Cosmetics Compliance in Australia: AICIS, the Therapeutic Goods Line and Ingredient Labelling
Australia regulates cosmetics through an unusual split. The ingredients are industrial chemicals under AICIS, the finished-product labelling sits under consumer law, and the moment a product makes a therapeutic claim it can fall to the TGA. Here is how the pieces fit for brands entering the market.
Australia regulates cosmetics in three separate pieces
Australia does not have a single cosmetics regulation the way the EU does. Instead, three separate regimes apply to different aspects of the same product: the chemicals in it, the label on it, and the claims made about it. Understanding this split is the whole game, because a brand can satisfy one regime and still be non-compliant under another.
In short: cosmetic ingredients are treated as industrial chemicals and fall under AICIS; finished-product ingredient labelling is a consumer-law obligation; and any therapeutic claim can pull a product into the Therapeutic Goods Administration's remit. We take each in turn.
The ingredients: AICIS
Most cosmetic ingredients are industrial chemicals in Australian law, and their import and manufacture are regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS) under the Industrial Chemicals Act 2019, which replaced the former NICNAS scheme in 2020.
Any business that imports or manufactures cosmetics for commercial supply in Australia must register with AICIS and ensure each chemical introduction is categorised by risk. Introductions fall into categories such as listed, exempted, reported, and assessed, and each carries its own records, reporting, or assessment obligations. The Australian Inventory of Industrial Chemicals lists chemicals already available for use, and whether an ingredient is on the Inventory affects how a new introduction is treated.
The important shift for brands arriving from the EU or US is that in Australia the ingredient obligation attaches to the act of introducing the chemical, not only to the finished cosmetic. Registration and correct categorisation come first.
The label: consumer-law ingredient labelling
Separately from AICIS, cosmetics supplied in Australia must carry an ingredient list on the label. This is a consumer product information obligation administered through Australian consumer law rather than through the chemicals scheme, and it exists so that consumers can see what a product contains.
Ingredients are listed using recognised naming conventions, in line with the INCI approach used internationally, generally in order of concentration with the usual conventions for lower-concentration ingredients. Brands should treat the Australian ingredient panel as its own deliverable, aligned with but not identical to the panels required in other markets.
The claims: the therapeutic goods line
The line that catches brands most often is the boundary with the Therapeutic Goods Administration. Under the Therapeutic Goods Act 1989, a product represented to have a therapeutic effect, or whose main use is therapeutic, is a therapeutic good and must generally be entered on the Australian Register of Therapeutic Goods before it can be supplied. That is a fundamentally heavier regime than cosmetics.
Claims are usually what decide it. Wording about treating, preventing, or curing a condition, or otherwise having a therapeutic effect, can move a product from cosmetic to therapeutic good. Certain product types sit on the boundary by their nature; sunscreens are the classic example, where products whose primary purpose is sun protection are regulated as therapeutic goods, while some secondary sun-protection cosmetics are treated differently. The safe practice is to decide the intended claims early and design the product and its marketing to sit clearly on one side of the line.
Ingredient scheduling and other controls
Some ingredients are subject to scheduling under the national Poisons Standard, which can restrict their use, their concentration, or the warnings required. Screening a formula against these controls, alongside the AICIS categorisation, is part of a proper pre-market review.
Because Australia's requirements are spread across chemicals law, consumer law, and therapeutic goods law, the failure mode is almost always a product that was assessed against one of the three and shipped without checking the other two.
A workable market-entry sequence
The reliable order for Australia is: register the business with AICIS and categorise each ingredient introduction; decide the product's claims and confirm it sits on the cosmetic side of the therapeutic goods line, or plan for the TGA if it does not; screen the formula against the Poisons Standard and any restricted-ingredient controls; and build a compliant Australian ingredient label. Run in that order, Australian entry is very manageable. Run out of order, and brands discover the AICIS or therapeutic-goods obligation only after they have committed to packaging and claims.
