In particular it’s essential to understand the difference between Cosmetic and Therapeutic products before you start manufacturing.
The guidelines relating to each of these common categories have been created to help regulate the safety grades of products and, ultimately, ensure the Australian population is kept healthy and safe at all times. Each category is subject to its own unique compliance and risk guidelines, so it’s important to know which is relevant to your product(s).
A ‘cosmetic’ product refers to a substance or product that is designed to be used on any external part of the body, or inside the mouth. The purpose of these products can vary greatly – from changing odour and appearance, to cleansing and protecting, to keeping one or more parts of the body in good condition.
Just some examples of cosmetics include:
There are many TGA regulations relating to the safe production and sale of cosmetics in Australia. Some of the strictest concern the way these products are labelled. As of 2020, the Consumer Goods (Cosmetic) Information Standard has set out mandatory labelling guidelines for all ingredients used in cosmetic products. These are intended to reduce the risk of consumers accidentally exposing themselves to ingredients that may cause an allergic reaction, reduce the risk of harm through improper use or accidental ingestion, and allow customers to more effectively choose and compare products.
‘Therapeutic’ goods are treated quite differently to cosmetics. They are classified by the TGA as health-related products, intended to be used in relation to promoting or preserving human health. Again, they can span a wide range of use. This includes preventing, curing, influencing, modifying and controlling diseases, injuries and other health-related conditions.
Generally speaking, therapeutic goods will fall into one of three categories:
It can be easy to confuse some therapeutic products with cosmetics, and vice versa. Typically, the differentiation comes down to the product’s primary nature or purpose. Take sunscreen, for example. Due to the primary nature of protecting the human body from UV radiation and prevention of skin cancer, sunscreen actually falls into a Therapeutic category. This means a product such as sunscreen must follow a strict set of regulations and compliances as set out by the TGA. Find out more about sunscreen compliance.
If you’re ever unsure, the Australian Government provides a free online tool to help businesses determine if their products are cosmetic or therapeutic. You can access it here:
Understanding the TGA rules, compliances and definitions that apply to therapeutic and cosmetic products can be confusing. But it’s critical to ensure your products are safe and legally able to be used in the Australian market. Contact us to discuss the regulations that apply to your product(s).
