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Register your business for the 2020-21 registration year

Anti-dandruff and anti-acne skin-care products

Anti-dandruff and anti-acne skin-care products are determined to be either therapeutic goods or cosmetics, based on their composition, their proposed claims and the way they’re marketed. 

What are cosmetic anti-dandruff and anti-acne skin-care products

Cosmetic anti-dandruff products are applied to the surface of the scalp. They control or prevent dandruff through cleansing, moisturising, exfoliating or drying the scalp. They include:

  • shampoos
  • conditioners

Cosmetic anti-acne products are applied to the surface of the skin and work through cleansing, moisturising, exfoliating or drying the skin. They include:

  • spot treatments
  • cleansers and gels
  • face scrubs
  • masks
  • creams

What are therapeutic anti-dandruff and anti-acne skin-care products

Anti-dandruff and anti-acne skin-care products are classed as ‘therapeutic goods’ if they:

Who regulates the ingredients in anti-dandruff and anti-acne skin-care products

The Therapeutic Goods Administration (TGA) is responsible for regulating anti-dandruff and anti-acne skin-care products that are therapeutic goods or marketed as having therapeutic effects. 

For example:

  • shampoo with a label that says it cures dandruff is considered a therapeutic good because it claims to cure a chronic disease
  • anti-acne cream with a label that says it stops or heals acne is considered a therapeutic good because it claims to heal a chronic skin condition

However, certain anti-dandruff and anti-acne skin-care products are excluded from TGA regulation under the Therapeutic Goods (Excluded Goods) Determination 2018. We are responsible for regulating the ingredients in these products because they’re classed as cosmetics.

These products include:

  • anti-dandruff hair-care products that are advertised or presented for supply as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp
  • anti-acne skin-care products —including spot treatments, cleansers, face scrubs and masks — that do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, and are advertised or presented for supply as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin

Still not sure? Our decision tool can help you determine whether the ingredients in your product are regulated as cosmetics or therapeutic goods.

What are my obligations if I want to import or manufacture cosmetic anti-dandruff and anti-acne skin-care products

Registration

If the ingredients in your products are regulated as cosmetics, you must register your business with us before you import or manufacture (‘introduce’) them for commercial purposes. You register your business with us, not your products.

Registration applies even if another business is already importing the same (or similar) chemicals. 

Note: If your product is formulated in Australia by blending (mixing) ingredients that you bought locally in Australia, you do not need to register with us for this purpose.

Learn more about registration and who must register.

Categorisation

Every industrial chemical in the cosmetic anti-dandruff and anti-acne skin-care products that you want to introduce must be authorised under 1 of our 5 main categories:

  • Listed (on our Inventory)
  • Exempted
  • Reported
  • Assessed
  • Commercial Evaluation Authorisation

Your obligations for each category will depend on the level of risk to human health and the environment from your introduction.

Reporting

If all the ingredients in your products are listed on our Inventory and your introduction of these chemicals is within the terms of that listing, you do not need to report any information about these chemicals to us. However, you still have registration and annual declaration obligations.

If you’re introducing cosmetic anti-dandruff and anti-acne skin-care products containing ingredients that are authorised under our exempted category (‘very low risk’ to human health and the environment), you must submit a once-off exempted introduction declaration after you import or manufacture them. This obligation is separate to your registration and annual declaration obligations.

Learn more about exempted introduction declarations.

If you’re introducing cosmetic anti-dandruff and anti-acne skin-care products containing ingredients that are authorised under our reported category (‘low risk’ to human health and the environment), you must submit a once-off pre-introduction report before you import or manufacture them. This obligation is separate to your registration and annual declaration obligations. 

Learn more about pre-introduction reports.

If you’re introducing cosmetic anti-dandruff and anti-acne skin-care products that contain ingredients that are not on the Inventory and are in the assessed category, you must apply for an assessment certificate before you can introduce the chemicals. 

Learn how to apply for an assessment certificate.

Record keeping

You must keep certain records about your chemical introductions to confirm they comply with our laws. You must keep these records for 5 years, even after you’ve stopped introducing your chemical.

Learn more about your reporting and record-keeping obligations. [LINK to page]

Annual declarations

Regardless of the introduction category, you must submit an annual declaration at the end of every registration year. This is a declaration you make about the industrial chemicals you imported or manufactured in the previous registration year and confirms that your introductions were authorised under our laws.

Other government standards 

If your introduction is for an end use in cosmetics or consumer goods, you must ensure that it complies with other government standards including those established by:

Does your product include a flavour or fragrance chemical?

Cosmetic anti-dandruff and anti-acne skin-care products may include flavour and fragrance chemicals. If the chemical identity of these ingredients is protected as a trade secret, you can choose to introduce them using the ‘reported introduction — low-risk flavour or fragrance blend’ pathway — without going through the process of working out the highest indicative risk. However, they must meet the requirements of this category.

If you use this pathway, you will need to nominate a chemical data provider who can provide us with information about the chemicals.

Learn more about categorisation of flavour and fragrance blends.

Use of animal test data

The ban on the use of new animal test data for ingredients solely used in cosmetics started on 1 July 2020. If the chemical ingredients you want to introduce have an end use in cosmetics (or multiple end uses that include a use in cosmetics), you must confirm that you have complied with the rules on using animal test data to categorise your introduction.

You do this when you either:

  • submit an exempted introduction declaration (if relevant)
  • submit a pre-introduction report (if relevant)

Learn more about the rules on using animal test data. [LINK to page]

Frequently asked questions 

Q. I wish to import new anti-acne products (active ingredient 0.5% salicylic acid and 1.0% salicylic acid) and intend to market them as cosmetic products in Australia. Can you provide some guidance around the claims that can be made for cosmetics? Apart from registering my business with you, what other regulatory requirements are there?

In Australia, you can only market anti-acne skin-care products as cosmetics if they do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, and are advertised or presented for supply as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin. For more information, see the Therapeutic Goods (Excluded Goods) Determination 2018.

Once you have confirmed your products are cosmetics, you need to:

  • register your business with us
  • check that every ingredient in the product is listed on our Inventory — making sure you can meet any terms of the listing for that chemical

If any ingredient is not listed on the Inventory, or it’s new to Australia, you will need to check it is authorised under our other introduction categories: 

  • Exempted
  • Reported
  • Assessed
  • Commercial Evaluation Authorisation

Your obligations for each category will depend on the level of risk to human health and the environment from your introduction.

For more information, see our guide to categorising your chemical importation or manufacture.

If your product is a cosmetic, it must also comply with the mandatory standard for cosmetic labelling, which includes the listing of ingredients, and any other relevant regulations.

Q. Selenium sulfide (SeS2) is listed on the Inventory, but is there any limit to how much can be used in an anti-dandruff shampoo?

The Poisons Standard regulates the use of chemicals in consumer products, including selenium sulfide. 

Your product must also comply with the Therapeutic Goods (Excluded Goods) Determination 2018 to be classed as a cosmetic. 

Learn more about the regulation of chemicals in Australia, including banned or restricted chemicals.

Q. I would like to find out the labelling requirements for imported anti-acne skin-care products that are not therapeutic goods.

Consumer and cosmetic products must comply with Australian laws for labelling and product safety. However, we don't set or enforce labelling requirements for consumer and cosmetics in Australia and we don’t provide specific advice about this. 

For more help on this topic, see labelling, SDS and packaging.

Q. I am developing a range of natural skin-care products. The product health claims will state that they’re moisturising, hydrating and barrier protective, and may eradicate skin issues such as eczema, acne and psoriasis. 

Do I submit my product testing results and labelling to you for your approval? Do you check safety levels of ingredients? 

You will need to check the Therapeutic Goods (Excluded Goods) Determination 2018 to make sure you are not advertising your products as therapeutic goods. However, the claims you are planning to make indicate that your products will have therapeutic effects and should be regulated by the TGA. For more help on this topic, see the Australian Regulatory Guidelines for Advertising Therapeutic Goods.

We don’t test or approve products, and we don’t provide specific advice about labelling. For more help on this topic, see labelling, SDS and packaging.

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