Cosmetic Ingredient Regulations in Australia

Cosmetic Ingredient Regulations in Australia: What Beauty Businesses Need to Know

Cosmetic ingredient regulation in Australia can be confusing.

Beauty businesses frequently hear that an ingredient is “approved,” “TGA approved,” “AICIS approved,” “banned in Australia” or “safe because it is natural.”

These descriptions can be misleading.

Australia does not have one simple list containing every cosmetic ingredient that is either permitted or prohibited.

Instead, cosmetic ingredients can be affected by several regulatory frameworks depending on the chemical, its concentration, how the product is used, the claims made about the product and whether the product is actually a cosmetic or a therapeutic good.

For beauty salons, cosmetic retailers, skincare brands and businesses importing or manufacturing products, understanding these distinctions is important.

Who Regulates Cosmetics in Australia?

There is no single regulator responsible for every aspect of cosmetics.

Different Australian regulatory systems can apply to different aspects of a cosmetic product.

Important authorities include:

  • Australian Industrial Chemicals Introduction Scheme (AICIS)
  • Therapeutic Goods Administration (TGA)
  • Australian Competition and Consumer Commission (ACCC)
  • state and territory authorities.

The applicable requirements depend on the product and what the business is doing with it.

What Is AICIS?

The Australian Industrial Chemicals Introduction Scheme (AICIS) regulates the importation and manufacture — referred to as the “introduction” — of industrial chemicals in Australia.

This includes almost all chemical ingredients used in:

  • skincare
  • makeup
  • haircare
  • personal-care products
  • perfumes and fragrances
  • nail products
  • soaps
  • many other cosmetics.

AICIS replaced the former National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020.

Businesses should therefore be cautious when relying on older information referring to NICNAS or the former Australian Inventory of Chemical Substances.

The current framework operates under AICIS and the Australian Inventory of Industrial Chemicals.

AICIS Does Not “Approve” Finished Cosmetics

This is an important distinction.

AICIS regulates the introduction of industrial chemicals.

It does not generally assess and approve every finished cosmetic product before that product can be sold.

Therefore, descriptions such as:

“AICIS-approved cosmetic”

can be misleading.

A business importing or manufacturing cosmetics needs to determine whether it has AICIS registration and chemical-introduction obligations and whether the individual chemical ingredients are lawfully introduced under the appropriate regulatory category.

What Is Legally Considered a Cosmetic?

Broadly, a cosmetic is a substance or preparation intended for contact with external parts of the human body — including certain uses in the oral cavity and on teeth — for purposes such as:

  • changing appearance
  • cleansing
  • perfuming
  • protecting
  • maintaining the body in good condition
  • altering body odour.

Common examples include:

  • moisturisers
  • cleansers
  • shampoos
  • conditioners
  • makeup
  • perfumes
  • deodorants
  • nail polish
  • some oral-care products.

However, a product that appears to be skincare or a cosmetic can instead become a therapeutic good depending on factors including its ingredients, claims, primary purpose and how it is used.

That distinction can fundamentally change its regulatory requirements.

Salon-Compliance-Documents-Australia-ABA

Cosmetics Versus Therapeutic Goods

One of the most important compliance issues for beauty businesses is determining whether a product is actually a cosmetic.

The TGA regulates therapeutic goods.

A product may fall within the therapeutic-goods framework where it is intended or represented as having a therapeutic effect.

For example, there is an important difference between saying a cosmetic:

“helps skin look smoother and more hydrated”

and making claims that a product:

“treats eczema”
“heals dermatitis”
“treats acne”
“repairs damaged tissue”
or otherwise treats or prevents a medical condition.

The product’s ingredients and how it is administered or used can also affect classification.

Beauty businesses should therefore consider product claims as carefully as product ingredients.

There Is No Single Australian “Banned Ingredients List”

Businesses sometimes search for a definitive list of ingredients banned from cosmetics in Australia.

Australia’s regulatory system does not work that way.

There is no single downloadable list containing every chemical that is prohibited or restricted in every Australian cosmetic product.

Restrictions can arise through several regulatory mechanisms.

An important starting point is the Poisons Standard, formally known as the Standard for the Uniform Scheduling of Medicines and Poisons.

The Poisons Standard can impose restrictions including:

  • concentration limits
  • conditions of use
  • labelling requirements
  • restrictions on supply
  • classification as a medicine or poison.

Businesses importing or manufacturing cosmetics may also need to check the Australian Inventory of Industrial Chemicals and applicable AICIS requirements.

The Australian Inventory of Industrial Chemicals

The Australian Inventory of Industrial Chemicals contains industrial chemicals available for introduction under specified conditions.

However, simply finding an ingredient on the Inventory does not mean:

“This ingredient is approved for unlimited cosmetic use.”

An Inventory listing can contain terms or restrictions that must be followed.

Businesses need to consider the complete listing and whether their proposed introduction meets its conditions.

If an ingredient is not on the Inventory, this does not automatically mean that it is banned.

Instead, the business may need to determine whether another AICIS introduction category applies.

AICIS Introduction Categories

Industrial chemical introductions can fall into different regulatory categories depending on circumstances and risk.

The main categories include:

  • listed
  • exempted
  • reported
  • assessed
  • commercial evaluation authorisation.

Different categories carry different obligations.

These can include:

  • pre-introduction reporting
  • declarations
  • assessment requirements
  • record keeping
  • annual declarations.

Businesses introducing cosmetic ingredients should determine the appropriate category rather than assuming that an ingredient is legal merely because another company appears to sell a similar product.

Importing Finished Cosmetics

A particularly important rule applies to businesses importing finished cosmetics from overseas for commercial purposes.

If an Australian business imports cosmetics containing industrial chemicals for sale, it may need to register with AICIS.

This can apply even where:

  • the product is already manufactured
  • it arrives fully packaged
  • it carries an overseas brand
  • another Australian business already imports the same product
  • only a small quantity is imported
  • the overseas supplier says the product has been approved elsewhere.

There is not simply a small-quantity exemption allowing commercial importers to ignore AICIS registration.

Beauty businesses importing Korean skincare, Japanese cosmetics, professional products or private-label products should pay particular attention to these obligations.

Buying Cosmetics from an Australian Supplier

The position can be different where a salon simply purchases finished cosmetic products from an Australian supplier and resells or uses them.

A business that is only reselling industrial chemicals or cosmetic products that it purchased within Australia generally does not register with AICIS merely for that resale activity.

The Australian importer or manufacturer may instead be the party responsible for the introduction.

This distinction is one reason salons should know whether they are purchasing locally or directly importing products themselves.

Making Your Own Skincare Products

Beauty businesses increasingly manufacture private-label, handmade or salon-branded skincare products.

AICIS obligations depend partly on where ingredients come from and how the product is made.

For example, a business may not need AICIS registration merely because it blends ingredients purchased entirely from Australian suppliers, provided the process does not result in a chemical reaction that creates industrial chemicals.

However, if a business imports ingredients from overseas to manufacture products for commercial sale, AICIS registration and introduction requirements can apply.

Even ingredients marketed as “natural” or “organic” can be regulated industrial chemicals.

Natural Does Not Mean Unregulated

Natural ingredients are not automatically exempt from chemical regulation.

Ingredients such as:

  • essential oils
  • botanical extracts
  • plant oils
  • fragrances
  • naturally derived compounds

can still fall within Australia’s industrial chemical framework.

Whether a substance satisfies the specific legal definition of a naturally occurring chemical is a regulatory question.

A marketing description such as “100% natural” does not itself establish that an ingredient is exempt from AICIS requirements.

Organic Does Not Mean Government Approved

The term organic can also create confusion.

A cosmetic being described as organic does not mean that the Australian Government has approved the finished cosmetic product as safe or effective.

Businesses making organic claims must ensure that those claims are accurate and not misleading.

Third-party organic certification may be useful for businesses wanting independent verification, but the existence or absence of voluntary organic certification should not be confused with compliance with Australian chemical, consumer or therapeutic-goods legislation.

“Chemical-Free” Cosmetics

Claims that cosmetics are “chemical free” should generally be avoided.

Water is a chemical substance. Plant extracts contain chemicals. Essential oils contain chemical constituents.

The relevant safety question is not whether a cosmetic contains “chemicals,” but whether its ingredients are appropriately used and comply with the regulatory requirements applying to them.

Marketing that presents “natural” as automatically safe and “chemical” as automatically dangerous can be scientifically misleading.

Preservatives

Preservatives are important in many cosmetic formulations because they can help prevent microbial contamination and product deterioration.

Some preservative chemicals can be subject to restrictions or concentration limits.

However, it is misleading to make broad statements such as:

“Parabens are banned in Australia.”

The regulatory position depends on the particular chemical and applicable conditions.

Businesses should check individual ingredients rather than relying on social-media lists of supposedly “toxic” or “banned” cosmetic ingredients.

Fragrances and Flavour Ingredients

Fragrance and flavour formulations can contain multiple chemical ingredients.

These chemicals can also fall within AICIS requirements.

Special regulatory pathways can apply in certain circumstances where the chemical identity of fragrance or flavour ingredients is commercially confidential.

Businesses importing or manufacturing fragrance-containing products should not assume that “fragrance” being listed as one ingredient on a finished product removes their regulatory obligations concerning the chemicals being introduced.

Colourants

Colourants used in cosmetic products can also be industrial chemicals.

Their regulatory status should be assessed under the applicable Australian requirements rather than by assuming that approval in Europe, the United States or another overseas market automatically authorises unrestricted use in Australia.

Overseas regulatory status can be useful information, but Australian requirements still need to be considered.

The Poisons Standard

The Poisons Standard is particularly important when checking ingredients.

A chemical’s scheduling can affect matters such as:

  • permitted concentration
  • product classification
  • availability
  • packaging
  • labelling
  • supply.

Businesses should search using the actual chemical name rather than relying solely on trade names.

State and territory legislation gives effect to scheduling decisions and can create additional requirements.

Sunscreens

Sunscreen regulation demonstrates why businesses should not assume every topical product is an ordinary cosmetic.

Many primary sunscreens are regulated as therapeutic goods by the TGA.

Some products containing sunscreen ingredients can instead qualify as secondary sunscreens and may be regulated differently where applicable criteria are satisfied.

Businesses manufacturing, importing or private-labelling sunscreen products should therefore establish the product’s actual regulatory classification before supply.

Skin-Whitening and Pigmentation Products

Products promoted for skin whitening or pigmentation require particular attention.

Some products can fall within the therapeutic-goods framework because of their ingredients or because they act on physiological processes such as melanin production.

The fact that a product is applied topically does not automatically make it a cosmetic.

Businesses should check both the formulation and the claims being made.

Anti-Acne Products

Anti-acne products provide another useful example.

Whether a product is a cosmetic or therapeutic good can depend on:

  • ingredients
  • formulation
  • intended use
  • claims
  • how it is marketed.

A cosmetic intended to cleanse oily or blemish-prone skin is not necessarily regulated in the same way as a product represented as treating acne as a medical condition.

Salon owners should be particularly careful when rewriting manufacturers’ product descriptions for their own websites.

Changing cosmetic language into therapeutic claims can potentially change the regulatory implications of the advertising.

Antibacterial Products

Products making antibacterial or antimicrobial claims can also fall under different regulatory frameworks depending on their composition and claims.

A cosmetic cleansing claim should not automatically be expanded into claims that a product kills pathogens, prevents infection or treats disease.

Where stronger therapeutic claims are made, TGA requirements may apply.

Cosmetic Injectables Are Not Ordinary Cosmetics

Cosmetic injectables should not be treated as cosmetics simply because their purpose is aesthetic.

Products such as botulinum toxin products and certain dermal fillers fall within the therapeutic-goods framework.

Prescription medicines are also subject to significant restrictions concerning prescribing, supply, administration and advertising.

Beauty businesses should therefore keep cosmetic injectable compliance separate from ordinary cosmetic ingredient compliance.

Tattoo and Permanent Makeup Pigments

Pigments and chemicals used in tattoo and permanent makeup inks can fall within the industrial chemicals framework.

Businesses offering cosmetic tattooing or permanent makeup should therefore not assume that pigments are unregulated merely because they are not ordinary skincare products.

Additional state and territory public-health and skin-penetration requirements can also apply to these services.

Cosmetic Labelling

AICIS does not administer Australia’s cosmetic labelling requirements.

Ingredient labelling for cosmetics supplied to consumers is subject to Australia’s mandatory information standard for cosmetics ingredients, administered within the consumer product framework.

Businesses should therefore distinguish between:

  • chemical introduction requirements
  • ingredient labelling requirements
  • therapeutic-goods requirements
  • general consumer law.

Meeting one does not automatically satisfy the others.

Ingredient Names

Businesses should not rely on the assumption that every Australian regulatory requirement can be satisfied simply by using an INCI ingredient name.

International Nomenclature of Cosmetic Ingredients terminology is widely used throughout the cosmetics industry, but businesses still need to ensure their labels comply with the actual Australian mandatory information standard.

Regulatory chemical identification for AICIS purposes can also require more precise chemical information than appears on a consumer-facing ingredient list.

Safety Data Sheets

Safety Data Sheets, commonly called SDSs, are another area that can cause confusion.

An SDS is an important workplace chemical safety document where one is required.

It is not proof that a cosmetic product has been approved by AICIS, TGA or another regulator.

Businesses handling hazardous workplace chemicals should separately consider their work health and safety obligations.

Product Safety and Australian Consumer Law

Cosmetics are also consumer products.

Australian Consumer Law imposes obligations relating to product safety, misleading representations and consumer guarantees.

Businesses should therefore ensure that claims such as:

  • hypoallergenic
  • dermatologist tested
  • clinically proven
  • non-toxic
  • organic
  • natural
  • vegan
  • cruelty free
  • chemical free
  • pregnancy safe

are accurate and can be appropriately substantiated where necessary.

Regulatory compliance does not give businesses permission to make unsupported marketing claims.

Salon-Compliance-Documents-Australia-ABA

Animal Testing and Cosmetic Ingredients

Australia introduced restrictions concerning the use of new animal test data for industrial chemicals used solely in cosmetics from 1 July 2020.

Restrictions can also apply to new animal test data for chemicals with multiple end uses that include cosmetic use.

These rules form part of the AICIS chemical-introduction framework.

Businesses should avoid simplifying this into the statement:

“Animal testing of cosmetics is completely banned in Australia.”

The actual legal framework concerns the use of certain animal test data for regulatory purposes and contains specific rules and circumstances.

Overseas Products Are Not Automatically Compliant in Australia

A product being legal in:

  • the European Union
  • United Kingdom
  • United States
  • Korea
  • Japan
  • another overseas market

does not automatically establish that it complies with Australian requirements.

Businesses importing cosmetics should conduct Australian regulatory checks rather than relying solely on the manufacturer’s overseas compliance documents.

This is particularly important for private-label products and products purchased through international marketplaces.

Salon Owners Versus Importers and Manufacturers

A salon that purchases professional skincare products from an Australian distributor is in a very different regulatory position from a business that imports those products directly.

Before deciding what compliance obligations apply, determine whether your business is acting as:

  • an end user
  • retailer
  • Australian importer
  • manufacturer
  • private-label brand
  • therapeutic-goods sponsor.

The answer can significantly change your responsibilities.

Before Importing or Manufacturing a Cosmetic

Businesses should consider the following checks:

  1. Is the product genuinely a cosmetic?
  2. Could its ingredients, intended purpose or claims make it a therapeutic good?
  3. Am I importing or manufacturing industrial chemicals for commercial purposes?
  4. Do I need to register my business with AICIS?
  5. What is the introduction category for each relevant chemical?
  6. Is each ingredient on the Australian Inventory of Industrial Chemicals?
  7. If it is on the Inventory, are there conditions or restrictions attached to its introduction?
  8. If it is not on the Inventory, what introduction category applies?
  9. Does the Poisons Standard impose restrictions?
  10. Does the product comply with Australian cosmetic ingredient-labelling requirements?
  11. Are all marketing claims accurate and appropriate for a cosmetic?
  12. Are there additional consumer product safety requirements?
  13. Are appropriate records being maintained?

Record-Keeping Requirements

Businesses introducing industrial chemicals have record-keeping obligations under AICIS.

Depending on the introduction, records may be required to demonstrate matters such as:

  • chemical identity
  • introduction category
  • quantities
  • use
  • compliance with applicable conditions.

AICIS requires certain introduction records to be retained for five years.

Businesses should therefore obtain adequate ingredient and regulatory information from overseas suppliers before importing products.

A supplier refusing to disclose sufficient information can create significant compliance difficulties for the Australian importer.

Annual Declarations

Registered introducers generally have annual declaration obligations.

An annual declaration confirms information relating to industrial chemicals introduced during the previous registration year.

This is separate from registration itself and from other declarations or reports that may apply to particular introduction categories.

Businesses should maintain a compliance calendar so these obligations are not overlooked.

Common Cosmetic Ingredient Compliance Mistakes

“The ingredient isn’t on the Inventory, so it’s banned.”

Not necessarily. Another introduction category may apply.

“It’s natural, so AICIS doesn’t regulate it.”

Not necessarily. Many ingredients described as natural or organic are regulated industrial chemicals.

“The finished product is manufactured overseas, so the manufacturer is responsible.”

If your Australian business commercially imports the product, you can have Australian regulatory obligations.

“The supplier says it is FDA approved.”

Overseas regulatory status does not replace Australian requirements.

“AICIS approved the product.”

AICIS generally regulates industrial chemical introductions rather than approving finished cosmetics.

“All cosmetics need TGA approval.”

Incorrect. Ordinary cosmetics generally fall outside the therapeutic-goods framework.

“It’s skincare, so it cannot be a therapeutic good.”

Incorrect. Ingredients, intended purpose and therapeutic claims can affect classification.

“It’s sold by other Australian businesses, so it must be compliant.”

Never use another retailer’s conduct as evidence of regulatory compliance.

Where Beauty Businesses Should Check

For current information, useful official sources include:

  • Australian Industrial Chemicals Introduction Scheme (AICIS)
  • Australian Inventory of Industrial Chemicals
  • Therapeutic Goods Administration (TGA)
  • Poisons Standard
  • Australian Competition and Consumer Commission (ACCC)
  • Product Safety Australia
  • relevant state and territory authorities.

Businesses importing or manufacturing complex products may also need specialist regulatory or legal advice.

The Key Principle

The question:

“Is this cosmetic ingredient allowed in Australia?”

often does not have a simple yes-or-no answer.

A better series of questions is:

What is the chemical?

How is it being introduced?

What concentration and use are proposed?

What conditions apply to its introduction?

Does the Poisons Standard affect it?

Is the finished product genuinely a cosmetic?

What claims are being made?

This approach provides a much more accurate picture of Australian cosmetic ingredient compliance than relying on generic lists of supposedly “approved” and “banned” ingredients.

Important Disclaimer

This article provides general educational information for Australian beauty businesses and does not constitute legal, chemical safety or regulatory advice.

Requirements can change and depend on individual chemicals, formulations, concentrations, intended uses, claims and business activities.

Businesses importing or manufacturing cosmetics should verify current requirements directly with AICIS, the TGA and other relevant Australian authorities before introducing products or ingredients into Australia.

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