TGA vs AICIS

Two figures bowing forward — navigating Australian cosmetic regulations TGA and AICIS

Most founders come to us with a product vision already formed. They want to make a sunscreen, hair growth serum or sometimes a product that helps with acne or eczema. The idea is clear — the regulatory reality, less so. Often it all looks and sounds good on paper, but there's some restrictions and regulatory nuance you need to consider before launching to market. 

Ultimately it depends on what your product claims to do. That's where TGA, AICIS, and the ACCC come in — three different bodies, three different scopes, and a lot of confusion about which one actually applies to you.

Here's the plain english version, and hopefully some answers to what feels like confusing acronyms and 'legal stuff'. 

First, Let's Clear Up the Confusion

The confusion exists because three separate regulatory bodies touch cosmetics in Australia — and they each do very different things:

  • AICIS (Australian Industrial Chemicals Introduction Scheme) — regulates the ingredients (industrial chemicals) used in cosmetics
  • TGA (Therapeutic Goods Administration) — regulates therapeutic goods: medicines, medical devices, complementary medicine
  • ACCC / Product Safety — regulates labelling and consumer safety for cosmetic products

Three regulators. Three different scopes. And the government websites for each are written for compliance officers, not brand founders building their first product.

What makes it more challenging is that they use overlapping language. Words like "registration," "notification," "compliance," and "listed" mean different things depending on which body you're dealing with. Let's break each one down — what it actually does, and whether it applies to you.

What Is AICIS — and Does It Apply to You?

AICIS stands for the Australian Industrial Chemicals Introduction Scheme. It replaced the old system (NICNAS) in July 2020 and is administered by the Australian Government Department of Health.

In plain English: AICIS regulates the chemical ingredients used in cosmetics — not the finished product itself.

Australia maintains a database called the Australian Inventory of Industrial Chemicals (AIIC) — a list of chemicals already assessed and approved for use in Australia. Any cosmetic ingredient introduced into Australia needs to either be listed on the AIIC, or be introduced under a specific AICIS authorisation.

The vast majority of standard cosmetic ingredients are already on the AIIC. Cetearyl alcohols, glycerins, niacinamides, hyaluronic acids, essential oils, surfactants — almost certainly already listed. No additional action needed on your part.

The obligation falls on whoever introduces the chemical into Australia — typically the raw ingredient manufacturer or importer, not the brand founder. If you're working with an Australian formulator, this is already handled. The only time AICIS gets complicated is if you want to use a novel ingredient not yet on the AIIC — that triggers an introduction process that takes time and money. For the vast majority of cosmetic products, AICIS is already taken care of, and at least for us personally, that's why we always work with Australian raw ingredient suppliers and distributors. 

What Is the TGA — and When Does It Matter for Cosmetics?

This is where the biggest misconception lives. The question comes up constantly:

"I need to register my moisturiser with the TGA, right?"

No, not always. 

The TGA regulates therapeutic goods, think,medicines, medical devices, and some complementary medicines. If a product needs to be supplied as a therapeutic good in Australia, it must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) before it can be sold. That's a significant regulatory and financial burden.

The key fact: cosmetics are not regulated by the TGA, because most cosmetics don't claim to offer therapeutic or medical claims. The TGA only enters the picture if your product makes therapeutic claims — claims that it treats, prevents, diagnoses, or cures a disease, condition, or ailment. Cross that line and your product is no longer a cosmetic. It's a therapeutic good, and the full weight of TGA regulation applies.

For most cosmetic brand founders, the TGA is simply not relevant. Unless you make the wrong claim on your label.

The Not So Obvious Claims That Change Things

The difference between a cosmetic and a therapeutic good often comes down to a single word on your label or marketing material. The formulation can be identical. The ingredients can be identical. But the claim determines the regulatory category.

Cosmetic claims describe the product's effect on appearance, cleansing, or maintenance of the body in a normal, healthy state. Therapeutic claims describe the product's effect on a disease, condition, or bodily function beyond normal cosmetic use. Real examples across categories, because this is where founders get caught:

Skincare

✅ Cosmetic claim (fine)

❌ Therapeutic claim (triggers TGA)

Moisturises and hydrates skin

Treats eczema

Promotes a brighter complexion

Treats hyperpigmentation

Helps maintain healthy-looking skin

Repairs damaged skin cells

Reduces the appearance of fine lines

Anti-ageing treatment (context-dependent)

 

Haircare

✅ Cosmetic claim (fine)

❌ Therapeutic claim (triggers TGA)

Helps maintain healthy-looking hair

Promotes hair growth

Adds volume and shine

Prevents hair loss

Gently cleanses the scalp

Treats dandruff (can cross the line)

 
Body Care

✅ Cosmetic claim (fine)

❌ Therapeutic claim (triggers TGA)

Soothes and softens dry skin

Treats dermatitis

Refreshes and deodorises

Kills bacteria that cause body odour

Gently exfoliates

Treats acne


Once you understand the pattern, it becomes obvious, but basically the cosmetic claim describes how the product looks, feels, or maintains. The therapeutic claim describes how it treats, prevents, or cures.

The tricky part is that the line isn't always obvious. "Soothes dry skin" is cosmetic. "Relieves the symptoms of eczema" is therapeutic. The product inside the bottle could be exactly the same — it's the words on the outside that determine your regulatory obligation.

This is where most founders run into trouble, not because they're trying to make therapeutic claims, but because they genuinely want their product to do something meaningful, and the natural language for that drifts into therapeutic territory without them realising.

If your product does cross into therapeutic territory, that's not the end of the road, but it changes the business equation. TGA registration or listing adds real cost, because it carries real responsibility around safety and efficacy evidence, ARTG fees, ongoing compliance obligations. It inherently limits the number of manufacturers who can produce your product, and in some instances might extend your time to market. Some founders work through that process because the category is worth it but many others find that repositioning the claims, focusing on appearance and maintenance rather than treatment, achieves the product vision without the regulatory overhead. That's a business decision, and it's worth making consciously rather than discovering mid-production. It really comes down to what you're looking to create, assess whether you need to use ARTG listed chemicals, and where your brand is positioned in market. 

The practical advice: review your intended claims with your formulator before you write a single word of packaging copy. It's a far easier conversation at the start than a painful one after you've printed labels.

What About Labelling? (The ACCC Piece)

Separate from both TGA and AICIS, every cosmetic sold in Australia must meet mandatory labelling requirements under consumer product safety law — administered by the ACCC and Product Safety Australia.

Your label must include:

  • Full INCI ingredient list — in descending order of concentration (ingredients at 1% or below can be listed in any order after that threshold)
  • Product name
  • Net contents — weight or volume
  • Warnings — if applicable (e.g., for certain ingredients like hydroperoxides in hair dyes)
  • Name and address of the manufacturer or importer, or the Australian business responsible for the product

This applies to every cosmetic sold in Australia. No exceptions. Getting labelling right matters and it's often the first thing a retailer checks, and the area where the ACCC actually conducts compliance reviews in the cosmetics space.

If you're working with a formulator, they should provide the correct INCI list. The rest — product name, net contents, supplier details, warnings — sits with you as the brand owner. Get it right from the start.

Where Your Manufacturer Fits In

At Labwork, we formulate and manufacture cosmetic products — hair care, skin care, body care. That's our lane, and we stay in it. We do not formulate therapeutic goods. That's an important boundary, and we're upfront about it.

We hope that whoever you work with does this, but what we focus on is making sure the foundations are right before we start formulating. That means understanding what you can and can't claim about your product before we write a formulation brief. When a product concept comes through our door, we look at the intended positioning and claims before we write a brief. If something is drifting toward therapeutic territory, we raise it early — not to shut the idea down, but to help the founder understand the options and make the right call for their business. Sometimes that means repositioning the claims. Sometimes it means acknowledging that the product they want to build is a therapeutic good and pointing them toward the right pathway.

We work with ingredients already listed on the AIIC, sourced from compliant suppliers. We provide the correct INCI list. And we help you understand what your product can realistically claim, based on the ingredients, the formulation, and the regulatory reality in Australia.

Frequently Asked Questions

Do I need to register my cosmetic with the TGA?

No — not if it's a cosmetic. The TGA regulates therapeutic goods, not cosmetics. Your product only falls under TGA jurisdiction if it makes therapeutic claims (e.g., "treats acne," "prevents hair loss"). If your claims describe appearance, cleansing, or maintaining the body in a normal state, the TGA doesn't apply to you.

How do I know if my cosmetic ingredients are AICIS-compliant?

Ask your formulator or ingredient supplier. If you're working with an Australian formulator, they should be sourcing ingredients already listed on the Australian Inventory of Industrial Chemicals (AIIC). For most standard cosmetic ingredients, this is already the case. If you're importing a finished product, confirm with your overseas manufacturer that the ingredients comply with AICIS requirements for Australia.

What's the difference between a cosmetic claim and a therapeutic claim?

A cosmetic claim describes how a product affects appearance, cleansing, or body maintenance — "moisturises skin," "adds shine to hair," "gently exfoliates." A therapeutic claim describes treating, preventing, or curing a condition — "treats eczema," "promotes hair growth," "repairs damaged cells." Same product, different words, completely different regulatory category. When in doubt, keep it cosmetic.

What happens if I accidentally make a therapeutic claim on my cosmetic product?

Your product is legally classified as a therapeutic good — regardless of what's actually in the bottle. It needs to be listed or registered on the ARTG before it can be legally supplied. Supplying an unregistered therapeutic good carries significant penalties. In practice: pull the product, re-label, and potentially go through TGA registration. Prevention is far easier than correction.

Ready to Start Formulating?

If you've got a product concept and want to make sure you're building on solid ground — from formulation to claims to compliance — get in touch. We'll have an honest conversation about what's possible, what's practical, and what's the right next step for your brand.

This is general information, not legal or regulatory advice. For specific situations, consult a regulatory consultant or the relevant authority (TGA, AICIS, or ACCC).

 

2 comments

  • Ronell Hamid on

    Hi! I would like to make some skin care formulas and a brand. If someone can get in touch please

  • Rani Sharma on

    Good afternoon, I have read everything on LABWORK, I request from you if I can have a PDF of cosmetic wording I must or should put on my labels.
    Thank you for your kindness and I look forward to hearing from you soon.
    Kind regards Rani. 🌺

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