Dental hygiene products and cosmetic toothpaste are used to maintain dental health. They include:
- toothpastes, powders and gels
- mouth washes
- breath fresheners
How Are Toothpaste Ingredients Regulated?
Toothpaste and oral hygiene products in Australia are either considered therapeutic goods or cosmetics, based on:
- Advertisement or presentation of the product
- The claims made about the product
- the product’s intended use
- the product’s ingredients
A toothpaste or oral hygiene product that is marketed as a medicine or has a therapeutic effect must go through the Therapeutic Goods Administration (TGA). A tooth paste or dental hygiene product is classified as a ‘therapeutic’ item if it:
- These goods do not comply with the Meaningful Use (Excluded Goods) Determination 2018
- The Poisons Standard prohibits the use of certain ingredients in cosmetics
- Phytotherapeutic claims
- The label of mouthwash claiming to prevent gingivitis makes it a therapeutic good
- The label of a tooth paste stating that it cures gingivitis qualifies it as a therapeutic good
The Therapeutic Goods (Excluded Goods) Determination 2018 exempts certain toothpastes and oral hygiene products from TGA regulation, and they are classified as cosmetics.
As long as these products meet the following criteria, we are responsible for regulating their ingredients:
- Poisons Standard Schedules 2, 3, 4 and 8 do not apply to them
- Advertisements or supply lists for the products imply only the benefits associated with improved oral health, including preventing tooth decay or preventing tooth decay through fluoride.
- Other health benefits, such as benefits related to gum disease or periodontal disease, are not claimed for the product.
What Are My Obligations As A Manufacturer Or Importer Of Cosmetic Toothpaste?
Cosmetic Toothpaste suppliers and oral hygiene products containing ingredients that meet the requirements for industrial chemicals are regulated as industrial chemicals in Australia. In other words, before you import or manufacture (or otherwise introduce) these products commercially, your business must be registered with our agency. Not your products, but your business needs to be registered with us.
Registrants are still required to register even if another company imports the same (or similar) chemicals.
Chemicals that you want to introduce in cosmetic toothpastes and oral hygiene products must be listed under one of our five categories:
- Commercial Evaluation Authorisation
Each category of obligations will depend on the extent to which your introduction will pose a health and environmental threat.
You must submit a once-off exempted introduction declaration after importing or manufacturing cosmetic toothpaste and oral hygiene products with ingredients that have been authorised under our exempted category (‘very low risk’ to human health and the environment). Your annual declaration obligations are distinct from this requirement.
Cosmetic toothpastes and oral hygiene products that have ingredients authorised under our reported category (‘low risk’) require a once-off pre-introduction report. Your annual declaration obligations are distinct from this requirement.