Are my Creations Cosmetics or Therapeutic Goods

Large blue question mark with fireworks around it to depict "Are my Creations Cosmetics or Therapeutic Goods"

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

 Cosmetic and Therapeutic Goods

   Last update February 2021

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In Australia, chemicals are regulated according to their use.

AICIS (formerly 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.

Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:

  • the primary use of the product

  • the ingredients in the product

  • the claims made about the product

We regulate chemicals that are imported or manufactured for an 'industrial' use – including the ingredients in cosmetics.

The Therapeutic Goods Administration (TGA) regulates medicines and products that are marketed as having a ‘therapeutic’ effect – including most skin-whitening lotions, primary sunscreens, disinfectants, complementary medicines and blood products.


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?

A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or affect the structure or functions of the human body.

If your product is for therapeutic use, read the TGA's regulation basics for more information.

Examples of therapeutics

  • Primary sunscreens (products that are primarily used for protection from UV radiation) are regulated as therapeutics
  • Moisturisers that contain a sun-screening agent as a secondary component and have a stated therapeutic purpose ('helps protect skin from the damaging effects of UV radiation') are regulated as medicines
  • Skin-whitening lotions that inhibit the physiological process of melanin production are regulated as medicines. For example, products that contain the chemical hydroquinone
  • Tablets can have side effects or interact in unwanted ways with other prescriptions, and are regulated as medicines.

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.

A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth  to change its odour or appearance, cleanse it, keep it in good condition or protect it.

It’s important to note we don't set or enforce labelling requirements for cosmetics in Australia and don’t provide specific advice about this. For more help on this topic, see labelling, SDS and packaging.

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.

Face and nail

      • Lipstick and lip balms with SPF sunscreen that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018

      • Nail care products including nail hardeners and products to deter nail biting

      • Make-up such as mascara, eyeshadow, primer and bronzer

      • Nail polish and varnish

      • Tinted bases and foundation without SPF sunscreen, including liquids, pastes and powders

      • Make-up removers

      • Lipstick and lip balms without SPF sunscreen

      • Face masks and scrubs

Hair care and hairdressing products

      • Anti-dandruff hair care products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018

      • Hair tints, hair dyes and bleaches

      • Products for waving, straightening and fixing hair

      • Hair-setting products such as gels, sprays and lotions

      • Shampoo and hair-cleansing products, including lotions and powders

      • Hair conditioner

      • Hairdressing products such as lotions, lacquers and brilliantines

Oral and dental hygiene

      • Toothpaste and gel

      • Denture cleansers and adhesives

      • Some dental bleaches and whiteners

Desensitising toothpastes and gels are not cosmetics. They are therapeutics and are regulated by the TGA.

Perfumes

      • Perfumes and colognes

      • Eau de toilette

      • Eau de colognes

      • Eau de parfum

Personal hygiene

      • Feminine hygiene products such as intimate cleaners, deodorants, wash, powder, moisturisers and gels. We do not regulate pads, tampons and panty liners because they are classified as articles.

      • Deodorants

      • Cleansers, including soap, deodorant, astringent and skin washes

      • Shaving products, such as creams, foams and lotions

      • Bath and shower preparations, such as salts, foams, oils and gels

      • Depilatories

      • After-bath powders

      • Hygienic powders

Skin care

    • Secondary sunscreen products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018

    • Anti-acne skin care products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018

    • Skin moisturisers without SPF sunscreen such as creams, lotions, gels and foams

    • Sunbathing products without SPF sunscreen or with SPF sunscreen

    • Emollients such as creams, emulsions, lotions, gels and oils for the skin

    • 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)

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 AICIS (formerly NICNAS). Read more about blending and manufacturing chemicals.

  • AICIS requirements

    • all importers of cosmetics or cosmetic ingredients and/or manufacturers of cosmetic ingredients must be registered with AICIS.
    • all ingredients in a cosmetic product must be listed on the Australian inventory of chemical substances (AICS) or notified to AICIS for pre-market assessment unless an exemption applies.
    • all ingredients not on the aics and notified to AICIS 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

     Still not sure?

    Our decision tool can help you determine whether your product is a cosmetic or therapeutic good.

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12 comments

GPC Gateway – glad you like it. Your website looks like it will be helpful to those needing regulatory assistance also

Kerry Pearson

Informative article on the difference between cosmetic and therapeutic products! Understanding the legalities surrounding these categories is crucial for businesses in the beauty industry. The article provides clear explanations and practical insights, helping readers navigate the regulatory landscape effectively. Well-written and useful resource! #Cosmetics #TherapeuticProducts
Visit: https://www.gpcgateway.com/home

GPC gateway

Hi Kristy,
If you stay with the facts about your products you will be fine. Soap will clean, creams will moisturise but healing and therapeutic are not facts without testing that most cannot afford.

Kerry Pearson

Hello Kerry,

Hope you are well? I have read and spent quite a lot of time reading AISIC, ACCC, TGA websites and even spoke to these companies on the phone. Of course, they are limited in what they can help you with and don’t go beyond any information that is already on the perspective websites. I’m just still unclear if I can use the word "moisturizing etc. For now, I am trying to keep my costs at a minimum so I’m opting out of speaking to a lawyer or broker that deal in cosmetic industries.

I have read some of your above responses and I understand that I am able to use and make claims such as ‘moisturizing’ but not the words ‘healing’ or ‘therapy’ etc.? is this correct?

Thank you so much for your time.

Kristy

Kristy Vardouniotis

Hi Michelle, As long as these are the basic product they are not therapeutic. Do not make any claims that they will do more than moisturise, clean etc, as any healing claims need to be substantiated and need to be tested for their therapeutic qualities with the TGA

Kerry Pearson

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