing nails

    • Tinted bases/foundation (liquids, pastes, powders) without SPF

    • Products for making-up and removing make-up from the face and eyes

    • Products without SPF that are intended for application to the lips

    • Face masks and scrubs

  • Hair care and hairdressing products

    • Hair tints and dyes and bleaches

    • Products for waving, straightening, and fixing hair

    • Hair setting products (e.g. gels, sprays, lotions)

    • Hair cleansing products such as lotions, powders, shampoos

    • Hair conditioning products (e.g. lotions, creams, oils)

    • Hairdressing products (e.g. lotions, lacquers, brilliantines)

  • Oral hygiene

    Products for care of the teeth and the mouth (other than desensitising toothpastes/gels) including dental bleaches/whiteners and denture cleansers and adhesives.

  • Perfumes

    • Perfumes

    • Toilet waters

    • Eau de colognes

  • Personal hygiene

    • Feminine hygiene products

    • Deodorants

    • 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.)

    • Depilatories

    • After-bath powders

    • Hygienic powders

  • Skin care

    • Moisturising products for dermal application eg creams, lotions, gels, foams (without SPF)

    • Sunbathing products (without SPF or SPF <4)

    • Emollients eg creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc)

    • Products for tanning without sun (without SPF)

    • Some skin-whitening products (without SPF)

    • Anti-wrinkle products (without SPF)

    • Anti-ageing products (without SPF)

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.

  • NICNAS requirements

    • 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 (AICS) or notified to NICNAS for pre-market assessment unless an exemption applies.

    • All ingredients not on the AICS and notified to NICNAS will be subject to public health, work health and safety (WHS), and environmental risk assessment.

    • All ingredients not on the AICS and introduced under an exemption from notification and some permit categories are subject to annual reporting and record keeping requirements.

    • The Cosmetics Standard 2007 describes additional requirements for anti-dandruff products, oral hygiene products, anti-acne products, anti-bacterial skin products, or skin and nail products containing sunscreen as a secondary function.

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