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Toothpaste and oral hygiene products

Most toothpastes are classed as cosmetics, while many oral hygiene products are classed as therapeutic goods.

What are toothpaste and oral hygiene products?

Cosmetic toothpaste and oral hygiene products are used to care for the teeth and mouth. They include:

  • toothpastes, powders and gels
  • mouth washes
  • breath fresheners

Who regulates the ingredients in toothpaste and oral hygiene products?

In Australia, toothpaste and oral hygiene products are regulated as either therapeutic goods or cosmetics, depending on:

  • how the product is advertised or presented for supply
  • the claims made by the product
  • the product’s intended use
  • the product’s ingredients

The Therapeutic Goods Administration (TGA) is responsible for regulating toothpaste and oral hygiene products that are medicines or marketed as having therapeutic effects. Toothpaste and oral hygiene products are classed as ‘therapeutic’ goods if they:

For example:

  • mouthwash with a label that says it stops gum disease is a therapeutic good because it claims to prevent a disease
  • toothpaste with a label that says it cures gingivitis is a therapeutic good because it claims to cure a disease 

However, certain toothpaste and oral hygiene products — including dentifrices, mouth washes and breath fresheners — are excluded from TGA regulation under the Therapeutic Goods (Excluded Goods) Determination 2018 and are classed as cosmetics.

We are responsible for regulating the ingredients in these products as long as they meet the following criteria:

  • they don’t contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard
  • they’re advertised or presented for supply so that the only benefits claimed to result from the use of the product are consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay
  • benefits in relation to other diseases or ailments, such as gum or other oral disease or periodontal condition, are not claimed to result from using the product

What are my obligations as an importer or manufacturer of cosmetic toothpaste and oral hygiene products?

Registration

Product ingredients that meet the requirements for cosmetic toothpaste and oral hygiene products are regulated as industrial chemicals in Australia. Therefore, you must register your business with us before you import or manufacture (‘introduce’) these types of products for commercial purposes. You register your business with us, not your products or ingredients.

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

Learn more about registration and who must register.

Categorisation

Every industrial chemical in the cosmetic toothpaste and oral hygiene products that you want to introduce must be authorised under one of our 5 main categories:

  • Listed
  • 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 you’re introducing cosmetic toothpaste and oral hygiene products that contain 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 annual declaration obligations.

Learn more about exempted introduction declarations.

If you’re introducing cosmetic toothpaste and oral hygiene 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 annual declaration obligations. 

Learn more about pre-introduction reports.

If you’re introducing cosmetic toothpaste and oral hygiene products containing 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, beginning immediately after the end of the registration year, even after you’ve stopped introducing your chemical.

Learn more about your reporting and record-keeping obligations.

Annual declarations

Regardless of the introduction category, you must submit an annual declaration by 30 November after 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.

Learn more about annual declarations.

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?

Toothpaste and oral hygiene products usually 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 pathway.

If you use this pathway, you will need to nominate a chemical data provider who can provide 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 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.

Frequently asked questions 

Q. How do the new AICIS regulations affect toothpaste and oral hygiene products?

If your product meets the criteria for a cosmetic toothpaste or oral hygiene product, you must register your business with us before you introduce the product into Australia. Learn more about registration and who must register

After registering, you must check that each ingredient in the product you want to introduce is listed on the Inventory. If an ingredient is not listed on the Inventory, you must categorise it as an exempted, reported or assessed introduction.

Q. I would like to confirm the packaging and labelling requirements for toothpaste and oral hygiene products.

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 making toothpaste that I want to take to a commercial level. I would like to add essential oils to provide freshness and flavour. Are you able to provide a list of approved essential oils and any other information I should know in relation to going commercial with such a product?

A. We don’t provide lists of approved product ingredients. However, once you’re sure your toothpaste will be a cosmetic product – not a therapeutic good – start by searching our Inventory for every ingredient that you plan to include in the product. If the ingredients are listed on the Inventory, you must ensure you can comply with any listed obligations or restrictions. If an ingredient is not listed on the Inventory, you must categorise it as an exempted, reported or assessed introduction.

You should also check the Poisons Standard to ensure the ingredients you plan to include in your toothpaste do not exceed the stated amount for this use.

Q. Are toothpastes for sensitive teeth classed as cosmetics?

No, toothpastes for sensitive teeth are classed as therapeutic goods because they make therapeutic claims and do not meet the requirements of the Therapeutic Goods (Excluded Goods) Determination 2018.

Q. What are the limits on using sodium fluoride, hydrogen peroxide and cetylpyridinium chloride in cosmetic mouthwash products under AICIS?

It’s important to note that a mouthwash must meet the requirements of the Therapeutic Goods (Excluded Goods) Determination 2018 to be classed as a cosmetic product in Australia .

If the ingredients in the mouthwash do not meet these requirements, then they are regulated by the TGA.

You should also check the Poisons Standard to ensure the ingredients you’ve mentioned do not exceed the stated amount for this use.

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