AICIS vs TGA: What Every Cosmetic Founder Needs to Know

Most founders launching a beauty brand in Australia have heard of both AICIS and TGA at some point. Few can confidently explain the difference. Even fewer realise that getting this wrong can stall a product launch by months, or force a rebrand after manufacturing has already started. So let’s untangle it.

AICIS regulates the chemicals in your product. TGA regulates the claims you make.

That’s the cleanest way to think about it. AICIS, the Australian Industrial Chemicals Introduction Scheme, replaced NICNAS back in 2020. It governs every industrial chemical introduced into Australia, including the ones in cosmetics. If you import or manufacture cosmetic products here, your formulation has to meet AICIS requirements. There’s no way around it. The TGA, Therapeutic Goods Administration, only steps in when your product crosses the line from cosmetic to therapeutic. Primary sunscreens at SPF 4 and above (or secondary sunscreens like SPF moisturisers above SPF 15), products treating medical conditions, anything making serious medical claims. Most boutique skincare brands never need to talk to the TGA at all. The ones who do, usually find out the hard way.

What AICIS actually requires

For a typical cosmetic launch, AICIS compliance comes down to a few practical things. Every ingredient in your formula needs to be either on the Australian Inventory of Industrial Chemicals or covered by an exemption. If you’re using a unique imported ingredient that’s never been used here, that’s a genuine compliance step, not impossible, but it adds time and cost. You also need to keep records. AICIS expects manufacturers and importers to maintain documentation showing what chemicals are being introduced, in what volumes, and how they’re being categorised under the scheme’s tiered system. Most products fall under the “Listed” or “Reported” categories, which require less paperwork than the “Assessed” category reserved for higher-risk chemicals. The good news: this is all behind-the-scenes work. Your manufacturer should be handling this, not you. If your manufacturer can’t explain their AICIS compliance approach when you ask, that’s a red flag.

Where TGA enters the picture

The TGA gets involved when your product does something therapeutic, or claims to. The big one for skincare brands is sunscreen. Any product with an SPF claim above the cosmetic threshold needs to be on the Australian Register of Therapeutic Goods. The two thresholds to know: primary sunscreens (where sun protection is the principal claim) require TGA listing at SPF 4 and above; secondary sunscreens (SPF incorporated into a moisturiser, foundation, or daily cream where the principal use is cosmetic) are exempt from TGA listing up to SPF 15. Most contract manufacturers in Australia won’t even quote on a high-SPF product because the regulatory burden is so much heavier, Epilab included. For higher-SPF projects, we facilitate manufacturing through our network of TGA-licensed partner facilities and project-manage the regulatory pathway alongside the partner so brand owners deal with one point of contact. Acne treatments. Anti-fungal products. Anything claiming to treat eczema, dermatitis, or psoriasis. Products that claim to grow hair. All of these slide into TGA territory. The grey area trips up a lot of founders. “Reduces wrinkles” is usually cosmetic. “Treats wrinkles” can be read as therapeutic. “Brightens skin” is fine. “Treats hyperpigmentation” probably isn’t. Your label copy and your website claims need to be consistent with the regulatory category you’ve chosen.

The most common founder mistakes

A few patterns we see again and again. The first is making medical-sounding claims because they convert better in marketing copy. “Clinically proven to eliminate fine lines” sounds powerful. It also drags your product into TGA territory whether you intended to or not. The fix is to stay descriptive, not therapeutic, “visibly smooths” instead of “eliminates”, “appears to” instead of “treats”. The second is assuming overseas formulas are automatically AICIS-compliant. They’re not. A bestseller in the US, UK, or EU might contain an ingredient that’s restricted in Australia, or one that simply hasn’t been registered here yet. This is where founders sometimes lose months when they discover their dream formula has to be reworked. The third is the “I’ll deal with compliance later” approach. Compliance shapes formulation choices, packaging label design, retailer requirements, and export options. Trying to retrofit it after the fact is more expensive than building it in from the start.

What this means practically

If you’re at the concept stage, two things matter. Be honest with yourself about what your product actually does. If it’s a cosmetic, making the skin look or feel better without claiming to treat a medical condition, you’re in AICIS territory only, and your manufacturer handles most of the compliance work behind the scenes. If you genuinely want to make a therapeutic claim, factor in significantly more time, money, and documentation. Get your manufacturer involved in the compliance conversation early. A good contract manufacturer has worked through hundreds of these decisions and can flag issues before they cost you anything. They’ll tell you whether your dream ingredient list has any AICIS landmines, whether your marketing copy is pulling you toward TGA territory, and whether your packaging claims need rewording.

The boring summary

AICIS = the chemicals in your product. TGA = the claims about your product. Most cosmetic brands only deal with AICIS, and most AICIS work is handled by the manufacturer. The TGA enters the picture when claims become therapeutic, and once you’re in that conversation, your timeline and budget both change significantly. The founders who avoid trouble are the ones who decide which category their product belongs to before they finalise the formula, the packaging, or the brand voice. The ones who get caught are usually the ones who chose a marketing claim first and then tried to make the regulatory side fit around it.

Related reading

• Bespoke cosmetic formulation in Australia
• How much does it actually cost to launch a skincare brand in Australia?
• Transparent cosmetic manufacturing pricing in Australia

If you’re working through this for the first time and want to talk through which side of the line your product sits on, Epilab offers free consultations for early-stage founders before any formulation work begins.

Related: see our Melbourne cosmetic contract manufacturer overview.