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Australia cosmetics regulation: AICIS, the ACCC, the TGA, and New Zealand

Three regulators share skincare in Australia. Here is who does what, how AICIS registration and ingredient categorization work, when a product becomes a TGA therapeutic good, and how New Zealand differs, as of October 2026.

Not legal adviceThis guide explains Australian and New Zealand rules and regulator guidance as we read them in October 2026. It is not legal advice. Check your product with AICIS, the TGA, the NZ EPA or a local regulatory consultant before you sell.
Short answer

Australia has no product notification for cosmetics. Instead the business that imports cosmetics must register with AICIS (the Australian Industrial Chemicals Introduction Scheme) before the first import, whatever the value, categorize every ingredient (most are listed on the Australian Inventory of Industrial Chemicals), file an annual declaration by 30 November and keep records for 5 years. Labels must follow the Consumer Goods (Cosmetics) Information Standard 2020 enforced by the ACCC. A product with therapeutic claims, a primary sunscreen, or a secondary sunscreen outside the conditions of the Therapeutic Goods (Excluded Goods) Determination 2018 is a TGA therapeutic good that must be in the ARTG before sale. New Zealand regulates cosmetics through the EPA's Cosmetic Products Group Standard, updated from 1 January 2026, again with no pre-market filing.

Three regulators, three questions

RegulatorLawWhat it asks
AICIS, in the Department of HealthIndustrial Chemicals Act 2019 (in force since 1 July 2020)Is the importer registered, and is every chemical in the cosmetic authorized to be introduced?
ACCC (Australian Competition and Consumer Commission)Australian Consumer Law; Consumer Goods (Cosmetics) Information Standard 2020Is the ingredient label right, are the claims true, and is the product safe?
TGA (Therapeutic Goods Administration)Therapeutic Goods Act 1989; Therapeutic Goods (Excluded Goods) Determination 2018Is this really a cosmetic, or a therapeutic good that must be in the ARTG?

Two more rule sets touch skincare: the Poisons Standard, which can restrict or schedule substances, and import rules at the Australian Border Force (duty, GST, and the origin marking "Made in Korea"). Our guide to starting a skincare brand in Australia covers the business setup, duty and costs; this page goes deeper into the regulation.

Who is legally responsible

  • The introducer. Under the Industrial Chemicals Act, a business that imports cosmetics for commercial purposes introduces the chemicals in them. It must be registered with AICIS and must authorize each introduction. A Korean manufacturer cannot register for you; the Australian importer does.
  • The supplier. Under the Australian Consumer Law, the business that supplies the cosmetic in Australia is responsible for the information standard, truthful claims and consumer guarantees, and for mandatory injury reports and recall notices to the ACCC.
  • The sponsor. If the product is a therapeutic good, such as a primary sunscreen, an Australian sponsor holds its ARTG entry and carries the TGA obligations.

Step by step: from formula to legal sale

The example is a niacinamide serum and a gentle cleanser made in Korea, sold by a Sydney online brand.

  1. Keep the claims cosmetic

    Check every claim on the label, site and ads against the TGA's cosmetic or therapeutic guidance. "Helps your skin look even and smooth" is cosmetic; "reduces skin pigmentation" is therapeutic. Decide on any SPF now.

  2. Get the ingredient data from your manufacturer

    INCI names, CAS numbers and concentrations for every ingredient, including fragrance components where the supplier provides them.

  3. Register the business with AICIS

    Before the first import. Choose the registration level from the value of industrial chemicals you introduced in the previous financial year; a new importer usually starts at Level 1.

  4. Categorize each chemical

    Most cosmetic ingredients are on the Australian Inventory, the "listed" category. Anything else needs another category before import (see below).

  5. Label to the information standard

    Ingredient list on the container, in the required order, with English or INCI names, plus net quantity and "Made in Korea".

  6. Import

    Through the Australian Border Force with an import declaration, duty (free for qualifying Korean goods under KAFTA with the origin document) and 10% GST.

  7. Keep records and declare

    Keep the AICIS records for 5 years, renew the registration by 31 August and file the annual declaration by 30 November.

AICIS registration in depth

AICIS says businesses importing cosmetics to sell must register before importing, and that there is no value threshold: even finished, branded products bought overseas trigger registration. Key points:

  • Registration year: 1 September to 31 August. Registration is not pro rata, and you renew each year you introduce chemicals.
  • Level and charge: based on the total value of industrial chemicals introduced in the previous financial year. For 2026 to 2027, a Level 1 registrant (under A$50,000) pays A$85, as of October 2026. AICIS announced a one-off levy discount for 2026 to 2027, with levies returning to 2025 to 2026 levels from 2027 to 2028, so check the fee page each year.
  • What you register: the business, not each product. One registration covers all your cosmetics.
  • Value records: keep invoices, purchase orders and import declarations that prove the value used to choose your level.
Before importWhen an importer must be registered with AICIS
30 NovemberAnnual declaration deadline for every registrant
5 yearsHow long AICIS records must be kept

Categorizing every ingredient

Every industrial chemical you introduce must fit an authorization category. AICIS describes listed, exempted, reported and assessed introductions, plus commercial evaluation authorizations.

CategoryWhen it appliesWhat you do
ListedThe chemical is on the Australian Inventory of Industrial Chemicals and you meet any conditions on its entryKeep records; no report before import
ExemptedVery low risk introductions that meet the rules for this categoryKeep records and file a declaration after the registration year
ReportedLow risk introductions that meet the criteriaSubmit a pre-introduction report before import, then keep records
AssessedAnything that fits no other categoryApply for an assessment certificate before import (a costly, slow route)

How to check. Search the Inventory by CAS number, not by INCI name, because one INCI name can cover several chemical identities. Botanical extracts, new peptides and novel actives are the ingredients most likely to need more than a listed check, so ask your manufacturer for CAS numbers early.

Animal test data. For a chemical introduced only for use in cosmetics, AICIS bans the use of new animal test data (from tests on or after 1 July 2020) to categorize it, with limited exceptions. If a categorization would depend on such data, the chemical cannot be introduced for a cosmetic end use.

Declarations, reports and records

  • Annual declaration. Every registered introducer submits a declaration for each registration year in which it introduced chemicals, by 30 November after the year ends, through AICIS Business Services. This applies to importers of ready-made cosmetics too.
  • Exempted introduction declarations and pre-introduction reports are separate filings for those categories, with their own timing.
  • Records. AICIS asks introducers to keep records for 5 years, even after they stop introducing a chemical, and to provide them within 20 working days if AICIS asks.
ExampleA brand imports A$30,000 of serum and cleanser between March and June 2027. It registers at Level 1 before the first shipment, for the year ending 31 August 2027. Every ingredient is on the Inventory, so all introductions are listed. It keeps the INCI and CAS list, invoices and import declarations, renews by 31 August 2027 if it keeps importing, and files its declaration by 30 November 2027.

The cosmetics information standard

The Consumer Goods (Cosmetics) Information Standard 2020 is a mandatory standard under the Australian Consumer Law, enforced by the ACCC:

  • The ingredient list goes on the container, or on the product if there is no container; if size or shape makes that impossible, it must be displayed another way, prominently, near the product.
  • Names are English names or INCI names. Fragrances and flavors are disclosed without their full composition.
  • Order: descending by mass or volume, or ingredients at 1% or more in descending order, then the rest in any order, then color additives.
  • Percentages are not required (hand sanitizer alcohol content is the exception).
  • A supplier can ask the Minister for approval to show a trade secret ingredient as "other ingredients".

Free samples, testers and therapeutic goods are outside the standard. Imported goods also need the country of origin, and net quantity rules apply under trade measurement law. Full label details are in our label requirements by country; ask for a label proof check before printing.

Cosmetic or therapeutic good

The TGA looks at the claims, the ingredients and how the product is presented. Products for preventing, treating or curing a disease or condition, or for influencing a physiological process, are therapeutic goods. The Therapeutic Goods (Excluded Goods) Determination 2018 then carves some borderline products back out as cosmetics if they meet strict conditions. According to TGA and NHMRC guidance, examples include:

  • Anti-acne skin care that prevents acne only through cleansing, moisturizing, exfoliating or drying the skin.
  • Anti-dandruff hair care that controls dandruff only through cleansing, moisturizing, exfoliating or drying the scalp.
  • Moisturizers, tinted bases and lip products with SPF that meet the sunscreen conditions below.

A product that fails any condition of its entry is not excluded and must meet the full therapeutic goods rules, including ARTG entry before it is imported, supplied or advertised. Words like "treats acne", "heals eczema", "repairs damaged skin" or "reduces pigmentation" take a product out of the cosmetic route. See our cosmetic vs drug claims guide.

Sunscreens: therapeutic vs cosmetic

ProductStatusWhat applies
Primary sunscreen (main purpose is UV protection), SPF 4 or moreTherapeutic goodListed in the ARTG (AUST L number) by an Australian sponsor; permitted ingredients; manufacture under TGA-accepted GMP; testing and labeling to the AS/NZS 2604:2021 sunscreen standard
Moisturizer with SPF 4 to 15, pack of 300 mL or 300 g or less, not presented as water resistant, no skin cancer claimsExcluded: cosmeticCosmetic rules (AICIS, ACCC), and the sunscreen standard's testing and labeling
Moisturizer or after-sun product with an SPF above 15, or outside any condition aboveTherapeutic good (secondary sunscreen)ARTG listing like a primary sunscreen
Tinted base or foundation, or lip product, with SPF 4 or more meeting its conditionsExcluded: cosmeticCosmetic rules and the conditions in the Determination

Only sunscreens with SPF 30 or more can make high-level claims about reducing the risk of skin cancer, and cosmetic sunscreens cannot make such claims at all. In March 2026 the TGA consulted on further changes, including limits on high SPF claims by excluded (cosmetic) sunscreens; as of October 2026 treat it as a proposal and check the TGA before you plan an SPF product. Our sunscreen regulation guide compares markets.

Claims, injuries and recalls

  • Claims. The Australian Consumer Law bans misleading or deceptive conduct and false representations. You must be able to back every claim, such as "clinically proven" or "reduces fine lines in 4 weeks", with evidence.
  • Mandatory injury reports. A supplier who becomes aware that a consumer good caused, or may have caused, death, serious injury or illness must report it to the ACCC within 2 days.
  • Recalls. A supplier that voluntarily recalls consumer goods because they may cause injury must notify the responsible Minister through the ACCC within 2 days of starting the recall. The Minister can also order a compulsory recall.
  • Ingredient bans. The Poisons Standard and AICIS evaluations can restrict a chemical; AICIS can vary or cancel an introduction's authorization.

The incident and recall plan is in our recalls and adverse events guide.

New Zealand: the Cosmetic Products Group Standard

New Zealand regulates cosmetics as hazardous substances under the Hazardous Substances and New Organisms (HSNO) Act, through the Environmental Protection Authority's Cosmetic Products Group Standard 2020. There is no product registration or notification: the importer or manufacturer makes sure each product complies and keeps its records.

The EPA updated the group standard in January 2024, and the update came into effect on 1 January 2026. The main changes: the scope now covers any cosmetic that contains a hazardous ingredient, even if the finished product is not hazardous; the schedules of prohibited, restricted and allowed ingredients (Schedules 4 to 8) were updated, largely to align with Europe; PFAS are being phased out; nanomaterial record keeping changed; and IFRA Standards for fragrance ingredients are referenced.

DateWhat applies in New Zealand
1 January 2026Importers and manufacturers may only import or make products that meet the updated group standard
1 January 2027Retailers stop selling products that do not meet the new rules; no import or manufacture of cosmetics containing PFAS
30 June 2027Non-compliant products must be disposed of
1 July 2027No import or manufacture of cosmetics with more than 10% homosalate
1 January 2028No sale of cosmetics containing PFAS
1 July 2028No sale of cosmetics with more than 10% homosalate

Sunscreen is a cosmetic in New Zealand, and the Sunscreen (Product Safety Standard) Act 2022 makes the AS/NZS 2604 sunscreen standard mandatory for products it covers. A product that is a cosmetic in New Zealand can be a therapeutic good in Australia, so plan both labels separately. More on New Zealand and Australia on our market pages.

What the importer does and what we provide

TaskAustralian or NZ importerKoreanOEM
AICIS registration and annual declarationThe importer, before the first importNot possible for a foreign manufacturer; we prepare the data
Ingredient categorizationThe importer decides and keeps recordsFull INCI list after the NDA, with the ingredient details the importer needs; MSDS and specification
Label under the information standardSupplier approves; designer supplies artworkLabel proof check against the Australian standard or the NZ group standard
Therapeutic sunscreen in the ARTGAustralian sponsorNot included; sunscreen quoted case by case from 10,000 units
Safety and claims evidenceHolds itCOA and microbiology per batch, stability data; challenge test from USD 1,000 per formula; patch test from USD 1,000
CustomsImport declaration, GST, customs brokerCommercial invoice, packing list, Certificate of Origin for KAFTA
Common mistakes
  • Importing the first shipment before registering with AICIS. Registration must come first, at any value.
  • Checking the Inventory by INCI name only. Use CAS numbers.
  • Forgetting the annual declaration by 30 November, even when every ingredient was listed.
  • Printing a Korean moisturizer's "SPF 50+" claim on an Australian label. Above SPF 15 it is a therapeutic good.
  • Calling a brightening serum a "pigmentation treatment". That is a therapeutic claim.
  • Putting the ingredient list only on a website or leaflet when it fits on the container.
  • Assuming the same label works in New Zealand. The NZ group standard has its own label and ingredient rules.
Checklist
  • Every claim on the label, website and ads checked against the TGA guidance.
  • SPF decision made: none, excluded cosmetic SPF, or a therapeutic sunscreen with a sponsor.
  • INCI names, CAS numbers and concentrations received from the manufacturer.
  • AICIS registration done before the first import, at the right level.
  • Each chemical categorized; any reported introduction filed before import.
  • Ingredient list on the container in the required order, with English or INCI names.
  • "Made in Korea" and net quantity on the label; label proof approved.
  • Origin document for KAFTA requested with the shipment.
  • AICIS records kept for 5 years; renewal by 31 August; declaration by 30 November.
  • ACCC mandatory injury reporting and recall notification steps written down.
  • For New Zealand: product assigned to the Cosmetic Products Group Standard and checked against Schedules 4 to 8, PFAS and homosalate dates noted.

How KoreanOEM helps

We are a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea at an ISO 22716 (cosmetics GMP) facility. For Australia and New Zealand, registration stays with your local importer; we prepare everything about the product so the filings are quick.

  • Full INCI list after the NDA, with the ingredient details your importer needs to categorize each chemical.
  • COA and microbiology for every batch, MSDS, specification and stability data.
  • Formulas kept cosmetic at the brief stage, with Australian claim wording in mind.
  • A label proof check against the Australian information standard or the NZ group standard.
  • Certificate of Origin for the KAFTA duty rate, and a Certificate of Free Sale (USD 100 per certificate up to 10 products) if your importer or retailer asks for one.

For a sunscreen, tell us early: SPF 50+ PA++++ textures start at 10,000 units, and a therapeutic sunscreen needs an Australian sponsor. Fees are on our fees page.

Frequently asked questions

Do I need to register cosmetics with AICIS?
You register the business, not each product. AICIS says a business importing cosmetics to sell must register before importing, whatever the value, and must authorize each chemical in the products, usually as a listed introduction on the Australian Inventory.
How much does AICIS registration cost?
It depends on the value of industrial chemicals you introduced in the previous financial year. For 2026 to 2027, Level 1 (under A$50,000) costs A$85, as of October 2026; check the AICIS fees page each year.
Do I need TGA approval to sell skincare in Australia?
Not for cosmetics. A product needs to be in the ARTG only if it is a therapeutic good, such as a primary sunscreen, a secondary sunscreen outside the excluded goods conditions, or a product making therapeutic claims.
Can I sell a moisturizer with SPF as a cosmetic in Australia?
Yes, if it claims SPF 4 to 15, comes in a pack of 300 mL or 300 g or less, is not presented as water resistant and makes no skin cancer claims, under the Therapeutic Goods (Excluded Goods) Determination 2018. It must still meet the sunscreen standard's testing and labeling rules.
How must ingredients be listed on an Australian cosmetic label?
On the container, using English or INCI names, in descending order by mass or volume, or ingredients at 1% or more in descending order followed by the rest in any order and then colors, under the Consumer Goods (Cosmetics) Information Standard 2020.
What is the AICIS annual declaration?
A declaration every registered introducer submits through AICIS Business Services by 30 November after each registration year in which it introduced industrial chemicals, including importers of finished cosmetics.
Do cosmetics need registering in New Zealand?
No. There is no product registration; the importer or manufacturer must make sure each product meets the EPA's Cosmetic Products Group Standard 2020, updated from 1 January 2026, and keep records.
When are PFAS banned in New Zealand cosmetics?
Under the updated group standard, cosmetics containing PFAS may not be imported or made from 1 January 2027, may not be sold from 1 January 2028 and must be disposed of by 30 June 2028.

Sources

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.

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